CLARITHROMYCIN VIATRIS 500 mg FILM-COATED TABLETS

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

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

Antibiotics are used to treat bacterial infections and do not work for viral infections such as flu or common cold.

It is important that you follow the instructions regarding the dose, intake, and duration of treatment indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

Claritromicina Viatris is used to treat infections caused by sensitive germs in adults and adolescents from 12 to 18 years:

• Upper respiratory tract infections, such as pharyngitis (infection of the pharynx that causes sore throat), tonsillitis (infection of the tonsils), and sinusitis (infection of the paranasal sinuses around the forehead, cheeks, and eyes).
• Lower respiratory tract infections, such as acute bronchitis (infection and inflammation of the bronchi), exacerbation of chronic bronchitis (worsening of prolonged or recurrent lung inflammation), and bacterial pneumonia (inflammation of the lungs caused by bacteria). (see section warnings and precautions)
• Infections of the skin and soft tissues, 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 warnings and precautions)
• Gastric and duodenal ulcer
• And in the prevention and treatment of infections produced by mycobacteria.

2. What you need to know before you take Claritromicina Viatris

Do not takeClaritromicina Viatris:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Claritromicina 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 medications known as colchicine, triazolam, midazolam (for anxiety or insomnia), lovastatin, simvastatin.
• If you are diabetic and taking hypoglycemic agents (medications to lower blood sugar levels such as nateglinide, pioglitazone, rosiglitazone, and repaglinide, sulfonylureas, or calcium channel blockers) and claritromicina may lower blood sugar levels too much. Careful glucose monitoring is recommended.
• If you are taking a medication called warfarin (blood anticoagulant).
• If you have myasthenia gravis, a condition where your muscles weaken and get tired easily.
• If you develop severe or prolonged diarrhea during or after taking claritromicina, consult your doctor immediately.

If any of these situations affect you, consult your doctor before taking claritromicina.

Children and adolescents

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

Elderly patients

Since claritromicina is eliminated by the liver and kidneys, caution should be exercised in patients with liver failure, moderate or severe renal insufficiency, and in elderly patients.

Other medicines andClaritromicina Viatris

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

Do not take Claritromicina Viatris with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, some medications for high cholesterol, and medications known to cause serious heart rhythm disturbances (see Do not take Claritromicina Viatris).

This is especially important if you are taking medications for:

• Heart problems (e.g., digoxin, verapamil, quinidine, or disopyramide).
• Blood thinning (e.g., warfarin or other anticoagulants, e.g., 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 medication called:

• 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 (immunosuppressant).
• Rifabutin (for the treatment of some infections).
• Tacrolimus or sirolimus (for organ transplants and severe eczema).
• Sildenafil, tadalafil, or vardenafil (for treating impotence in adult men or for pulmonary arterial hypertension (elevated blood pressure in the pulmonary blood vessels)).
• Zidovudine (for treating viruses).
• St. John's Wort (herbal product for treating depression).
• Phenobarbital (medication for treating epilepsy).
• Nevirapine and efavirenz may decrease claritromicina levels.
• Rifampicin or rifapentine (for treating tuberculosis).
• Omeprazole (for treating stomach acid and stomach or intestinal ulcers).
• Ritonavir (antiviral medication used in HIV infection treatment) may increase claritromicina levels. The combination of atazanavir, etravirine, and saquinavir (also antiviral medications used in HIV infection treatment) with claritromicina may increase both atazanavir (or saquinavir) and claritromicina levels.
• Itraconazole (an antifungal) taken with claritromicina may increase the levels of both medications.
• Fluconazole, another antifungal medication, may increase claritromicina levels.
• Tolterodine (for treating overactive bladder symptoms). In some patients, tolterodine levels may increase when taken with claritromicina.
• Quetiapine (for schizophrenia or other psychiatric conditions).
• Beta-lactam antibiotics (certain penicillins and cephalosporins)
• Aminoglycosides (used as antibiotics to treat infections).
• Calcium channel blockers (medications for treating high blood pressure).
• Hydroxychloroquine or chloroquine (used to treat diseases such as rheumatoid arthritis or to treat or prevent malaria). Taking these medications at the same time as claritromicina may increase the risk of abnormal heart rhythms and other serious adverse reactions affecting the heart.
• Corticosteroids, administered orally, by injection, or inhaled (used to suppress the immune system; this is useful in treating a wide variety of diseases)

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The safety of claritromicina during pregnancy has not been established, so your doctor will carefully weigh the benefits against the potential risks, especially during the first three months of pregnancy.

Claritromicina passes into breast milk, so breastfeeding should be interrupted during treatment with claritromicina.

Driving and using machines

Since claritromicina can cause dizziness, vertigo, confusion, and disorientation, you should exercise caution when driving or using hazardous machinery during treatment with claritromicina.

Claritromicina Viatris contains sodium

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

3. How to take Claritromicina Viatris

Claritromicina Viatris tablets are administered orally.

Follow the administration instructions for Claritromicina Viatris exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and children over 12 years:

Patients with respiratory tract, skin, and soft tissue infections

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

Helicobacter pylori eradication in patients with duodenal ulcers (adults):

In patients with peptic ulcer associated with Helicobacter pylori, the recommended treatments are: Triple therapy: one Claritromicina Viatris tablet twice a day, with 30 mg of lansoprazole, twice a day, and 1000 mg of amoxicillin, twice a day, for 10 days.

Or one Claritromicina Viatris tablet with 1000 mg of amoxicillin and 20 mg of omeprazole, all administered twice a day, for 7 to 10 days.

Elderly patients

As for adults.

Patients with mycobacterial infections:

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

Patients with renal insufficiency:

In patients with renal insufficiency and a creatinine clearance of less than 30 ml/min, the dose of claritromicina should be reduced to half, i.e., 250 mg once a day, or 250 mg twice a day in more severe infections. In these patients, treatment should be interrupted at 14 days. Since the tablet cannot be halved, the daily dose cannot be less than 500 mg/day, so Claritromicina Viatris should not be administered in this group of patients.

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

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

Your doctor will indicate the duration of your treatment.

Use in children:

The suitable presentations of claritromicina for infants from 6 months and children under 12 years are in the form of oral suspension granules.

If you take more Claritromicina Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (Tel: 91 562 04 20) indicating the medicine and the amount ingested. You can expect the appearance of digestive disorders, and your doctor will try to quickly eliminate the claritromicina that your body has not yet absorbed. Hemodialysis or peritoneal dialysis is not effective. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Claritromicina Viatris

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

Take the tablet as soon as you remember and continue respecting the 12-hour interval between intake and intake.

If you stop taking Claritromicina Viatris

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

If you have any other 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 all people suffer from them.

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

• If you develop severe or prolonged diarrhea, which may contain blood or mucus, during or after clarithromycin treatment.
• 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 and scaly rash with bumps 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 (alteration of taste).
• Headache.
• Vasodilation (dilation of blood vessels).
• Diarrhea.
• Vomiting.
• Dyspepsia (difficulty and discomfort in digesting).
• Nausea.
• Abdominal pain (stomach).
• Abnormal liver function.
• Eczema (inflammation of the skin accompanied by itching, redness, and occasional appearance of 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, under the skin).
• Candidiasis (infection of the skin and mucous membranes caused by fungi of the genus Candida).
• Gastroenteritis (inflammation of the stomach and intestine).
• Infections, vaginal infection.
• Leukopenia (decrease in white blood cells), neutropenia (decrease in neutrophils in blood), thrombocytosis (excessive level of platelets in blood), eosinophilia (increase in eosinophils in blood).
• Anaphylactoid reaction (allergic reaction).
• Hypersensitivity.
• Anorexia (decreased appetite).
• Anxiety.
• Nervousness.
• Loss of consciousness.
• Dyskinesia (involuntary movements of the face).
• Dizziness.
• Vertigo.
• Somnolence.
• Tremor.
• Ear disorders.
• Tinnitus or ear noise (abnormal auditory sensation perceived only by oneself).
• Cardiac arrest.
• Atrial fibrillation.
• Prolongation of the QT interval on the electrocardiogram.
• Extrasystoles (premature heart contractions, i.e., early heartbeats).
• Palpitations (perceptible and more frequent than normal heartbeats).
• Asthma (inflammation of the respiratory tract causing difficulty breathing).
• Epistaxis (nasal bleeding).
• Pulmonary embolism.
• Esophagitis (inflammation of the esophagus, part of the digestive tube that goes from the pharynx to the stomach).
• Gastroesophageal reflux (condition in which stomach contents return from the stomach to 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 swelling).
• 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-glutamyltransferase).
• Dermatitis (inflammation of the skin).
• Pruritus (itching).
• Urticaria.
• Maculopapular rash (type of rash that does not rise above the skin surface, with discolored and reddened skin and inflammation).
• Muscle spasms.
• Musculoskeletal stiffness.
• Myalgia (muscle pain).
• Increased creatinine and urea in blood.
• Discomfort.
• Pyrexia (fever).
• Asthenia (weakness, fatigue).
• Chest pain.
• Chills.
• Fatigue.
• Abnormal albumin/globulin ratio in blood.
• Increased alkaline phosphatase and lactate dehydrogenase in blood.

Unknown Frequency(cannot be estimated from available data):

• Erysipelas (fever accompanied by rash, itching, and redness of the skin).
• Pseudomembranous colitis.
• Agranulocytosis (decrease or absence of granulocytes in blood).
• Thrombocytopenia (decrease in platelets in blood).
• Anaphylactic reaction (allergic reaction).
• Angioedema (swelling and fluid accumulation under the skin).
• Hypoglycemia (decrease in blood glucose or sugar level).
• Psychotic disorder.
• Confusional state.
• Depersonalization (loss of one's identity).
• Depression.
• Disorientation.
• Hallucinations (seeing or hearing things that do not exist).
• Abnormal dreams.
• Mania (euphoria or hyperactivity).
• Seizures.
• Ageusia (loss of taste).
• Parosmia (alteration of the sense of smell).
• Anosmia (loss of smell).
• Paresthesia (disorder of sensitivity such as tingling or numbness).
• Deafness.
• Torsade de Pointes(specific ventricular tachycardia).
• Ventricular tachycardia (acceleration of heartbeats).
• Ventricular fibrillation.
• Hemorrhage.
• Acute pancreatitis (inflammation of the pancreas).
• Discoloration of the tongue and teeth.
• Liver failure (total or partial inability of the liver to perform its functions properly).
• Hepatocellular jaundice (yellowish discoloration 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).
• Acute generalized exanthematous pustulosis.
• Toxic epidermal necrolysis.
• Acne.
• Rhabdomyolysis (severe muscle problems).
• Myopathy (muscle diseases).
• Renal failure (total or partial inability of the kidneys to perform their functions properly).
• Interstitial nephritis (inflammation of the kidneys).
• Increased international normalized ratio and prolonged prothrombin time (laboratory tests to evaluate blood coagulation).
• Abnormal urine color.
• Pseudomembranous colitis (infection and inflammation of the large intestine). Inflammation of the colon has been reported with almost all antibacterial medicines, including clarithromycin. Symptoms include diarrhea after taking clarithromycin. Inform your doctor immediately if you experience diarrhea.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date stated on the packaging after the abbreviation CAD or EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Clarithromycin Viatris

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

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

Appearance of the Product and Package Contents

Coated tablets, white, capsule-shaped.

It is packaged in blisters, in packs of 14, 21 tablets or clinical pack of 500 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.U.

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 Last Revision of this Leaflet:May 2025

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