Clarithromycin Tarbis 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clarithromycin Tarbis 500 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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Claritromicina is an antibiotic that belongs to the macrolide group and works by eliminating bacteria.

This medicine is used to treat infections caused by susceptible bacteria in adults and adolescents aged 12 to 18 years:

• Upper respiratory tract infections, 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).
• Lower respiratory tract infections, such as acute bronchitis (infection and inflammation of the bronchi), acute exacerbation of chronic bronchitis (worsening of long-term or recurrent lung inflammation), and bacterial pneumonia (lung inflammation caused by bacteria). (See section on warnings and precautions).
• Skin and soft tissue infections, such as folliculitis (infection of one or more hair follicles), cellulitis (acute inflammation of the skin), and erysipelas (a type of skin infection). (See section on warnings and precautions).
• Gastric and duodenal ulcers.
• And in the prevention and treatment of infections caused by mycobacteria.

2. What you need to know before taking Clarithromycin Tarbis

Do not take Clarithromycin Tarbis

• 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 suffer from 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 medications called terfenadine, astemizole (used 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 being treated with oral midazolam (for anxiety or to help sleep).
• If you have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia).
• If you or a family member has a history of heart rhythm disorders (ventricular arrhythmia, including Torsade de Pointes) or abnormalities on 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

Consult your doctor or pharmacist before starting clarithromycin:

• 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 have diabetes and are taking hypoglycaemic agents (medicines to lower blood sugar such as nateglinide, pioglitazone, rosiglitazone, repaglinide, sulfonylureas, or insulin), as clarithromycin may excessively lower blood glucose. 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 diarrhoea during or after taking clarithromycin, consult your doctor immediately.

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

Children and adolescents

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

Elderly patients

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

Taking Clarithromycin Tarbis with other medicines

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.

This medicine must not be taken with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, certain medicines used to treat high cholesterol, or medicines known to cause serious disturbances in heart rhythm (see "Do not take Clarithromycin Tarbis").

This is especially important if you are taking medicines for:

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

Or if you are taking any of the following medicines:

• Theophylline (used in patients with breathing difficulties such as asthma).
• Triazolam, alprazolam, or midazolam (sedatives).
• Cilostazol (for poor circulation).
• Methylprednisolone (a corticosteroid).
• Ibrutinib or vinblastine (for cancer treatment).
• Cyclosporine (an immunosuppressant).
• Rifabutin (for treating certain infections).
• Tacrolimus or sirolimus (for organ transplants and severe eczema).
• Sildenafil, tadalafil, or vardenafil (to treat erectile dysfunction in adult men or pulmonary arterial hypertension (high blood pressure in the blood vessels of the lungs)).
• Zidovudine (to treat viruses).
• St. John’s wort (a herbal product used to treat depression).
• Phenobarbital (a medicine used to treat epilepsy).
• Nevirapine and efavirenz may reduce levels of clarithromycin.
• Rifampicin or rifapentine (for treating tuberculosis).
• Omeprazole (for treating stomach acid and gastric 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 HIV treatment) 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 used to treat high blood pressure).
• Hydroxychloroquine or chloroquine (used to treat conditions 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 range of diseases).

Pregnancy, breastfeeding, and fertility

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

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

Clarithromycin passes into breast milk, so 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 this medicine.

Clarithromycin Tarbis contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially "sodium-free".

3. How to take Clarithromycin Tarbis

Clarithromycin Tarbis is administered orally.

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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, although in more severe infections the dose may be increased to 500 mg twice daily. The usual duration of treatment is 5 to 14 days, excluding community-acquired pneumonia and sinusitis, which require 6 to 14 days of therapy.

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

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

Or one tablet of Clarithromycin Tarbis with 1,000 mg of amoxicillin and 20 mg of 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 one tablet of Clarithromycin Tarbis every 12 hours. The duration of treatment should be determined by the physician.

Patients with renal impairment:

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

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 advise you on the duration of your treatment.

Use in children and adolescents

The appropriate formulations for children from 6 months of age and adolescents under 12 years of age are: Clarithromycin granules for oral suspension.

If you feel that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

If you take more Clarithromycin Tarbis than you should

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

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

If you forget to take Clarithromycin Tarbis

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

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

If you stop treatment with Clarithromycin Tarbis

Do not discontinue treatment early, as even if you already feel better, your illness could worsen or recur. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

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

Frequent and very frequent reactions associated with clarithromycin treatment in both adults and children include abdominal pain, diarrhoea, 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 order of decreasing severity within each body system:

Very common (may affect more than 1 in 10 patients with the intravenous formulation): phlebitis (inflammation of the vein) at the injection site.

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

• Gastrointestinal system: diarrhoea, 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: vasodilation (dilation of blood vessels throughout the body).
• Hepatic disorders: abnormal liver function tests.
• Administration site reactions: pain and inflammation at the injection site (only with the intravenous formulation).

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

• Infections: cellulitis (only with the intravenous 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 the intravenous formulation), hypersensitivity (exaggerated allergic response to external agents).
• Eating disorders: anorexia, decreased appetite.
• Psychiatric disorders: anxiety, nervousness (the latter only with granules for oral suspension).
• Nervous system: loss of consciousness and difficulty moving (both effects, only with the intravenous formulation), dizziness, somnolence, tremor.
• Ear and balance: vertigo, hearing disturbances, tinnitus.
• Cardiac disorders: cardiac arrest and cardiac rhythm disturbances (atrial fibrillation) (both effects, only with the intravenous formulation), QT interval prolongation (an ECG indicator of potential ventricular arrhythmias), extrasystoles (premature heartbeat relative to normal heart rate, only with the intravenous formulation), palpitations (irregular heartbeats).
• Respiratory disorders: asthma (difficulty breathing, chest tightness, and nocturnal or early morning cough, only with the intravenous formulation), epistaxis (only with prolonged-release tablets), pulmonary embolism (blockage of the pulmonary artery causing one-sided chest pain, cough, and breathing difficulty, only with the intravenous formulation).
• Gastrointestinal disorders: oesophagitis (only with the intravenous formulation), gastroesophageal reflux disease (damage to the oesophagus causing burning sensation, chronic cough, shortness of breath, and difficulty swallowing, only with prolonged-release tablets), gastric mucosal inflammation (gastritis), anal and rectal pain (only with prolonged-release tablets), oral mucosal inflammation, tongue inflammation, abdominal distension (only with immediate-release tablets), constipation, dry mouth, belching, flatulence.
• Hepatic disorders: reduced 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-glutamyl transferase (another liver enzyme, only with immediate-release tablets).
• Skin: bullous dermatitis (blistering rash, only with the intravenous formulation), pruritus, urticaria (edematous, red, itchy skin lesions), maculopapular rash (skin lesion with a papule or bump on a spot, only with granules for oral suspension).
• Musculoskeletal disorders: muscle spasms (only with granules for oral suspension), musculoskeletal rigidity (only with the intravenous formulation), muscle pain (only with prolonged-release tablets).
• Renal disorders: increased serum creatinine and serum urea (both effects indicating impaired kidney function, only with the intravenous 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 the intravenous 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 (diarrhoea 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 platelet count.
• Immune system disorders: anaphylactic reaction (generalized allergic reaction), angioedema (swelling beneath 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, olfactory disturbance, loss or decreased sense of smell, tingling, numbness, or burning sensation in hands, feet, arms, or legs.
• Ear: deafness.
• Cardiac 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: haemorrhage.
• Gastrointestinal disorders: acute pancreatitis (acute inflammation of the pancreas), tongue discoloration, tooth discoloration.
• Hepatic disorders: liver 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 bumps under the skin and blisters, accompanied by fever, primarily located in skin folds, trunk, and upper limbs), and toxic epidermal necrolysis (widespread blistering and skin peeling, particularly around the mouth, nose, eyes, and genitals, leading to widespread skin detachment (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 you should consult your doctor for appropriate management.
• Musculoskeletal disorders: rhabdomyolysis (muscle breakdown that may lead to kidney damage), myopathy (muscle disease of various causes).
• Renal disorders: kidney failure, interstitial nephritis (inflammation of renal tubules).
• Laboratory tests: increased international normalized ratio (calculation to detect blood coagulation), prolonged prothrombin time (indicates impaired blood coagulation), and abnormal urine colour.

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.

Following marketing of the medicine, reports of central nervous system effects (e.g. somnolence and confusion) have been received with concomitant use of clarithromycin and triazolam. Patient monitoring is advised.

In some reports of rhabdomyolysis, clarithromycin was administered concomitantly with statins, fibrates, colchicine, or allopurinol (see section 2. Do not take Claritromicina Tarbis and Warnings and precautions).

Rarely, there have been reports of prolonged-release clarithromycin tablets appearing in faeces. Many of these cases occurred in patients with anatomical gastrointestinal disorders [including ileostomy or colostomy (surgery to artificially divert intestinal waste from the ileum or colon)] or functional gastrointestinal disorders (conditions caused by a bodily defect) with shortened gastrointestinal transit time. In several reports, tablet residues appeared in the context of diarrhoea. It is recommended that patients who notice tablet residues in their faeces and do not experience improvement 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 over long periods for mycobacterial infections, it is often difficult to distinguish adverse effects possibly associated with clarithromycin administration from those caused by the disease or other comorbid conditions related to 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, diarrhoea, skin rash, flatulence, headache, constipation, hearing disturbances, and elevated transaminases (which may indicate liver, pancreas, heart, or muscle involvement). Less frequently reported were breathing difficulty, insomnia, and dry mouth. Incidence rates were similar in patients receiving 1,000 mg and 2,000 mg, but were generally 3 to 4 times higher 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, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clarithromycin Tarbis

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

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clarithromycin Tarbis

• The active substance is clarithromycin. Each coated tablet contains 500 mg of clarithromycin.
• The other components are:
• Core: pregelatinized corn starch, sodium croscarmellose, povidone 25, microcrystalline cellulose (E-460), anhydrous colloidal silica, magnesium stearate.
• Coating: hypromellose (hydroxypropyl methylcellulose), titanium dioxide (E-171), talc, propylene glycol (E-1520).

Appearance of the product and contents of the pack

Claritromycin Tarbis is presented as white, capsule-shaped, coated tablets in packs containing 14 or 21 coated tablets in PVC/aluminum blisters or clinical packs of 500 coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

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 revision of this package leaflet: February 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) http://www.aemps.gob.es/