Pylera

Warning! Keep the package leaflet. Information on the immediate packaging in a foreign language.
Pylera, 140 mg + 125 mg + 125 mg, capsules, hard
Bismuthi kalii subcitras + Metronidazolum + Tetracyclini hydrochloridum
Please read the leaflet carefully before using this medicine, as it contains important information for the patient.

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

Contents of the leaflet

1. What Pylera is and what it is 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 PYLERA IS AND WHAT IT IS USED FOR
Pylera contains three different active substances: bismuth potassium citrate, metronidazole, and tetracycline hydrochloride. Tetracycline and metronidazole belong to a group of medicines called antibiotics. Bismuth potassium citrate supports the antibiotics in treating infection.
Pylera contains a combination of substances used to treat adult patients infected with Helicobacter pylori (H. pylori) who have or have had stomach ulcers. H. pylori is a bacterium present in the stomach lining.
Pylera must be taken together with a medicine called omeprazole. Omeprazole is a medicine that works by reducing the amount of acid produced by the stomach. Pylera, when taken together with a proton pump inhibitor (e.g. omeprazole), acts synergistically to eradicate 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 disorders;
• if you have liver disorders;
• if you are allergic (hypersensitive) to bismuth potassium citrate, metronidazole or other nitroimidazole derivatives, tetracycline, or any other component of Pylera (listed in section 6);
• if you have Cockayne's syndrome (see "Warnings and precautions").

Warnings and precautions
Before starting Pylera, discuss this with your doctor or pharmacist.
In patients with Cockayne's syndrome, cases of severe, irreversible liver damage/acute liver failure, including fatal cases occurring very rapidly after starting systemic metronidazole treatment, have been reported.
Inform your doctor immediately and discontinue metronidazole if any of the following occur:

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

Metronidazole, one of the components of this medicine, may exacerbate changes in the ECG, specifically QT interval prolongation, leading to delayed electrical signal conduction and heart rhythm disturbances (arrhythmias), when administered together with substances that may cause similar ECG changes. Discuss this with your doctor before starting Pylera, especially if you have previously experienced such ECG changes or heart rhythm disorders (see "Pylera with other medicines").

When to exercise particular caution when taking Pylera

• if you are scheduled for X-ray imaging, as Pylera may affect imaging results;
• if you are scheduled for blood tests, as Pylera may affect the results of certain blood tests;
• if you have previously been diagnosed with intolerance to certain sugars.

Avoid exposure to sunlight and use of sunbeds during treatment with Pylera, as it may increase sensitivity to sunlight. In case of sunburn, consult your doctor.

Children and adolescents
Pylera capsules must not be given to children under 12 years of age and are not recommended for children aged 12 to 18 years.

Pylera with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
In particular, inform your doctor if you are taking or have recently taken any of the following medicines:

• lithium, used in the treatment of certain psychiatric disorders;
• medicines used to thin the blood or prevent blood clots (e.g. warfarin);
• phenytoin and phenobarbital, used in epilepsy;
• methoxyflurane (an anaesthetic);
• other antibiotics, especially penicillins;
• dietary supplements containing iron, zinc, or sodium hydroxide;
• long-term use of Pylera with other bismuth-containing medicines may affect the nervous system;
• busulfan and fluorouracil, used in chemotherapy;
• cyclosporine, used to suppress immune response after organ transplantation;
• disulfiram, used in the treatment of alcohol dependence;
• ranitidine, used for indigestion and heartburn;
• retinoids, used in the treatment of skin diseases;
• atovaquone, used to treat lung infections;
• medicines known to cause ECG changes (QT interval prolongation) and whose blood concentration may be increased by metronidazole. Such 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).

Do not take antacids containing aluminium, calcium, or magnesium at the same time as Pylera.

Pylera with food, drink, or alcohol
Take Pylera with a full glass of water (250 ml), after meals and at bedtime (preferably after a light snack).
Do not consume dairy products (e.g. milk or yoghurt) or drinks containing calcium at the same time as Pylera or during treatment with Pylera, as this may affect the medicine’s effectiveness.
Do not drink alcohol during treatment with Pylera and for 24 hours after completing treatment.
Drinking alcohol during treatment may cause unpleasant adverse reactions such as nausea, vomiting, abdominal pain (cramps), hot flushes, and headache.
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription.

Pregnancy and breastfeeding
Do not take Pylera if you are, think you may be, or are planning to become pregnant.
If you become pregnant during treatment, contact your doctor immediately.
Do not breastfeed while taking Pylera, as small amounts of its components may pass into breast milk.

Driving and using machines
Do not drive or operate machinery if you experience dizziness, drowsiness, seizures, or temporary blurred or double vision.

Pylera contains monohydrate lactose and potassium
Pylera contains monohydrate lactose, a type of sugar. If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Pylera contains 96 mg of potassium per dose (3 capsules, each containing 32 mg potassium), which should be considered in patients with impaired kidney function and in patients monitoring potassium intake in their diet.

3. HOW TO USE PYLERA

This medicine should always be taken exactly as prescribed by your doctor. Pylera must be taken together with a proton pump inhibitor (e.g., omeprazole). If in doubt, consult your doctor or pharmacist again.
Adults and elderly patients
Do not open the capsules; swallow them whole.
Take 3 capsules of Pylera after breakfast, 3 capsules after lunch, 3 capsules after dinner, and 3 capsules at bedtime (preferably after a light snack), for a total of 12 capsules per day.
Swallow the capsules whole, while sitting upright, with a full glass of water (250 ml) to avoid throat irritation. Do not lie down immediately after taking Pylera. It is important to complete the full course of treatment (10 days) and take all 120 capsules.
Take one tablet (capsule) of omeprazole 20 mg together with the Pylera doses taken after breakfast and after dinner (a total of 2 tablets (capsules) of omeprazole per day).
Daily dosing schedule for Pylera

Overdose of Pylera
If you take more Pylera than recommended, contact your doctor or go to the nearest hospital emergency department immediately. Bring the medicine container and any remaining capsules with you so the doctor knows which medicine has been taken.

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

Stopping treatment with Pylera
It is important to complete the full course of treatment, even if you start to feel better after a few days. If treatment is stopped too early, the infection may not be completely cured and symptoms may return or worsen. Resistance to tetracycline and/or metronidazole (antibiotics) may also develop.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If any of the following conditions occur, stop taking the medicine Pylera immediately and contact your doctor or go to the emergency department of the nearest hospital:

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

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 syndrome)) (See below under "Unknown" adverse reactions).

A serious, but very rare adverse reaction is brain disease (encephalopathy). Symptoms vary, but the patient may experience fever, neck stiffness, headache, seeing or hearing things that do not exist. The patient may also have difficulty moving arms and legs, difficulty speaking, or feel confused. If such symptoms occur, inform your doctor immediately.

Other possible adverse reactions
Very common (may affect more than 1 in 10 people):

• changes in stool consistency and colour, including black stools;
• diarrhoea;
• nausea;
• unusual or metallic taste in the mouth.

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

• abdominal pain;
• constipation;
• dry mouth;
• vomiting;
• flatulence / bloating;
• headache;
• feeling weak;
• feeling of lack of energy and tiredness;
• general malaise;
• vaginal infections – symptoms include itching and irritation in the genital area, burning sensation or yellowish/white vaginal discharge;
• blood tests may show increased liver enzyme activity (aminotransferases);
• darkening of urine;
• loss or decrease of appetite;
• dizziness;
• feeling sleepy;
• 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 make swallowing or breathing difficult; itchy raised rash or hives);
• feeling of abdominal bloating;
• hiccups or belching;
• mouth ulcers / oral ulceration;
• changes in tongue colour (black tongue);
• swelling of the tongue;
• chest pain, feeling of discomfort in the chest;
• fungal infection (candidiasis), which may affect the mouth (symptoms include white patches inside the mouth) or genital area (symptoms include intense itching, burning, irritation);
• numbness;
• tingling;
• tremor;
• feeling of anxiety, depression or difficulty sleeping;
• memory disturbances;
• skin disorders such as itching or burning (urticaria);
• blurred vision;
• dizziness.

Unknown (frequency cannot be estimated from the available data):

• serious illness with blisters on the skin, in the mouth, around the eyes and genital organs (Stevens-Johnson syndrome);
• serious illness with blisters on the skin (Lyell's syndrome, toxic epidermal necrolysis);
• flu-like symptoms, facial rash spreading to the whole body with high fever, elevated liver enzymes in blood tests, increased number of certain white blood cells (eosinophilia), and enlarged lymph nodes (DRESS);
• blisters (skin blisters) and skin peeling;
• aseptic meningitis: a syndrome including fever, nausea, vomiting, headache, neck stiffness, 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 weakness in hands or feet (peripheral neuropathy);
• inflammation of the large intestine (pseudomembranous colitis).

Reporting of adverse reactions
If any adverse reactions occur, including any 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, 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
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. HOW TO STORE PYLERA

Keep this medicine out of the 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 stated month.
No special temperature storage conditions are required. Store in the original packaging to protect from light and moisture.
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. PACK CONTENTS AND OTHER INFORMATION

What Pylera contains
The active substances in this medicinal product are bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride.
Each capsule contains 140 mg of bismuth subcitrate potassium (equivalent to 40 mg of bismuth oxide), 125 mg of metronidazole, and 125 mg of tetracycline hydrochloride.
Other ingredients: magnesium stearate (E 572), monohydrate lactose, talc (E 553b).
Capsule shell: titanium dioxide (E 171), gelatin, and printing ink containing shellac, propylene glycol, and red iron oxide (E 172).
This medicine contains monohydrate lactose and potassium. See section 2.

What Pylera looks like and contents of the pack
Elongated, white, opaque capsule, with the Aptalis Pharma logo printed on the body of the capsule and "BMT" printed in red on the cap. The capsules contain white powder and additionally a small opaque capsule containing yellow powder.

Pylera capsules are available in HDPE bottles with child-resistant closure, containing a desiccant (silica gel) and an absorbent material roll, packed in a cardboard box. The bottle contains 120 capsules.

To protect against moisture, a desiccant (silica-containing package) and an absorbent material roll are included in the bottle. The desiccant or the absorbent roll must not be ingested.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Portugal, 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
Poland

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

Marketing Authorisation number in Portugal, country of export: 5398243
Parallel Import Authorisation number: 131/23

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Belgium: Tryplera
Austria, Czech Republic, France, Spain, Germany, Poland, Portugal, Slovakia, Italy: Pylera