Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Oseltamivir 45 mg Hard Capsules
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Oseltamivir phosphate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Oseltamivir is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza). It can be used when you have flu symptoms, and the flu virus is known to be going round in your community. Oseltamivir can also be prescribed for adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis – for instance, if you have been in contact with someone who has flu. Oseltamivir may be prescribed for adults, adolescents, children and infant (including full-term newborn babies) as preventive treatment in exceptional circumstances – for example, if there is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide sufficient protection.
Oseltamivir belongs to a group of medicines named neuraminidase inhibitors. These medicines prevent the flu virus from spreading inside the body. They help to ease or prevent the symptoms of the flu virus infection. Influenza, usually called flu, is an infection caused by a virus. The signs of flu often include a sudden fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness. These symptoms can also be caused by other infections. True influenza infection only occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community. Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness. 2.
What you need to know before you take it
e Oseltamivir
Do not take Oseltamivir: if you are allergic (hypersensitive) to oseltamivir or any of the other ingredients of this medicine (listed in section 6). Talk to your doctor if this applies to you. Do not take Oseltamivir. Warnings and precautions: 1
Before you take Oseltamivir, make sure the prescribing doctor knows: if you are allergic to other medicines if you have problems with your kidneys. If so, your dose may need adjustment if you have a severe medical condition, which may require immediate hospitalisation if your immune system is not working if you have chronic heart disease or respiratory disease. During treatment with Oseltamivir, tell a doctor immediately: if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents. These may be signs of rare but serious side effects. Oseltamivir is not a flu vaccine Oseltamivir is not a vaccine: it treats infection, or prevents the flu virus spreading. A vaccine gives you antibodies against the virus. Oseltamivir will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor. Other medicines and Oseltamivir Tell your doctor or pharmacist if you are taking any other rmedicines, or have rcently taken any. This includes medicines obtained without a prescription. The following medicines are particularly important: chlorpropamide (used to treat diabetes) methotrexate (used to treat e.g. rheumatoid arthritis) phenylbutazone (used to treat pain and inflammation) probenecid (used to treat gout) Pregnancy and breast-feeding If you are pregnant or think you may be pregnant or are planning to have a baby, you must tell your doctor. Your doctor can decide if Oseltamivir is right for you. The effects on breast-fed infants are unknown. You must tell your doctor if you are breast-feeding so that your doctor can decide if Oseltamivir is right for you. Ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Oseltamivir has no effect on your ability to drive or use machines. Information about some of the ingredients of Oseltamivir This product contains small amounts of ethanol (alcohol), less than 100 mg per dose. Ethanol originates from the ink used on the capsule. This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'. 3.
How to take it
Oseltamivir
Take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Take Oseltamivir as soon as possible, ideally within two days of the flu symptoms starting. The recommended doses
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For treating flu, take two doses daily. It is usually convenient to take one dose in the morning and one in the evening. It is important to complete the whole 5-day course, even if you start to feel better quickly. For adult patients with a weak immune system, treatment will continue for 10 days. For preventing flu or after being exposed to an infected person, take one dose daily for 10 days. It is best to take this in the mornings with breakfast. In special situations, such as widespread flu or for patients with a weak immune system, treatment will continue for up to 6 or 12 weeks. The recommended dose is based on the patient's body weight. You must use the amount of oral capsules prescribed by the doctor. Adults, and adolescents 13 years and over: Body weight Treating flu: dose for 5 days
Treating flu (Immunocompromised Patients): dose for 10 days* More than 40 kg 75 mg** twice daily 75 mg** twice daily *For patients with a weak immune system, treatment is for 10 days ** 75 mg can be made up of a 30 mg capsule plus a 45 mg capsule
Children 1 to 12 years: Body weight
Treating flu: dose for 5 days
Treating flu (Immunocompromised Patients): dose for 10 days* 30 mg twice daily 45 mg twice daily
10 to 15 kg 30 mg twice daily More than 15 kg and up 45 mg twice daily to 23 kg More than 23 kg and up 60 mg twice daily 60 mg twice daily to 40 kg More than 40 kg 75 mg** twice daily 75 mg** twice daily
- For children with a weak immune system, treatment is for 10 days ** 75 mg can be made up of a 30 mg capsule plus a 45 mg capsule
Preventing flu: dose for 10 days
75 mg** once daily
Preventing flu: dose for 10 days
30 mg once daily 45 mg once daily 60 mg once daily 75 mg** once daily
Infants less than 1 year (0 to 12 months) Giving Oseltamivir to infants less than 1 year old for preventing flu during flu pandemic should be based upon the judgment of a doctor after considering the potential benefit versus any potential risk to the infant. Body weight
Treating flu (Immunocompromised Patients): dose for 10 days* 3 mg per kg body weight**, twice daily
Treating flu: dose for 5 days
3 kg to 10+ kg
Preventing flu: dose for 10 days
3 mg per kg body 3 mg per kg**, weight**, once daily twice daily
- For infants with a weak immune system, treatment is for 10 days **mg per kg = mg for each kilogram of the infant's body weight. For example: If a 6-month-old weighs 8 kg, the dose is 8 kg x 3mg per kg = 24 mg 3
Method of administration Swallow the capsules whole with water. Do not break or chew the capsules. Oseltamivir can be taken with or without food, although taking it with food can reduce the chance of feeling or being sick (nausea or vomiting). People who find it hard to take capsules can use a liquid medicine, oseltamivir powder for oral suspension, which may be available and is the preferred product. A pharmacy compounded suspension can not be prepared from the capsules. If you need a liquid medicine, but it's not available, you can make a liquid form of Oseltamivir from these capsules (see Making liquid Oseltamivir at home). If you take more Oseltamivir than you should Stop taking Oseltamivir and contact a doctor or pharmacist immediately. In most cases of overdose, people have not reported any side effects. When side effects were reported, they were similar to those from normal doses, as listed in section 4. Overdose has been reported to have occurred more frequently when Oseltamivir was given to children than to adults and adolescents. Caution should be exercised when preparing liquid Oseltamivir for children and when administering Oseltamivir capsules or liquid Oseltamivir to children. If you forget to take Oseltamivir Do not take a double dose to make up for a forgotten capsule. If you stop taking Oseltamivir There are no side effects when you stop Oseltamivir. But if Oseltamivir is stopped earlier than your doctor told you, the symptoms of flu may come back. Always complete the course that your doctor prescribed. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of the side effects listed below may also be caused by influenza. The following serious side effects have been rarely reported since oseltamivir has been marketed: Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin swelling, itchy rashes, low blood pressure and breathing difficulties Hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of the skin and white of the eyes, change in stool color, changes in behaviour Angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head and neck area, including eyes and tongue, with difficulties breathing Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly lifethreatening allergic reaction, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding of larger areas of skin, possible breathing difficulties and low blood pressure Gastrointestinal bleeding: prolonged bleeding from the large bowel or spitting up blood Neuropsychiatric disorders, as described below. If you notice any of these symptoms, get medical help immediately. The most frequently (very common and common) reported side effects of Oseltamivir are feeling or being sick (nausea, vomiting), stomach ache, stomach upset, headache and pain. These side effects 4
mostly occur after the first dose of the medicine and will usually stop as treatment continues. The frequency of these effects is reduced if the medicinal product is taken with food. Rare but serious effects: get medical help at once (These may affect up to 1 in 1,000 people) During Oseltamivir treatment, rare events have been reported that include Convulsions and delirium, including altered level of consciousness Confusion, abnormal behaviour Delusions, hallucinations, agitation, anxiety, nightmares These are reported primarily among children and adolescents and often started suddenly and resolved rapidly. A few cases resulted in self-injury, some with fatal outcome. Such neuropsychiatric events have also been reported in patients with influenza who were not taking Oseltamivir. Patients, especially children and adolescents, should be closely monitored for the behavioural changes described above. If you notice any of these symptoms, especially in younger people, get medical help immediately. Adults and adolescents 13 and over: Very common side effects (may affect more than 1 in 10 people) Headache Nausea. Common side effects (may affect up to 1 in 10 people) Bronchitis Cold sore virus Cough Dizziness Fever Pain Pain in limb Runny nose Sleeping difficulties Sore throat Stomach ache Tiredness Upper abdominal fullness Upper respiratory tract infections (inflammation of the nose, throat and sinuses) Upset stomach Vomiting. Uncommon side effects (may affect up to 1 in 100 people) Allergic reactions Altered level of consciousness Convulsion Heart rhythm abnormalities Mild to severe liver function disorders Skin reactions (inflammation of the skin, red and itchy rash, scaling skin). Rare side effects (may affect up to 1 in 1,000 people) Thrombocytopenia (low platelet count) Visual disturbances. 5
Children 1 to 12 years: Very common side effects (may affect more than 1 in 10 people) Cough Nasal congestion Vomiting. Common side effects (may affect up to 1 in 10 people) Conjunctivitis (red eyes and discharge or pain in the eye) Ear inflammation and other ear disorders Headache Nausea Runny nose Stomach ache Upper abdominal fullness Upset stomach. Uncommon side effects (may affect up to 1 in 100 people) Inflammation of the skin Tympanic membrane (eardrum) disorder. Infants less than 1 year: The reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported for older children (1 year old or older). Additionally, diarrhoea and diaper rash have been reported. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. However, if you or your child are repeatedly sick, or if the influenza symptoms get worse or the fever continues Tell your doctor as soon as possible. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Oseltamivir
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Store below 30 °C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
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6.
Contents of the pack and other information
What Oseltamivir contains Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir. The other ingridients are:
- Capsule content: pregelatinized starch, povidone, croscarmellose sodium, talc and sodium stearyl fumarate
- Capsule shell: gelatin, black iron oxide (E172) and titanium dioxide (E171)
- Printing ink: shellac (E904), ethanol anhydrous (E1510), black iron oxide (E172), propanol, butanol, propylene glycol (E1520), ammonia solution (E527) and potassium hydroxide (E525). What Oseltamivir looks like and contents of the pack The 45 mg hard capsule consists of a grey opaque body with a black colour band, imprinted with "M" and a grey opaque cap imprinted with "45 mg". Imprints are black. Oseltamivir 45 mg hard capsules are available in blister packs of 10. Marketing Authorisation Holder Mercury Pharmaceuticals Limited Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom Manufacturer Pharmadox Healthcare Ltd, KW20A Kordin Industrial Park, Paola, PLA3000, Malta This leaflet was last revised in December 2023 ————————————————————————————————————————–INFORMATION FOR THE USER For people who find it hard to take capsules, including very young children, a liquid medicine, oseltamivir powder for oral suspension, may be available. If you need a liquid medicine, but it's not available, you can make liquid Oseltamivir from these capsules at home. The dose is the same for treating or preventing flu. The difference is how often it is given. Making liquid Oseltamivir at home If you have the right capsule for the dose needed (a 45 mg), you will open the capsule and stir its contents into one teaspoon (or less) of a suitable sweetened food product. This is usually suitable for children over 1 year. See the upper set of instructions.
If you need smaller doses, making liquid Oseltamivir from capsules involves extra steps. This is suitable for younger children and babies: they usually need a Oseltamivir dose of less than 45 mg. See the lower set of instructions.
Children 1 to 12 years To make a 45 mg dose, you need: 7
One 45 mg Oseltamivir capsule Sharp scissors One small bowl Teaspoon (5 ml spoon) Water Sweet food to hide the bitter taste of the powder. Examples are chocolate or cherry syrup, and dessert toppings such as caramel or fudge sauce. Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar. Step 1: Check the dose is correct To find the correct amount to use, find the patient's weight on the left of the table. Look at the right column to check the number of capsules you will need to give the patient for a single dose. The amount is the same whether treating or preventing flu. You should use only 45 mg capsules for 45 mg doses. Do not try to make a 30 mg, 60 mg or 75 mg dose by using the contents of 45 mg capsules. Use the appropriate size capsule instead. Speak to your doctor or pharmacist if you are not sure. Weight Up to 15 kg More than 15 kg up to 23 kg More than 23 kg up to 40 kg
Dose of Oseltamivir 30 mg 45 mg 60 mg
Number of capsules Do not use 45 mg capsules 1 capsule Do not use 45 mg capsules
45 mg dose
Step 2: Pour all the powder into a bowl
- Hold a 45 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors. Pour all of the powder into the bowl.
- Be careful with the powder, because it may irritate your skin and eyes.
Step 3: Sweeten the powder and give the dose
- Add a small amount – no more than 1 teaspoonful – of sweet food to the powder in the bowl. This is to hide the bitter taste of the Oseltamivir powder.
- Stir the mixture well.
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Give the whole contents of the bowl to the patient straight away. If there is some mixture left in the bowl, rinse the bowl with a small amount of water and get the patient to drink it all. Repeat this procedure every time you need to give the medicine. Infants less than 1 year To make a smaller single dose, you need: One 45 mg Oseltamivir capsule Sharp scissors Two small bowls (use separate pairs of bowls for each child) One large oral dose dispenser to measure out water – a 5 or 10 ml dispenser One small oral dose dispenser showing measurements of 0.1 ml, to give the dose Teaspoon (5 ml spoon) Water Sweet food to hide the bitter taste of the Oseltamivir. Examples are: chocolate or cherry syrup and dessert toppings such as caramel or fudge sauce. Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar. Step 1: Pour all the powder into a bowl –
Hold a 45 mg capsule upright over one of the bowls and carefully snip off the rounded tip with scissors. Be careful with the powder: it may irritate your skin and eyes. Pour all of the powder into the bowl, whatever the dose you are making. The amount is the same whether you are treating or preventing flu.
Step 2: Add water to dilute the medicine
- Use the larger dispenser to draw up 7.5 ml of water.
- Add the water to the bowl
- Stir the mixture with the teaspoon for about 2 minutes.
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Don't worry if not all of the powder dissolves. The undissolved powder is just inactive ingredients. Step 3: Choose the correct amount for your child's weight –
Look up the child's weight on the left side of the table. The column on the right of the table shows how much of the liquid mixture you will need to draw up.
Infants less than 1 year (including full-term new-born babies) Child's weight (nearest) 3 kg 3.5 kg 4 kg 4.5 kg 5 kg 5.5 kg 6 kg 6.5 kg 7 kg 7.5 kg 8 kg 8.5 kg 9 kg 9.5 kg 10 kg or more
How much mixture to draw up 1.5 ml 1.8 ml 2.0 ml 2.3 ml 2.5 ml 2.8 ml 3.0 ml 3.3 ml 3.5 ml 3.8 ml 4.0 ml 4.3 ml 4.5 ml 4.8 ml 5.0 ml
Step 4: Draw up the liquid mixture –
Make sure you have the right size dispenser. Draw up the correct amount of liquid mixture from the first bowl. Draw it up carefully so as not to include air bubbles. Gently squirt the correct dose into the second bowl.
Step 5: Sweeten the powder and give the dose
- Add a small amount – no more than 1 teaspoonful – of sweet food to second bowl. This is to hide the bitter taste of the Oseltamivir powder.
- Mix the sweet food and the Oseltamivir liquid well.
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Give the whole content of the second bowl (Oseltamivir liquid mixture with sweet food added) to the child straight away. If there is anything left in the second bowl, rinse the bowl with a small amount of water and get the child to drink it all. For children unable to drink from a bowl, spoon-feed or use a bottle to feed the child the remaining liquid. Give the child something to drink. Throw away any unused liquid left in the first bowl. Repeat this procedure every time you need to give the medicine.
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Frequently asked questions about Oseltamivir 45 mg Hard Capsules
How do I take Oseltamivir 45 mg Hard Capsules?
Oseltamivir 45 mg Hard Capsules comes as capsule containing 45mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Oseltamivir 45 mg Hard Capsules?
The active substance in Oseltamivir 45 mg Hard Capsules is oseltamivir phosphate.
Are there equivalent medicines to Oseltamivir 45 mg Hard Capsules?
Medicines with the same active substance, strength and form include: Tamiflu 45 mg Hard Capsules. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Oseltamivir 45 mg Hard Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Oseltamivir 45 mg Hard Capsules without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: oseltamivir phosphate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of influenza
Oseltamivir is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.
Prevention of influenza
- Post-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community.
- The appropriate use of Oseltamivir for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older.
- Oseltamivir is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2).
Oseltamivir is not a substitute for influenza vaccination.
The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations (see section 5.1).
4.2. Posology and method of administration
Posology
Oseltamivir 75 mg doses can be administered as either:
- one 75 mg capsule or
- one 30 mg capsule plus one 45 mg capsule
Commercially manufactured Oseltamivir powder for oral suspension (6 mg/ml) may be available and is the preferred product for paediatric and adult patients who have difficulties swallowing capsules or where lower doses are needed.
Adults, and adolescents 13 years and over
Treatment:
The recommended oral dose is 75 mg oseltamivir twice daily for 5 days for adolescents (13 to 17 years of age) and adults.
Body Weight
Recommended dose for 5 days
Recommended dose for 10 days*
Immunocompromised Patients
> 40 kg
75 mg twice daily
75 mg twice daily
* The recommended treatment duration in immunocompromised adults and adolescents is 10 days. See Special Populations, Immunocompromised Patients for more information.
Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.
Post-exposure prevention:
The recommended dose for prevention of influenza following close contact with an infected individual is 75 mg oseltamivir once daily for 10 days for adolescents (13 to 17 years of age) and adults.
Body Weight
Recommended dose for 10 days
Recommended dose for 10 days
Immunocompromised Patients
> 40 kg
75 mg once daily
75 mg once daily
Therapy should begin as soon as possible within two days of exposure to an infected individual.
Prevention during an influenza epidemic in the community:
The recommended dose for prevention of influenza during a community outbreak is 75 mg oseltamivir once daily for up to 6 weeks (or up to 12 weeks in immunocompromised patients, see sections 4.4, 4.8 and 5.1).
Paediatric population
Children 1 to 12 years of age
Oseltamivir 30 mg, 45 mg and 75 mg capsules and oral suspension are available for infants and children 1 year of age and older.
Treatment:
The following weight-adjusted dosing regimens are recommended for treatment of infants and children 1 year of age or older:
Body Weight
Recommended dose for 5 days
Recommended dose for 10 days*
Immunocompromised Patients
10 kg to 15 kg
30 mg twice daily
30 mg twice daily
> 15 kg to 23 kg
45 mg twice daily
45 mg twice daily
> 23 kg to 40 kg
60 mg twice daily
60 mg twice daily
> 40 kg
75 mg twice daily
75 mg twice daily
*The recommended treatment duration in immunocompromised children (≥1 year old) is 10 days. See Special Populations, Immunocompromised Patients for more information.
Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.
Post-exposure prevention:
The recommended post-exposure prevention dose of oseltamivir is:
Body Weight
Recommended dose for 10 days
Recommended dose for 10 days
For Immunocompromised Patients
10 kg to 15 kg
30 mg once daily
30 mg once daily
> 15 kg to 23 kg
45 mg once daily
45 mg once daily
> 23 kg to 40 kg
60 mg once daily
60 mg once daily
> 40 kg
75 mg once daily
75 mg once daily
Prevention during an influenza epidemic in the community:
Prevention during an influenza epidemic has not been studied in children below 12 years of age.
Infants 0 – 12 months of age
Treatment:
The recommended treatment dose for infants 0 - 12 months of age is 3 mg/kg twice daily.
This is based upon pharmacokinetic and safety data indicating that this dose in infants 0 - 12 months provides plasma concentrations of the pro-drug and active metabolite that are anticipated to be clinically efficacious with a safety profile comparable to that seen in older children and adults (see section 5.2). The following dosing regimen is recommended for treatment of infants 0 - 12 months of age:
Body Weight*
Recommended dose for 5 days
Recommended dose for 10 days**
Immunocompromised Patients
3 kg
9 mg twice daily
9 mg twice daily
4 kg
12 mg twice daily
12 mg twice daily
5 kg
15 mg twice daily
15 mg twice daily
6 kg
18 mg twice daily
18 mg twice daily
7 kg
21 mg twice daily
21 mg twice daily
8 kg
24 mg twice daily
24 mg twice daily
9 kg
27 mg twice daily
27 mg twice daily
10 kg
30 mg twice daily
30 mg twice daily
* This table is not intended to contain all possible weights for this population. For all patients under the age of 1 year, 3 mg/kg should be used to determine dose regardless of the weight of the patient.
Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.
** The recommended duration in immunocompromised infants (0-12 months old) is 10 days. See Special Populations, Immunocompromised Patients for more information
This dosing recommendation is not intended for premature infants, i.e. those with a post-conceptual age less than 36 weeks. Insufficient data are available for these patients, in whom different dosing may be required due to the immaturity of physiological functions.
Post-exposure prevention: The recommended prophylaxis dose for infants less than 1 year of age during a pandemic influenza outbreak is half of the daily treatment dose. This is based upon clinical data in infants and children 1 year of age or older and adults showing that a prophylaxis dose equivalent to half the daily treatment dose is clinically efficacious for the prevention of influenza. The following age-adjusted dosing prophylaxis regimen is recommended for infants 0 - 12 months of age (see section 5.2 for exposure simulation):
Age
Recommended dose for 10 days
Recommended dose for 10 days
Immunocompromised Patients
0 – 12 months
3 mg/kg once daily
3 mg/kg once daily
This dosing recommendation is not intended for premature infants, i.e. those with a post-conceptual age less than 36 weeks. Insufficient data are available for these patients, in whom different dosing may be required due to the immaturity of physiological functions.
Prevention during an influenza epidemic in the community:
Prevention during an influenza epidemic has not been studied in children 0-12 months of age.
For instructions on preparing the extemporaneous formulation, see section 6.6.
Special populations
Hepatic impairment
No dose adjustment is required either for treatment or for prevention in patients with hepatic dysfunction. No studies have been carried out in paediatric patients with hepatic disorder.
Renal impairment
Treatment of influenza:
Dose adjustment is recommended for adults and adolescents (13 to 17 years of age) with moderate or severe renal impairment. Recommended doses are detailed in the table below.
Creatine clearance
Recommended dose for treatment
> 60 (ml/min)
75 mg twice daily
> 30 to 60 (ml/min)
30 mg twice daily
> 10 to 30 (ml/min)
30 mg once daily
≤ 10 (ml/min)
Not recommended (no data available)
Haemodialysis patients
30 mg after each haemodialysis session
Peritoneal dialysis patients*
30 mg single dose
* Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients; the clearance of oseltamivir carboxylate is expected to be higher when automated peritoneal dialysis (APD) mode is used.
Treatment mode can be switched from APD to CAPD if considered necessary by a nephrologist.
Prevention of influenza:
Dose adjustment is recommended for adults and adolescents (13 to 17 years of age) with moderate or severe renal impairment as detailed in the table below.
Creatine clearance
Recommended dose for prevention
> 60 (ml/min)
75 mg once daily
> 30 to 60 (ml/min)
30 mg once daily
> 10 to 30 (ml/min)
30 mg every second day
≤ 10 (ml/min)
Not recommended (no data available)
Haemodialysis patients
30 mg after every second haemodialysis session
Peritoneal dialysis patients*
30 mg once weekly
* Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients; the clearance of oseltamivir carboxylate is expected to be higher when automated peritoneal dialysis (APD) mode is used.
Treatment mode can be switched from APD to CAPD if considered necessary by a nephrologist.
There is insufficient clinical data available in infants and children (12 years of age and younger) with renal impairment to be able to make any dosing recommendation.
Elderly
No dose adjustment is required, unless there is evidence of moderate or severe renal impairment.
Immunocompromised patients
Treatment: For treatment of influenza, the recommended duration for immunocompromised patients is 10 days (see sections 4.4, 4.8 and 5.1). No dose adjustment is necessary Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza
Seasonal prophylaxis: Longer duration of seasonal prophylaxis up to 12 weeks has been evaluated in immunocompromised patients (see sections 4.4, 4.8 and 5.1).
Method of administration
Oral use.
Patients who are unable to swallow capsules may receive appropriate doses of commercially manufactured Oseltamivir powder for oral suspension.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Oseltamivir is effective only against illness caused by influenza viruses. There is no evidence for efficacy of oseltamivir in any illness caused by agents other than influenza viruses (see section 5.1).
Oseltamivir is not a substitute for influenza vaccination.
Use of oseltamivir must not affect the evaluation of individuals for annual influenza vaccination. The protection against influenza lasts only as long as oseltamivir is administered. Oseltamivir should be used for the treatment and prevention of influenza only when reliable epidemiological data indicate that influenza virus is circulating in the community. Susceptibility of circulating influenza virus strains to oseltamivir has been shown to be highly variable (see section 5.1). Therefore, prescribers should take into account the most recent information available on oseltamivir susceptibility patterns of the currently circulating viruses when deciding whether to use oseltamivir.
Severe concomitant condition
No information is available regarding the safety and efficacy of oseltamivir in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalisation.
Immunocompromised patients
The efficacy of oseltamivir in either treatment or prophylaxis of influenza in immunocompromised patients has not been firmly established (see section 5.1).
Cardiac / respiratory disease
Efficacy of oseltamivir in the treatment of subjects with chronic cardiac disease and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population (see section 5.1).
Paediatric population
No data allowing a dose recommendation for premature children (< 36 weeks post-conceptual age) are currently available.
Severe renal impairment
Dose adjustment is recommended for both treatment and prevention in adolescents (13 to 17 years of age) and adults with severe renal impairment. There is insufficient clinical data available in infants and children (1 year of age or older) with renal impairment to be able to make any dosing recommendation (see sections 4.2 and 5.2).
Neuropsychiatric events
Neuropsychiatric events have been reported during administration of Oseltamivir in patients with influenza, especially in children and adolescents. These events are also experienced by patients with influenza without oseltamivir administration. Patients should be closely monitored for behavioural changes, and the benefits and risks of continuing treatment should be carefully evaluated for each patient (see section 4.8).
Oseltamivir hard capsules contain alcohol
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.
4.5. Interaction with other medicinal products and other forms of interaction
Pharmacokinetic properties of oseltamivir, such as low protein binding and metabolism independent of the CYP450 and glucuronidase systems (see section 5.2), suggest that clinically significant drug interactions via these mechanisms are unlikely.
Probenecid
No dose adjustment is required when co-administering with probenecid in patients with normal renal function. Co-administration of probenecid, a potent inhibitor of the anionic pathway of renal tubular secretion, results in an approximate 2-fold increase in exposure to the active metabolite of oseltamivir.
Amoxicillin
Oseltamivir has no kinetic interaction with amoxicillin, which is eliminated via the same pathway, suggesting that oseltamivir interaction with this pathway is weak.
Renal elimination
Clinically important drug interactions involving competition for renal tubular secretion are unlikely, due to the known safety margin for most of these substances, the elimination characteristics of the active metabolite (glomerular filtration and anionic tubular secretion) and the excretion capacity of these pathways. However, care should be taken when prescribing oseltamivir in subjects when taking co-excreted agents with a narrow therapeutic margin (e.g. chlorpropamide, methotrexate, phenylbutazone).
Additional information
No pharmacokinetic interactions between oseltamivir or its major metabolite have been observed when co-administering oseltamivir with paracetamol, acetylsalicylic acid, cimetidine, antacids (magnesium and aluminium hydroxides and calcium carbonates), rimantadine or warfarin (in subjects stable on warfarin and without influenza).
4.6. Fertility, pregnancy and lactation
Pregnancy
Influenza is associated with adverse pregnancy and foetal outcomes, with a risk of major congenital malformations, including congenital heart defects. A large amount of data on oseltamivir exposure of pregnant women from post-marketing reports and observational studies (more than 1000 exposed outcomes during the first trimester) indicate no malformative nor feto/neonatal toxicity by oseltamivir.
However, in one observational study, while the overall malformation risk was not increased, the results for major congenital heart defects diagnosed within 12 months of birth were not conclusive. In this study, the rate of major congenital heart defects following oseltamivir exposure during the first trimester was 1.76% (7 infants out of 397 pregnancies) compared to 1.01% in unexposed pregnancies from the general population (Odds Ratio 1.75, 95% Confidence Interval 0.51 to 5.98). The clinical significance of this finding is not clear, as the study had limited power. Additionally, this study was too small to reliably assess individual types of major malformations; moreover, women exposed to oseltamivir and women unexposed could not be made fully comparable, in particular whether or not they had influenza.
Animal studies do not indicate reproductive toxicity (see section 5.3).
The use of Oseltamivir may be considered during pregnancy if necessary and after considering the available safety and benefit information (for data on benefit in pregnant women please refer to section 5.1 “treatment of influenza in pregnant women”), and the pathogenicity of the circulating influenza virus strain.
Breast-feeding
In lactating rats, oseltamivir and the active metabolite are excreted in milk. Very limited information is available on children breast-fed by mothers taking oseltamivir and on excretion of oseltamivir in breast milk. Limited data demonstrated that oseltamivir and the active metabolite were detected in breast milk, however the levels were low, which would result in a subtherapeutic dose to the infant. Considering this information, the pathogenicity of the circulating influenza virus strain and the underlying condition of the breastfeeding woman, administration of oseltamivir may be considered, where there are clear potential benefits to breastfeeding mothers.
Fertility
Based on preclinical data, there is no evidence that Oseltamivir has an effect on male or female fertility (see section 5.3).
4.7. Effects on ability to drive and use machines
Oseltamivir has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The overall safety profile of Oseltamivir is based on data from 6049 adult/adolescent and 1473 paediatric patients treated with Oseltamivir or placebo for influenza, and on data from 3990 adult/adolescent and 253 paediatric patients receiving Oseltamivir or placebo/no treatment for the prophylaxis of influenza in clinical trials. In addition, 245immunocompromised patients (including 7 adolescents and 39 children) received Oseltamivir for the treatment of influenza and 475 immunocompromised patients (including 18 children, of these 10 Oseltamivir and 8 placebo) received Oseltamivir or placebo for the prophylaxis of influenza.
In adults/adolescents, the most commonly reported adverse reactions (ARs) were nausea and vomiting in the treatment studies, and nausea in the prevention studies. The majority of these ARs were reported on a single occasion on either the first or second treatment day and resolved spontaneously within 1-2 days. In children, the most commonly reported adverse reaction was vomiting. In the majority of patients, these ARs did not lead to discontinuation of Oseltamivir.
The following serious adverse reactions have been rarely reported since oseltamivir has been marketed: Anaphylactic and anaphylactoid reactions, hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice), angioneurotic oedema, Stevens-Johnson syndrome and toxic epidermal necrolysis, gastrointestinal bleeding and neuropsychiatric disorders.
(Regarding neuropsychiatric disorders, see section 4.4.)
Tabulated list of adverse reactions
The ARs listed in the tables below fall into the following categories:
Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare (< 1/10,000). ARs are added to the appropriate category in the tables according to the pooled analysis from clinical studies.
Treatment and prevention of influenza in adults and adolescents:
In adult/adolescent treatment and prevention studies, ARs that occurred the most frequently at the recommended dose (75 mg bid for 5 days for treatment and 75 mg od for up to 6 weeks for prophylaxis) are shown in Table 1.
The safety profile reported in subjects who received the recommended dose of Oseltamivir for prophylaxis (75 mg once daily for up to 6 weeks) was qualitatively similar to that seen in the treatment studies, despite a longer duration of dosing in the prophylaxis studies.
Table 1 Adverse reactions in studies investigating Oseltamivir for treatment and prevention of influenza in adults and adolescents or through post-marketing surveillance
System Organ Class (SOC)
Adverse reactions according to frequency
Very common
Common
Uncommon
Rare
Infections and infestation
Bronchitis, Herpes simplex, Nasopharyngitis, Upper respiratory tract infections, Sinusitis
Blood and lymphatic system disorders
Thrombocytopenia
Immune system disorders
Hypersensitivity reaction
Anaphylactic reactions, Anaphylactoid reactions
Psychiatric disorders
Agitation, Abnormal behaviour, Anxiety, Confusion, Delusions, Delirium, Hallucination, Nightmares, Self-injury
Nervous system disorders
Headache
Insomnia
Altered level of consciousness, Convulsion
Eye disorders
Visual disturbance
Cardiac disorders
Cardiac arrhythmia
Respiratory, thoracic and mediastinal disorders
Cough, Sore throat, Rhinorrhea
Gastrointestinal disorders
Nausea
Vomiting Abdominal pain (incl. upper abdominal pain), Dyspepsia
Gastrointestinal bleedings, Haemorrhagic Colitis
Hepatobiliary disorders
Elevated liver enzymes
Fulminant hepatitis, Hepatic failure, Hepatitis
Skin and subcutaneous tissue disorders
Eczema, Dermatitis, Rash, Urticaria
Angioneurotic oedema, Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis
General disorders and administration site conditions
Pain Dizziness (incl. vertigo), Fatigue, Pyrexia, Pain in limb
Treatment and prevention of influenza in children:
A total of 1473 children (including otherwise healthy children aged 1-12 years old and asthmatic children aged 6-12 years old) participated in clinical studies of oseltamivir given for the treatment of influenza. Of those, 851 children received treatment with oseltamivir suspension. A total of 158 children received the recommended dose of Oseltamivir once daily in a post-exposure prophylaxis study in households (n = 99), a 6-week paediatric seasonal prophylaxis study (n = 49) and a 12-week paediatric seasonal prophylaxis study in immunocompromised subjects (n = 10).
Table 2 shows the most frequently reported ARs from paediatric clinical trials.
Table 2 Adverse reactions in studies investigating Oseltamivir for treatment and prevention of influenza in children (age/weight-based dosing [30 mg to 75 mg o.d.])
System Organ Class (SOC)
Adverse reactions according to frequency
Very common
Common
Uncommon
Rare
Infections and infestation
Otitis media
Nervous system disorders
Headache
Eye disorders
Conjunctivitis (including red eyes, eye discharge and eye pain)
Ear and labyrinth disorders
Earache
Tympanic membrane disorder
Respiratory, thoracic and mediastinal disorders
Cough, Nasal congestion
Rhinorrhoea
Gastrointestinal disorders
Vomiting
Abdominal pain (incl. upper abdominal pain), Dyspepsia, Nausea
Skin and subcutaneous tissue disorders
Dermatitis (including allergic and atopic dermatitis)
Description of selected adverse reactions
Psychiatric disorders and nervous system disorders
Influenza can be associated with a variety of neurologic and behavioural symptoms which can include events such as hallucinations, delirium, and abnormal behaviour, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.
In patients with influenza who were receiving Oseltamivir, there have been post-marketing reports of convulsions and delirium (including symptoms such as altered level of consciousness, confusion, abnormal behaviour, delusions, hallucinations, agitation, anxiety, nightmares), in a very few cases resulting in self-injury or fatal outcomes. These events were reported primarily among paediatric and adolescent patients and often had an abrupt onset and rapid resolution. The contribution of Oseltamivir to those events is unknown. Such neuropsychiatric events have also been reported in patients with influenza who were not taking Oseltamivir.
Hepato-biliary disorders
Hepato-biliary system disorders, including hepatitis and elevated liver enzymes in patients with influenza-like illness. These cases include fatal fulminant hepatitis/hepatic failure.
Other special populations
Paediatric population (infants less than one year of age)
In two studies to characterise the pharmacokinetics, pharmacodynamics and safety profile of oseltamivir therapy in 135 influenza infected children less than one year of age, the safety profile was similar among age cohorts with vomiting, diarrhoea and diaper rash being the most frequently reported adverse events (see section 5.2). Insufficient data are available for infants who have a post-conceptual age of less than 36 weeks.
Safety information available on oseltamivir administered for treatment of influenza in infants less than one year of age from prospective and retrospective observational studies (comprising together more than 2,400 infants of that age class), epidemiological databases research and post-marketing reports suggest that the safety profile in infants less than one year of age is similar to the established safety profile of children aged one year and older.
Older people and patients with chronic cardiac and/or respiratory disease
The population included in the influenza treatment studies is comprised of otherwise healthy adults/adolescents and patients “at risk” (patients at higher risk of developing complications associated with influenza, e.g. older people and patients with chronic cardiac or respiratory disease). In general, the safety profile in the patients “at risk” was qualitatively similar to that in otherwise healthy adults/adolescents.
Immunocompromised patients
The treatment of influenza in immunocompromised patients were evaluated in two studies receiving standard dose or high dose regimens (double dose or triple dose) of Oseltamivir (see section 5.1). The safety profile of Oseltamivir observed in these studies was consistent with that observed in previous clinical trials where Oseltamivir was administered for treatment of influenza in non-immunocompromised patients across all age groups (otherwise healthy patients or “at risk” patients [i.e.,those with respiratory and/or cardiac co-morbidities]). The most frequent adverse reaction reported in immunocompromised children was vomiting (28%).
In a 12-week prophylaxis study in 475 immunocompromised patients, including 18 children 1 to 12 years of age and older, the safety profile in the 238 patients who received oseltamivir was consistent with that previously observed in Oseltamivir prophylaxis clinical studies.
Children with pre-existing bronchial asthma
In general, the adverse reaction profile in children with pre-existing bronchial asthma was qualitatively similar to that of otherwise healthy children.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Reports of overdoses with Oseltamivir have been received from clinical trials and during post-marketing experience. In the majority of cases reporting overdose, no adverse events were reported.
Adverse events reported following overdose were similar in nature and distribution to those observed with therapeutic doses of Oseltamivir, described in section 4.8 Undesirable effects.
No specific antidote is known.
Paediatric population
Overdose has been reported more frequently for children than adults and adolescents. Caution should be exercised when administering Oseltamivir products to children.
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