Pilera

PATIENT INFORMATION LEAFLET: USER INFORMATION

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Pylera, 140 mg + 125 mg + 125 mg, hard capsules

Bismuth potassium dicitrate + Metronidazole + Tetracycline hydrochloride

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

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, 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 supports antibiotics in the treatment of infection. Pylera is used to treat adult patients infected with Helicobacter pylori (H. pylori)who have or have had stomach ulcers. H. pyloriis a bacterium 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 (e.g., omeprazole) has a combined effect aimed at curing the infection and relieving the 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 component of Pylera (listed in 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, cases of severe, irreversible liver damage/acute liver failure, including deaths, have been reported, 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 components of this medicine, may increase changes in the ECG recording, i.e., prolongation of the QT interval, leading to delayed conduction of electrical signals and heart rhythm disorders (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 disorders (see "Pylera and other medicines").

When to be particularly 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 previously had intolerance to certain sugars.

You should avoid exposure to the sun and use a sunbedwhile taking Pylera, as it may increase the effect of sunlight. If you get sunburned, you should see a 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 the medicines you plan to take, including those that are 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;
• Taking Pylera with other medicines containing bismuth for a long time may affect the nervous system;
• Busulfan and fluorouracil used in chemotherapy;
• Cyclosporine used to suppress the body's immune response after transplantation;
• 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 (QT interval prolongation) and in which the increase in blood concentration is caused by metronidazole. These substances include, among others:
• 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 beverages with 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 that are available without a prescription.

Pregnancy and breastfeeding

You should not take Pylera if you are pregnant, may be pregnant, or are breastfeeding. If you become pregnant during treatment, you should contact your doctor. While taking Pylera, you should not breastfeed, as small amounts of Pylera's components may pass into breast milk.

Driving and using machines

You should not drive or operate machines if you experience dizziness, drowsiness, seizures, or a feeling of temporary blurred or double vision.

Pylera contains lactose monohydrate and potassium

Pylera contains lactose monohydrate, which is a type of sugar. If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking the medicine. 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 potassium intake in their diet.

3. HOW TO TAKE PYLERA

This medicine should always be taken according to the doctor's instructions. Pylera should be taken with a medicine called a proton pump inhibitor (e.g., omeprazole). If you have any doubts, 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 essential 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 of Pylera

Taking a higher dose of Pylera than recommended

If you take a higher dose of Pylera than recommended, you should contact your doctor or go to the emergency room of the nearest hospital. You should bring the medicine bottle and the remaining capsules, so the doctor knows what medicine was 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. Do 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 essential 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 doubts about taking this medicine, you should consult 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 swallowing or breathing;
• itching, hives, or rash.

These may be symptoms of an allergic reaction.

• Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's 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 a fever, stiff neck, headache, see or hear things that do not exist. You may also have difficulty moving your arms and legs, speaking, or feeling confused. 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 elevated 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 including swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing; itching, hives, or rash;
• 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 infections (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)

• severe disease with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome);
• severe disease with blisters on the skin (Lyell's syndrome, toxic epidermal necrolysis);
• flu-like symptoms, rash on the face spreading to the whole body with high fever, elevated liver enzyme activity in blood tests, increased number of a certain type of white blood cell (eosinophilia), and swollen 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).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products 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. 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 packaging. The expiry date refers to the last day of the month. There are no special storage temperature requirements. Store in the original packaging 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, and 125 mg of tetracycline hydrochloride. The other ingredients are magnesium stearate (E 572), lactose monohydrate, talc (E 553b). The capsule shell contains titanium dioxide (E 171), gelatin, and a printing ink containing shellac, propylene glycol, and iron oxide red (E 172). Pylera contains lactose monohydrate and potassium. See section 2.

What Pylera looks like and contents of the pack

Pylera is a white, opaque, elongated capsule with the logo "Aptalis Pharma" printed on the body of the capsule and "BMT" printed in red on the cap of the capsule. The capsules contain a white powder and, in addition, a small, opaque capsule containing a yellow powder. Pylera capsules are available in HDPE bottles with a child-resistant closure, a desiccant, and a moisture-absorbing agent (silica gel) in a cardboard box. The bottle contains 120 capsules. To protect against moisture, the bottle contains a desiccant (silica gel) and a moisture-absorbing pad. You should not take the desiccant or the moisture-absorbing pad. For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Laboratoires Juvisé Pharmaceuticals, 149 boulevard Bataille de Stalingrad, 69100 Villeurbanne, France

Manufacturer:

Allergan Pharmaceuticals International Limited, Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Marketing authorization number in Portugal, the country of export: 5398243

Parallel import authorization number: 131/23

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 approval of the leaflet: 06.07.2023

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