Pylera

Package leaflet: Information for the patient

Warning! Keep the 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 all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• 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 other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
  Contents of the 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 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 in combination 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).

Warnings and precautions
Before starting Pylera, discuss this with your doctor or pharmacist.
Cases of severe hepatotoxicity / acute liver failure, including fatal cases with very rapid onset, have been reported in patients with Cockayne’s syndrome receiving systemic metronidazole-containing products. If you have Cockayne’s syndrome, your doctor should frequently monitor liver function during and after treatment with metronidazole.
You should immediately inform your doctor and stop taking metronidazole if any of the following occur:

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

When to exercise special caution when using Pylera

• if the patient is to undergo X-ray imaging, because Pylera may affect imaging results;
• if the patient is to undergo blood tests, because Pylera may affect the 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
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those obtained without a prescription.
In particular, inform your doctor if the patient is taking or has 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 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 alcohol dependence;
• ranitidine, used for indigestion and heartburn;
• retinoids, used in the treatment of skin diseases;
• atovaquone, used in the treatment of lung infections.

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 adverse reactions such as nausea, vomiting, abdominal pain (cramps), flushing, 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 pregnancy occurs 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 temporary blurred or double vision.
Pylera contains lactose monohydrate and potassium
Pylera contains lactose, which is a type of sugar. If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
Pylera contains 96 mg of potassium in one dose (3 capsules, each containing 32 mg potassium), which should be taken into account in patients with impaired kidney function and in patients controlling potassium intake in their diet.

3. HOW TO USE PYLERA

This medicine should always be taken as directed by the physician. 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 dinner (a total of 2 tablets/capsules of omeprazole per day).
Daily dosing schedule for Pylera:

Overdose of Pylera
If an overdose of Pylera has been taken, 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, 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 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 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 or (and) metronidazole (antibiotics) may also develop.

If you have any further questions about 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 experiences 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 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 below under "Not known" adverse reactions)

A serious, but very rare adverse reaction is brain disease
(encephalopathy). Symptoms vary, but the patient may experience fever, neck stiffness, headache,
seeing or hearing things that do not exist.
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 affect more than 1 in 10 people):

• changes in stool consistency and colour, including black-coloured stools;
• diarrhoea;
• nausea;
• unusual or metallic taste in the mouth.

Common (may affect 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 urine;
• loss or decrease of appetite;
• dizziness;
• feeling sleepy;
• 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 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;
• yeast 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.

Not known (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 to the whole 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 set 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 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, tell 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 PYLERA MEDICINAL PRODUCT

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 indicated.
There are no special requirements regarding storage temperature of the medicinal product.
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. Such measures will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Pylera contains
The active substances in this medicine are: bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride.
Each capsule contains: 140 mg bismuth subcitrate potassium (equivalent to 40 mg bismuth oxide), 125 mg metronidazole, 125 mg tetracycline hydrochloride.
Other ingredients are: 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 capsule, with the Aptalis Pharma logo printed on the body of the capsule and the code "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 HDPE bottles. The bottle contains 120 capsules.
To protect against moisture, a desiccant (silica gel pack) is included in the bottle. The desiccant must not be ingested.

For further information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in Portugal, 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
Poland

Repackaged in:
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

Chemiczno-Farmaceutyczna Spółdzielnia Pracy "ESPEFA"
ul. Juliusza Lea 208
30-133 Kraków
Poland

MEDICOFARMA S.A.
ul. Sokołowska 9 lok. U19
01-142 Warszawa
Poland

Marketing Authorisation number in Portugal, country of export: 5398243
Parallel Import Licence number: 249/22

This medicinal product is authorised for marketing in the European Economic Area (EEA) Member States under the following names:
Belgium: Tryplera
Austria, Czech Republic, France, Spain, Germany, Poland, Portugal, Slovakia, Italy: Pylera