Clarithromycin CINFA 250 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

claritromycin cinfa 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, 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 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.

Contents of the leaflet

1. What claritromycin cinfa is and what it is used for
2. What you need to know before taking claritromycin cinfa
3. How to take claritromycin cinfa
4. Possible side effects
5. How to store claritromycin cinfa

Pack contents and additional information

1. What claritromycin cinfa is and what it is used for

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

Clarithromycin cinfa is used for the treatment of infections caused by susceptible organisms in adults and adolescents aged 12 to 18 years:

1. 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).

2. 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 Warnings and Precautions.)

3. 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 Warnings and Precautions.)

4. Gastric and duodenal ulcers.

5. And for the prevention and treatment of infections caused by mycobacteria.

2. What you need to know before taking clarithromycin cinfa

Do not take clarithromycin cinfa

• If you are allergic to clarithromycin or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other antibiotics in the macrolide group (the group to which clarithromycin belongs).
• If you have a creatinine clearance of 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 (a medicine 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 medicines with clarithromycin may cause serious disturbances in heart rhythm. Consult your doctor for alternative medications.
• If you are taking ticagrelor (to prevent blood clots in your veins and used in heart attacks and other heart problems), ivabradine, or ranolazine (for angina pectoris).
• If you are taking other medicines known to cause serious disturbances in heart rhythm.
• If you are undergoing treatment with oral midazolam (for anxiety or to help you sleep).
• If you or a family member has a history of heart rhythm disorders (ventricular arrhythmia, including Torsade 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 medicines may increase the risk of adverse effects. Consult your doctor for alternative medications.
• If you have abnormally low levels of potassium or magnesium in your blood (hypokalemia or hypomagnesemia).
• If you have severe impairment of liver function together with kidney failure.
• If you are taking colchicine.
• If you are taking a medicine containing lomitapide.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take clarithromycin cinfa.

• 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, sulfonylureas, or insulin), as clarithromycin may lower blood glucose excessively. Careful monitoring of glucose levels 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 impairment, moderate or severe renal impairment, and in elderly patients.

Other medicines and clarithromycin cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• The following medicines must not be taken together with clarithromycin: astemizole, terfenadine (for allergy), cisapride (for gastrointestinal problems), domperidone, pimozide (for psychiatric disorders), ticagrelor, ranolazine, colchicine, certain medicines for treating high cholesterol, and medicines known to cause serious disturbances in heart rhythm (see Do not take clarithromycin cinfa).
• Warfarin or another anticoagulant, for example, dabigatran, rivaroxaban, apixaban, edoxaban (to thin the blood).

This is especially important if you are taking medicines for:

• Heart problems (e.g., digoxin, verapamil, quinidine, or disopyramide).
• Thinning the blood (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 impotence in adult men or for 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 to treat epilepsy).
• Nevirapine and efavirenz may reduce levels of clarithromycin.
• Rifampicin or rifapentine (to treat tuberculosis).
• Omeprazole (to treat 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).
• Hydroxychloroquine or chloroquine (used to treat diseases such as rheumatoid arthritis, or to treat or prevent malaria). Taking these medicines at the same time as 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 the treatment of a wide range of diseases).

Taking clarithromycin cinfa with food

Clarithromycin tablets may be taken before, during, or after meals, as the presence of food in the digestive tract does not alter the activity of the medicine.

Pregnancy and breastfeeding

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 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 use of 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 cinfa contains hydrogenated castor oil

This medicine may cause stomach discomfort and diarrhea because it contains hydrogenated castor oil.

clarithromycin cinfa contains sodium

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

3. How to take clarithromycin cinfa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Clarithromycin cinfa is administered orally.

Adults and children over 12 years of age:

Patients with respiratory tract, skin and soft tissue infections

The recommended 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 treatment regimens are:

Triple therapy: one 500 mg clarithromycin tablet twice daily, together with 30 mg lansoprazole twice daily and 1,000 mg amoxicillin twice daily for 10 days. Or one 500 mg clarithromycin tablet with 1,000 mg amoxicillin and 20 mg omeprazole, all administered twice daily, for 7 to 10 days.

Elderly patients:

Same as for adults.

Patients with mycobacterial infections:

The recommended average dose for prevention and treatment of mycobacterial infections is one 500 mg clarithromycin tablet 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 divided, the daily dose cannot be less than 500 mg/day; therefore, clarithromycin 500 mg tablets should not be administered to this patient group.

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

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 25 mg/ml granules for oral suspension and clarithromycin 50 mg/ml granules for oral suspension.

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

If you take more clarithromycin cinfa 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. Haemodialysis or 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 cinfa

Do not take a double dose to make up for the missed dose. Take the tablet as soon as possible and continue taking it at the same time each day.

If you stop treatment with clarithromycin cinfa

Do not discontinue treatment early, as even if you already feel better, your illness may 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).

Common and very common adverse reactions associated with clarithromycin treatment in both adults and children are abdominal pain, diarrhoea, nausea, vomiting, and taste disturbance. 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 patient populations with or without pre-existing mycobacterial infections.

Summary of adverse effects

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

• Very commonly observed (with the intravenous formulation): phlebitis (vein inflammation) at the injection site.

• Commonly observed with all medicines containing clarithromycin:

  • 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: dilation of blood vessels in the body (vasodilation).
  • Liver disorders: abnormal liver function tests.
  • Administration site disorders: pain and inflammation at the injection site (only with the intravenous formulation).

• Less commonly observed:

  • 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 reaction to external agents).
  • Feeding 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 the intravenous formulation), dizziness, somnolence, tremors.
  • Ear and balance: vertigo, hearing problems, tinnitus.
  • Cardiac disorders: cardiac arrest and disturbance of heart rhythm (atrial fibrillation) (both effects only with the intravenous formulation), QT interval prolongation (an ECG indicator that ventricular arrhythmias may occur), extrasystoles (premature heartbeat compared 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: inflammation of the oesophagus (only with the intravenous formulation), gastro-oesophageal reflux disease (damage to the oesophagus 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-glutamyl transferase (another liver enzyme, only with immediate-release tablets).
  • Skin: bullous dermatitis (blistering rashes, only with the intravenous formulation), pruritus, urticaria (edematous, red, and intensely itchy skin lesions), maculopapular eruption (skin lesion with a papule or wart 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).

• Observed with frequency not known:

  • Infections: pseudomembranous colitis (diarrhoea that may become severe), erysipelas (skin redness of variable extent that may cause pain, itching, and fever).
  • Blood disorders: decreased number of neutrophils (a type of white blood cell), decreased platelets.
  • 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, altered sense of smell, loss or decreased sense of smell, tingling, numbness, or burning sensations 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.
  • Digestive disorders: acute pancreatitis (acute inflammation of the pancreas), tongue discoloration, tooth discoloration.
  • Liver disorders: liver failure, hepatocellular jaundice (yellowing of the skin and eyes).
  • Skin: Stevens-Johnson syndrome (widespread blistering 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, mainly localized in skin folds, trunk, and upper limbs), toxic epidermal necrolysis (widespread blistering and skin peeling, particularly around the mouth, nose, eyes, and genitals, causing widespread skin shedding (more than 30% of body surface area)), drug reaction with eosinophilia and systemic symptoms (DRESS) (flu-like symptoms with skin rash, fever, lymphadenopathy, and abnormal blood tests such as increased white blood cells (eosinophilia) and elevated liver enzymes), 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 multiple causes).
  • Renal disorders: kidney failure, interstitial nephritis (inflammation of the 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.

After 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 Do not take Clarithromycin Cinfa and see Warnings and precautions).

Rarely, reports have been received that prolonged-release clarithromycin tablets appear 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 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.

Paediatric population

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 comorbid 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, diarrhoea, skin rash, flatulence, headache, constipation, hearing disturbances, and elevated transaminases (which may indicate liver, pancreas, heart, or muscle involvement). Less frequently observed were dyspnoea, 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 the 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 can also report them directly via 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 cinfa

Keep this medicine out of sight and reach of children.

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

Do not store above 30°C.

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

6. Contents of the pack and other information

Composition of claritromycin cinfa

• The active substance is clarithromycin. Each tablet contains 250 mg of clarithromycin.
• The other components are:

Tablet core: Hydrogenated castor oil, sodium croscarmellose, colloidal anhydrous silica, talc, microcrystalline cellulose, magnesium stearate.

Tablet coating: Titanium dioxide (E-171), quinoline yellow (E-104), iron oxide yellow (E-172), hypromellose and hydroxypropylcellulose.

Appearance of the product and contents of the pack

claritromycin cinfa is presented as yellow, oblong, biconvex, film-coated tablets. Each pack contains 14 or 500 tablets (hospital pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

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

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/67638/P_67638.html

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