Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Aciclovir suspension contains the active substance aciclovir. This belongs to a group of medicines called antivirals. It works by stopping the growth of viruses.
Aciclovir can be used to:
• Treat chickenpox.
• Treat shingles, and when started right after the rash appears, it can help reduce the nerve pain that can exist after the shingles rash has cleared.
• Treat cold sores, genital herpes and other herpes simplex infections (but not to be used to treat herpes simplex infections in new born infants or severe herpes simplex infections in children whose immune system work less well which means their bodies are less able to fight infections).
• Stop cold sores and genital herpes returning after you have had them.
• Prevent cold sores and genital herpes in people whose immune systems work less well.
You must talk to a doctor if you do not feel better or if you feel worse.
Do not take Aciclovir if: • You are allergic to aciclovir or valaciclovir or any of the other ingredients of this medicine (listed in section 6).
Do not take Aciclovir if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Aciclovir.
Warnings and precautions Talk to your doctor or pharmacist before taking Aciclovir if:
• You have kidney problems.
• You are over 65 years of age.
• You are thirsty. You must make sure you drink plenty of liquids such as water whilst taking this medicine.
• Your immune system is weak.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Aciclovir.
Children There is no data available to support the use of this medicine in stopping cold sores and genital herpes returning after having had them and treatment of shingles in children whose immune systems work well.
Other medicines and Aciclovir Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
• Probenecid - used to treat gout.
• Cimetidine - used to treat stomach ulcers.
• Mycophenolate mofetil - used to stop your body rejecting transplanted organs.
Taking Aciclovir with food and drink Food and drink should not affect the absorption of your medicine.
Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The ingredients in Aciclovir can pass into breast milk. If you are breast-feeding, you must check with your doctor before you take Aciclovir.
Driving and using machines Some side effects such as feeling drowsy or sleepy may impair your ability to concentrate and react. Make sure you are not affected before you drive or operate machinery.
Aciclovir contains Sorbitol (E420): This medicine contains 1575mg sorbitol in each 5ml which is equivalent to 315mg/ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you(or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
Methyl parahydroxybenzoate (E218): May cause an allergic reaction (possibly delayed).
Propylene glycol (E1520): This medicine contains 5mg propylene glycol in each 5 ml which is equivalent to 1mg/ml. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The dose that you should take will depend on what you have been given Aciclovir for.
Your doctor will discuss this with you.
Adults Treatment of chickenpox and shingles
• The usual dose is two 5 ml spoonfuls five times a day.
• You should space each dose by 4 hours.
Suggested times are: 7am, 11am, 3pm, 7pm and 11pm.
• You should take Aciclovir for seven days.
Treatment of cold sores and genital herpes
• The usual dose is one 2.5 ml spoonful five times a day.
• You should space each dose by 4 hours.
Suggested times are: 7am, 11am, 3pm, 7pm and 11pm.
• You should take Aciclovir for five days, or longer if your doctor tells you to.
Stopping these problems returning after you have had them • The usual dose is one 2.5 ml spoonful four times a day.
• You should try to space each dose by 6 hours.
• You should take Aciclovir until your doctor tells you to stop.
Preventing these problems in people whose immune systems work less well • The usual dose is one 2.5 ml spoonful four times a day. Your doctor may decide to double the dose to two 5ml spoonfuls four times daily in people whose immune system are severely impaired.
• You should try to space each dose by 6 hours.
• You should take Aciclovir until your doctor tells you to stop.
• Your doctor may decide to increase the dose or give a different form of this medicine by intravenous infusion.
Children Your doctor may adjust the dose of Aciclovir if it is for a child.
There is no data available to support the use of this medicine in stopping cold sores and genital herpes returning after having had them and treatment of shingles in children whose immune systems work well.
Treatment of cold sores and genital herpes:
• 2 years and over: one 2.5 ml spoonful five times a day.
• Under 2 years: other forms of this medicine are more suitable for children under 2 years.
Preventing these problems in children whose immune systems work less:
• 2 years and over: one 2.5 ml spoonful four times a day.
• Under 2 years: other forms of this medicine are more suitable for children under 2 years.
Treatment of chicken pox
• 6 years and over: two 5 ml spoonfuls four times a day.
• 2-5 years: one 5 ml spoonfuls four times a day.
• Under 2 years: one 2.5 ml spoonful four times a day.
• You should try to space each dose by 5 hours.
Suggested times are: 7am, 12noon,5pm and 10pm.
• Your child should take Aciclovir for five days.
Your doctor may adjust the dose of Aciclovir if: • You are over 65 years of age.
• You have kidney problems.
People over 65 years of age or with kidney problems: It is very important while you are taking Aciclovir that you drink water regularly during the day. This will help to reduce side effects that can affect the kidney or nervous system. Your doctor will closely monitor you for signs of these. Nervous system side effects might include feeling confused or agitated, or feeling unusually sleepy or drowsy.
Talk to your doctor before taking Aciclovir if any of the above apply.
Method of administration • Take this medicine by mouth.
• Use the spoon provided to carefully measure the dose needed (see figure below).
• Start to take Aciclovir as soon as possible.
• Shake the bottle well before use.
• Swallow the suspension.
• Wash the spoon with clean water after taking every dose.
If you take more Aciclovir than you should Aciclovir is not usually harmful, unless you take too much over several days. Talk to your doctor or pharmacist if you take too much Aciclovir. Take the medicine pack with you.
If you forget to take Aciclovir • If you forget to take Aciclovir, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Allergic reactions (may affect up to 1 in 1,000 people)
If you have an allergic reaction, stop taking Aciclovir and see a doctor straight away. The signs may include:
• Bumpy rash, itching or hives on your skin
• Swelling of your face, lips, tongue or other parts of your body (angioedema)
• Shortness of breath, wheezing or trouble breathing
• Unexplained fever (high temperature) and feeling faint, especially when standing up.
Other side effects include:
Common (may affect up to 1 in 10 people)
• Headache
• Feeling dizzy
• Feeling or being sick
• Diarrhoea
• Stomach pains
• Skin reaction after exposure to light (photosensitivity)
• Itching
• Feeling tired (fatigue)
• Fever.
Uncommon (may affect up to 1 in 100 people)
• Bumpy, itchy, hive-like rash(urticaria)
• Hair loss.
Rare (may affect up to 1 in 1,000 people)
• Difficulty breathing
• Effects on some blood and urine tests including changes in the levels of liver enzymes and blood count changes
• Swelling of you face, lips, mouth, tongue or throat (angioedema).
Very rare (may affect up to 1 in 10,000 people)
• Nosebleeds and bruising more easily than usual as a result of reduced numbers of blood platelets (thrombocytopenia)
• Reduction in the numbers of red blood cells (anaemia) and white blood cells (leukopenia)
• Feeling agitated or confused
• Shaking or tremors
• Hallucinations (Seeing or hearing things that are not there)
• Fits (seizures)
• Feeling unusually sleepy or drowsy
• Unsteadiness when walking and lack of coordination (ataxia)
• Difficulty speaking or hoarseness (dysarthria)
• Inability to think or judge clearly or concentrate
• Unconsciousness (coma)
• Disturbances of behaviour, speech and eye movements
• Damage or malfunction of the brain (encephalopathy) which is evident by an altered mental state
• Inflammation of the liver (hepatitis)
• Yellowing of your skin and whites of your eyes (jaundice)
• Kidney problems where you pass little or no urine
• Pain in your lower back, the kidney area of your back or above your hip (renal pain)
• Fatigue, decreased energy, weakness, shortness of breath, light-headedness, palpitations, looking pale (anaemia).
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 at: 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.
• 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 bottle label after EXP. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Do not refrigerate or freeze.
• Discard 30 days after first opening.
• Do not use this medicine if you notice that the suspension becomes discoloured or shows any signs of deterioration. Seek the advice of your pharmacist.
• 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 protect the environment.
What Aciclovir contains The active substance is aciclovir.
Each 5ml of oral suspension contains 400mg aciclovir.
The other ingredients are xanthan gum (E415), sorbitol liquid (non-crystallising) (E420), methyl parahydroxybenzoate (E218), orange flavour (containing propylene glycol (E1520)), vanilla flavour (containing propylene glycol (E1520)) and purified water.
What Aciclovir looks like and contents of the pack A white to off-white uniform oral suspension with orange and vanilla odour. It comes in an amber glass bottle with a child-resistant plastic cap. The pack also contains a 2.5-5ml double ended measuring spoon.
This medicine is available in a bottle containing 100ml of oral suspension.
Marketing Authorisation Holder and Manufacturer: SyriMed
Unit 4
Bradfield Road
Ruislip
Middlesex
HA4 0NU
UK
If this leaflet is hard to see or read, please call +44 (0) 208 515 3700 for help.
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
IE and UK (NI): Aciclovir 400mg/5ml Oral suspension
This leaflet was last revised in 08/2022.
PIL/UK/MFG108/03/SMD/v6
SyriMed
Address
Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU
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Aciclovir 400mg/5ml Oral Suspension comes as oral solution containing 400mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Aciclovir 400mg/5ml Oral Suspension is aciclovir.
Medicines with the same active substance, strength and form include: Aciclovir 400mg/5ml Oral Suspension. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Aciclovir 400mg/5ml Oral Suspension, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Aciclovir Suspension is indicated for the treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding neonatal HSV and severe HSV infections in immunocompromised children).
Aciclovir Suspension is indicated for the suppression (prevention of recurrences) of recurrent herpes simplex infections in immunocompetent patients.
Aciclovir Suspension is indicated for the prophylaxis of herpes simplex infections in immunocompromised patients.
Aciclovir Suspension is indicated for the treatment of varicella (chickenpox) and herpes zoster (shingles) infections. Studies have shown that early treatment of shingles with Aciclovir Suspension has a beneficial effect on pain and can reduce the incidence of post-herpetic neuralgia (zoster-associated pain).
Dosage for treatment of herpes simplex in Adults : For treatment of herpes simplex infections, 200mg Aciclovir suspension should be taken five times daily at approximately four hourly intervals omitting the night time dose. Treatment should continue for 5 days, but in severe initial infections this may have to be extended. In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut the dose can be doubled to 400mg Aciclovir suspension or alternatively intravenous dosing could be considered. Dosing should begin as early as possible after the start of an infection; for recurrent episodes this should preferably be during the prodromal period or when lesions first appear. Dosage for suppression of herpes simplex in adults : For suppression of Herpes simplex infections in immunocompetent patients, 200mg Aciclovir suspension should be taken FOUR times daily at approximately six-hourly intervals. Many patients may be conveniently managed on a regimen of 400mg Aciclovir suspension twice daily at approximately twelve-hourly intervals. Dosage titration down to 200mg Aciclovir suspension taken thrice daily at approximately eight-hourly intervals or even twice daily at approximately twelve-hourly intervals, may prove effective. Some patients may experience break-through infection on total daily doses of 800mg Aciclovir suspension. Therapy should be interrupted periodically at intervals of six to twelve months, in order to observe possible changes in the natural history of the disease. Dosage for prophylaxis of herpes simplex in adults : For prophylaxis of herpes simplex infections in immunocompromised patients, 200mg Aciclovir suspension should be taken FOUR times daily at approximately six hourly intervals. In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut, the dose can be doubled to 400mg Aciclovir suspension or, alternatively, intravenous dosing could be considered. The duration of prophylactic administration is determined by the duration of the period at risk. Dosage for treatment of varicella and herpes zoster in adults : For treatment of varicella and Herpes zoster infections, 800mg Aciclovir suspension should be taken five times daily at approximately four-hourly intervals, omitting the night time dose. Treatment should continue for seven days. In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing. Dosing should begin as early as possible after the start of an infection: treatment yields better results if initiated as soon as possible after the onset of the rash. Dosage for Infants and Children For treatment of herpes simplex infections, and prophylaxis of herpes simplex infections in the immunocompromised , children aged two years and over should be given adult dosages. Infants and children below the age of two years should be given half the adult dose. Do not dilute the oral suspension formulation. For treatment of varicella infections for Infants and children : 6 years and over: 800mg Aciclovir suspension four times daily. 2 to < 6 years: 400mg Aciclovir suspension four times daily. Under 2 years: 200mg Aciclovir suspension four times daily. Treatment should continue for five days. Dosing may be more accurately calculated as 20mg/kg body weight (not to exceed 800mg) Aciclovir suspension four times daily. No specific data are available on the suppression of herpes simplex infections or the treatment of herpes zoster infections in immunocompetent children. Dosage in the Elderly The possibility of renal impairment in the elderly must be considered and the dosage should be adjusted accordingly (see 'Dosage in Renal Impairment' below). Adequate hydration should be maintained. Dosage in Renal Impairment Caution is advised when administering aciclovir to patients with impaired renal function. Adequate hydration should be maintained. In the management of herpes simplex infections in patients with impaired renal function, the recommended oral doses will not lead to accumulation of aciclovir above levels that have been established by intravenous infusion. However, for patients with severe renal impairment (creatinine clearance less than 10 ml/minute) an adjustment of dosage to 200mg aciclovir twice daily at approximately twelve-hourly intervals is recommended. In the treatment of varicella and herpes zoster infections it is recommended to adjust the dosage to 800mg twice daily at approximately twelve-hourly intervals for patients with severe renal impairment (creatinine clearance less than 10ml/minute), and to 800mg three times daily at intervals of approximately eight hours for patients with moderate renal impairment (creatinine clearance in the range 10 to 25ml/minute). Method of administration For oral use only. <summary id="CONTRAINDICATIONS" data-evt="smpcSectionOpen"
Aciclovir Suspension is contraindicated in patients known to be hypersensitive to aciclovir and valaciclovir, or to any of the excipients listed in section 6.1. <summary id="CLINICAL_PRECAUTIONS" data-evt="smpcSectionOpen"
Use in patients with renal impairment and in elderly patients: Aciclovir is eliminated by renal clearance, therefore the dose must be adjusted in patients with renal impairment (see section 4.2 ) Elderly patients are likely to have reduced renal function and therefore the need for dose adjustment must be considered in this group of patients. Both elderly patients and patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored for evidence of these effects. In the reported cases, these reactions were generally reversible on discontinuation of treatment (see section 4.8 ). Prolonged or repeated courses of aciclovir in severely immune-compromised individuals may result in the selection of virus strains with reduced sensitivity, which may not respond to continued aciclovir treatment (see section 5.1). Hydration status Care should be taken to maintain adequate hydration in patients receiving high oral doses of aciclovir or valaciclovir. Excipients Warnings: Sorbitol (E420): This medicinal product contains 1575mg sorbitol in each 5ml which is equivalent to 315mg/ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Methyl parahydroxybenzoate (E218): May cause an allergic reaction (possibly delayed). Propylene glycol (E1520): This medicinal product contains 5mg propylene glycol in each 5 ml which is equivalent to 1mg/ml. <summary id="INTERACTIONS" data-evt="smpcSectionOpen"
No clinically significant interactions have been identified. Aciclovir is eliminated primarily unchanged in the urine via active renal tubular secretion. Any drugs administered concurrently that compete with this mechanism may increase aciclovir plasma concentrations. Probenecid and cimetidine increase the AUC of aciclovir by this mechanism, and reduce aciclovir renal clearance. Similarly increases in plasma AUCs of aciclovir and of the inactive metabolite of mycophenolate mofetil , an immunosuppressant agent used in transplant patients have been shown when the drugs are coadministered. However no dosage adjustment is necessary because of the wide therapeutic index of aciclovir. <summary id="PREGNANCY" data-evt="smpcSectionOpen"
Pregnancy:
The use of acyclovir should be considered only when the potential benefits outweigh the possibility of unknown risks.
A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of Aciclovir suspension. The registry findings have not shown an increase in the number of birth defects amongst aciclovir exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause.
Breast-feeding:
Following oral administration of 200mg aciclovir five times a day, aciclovir has been detected in breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to aciclovir dosages of up to 0.3mg/kg/day. Caution is therefore advised if Aciclovir suspension is to be administered to a nursing woman.
Fertility:
See clinical studies in section 5.3
The clinical status of the patient and the adverse event profile of Aciclovir Suspension should be borne in mind when considering the patient's ability to drive or operate machinery.
There have been no studies to investigate the effect of Aciclovir Suspension on driving performance or the ability to operate machinery. Further, a detrimental effect on such activities cannot be predicted from the pharmacology of the active substance.
The frequency categories associated with the adverse events below are estimates. For most events, suitable data for estimating incidence were not available. In addition, adverse events may vary in their incidence depending on the indication. The following convention has been used for the classification of undesirable effects in terms of frequency:- 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), very rare (<1/10,000). Blood and lymphatic system disorders: Very rare: Anaemia, leukopenia, thrombocytopenia Immune system disorders: Rare: Anaphylaxis Psychiatric and nervous system disorders: Common: Headache, dizziness Very rare: Agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy, coma. The above events are generally reversible and are usually reported in patients with renal impairment, or with other predisposing factors (see section 4.4). Respiratory, thoracic and mediastinal disorders: Rare: Dyspnoea Gastrointestinal disorders Common: Nausea, vomiting, diarrhoea, abdominal pains Hepatobiliary disorders Rare: Reversible rises in bilirubin and liver related enzymes Very rare: Hepatitis, jaundice Skin and subcutaneous tissue disorders: Common: Pruritus, rashes (including photosensitivity) Uncommon: Urticaria. Accelerated diffuse hair loss. Accelerated diffuse hair loss has been associated with a wide variety of disease processes and medicines, the relationship of the event to aciclovir therapy is uncertain. Rare: Angioedema Renal and urinary disorders: Rare: Increases in blood urea and creatinine Very rare: Acute renal failure, renal pain. Renal pain may be associated with renal failure . General disorders and administration site conditions: Common: Fatigue, fever 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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. <summary id="OVERDOSE" data-evt="smpcSectionOpen"
Symptoms & signs
Aciclovir is only partly absorbed in the gastrointestinal tract. Patients have ingested overdoses of up to 20g aciclovir on a single occasion, usually without toxic effects. Accidental, repeated overdoses of oral aciclovir over several days have been associated with gastrointestinal effects (such as nausea and vomiting) and neurological effects (headache and confusion).
Overdosage of intravenous aciclovir has resulted in elevations of serum creatinine, blood urea nitrogen and subsequent renal failure. Neurological effects including confusion, hallucinations, agitation, seizures and coma have been described in association with intravenous overdosage.
Management
Patients should be observed closely for signs of toxicity. Haemodialysis significantly enhances the removal of aciclovir from the blood and may, therefore, be considered a management option in the event of symptomatic overdose.
Ask anything about Aciclovir 400mg/5ml Oral Suspension. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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