Pylera

Warning! Keep the package leaflet! Information on the immediate packaging in a foreign language.
Pylera, 140 mg + 125 mg + 125 mg, hard capsules
Bismuth subcitrate potassium + Metronidazole + Tetracycline hydrochloride
Please read the entire leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, 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.

Table of 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 subcitrate potassium, metronidazole, and tetracycline hydrochloride. Tetracycline and metronidazole belong to a group of medicines called antibiotics. Bismuth subcitrate potassium enhances the effect of 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 gastric ulcers. H. pylori is a bacterium present in the gastric mucosa.
Pylera must be taken together with a medicine called omeprazole. Omeprazole is a medicine that reduces the amount of acid produced by the stomach. When taken together with a proton pump inhibitor (e.g., omeprazole), Pylera acts synergistically to eradicate the infection and reduce inflammation of the gastric mucosa.

2. Important information before using Pylera

When not to use Pylera

• if the patient is pregnant or breastfeeding,
• in patients under 12 years of age,
• if the patient has kidney disorders,
• if the patient has liver disorders,
• if the patient has hypersensitivity (allergy) to potassium bismuth citrate, metronidazole or other nitroimidazole derivatives, tetracycline, or to any other component of Pylera (listed in section 6),
• if the patient has Cockayne’s syndrome (see Warnings and precautions).

Warnings and precautions
Before starting treatment with Pylera, discuss this with your doctor or pharmacist.
Severe, irreversible liver damage/acute liver failure, including fatal cases occurring very rapidly after initiation of systemic metronidazole therapy, have been reported in patients with Cockayne’s syndrome.
Immediately inform your doctor and discontinue metronidazole if any of the following symptoms 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 conduction and cardiac arrhythmias, when administered concomitantly with substances that may cause similar ECG changes. Discuss this with your doctor before starting Pylera, especially if there have been previous ECG abnormalities or cardiac rhythm disorders (see "Pylera with other medicines").

When to exercise particular caution when using Pylera

• if the patient is to undergo X-ray imaging, as Pylera may affect imaging results;
• if the patient is to undergo blood tests, as Pylera may influence the results of certain blood tests;
• if the patient has previously been diagnosed with intolerance to certain sugars.

Avoid exposure to sunlight and use of sunbeds during treatment with Pylera, as it may enhance the effects of 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 is not recommended for children aged 12 to 18 years.
Pylera with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use, including those available without prescription.
In particular, inform your doctor if the patient is taking or has recently taken any of the following medicines:

• lithium, used to treat 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, particularly penicillins;
• dietary supplements containing iron, zinc, or sodium hydroxide;
• long-term use of Pylera with other medicines containing bismuth may affect the nervous system;
• busulfan and fluorouracil, used in chemotherapy;
• cyclosporine, used to suppress the 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 disorders;
• atovaquone, used to treat lung infections;
• medicines known to cause ECG changes (QT interval prolongation), and in which increased blood concentration may be caused by metronidazole. Such substances include, among others:
• Amiodarone (used to treat cardiac arrhythmias);
• Ondansetron (used to treat nausea and vomiting);
• Methadone (used as opioid substitution therapy);
• 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
Pylera should be taken 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 taking 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), flushing, and headache.
Inform your doctor or pharmacist about all medicines currently or recently taken, including those available without prescription.
Pregnancy and breastfeeding
Do not use Pylera if the patient is, may be, or suspects she may be pregnant.
If pregnancy occurs during treatment, contact your doctor immediately.
Breastfeeding should be avoided during treatment with Pylera, as small amounts of the components of Pylera may pass into breast milk.
Driving and operating machinery
Do not drive or operate machinery if dizziness, drowsiness, seizures, or transient blurred or double vision occur.
Pylera contains lactose monohydrate and potassium
Pylera contains lactose monohydrate, a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Pylera contains 96 mg of potassium in one dose (3 capsules, each containing 32 mg potassium), which should be taken into account in patients with impaired kidney function and in patients controlling 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
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 before bedtime (preferably after a 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 doses of Pylera taken after breakfast and dinner (a total of 2 tablets (capsules) of omeprazole per day).
Daily dosing schedule for Pylera

Overdose of Pylera
If you take more than the recommended dose of Pylera, contact your doctor or go to the emergency department of your nearest hospital immediately. Take 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 one. 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 or (and) metronidazole (antibiotics) may also develop.

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

4. Possible side effects

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

• 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 "Not known" adverse reactions).

A serious, but very rare side effect is brain disease
(encephalopathy). Symptoms vary, but the patient may have fever, neck stiffness, headache,
see or hear things that are not real. The patient may also have difficulty moving
arms and legs, difficulty speaking, or feel confused. If such symptoms occur, tell your doctor immediately.
Other possible side effects
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):

• stomach pain;
• constipation;
• dry mouth;
• vomiting;
• wind / bloating;
• headache;
• feeling weak;
• feeling of lack of energy and tiredness;
• general malaise;
• vaginal infections – symptoms include itching and irritation around the genital area, burning or yellowish/white vaginal discharge;
• blood tests may show increased liver enzyme (aminotransferase) activity;
• dark-coloured 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 oesophagus, which may make swallowing or breathing difficult; itchy raised rash or hives;
• feeling of abdominal bloating;
• hiccups or burping;
• open sores inside the mouth / mouth ulcers;
• changes in tongue colour (black tongue);
• swelling of the tongue;
• chest pain, discomfort in the chest;
• yeast infection (candidiasis), which may affect the mouth (symptoms: white patches inside the mouth) or genitals (symptoms: intense itching, burning, irritation);
• numbness;
• tingling;
• trembling;
• feeling anxious, depressed, or difficulty sleeping;
• memory disturbances;
• skin disorders such as itching or burning (urticaria);
• blurred vision;
• dizziness.

Not known (frequency cannot be estimated from the available data)

• serious illness with blistering of the skin, mouth, eyes and genital areas (Stevens-Johnson syndrome);
• serious illness with blistering of the skin (Lyell's syndrome, toxic epidermal necrolysis);
• flu-like symptoms, facial rash spreading over the whole body with high fever, elevated liver enzymes in blood tests, increased levels of a certain type of white blood cells (eosinophilia), and swollen lymph nodes (DRESS);
• blisters (skin blisters) and skin peeling;
• aseptic meningitis: a set of symptoms 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 the hands or feet (peripheral neuropathy);
• inflammation of the large intestine (pseudomembranous colitis);
• a neurological disorder called cerebellar syndrome, whose symptoms may include: difficulty with coordination of movements, speech and (or) walking, involuntary eye movements and tremor. This may resolve after stopping treatment.

Reporting of side effects
If you experience any side effects, including any not listed
in this leaflet, tell your doctor or pharmacist. Side effects 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 .
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store the medicine Pylera

Keep the medicine 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 stated month.
There are no special requirements regarding storage temperature. 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Pylera contains
The active substances in Pylera 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 are: magnesium stearate (E 572), lactose monohydrate, talc (E 553b), capsule shell: titanium dioxide (E 171), gelatin, and printing ink containing shellac, propylene glycol, and iron oxide red (E 172).
This medicine contains lactose monohydrate and potassium. See section 2.

What Pylera looks like and contents of the pack
Pylera is an elongated, opaque white hard capsule with the imprint “BMT” in red on the cap. The capsule contains a white powder and a small opaque capsule containing yellow powder.
Pylera capsules are supplied in HDPE bottles with a child-resistant closure, packed in a cardboard box. Each bottle contains 120 capsules.
To protect against moisture, a desiccant (silica gel) and a drying wick are included in the bottle. The desiccant and drying wick must not be ingested.
For further information, 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:
Skyepharma Production SAS
Zone Industrielle Chesnes Ouest
55 rue du Montmurier
38070 Saint Quentin Fallavier
France

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Portugal, country of export: 5398243
Parallel Import Licence Number: 472/21

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