Package leaflet: Information for the patient

X-Systo, 400 mg, film-coated tablets
Piwmecillinam hydrochloride
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What X-Systo is and what it is used for
What you need to know before taking X-Systo
How to take X-Systo
Possible side effects
How to store X-Systo
Contents of the pack and other information

1. What X-Systo is and what it is used for

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

2. Important information before taking X-Systo

Your doctor may prescribe a different dose of this medicine than that stated in this leaflet or recommend a different method of administration.
Always follow your doctor's instructions.
When not to take X-Systo:

If the patient is allergic (hypersensitive) to piwmecylinam or to any of the other ingredients of this medicine (listed in section 6).
If the patient is allergic (hypersensitive) to other antibiotics, such as penicillin or cephalosporins.
If the patient has ever experienced severe skin rash, skin peeling, blistering and/or oral ulcers after taking X-Systo or other beta-lactam antibiotics (such as amoxicillin, penicillin V, or flucloxacillin).
If the patient has oesophageal stricture.
If the patient has a condition that may reduce levels in the body of a substance called carnitine. Such conditions include carnitine transporter defect, methylmalonic aciduria, and propionic acidemia.

Warnings and precautions
Before starting X-Systo, discuss this with your doctor, pharmacist, or nurse.
The tablets should be swallowed with at least half a glass of liquid to help prevent the tablets from becoming stuck in the oesophagus.
Before starting treatment, the patient should inform the doctor if:

They suffer from porphyria;
They have recently taken X-Systo, as prolonged use of the medicine may reduce carnitine levels in the body.

During treatment:

Severe skin reactions have been reported in association with treatment with X-Systo, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If any symptoms related to these severe skin reactions described in section 4 occur, the patient must stop taking X-Systo and seek immediate medical advice.
If the patient develops sudden diarrhoea while taking X-Systo, they should inform their doctor immediately. Diarrhoea may be due to inflammation of the large intestine.
Administration of piwmecylinam to a pregnant woman shortly before delivery may affect the results of newborn screening tests for genetic disorders performed on her baby. One of these tests may yield a false positive result. A "false positive" result is a positive result indicating the presence of a disease in the child when in fact the disease is not present. This does not pose any risk to the newborn, but if the patient took X-Systo shortly before delivery, she should inform her doctor.

Children and adolescents
X-Systo must not be given to children and adolescents under 18 years of age, as the potential benefits may not outweigh the risks.
X-Systo and other medicines
Tell your doctor or pharmacist if the patient is currently taking, has recently taken, or might take any other medicines.
This is particularly important for the following medicines:

Probenecid (used to treat gout). This medicine may enhance the effect of X-Systo;
Methotrexate (used to treat rheumatism, cancer). Elimination of methotrexate from the body may be slower when taken together with X-Systo;
Valproate or valproic acid (used to treat epilepsy). Taking these medicines with X-Systo increases the risk of carnitine deficiency in the body;
Other medicines used for infections (e.g. tetracyclines, erythromycin, other beta-lactam antibiotics). These may affect the effectiveness of X-Systo.

X-Systo with food and drink
The medicine can be taken with or immediately after a meal. X-Systo should be swallowed with at least half a glass of water. It is important to take the medicine with plenty of fluid and well before bedtime. This helps prevent problems in the oesophagus.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
X-Systo may be taken during pregnancy.
Cases of false positive results in newborn screening tests simulating isovaleric acidemia have been reported. Administration of piwmecylinam to a pregnant woman shortly before delivery may affect the results of newborn screening tests for genetic disorders performed on her baby. One of these tests may yield a false positive result. A "false positive" result is a positive result indicating the presence of a disease in the child when in fact the disease is not present. This does not pose any risk to the newborn, but if the patient took X-Systo shortly before delivery, she should inform her doctor.
Breastfeeding
X-Systo may be taken during breastfeeding.
Fertility
No clinical studies have been conducted on the effect of the medicine on fertility.
Driving and operating machinery
X-Systo has no effect or has a negligible effect on the ability to drive and operate machinery.

3. How to take X-Systo

This medicine should always be taken exactly as described in the patient leaflet or as prescribed by your
doctor or pharmacist. If in doubt, consult your doctor, pharmacist, or nurse. The medicine should be taken at
regular intervals throughout the day. If the patient is to take the medicine three times a day, it should be taken
with breakfast, lunch, and dinner. X-Systo should be swallowed with at least half a glass of liquid. The timing of X-Systo tablet intake will be determined by the doctor.
The recommended dose is 400 mg three times daily.
Elderly patients: dose adjustment is not necessary.
Dose adjustment is not required in patients with impaired renal or hepatic function.
Taking more X-Systo than recommended
Contact your doctor immediately. It may be necessary to discontinue treatment with this medicine. The
patient may experience nausea, vomiting, or gastrointestinal disturbances.
If you forget to take X-Systo
If a dose is missed, the patient should take it as soon as they remember. The medicine should always be swallowed with at least half a glass of water or another liquid. The next dose should be taken at the usual time.
Stopping X-Systo
It is very important to stop taking this medicine exactly as directed by your doctor. Do not stop taking the
medicine, even if you feel better. Stopping treatment too early may cause your condition to worsen again.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions:
Stop taking X-Systo and contact your doctor immediately if you experience
any of the following symptoms:

Severe allergic reactions (anaphylactic reactions, angioedema, anaphylactic shock) – symptoms include, among others, sudden skin rash, swelling of the face, lips, tongue and (or) throat,
difficulty breathing or swallowing, fainting due to hypersensitivity. These reactions may
be life-threatening.
Reddish, flat, target-like or circular spots on the trunk, often with central blisters, peeling of the skin, and mucosal ulcers in the mouth, throat, nose, genital organs and eyes. Before these severe skin reactions occur, patients may experience fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Severe and prolonged bloody diarrhoea accompanied by abdominal pain and fever (colitis caused by Clostridium difficile bacteria).

Anaphylactic reactions and Clostridium difficile-induced colitis occur
not commonly and may affect fewer than 1 in 100 patients. The frequency of angioedema and anaphylactic shock is unknown.
Contact your doctor if the following serious adverse reaction occurs:

Bleeding from the skin and mucous membranes and skin bruising due to changes in blood parameters (low platelet count) (thrombocytopenia). Not common: occurring in fewer than 1 in 100 patients.

Other adverse reactions:
Common: occurring in fewer than 1 in 10 patients.

Vaginal fungal infection
Diarrhoea
Nausea

Not common: occurring in fewer than 1 in 100 patients.

Headache
Dizziness
Sensation of spinning
Vomiting
Abdominal pain
Indigestion (digestive problems)
Mouth or oesophageal ulceration, oesophagitis
Liver function disorders
Changes in blood and liver test results
Muscle weakness or loss of muscle mass. Fatigue or lack of energy. These symptoms may be caused by low levels of carnitine in the body.
Urticaria
Itching
Fatigue

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this
leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be
reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine X-Systo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What the medicinal product X-Systo contains

The active substance is pivmecillinam hydrochloride. One film-coated tablet of X-Systo contains 400 mg of pivmecillinam hydrochloride.
The other ingredients are: hydroxypropylcellulose, hypromellose 6 cps, magnesium stearate, microcrystalline cellulose, simethicone emulsion 30%, synthetic paraffin.

What X-Systo looks like and contents of the pack
X-Systo is a film-coated tablet in a capsule shape, white in colour, size 8 x 17 mm.
Pack sizes: 9, 10, 15 and 20 tablets in blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Karo Pharma AB
Box 16184
103 24 Stockholm
Sweden
[email protected]
Tel.: +48 885 500 706
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