Label: Information for the user

Claritromycin Viatris 500 mg film-coated tablets

Read this label carefully before you start taking this medicine, because it contains important information for you.

-Keep this label, as you may need to read it again.

-If you have any questions, consult 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 of the disease, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist,even if they are not listed in this label.See section 4.

Claritromicina is a medication that belongs to the group of macrolide antibiotics.

Claritromicina is used for the treatment of infections caused by susceptible microorganisms in adults and adolescents (12 years to less than 18 years):

Adults:

1. Upper respiratory tract infections, such as pharyngitis, tonsillitis, and sinusitis.
2. Lower respiratory tract infections, such as acute bronchitis, exacerbation of chronic bronchitis, and bacterial pneumonia.
3. Skin and soft tissue infections, such as folliculitis, cellulitis, and erysipelas.
4. Infections caused by mycobacteria (a type of bacteria).
5. Eradiation of the Helicobacter pylori bacteria in patients with gastric or duodenal ulcers.

Adolescents (12 years to less than 18 years):

1. Upper respiratory tract infections, such as pharyngitis.
2. Lower respiratory tract infections, such as bronchitis and bacterial pneumonia.
3. Acute otitis media.
4. Skin and soft tissue infections, such as impetigo, folliculitis, cellulitis, and abscesses.

Do not takeClaritromycin Viatris:

• If you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other components of this medication (listed in section 6).
• If you have a creatinine clearance of less than 30 ml/min.
• If you have an irregular heart rhythm.
• If you have severe kidney and liver problems.
• If you are taking ergotamine or dihydroergotamine or using inhalers of ergotamine for migraine while taking clarithromycin. Consult your doctor for alternative medications.
• If you are taking medications called terfenadine, astemizol (allergy medication), cisapride, or domperidone (used for stomach problems) or pimozide (used to treat certain psychiatric conditions) as taking these medications with clarithromycin may cause severe 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), ivabradinaor ranolazine (for angina pectoris).
• If you are taking other medications known to cause severe heart rhythm disturbances.
• If you have abnormally low levels of potassium in your blood (hypokalemia).
• If you or a family member has a history of heart rhythm disorders (ventricular arrhythmia, includingTorsade de Pointes) or abnormal electrocardiogram (ECG, heart electrical recording) called “prolongation of QT syndrome”.
• If you are taking medications called lovastatin or simvastatin (to lower cholesterol levels), as the combination of these medications may increase the risk of adverse effects. Consult your doctor for alternative medications.
• If you are taking colchicine (for gout).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Claritromycin 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 medications (medications to lower blood sugar such as nateglinide, pioglitazone, rosiglitazone, and repaglinide, sulfonylureas, or calcium channel blockers) and clarithromycin may lower blood sugar levels too much. Careful glucose control is recommended.
• If you are taking a medication called warfarin (blood thinner).
• If you have myasthenia gravis, a condition where your muscles weaken and tire easily.
• If you develop severe or prolonged diarrhea, during or after taking clarithromycin, consult your doctor immediately.
• If you have abnormally low levels of magnesium in your blood (hypomagnesemia) consult your doctor before taking this medication.

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

Children and adolescents

Do not administer this medication to children under 12 years old.

Older patients

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

Other medications andClaritromycin Viatris

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

Do not take Claritromycin Viatris with ergot alkaloids, astemizol, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, certain medications for high cholesterol, and medications known to cause severe heart rhythm disturbances (seeDo not take Claritromycin Viatris).

This is especially important if you are taking medications for:

• Heart problems (e.g. digoxin, verapamil, quinidine, or disopyramide).
• Thinning the blood (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 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).
• Ciclosporin (immunosuppressant).
• Rifabutin (for the treatment of certain infections).
• Tacrolimus or sirolimus (for organ transplants and severe eczema).
• Sildenafil, tadalafil, or vardenafil (to treat erectile dysfunction in adult men or for pulmonary hypertension).
• Zidovudine (for viral infections).
• St. John's Wort (herbal product for depression).
• Phenobarbital (medication for epilepsy).
• Nevirapine and efavirenz may decrease clarithromycin levels.
• Rifampicin or rifapentine (for tuberculosis).
• Omeprazole (for stomach acid and ulcers).
• Ritonavir (antiviral medication used in HIV treatment) may increase clarithromycin levels. The concomitant use of atazanavir, etravirine, and saquinavir (also antiviral medications used in HIV treatment) with clarithromycin may increase both atazanavir (or saquinavir) and clarithromycin levels.
• Itraconazole (antifungal) taken with clarithromycin may increase both medication levels.
• Fluconazole, another antifungal, may increase clarithromycin levels.
• Tolterodine (for 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 for infections).
• Calcium channel blockers (medications for high blood pressure).
• Hydroxychloroquine or chloroquine (used to treat conditions such as rheumatoid arthritis, or to treat or prevent malaria). Taking these medications with clarithromycin may increase the risk of abnormal heart rhythms and other severe adverse reactions affecting the heart.
• Corticosteroids, administered orally, by injection, or inhaled (used to suppress the immune system; this is useful in the treatment of a wide variety of diseases)

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Clarithromycin passes into breast milk, so it is recommended to stop breastfeeding during treatment with clarithromycin.

Driving and operating machinery

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

Claritromycin Viatris contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Claritromicina Viatris is presented in oral tablets. Take the tablets at the same time every day.

Since 500 mg tablets cannot be split, other commercial presentations are available for applying 250 mg doses.

Your doctor will indicate the dose and duration of your treatment with this medication. Do not take more doses than your doctor has indicated.

The recommended dose of claritromycin is:

Adults and adolescents (12 years of age to less than 18 years): the recommended dose is 250 mg twice a day. In more severe infections, the dose may be increased to 500 mg twice a day. The usual treatment duration is 5 to 14 days, excluding community-acquired pneumonia and sinusitis that require 6 to 14 days of therapy.

Use in children:The appropriate presentations of claritromycin for infants from 6 months and children under 12 years are in the form of granulated suspension for oral administration.

Patients with gastric or duodenal ulcers associated withHelicobacter pylori:

In patients with peptic ulcers associated withHelicobacter pylorithe recommended treatments are:

Triple therapy:

• One claritromycin 500 mg tablet, with 30 mg of lansoprazole and 1,000 mg of amoxicillin, all administered twice a day for 10 days.
• One claritromycin 500 mg tablet with 1,000 mg of amoxicillin and 20 mg of omeprazole, all administered twice a day for 7 to 10 days.

Patients with infections caused by mycobacteria:

The recommended median dose for the prevention and treatment of infections caused by mycobacteria is one 500 mg claritromycin tablet every 12 hours. The treatment duration 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 claritromycin dose 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 discontinued after 14 days.

If you estimate that the action of claritromycin is too strong or too weak, inform your doctor or pharmacist.

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 Toxicological Information Service (Tel: 91 562 04 20) indicating the medication and the amount ingested. Gastrointestinal disturbances are expected to appear, and your doctor will try to quickly eliminate the claritromycin that your body has not yet absorbed. Hemodialysis or peritoneal dialysis is not effective. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Claritromicina Viatris

Do not take a double dose to compensate for the missed doses.

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

If you interrupt treatment with Claritromicina Viatris

Do not discontinue treatment before your doctor tells you to, as your condition may worsen or recur.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 taking clarithromycin.
• If you develop a skin rash, difficulty breathing, dizziness, 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 bumps under the skin and blisters (pustular exanthema). The frequency of this side effect is considered unknown (cannot be estimated from available data).

Other side 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).
• Disturbance of taste.
• Headache.
• Vasodilation (widening of blood vessels).
• Diarhea.
• Vomiting.
• Indigestion (difficulty and discomfort with digestion).
• Nausea.
• Abdominal pain (stomach).
• Abnormal liver function.
• Eczema (inflammation of the skin accompanied by itching, redness, and occasional appearance of vesicles).
• Hyperhidrosis (excessive sweating).
• Pain and inflammation at the injection site.

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

• Cellulitis (inflammation of subcutaneous tissue, beneath the skin).
• Candidiasis (infection of the skin and mucous membranes produced by fungi of the genus Candida).
• Gastroenteritis (inflammation of the stomach and intestine).
• Infections, vaginal infection.
• Leucopenia (decrease in white blood cells), neutropenia (decrease in neutrophils, a type of white blood cell), thrombocytopenia (excessive level of platelets in the blood), eosinophilia (increase in eosinophils, a type of white blood cell).
• Anaphylactoid reaction (allergic reaction).
• Hypersensitivity.
• Anorexia (decrease in appetite).
• Anxiety.
• Nervousness.
• Loss of consciousness.
• Dyskinesia (involuntary movements of the face).
• Dizziness.
• Somnolence.
• Tremor.
• Ear disorders.
• Tinnitus or ear ringing (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., heartbeats that come too early).
• Palpitations (heartbeats that are perceptible and more frequent than normal).
• Asthma (inflammation of the respiratory tract causing difficulty breathing).
• Nasal hemorrhage.
• Pulmonary embolism.
• Esophagitis (inflammation of the esophagus, part of the digestive tract that goes from the pharynx to the stomach).
• Gastroesophageal reflux (condition in which stomach contents return back 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.
• Eructation.
• Flatulence (gas).
• Biliary obstruction (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 surface of the skin, with skin discoloration and inflammation).
• Muscle spasms.
• Musculoskeletal stiffness.
• Muscle pain.
• Increased creatinine and urea in the blood.
• Malaise.
• Fever.
• Weakness.
• Chest pain.
• Chills.
• Fatigue.
• Abnormal albumin/globulin ratio in the blood.
• Increased alkaline phosphatase and lactate dehydrogenase in the blood.

Unknown frequency(cannot be estimated from available data):

• Erysipelas (fever accompanied by rash, itching, and redness of the skin).
• Agranulocytosis (decrease or absence of granulocytes in the blood, a type of white blood cell).
• Thrombocytopenia (decrease in platelets in the blood).
• Anaphylactic reaction (allergic reaction).
• Angioedema (swelling and accumulation of fluid under the skin).
• Hypoglycemia (decrease in the amount of glucose or sugar in the blood).
• Psychotic disorder.
• Confusional state.
• Depersonalization (loss of one's own identity).
• Depression.
• Disorientation.
• Hallucinations (seeing or hearing things that do not exist).
• Abnormal dreams.
• Mania (euphoria or hyperactivity).
• Seizures.
• Ageusia (loss of sense of taste).
• Parosmia (disturbance of the sense of smell).
• Anosmia (loss of sense of smell).
• Paresthesia (disturbance of sensitivity, such as tingling or numbness).
• Deafness.
• Torsades de Pointes(specific ventricular tachycardia).
• Ventricular tachycardia (acceleration of heartbeats).
• Ventricular fibrillation.
• Bleeding.
• Acute pancreatitis (inflammation of the pancreas).
• Decoloration of the tongue and teeth.
• Acute liver failure (total or partial inability of the liver to perform its functions properly).
• Hepatocellular jaundice (yellow 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).
• Acne.
• Rhabdomyolysis (severe muscle problems).
• Myopathy (muscle diseases).
• Renal insufficiency (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 drugs, including clarithromycin. Your symptoms may include diarrhea after taking clarithromycin. Inform your doctor immediately if you experience diarrhea.

Reporting of side effects

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

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

Store below 30°C.

Do not use this medication after the expiration date that appears on the packaging after the abbreviation CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Claritromicina Viatris

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

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

Appearance of the product and contents of the packaging

Coated tablets, white, in capsule shape.

It is presented in blister packs, in packaging of 14, 21 tablets or clinical packaging of 500 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing

Kern Pharma, S.L.

C/ Venus, 72 - Polígono Industrial Colon II

08228 - Terrassa (Barcelona)

Spain

Last review date of this leaflet:March 2024

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