Package Leaflet: Information for the User

Clarithromycin Cinfa 500 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicinebecause 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 pass it on to others even if their symptoms are the same as yours. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

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

1. Upper respiratory tract infections, such as pharyngitis (throat infection 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), exacerbation of chronic bronchitis (prolonged or recurring inflammation of the lungs), and bacterial pneumonias (inflammation of the lungs caused by bacteria). (see warnings and precautions section).
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 warnings and precautions section).
4. Peptic ulcers and duodenal ulcers.

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

Do not take clarithromycin cinfa

• If you are allergic to clarithromycin or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other macrolide antibiotics (to which clarithromycin belongs).
• If you have a creatinine clearance of less than 30 ml/min.
• If you have an irregular heart rhythm.
• If you have severe liver and kidney problems.
• If you are taking ergotamine or dihydroergotamine or using ergotamine inhalers (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 being treated with midazolam oral (for anxiety or to help you fall asleep).
• If you or a family member has a history of heart rhythm disorders (ventricular arrhythmia, including Torsade de Pointes) or abnormal electrocardiogram (ECG, heart electrical recording) called "prolongation of 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 have abnormally low levels of potassium or magnesium in your blood (hypopotasemia or hypomagnesemia).
• If you have severe liver dysfunction combined with kidney failure.
• If you are taking colchicine.
• If you are taking a medication with lomitapida.

Warnings and precautions

Consult 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. 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 levels such as nateglinida, pioglitazona, rosiglitazona and repaglinida, sulfonilureas or insulin) and clarithromycin may lower blood sugar levels too much. Careful glucose control is recommended.
• If you are taking a medication called warfarin (blood thinner).
• If you have myasthenia gravis, a condition where your muscles weaken and tire easily.
• If you develop severe or prolonged diarrhea, during or after taking clarithromycin, consult your doctor immediately.

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

Children and adolescents

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

Older patients

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

Other medications and clarithromycin cinfa

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

• The following medications should not be taken with clarithromycin: astemizol, terfenadine (for allergies), cisaprida (for gastrointestinal problems), domperidone, pimozida (for psychiatric disorders), ticagrelor, ranolazina, colchicine, certain medications for high cholesterol and medications known to cause severe heart rhythm disturbances (see Do not take clarithromycin cinfa).
• Warfarin or other anticoagulants, such as dabigatrán, rivaroxabán, apixabán, edoxabán (to thin the blood).

This is especially important if you are taking medications for:

• Heart problems (e.g. digoxina, verapamilo, quinidina or disopiramida).
• Thinning the blood (e.g. warfarin).
• Migraines (e.g. ergotamine or dihydroergotamine).
• 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 (to treat erectile dysfunction in adult men or for pulmonary hypertension).
• Zidovudina (to treat viruses).
• St. John's Wort (herbal product for treating depression).
• Fenobarbital (medication for 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 combination 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 syndrome). In some patients, tolterodina levels may increase when taken with clarithromycin.
• Quetiapina (for schizophrenia or other psychiatric conditions).
• Beta-lactam antibiotics (certain penicillins and cephalosporins).
• Aminoglycosides (used as antibiotics for infections).
• Calcium channel blockers (medications for high blood pressure).
• Hydroxychloroquine or chloroquine (used to treat conditions such as rheumatoid arthritis, or to treat or prevent malaria). Taking these medications with clarithromycin may increase the risk of abnormal heart rhythms and other severe adverse effects 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).

Taking clarithromycin cinfa with food

Clarithromycin tablets can be taken before, during or after meals, as the presence of food in the digestive tract does not affect the activity of the medication.

Pregnancy and breastfeeding

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

The safety of clarithromycin during pregnancy has not been established, so your doctor will 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.

clarithromycin cinfa contains hydrogenated ricin oil

This medication may cause stomach discomfort and diarrhea because it contains hydrogenated ricin oil.

clarithromycin cinfa contains sodium

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

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

claritromicina cinfa is administered orally.

Adults and children over 12 years:

Patients with respiratory tract, skin, and soft tissue infections

The recommended dose is 250 mg 2 times a day for 7 days, although in more severe infections, the dose may be increased to 500 mg 2 times a day. The usual duration of treatment is 5 to 14 days, excluding community-acquired pneumonia and sinusitis that require 6 to 14 days of therapy.

Eradiation ofHelicobacter pyloriin patients with duodenal ulcers (adults):

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

Triple therapy: one tablet of claritromicina 500 mg tablets twice a day, with 30 mg of lansoprazol, 2 times a day and 1,000 mg of amoxicilina twice a day for 10 days. Or one tablet of claritromicina 500 mg tablets with 1,000 mg of amoxicilina and 20 mg of omeprazol, administered all of them twice a day, for 7 to 10 days.

Older patients

As adults.

Patients with infections produced by mycobacteria:

The recommended average dose for the prevention and treatment of infections produced by mycobacteria is one tablet of claritromicina 500 mg tablets, 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 less than 30 ml/min, the dose of claritromicina should be reduced to half, that is, 250 mg once a day, or 250 mg twice a day in more severe infections. In these patients the treatment should be interrupted at 14 days. Since the tablet cannot be dosed to half, the daily dose cannot be less than 500 mg/day, so claritromicina 500 mg tablets should not be administered 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

The suitable presentations for children, from 6 months, and adolescents under 12 years are: claritromicina 25 mg/ml granulated for oral suspension and claritromicina 50 mg/ml granulated for oral suspension.

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

If you take more claritromicina cinfa than you should

If you have taken more claritromicina than you should, you can expect the appearance of digestive disorders and consult your doctor or pharmacist immediately, as they should try to quickly eliminate the claritromicina 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 claritromicina cinfa

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 the treatment with claritromicina cinfa

Do not suspend the treatment before, as although you may already be feeling better, your disease could worsen or reappear.

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 in the incidence of these gastrointestinal adverse reactions were observed 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 (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 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).

• Less common 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 disorders: 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 of the auricle) (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 oppression, and nocturnal or morning cough, only with intravenous formulation), nasal hemorrhages (only with prolonged-release tablets), pulmonary embolism (blockage of the pulmonary artery that causes chest pain on one side, cough, and difficulty breathing, only with intravenous formulation).
• Gastrointestinal disorders: esophageal inflammation (only with intravenous formulation), gastroesophageal reflux disease (damage to the esophagus that causes burning sensation, chronic cough, lack of air, and difficulty swallowing, only with prolonged-release tablets), gastric mucosa inflammation, 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, increased aspartate aminotransferase, and increased gamma-glutamyltransferase (only with immediate-release tablets).
• Skin: dermatitis bullous (bullous eruptions, only with intravenous formulation), itching, urticaria (edematous, red, and itchy skin lesions), maculopapular rash (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 renal function, only with intravenous formulation).
• General disorders: discomfort (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 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 disorders: anaphylactic reaction (generalized allergic reaction), angioedema (swelling under the skin).
• Psychiatric disorders: psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, and daydreaming (perceptions of attenuated external stimuli).
• Nervous system: convulsions, decreased or lost sense of taste, altered sense of smell, lost or decreased sense of smell, paresthesia, numbness, or acorchamiento 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, icterus hepatocelular (yellow discoloration of the skin and eyes).
• Skin: Stevens-Johnson syndrome (generalized eruption with blisters and skin peeling, primarily affecting genital, oral, and trunk areas), generalized acute exanthematous pustulosis (generalized scaly eruption with red color, with subcutaneous nodules and blisters, accompanied by fever, primarily located in skin folds, trunk, and upper limbs), and 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), systemic symptoms such as fever, glandular inflammation, and abnormal blood test results (such as eosinophilia and elevated liver enzymes) [drug reaction with eosinophilia and systemic symptoms (DRESS)] acne. If these types of reactions occur, discontinue clarithromycin treatment immediately and consult a doctor to initiate appropriate treatment.
• Musculoskeletal disorders: rhabdomyolysis (muscle breakdown that can cause renal damage), myopathy (muscle disease of multiple causes).
• Renal disorders: renal 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. It is suggested to monitor the patient.

In some reports of rhabdomyolysis, clarithromycin was administered concomitantly with statins, fibrates, colchicine, or allopurinol (see Do not take clarithromycin cinfa and seeWarnings 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 gastrointestinal disorders (caused by a defect in the body) with shortened gastrointestinal transit time. In several reports, tablet residues 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 change to another clarithromycin formulation (e.g., suspension) or to another antibiotic.

Pediatric population

It is expected that the frequency, type, and severity of adverse reactions in children will be the same as in adults.

Immunocompromised patients

In patients with AIDS and in 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 adverse reactions possibly associated with clarithromycin administration from those 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). Less frequently, 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 smaller percentage of patients in both dosing groups had elevated blood urea nitrogen levels (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 adverse effect is considered unknown (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 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 adverse 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.

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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of clarithromycin cinfa

• The active ingredient is clarithromycin. Each tablet contains 500 mg of clarithromycin.
• The other components are:

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

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

Appearance of the product and contents of the packaging

clarithromycincinfa is presented in the form of yellow,oval, biconvex,film-coated tablets. Each package contains 14, 21, or 500(clinical package)tablets.

Only some package sizes may be commercially marketed

Marketing authorization holder and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:March 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/67639/P_67639.html

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