Pilera

Patient Information Leaflet: User Information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Pylera, 140 mg + 125 mg + 125 mg, hard capsules

Bismuth potassium subcitrate + Metronidazole + Tetracycline hydrochloride

You should read the contents of the leaflet before taking 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.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any 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 pack and other information

1. What is Pylera and what is it used for

Pylera contains 3 different active substances: bismuth potassium subcitrate, metronidazole, and tetracycline hydrochloride. Tetracycline and metronidazole belong to a group of medicines called antibiotics. Bismuth potassium subcitrate helps the antibiotics treat the infection.
Pylera is 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 (such as omeprazole) has a combined effect aimed at curing the infection and relieving the inflammation 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 is allergic(hypersensitive) to bismuth potassium subcitrate, metronidazole, or other nitroimidazole derivatives, tetracycline, or 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, the patient should discuss it with their doctor or pharmacist.
In patients with Cockayne syndrome, cases of severe, irreversible liver damage/acute liver failure, including deaths, have been reported, which occurred very shortly after starting systemic metronidazole treatment.
The patient should immediately inform their doctor and stop taking metronidazole if they experience:

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

Metronidazole, one of the components of this medicine, may increase changes in the ECG recording, i.e., prolongation of the QT interval, leading to delayed conduction of electrical signals and heart rhythm disorders (arrhythmias), when administered with compounds that may cause similar changes in the ECG recording. Before starting treatment with Pylera, the patient should discuss it with their doctor, especially if they have previously had such changes in the ECG recording or heart rhythm disorders (see "Pylera and other medicines").

When to be cautious 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.

Avoid exposure to sunlight and sunbedsduring treatment with Pylera, as it may increase the effect of sunlight. In case of sunburn, the patient 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
In particular, the patient should inform their doctor if they 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;
• Cyclosporin used to suppress the body's immune response after transplantation;
• Disulfiram used in people with alcohol problems;
• Ranitidine used in indigestion and heartburn;
• Retinoids used to treat skin diseases;
• Atovaquone used to treat lung infections.
• Medicines known to cause changes in the ECG recording (prolongation of the QT interval) and for which increased blood levels are caused by metronidazole. These substances include:
• 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 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).
Do 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.
Do not drink alcoholwhile taking Pylera and for 24 hours after finishing treatment.
Drinking alcohol during treatment may cause unpleasant side effects, such as nausea, vomiting, abdominal pain (abdominal cramps), hot flashes, and headache.
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

Do not take Pylera if you are, may be, or think you may be pregnant.
If you become pregnant during treatment, consult your doctor.
Do not breastfeed while taking Pylera, as small amounts of Pylera's components may pass into breast milk.

Driving and using machines

Do not drive or operate machinery if you experience dizziness, drowsiness, seizures, or a feeling of temporary 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, you should consult your doctor before taking Pylera.
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 reduced kidney function and in patients controlling their potassium intake.

3. How to take Pylera

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

Adults and the elderly

Do not open the capsules, but swallow them whole.
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.
Swallow the capsules whole, sitting upright, with 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.
Take one omeprazole tablet (capsule) 20 mg with the Pylera doses taken after breakfast and dinner (for a total of 2 omeprazole tablets (capsules) per day).
Daily dosing schedule for Pylera

Taking more Pylera than prescribed

If you take more Pylera than prescribed, consult your doctor or go to the emergency room of your nearest hospital. Bring the medicine bottle and any remaining capsules with you, so the doctor knows what medicine you have taken.

Missing a dose of Pylera

If you miss a dose, 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), consult 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 the 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, consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following, stop taking Pylera and consult your doctor or go to the emergency room of your nearest hospital:

• Swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing;
• Itchy, 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 feel confused. If you experience such symptoms, tell your doctor immediately.

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;
• Wind/bloating;
• Headache;
• Feeling weak;
• Feeling tired and lacking energy;
• General feeling of being unwell;
• Vaginal infections - symptoms include itching and irritation in the genital area, burning or yellow/white discharge from the vagina;
• Blood tests may show increased 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 include swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing; itchy, lumpy rash or hives;
• Feeling bloated;
• Hiccup 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;
• Trembling;
• 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 temperature, elevated liver enzymes in blood tests, increased number of a certain type of white blood cell (eosinophilia), and swollen 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 arms or legs (peripheral neuropathy);
• Colitis (pseudomembranous colitis).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 month.
There are no special storage instructions. 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Pylera contains

The active substances of Pylera are bismuth potassium subcitrate, metronidazole, and tetracycline hydrochloride.
Each capsule contains 140 mg of bismuth potassium subcitrate (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), capsule shell: 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 contents of the pack

Pylera is a white, non-transparent, elongated capsule with the logo "Aptalis Pharma" printed on the body of the capsule and "BMT" printed in red on the cap of the capsule. The capsules contain a white powder and a 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) and a drying agent. Do not swallow the desiccant or drying agent.
For more detailed information, consult 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Spanish marketing authorization number:686167.7

Parallel import authorization number: 86/23

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: 18.05.2023

[Information about trademark]