X-sisto

Package Leaflet: Information for the Patient

X-Systo, 400 mg, Coated Tablets

Pivmecillinam Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is X-Systo and what is it used for
• 2. Important information before taking X-Systo
• 3. How to take X-Systo
• 4. Possible side effects
• 5. How to store X-Systo
• 6. Contents of the pack and other information

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

X-Systo belongs to a group of medicines called penicillins. It is a type of antibiotic. The action of X-Systo is to kill bacteria that cause infections.
X-Systo is used to treat urinary tract infections (cystitis) in adults.

2. Important information before taking X-Systo

Your doctor may prescribe a different dose of X-Systo than stated in this leaflet or recommend a different way of taking the medicine.
Always follow the doctor's instructions.

When not to take X-Systo:

• 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, such as penicillin or cephalosporins.
• If you have ever had a severe skin rash or skin peeling, blistering, and (or) ulcers in the mouth after taking X-Systo or other beta-lactam antibiotics (such as amoxicillin, penicillin V, and flucloxacillin).
• If you have been diagnosed with esophageal narrowing.
• If you have a condition that may decrease the level of a substance called carnitine in your body. These conditions include carnitine transporter defect, methylmalonic aciduria, and propionic acidemia.

Warnings and precautions

Before starting to take X-Systo, discuss it with your doctor, pharmacist, or nurse.
Swallow the tablets with at least half a glass of liquid to prevent the tablets from getting stuck in the esophagus.
Before starting treatment, tell your doctor if:

• you have porphyria;
• you have taken X-Systo recently, as long-term use of the medicine may decrease the level of carnitine in your body.

During treatment:

• Severe skin reactions have been reported in association with X-Systo treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If you experience any symptoms related to these severe skin reactions described in section 4, stop taking X-Systo and seek medical attention immediately.
• If you experience sudden diarrhea while taking X-Systo, inform your doctor immediately. The cause of the diarrhea may be colitis.
• Taking pivmecillinam during pregnancy shortly before delivery may affect the results of genetic screening tests performed on the newborn. One of these tests may give a false-positive result. A false-positive result is a positive result that indicates the presence of a particular disease in the child, even though the disease is not actually present. This does not pose any risk to the newborn, but if you have taken X-Systo shortly before delivery, you should inform your doctor.

Children and adolescents

This medicine should 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 about all medicines you are taking, have recently taken, or might take.
This is especially 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). The elimination of methotrexate from the body may be slower if taken with X-Systo;
• valproate or valproic acid (used to treat epilepsy). Taking these medicines with X-Systo may increase the risk of carnitine deficiency in the body;
• other medicines used to treat infections (e.g., tetracyclines, erythromycin, other beta-lactam antibiotics). They may affect the efficacy of X-Systo.

X-Systo with food and drink

The medicine can be taken with or without food. X-Systo should be swallowed with at least half a glass of water. It is essential to take the medicine with a large amount of liquid and long before bedtime. This helps prevent problems in the esophagus.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
X-Systo can be taken during pregnancy.
There have been reports of false-positive results in newborn screening tests simulating the presence of isovaleric acidemia. Taking pivmecillinam during pregnancy shortly before delivery may affect the results of genetic screening tests performed on the newborn. One of these tests may give a false-positive result. A false-positive result is a positive result that indicates the presence of a particular disease in the child, even though the disease is not actually present. This does not pose any risk to the newborn, but if you have taken X-Systo shortly before delivery, you should inform your doctor.

Driving and using machines

X-Systo has no or negligible influence on the ability to drive and use machines.

3. How to take X-Systo

Always take this medicine exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor, pharmacist, or nurse. The medicine should be taken at equal intervals during the day. If you are supposed to take the medicine three times a day, take it at breakfast, lunch, and dinner time. X-Systo should be swallowed with at least half a glass of liquid. The duration of treatment is determined by your doctor.
The recommended dose is 400 mg three times a day.
Elderly patients: no dose adjustment is necessary.
Dose adjustment is not necessary for patients with impaired renal or hepatic function.

If you take more X-Systo than you should

Inform your doctor immediately. It may be necessary to stop taking the medicine. You may experience nausea, vomiting, or stomach upset.

If you forget to take X-Systo

If you miss a dose, take it as soon as you remember. Always swallow the tablet with at least half a glass of water or other liquid. Take the next dose at the usual time.

Stopping X-Systo treatment

It is very important to finish the treatment as advised by your doctor. Do not stop taking the medicine, even if you feel better. If you stop the treatment too early, your condition may worsen.
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, X-Systo can cause side effects, although not everybody gets them.

Serious side effects:

Stop taking X-Systo and seek medical attention immediately if you experience any of the following symptoms:

• Severe allergic reactions (anaphylactic reactions, angioedema, anaphylactic shock) - symptoms include sudden skin rash, swelling of the face, lips, tongue, and (or) throat,

difficulty breathing or swallowing, fainting due to hypersensitivity. These reactions can be life-threatening.

• Red, flat, target-like, or circular patches on the torso, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. Before the onset of these severe skin reactions, patients may experience 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).
• Prolonged and severe bloody diarrhea with abdominal pain and fever (Clostridium difficile-associated colitis).

Anaphylactic reactions and Clostridium difficile-associated colitis are not very common and may occur less frequently than in 1 in 100 patients. The frequency of angioedema and anaphylactic shock is not known.
Inform your doctor if you experience the following serious side effect:

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

Other side effects:

Common: occurring in less than 1 in 10 patients.

• Vaginal fungal infection
• Diarrhea
• Nausea

Uncommon: occurring in less than 1 in 100 patients.

• Headache
• Dizziness
• Feeling of spinning
• Vomiting
• Abdominal pain
• Indigestion (digestive problems)
• Ulcers in the mouth or esophagus, esophagitis
• 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 carnitine levels in the body.
• Hives
• Itching
• Fatigue

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store X-Systo

Keep the medicine out of the 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 month.
There are no special precautions for storage.
Medicines should 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 pack and other information

What X-Systo contains

• The active substance is pivmecillinam hydrochloride. One X-Systo coated tablet 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 white, capsule-shaped coated 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 authorization holder and manufacturer

Marketing authorization holder:
Karo Pharma AB
Box 16184
103 24 Stockholm
Sweden
[email protected]
Phone: +48 885 500 706
Manufacturer:
Recipharm Strängnäs AB
Mariefredsvägen 35
S-645 41 Strängnäs
Sweden

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

Belgium: Selexid 400 mg Tablets
Denmark: Pivmecillinamhydrochlorid Karo Pharma
Netherlands: Selexid 400 mg Film-coated Tablets
Ireland: Pivmecillinam hydrochloride Karo Pharma 400 mg film-coated tablets
Italy: XSYSTO
Luxembourg: Selexid 400 mg Film-coated Tablets
Poland: X-Systo 400 mg Coated Tablets
Spain: Selexid 400 mg Film-coated Tablets
Germany: X-SYSTO 400 mg Film-coated Tablets

Date of last revision of the leaflet: