Label:information for theuser

Pylera 140 mg/125 mg/125 mg capsules

potassium bismuth subcitrate

metronidazole

tetracycline hydrochloride

Read this label carefully before starting to take the medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What Pylera is and for what it is used

2.What you need to know before starting to take Pylera

3.How to take Pylera

4.Possible adverse effects

5.Storage of Pylera

6.Contents of the package and additional information

Pylera contains 3active principlesdifferent: potassium bismuth subcitrate, metronidazole and tetracycline hydrochloride.Tetracycline and metronidazole belong to a group of medications called antibiotics. Potassium bismuth subcitrate helps the antibiotics treat the infection.

Pylera contains a group of medications used to treat adult patients infected withHelicobacter pylori (H. pylori)who have or have had an ulcer.H. pyloriis a bacteria found in the stomach.

Pylera must be taken with a medication called omeprazole.Omeprazole is a medication that works by reducing the amount of acid produced by your stomach.When taking Pylera with omeprazole, both products work together to treat the infection and reduce stomach lining inflammation.

Do not take Pylera

• if you arepregnant or breastfeeding
• if you areless than 12 years oldof age
• if you havekidney problems
• if you haveliver problems
• if you areallergic(hypersensitive)to potassium bismuth subcitrate, metronidazole or to any other derivatives of nitroimidazole, tetracycline or to any of the other components of Pylera (listed in Section 6)
• if you haveCockayne syndrome (see Warnings and precautions)

Warnings and precautions

Consult your doctor or pharmacist before taking Pylera.

Severe irreversible liver toxicity or acute liver failure, including cases with fatal outcome, have been reported to occur rapidly after the initiation of systemic metronidazole therapy in patients with Cockayne syndrome.

Inform your doctor immediately and stop taking metronidazole if you experience:

• stomach pain, loss of appetite, nausea, vomiting, fever, general feeling of discomfort, fatigue, jaundice, dark urine, clay-colored stools or itching.

The metronidazole component of this medication may increase the risk of changes in the electrocardiogram that is a prolongation of the QT interval, which causes a delay in the transmission of electrical signals and arrhythmias, when administered concomitantly with other compounds that may cause similar changes in the electrocardiogram. Consult your doctor before starting Pylera, especially if you have experienced arrhythmias or similar changes in an electrocardiogram (see section “Other medications and Pylera”).

Be especially careful with Pylera

• if you need to have an X-ray, as Pylera may alter the results of X-rays
• if you need to have blood tests, as Pylera may alter the results of these tests
• if your doctor has told you that you are intolerant to some sugars

Avoid the sun and UVA cabinsduring treatment with Pylera as it may exacerbate the effects of the sun. Contact your doctor if you experience sunburn.

Children and adolescents

Do not administer Pylera capsules to children under 12 years of age, and do not recommend in patients from12 to18 years of age.

Pylera with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication, including those acquired without a prescription.

Especially, inform your doctor if you are using or have used recently any of the following medications:

• lithium used to treat certain mental illnesses
• medications used to thin the blood or prevent blood clotting (e.g. warfarin)
• phenytoin and phenobarbital for epilepsy
• methoxyflurane (an anesthetic)
• other antibiotics, especially penicillin
• supplements containing iron, zinc or sodium bicarbonate
• The combination of Pylera with other medications containing bismuth, used long-term, may affect the nervous system
• busulfan and fluorouracil used for chemotherapy
• cyclosporine used to reduce the immune reaction of your body after a transplant
• disulfiram used to treat people with alcoholism
• ranitidine used for indigestion and heartburn
• retinoids for skin disorders
• atoxavacuonafor treating a lung infection
• medications that cause changes in the electrocardiogram (prolongation of the QT interval) and for which an increase in blood concentrations may be caused by the concomitant administration with metronidazole. Examples of such substances are:
• • amiodarone (used to treat arrhythmias);
  • ondansetron (used to treat nausea and vomiting);
  • methadone (used as a substitute treatment in cases of 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, drinks and alcohol

Take Pylera with a full glass of water (250 ml)aftermeals and at bedtime (preferably after a snack).

Do not eat or drink anylactose-containing products(such as milk or yogurt) or drinks withadded calciumat the same time as Pylera capsules or during the entire treatment with Pylera, as they may affect the functioning of Pylera.

Do not drink anyalcoholduring treatment with Pylera or for at least 24 hours after completing treatment.Drinking alcoholduring treatment with Pylera may cause unpleasant side effects such as nausea, vomiting, stomach pain (colic), hot flashes and headache.

Pregnancy and breastfeeding

Do not take Pylera if you are pregnant, may become pregnant during treatment or think you may be pregnant. Talk to your doctor if you become pregnant during treatment with Pylera.

Do not breastfeed during treatment with Pylera, as small amounts of the components of Pylera may pass into breast milk.

Driving and operating machines

Do not drive or operate tools or machines if you feel dizzy, drowsy, experience seizures (convulsions) or have blurred vision or double vision.

Pylera contains lactose, potassium and other excipients.

Pylera contains lactose, a type of sugar. If your doctor has told you that you are intolerant to certain sugars, consult with him before taking this medication.

Patients with renal insufficiency or on low-potassium diets should note that Pylera contains approximately 96mg of potassium per dose (3 capsules containing 32 mg of potassium each).

Follow exactly the administration instructions of this medication as indicated by your doctor. Pylera should be taken along with a medication called omeprazol. In case of doubt, consult your doctor or pharmacist again.

Adults and elderly patients

Do not open the capsules and swallow them whole.

Take 3 Pylera capsules after breakfast, 3 capsules after lunch, 3 capsules after dinner, and 3 capsules at bedtime (preferably after a snack), that is, a total of 12 capsules per day. Swallow the capsules whole while seated and with a full glass of water (250 ml) to avoid any throat irritation. Do not lie down immediately after taking Pylera. It is essential to complete the full treatment (10 days) and take the 120 capsules.

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

Daily dosing schedule for Pylera

If you take more Pylera than you should

If you take more doses of Pylera per day than recommended, you must inform your doctor or go to the nearest hospital emergency department. Bring the bottle and all remaining capsules. This is so the doctor knows what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

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, skip the missed dose. Do not take a double dose to compensate for the missed doses.
If you forget to take more than 4 consecutive doses of Pylera (1 day), contact your doctor.

If you interrupt treatment with Pylera

It is essential that you complete the full treatment even if you start feeling better after a few days.If you interrupt treatment with Pylera too soon, it is possible that the infection will not be completely cured and that the symptoms of the infection will return or worsen.You may also develop resistance to tetracycline and/or metronidazole (antibiotics).

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Stop taking Pylera and contact your doctor or go to the hospital immediately if you experience or observe any of the following:

• inflammation of the face, lips, tongue, or throat that may cause difficulty swallowing or breathing.
• a rash with hives and itching or urticaria.

This could be a sign of an allergic reaction.

• Severe skin reactions(Stevens-Johnson syndrome,toxic epidermal necrolysis (Lyell syndrome),drug reaction with eosinophilia and systemic symptoms (DRESS)) (See below for "Unknown frequency" adverse reactions).

A very rare severe adverse reaction is encephalopathy. Symptoms vary, but you may experience fever, neck stiffness, headache, or see or hear things that are not there. You may also have trouble using your arms and legs or speaking, or feel confused. Talk to your doctor immediately if you notice any of these adverse reactions.

Other possible side effects

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

• Changes in stool consistency or color, including dark stools (black stools)
• Diarrhea
• Nausea
• Bad taste in the mouth or metallic taste

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

• Abdominal pain
• Constipation

• Dry mouth
• Vomiting
• Flatulence / gas
• Headache
• Feeling weak
• Feeling tired or lack of energy
• General feeling of being unwell
• Vaginal infection – symptoms include itching and irritation of the genital area, burning sensation, or white or yellowish vaginal discharge
• Blood tests may show an increase in liver enzymes (transaminases)
• Dark urine
• Loss or decrease of appetite
• Feeling dizzy or lightheaded
• Numbness
• Itching or hives (urticaria)

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

• Medication allergy (symptoms include inflammation of the face, lips, tongue, or throat that may cause difficulty swallowing or breathing, or a rash with hives and itching or urticaria).
• Swelling / abdominal swelling
• Belching or gas
• Sores in the mouth / mouth ulcers
• Changes in tongue color (dark tongue)
• Swollen tongue
• Chest pain, chest discomfort
• Fungal infections (candida), which may occur in the mouth (symptoms include white patches in the mouth) or genitals (symptoms include severe itching, burning sensation, inflammation)
• Numbness
• Itching or hives (urticaria)
• Tremors
• Feeling anxious, depressed, or having trouble sleeping
• Memory alteration
• Itching or hives (urticaria)
• Blurred vision
• Dizziness (head spinning)

Unknown frequency(cannot be estimated from available data):

• Severe disease with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome)
• Severe disease with blistering of the skin (Lyell syndrome,toxic epidermal necrolysis)
• Pseudogripal symptoms, facial eruption, and then widespread eruption with high fever, elevated liver enzymes observed in blood tests, eosinophilia, and lymph node enlargement (DRESS)
• Blistering of the skin and exfoliation (peeling) of the skin
• Asymptomatic meningitis: a group of symptoms that include: fever, nausea, vomiting, headache, neck stiffness, and extreme sensitivity to bright light. This may be caused by inflammation of the membranes that cover the brain and spinal cord (meningitis).
• Nerve damage that may cause numbness, tingling, pain, and a feeling of weakness in arms and legs (peripheral neuropathy).
• Inflammation of the large intestine (pseudomembranous colitis).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pylera

The active principles 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 iron oxide red (E172).

This medicine contains lactose and potassium. See section 2.

Appearance of Pylera and contents of the packaging

Pylera capsules are hard, elongated, white and opaque with “BMT” printed in red ink on the cap.They contain a white powder and a smaller opaque white capsule containing a yellow powder.

Pylera capsules are available in high-density polyethylene bottles of 120 capsules.

The bottle includes a desiccant (silica packet) and a rayon coil to keep the medicine dry.Do not ingest the desiccant or the rayon coil.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

LABORATOIRES JUVISE PHARMACEUTICALS

149 Boulevard Bataille de Stalingrad

69100 Villeurbanne

France

Responsible manufacturer

SKYEPHARMA PRODUCTION SAS

Zone Industrielle Chesnes Ouest,

55 rue du Montmurier

38070 Saint Quentin Fallavier

France

This medicine is authorized in the member states of the European Economic Area with the following names:

Belgium: Tryplera

Germany, Austria, Slovakia, Spain, France, Italy, Poland, Portugal, Czech Republic: Pylera

Last review date of this leaflet :11/2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/