151233PIL01

Package leaflet: Information for the patient Selexid® 200 mg Film-coated Tablets pivmecillinam hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • In this leaflet Selexid® 200 mg Film-coated Tablets will be called Selexid.

What is in this leaflet: If you take Selexid for a long time, your doctor 1. What Selexid® is and what it is used for may take regular blood tests. This is to check 2. What you need to know before you take if your kidneys and liver are working properly. Selexid® 3. How to take Selexid® Other medicines and Selexid 4. Possible side effects Tell your doctor or pharmacist if you are 5. How to store Selexid® taking, have recently taken or might take any 6. Contents of the pack and other information other medicines. This includes any medicines which you have bought without a prescription. ® 1. What Selexid is and what it is used for Selexid belongs to a group of medicines You must tell your doctor or pharmacist if you called . It is a type of . are taking any of the following medicines: • Methotrexate: for arthritis or psoriasis. You Selexid works by killing germs (bacteria) that may need to take a different dose of cause infections. methotrexate. • Probenecid: for gout. This may increase the If the infection is not treated, germs can effect of Selexid. continue to grow in your body. The infection • Valproic acid or valproate: for epilepsy. will make you feel very unwell, and could • Any other antibiotic: for treating an infection even be life-threatening. such as erythromycin or tetracycline. This may have an effect on how Selexid Selexid is used to treat: works in your body. • Infections of the bladder or tubes leading from the kidneys (urinary tract infections). Selexid with food and drink • Infections caused by a bacteria called Selexid should be taken during or after a Salmonella (salmonellosis). meal. Tablets must be swallowed whole with at least half a glass of fluid, while sitting or You must talk to a doctor if you do not feel standing (see section 3 ‘How to take Selexid®’). better or if you feel worse after completing your prescribed course of Selexid. It is important to take your medicine with plenty of fluid. This will stop you getting mouth 2. What you need to know before you ulcers or ulcers in your food pipe. Please read ® take Selexid section 4 of this leaflet so you can spot any Do not take Selexid: signs this may be happening to you. • If you are allergic (hypersensitive) to pivmecillinam hydrochloride or any of the Pregnancy and breast-feeding other ingredients of this medicine (listed in If you are pregnant or breast-feeding, think section 6). you may be pregnant or are planning to have • If you are allergic (hypersensitive) to other a baby, ask your doctor or pharmacist for such as or advice before taking this medicine. . Tell your doctor if you become pregnant while • If you know you have any condition that can taking this medicine. make your food pipe become narrow. • If you know you have any condition that may Driving and using machines reduce the amount of a substance called Usually your medicine may have very little in your body. Such conditions effect on your ability to drive or use machines. include primary carnitine deficiency or Check with your doctor if you feel any side kidney dialysis. effect that may stop you from driving or using machines. Warnings and precautions Talk to your doctor or pharmacist before 3. How to take Selexid® taking Selexid: Always take this medicine exactly as your doctor or pharmacist has told you. Check with • If you know that you have a condition called your doctor or pharmacist if you are not sure. porphyria. • If you are taking other medicines used to How much Selexid to take treat epilepsy, called valproic acid or Your doctor will tell you how many tablets to valproate. take, or give to your child. Your doctor will tell • If you are taking another antibiotic called you how many times each day to take your . medicine. • If you have recently taken a course of Selexid. You should take the medicine at equally • If you have been taking Selexid for a long spaced times in the day. time already. Remember to always swallow the tablets Tell your doctor or pharmacist if you have whole during or immediately after a meal and diarrhoea, fever or pain in the stomach after with at least half a glass of fluid, while sitting the use of Selexid. or standing. It is very important to take all the medicine • Getting a fever or infections more often. your doctor has told you to take. This may be due to a change in certain types of cells found in your body. Urinary Tract Infections: • Muscle weakness or muscle loss. This may be due to a decrease in the amount of a Adults and children weighing more than 40 kg: substance called carnitine in your body. • Acute infection: The usual starting dose is • Headache. 2 tablets taken immediately. Then take • Dizziness. 1 tablet every 8 hours. Continue until you • Light-headedness. have taken all 10 tablets in the pack. • Yellowing of the skin or eyes. • Repeated infection: The usual dose is • Unusually dark urine. 6 - 8 tablets each day. Take 2 tablets • Small changes in blood test results. Your three or four times each day. doctor can explain this more. • Rash. For other type of infections or for children • Hives (urticaria). weighing less than 40 kg: • Itching skin (pruritus). Your doctor will prescribe the right dose for you. • Tiredness or lack of energy. If you take more Selexid than you should Reporting of side effects Tell your doctor straight away. You may need If you get any side effects, talk to your doctor to stop taking this medicine. or pharmacist. This includes any possible side effects not listed in this leaflet. You can also You may be sick, or feel sick, or get an upset report side effects directly via the Yellow Card stomach. Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide If you forget to take Selexid more information on the safety of this If you forget to take your medicine, take it a as medicine. soon as you remember. If you can, take it during or immediately after a meal, but always 5. How to store Selexid® take with half a glass of water, while sitting or • Keep this medicine out of the sight and standing. Then take the next dose at the usual reach of children. time. • Do not use this medicine after the expiry Do not take a double dose to make up for a date which is stated on the carton. forgotten tablet. The expiry date refers to the last day of that month. If you stop taking Selexid • Store below 25°C in a dry place. It is very important to take all the medicine that your doctor has told you to take. You must Do not throw away any medicines via finish this medicine even if you feel better. You wastewater or household waste. Ask your must do this because otherwise you may feel pharmacist how to throw away medicines you ill again. no longer use. These measures will help protect the environment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 6. Contents of the pack and other information 4. Possible side effects What Selexid contains Like all medicines, this medicinecan cause • The active substance is pivmecillinam side effects, although not everybody gets them. hydrochloride. Selexid contains 200 milligrams of Important side effects to look out for: pivmecillinam hydrochloride in each tablet. You must get urgent medical help if you have • The other ingredients are cellulose any of the following symptoms. You may be microcrystalline, hydroxypropylcellulose, having an allergic reaction: magnesium stearate, hypromellose, • You have difficulty breathing. simethicone and synthetic paraffin. • Your face or throat swell. • Your skin develops a severe rash or areas What Selexid looks like and contents of the of sudden swelling. pack Selexid is a white tablet. There is a picture of You must get urgent medical help if you have a lion on one side of the tablet. The other side the following symptom: has 137 written on it. • Severe diarrhoea caused by inflammation of the colon (large intestine). Selexid comes in blister packs of 10 and 18 tablets. Other possible side effects: Not all pack sizes may be marketed. Common (may affect up to 1 in 10 people) • Feeling sick (nausea). Marketing Authorisation Holder and • Diarrhoea. Manufacturer • Infection or inflammation of the vagina Marketing (Vulvovaginal mycotic infection). Authorisation Holder: Karo Pharma AB Uncommon (may affect up to 1 in 100 people) Box 16184, 103 24 Stockholm • Being sick (vomiting). Sweden • Inflammation of the colon (large intestine), [email protected] causing diarrhoea (usually with blood and Manufacturer: Recipharm Strängnäs AB mucus) and stomach pain. Mariefredsvägen 35, S-645 41 • Stomach pain. Strängnäs, Sweden • Indigestion. • Trouble chewing or swallowing your food. This leaflet was last revised in January 2019. This may be due to mouth ulcers, ulcers in ® your food pipe or inflammation of your food Registered Trade Mark pipe, from taking the tablets with insufficient fluids. • Bruising or bleeding more easily. 151233PIL01