Pylera

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Pylera, 140 mg + 125 mg + 125 mg, hard capsules
Bismuthi kalii subcitras + Metronidazolum + Tetracyclini hydrochloridum
Please read the leaflet before using the 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Leaflet Contents

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 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 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. When taken together with a proton pump inhibitor (e.g., omeprazole), Pylera exerts a combined effect aimed at eradicating the infection and reducing inflammation of the stomach lining.

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 a known allergy (hypersensitivity) 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.
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.
Immediately inform your doctor 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. This should be discussed with your doctor before starting Pylera, especially if you previously had such ECG changes or heart rhythm disorders (see "Pylera with other medicines").

When to exercise special caution when using Pylera

• if the patient is to undergo X-ray imaging, because Pylera may affect the results of X-ray examinations;
• if the patient is to undergo blood tests, because Pylera may affect 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 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 agent);
• other antibiotics, particularly 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 the body's immune response after 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 in the treatment of 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 in the treatment of heart rhythm disorders);
  • 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

Take Pylera with a full glass of water (250 ml), after meals and at bedtime (preferably after a light snack).

Do not eat or drink dairy products (e.g. milk or yoghurt) or beverages 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 while taking Pylera and for 24 hours after completing treatment.
Drinking alcohol during treatment may cause unpleasant side effects such as nausea, vomiting, abdominal pain (cramps), flushing, 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 use Pylera if you are, may be, or suspect you could be 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 operating machinery

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

Pylera contains lactose monohydrate and potassium

Pylera contains lactose monohydrate, a type of sugar. If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this 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 impaired kidney function and in patients who need to control potassium intake in their diet.

3. How to take Pylera

This medicine should always be taken exactly as directed by your doctor. Pylera should be taken together with a medicine called a proton pump inhibitor (e.g. omeprazole). If you have any doubts, please 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 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 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 than the recommended dose of Pylera, contact your doctor or go to the nearest hospital emergency department 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 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 doubts regarding 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 experience them.
If any of the following conditions occur, stop taking
Pylera immediately and contact your doctor or go to the accident and emergency department
of your 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 section below "Unknown" side effects).

A serious, but very rare side effect is brain disease
(encephalopathy). Symptoms may vary, but the patient may experience fever, neck stiffness, headache,
seeing or hearing things that are not real. The patient may also have difficulty moving
arms and legs, speaking, or may feel confused. If such symptoms occur, inform your doctor immediately.
Other possible side effects
Very common (may affect more than 1 in 10 people):

• changes in the consistency and colour of faeces, 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 or yellowish/white vaginal discharge;
• blood tests may show increased liver enzyme activity (aminotransferases);
• dark urine;
• loss or reduced 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;
• open sores inside the mouth / mouth ulcers;
• changes in tongue colour (black tongue);
• swelling of the tongue;
• chest pain, 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 restlessness, depression or difficulty sleeping;
• memory disturbances;
• skin disorders such as itching or burning (urticaria);
• blurred vision;
• dizziness.

Unknown (frequency cannot be estimated from available data)

• serious illness with blisters on the skin, inside the mouth, eyes and genital areas (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 a certain type of white blood cells (eosinophilia), and enlarged lymph nodes (DRESS);
• blisters (skin blisters) and peeling of the skin;
• 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 hands or legs (peripheral neuropathy);
• inflammation of the large intestine (pseudomembranous colitis).

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 to provide more information on the safety of this medicine.

5. How to store Pylera

Keep this 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 storage temperature requirements. 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Pylera contains
The active substances in Pylera are bismuth potassium citrate, metronidazole, and tetracycline hydrochloride.
Each capsule contains 140 mg of bismuth potassium citrate (equivalent to 40 mg of bismuth oxide), 125 mg of metronidazole, and 125 mg of tetracycline hydrochloride.
The other ingredients are: magnesium stearate (E 572), monohydrate lactose, talc (E 553b), and capsule coating: 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
An elongated, opaque white capsule, with the Aptalis Pharma logo printed on the body of the capsule and "BMT" printed in red on the cap. The capsules contain a white powder and additionally a small opaque capsule containing yellow powder.
Pylera capsules are available in HDPE bottles. The bottle contains 120 capsules.
To protect against moisture, a desiccant (silica gel pack) and a drying wick are included in the bottle. Do not ingest the desiccant or drying wick.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing Authorization Holder in Spain, the country of export:
AbbVie Spain, S.L.U.
Avenida de Burgos 91
28050 Madrid, Spain

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

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 Authorization Number in Spain, the country of export: 686167.7
Parallel Import Authorization Number: 86/23

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