Pylera

Warning! Keep this 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 for future reference.
• If you have any questions, consult your doctor or pharmacist.
• 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 similar.
• 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 package leaflet

1. What Pylera is and what it is used for
2. What you need to know 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 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. Pylera, when taken together with a proton pump inhibitor (e.g. omeprazole), acts in combination to eradicate the infection and reduce gastric mucosal inflammation.

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 bismuth subcitrate potassium, 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, 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 heart rhythm disturbances (arrhythmias), especially when administered with substances that may cause similar ECG changes. Discuss this 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 scheduled for X-ray examinations, as Pylera may affect imaging results;
• if the patient is scheduled for blood tests, as Pylera may affect the results of certain blood tests;
• if the patient has previously experienced 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, including those obtained without a prescription, as well as any medicines you plan to take.
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 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 in the treatment of lung infections.
• medicines known to cause ECG changes (QT interval prolongation), and whose blood concentrations may be increased by metronidazole. These 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 taking Pylera or during treatment with Pylera, as this may affect the effectiveness of the medicine.
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 obtained 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 components may pass into breast milk.
Driving and operating machinery
Do not drive or operate machinery if you experience dizziness, drowsiness, seizures, or transient blurred or double vision.
Pylera contains lactose monohydrate and potassium
Pylera contains lactose monohydrate, 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 per 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 are monitoring potassium intake in their diet.

3. How to take 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 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 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 dinner (a total of 2 tablets (capsules) of omeprazole per day).
Daily dosing schedule for Pylera

Overdose of Pylera
In case of an overdose of Pylera, contact your physician or go to the emergency department of the nearest hospital. Bring the medication container and any remaining capsules so the doctor knows which medication has been taken.

Missed dose of Pylera
If a dose of Pylera is missed, 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 the patient feels better after a few days. Stopping treatment too early may result in the infection not being completely eradicated, 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 medication, 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
the medicine Pylera 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 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 the section "Unknown" adverse reactions).

A serious, but very rare adverse reaction is brain disease
(encephalopathy). Symptoms vary, but the patient may develop fever, neck stiffness, headache,
see or hear things that are not real. The patient may also experience difficulty moving
arms and legs, have problems speaking, or 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 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 occur in 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 sores / oral 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 genitals (symptoms include intense itching, burning, irritation);
• numbness;
• tingling;
• tremor;
• feeling anxious, depressed, or having 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 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 entire body with high fever, elevated liver enzymes in blood tests, increased number of certain white blood cells (eosinophilia), and enlarged lymph nodes (DRESS);
• blisters (blisters on the skin) and peeling of the skin;
• aseptic meningitis: a syndrome 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 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 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 .
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store the medicine Pylera

Keep the 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.
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 this medicine 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.
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 iron oxide red (E 172).
This medicine contains monohydrate lactose and potassium. See section 2.

What Pylera looks like and contents of the pack
An elongated, white, opaque hard capsule with the red imprint "BMT" on the cap. Each capsule contains a white powder and a small opaque capsule containing yellow powder.
Pylera capsules are available in an HDPE bottle with a child-resistant closure, placed in a cardboard box. The bottle contains 120 capsules.
To protect against moisture, a desiccant (silica gel pack) and a roll of artificial silk are included in the bottle. The desiccant and the roll of artificial silk must not be ingested.

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

Marketing authorisation holder in the Czech Republic, 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

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 the Czech Republic, country of export: 09/248/14-C
Parallel import authorisation number: 102/25

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