Pylera

Warning! Keep the package 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 entire leaflet before using this medicine, as it contains important information
for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It 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 package 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 IS PYLERA AND WHAT IS IT 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 the 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 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 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 have been reported, including fatal cases occurring very rapidly after initiation of systemic metronidazole therapy.
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), especially when administered with substances that may cause similar ECG changes. Before starting Pylera, discuss this with your doctor, particularly if you have previously experienced such ECG changes or cardiac arrhythmias (see "Pylera with other medicines").

When to exercise particular caution when using Pylera

• if the patient is scheduled for X-ray examinations, as Pylera may affect imaging results.
• if the patient is scheduled for 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 the 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 currently used or recently used, 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, 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 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 to treat lung infections;
• medicines known to cause changes in the ECG (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 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 snack).
Do not consume dairy products (e.g. milk or yoghurt) or beverages containing calcium at the same time as Pylera or during treatment with Pylera, as this may affect the medicine's efficacy.
Do not drink alcohol during treatment with Pylera and for 24 hours after completing treatment.
Consuming 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 used or recently used, including those available without a prescription.

Pregnancy and breastfeeding
Do not use Pylera if you are, may be, or suspect you may be pregnant.
If you become pregnant during treatment, contact your doctor immediately.
Do not breastfeed while taking Pylera, as small amounts of its active ingredients may pass into breast milk.

Driving and operating machinery
Do 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, a type of sugar. If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Pylera contains 96 mg of potassium in a single dose (3 capsules, each containing 32 mg potassium). This should be taken into account in patients with impaired kidney function and in patients who are monitoring their dietary potassium intake.

3. HOW TO USE PYLERA

This medicine should always be taken as directed 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 at 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 irritation of the throat. 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 after dinner (a total of 2 tablets (capsules) of omeprazole per day).
Daily dosing schedule for Pylera

Overdose of Pylera
In case of taking a higher than recommended dose of Pylera, contact your doctor or go to the emergency department of the nearest hospital. Bring the medicine bottle 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 the next dose, skip the missed dose. Do not take a double dose to make up for a missed one. If more than 4 consecutive doses of Pylera (1 day) are missed, contact your doctor.

Stopping treatment with Pylera
It is important to complete the full course of treatment, even if you 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 ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following conditions occur, stop taking
Pylera and contact your doctor or go immediately 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 section below "Not known" adverse reactions).

A serious, although very rare adverse reaction is brain disease (encephalopathy). Symptoms may vary, but the patient may experience 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 may feel confused. If such symptoms occur, inform your doctor immediately.
Other possible adverse reactions
Very common (may occur in 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 occur in up to 1 in 10 people):

• abdominal pain;
• constipation;
• dry mouth;
• vomiting;
• flatulence / bloating;
• headache;
• feeling weak;
• feeling of lack of energy and fatigue;
• 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);
• darkening of the urine;
• loss or decrease of appetite;
• dizziness;
• feeling sleepy;
• skin problems such as redness (rash).

Uncommon (may occur in 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;
• fungal infection (candidiasis), which may affect the mouth (symptoms: white patches inside the mouth) or genital area (symptoms: intense itching, burning, irritation);
• numbness;
• tingling;
• tremor;
• 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 available data)

• serious illness with blisters on the skin, in 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

levels of a certain type of white blood cells (eosinophilia) and swollen 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal 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
Reporting adverse reactions helps to 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 after EXP on the carton and bottle.
The expiry date refers to the last day of the stated month.
No special temperature storage requirements apply. Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE 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.
The other ingredients are: magnesium stearate (E 572), lactose monohydrate, talc (E 553b); the capsule shell: titanium dioxide (E 171), gelatin, and printing ink containing shellac, propylene glycol, and red iron oxide (E 172).
The medicine contains 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 the inscription "BMT" in red on the cap. The capsules contain white powder and additionally a small opaque capsule containing yellow powder.

Pylera capsules are available in an HDPE bottle with a child-resistant closure, containing a piece of synthetic silk and a desiccant (silica gel), all packed in a cardboard box.
The bottle contains 120 capsules.

To protect against moisture, a desiccant (silica-containing pack) and a piece of synthetic silk are included in the bottle. The desiccant or the piece of synthetic silk must not be ingested.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Spain, the country of export:
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
Allergan Pharmaceuticals International Limited
Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland

Parallel Importer:
Aga Kommerz spol. s r.o.
Frydecka 2006, 737 01 Czesky Tesin, Czech Republic

Repackaged in:
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Manufacturing site: Euceryn Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków

Marketing Authorisation Number in Spain, the country of export: 686167.7
Parallel Import Licence Number: 291/24

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