Pylera

Package leaflet: Information for the patient

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 entire leaflet before taking 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. This medicine may harm others, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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 effectiveness 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 Pylera is taken together with a proton pump inhibitor (e.g., omeprazole), the combined effect aims 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 bismuth potassium citrate, metronidazole or other nitroimidazole derivatives, tetracycline, or to any other component of Pylera (listed in section 6);
• if the patient has Cockayne 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 syndrome.
Immediately contact 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 concomitantly with drugs that may cause similar ECG changes. Discuss this with your doctor before starting Pylera, especially if you have previously had such ECG changes or heart rhythm disorders (see “Pylera with other medicines”).

When to exercise particular caution when using Pylera

• if the patient is scheduled for X-ray imaging, as Pylera may affect imaging results;
• if the patient is scheduled for blood tests, as Pylera may affect 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 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 is 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 obtained without a prescription.
In particular, inform your doctor if you are taking or have 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 for 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 organ transplantation;
• disulfiram used in the treatment of alcohol dependence;
• ranitidine used for indigestion and heartburn;
• retinoids used to treat 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 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 before 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 during treatment with Pylera and for 24 hours after completing treatment.
Drinking alcohol during treatment may cause unpleasant side effects 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 could be pregnant.
If you become pregnant during treatment, contact your doctor immediately.
Do not breastfeed while taking Pylera, as small amounts of the 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 been previously 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). This should be taken into account in patients with impaired kidney function and in patients who need to monitor their potassium intake.

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 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 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 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 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 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 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 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 immediately:

• 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)) (see below under the section "Not known" side effects).

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, inform your doctor immediately.
Other possible side effects
Very common (may occur in 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 occur in up to 1 in 10 people):

• abdominal 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 genitals, burning or yellowish/white vaginal discharge;
• blood tests may show increased liver enzyme activity (aminotransferases);
• dark-coloured urine;
• loss of or reduced 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 ulcers / oral ulceration;
• 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;
• trembling;
• feeling anxious, depressed or having 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 certain white blood cells (eosinophilia) and enlarged lymph nodes
(DRESS);

• blisters (blisters on the skin) and skin peeling;
• 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 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 movement, speech and (or) walking, involuntary eye movements and tremor. This may resolve after stopping treatment. Reporting of side effects If any side effects occur, including any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of 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 . Side effects can also be reported to the marketing authorisation holder or parallel importer. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store the medicine 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.
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. This will help protect the environment.

6. Contents of the pack and other information

What Pylera contains
The active substances 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).
Capsule shell: titanium dioxide (E 171), gelatin.
Printing ink: shellac, propylene glycol, and iron oxide red (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 a red "BMT" printed on the cap. The capsules contain white powder and a small opaque capsule containing yellow powder.
Pylera capsules are available in HDPE bottles. Each bottle contains 120 capsules.
To protect against moisture, a desiccant (silica gel pack) and a piece of artificial silk are included in the bottle. The desiccant and the piece 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 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warszawa
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. k.
ul. Działkowa 56
02-234 Warszawa
CEFEA Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Synoptis Industrial Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów

Marketing Authorisation Number in the Czech Republic, country of export: 09/248/14-C
Parallel Import Licence Number: 67/26
This medicinal product is authorised for sale in the European Economic Area under the following names:
Belgium: Tryplera
Austria, Czech Republic, France, Spain, Germany, Poland, Portugal, Slovakia, Italy: Pylera