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.
Pivmecillinam 200mg film-coated tablets
⚠ 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 Pivmecillinam hydrochloride 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 Pivmecillinam belongs to a group of medicines called penicillins. It is a type of antibiotic. Pivmecillinam works by killing germs (bacteria) that cause infections. If the infection is not treated, germs can continue to grow in your body. The infection will make you feel very unwell, and could even be life-threatening. Pivmecillinam hydrochloride is used to treat:
- Infections of the bladder or tubes leading from the kidneys (urinary tract infections).
- Infections caused by a bacteria called Salmonella (salmonellosis). You must talk to a doctor if you do not feel better or if you feel worse after completing your prescribed course of Pivmecillinam hydrochloride.
What you need to know before you take it
e Pivmecillinam hydrochloride Do not take Pivmecillinam hydrochloride
- If you are allergic (hypersensitive) to pivmecillinam hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- If you are allergic (hypersensitive) to other antibiotics. Such as penicillin or cephalosporins.
- If you know you have any condition that can make your food pipe become narrow.
- If you know you have any condition that may reduce the amount of a substance called carnitine in your body. Such conditions include primary carnitine deficiency or kidney dialysis. Warnings and precautions Talk to your doctor or pharmacist before taking Pivmecillinam hydrochloride.
- If you know that you have a condition called porphyria.
- If you are taking other medicines used to treat epilepsy, called valproic acid or valproate.
- If you are taking another antibiotic called pivampicillin.
- If you have recently taken a course of Pivmecillinam.
- If you have been taking pivmecillinam for a long time already. Severe skin reactions (SCAR) have been reported in association with Pivmecillinam. Stop taking Pivmecillinam and seek medical help immediately if you experience any of the symptoms described in section 4, as you may need urgent medical treatment. Tell your doctor or pharmacist if you have diarrhoea, fever or pain in the stomach after the use of pivmecillinam.
If you take Pivmecillinam hydrochloride for a long time, your doctor may take regular blood tests. This is to check if your kidneys and liver are working properly. Other medicines and Pivmecillinam hydrochloride Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any medicines which you have bought without a prescription. You must tell your doctor or pharmacist if you are taking any of the following medicines:
- Methotrexate: for arthritis or psoriasis. You may need to take a different dose of methotrexate.
- Probenecid: for gout. This may increase the effect of Pivmecillinam hydrochloride.
- Valproic acid or valproate: for epilepsy.
- Any other antibiotic: for treating an infection such as erythromycin or tetracycline. This may have an effect on how Pivmecillinam hydrochloride works in your body. Pivmecillinam hydrochloride with food and drink Pivmecillinam hydrochloride should be taken during or after a meal. Tablets must be swallowed whole with at least half a glass of fluid, while sitting or standing (see section 3'). It is important to take your medicine with plenty of fluid. This will stop you getting mouth ulcers or ulcers in your food pipe. Please read section 4 of this leaflet so you can spot any signs this may be happening to you. 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. Pregnancy This medicine can be taken during pregnancy. Some cases of false-positive newborn screening tests simulating the presence of isovaleric acidaemia have been reported. The intake of pivmecillinam shortly before delivery may affect the neonatal screening for metabolic disorders and give a false positive result. A "false positive" means that the test wrongly indicates that your child has the disorder. There is no risk for the newborn, but you should tell your doctor if you took shortly before delivery. Tell your doctor if you become pregnant while taking this medicine. Breast-feeding This medicine can be taken during breast-feeding. Fertility Clinical studies concerning fertility have not been done. Driving and using machines Usually your medicine may have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines.
How to take it
Pivmecillinam hydrochloride Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor, pharmacist if you are not sure. How much Pivmecillinam hydrochloride 200 mg filmcoated tablets to take Your doctor will tell you how many tablets to take or give to your child. Your doctor will tell you how many times each day to take your medicine. You should take the medicine at equally spaced times in the day. Remember to always swallow the tablets whole during or immediately after a meal and with at least half a glass of fluid, while sitting or standing. It is very important to take all the medicine your doctor has told you to take.
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Package leaflet: Information for the user
The intake of pivmecillinam shortly before delivery may affect the neonatal screening for inherited metabolic disorders and give a false positive result. A" false positive" means that the test wrongly indicates that your child has the disorder. There is no risk for the newborn, but you should tell your doctor if you took pivmecillinam shortly before delivery.
Urinary Tract Infections:
•
Adults and children weighing more than 40 kg:
- Acute infection: The usual starting dose is 2 tablets taken immediately. Then take 1 tablet every 8 hours. Continue until you have taken all tablets in the pack.
- Repeated infection: The usual dose is 6-8 tablets each day. Take 2 tablets three or four times each day.
• • • •
If you take more Pivmecillinam hydrochloride than you should Tell your doctor straight away. You may need to stop taking this medicine. You may be sick, or feel sick, or get an upset stomach. If you forget to take Pivmecillinam hydrochloride If you forget to take your medicine, take it as soon as you remember. If you can, take it during or immediately after a meal, but always take with half a glass of water while sitting or standing. Then take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet. If you stop taking Pivmecillinam hydrochloride It is very important to take all the medicine that your doctor has told you to take. You must finish this medicine even if you feel better. You must do this because otherwise you may feel ill again. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Important side effects to look out for: You must get urgent medical help if you have any of the following symptoms. You may be having a severe allergic reaction, which may be life-threatening:
- You have difficulty breathing or swallowing.
- Your face, lips, tongue and/or throat swell.
- Your skin develops a sudden rash or areas of sudden swelling.
- You faint due to hypersensitivity. Stop taking Pivmecillinam and seek medical help immediately as you may need urgent medical treatment, if you experience any of the following symptoms:
- Severe diarrhoea caused by inflammation of the colon (large intestine).
- Skin peeling, scaling, or blistering (with or without pus) which may also affect your eyes,mouth, nose or genitals, itching, severe rash, bumps under the skin, skin pain, skin color changes (redness, yellowing, purplish); swelling and redness of eye or face; flu-like feeling,fever, chills, body aches, swollen glands, cough, shortness of breath, chest pain or discomfort (Severe Cutaneous Adverse Reactions (SCAR), not known frequency). Other possible side effects: Common: may affect upto 1 in 10 people
- Infection or inflammation of the vagina (Vulvovaginal mycotic infection).
- Diarrhoea.
- Feeling sick (nausea). Uncommon: may affect upto 1 in 100 people
- Headache
- Dizziness
- Being sick (vomiting)
- Stomach Pain
- Inflammation of the colon (large intestine), causing diarrhoea (usually with blood and mucus) and stomach pain.
- Indigestion.
- Trouble chewing or swallowing your food. This may be due to mouth ulcers, ulcers in your food pipe or inflammation of your food pipe, from taking the tablets with insufficient fluids.
- Bruising or bleeding more easily.
- Getting a fever or infections more often. This may be due to a change in certain types of cells found in your body.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 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.
How to store it
Pivmecillinam hydrochloride Keep this medicine out of the sight and reach of children. Store below 30°C. Store in the original package in order to protect from moisture. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. 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.
Contents of the pack and other information
What Pivmecillinam hydrochloride contains
- The active substance is pivmecillinam hydrochloride. Each film-coated tablet contains 200 mg of pivmecillinam hydrochloride. –
The other ingredients are: Tablet core: Cellulose microcrystalline, magnesium stearate. Film coating: Hypromellose, triacetin.
What Pivmecillinam hydrochloride looks like and contents of the pack Film-coated tablet. White to off-white, round shaped, biconvex, film coated tablets debossed with 'F' on one side and '48' on the other side. Pivmecillinam hydrochloride film-coated tablets are available in triple laminated cold form aluminium blister packs. Pack sizes: 2, 10, 14 and 100 film-coated tablets Not all pack sizes may be marketed Marketing Authorisation Holder Milpharm Limited 1 Roundwood Avenue Stockley Park, Uxbridge UB11 1AF United Kingdom Manufacturer APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta or Milpharm Limited 1 Roundwood Avenue Stockley Park, Uxbridge UB11 1AF United Kingdom This leaflet was last revised in 10/2025.
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For other type of infections, for pregnant women or for children weighing less than 40 kg: Your doctor will prescribe the right dose for you.
• • • •
Muscle weakness or muscle loss. This may be due to a decrease in the amount of a substance called carnitine in your body. Light-headedness. Yellowing of the skin or eyes. Unusually dark urine. Small changes in blood test results. Your doctor can explain this more. Rash. Hives (urticaria). Itching skin (pruritus). Tiredness or lack of energy.
Frequently asked questions about Pivmecillinam 200mg film-coated tablets
How do I take Pivmecillinam 200mg film-coated tablets?
Pivmecillinam 200mg film-coated tablets comes as tablet containing 200mg. 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 Pivmecillinam 200mg film-coated tablets?
The active substance in Pivmecillinam 200mg film-coated tablets is pivmecillinam hydrochloride.
Are there equivalent medicines to Pivmecillinam 200mg film-coated tablets?
Medicines with the same active substance, strength and form include: Selexid 200 mg Film-coated Tablets. 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 Pivmecillinam 200mg film-coated tablets, 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 Pivmecillinam 200mg film-coated tablets 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: pivmecillinam hydrochloride
- 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
Pivmecillinam is indicated for the treatment of infections due to mecillinam sensitive organisms (see section 5.1), including:
• • urinary tract infections
• • salmonellosis
• Preliminary experience in a small number of patients suggests that Pivmecillinam hydrochloride 200 mg film-coated tablets may be a useful alternative antibiotic in the treatment of acute typhoid fever and in some carriers of salmonellae when antibiotic treatment is considered essential.
• Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2. Posology and method of administration
Posology
Adults
Urinary tract infections:
• Acute uncomplicated cystitis: 72 hour course of 2 tablets immediately followed by 1 tablet 3 times daily to a total of 10 tablets.
• Chronic or recurrent bacteriuria: 2 tablets three to four times daily.
Salmonellosis:
• Enteric fever: 1.2-2.4 g daily for 14 days.
• Salmonella carriers: 1.2-2.4 g daily for 2-4 weeks.
Pregnant women
Acute cystitis: 7 day course of 2 tablets immediately followed by 1 tablet 3 times daily to a total of 22 tablets.
Paediatric population
Children weighing more than 40 kg
Urinary tract infections:
• Acute uncomplicated cystitis: 72 hour course of 2 tablets immediately followed by 1 tablet 3 times daily to a total of 10 tablets. • Chronic or recurrent bacteriuria: 2 tablets three to four times daily.
Salmonellosis:
• Enteric fever: 1.2-2.4 g daily for 14 days.
• Salmonella carriers: 1.2-2.4 g daily for 2-4 weeks.
Children weighing less than 40 kg:
• Urinary tract infections: 20-40 mg/kg body weight, daily, in 3 to 4 divided doses.
• Salmonellosis: 30-60 mg/kg body weight, daily, in 3 to 4 divided doses.
Elderly population:
Renal excretion of mecillinam is delayed in the elderly, but significant accumulation of the drug is not likely at the recommended adult dosage of Pivmecillinam hydrochloride tablets.
Method of administration
Route of administration is oral. The tablet must be taken with at least half a glass of fluid and preferably taken with or immediately after a meal.
4.3. Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Hypersensitivity to penicillins and/or cephalosporins
• Any conditions resulting in impaired transit through the oesophagus.
• Genetic metabolism anomalies known to be leading to severe carnitine deficiency such as carnitine transporter defect, methylmalonic aciduria or propionic acidaemia.
4.4. Special warnings and precautions for use
During long term use, it is advisable to carry out routine liver and kidney function tests.
• Severe cutaneous adverse reactions (SCAR) such as acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported in relation to beta-lactam treatment, including Pivmecillinam. When SCAR is suspected, Pivmecillinam should be discontinued immediately, and appropriate therapy and/or measures should be taken.
• Pseudomembranous colitis caused by Clostridium difficile may occur. If diarrhoea occurs after use, the possibility of pseudomembranous colitis should be considered, and appropriate actions should be taken.
• Pivmecillinam should be used with caution in patients with porphyria since pivmecillinam has been associated with acute attacks of porphyria.
• As with other antibiotics which are excreted mainly by the kidneys, raised blood levels of mecillinam may occur if repeated doses are given to patients with impaired renal function.
• Concurrent treatment with valproic acid, valproate or other medication liberating pivalic acid should be avoided due to increased risk of carnitine depletion.
• Pivmecillinam hydrochloride film-coated tablets should be used with caution for long-term or frequently-repeated treatment, due to the possibility of carnitine depletion. Symptoms of carnitine depletion include muscle aches, fatigue, and confusion.
• Interference with neonatal screening tests: The intake of pivmecillinam shortly before delivery may cause a false positive test for isovaleric acidemia in the newborn as part of neonatal screening. This may be due to the formation of pivaloylcarnitine simulating the presence of isovalerylcarnitine. It is therefore recommended to include a second tier screening test for each sample obtained from newborns tested positive for isovaleric acidaemia if those findings are suspected of being pivmecillinam-related false positive (see section 4.6).
• The tablets must be taken with at least half a glass of fluid due to the risk of oesophageal ulceration.
4.5. Interaction with other medicinal products and other forms of interaction
• Simultaneous administration of probenecid reduces the excretion of penicillins and hence increases the blood level of the antibiotic.
• Clearance of methotrexate from the body can be reduced by concurrent use of penicillins.
• Concurrent treatment with valproic acid, valproate or other medication liberating pivalic acid should be avoided due to increased risk of carnitine depletion.
• The bactericidal effect of penicillins may be hindered by concurrent administration of products with bacteriostatic effect, for instance erythromycin and tetracyclines.
4.6. Fertility, pregnancy and lactation
Pregnancy
A large amount of data on pregnant women (more than 40 000 pregnancy outcomes) indicates no malformative nor feto/neonatal toxicity of pivmecillinam. Pivmecillinam can be used for treatment of acute uncomplicated cystitis during pregnancy, if clinically needed.
Some cases of false-positive newborn screening tests simulating the presence of isovaleric acidaemia have been reported. The intake of pivmecillinam shortly before delivery may cause a false positive test for isovaleric acidaemia in the newborn as part of neonatal screening (see section 4.4).
Breast-feeding
Mecillinam is excreted in human milk, but at therapeutic doses of Pivmecillinam no effects on the breast-fed newborns/infants are anticipated. Pivmecillinam can be used during breast-feeding.
Fertility
There are no clinical studies on the effect of Pivmecillinam hydrochloride on fertility. A pre-clinical study did not show an effect on fertility in rats.
4.7. Effects on ability to drive and use machines
Pivmecillinam hydrochloride has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
The estimation of the frequency of undesirable effects is based on an analysis of pooled data from clinical studies and spontaneous reporting.
The most frequently reported adverse reactions are nausea and diarrhoea.
Anaphylactic reactions and fatal pseudomembranous colitis (see section 4.4) have been reported.
Severe cutaneous adverse reactions (SCAR) including acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported (see section 4.4).
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
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
Not known (cannot be estimated from the available data)
Infections and infestations
Common:
Vulvovaginal mycotic infection
Uncommon:
Clostridium difficile colitis
Blood and lymphatic system disorders
Uncommon:
Thrombocytopenia
Immune system disorders
Uncommon:
Anaphylactic reaction
Not known:
Anaphylactic shock
Metabolism and nutrition disorders
Uncommon:
Carnitine decreased
Nervous system disorders
Uncommon:
Headache
Dizziness
Ear and labyrinth disorders
Uncommon:
Vertigo
Gastrointestinal disorders
Common:
Diarrhoea
Nausea
Uncommon:
Vomiting
Abdominal pain
Dyspepsia
Oesophageal ulcer
Oesophagitis
Mouth ulceration
Hepatobiliary disorders
Uncommon:
Hepatic function abnormal
Skin and subcutaneous tissue disorders
Uncommon:
Rash*
Urticaria
Pruritus
Not known:
Severe cutaneous adverse reactions** including acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis
Angioedema
General disorders and administration site conditions
Uncommon:
Fatigue
*Various types of rash reactions such as erythematous, macular or maculo-papular have been reported.
**Very few cases have been reported post-marketing, frequency cannot be established
Class adverse reactions of beta-lactam antibiotics
• Slight reversible increase in aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatase, and bilirubin
• Neutropenia
• Eosinophilia
Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults, based on limited data.
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 at: www.mhra.gov.uk/yellowcard. or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
There is no experience of overdose with Pivmecillinam hydrochloride tablets. However, excessive doses are likely to induce nausea, vomiting abdominal pain and diarrhoea. Treatment should be restricted to symptomatic and supportive measures.
💬 Ask about this leaflet
Ask anything about Pivmecillinam 200mg film-coated tablets. 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.