PYLERA 140 mg/125 mg/125 mg CAPSULES

2. What you need to know before taking Pylera

Do not take Pylera

• if you are pregnant or breastfeeding
• if you are under 12 years old
• if you have kidney problems
• if you have liver problems
• if you are allergic (hypersensitive)to potassium bismuth subcitrate, metronidazole, or other nitroimidazole derivatives, tetracycline, or any of the other components of Pylera (listed in Section 6)
• if you have Cockayne syndrome (see Warnings and precautions).

Warnings and precautions

Consult your doctor or pharmacist before taking Pylera.

There have been reports of severe, irreversible liver toxicity/liver failure, including cases with a fatal outcome, occurring very rapidly after the start of systemic use of metronidazole 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 malaise, fatigue, jaundice, dark urine, clay-colored stools, or itching.

Metronidazole, a component of this medicine, may increase the risk of changes in the electrocardiogram that cause a prolongation of the QT interval, leading to a delay in the transmission of electrical signals and anomalies in heart rate (arrhythmia), 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 changes of this type in an electrocardiogram (see section "Other medicines and Pylera").

Be careful with Pylera

• if you need to have an X-ray, as Pylera may alter the results of the X-ray
• if you need to have a blood test, as Pylera may alter the results of the test
• if your doctor has told you that you have an intolerance to some sugars

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

Children and adolescents

Pylera capsules should not be given to children under 12 years old, and they are not recommended for patients between 12 and 18 years old.

Taking Pylera with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

In particular, inform your doctor if you are using or have recently used 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 for epilepsy
• methoxyflurane (an anesthetic)
• other antibiotics, especially penicillin
• supplements containing iron, zinc, or sodium bicarbonate
• the combination of Pylera with other drugs containing bismuth, used long-term, may affect the nervous system
• busulfan and fluorouracil used for chemotherapy
• cyclosporine used to reduce the immune response of your body after a transplant
• disulfiram used to treat people with alcohol problems
• ranitidine used for indigestion and heartburn
• retinoids for skin disorders
• atovaquone used to treat a lung infection
• medicines that cause changes in the electrocardiogram (prolongation of the QT interval) and for which an increase in blood concentrations may be caused by concomitant administration with metronidazole. Examples of this type of substance are:
• • amiodarone (used to treat heart rhythm disorders);
  • 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.

Taking 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 any dairy products(such as milk or yogurt) or beverages with added calciumat the same time as Pylera capsules or during the entire treatment with Pylera, as they may affect how Pylera works.

Do not drink alcoholduring treatment with Pylera or for at least 24 hours after completing the treatment. Drinking alcohol during treatment with Pylera may cause unpleasant side effects such as nausea, vomiting, stomach pain (colic), flushing, 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 using machines

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

Pylera contains lactose, potassium, and other excipients.

Pylera contains lactose, which is a type of sugar. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Pylera

Follow the administration instructions for this medicine exactly as indicated by your doctor. Pylera must be taken with a medicine called omeprazole. If in 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), for a total of 12 capsules per day. Swallow the capsules whole while sitting 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 all 120 capsules.

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

Daily dosage schedule of Pylera

If you take more Pylera than you should

If you take more doses of Pylera per day than recommended, inform your doctor or go to the nearest hospital emergency department. Take the bottle and any remaining capsules with you. 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 Toxicology Information Service, phone 915 620 420, indicating the medicine 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 make up for missed doses. If you forget to take more than 4 consecutive doses of Pylera (1 day), contact your doctor.

If you stop taking Pylera

It is essential to complete the full treatment, even if you start to feel better after a few days. If you stop treatment with Pylera too soon, the infection may not be completely cured, and the symptoms of the infection may 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

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

This may 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 "Frequency not known" adverse reactions).

A very rare but serious side effect is brain disease (encephalopathy). Symptoms vary, but you may experience fever, stiff neck, headache, or see or hear things that are not there. You may also have problems using your arms and legs or speaking, or feel confused. Talk to your doctor immediately if you notice any of these side effects.

Other possible side effects

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

• changes in stool consistency or color, including dark-colored 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 lacking energy
• general malaise
• vaginal infection - symptoms include itching and irritation of the genital area, burning sensation or yellow/white vaginal discharge
• blood tests may show an increase in liver enzyme levels (transaminases)
• dark-colored urine
• loss of appetite or decreased appetite
• feeling dizzy or lightheaded
• feeling numb
• 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 that may cause difficulty swallowing or breathing, or a rash with hives and itching (urticaria))
• feeling bloated or swollen abdomen
• belching or gas
• mouth ulcers or sores
• changes in tongue color (dark tongue)
• swollen tongue
• chest pain or discomfort
• fungal infections (candida), which can occur in the mouth (symptoms include white patches in the mouth) or genitals (symptoms include severe itching, burning sensation, inflammation)
• numbness
• tingling or pins and needles
• tremors
• feeling anxious, depressed, or having difficulty sleeping
• memory problems
• skin problems such as itching or hives (urticaria)
• blurred vision
• vertigo (feeling like the room is spinning)

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

• Severe skin disease with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome)
• Severe skin disease with blistering of the skin (toxic epidermal necrolysis, Lyell syndrome)
• Flu-like symptoms, rash on the face and then widespread rash with high fever, increased liver enzyme levels observed in blood tests, increased eosinophils, and swollen lymph nodes (DRESS)
• Blistering of the skin and peeling (exfoliation) of the skin
• Aseptic meningitis: a group of symptoms that include fever, nausea, vomiting, headache, stiff neck, and sensitivity to bright light. This may be caused by inflammation of the membranes covering the brain and spinal cord (meningitis).
• Nerve damage that can cause numbness, tingling, pain, and a feeling of weakness in arms and legs (peripheral neuropathy).
• Inflammation of the large intestine (pseudomembranous colitis).
• A neurological disorder called cerebellar syndrome, which includes symptoms such as difficulty coordinating movements, speech, and/or walking, as well as involuntary eye movements and tremors. This may disappear when treatment is stopped.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pylera

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

• Do not use this medicine after the expiration date stated on the carton and bottle after "EXP". The expiration date is the last day of the month indicated.
• This medicine does not require any special storage temperature. Store in the original packaging to protect it from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Pylera Composition

The active ingredients are potassium bismuth subsalicylate, metronidazole, and tetracycline hydrochloride.

Each capsule contains 140 mg of potassium bismuth subsalicylate (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 that contains shellac, propylene glycol, and red iron oxide (E172).

This medication contains lactose and potassium. See section 2.

Appearance of Pylera and Container Content

The Pylera capsules are hard, elongated, white, and opaque with "BMT" printed on the cap in red ink. They contain a white powder plus a smaller opaque white capsule that contains a yellow powder.

The 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 medication dry. Do not ingest the desiccant or the rayon coil.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medication is authorized in the Member States of the European Economic Area under the following names:

Belgium: Tryplera

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

Date of the last revision of this leaflet:06/2025

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