SELEXID 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Selexid 400 mg film-coated tabletsEFG

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Selexid and what is it used for
2. What you need to know before you take Selexid
3. How to take Selexid
4. Possible side effects
5. Storage of Selexid
6. Contents of the pack and other information

1. What is Selexid and what is it used for

Selexid belongs to a group of medicines called penicillins. It is a type of antibiotic. Selexid works by killing the bacteria that cause infections.

Selexid is used to treat bladder infections (cystitis) in adults.

2. What you need to know before you take Selexid

Your doctor may have prescribed a different use or dose than what is indicated in this information. Follow your doctor's instructions exactly.

Do not take Selexid:

• If you are allergic (hypersensitive) to pivmecillinam or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to other antibiotics. These antibiotics include penicillins and cephalosporins.
• If you have ever experienced a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking Selexid 400 mg film-coated tablets EFG or other beta-lactam antibiotics (such as amoxicillin, penicillin V, and flucloxacillin).
• If you have a narrowing of the digestive tract.
• If you have a disorder that can reduce the amount of a substance called carnitine in your body. These disorders include a carnitine transporter defect, methylmalonic aciduria, and propionic acidemia.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Selexid. The tablets should be taken with at least half a glass of liquid to avoid the tablets getting stuck in the digestive tract.

Before starting treatment, inform your doctor:

• If you have porphyria.
• If you have recently used Selexid, as prolonged use can reduce the amount of carnitine in your body.

During treatment:

• Severe skin reactions (SSR), including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in relation to treatment with Selexid 400 mg film-coated tablets EFG. Stop treatment with Selexid 400 mg film-coated tablets EFG and seek immediate medical attention if you experience any of the symptoms related to severe skin reactions described in section 4.
• If you experience sudden diarrhea while taking Selexid, inform your doctor immediately. This may be due to inflammation of the intestine (colitis).
• Taking pivmecillinam shortly before birth may affect the results of neonatal tests for detecting hereditary metabolic disorders and give a false positive result. A "false positive" means that the result incorrectly indicates that the baby has a disorder. There is no risk to the neonate, but you should inform your doctor that you have taken Selexid shortly before birth.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as the potential benefits may not outweigh the risks.

Taking Selexid with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Inform your doctor or pharmacist if you are taking any of the following medicines:

• Probenecid (for the treatment of gout). This may enhance the effect of Selexid.
• Methotrexate (for the treatment of rheumatism and cancer). The excretion of methotrexate from your body may be slower if used with Selexid.
• Valproate or valproic acid (for the treatment of epilepsy). This increases the risk of having too low a level of carnitine in your body if used with Selexid.
• Other antibiotics (e.g., tetracyclines, erythromycin, other beta-lactam antibiotics).

This may affect the effect of Selexid.

Taking Selexid with food and drinks

You can take the medicine with or immediately after a meal. Selexid should be taken with at least half a glass of water. It is important that you take your medicine with plenty of liquid and a long time before going to bed. This will prevent digestive tract disorders.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Selexid can be used during pregnancy.

There have been reports of false positives in neonatal screening tests, where it has simulated the presence of isovaleric acidemia. Taking pivmecillinam shortly before birth may affect the results of neonatal tests for detecting hereditary metabolic disorders and give a false positive result. A "false positive" means that the result incorrectly indicates that the baby has a disorder. There is no risk to the neonate, but you should inform your doctor that you have taken Selexid shortly before birth.

Breastfeeding

Selexid can be used during breastfeeding.

Fertility

No clinical studies have been conducted regarding fertility.

Driving and using machines

The influence of Selexid on the ability to drive and use machines is negligible.

3. How to take Selexid

Follow the instructions for administration of this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor, pharmacist, or nurse. You should take the medicine at equal intervals of time during the day. For example, if you need to take it three times a day, take it at breakfast, lunch, and dinner time. Selexid should be taken with at least half a glass of liquid. Your doctor will tell you how long you need to use Selexid tablets.

The recommended dose is 400 mg 3 times a day.

Elderly patients: No dose adjustment is necessary.

In case of renal or hepatic insufficiency, no dose adjustment is necessary.

If you take more Selexid than you should

Inform your doctor immediately. You may need to stop taking this medicine. You may feel nauseous, vomit, or have stomach disorders.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Selexid

If you forget to take the medicine, take it as soon as you remember. You should take it with at least half a glass of water or other liquid. Then, take the next dose at the usual time.

If you stop taking Selexid

It is very important that you take all the medicine that your doctor has indicated. You should finish this medicine even if you feel better, otherwise, you may become ill again.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

Stop treatment with Selexid and seek immediate medical attention if you notice any of the following symptoms:

• Severe allergic reactions (anaphylactic reactions, angioedema, anaphylactic shock): symptoms can include skin rash, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, fainting due to hypersensitivity. These reactions can be life-threatening.
• Red, non-raised, target-like or circular patches on the trunk, often with central blisters, skin peeling, mouth ulcers, and/or genital and eye ulcers. These severe skin reactions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
• Severe, bloody diarrhea with stomach pain and fever (Clostridium difficile colitis).

Anaphylactic reactions and Clostridium difficile colitis are rare and may affect up to 1 in 100 people. The occurrence of angioedema and anaphylactic shock is unknown.

Contact your doctor if you notice the following seriousside effects:

• Bleeding from the skin and mucous membranes, as well as bruising of the skin caused by changes in the blood (low platelet count) (thrombocytopenia). Uncommon: may affect up to 1 in 100 people.

Other side effects:

Frequent (may affect up to 1 in 10 people)

• Fungal infection of the vagina
• Diarrhea
• Feeling of nausea

Uncommon (may affect up to 1 in 100 people)

• Headache
• Dizziness
• Feeling of vertigo
• Vomiting
• Stomach pain
• Indigestion (digestive problems)
• Ulcers in the mouth or digestive tract, inflammation of the digestive tract
• Disorders of liver function
• Changes in hematological or hepatic values
• Weakness or muscle loss. Fatigue or lack of energy. A low level of carnitine in your body can cause these symptoms.
• Hives
• Itching
• Fatigue

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that the side effects are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Selexid

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 after EXP. The expiry date is the last day of the month stated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Selexid

• The active substance is pivmecillinam hydrochloride. One Selexid tablet contains 400 mg of pivmecillinam hydrochloride.
• The other ingredients are hydroxypropylcellulose, hypromellose 6 cps, magnesium stearate, microcrystalline cellulose, simethicone emulsion 30%, and synthetic paraffin.

Appearance and packaging of the product

Selexid is a white, capsule-shaped, film-coated tablet, 8 x 17 mm in size.

Pack sizes:

9, 10, 15, and 20 tablets in blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Karo Pharma AB

Box 16184

103 24 Stockholm

Sweden

Manufacturer:

Recipharm Strängnäs AB, Mariefredsvägen 35, S-645 41 Strängnäs, Sweden

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo n° 29

08022 Barcelona

Spain

Phone: +34 93 205 86 86

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Selexid® 400 mg Tabletten

Denmark: Pivmecillinamhydrochlorid Karo Pharma

Netherlands: Selexid® 400 mg Filmomhulde tabletten

Ireland: Pivmecillinam hydrochloride Karo Pharma 400 mg film-coated tablets

Italy: XSYSTO®

Luxembourg: Selexid® 400 mg Comprimés pelliculés

Poland: X-SYSTO® 400 mg Tabletki powlekane

Spain: Selexid® 400 mg Comprimidos recubiertos con película

Germany: X-SYSTO® 400 mg Filmtabletten

Date of last revision of this leaflet: February 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.