Clarithromycin Vir 250 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Claritromycin Vir 250 mg film-coated tablets EFG

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

• Keep this leaflet. 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 you, because 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.

Leaflet contents

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

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

Clarithromycin is an antibiotic belonging to the macrolide group and works by eliminating bacteria.

Claritromycin Vir 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), exacerbations of chronic bronchitis (worsening of long-term or recurrent lung inflammation), and bacterial pneumonias (lung inflammation caused by bacteria). See 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 Warnings and precautions.
• Gastric and duodenal ulcers.
• And in the prevention and treatment of infections caused by mycobacteria.

2. What you need to know before taking Clarithromycin Vir

Do not take Clarithromycin Vir:

• 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 medications.
• If you are taking medicines known as terfenadine, astemizole (medicines 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 with clarithromycin may cause serious disturbances in heart rhythm. Consult your doctor for alternative medications.
• If you are taking ticagrelor (to prevent blood clots, 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 (electrocardiogram changes) or magnesium in the blood (hypokalemia or hypomagnesemia).
• If you or a family member have a history of heart rhythm disorders (ventricular arrhythmia, including Torsades 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 with clarithromycin may increase the risk of adverse effects. Consult your doctor for alternative medications.
• 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 taking Clarithromycin Vir:

• 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, sulfonamides, or calcium channel blockers), as clarithromycin may excessively lower glucose levels. Careful monitoring of blood glucose 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 insufficiency, moderate or severe renal insufficiency, and in elderly patients.

Other medicines and Clarithromycin Vir

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.

Clarithromycin must not be taken with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, certain medicines for treating high cholesterol, or medicines known to cause serious disturbances in heart rhythm. See Do not take Clarithromycin Vir.

This is especially important if you are taking medicines for:

• Heart problems (e.g., digoxin, verapamil, quinidine, or disopyramide).
• Blood thinning (e.g., warfarin).
• 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 medicine 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 (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 for treating epilepsy).
• Nevirapine and efavirenz may decrease levels of clarithromycin.
• Rifampicin or rifapentine (for treating tuberculosis).
• Omeprazole (for treating stomach acidity and stomach or intestinal ulcers).
• Ritonavir (an antiviral medicine used in the treatment of HIV infection) may increase levels of clarithromycin. Concomitant use of atazanavir, etravirine, and saquinavir (also antiviral medicines used in the treatment of HIV infection) with clarithromycin may increase levels of both atazanavir (or saquinavir) and clarithromycin.
• Itraconazole (an antifungal) taken together with clarithromycin may increase levels of both medicines.
• Fluconazole, another antifungal medicine, may increase levels of clarithromycin.
• Tolterodine (to treat symptoms of overactive bladder syndrome). In some patients, levels of tolterodine 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).
• Warfarin or other anticoagulants, e.g., dabigatran, rivaroxaban, apixaban, edoxaban (to thin the blood).
• 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 effects affecting the heart.
• Corticosteroids administered orally, by injection, or by inhalation (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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The safety of clarithromycin during pregnancy has not been established, so 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 using machines

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

Clarithromycin Vir contains propylene glycol

This medicine contains 2,610 mg of propylene glycol in each tablet.

3. How to take Claritromycin Vir

Claritromycin Vir is administered orally.

Follow exactly the dosage instructions given 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 patients with peptic ulcer associated with Helicobacter pylori, the recommended treatments are:

Triple therapy: 2 tablets of 250 mg clarithromycin twice daily, together with 30 mg lansoprazole twice daily and 1,000 mg amoxicillin twice daily for 10 days.

or 2 tablets of 250 mg clarithromycin with 1,000 mg amoxicillin and 20 mg omeprazole, all administered twice daily, for 7 to 10 days.

Elderly patients:

As for adults.

Patients with mycobacterial infections:

The recommended average dose for prevention and treatment of mycobacterial infections is 2 tablets of 250 mg every 12 hours. The duration of treatment should be determined by the physician.

Patients with renal impairment:

In patients with renal impairment and creatinine clearance 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.

Follow these instructions unless your doctor has given you different advice. Remember to take your medicine. Take the tablets at the same time each day.

Your doctor will determine the duration of your treatment.

Use in children and adolescents

Claritromycin Vir 250 mg is not suitable for children and adolescents under 12 years of age.

If you think that the effect of Claritromycin Vir is too strong or too weak, consult your doctor or pharmacist.

If you take more Claritromycin Vir than you should

If you have taken more Claritromycin Vir than you should, gastrointestinal disturbances may be expected. Contact your doctor or pharmacist immediately, as measures should be taken to rapidly eliminate any clarithromycin not yet absorbed by your body. Hemodialysis or peritoneal dialysis are not effective.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Claritromycin Vir

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

Take the tablet as soon as possible and continue taking it at the same time each day.

If you stop taking Claritromycin Vir

Do not stop treatment early, 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 produce adverse effects, although not everyone will experience them.

Adverse effects are classified as very common (may affect more than 1 in 10 patients), common (may affect up to 1 in 10 patients), uncommon (may affect up to 1 in 100 patients), and frequency not known (cannot be estimated from the available data).

Frequent and very common reactions associated with clarithromycin treatment in both adults and children are abdominal pain, diarrhea, nausea, vomiting, and altered taste. These adverse reactions are usually mild in intensity and consistent with the known safety profile of macrolide antibiotics (see below).

There were no significant differences in the incidence of these gastrointestinal adverse reactions during clinical trials between patients with or without pre-existing mycobacterial infections.

Summary of adverse effects

Adverse effects are listed in descending order of severity within each body system:

• Very commonly observed (may affect more than 1 in 10 patients, with the intravenous injection formulation): phlebitis (vein inflammation) at the injection site.

• Frequently observed (may affect up to 1 in 10 patients) with all medicines containing clarithromycin:

• Gastrointestinal system: diarrhea, vomiting, gastric discomfort impairing digestion (dyspepsia), nausea, abdominal pain.

• Nervous system: altered taste sensation, headache, taste disturbance.

• Skin: mild skin rashes, excessive sweating.

• Psychiatric disorders: insomnia.

• Vascular disorders: dilation of blood vessels in the body (vasodilation).

• Liver disorders: abnormal liver function tests.

• Administration site reactions: pain and inflammation at the injection site (only with intravenous injection formulation).

• Uncommonly observed (may affect up to 1 in 100 patients):

• Infections: cellulitis (only with intravenous injection formulation), candidiasis (fungal infection), gastroenteritis (only with prolonged-release tablets), infection (only with granules for oral suspension), vaginal infection.

• Blood disorders: decreased white blood cells, decreased neutrophils (a type of white blood cell, only with immediate-release tablets), increased platelets and, to a lesser extent, increased red and white blood cells in blood (only with granules for oral suspension), increased eosinophils (a type of white blood cell, only with immediate-release tablets).

• Immune system disorders: anaphylactoid reaction (generalized allergic reaction, only with intravenous injection formulation), hypersensitivity (exaggerated allergic reaction to external agents).

• Eating disorders: anorexia, decreased appetite.

• Psychiatric disorders: anxiety and nervousness (the latter only with granules for oral suspension).

• Nervous system: loss of consciousness and difficulty moving (both effects, only with intravenous injection formulation), dizziness, somnolence, tremors.

• Ear and balance: vertigo, hearing problems, tinnitus.

• Heart disorders: cardiac arrest and heart rhythm disturbances (atrial fibrillation) (both effects, only with intravenous injection formulation), QT interval prolongation (an ECG indicator of possible ventricular arrhythmias), extrasystoles (premature heartbeat relative to normal heart rate, only with intravenous injection formulation), palpitations (irregular heartbeats).

• Respiratory disorders: asthma (difficulty breathing, chest tightness, and nocturnal or early morning cough, only with intravenous injection formulation), epistaxis (only with prolonged-release tablets), pulmonary embolism (blockage of the pulmonary artery causing one-sided chest pain, cough, and difficulty breathing, only with intravenous injection formulation).

• Gastrointestinal disorders: esophagitis (only with intravenous injection formulation), gastroesophageal reflux disease (damage to the esophagus causing burning sensation, chronic cough, shortness of breath, and difficulty swallowing, only with prolonged-release tablets), inflammation of the stomach lining (gastritis), anal and rectal pain (only with prolonged-release tablets), inflammation of the oral mucosa, inflammation of the tongue, abdominal distension (only with immediate-release tablets), constipation, dry mouth, belching, flatulence.

• Liver disorders: decreased or suppressed bile flow to the intestine and liver inflammation (hepatitis) (both effects, only with immediate-release tablets), increased alanine aminotransferase (liver enzyme), aspartate aminotransferase (another liver enzyme), and gamma-glutamyltransferase (another liver enzyme, only with immediate-release tablets).

• Skin: bullous dermatitis (blistering eruptions, only with intravenous injection formulation), pruritus, urticaria (edematous, red, itchy skin lesions), maculopapular rash (skin lesion with a papule or bump on a flat spot, only with granules for oral suspension).

• Musculoskeletal disorders: muscle spasms (only with granules for oral suspension), musculoskeletal rigidity (only with intravenous injection formulation), muscle pain (only with prolonged-release tablets).

• Kidney disorders: increased serum creatinine and serum urea (both effects indicating impaired kidney function, only with intravenous injection formulation).

• General disorders: malaise (only with immediate-release tablets), chest pain, chills, and fatigue (the last three only with immediate-release tablets).

• Laboratory tests: abnormal albumin-globulin ratio (only with intravenous injection formulation), increased serum alkaline phosphatase and increased blood lactate dehydrogenase (the last two only with immediate-release tablets).

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

• Infections: pseudomembranous colitis (diarrhea that may become severe), erysipelas (skin redness of variable extent that may cause pain, itching, and fever).

• Blood disorders: decreased neutrophil count (a type of white blood cell), decreased platelets.

• Immune system disorders: anaphylactic reaction (generalized allergic reaction), angioedema (swelling under the skin).

• Psychiatric disorders: psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, hypnagogic hallucinations (attenuated perception of external stimuli).

• Nervous system: seizures, decreased or loss of taste sensation, altered sense of smell, loss or decreased sense of smell, tingling, numbness, or burning sensations in hands, feet, arms, or legs.

• Ear: deafness.

• Heart disorders: torsades de pointes (a type of ventricular tachycardia), ventricular tachycardia (accelerated heartbeat exceeding 100 beats per minute with at least 3 consecutive irregular beats).

• Vascular disorders: hemorrhage.

• Digestive disorders: acute pancreatitis (acute inflammation of the pancreas), tongue discoloration, tooth discoloration.

• Liver disorders: liver function failure, hepatocellular jaundice (yellowing of the skin and eyes).

• Skin: Stevens-Johnson syndrome (widespread rash with blisters and skin peeling, mainly affecting genital, oral, and trunk areas), acute generalized exanthematous pustulosis (widespread scaly red rash with subcutaneous bumps and blisters, accompanied by fever, mainly localized in skin folds, trunk, and upper limbs), and toxic epidermal necrolysis (widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals, causing widespread skin peeling (more than 30% of body surface), flu-like symptoms with skin rash, fever, lymph node swelling, and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) [drug reaction with eosinophilia and systemic symptoms (DRESS)], acne. If any of these reactions occur, treatment with clarithromycin must be stopped immediately and a doctor should be consulted for appropriate management.

• Musculoskeletal disorders: rhabdomyolysis (muscle breakdown that may cause kidney damage), myopathy (muscle disease of multiple causes).

• Kidney disorders: kidney function failure, interstitial nephritis (inflammation of renal tubules).

• Laboratory tests: increased international normalized ratio (calculation to detect blood coagulation), prolonged prothrombin time (indicates coagulation deficiency), and abnormal urine color.

Specific adverse effects

Phlebitis at the injection site, pain at the injection site, pain at the venipuncture site, and inflammation at the injection site are specific to the intravenous formulation of clarithromycin.

Post-marketing reports have described central nervous system effects (e.g., somnolence and confusion) with concomitant use of clarithromycin and triazolam. Patient monitoring is advised.

In some rhabdomyolysis reports, clarithromycin was administered concomitantly with statins, fibrates, colchicine, or allopurinol; see Do not take Claritromycin Vir and Warnings and precautions.

Rarely, there have been reports of prolonged-release clarithromycin tablets appearing in feces. Many of these cases occurred in patients with gastrointestinal anatomical disorders [including ileostomy or colostomy (surgery to artificially divert intestinal waste from the ileum or colon)] or functional disorders (conditions caused by a bodily defect) with shortened gastrointestinal transit time. In several reports, tablet residues appeared in the context of diarrhea. Patients who notice tablet residues in their feces and do not experience improvement are advised to switch to another formulation of clarithromycin (e.g., suspension) or to another antibiotic.

Adverse effects in children and adolescents

The frequency, type, and severity of adverse reactions in children are expected to be the same as in adults.

Immunocompromised patients

In patients with AIDS and other immunocompromised patients treated with high doses of clarithromycin for prolonged periods for mycobacterial infections, it is often difficult to distinguish adverse effects possibly associated with clarithromycin administration from those caused by the disease itself or by other conditions associated with AIDS.

In adult patients treated with total daily doses of 1,000 mg and 2,000 mg of clarithromycin, the most frequent adverse reactions were: nausea, vomiting, taste disturbance, abdominal pain, diarrhea, skin rash, flatulence, headache, constipation, hearing disturbances, and elevated transaminases (which may indicate liver, pancreas, heart, or muscle involvement). Less frequently observed were respiratory difficulty, insomnia, and dry mouth. Incidences were similar in patients treated with 1,000 mg and 2,000 mg, but were generally 3 to 4 times more frequent in those receiving a total daily dose of 4,000 mg of clarithromycin.

In these immunocompromised patients, approximately 2% to 3% receiving 1,000 mg or 2,000 mg of clarithromycin daily developed severely abnormal elevations in transaminase levels, as well as abnormally low white blood cell and platelet counts. A smaller percentage of patients in both dosage groups also had elevated blood urea nitrogen levels (which may indicate reduced kidney function). In patients receiving 4,000 mg daily, slightly higher incidences of abnormal values were observed for all parameters except white blood cell count.

Contact a doctor immediately if you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this adverse effect is considered not known (cannot be estimated from available data).

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 not listed in this leaflet. You may also report them directly through 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 Vir

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Claritromycin Vir

• The active substance is clarithromycin. Each tablet contains 500 mg of clarithromycin.
• The other components (excipients) are pregelatinized corn starch, sodium croscarmellose, povidone 25, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E-171), talc and propylene glycol.

Appearance of the product and contents of the pack

Claritromycin Vir 500 mg is presented as white, round, film-coated tablets in packs containing 14, 21 and 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70. Polígono Industrial URTINSA II

28923 Alcorcón – Madrid

Spain

Manufacturer

KERN PHARMA, S.L.

C/ Venus, 72. Polígono Ind. Colón II

08228 Terrassa (Barcelona)

Spain

Or

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70. Polígono Industrial URTINSA II

28923 Alcorcón – Madrid

Spain

Date of the most recent review of this leaflet: March 2024

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