Pilera

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Pylera

140 mg + 125 mg + 125 mg, hard capsules

Bismuth potassium subcitrate + Metronidazole + Tetracycline hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

You should keep this leaflet, so that you can read it again if you need to.

You should consult a doctor or pharmacist if you have any further doubts.

This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Pylera and what is it 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 packaging and other information

1. WHAT IS PYLERA AND WHAT IS IT USED FOR

Pylera contains 3 different active substances: bismuth potassium citrate, metronidazole, and tetracycline hydrochloride. Tetracycline and metronidazole belong to a group of medicines called antibiotics. Bismuth potassium citrate helps antibiotics in the treatment of infection.
Pylera contains a group of substances used to treat adult patients infected with Helicobacter pylori (H. pylori), who have or have had stomach ulcers. H. pyloriis a bacterium present in the stomach lining.
Pylera should be taken with a medicine called omeprazole.Omeprazole is a medicine that works by reducing the amount of acid produced by the stomach. Pylera taken with a proton pump inhibitor (e.g., omeprazole) has a combined effect aimed at curing the infection and alleviating the inflammatory process of the stomach lining.

2. IMPORTANT INFORMATION BEFORE TAKING PYLERA

When not to take Pylera

• if the patient is pregnant or breastfeeding
• in patients under 12 years of age
• if the patient has kidney problems
• if the patient has liver problems
• if the patient has been diagnosed with an allergy (hypersensitivity) to bismuth potassium citrate, metronidazole, or other nitroimidazole derivatives, tetracycline, or any other component of Pylera (listed in section 6)

Warnings and precautions

Before starting treatment with Pylera, you should discuss it with your doctor or pharmacist.
There have been reports of severe hepatotoxicity/acute liver failure, including fatal cases with a very rapid course, in patients with Cockayne syndrome receiving systemic metronidazole products. If you have Cockayne syndrome, your doctor should also monitor liver function frequently during and after treatment with metronidazole.
You should immediately inform your doctor and stop taking metronidazole if you experience:

• abdominal pain, loss of appetite, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, dark stools, or itching

When to be particularly careful when taking Pylera

• if the patient is to undergo X-ray examination, as Pylera may affect the results of the examination
• if the patient is to undergo blood tests, as Pylera affects the results of some blood tests
• if the patient has previously been diagnosed with intolerance to certain sugars

You should avoid exposure to the sun and use of a sunbedduring treatment with Pylera, as it may enhance the effect of sunlight. In case of sunburn, you should consult a doctor.

Children and adolescents

Pylera capsules should not be given to children under 12 years of age and are not recommended for children between 12 and 18 years of age.

Pylera and other medicines

You should tell 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, you should inform your doctor if you are taking or have recently taken any of the following medicines:

• lithium used to treat certain mental disorders
• medicines used to thin the blood or prevent blood clots (e.g., warfarin)
• phenytoin and phenobarbital used in epilepsy
• methoxyflurane (an anesthetic)
• other antibiotics, especially penicillins
• dietary supplements containing iron, zinc, 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 people with alcohol problems
• ranitidine used in heartburn and acid reflux
• retinoids used in the treatment of skin diseases
• atovaquone used in the treatment of lung infections

You should not take antacids containing aluminum, 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), aftermeals and before bedtime (preferably after a snack).
You should not eat or drink dairy products(e.g., milk or yogurt) or beverages with calciumat the same time as taking Pylera and during treatment with Pylera, as this may affect the action of the medicine.
You should not drink alcoholduring 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 (abdominal cramps), hot flashes, and headache.
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription.

Pregnancy and breastfeeding

You should not take Pylera if you are pregnant, may be pregnant, or suspect you may be pregnant.
If you become pregnant during treatment, you should contact your doctor.
While taking Pylera, you should not breastfeed, as small amounts of Pylera components may pass into breast milk.

Driving and operating machinery

You should not drive or operate machinery if you experience dizziness, drowsiness, seizures, or a feeling of temporary blurred or double vision.

Pylera contains lactose and potassium

Pylera contains lactose, which is a type of sugar. If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking Pylera.
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 reduced kidney function and in patients controlling potassium levels in their diet.

3. HOW TO TAKE PYLERA

This medicine should always be taken exactly as prescribed by your doctor. Pylera should be taken with a medicine called a proton pump inhibitor (e.g., omeprazole). If you are unsure, you should consult your doctor or pharmacist again.

Adults and the elderly

You should not open the capsules but swallow them whole.
You should take 3 Pylera capsules 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.
You should swallow the capsules whole, sitting upright, and drink a full glass of water (250 ml) to avoid irritating the throat. Do not lie down immediately after taking Pylera. It is essential to complete the full treatment cycle (10 days) and take all 120 capsules.
You should take one omeprazole tablet (capsule) 20 mg with Pylera doses taken after breakfast and dinner (for a total of 2 omeprazole tablets/capsules per day).
Daily dosing schedule for Pylera:

Taking a higher dose of Pylera than recommended

If you take a higher dose of Pylera than recommended, you should contact your doctor or go to the emergency room of the nearest hospital. You should bring the medicine bottle and any remaining capsules, so the doctor knows what medicine was taken.

Missing a dose of Pylera

If you miss a dose, you should take it as soon as you remember. However, if it is almost time for the next dose, you should skip the missed dose.
You should not take a double dose to make up for the missed dose. If you miss more than 4 consecutive doses of Pylera (1 day), you should contact your doctor.

Stopping treatment with Pylera

It is essential to complete the full treatment cycle, even if you feel better after a few days. If you stop treatment too early, the infection may not be fully cured, and symptoms of the infection may return or worsen. Resistance to tetracycline or (and) metronidazole (antibiotics) may also develop.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Pylera can cause side effects, although not everybody gets them.

In case of the following conditions, you should stop taking Pylera and contact your doctor or go to the emergency room of the nearest hospital:

• swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing
• itching, lumpy 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 "Unknown" side effects)

A severe but very rare side effect is brain disease (encephalopathy). The symptoms are varied, but you may have a fever, stiff neck, headache, see or hear things that do not exist.
You may also have difficulty moving your arms and legs, speaking, or have a feeling of confusion. If you experience such symptoms, you should immediately tell your doctor.

Other possible side effects

Very common(may affect more than 1 in 10 people):

• changes in stool consistency and color, including blackening of the stool
• diarrhea
• nausea
• unusual or metallic taste in the mouth

Common(may affect up to 1 in 10 people):

• abdominal pain
• constipation
• dry mouth
• vomiting
• gas/flatulence
• headache
• feeling weak
• feeling tired and fatigued
• general malaise
• vaginal infections - symptoms including itching and irritation in the genital area, burning, or yellow/white discharge from the vagina
• blood tests may indicate elevated liver enzyme activity (aminotransferases)
• dark urine
• loss of or decreased appetite
• dizziness
• feeling drowsy
• skin problems, such as redness (rash)

Uncommon(may affect up to 1 in 100 people):

• allergic reaction to the medicine (symptoms including swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing; itching, lumpy rash, or hives)
• feeling bloated
• hiccups or belching
• open sores in the mouth/oral ulcers
• changes in tongue color (dark tongue)
• tongue swelling
• chest pain, feeling uncomfortable in the chest
• fungal infection (candidiasis), which may include the mouth (symptoms are white patches in the mouth) or genitals (symptoms are intense itching, burning, irritation)
• numbness
• tingling
• tremors
• feeling anxious, depressed, or having difficulty sleeping
• memory problems
• skin problems, such as itching or burning (hives)
• blurred vision
• dizziness

Unknown(frequency cannot be estimated from the available data):

• severe disease with blisters on the skin, in the mouth, around the eyes, and genitals (Stevens-Johnson syndrome)
• severe disease with blisters on the skin (Lyell's syndrome, toxic epidermal necrolysis)
• flu-like symptoms, rash on the face spreading to the whole body with high fever, elevated liver enzyme activity in blood tests, increased levels of a certain type of white blood cell (eosinophilia), and enlarged lymph nodes (DRESS)
• blisters (bubbles on the skin) and skin peeling
• aseptic meningitis: a syndrome of symptoms including fever, nausea, vomiting, headache, stiff neck, 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 a feeling of weakness in the hands or feet (peripheral neuropathy)
• inflammation of the colon (pseudomembranous colitis)

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, ul. 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 side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PYLERA

The medicine should be stored out of sight and reach of children.
You should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special storage instructions for the medicinal product.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What Pylera contains

The active substances of Pylera are: bismuth potassium citrate, metronidazole, and tetracycline hydrochloride.
Each capsule contains: 140 mg of bismuth potassium citrate (corresponding to 40 mg of bismuth oxide), 125 mg of metronidazole, 125 mg of tetracycline hydrochloride.
The other ingredients are: magnesium stearate (E 572), lactose monohydrate, talc (E 553b), coating: titanium dioxide (E 171), gelatin, and printing ink containing shellac, propylene glycol, and iron oxide red (E 172).
Pylera contains lactose monohydrate and potassium. See section 2.

What Pylera looks like and what the packaging contains

Pylera is a white, non-transparent, elongated capsule with the logo "Aptalis Pharma" printed on the capsule body and "BMT" printed in red on the capsule cap. The capsules contain a white powder and an additional small, non-transparent capsule containing a yellow powder.
Pylera capsules are available in HDPE bottles. Each bottle contains 120 capsules.
To protect against moisture, the bottle contains a desiccant (silica gel). You should not swallow the desiccant.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

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

Manufacturer:

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

Parallel importer:

ProCarePlus Pharma S.A.
ul. Bobrzyńskiego 14
30-348 Kraków

Repackaged by:

CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Chemiczno-Farmaceutyczna Spółdzielnia Pracy "ESPEFA"
ul. Juliusza Lea 208
30-133 Kraków
MEDICOFARMA S.A.
ul. Sokołowska 9 lok. U19
01-142 Warszawa
Marketing authorization number in Portugal, the country of export:5398243
Parallel import authorization number:249/22

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium: Tryplera
Austria, Czech Republic, France, Spain, Germany, Poland, Portugal, Slovakia, Italy: Pylera
Date of leaflet approval:07.06.2022
[Information about the trademark]