Clarithromycin Viatris 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Clarithromycin Viatris 500 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as 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, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Clarithromycin Viatris is and what it is used for
2. What you need to know before taking Clarithromycin Viatris
3. How to take Clarithromycin Viatris
4. Possible side effects
5. How to store Clarithromycin Viatris
6. Contents of the pack and other information

1. What Claritromycin Viatris is and what it is used for

Clarithromycin is a medicine that belongs to the group of macrolide antibiotics and works by eliminating bacteria.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, frequency, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Claritromycin Viatris is used to treat infections caused by susceptible organisms in adults and adolescents aged 12 to 18 years:

• Infections of the upper respiratory tract, such as pharyngitis (infection of the pharynx causing sore throat), tonsillitis (infection of the tonsils), and sinusitis (infection of the paranasal sinuses located around the forehead, cheeks, and eyes).
• Infections of the lower respiratory tract, such as acute bronchitis (infection and inflammation of the bronchi), acute exacerbation of chronic bronchitis (worsening of long-term or recurrent lung inflammation), and bacterial pneumonia (lung inflammation caused by bacteria). (see section on warnings and precautions)
• Skin and soft tissue infections, such as folliculitis (infection of one or more hair follicles), cellulitis (acute inflammation of the skin), and erysipelas (a type of skin infection). (see section on warnings and precautions)
• Gastric and duodenal ulcers
• And for the prevention and treatment of infections caused by mycobacteria.

2. What you need to know before taking Clarithromycin Viatris

Do not take Clarithromycin Viatris:

• If you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or to any of the other ingredients of this medicine (listed in section 6).
• If your creatinine clearance is less than 30 ml/min.
• If you have an irregular heartbeat.
• If you have severe kidney or liver problems.
• If you are taking ergotamine or dihydroergotamine, or using ergotamine inhalers for migraine while taking clarithromycin. Consult your doctor for alternative medicines.
• If you are taking medicines called terfenadine, astemizole (a medicine for hay fever or allergies), cisapride or domperidone (used for stomach problems), or pimozide (a medicine used to treat certain psychiatric conditions), as taking these medicines with clarithromycin may cause serious disturbances in heart rhythm. Consult your doctor for alternative medicines.
• If you are taking ticagrelor (to prevent blood clots in your veins, used in heart attacks and other heart problems), ivabradine, or ranolazine (for angina pectoris).
• If you are taking other medicines known to cause serious disturbances in heart rhythm.
• If you are undergoing treatment with oral midazolam (for anxiety or to help sleep).
• If you have abnormally low levels of potassium or magnesium in your blood (hypokalemia or hypomagnesemia).
• If you or a family member has a history of heart rhythm disorders (ventricular arrhythmia, including Torsade de Pointes) or abnormalities in the electrocardiogram (ECG, electrical recording of the heart) known as "QT prolongation syndrome".
• If you are taking medicines called lovastatin or simvastatin (to lower cholesterol levels), as combining these medicines may increase the risk of adverse effects. Consult your doctor for alternative medicines.
• If you are taking colchicine (for gout).
• If you are taking a medicine containing lomitapide.

Warnings and precautions

Talk to your doctor or pharmacist before starting Clarithromycin Viatris:

• If you have heart, kidney, or liver problems.
• If you have or are prone to fungal infections (e.g., thrush).
• If you are pregnant or breastfeeding.
• If you are taking medicines known as colchicine, triazolam, midazolam (for anxiety or insomnia), lovastatin, or simvastatin.
• If you are diabetic and taking hypoglycemic agents (medicines to lower blood sugar such as nateglinide, pioglitazone, rosiglitazone, repaglinide, sulfonylureas, or calcium channel blockers), as clarithromycin may lower blood glucose excessively. Careful monitoring of glucose levels is recommended.
• If you are taking a medicine called warfarin (a blood thinner).
• If you have myasthenia gravis, a condition in which your muscles become weak and tire easily.
• If you develop severe or prolonged diarrhea during or after taking clarithromycin, consult your doctor immediately.

If any of these situations apply to you, consult your doctor before taking clarithromycin.

Children and adolescents

Do not give this medicine to children under 12 years of age.

Elderly patients

Since clarithromycin is eliminated via the liver and kidneys, caution should be exercised in patients with hepatic impairment, moderate or severe renal impairment, and in elderly patients.

Other medicines and Clarithromycin Viatris

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

Claritromycin Viatris must not be taken with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, certain medicines for high cholesterol, and medicines known to cause serious disturbances in heart rhythm (see Do not take Clarithromycin Viatris).

This is especially important if you are taking medicines for:

• Heart problems (e.g., digoxin, verapamil, quinidine, or disopyramide).
• Blood thinning (e.g., warfarin or other anticoagulants such as dabigatran, rivaroxaban, apixaban, edoxaban).
• Migraine (e.g., ergotamine or dihydroergotamine).
• Epilepsy or bipolar disorder (carbamazepine, valproate, phenobarbital, or phenytoin).
• High cholesterol (e.g., simvastatin or lovastatin).

Or if you are taking any of the following medicines:

• Theophylline (used in patients with breathing difficulties such as asthma).
• Triazolam, alprazolam, or midazolam (sedatives).
• Cilostazol (for poor circulation).
• Methylprednisolone (a corticosteroid).
• Ibrutinib or vinblastine (for cancer treatment).
• Cyclosporine (an immunosuppressant).
• Rifabutin (for treating certain infections).
• Tacrolimus or sirolimus (for organ transplants and severe eczema).
• Sildenafil, tadalafil, or vardenafil (to treat erectile dysfunction in adult men or pulmonary arterial hypertension (high blood pressure in the blood vessels of the lungs)).
• Zidovudine (to treat viruses).
• St. John's wort (a herbal product used to treat depression).
• Phenobarbital (a medicine to treat epilepsy).
• Nevirapine and efavirenz may reduce the levels of clarithromycin.
• Rifampicin or rifapentine (to treat tuberculosis).
• Omeprazole (to treat stomach acid and stomach or intestinal ulcers).
• Ritonavir (an antiviral medicine used in the treatment of HIV infection) may increase the levels of clarithromycin. Concomitant use of atazanavir, etravirine, and saquinavir (also antiviral medicines used in the treatment of HIV infection) with clarithromycin may increase the levels of both atazanavir (or saquinavir) and clarithromycin.
• Itraconazole (an antifungal) taken together with clarithromycin may increase the levels of both medicines.
• Fluconazole, another antifungal medicine, may increase the levels of clarithromycin.
• Tolterodine (to treat symptoms of overactive bladder syndrome). In some patients, tolterodine levels may increase when taken with clarithromycin.
• Quetiapine (for schizophrenia or other psychiatric conditions).
• Beta-lactam antibiotics (certain penicillins and cephalosporins).
• Aminoglycosides (used as antibiotics to treat infections).
• Calcium channel blockers (medicines to treat high blood pressure).
• Hydroxychloroquine or chloroquine (used to treat diseases such as rheumatoid arthritis, or to treat or prevent malaria). Taking these medicines together with clarithromycin may increase the risk of abnormal heart rhythms and other serious adverse reactions affecting the heart.
• Corticosteroids, administered orally, by injection, or by inhalation (used to suppress the immune system; this is useful in the treatment of a wide range of diseases).

Pregnancy, lactation and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The safety of clarithromycin during pregnancy has not been established; therefore, your doctor must carefully weigh the benefits against the potential risks, especially during the first three months of pregnancy.

Clarithromycin passes into breast milk; therefore, breastfeeding should be discontinued during treatment with clarithromycin.

Driving and operating machinery

Since clarithromycin may cause dizziness, vertigo, confusion, and disorientation, caution should be exercised when driving or operating hazardous machinery during treatment with clarithromycin.

Claritromycin Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Claritromycin Viatris

Claritromycin Viatris tablets are administered orally.

Follow exactly the instructions for use of Claritromycin Viatris provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and children over 12 years of age:

Patients with respiratory tract, skin, and soft tissue infections

The usual dose is 250 mg twice daily for 7 days; however, in more severe infections, the dose may be increased to 500 mg twice daily. The usual duration of treatment is 5 to 14 days, except for community-acquired pneumonia and sinusitis, which require 6 to 14 days of therapy.

Eradication of Helicobacter pylori in patients with duodenal ulcers (adults):

For peptic ulcer patients associated with Helicobacter pylori, the recommended treatments are: Triple therapy: one Claritromycin Viatris tablet twice daily, together with 30 mg of lansoprazole twice daily and 1,000 mg of amoxicillin twice daily for 10 days.

Or one Claritromycin Viatris tablet with 1,000 mg of amoxicillin and 20 mg of omeprazole, all administered twice daily, for 7 to 10 days.

Elderly patients

Same as for adults.

Patients with mycobacterial infections:

The recommended average dose for prevention and treatment of mycobacterial infections is one Claritromycin Viatris tablet every 12 hours. The duration of treatment should be determined by the physician.

Patients with renal impairment:

In patients with renal impairment and a creatinine clearance of less than 30 ml/min, the dose of clarithromycin should be reduced by half, i.e., 250 mg once daily, or 250 mg twice daily in more severe infections. In these patients, treatment should be discontinued after 14 days. Since the tablet cannot be divided, the daily dose cannot be less than 500 mg/day; therefore, Claritromycin Viatris should not be administered to this group of patients.

Follow these instructions unless your doctor has given you different ones.

Remember to take your medicine. Take the tablets at the same time each day.

Your doctor will advise you on how long your treatment should last.

Use in children:

The appropriate formulations of clarithromycin for infants from 6 months of age and children under 12 years of age are granules for oral suspension.

If you take more Claritromycin Viatris than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (Tel: 91 562 04 20), indicating the medication and the amount ingested. Gastrointestinal disturbances may be expected, and your doctor will attempt to rapidly eliminate any clarithromycin not yet absorbed by your body. Hemodialysis and peritoneal dialysis are ineffective. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Claritromycin Viatris

Do not take a double dose to make up for missed doses.

Take the tablet as soon as you remember, and then continue taking your doses every 12 hours apart.

If you interrupt treatment with Claritromycin Viatris

Do not stop treatment before your doctor tells you to, as, even if you feel better, your condition could worsen or recur.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking clarithromycin and seek immediate medical help if you experience any of the following allergic reactions:

• If you develop severe or prolonged diarrhoea, which may contain blood or mucus, during or after treatment with clarithromycin.
• If you develop a skin rash, difficulty breathing, fainting, or swelling of the face and throat, contact your doctor immediately, as these may be signs of an allergic reaction.
• Contact a doctor as soon as possible if you experience a severe skin reaction: a red, scaly rash with lumps under the skin and blisters (exanthematous pustulosis). The frequency of this adverse effect is considered unknown (cannot be estimated from available data).

Other adverse effects include:

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

• Phlebitis (inflammation of the veins) at the injection site.

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

• Insomnia (difficulty falling asleep).
• Dysgeusia (altered taste).
• Headache.
• Vasodilation (dilation of blood vessels).
• Diarrhoea.
• Vomiting.
• Dyspepsia (difficulty and discomfort during digestion).
• Nausea.
• Abdominal pain (stomach).
• Abnormal liver function.
• Eczema (inflammation of the skin accompanied by itching, redness, and occasionally blisters).
• Hyperhidrosis (excessive sweating).
• Pain and inflammation at the injection site.

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

• Cellulitis (inflammation of the subcutaneous tissue beneath the skin).
• Candidiasis (fungal infection of the skin and mucous membranes caused by fungi of the genus Candida).
• Gastroenteritis (inflammation of the stomach and intestines).
• Infections, vaginal infection.
• Leukopenia (decreased white blood cells or leukocytes in blood), neutropenia (decreased neutrophils in blood, a type of white blood cell), thrombocytosis (excessively high platelet count in blood), eosinophilia (increased eosinophils in blood, a type of white blood cell).
• Anaphylactoid reaction (allergic reaction).
• Hypersensitivity.
• Anorexia (decreased appetite).
• Anxiety.
• Restlessness.
• Loss of consciousness.
• Dyskinesia (involuntary facial movements).
• Dizziness.
• Vertigo.
• Somnolence.
• Tremor.
• Ear disorders.
• Tinnitus (abnormal auditory sensation perceived only by the individual).
• Cardiac arrest.
• Atrial fibrillation.
• Prolongation of the QT interval on electrocardiogram.
• Extrasystoles (premature heartbeats, i.e., heartbeats occurring earlier than normal).
• Palpitations (noticeable and more frequent than normal heartbeats).
• Asthma (inflammation of the airways causing breathing difficulty).
• Epistaxis (nosebleed).
• Pulmonary embolism.
• Esophagitis (inflammation of the esophagus, the part of the digestive tract extending from the pharynx to the stomach).
• Gastroesophageal reflux (a condition in which stomach contents flow back from the stomach into the esophagus).
• Gastritis (inflammation of the stomach).
• Proctalgia (pain in the anus or rectum).
• Stomatitis (inflammation of the oral mucosa).
• Glossitis (inflammation of the tongue).
• Abdominal distension (abdominal bloating).
• Constipation.
• Dry mouth.
• Belching.
• Flatulence (gas).
• Cholestasis (reduction or obstruction of bile flow from the liver).
• Hepatitis (inflammation of the liver).
• Increased liver enzymes (alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase).
• Dermatitis (inflammation of the skin).
• Pruritus (itching).
• Urticaria.
• Maculopapular rash (a type of rash not raised above the skin surface, with discolored skin spots, redness, and inflammation).
• Muscle spasms.
• Musculoskeletal stiffness.
• Myalgia (muscle pain).
• Increased creatinine and urea in blood.
• Malaise.
• Pyrexia (fever).
• Asthenia (weakness, fatigue).
• Chest pain.
• Chills.
• Fatigue.
• Abnormal blood albumin/globulin ratio.
• Increased alkaline phosphatase and lactate dehydrogenase in blood.

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

• Erysipelas (fever accompanied by rash, itching, and redness of the skin).
• Pseudomembranous colitis.
• Agranulocytosis (decreased or absent granulocytes in blood, a type of white blood cell).
• Thrombocytopenia (decreased platelets in blood).
• Anaphylactic reaction (allergic reaction).
• Angioedema (swelling and fluid accumulation under the skin).
• Hypoglycemia (decreased blood glucose or sugar levels).
• Psychotic disorder.
• Confusional state.
• Depersonalization (loss of self-identity).
• Depression.
• Disorientation.
• Hallucinations (seeing or hearing things that do not exist).
• Abnormal dreams.
• Mania (euphoria or hyperactivity).
• Seizures.
• Ageusia (loss of taste sensation).
• Parosmia (distorted sense of smell).
• Anosmia (loss of smell).
• Paresthesia (sensory disturbances such as tingling or numbness).
• Deafness.
• Torsade de pointes (a specific type of ventricular tachycardia).
• Ventricular tachycardia (rapid heartbeat).
• Ventricular fibrillation.
• Bleeding.
• Acute pancreatitis (inflammation of the pancreas).
• Discoloration of the tongue and teeth.
• Hepatic failure (partial or complete inability of the liver to properly perform its functions).
• Hepatocellular jaundice (yellowing of the skin and eyes).
• Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome).
• Acute generalized exanthematous pustulosis.
• Toxic epidermal necrolysis.
• Acne.
• Rhabdomyolysis (serious muscle problems).
• Myopathy (muscle diseases).
• Renal failure (partial or complete inability of the kidneys to properly perform their functions).
• Interstitial nephritis (inflammation of the kidneys).
• Increased international normalized ratio and prolonged prothrombin time (laboratory tests to assess blood coagulation).
• Abnormal urine coloration.
• Pseudomembranous colitis (infection and inflammation of the large intestine). Inflammation of the colon has been reported with nearly all antibacterial medicines, including clarithromycin. Symptoms include diarrhoea occurring after taking clarithromycin. Inform your doctor immediately if you experience diarrhoea.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clarithromycin Viatris

Keep this medicine out of sight and reach of children.

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after the abbreviation EXP or CAD. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clarithromycin Viatris

The active substance is clarithromycin. Each tablet contains 500 mg of clarithromycin.

The other components (excipients) are: pregelatinized maize starch, sodium croscarmellose, povidone 25 (E-1201), microcrystalline cellulose (E-460), colloidal anhydrous silica, magnesium stearate (E-470B), hypromellose (E-464), titanium dioxide (E-171), talc (E-553B) and propylene glycol (E-1520).

Appearance of the product and contents of the pack

Film-coated tablets, white, capsule-shaped.

Presented in blisters, in packs of 14, 21 tablets or clinical pack of 500 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Kern Pharma, S.L.

C/ Venus, 72 - Polígono Industrial Colon II

08228 - Terrassa (Barcelona)

Spain

Date of the most recent revision of this leaflet: May 2025

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