Pilera

PATIENT INFORMATION LEAFLET: USER INFORMATION

Pylera 140 mg + 125 mg + 125 mg hard capsules

Bismuth potassium dicitrate+Metronidazole+Tetracycline hydrochloride

You should read the contents of this leaflet carefully before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further questions.
• This medicine has been prescribed specifically for you. 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. WHAT IS PYLERA AND WHAT IS IT USED FOR

Pylera contains 3 different active substances: bismuth potassium dicitrate, metronidazole and tetracycline hydrochloride. Tetracycline and metronidazole belong to a group of medicines called antibiotics. Bismuth potassium dicitrate helps the antibiotics to treat the infection.
Pylera is used to treat adult patients infected with Helicobacter pylori (H. pylori)who have or have had stomach ulcers. H. pyloriis a bacteria present in the stomach lining.
Pylera should be taken with a medicine called omeprazole.Omeprazole is a medicine that works by reducing the amount of acid produced by the stomach. Pylera taken together with a proton pump inhibitor (such as omeprazole) has a combined effect to cure the infection and reduce inflammation of the stomach lining.

2. IMPORTANT INFORMATION BEFORE TAKING PYLERA

When not to take Pylera

• if you are pregnant or breastfeeding.
• in patients under 12 years of age.
• if you have kidney problems.
• if you have liver problems.
• if you are allergic (hypersensitive) to bismuth potassium dicitrate, metronidazole or other nitroimidazole derivatives, tetracycline or any other ingredient of Pylera (see section 6).
• if you have Cockayne syndrome (see Warnings and precautions).

Warnings and precautions

Before starting treatment with Pylera, you should discuss it with your doctor or pharmacist.
In patients with Cockayne syndrome, there have been reports of severe, irreversible liver damage/acute liver failure, including cases of death, which occurred very shortly after starting systemic metronidazole treatment.
You should immediately inform your doctor and stop taking metronidazole if you experience:

• abdominal pain, loss of appetite, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, dark stools or itching.

Metronidazole, one of the ingredients of this medicine, may increase changes in the ECG recording, i.e. prolongation of the QT interval, which can lead to delayed conduction of electrical signals and heart rhythm disturbances (arrhythmias), when given with compounds that can cause similar changes in the ECG recording. Before starting treatment with Pylera, you should discuss it with your doctor, especially if you have previously had such changes in the ECG recording or heart rhythm disturbances (see "Pylera and other medicines").

When to be careful when taking Pylera

• if you are going to have an X-ray, as Pylera may affect the results of the X-ray.
• if you are going to have blood tests, as Pylera affects the results of some blood tests.
• if you have ever had intolerance to some sugars.

You should avoid exposure to the sun and use of sunbedsduring treatment with Pylera, as it may increase the effect of sunlight. If you get sunburn, you should contact your doctor.

Children and adolescents

Pylera capsules should not be given to children under 12 years of age and are not recommended for children between 12 and 18 years of age.

Pylera and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.
In particular, you should inform your doctor if you are taking or have recently taken any of the following medicines:

• lithium used to treat certain mental disorders;
• medicines used to thin the blood or prevent blood clots (e.g. warfarin);
• phenytoin and phenobarbital used in epilepsy;
• methoxyflurane (an anesthetic);
• other antibiotics, especially penicillins;
• dietary supplements containing iron, zinc, sodium hydroxide;
• long-term use of Pylera with other bismuth-containing medicines may affect the nervous system;
• busulfan and fluorouracil used in chemotherapy;
• cyclosporin used to suppress the body's immune response after a transplant;
• disulfiram used in people with alcohol problems;
• ranitidine used in indigestion and heartburn;
• retinoids used to treat skin diseases;
• atovaquone used to treat lung infections;
• medicines known to cause changes in the ECG recording (prolongation of the QT interval) and for which increased blood levels are caused by metronidazole.

Such substances include:

• Amiodarone (used to treat heart rhythm disorders);
• Ondansetron (used to treat nausea and vomiting);
• Methadone (used as replacement therapy in opioid dependence);
• Domperidone (used to treat nausea and vomiting)

You should not take antacids containing aluminum, calcium or magnesium at the same time as Pylera.

Pylera with food, drink or alcohol

Pylera should be taken with a full glass of water (250 ml), aftermeals and before bedtime (preferably after a snack).
You should not eat or drink dairy products(e.g. milk or yogurt) or drinks containing calciumat the same time as taking Pylera and during treatment with Pylera, as this may affect the action of the medicine.
You should not drink alcoholwhile taking Pylera and for 24 hours after finishing treatment.
Drinking alcohol during treatment may cause unpleasant side effects, such as nausea, vomiting, abdominal pain (abdominal cramps), hot flashes and headache.
You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, including those available without a prescription.

Pregnancy and breastfeeding

You should not take Pylera if you are pregnant, may be pregnant or think you may be pregnant.
If you become pregnant during treatment, you should contact your doctor.
You should not breastfeed while taking Pylera, as small amounts of Pylera ingredients may pass into breast milk.

Driving and using machines

You should not drive or operate machinery if you experience dizziness, drowsiness, seizures or temporary blurred or double vision.

Pylera contains lactose and potassium

Pylera contains lactose, which is a type of sugar. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking Pylera.
Pylera contains 96 mg of potassium in one dose (3 capsules, each containing 32 mg of potassium), which should be taken into account in patients with reduced kidney function and in patients controlling their potassium intake.

3. HOW TO TAKE PYLERA

This medicine should always be taken as directed by your doctor. Pylera should be taken with a medicine called a proton pump inhibitor (such as omeprazole). If you are unsure, you should contact your doctor or pharmacist again.

Adults and the elderly

You should not open the capsules, but swallow them whole.
You should take 3 Pylera capsules after breakfast, 3 capsules after lunch, 3 capsules after dinner and 3 capsules before bedtime (preferably after a snack), for a total of 12 capsules per day.
You should swallow the capsules whole, sitting upright, with a full glass of water (250 ml), to avoid irritating the throat. Do not lie down immediately after taking Pylera. It is important to complete the full treatment cycle (10 days) and take all 120 capsules.
You should take one omeprazole tablet (capsule) 20 mg with the Pylera doses taken after breakfast and dinner (for a total of 2 omeprazole tablets (capsules) per day).
Daily dosing schedule for Pylera

Taking more Pylera than prescribed

If you take more Pylera than prescribed, you should contact your doctor or go to the emergency room of the nearest hospital. You should take the medicine bottle and the remaining capsules with you, so the doctor knows what medicine you have taken.

Missing a dose of Pylera

If you miss a dose, you should take it as soon as you remember. However, if it is almost time for the next dose, you should skip the missed dose. You should not take a double dose to make up for the missed dose. If you miss more than 4 consecutive doses of Pylera (1 day), you should contact your doctor.

Stopping treatment with Pylera

It is important to complete the full treatment cycle, even if you feel better after a few days. If you stop treatment too early, the infection may not be fully cured and the symptoms of the infection may return or worsen. Resistance to tetracycline or (and) metronidazole (antibiotics) may also develop.
If you have any further questions about the use of this medicine, you should contact your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

If you experience any of the following, you should stop taking Pylera and contact your doctor or go to the emergency room of the nearest hospital:

• swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing or breathing;
• itching, lumpy rash or hives.

These may be symptoms of an allergic reaction.

• Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), drug reaction with eosinophilia and systemic symptoms (DRESS)) (See below under "Unknown" side effects).

A severe but very rare side effect is brain disease (encephalopathy). The symptoms are varied, but you may have fever, stiff neck, headache, see or hear things that do not exist. You may also have difficulty moving your arms and legs, speaking or have a feeling of confusion. If you experience such symptoms, you should immediately tell your doctor.

Other possible side effects

Very common(may affect more than 1 in 10 people):

• changes in stool consistency and color, including blackening of the stool;
• diarrhea;
• nausea;
• unusual or metallic taste in the mouth.

Common(may affect up to 1 in 10 people):

• abdominal pain;
• constipation;
• dry mouth;
• vomiting;
• wind/bloating;
• headache;
• feeling weak;
• feeling tired;
• general malaise;
• vaginal infections - symptoms including itching and irritation in the genital area, burning or yellow/white discharge from the vagina;
• blood tests may show increased liver enzyme activity (aminotransferases);
• dark urine;
• loss of or decreased appetite;
• dizziness;
• feeling drowsy;
• skin problems, such as redness (rash).

Uncommon(may affect up to 1 in 100 people):

• allergic reaction to the medicine (symptoms include swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing or breathing; itching, lumpy rash or hives;
• feeling bloated;
• hiccups or belching;
• mouth ulcers/oral thrush;
• changes in tongue color (dark tongue);
• tongue swelling;
• chest pain, feeling uncomfortable in the chest;
• fungal infection (candidiasis), which may include the mouth (symptoms are white patches in the mouth) or genitals (symptoms are intense itching, burning, irritation);
• numbness;
• tingling;
• tremors;
• feeling anxious, depressed or having difficulty sleeping;
• memory problems;
• skin problems, such as itching or burning (hives);
• blurred vision;
• dizziness.

Unknown(frequency cannot be estimated from the available data)

• serious disease with blisters on the skin, in the mouth, around the eyes

and genitals (Stevens-Johnson syndrome);

• serious disease with blisters on the skin (Lyell syndrome, toxic epidermal necrolysis);
• flu-like symptoms, rash on the face spreading to the whole body with high temperature, elevated liver enzymes in blood tests, increased number of a certain type of white blood cell (eosinophilia) and enlarged lymph nodes (DRESS);
• blisters (bubbles on the skin) and skin peeling;
• aseptic meningitis: a syndrome of symptoms including fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to light. This may be caused by inflammation of the membranes covering the brain and spinal cord (meningitis);
• nerve damage, which may cause numbness, tingling, pain or a feeling of weakness in the arms or legs (peripheral neuropathy);
• inflammation of the colon (pseudomembranous colitis).
• a neurological disorder called cerebellar syndrome, whose symptoms may include: difficulty in coordinating movements, speaking and/or walking, involuntary eye movements and tremors. This may resolve after stopping treatment.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PYLERA

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine. Store in the original package to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Pylera contains

The active substances of Pylera are bismuth potassium dicitrate, metronidazole and tetracycline hydrochloride.
Each capsule contains 140 mg of bismuth potassium dicitrate (which corresponds to 40 mg of bismuth oxide), 125 mg of metronidazole, 125 mg of tetracycline hydrochloride.
The other ingredients are: magnesium stearate (E572), lactose monohydrate, talc (E553b), titanium dioxide (E171), gelatin and ink for printing containing shellac, propylene glycol and iron oxide red (E 172).
Pylera contains lactose and potassium. See section 2.

What Pylera looks like and what the pack contains

Pylera is a white, opaque, elongated capsule with "BMT" printed in red on the capsule cap. The capsules contain a white powder and also a small, opaque capsule containing a yellow powder.
Pylera capsules are available in high-density polyethylene (HDPE) bottles. The bottle contains 120 capsules.
To protect against moisture, the bottle contains a desiccant (silica gel) and a rayon coil. You should not take the desiccant or the rayon coil.

Marketing authorization holder

LABORATOIRES JUVISE PHARMACEUTICALS
149 Boulevard Bataille de Stalingrad
69100 Villeurbanne
France

Manufacturer

SKYEPHARMA PRODUCTION SAS
Zone Industrielle Chesnes Ouest,
55 rue du Montmurier
38070 Saint Quentin Fallavier
France

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

Belgium: Tryplera Austria, Czech Republic, France, Spain, Germany, Poland, Portugal, Slovakia, Italy: Pylera

Date of last revision of the leaflet: 04/2025.