PATIENT INFORMATION LEAFLET

Claritromycin Vir 500 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Claritromycin Vir 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.Storage of Claritromycin Vir

6.Contents of the pack and additional information

Claritromicina is an antibiotic that belongs to the group of macrolides and acts by eliminating bacteria.

Claritromicina Vir is used for the treatment of 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 located 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 the prolonged or repeated inflammation of the lungs) and bacterial pneumonias (inflammation of the lungs 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.
• Peptic ulcer and duodenal ulcer.
• And in the prevention and treatment of infections produced by mycobacteria.

Do not take Claritromicina Vir:

• 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 migraines while taking clarithromycin. Consult your doctor for alternative medications..
• If you are taking medications called terfenadine, astemizol (allergy medication), cisaprida, or domperidone (used for stomach problems) or pimozida (used to treat certain psychiatric disorders) 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), ivabradina, or ranolazina (for angina pectoris).
• If you are taking other medications known to cause severe heart rhythm disturbances.
• If you are taking midazolam oral (for anxiety or to help fall asleep).
• If you have abnormally low levels of potassium (electrolyte imbalance) or magnesium in your blood (hypokalemia or hypomagnesemia).
• If you or a family member has a history of heart rhythm disorders (ventricular arrhythmia, including Torsades de Pointes) or abnormal electrocardiogram (ECG) readings called "prolonged QT syndrome).
• If you are taking medications called lovastatina or simvastatina (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).
• If you are taking a medication with lomitapida.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Claritromicina Vir:

• If you have heart, kidney, or liver problems.
• If you have or are prone to fungal infections (e.g., mouth ulcers).
• If you are pregnant or breastfeeding.
• If you are taking medications known as colchicine, triazolam, midazolam (for anxiety or insomnia), lovastatina, simvastatina.
• If you are diabetic and taking hypoglycemic medications (medications to lower blood sugar such as nateglinida, pioglitazona, rosiglitazona, and repaglinida, sulfonilureas, or calciocanal) and clarithromycin may lower blood sugar levels too much. A careful control of blood sugar levels 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 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 older patients.

Other medications and Claritromicina Vir

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 clarithromycin with ergot alkaloids, astemizol, terfenadine, cisaprida, domperidone, pimozida, ticagrelor, ranolazina, colchicine, certain medications for high cholesterol, or medications known to cause severe heart rhythm disturbances.See Do not take Claritromicina Vir.

This is especially important if you are taking medications for:

• Heart problems (e.g., digoxina, verapamilo, quinidina, or disopiramida).
• Thinning the blood (e.g., warfarina).
• Migraines (e.g., ergotamina or dihidroergotamina).
• Epilepsy or bipolar disorder (carbamazepina, valproato, fenobarbital, or fenitoína).
• High cholesterol (e.g., simvastatina or lovastatina).

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).
• Ciclosporina (immunosuppressant).
• Rifabutina (for treating certain infections).
• Tacrolimus or sirolimus (for organ transplants and severe eczema).
• Sildenafil, tadalafilo, or vardenafilo (for treating erectile dysfunction in adult men or for pulmonary hypertension).
• Zidovudine (for treating viruses).
• St. John's Wort (herbal product for treating depression).
• Fenobarbital (medication for treating epilepsy).
• Nevirapina and efavirenz may decrease clarithromycin levels.
• Rifampicina or rifapentina (for treating tuberculosis).
• Omeprazol (for treating stomach acid and ulcers).
• Ritonavir (antiviral medication used in HIV treatment) may increase clarithromycin levels. The concomitant use of atazanavir, etravirina, and saquinavir (also antiviral medications used in HIV treatment) with clarithromycin may increase both atazanavir (or saquinavir) and clarithromycin levels.
• Itraconazol (antifungal medication) taken with clarithromycin may increase both medication levels.
• Fluconazol, another antifungal medication, may increase clarithromycin levels.
• Tolterodina (for treating overactive bladder symptoms). In some patients, tolterodina levels may increase when taken with clarithromycin.
• Quetiapina (for schizophrenia or other psychiatric conditions).
• Beta-lactam antibiotics (certain penicillins and cefalosporins)
• Aminoglycosides (used as antibiotics for infections).
• Calcium channel blockers (medications for high blood pressure).
• Warfarina or other anticoagulants, such as dabigatrán, rivaroxabán, apixabán, edoxabán (to thin the blood).
• 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 treating a wide variety of diseases).

Pregnancy, lactation, and fertility

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

The safety of clarithromycin during pregnancy has not been established, so your doctor will 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, you should exercise extreme caution when driving or operating hazardous machinery during treatment with clarithromycin.

Claritromicina Vir contains propylenglycol

This medication contains 2,610 mg of propylenglycol in each tablet.

Clarithromycin Vir is administered orally.

Follow exactly the medication administration instructions indicated by your doctor, or pharmacist. In case of 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.

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

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

Triple therapy: one 500 mg clarithromycin tablet twice a day, with 30 mg of lansoprazole, twice a day, and 1,000 mg of amoxicillin twice a day for 10 days.

or one 500 mg clarithromycin tablet with 1,000 mg of amoxicillin and 20 mg of omeprazole, administered twice a day, for 7 to 10 days.

Older patients

As adults.

Patients with infections caused by mycobacteria:

The recommended dose for the prevention and treatment of infections caused by mycobacteria is one 500 mg 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 clarithromycin 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.

Since the tablet cannot be halved, the daily dose cannot be less than 500 mg/day, so Claritomicina Vir 500 mg should not be administered in this group of patients. There is Claritromicina Vir 250 mg for administration in this group of patients.

Follow these instructions unless your doctor has given you other indications. Remember to take your medication. Take the tablets at the same time every day.

Your doctor will indicate the duration of your treatment.

Use in children and adolescents

Claritromycin Vir 500 mg is not suitable for children and adolescents under 12 years.

If you think 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, you can expect gastrointestinal disturbances. Consult your doctor or pharmacist immediately, as they will try to quickly eliminate the clarithromycin that your body has not yet absorbed. Hemodialysis or peritoneal dialysis is not effective.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Claritromycin Vir

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

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

If you interrupt treatment withClaritromycin Vir

Do not stop treatment prematurely, as although you may already be feeling better, your disease could 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 can cause side effects, although not everyone will experience them.

Side effects are classified as very common (can affect more than 1 in 10 patients), common (can affect up to 1 in 10 patients), uncommon (can affect up to 1 in 100 patients), and unknown frequency (cannot be estimated from available data).

The most common and more common adverse reactions related to clarithromycin treatment, both in adults and children, are abdominal pain, diarrhea, nausea, vomiting, and taste alteration. These adverse reactions are usually mild in intensity and coincide with the known safety profile of macrolide antibiotics (see below).

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

Summary of side effects

Side effects are described in order of decreasing severity within the same body system:

• Very common (can affect more than 1 in 10 patients, with the intravenous formulation): phlebitis (inflammation of the vein) at the injection site.
• With all clarithromycin-containing medicines, the following have been observed with common (can affect up to 1 in 10 patients) frequency:

• Gastrointestinal system: diarrhea, vomiting, dyspepsia (digestive disorder that makes digestion difficult), nausea, abdominal pain.
• Nervous system: taste alteration, headache, taste alteration.
• Skin: mild skin eruptions, excessive sweating.
• Psychiatric disorders: insomnia.
• Vascular disorders: vasodilation.
• Liver disorders: abnormal liver function tests.
• Administration site disorders: pain and inflammation at the injection site (only with the intravenous formulation).

• Uncommon (can affect up to 1 in 100 patients) have been observed the following:

• Infections: cellulitis (only with the intravenous formulation), candidiasis (infection by a type of fungus), gastroenteritis (only with prolonged-release tablets), infection (only with oral suspension granules), vaginal infection.
• Blood abnormalities: decreased white blood cells, decreased neutrophils (a type of white blood cell, only with immediate-release tablets), increased platelets and, to a lesser extent, red and white blood cells in the blood (only with oral suspension granules), increased eosinophils (a type of white blood cell, only with immediate-release tablets).
• Immune system: anaphylactoid reaction (generalized allergic reaction, only with intravenous formulation), hypersensitivity (exaggerated allergic reaction to external agents).
• Food disorders: anorexia, decreased appetite.
• Psychiatric disorders: anxiety and nervousness (the latter only with oral suspension granules).
• Nervous system: loss of consciousness and difficulty moving (both effects, only with intravenous formulation), dizziness, somnolence, tremors.
• Auditory and balance disorders: vertigo, hearing problems, tinnitus.
• Cardiac disorders: cardiac arrest and alteration of heart rhythm (fibrillation) (both effects, only with intravenous formulation), prolongation of the QT interval (electrocardiogram indicator of potential ventricular arrhythmias), extrasystoles (premature heartbeat, only with intravenous formulation), palpitations (alterations in heartbeats).
• Respiratory disorders: asthma (difficulty breathing, chest tightness, and nocturnal or morning cough, only with intravenous formulation), nasal hemorrhages (only with prolonged-release tablets), pulmonary embolism (blockage of the pulmonary artery causing chest pain on one side, cough, and difficulty breathing, only with intravenous formulation).
• Gastrointestinal disorders: esophagitis (inflammation of the esophagus, only with intravenous formulation), gastroesophageal reflux disease (damage to the esophagus causing burning sensation, chronic cough, lack of air, and difficulty swallowing, only with prolonged-release tablets), gastritis (inflammation of the stomach lining), anal and rectal pain (only with prolonged-release tablets), oral mucosa inflammation, tongue inflammation, 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), increased aspartate aminotransferase (another liver enzyme), and increased gamma-glutamyltransferase (another liver enzyme, only with immediate-release tablets).
• Skin: dermatitis bullous (vesicular eruptions, only with intravenous formulation), pruritus, urticaria (edematous, red, and itchy skin lesions), maculopapular eruption (skin lesion with a papule or wart on a patch, only with oral suspension granules).
• Musculoskeletal disorders: muscle spasms (only with oral suspension granules), musculoskeletal rigidity (only with intravenous formulation), muscle pain (only with prolonged-release tablets).
• Renal disorders: increased serum creatinine and urea (both effects, indicating impaired kidney function, only with intravenous formulation).
• General disorders: malaise (only with immediate-release tablets), chest pain, chills, and fatigue (the latter three, only with immediate-release tablets).
• Laboratory tests: abnormal albumin-globulin ratio (only with intravenous formulation), increased serum alkaline phosphatase, and increased lactate dehydrogenase in blood (both effects, only with immediate-release tablets).

• Unknown frequency (frequency cannot be determined from available data) have been observed the following:

• Infections: pseudomembranous colitis (diarrhea that can be severe), erysipelas (skin redness of variable extent that can cause pain, itching, and fever).
• Blood abnormalities: decreased neutrophils (a type of white blood cell), decreased platelets.
• Immune system: anaphylactic reaction (generalized allergic reaction), angioedema (subcutaneous swelling).
• Psychiatric disorders: psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, daydreaming (attenuated perceptions of external stimuli).
• Nervous system: convulsions, decreased or lost sense of taste, altered sense of smell, lost or decreased sense of smell, paresthesia, numbness, or coldness in hands, feet, arms, or legs.
• Auditory disorders: hearing loss.
• Cardiac disorders:torsades de pointes(a type of ventricular tachycardia), ventricular tachycardia (acceleration of heartbeats with more than 100 beats per minute with at least 3 irregular consecutive beats).
• Vascular disorders: hemorrhage.
• Gastrointestinal disorders: acute pancreatitis (inflammation of the pancreas), tongue discoloration, tooth discoloration.
• Liver disorders: liver function failure, icteric hepatocellular (yellow discoloration of skin and eyes).
• Skin: Stevens-Johnson syndrome (generalized eruption with blisters and skin peeling, mainly affecting genital, oral, and trunk areas), generalized acute exanthematous pustulosis (generalized scaly eruption with red color, with subcutaneous nodules and blisters, accompanied by fever, mainly located in skin folds, trunk, and upper limbs), toxic epidermal necrolysis (generalized eruption with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals, causing generalized skin peeling (more than 30% of body surface area)) and symptoms of a flu-like illness with skin eruption, fever, glandular inflammation, and abnormal blood test results (such as increased eosinophils and elevated liver enzymes) [drug reaction with eosinophilia and systemic symptoms (DRESS)] should be immediately discontinued and a suitable treatment should be initiated by a doctor.
• Musculoskeletal disorders: rhabdomyolysis (muscle breakdown that can cause kidney damage), myopathy (muscle disease of multiple causes).
• Renal 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 a coagulation disorder), and abnormal urine color.

Specific side effects

Flebitis 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.

After marketing, reports have been received of central nervous system effects (e.g., somnolence and confusion) with the simultaneous use of clarithromycin and triazolam. Monitoring of the patient is suggested.

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

Rarely, there have been reports of clarithromycin prolonged-release tablets appearing in the stool, many of these cases have occurred in patients with anatomical (including ileostomy or colostomy) or functional (caused by a defect in the body) gastrointestinal disorders with shortened gastrointestinal transit time. In several reports, the residues of tablets have appeared in the context of diarrhea. It is recommended that patients who present tablet residues in the stool and do not experience any improvement, switch to another clarithromycin formulation (e.g., suspension) or another antibiotic.

Side 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 patients with damaged immune systems, treated with high doses of clarithromycin for long periods of time for mycobacterial infections, it is often difficult to distinguish side effects possibly associated with clarithromycin administration from effects caused by the disease or other diseases that the patient may have along with AIDS.

In adult patients treated with daily total doses of 1,000 mg and 2,000 mg of clarithromycin, the most common adverse reactions that appeared were: nausea, vomiting, taste alteration, abdominal pain, diarrhea, skin rash, flatulence, headache, constipation, altered hearing, and elevated transaminases (which can indicate liver, pancreas, heart, or muscle damage). With lower frequency, difficulty breathing, insomnia, and dry mouth appeared. Incidences were similar in patients treated with 1,000 mg and 2,000 mg, but generally were 3 to 4 times more frequent in those who received a daily total dose of 4,000 mg of clarithromycin.

In these immunocompromised patients, around 2% to 3% who received daily 1,000 mg or 2,000 mg of clarithromycin presented severely abnormal elevated transaminases, as well as abnormally low white blood cell and platelet counts. A lower percentage of patients in both dosing groups had elevated blood urea nitrogen (which can indicate impaired renal function). In patients who received daily 4,000 mg, slightly higher incidences of abnormal values in all parameters, except white blood cell count, were observed.

Consult a doctor as soon as possible if you experience a severe skin reaction: a red, scaly rash with subcutaneous nodules and blisters (pustular exanthema). The frequency of this side effect is considered unknown (cannot be estimated from available data).

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 prospectus. 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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. 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 the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Claritromicina Vir

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

Appearance of the product and contents of the packaging

Claritromicina Vir 500 mg is presented in the form of coated film tablets, round, white, in packaging with 14, 21, and 500 tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón – Madrid

Spain

Responsible for manufacturing

KERN PHARMA, S.L.

C/ Venus, 72. Polígono Ind. Colón II

08228 Terrassa (Barcelona)

Spain

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Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón – Madrid

Spain

Last review date of this leaflet: March 2024

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