Pylerea

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pylera 140 mg/125 mg/125 mg capsules

bismuth subcitrate potassium
metronidazole
tetracycline hydrochloride
Please read this leaflet carefully before taking Pylera as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

What this leaflet contains:

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 3 different active substances: potassium bismuth subcitrate, metronidazole, and tetracycline hydrochloride. Tetracycline and metronidazole belong to a group of medicines called antibiotics. Potassium bismuth subcitrate helps the antibiotics to treat the infection.
Pylera contains a combination of medicines used to treat adult patients with Helicobacter pylori (H. pylori) infection who have or have had an ulcer. H. pylori is a bacterium found 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. Taking Pylera together with omeprazole helps treat the infection and reduce inflammation of the stomach lining.

2. WHAT YOU SHOULD KNOW BEFORE TAKING PYLERA

Do not take Pylera:

• if you are pregnant or breastfeeding
• if you are under 12 years of age
• if you have kidney problems
• if you have liver problems
• if you are allergic (hypersensitive) to potassium subcitrate bismuth, metronidazole, or other nitroimidazole derivatives, tetracycline, or any of the other ingredients of Pylera (see section 6)
• if you have Cockayne syndrome (see Warnings and Precautions)

Warnings and precautions
Talk to your doctor or pharmacist before taking Pylera.
In patients with Cockayne syndrome, cases of severe irreversible liver toxicity/acute liver failure have been reported, including fatal cases with very rapid onset after starting systemic metronidazole treatment.
Immediately inform your doctor and stop taking metronidazole if you experience:

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

Metronidazole, one of the components of this medicine, may increase the risk of ECG changes, such as QT interval prolongation, leading to delayed electrical conduction and heart rhythm abnormalities (arrhythmias), especially when administered together with drugs that may cause similar ECG changes. Talk to your doctor before taking Pylera, particularly if you have previously experienced such ECG changes or arrhythmias (see “Other medicines and Pylera”).

Be especially careful with Pylera:

• if you are scheduled for X-ray examinations, as Pylera may interfere with test results
• if you are scheduled for blood tests, as Pylera may affect test results
• if your doctor has diagnosed you with an intolerance to certain sugars.

During treatment with Pylera, avoid exposure to sunlight and sunbeds, as the medicine may increase photosensitivity. Inform your doctor if you develop sunburn or skin redness (sunburn reaction).

Children and adolescents
Pylera capsules must not be administered to children under 12 years of age and is not recommended in adolescents aged 12 to 18 years.

Other medicines and Pylera
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines, including those 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 mental illnesses
• medicines used to thin the blood or prevent blood clotting (e.g. warfarin)
• phenytoin and phenobarbital, used for epilepsy
• methoxyflurane (an anaesthetic)
• other antibiotics, particularly penicillin
• iron, zinc, or sodium bicarbonate-containing supplements
• prolonged co-administration of Pylera with other bismuth-containing drugs may affect the nervous system
• busulfan and fluorouracil, used in chemotherapy
• cyclosporine, used to suppress immune response after organ transplantation
• disulfiram, used in the treatment of alcoholism
• ranitidine, used for indigestion and heartburn
• retinoids, used for skin disorders
• atovaquone, used to treat a lung infection
• medicines known to cause ECG changes (QT interval prolongation) whose blood concentrations may increase due to metronidazole. Examples include:
  o Amiodarone (used to treat heart rhythm abnormalities);
  o Ondansetron (used to treat nausea and vomiting);
  o Methadone (used in opioid dependence therapy);
  o Domperidone (used to treat nausea and vomiting)

Do not take antacids containing aluminium, calcium, or magnesium together with Pylera.

Pylera with food, drinks, and alcohol
Pylera should be taken with a full glass of water (250 ml) after main meals and before going to bed (preferably after a snack).
During treatment with Pylera, avoid dairy products (such as milk or yoghurt) or drinks fortified with calcium, as they may interfere with the medicine’s effectiveness.
Avoid alcoholic beverages during treatment with Pylera and for at least 24 hours after stopping the treatment.
Consuming alcohol during Pylera treatment may cause unpleasant side effects such as nausea, vomiting, stomach pain (abdominal cramps), flushing, and headache.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.

Pregnancy and breastfeeding
Do not take Pylera if you are pregnant, if you may become pregnant during treatment, or if you suspect you are pregnant. Inform your doctor if you become pregnant during treatment with Pylera.
Do not breastfeed during treatment with Pylera, as trace amounts of its components may pass into breast milk.

Driving and using machines
Do not drive or operate tools or machinery if you feel dizzy, drowsy, have seizures, or experience temporary blurred vision or double vision.

Pylera contains lactose and potassium
Pylera contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, please consult them before taking this medicine.
Pylera contains approximately 96 mg of potassium per dose (3 capsules containing 32 mg of potassium each). This should be taken into account in patients with impaired kidney function or those on a low-potassium diet.

3. HOW TO TAKE PYLERA

Take this medicine exactly as directed by your doctor. Pylera must be taken together with a medicine called omeprazole. If you have any doubts, consult your doctor or pharmacist.

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 help prevent throat irritation. Do not lie down immediately after taking Pylera. It is important to complete the full course of treatment (10 days) and to take all 120 capsules.

Take one 20 mg capsule/tablet of omeprazole at breakfast and one at dinner, together with the doses of Pylera (for a total of 2 capsules/tablets of omeprazole per day).

Daily dosing schedule for Pylera

If you take more Pylera than you should
If you take a dose of Pylera higher than the recommended daily dose, inform your doctor or go to the nearest emergency room. Take the bottle and any remaining capsules with you, so that the doctor is aware of the medicine you have taken.

If you forget to take Pylera
If you forget to take Pylera, take it as soon as you remember. However, if it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for the forgotten dose.

If you miss more than 4 consecutive doses of Pylera (1 day), contact your doctor.

If you stop taking Pylera
It is important to complete the entire course of treatment, even if you start to feel better after a few days. If you stop Pylera too early, the infection may not be completely cured and your symptoms may return or worsen. You may also develop resistance to tetracycline and/or metronidazole (antibiotics).

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Stop treatment with Pylera and contact a doctor or go to hospital immediately if you develop or notice any of the following effects:

• swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing
• skin rash with itching and lumps or hives

These may be signs of an allergic reaction.

• Serious skin adverse reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)) (see “Frequency not known” below).

A serious but very rare adverse effect is a brain disorder (encephalopathy). Symptoms may vary, but you may develop fever, neck stiffness, headache, and see or hear things that are not real. You may also have difficulty using your arms and legs, trouble speaking, or feel confused. Inform your doctor immediately if you notice these adverse effects.

Other possible adverse effects
Very common (may affect more than 1 in 10 people):

• changes in the consistency or colour of stools, including black stools
• diarrhoea
• nausea
• bad taste or metallic taste

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

• abdominal pain
• constipation
• dryness of the mouth
• vomiting
• flatulence / bloating
• headache
• weakness
• feeling tired or lacking energy
• general feeling of being unwell
• vaginal infection with symptoms such as itching and irritation in the genital area, burning sensation or yellowish/white vaginal discharge
• increased levels of liver enzymes (transaminases) in blood tests
• black-coloured urine
• loss or decrease of appetite
• dizziness / feeling confused
• drowsiness
• skin problems such as redness (rash)

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

• allergic reaction to the medicine (with symptoms such as swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing or breathing, or skin rash with itching and lumps or hives)
• feeling of bloating / abdominal swelling
• belching
• mouth sores / mouth ulcers
• changes in tongue colour (dark-coloured tongue)
• swelling of the tongue
• chest pain, chest discomfort
• yeast infections (candidiasis), which may occur in the mouth (with symptoms such as white patches) or genitals (severe itching, burning sensation, pain)
• numbness
• tingling / sensation of "pins and needles"
• tremor
• anxiety, depression or sleep disturbances
• memory problems
• skin problems such as itching or hives
• blurred vision
• dizziness (spinning sensation)

Frequency not known (frequency cannot be estimated from the available data):

• severe illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)
• severe illness with blistering of the skin (Lyell's syndrome, toxic epidermal necrolysis)
• flu-like symptoms, facial rash followed by widespread rash accompanied by high body temperature, elevated liver enzymes in blood tests, high levels of a type of white blood cells (eosinophilia), swollen lymph nodes (DRESS)
• blistering and peeling of the skin (skin desquamation)
• aseptic meningitis: a group of symptoms including fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. These may be due to 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)
• inflammation of the large intestine (pseudomembranous colitis)
• a neurological disorder called cerebellar syndrome, whose symptoms may include difficulty coordinating movements, speaking and/or walking, involuntary eye movements and tremor. This may resolve upon discontinuation of treatment.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PYLERA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the
original packaging to protect the medicine from light and moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Pylera contains
The active substances are potassium bismuth subcitrate, metronidazole and tetracycline hydrochloride. Each capsule contains 140 mg of potassium bismuth subcitrate (equivalent to 40 mg of bismuth oxide), 125 mg of metronidazole and 125 mg of tetracycline hydrochloride.
The other components are: magnesium stearate (E572), lactose monohydrate, talc (E553b), titanium dioxide (E171), gelatin and printing ink containing shellac, propylene glycol and red iron oxide (E172).
This medicine contains lactose and potassium. See section 2.

Description of the appearance of Pylera and pack contents
Pylera capsules are white, opaque, elongated-shaped hard capsules with 'BMT' printed in red ink on the cap. They contain a white powder and a smaller capsule, also white and opaque, containing a yellow powder.
Pylera capsules are available in high-density polyethylene bottles containing 120 capsules.
A desiccant (silica gel) and a rayon wadding are included in the bottle to protect the medicine from moisture. Do not eat the desiccant or the rayon wadding.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
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

This medicine is authorised in the European Economic Area member states with the following names:
Belgium: Tryplera
Austria, Germany, France, Italy, Poland, Portugal, Czech Republic, Slovakia, Spain: Pylera