XsySto

Patient Information Leaflet

XSYSTO 400 mg film-coated tablets

Pivmecillinam hydrochloride
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What XSYSTO is and what it is used for

XSYSTO belongs to a group of medicines called penicillins. It is a type of antibiotic. XSYSTO
works by killing the germs (bacteria) that cause infections.
XSYSTO is used to treat bladder infections (cystitis) in adults.

2. What you need to know before taking XSYSTO

Your doctor may have prescribed a different dosage or usage than that stated in this leaflet. Always follow your doctor's instructions.
Do not take XSYSTO:

• If you are allergic (hypersensitive) to pivmecillinam or to any of the ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to other antibiotics. These include penicillins or cephalosporins.
• If you have narrowing of the oesophagus.
• If you have a condition that may lead to reduced levels in your body of a substance called carnitine. Such conditions include carnitine transporter defect, methylmalonic aciduria, and propionic acidemia.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking XSYSTO. The tablets should be taken with at least half a glass of liquid to avoid them becoming stuck in the oesophagus.
Inform your doctor before starting treatment:

• If you have porphyria
• If you have recently taken XSYSTO, as prolonged use may reduce the amount of carnitine in your body

During treatment:

• If you suddenly develop diarrhoea while taking XSYSTO, inform your doctor immediately. This may be due to inflammation of the intestine (colitis).
• Taking pivmecillinam shortly before delivery may interfere with newborn screening tests for inherited metabolic disorders and cause a false positive result. A "false positive" means the test incorrectly indicates the presence of a disorder in the newborn. There is no risk to the newborn, but it is important to inform your doctor if you have taken XSYSTO shortly before delivery.

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.
Other medicines and XSYSTO
Inform 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 using any of the following medicines:

• Probenecid (used to treat gout). It may increase the effect of XSYSTO.
• Methotrexate (used to treat rheumatism and cancer). Elimination of methotrexate from the body may be slower when taken with XSYSTO.
• Valproate or valproic acid (used to treat epilepsy). This increases the risk of carnitine deficiency when taken with XSYSTO.
• Other anti-inflammatory drugs (e.g. tetracyclines, erythromycin, other beta-lactam antibiotics). These may affect the effect of XSYSTO.

XSYSTO with food and drink
You may take this medicine during or immediately after meals. You must take XSYSTO with at least half a glass of water. It is important to take the medicine with plenty of fluid and well before going to bed. This will help prevent problems with the oesophagus.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
XSYSTO may be taken during pregnancy.
There have been reports of false positive results in newborn screening tests that mimic a metabolic disorder called isovaleric acidemia. Taking pivmecillinam shortly before delivery may interfere with newborn screening for inherited metabolic disorders and produce a false positive result. A "false positive" means the test incorrectly indicates the presence of the disorder in the newborn. There is no risk to the newborn, but it is important to inform your doctor if you have taken XSYSTO shortly before delivery.
Breast-feeding
XSYSTO may be taken during breast-feeding.
Fertility
No clinical studies on fertility have been conducted.
Driving and using machines
XSYSTO has no effect or only a negligible effect on the ability to drive or use machines.

3. How to take XSYSTO

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor, pharmacist, or nurse. You must take the medicine at regular intervals throughout the day. If you are to take it three times a day, take it with breakfast, lunch, and dinner. XSYSTO should be taken with at least half a glass of liquid. Your doctor will tell you how long you need to take XSYSTO tablets.

The recommended dose is 400 mg three times daily.

Elderly: dose adjustment is not required.

In case of reduced renal or hepatic function, dose adjustment is not required.

If you take more XSYSTO than you should:

Inform your doctor immediately. It may be necessary to discontinue the medicine. You may feel unwell, experience general malaise, or have stomach disturbances.

If you forget to take XSYSTO:

If you forget to take your dose, take it as soon as you remember. Always take it with half a glass of water or another liquid. Then take your next dose at the usual time.

If you stop taking XSYSTO:

It is very important to take the amount of medicine prescribed by your doctor. You must complete the full course of treatment, even if you feel better. This is necessary to prevent your symptoms from returning.

If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

More serious side effects:

Uncommon: may affect up to 1 in 100 people.

• Sudden rash, swelling of the face and/or throat, difficulty breathing or fainting due to hypersensitivity (anaphylactic reaction). Seek immediate medical help because you may need urgent medical treatment.
• Severe and persistent diarrhoea with blood, stomach pain and fever (pseudomembranous colitis). Seek immediate medical help because you may need urgent medical treatment.
• Bleeding from the skin and mucous membranes and appearance of bruises due to changes in the blood (low platelet count) (thrombocytopenia). Contact your doctor.

Other side effects:

Common: may affect up to 1 in 10 people

• Vaginal fungal infections
• Diarrhoea
• Feeling unwell (nausea)

Uncommon: may affect up to 1 in 100 people

• Headache
• Dizziness
• Feeling unwell (vomiting)
• Stomach pain
• Mouth or oesophageal ulcers, inflammation of the oesophagus
• Liver function disorders
• Changes in blood or liver test values
• Muscle weakness or loss of muscle tone. Tiredness or lack of energy. A deficiency of carnitine in the body may cause these symptoms.
• Hives (urticaria)
• Itching (pruritus)
• Fatigue

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store XSYSTO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What XSYSTO contains

• The active substance is pivmecillinam hydrochloride. One 400 mg film-coated tablet of XSYSTO contains 400 mg of pivmecillinam hydrochloride.
• The other components are hydroxypropyl cellulose, hypromellose 6 cps, magnesium stearate, microcrystalline cellulose, simeticone emulsion 30%, synthetic paraffin.

Description of the appearance of XSYSTO and contents of the pack
XSYSTO is a white, film-coated, capsule-shaped tablet, 8 x 17 mm in size.
Pack sizes:
9, 10, 15 and 20 tablets in a blister pack.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Karo Pharma AB
Box 16184
103 24 Stockholm
Sweden
Manufacturer:
Recipharm Strängnäs AB, Mariefredsvägen 35, S-645 41 Strängnäs, Sweden

This medicinal product is authorised in the European Economic Area countries 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 pelicula
Germany: X-SYSTO 400 mg Filmtabletten

This patient information leaflet has been last updated on: