Clarithromycin Sun 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

SUN Clarithromycin 500 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What SUN Clarithromycin 500 mg tablets are and what they are used for
2. What you need to know before taking SUN Clarithromycin 500 mg tablets
3. How to take SUN Clarithromycin 500 mg tablets
4. Possible adverse effects
5. How to store SUN Clarithromycin 500 mg tablets
6. Contents of the pack and other information

1. What Claritromicina SUN 500 mg tablets are and what they are used for

Claritromicina SUN is an antibiotic belonging to the macrolide group. Antibiotics stop the growth of certain bacteria.

Claritromicina SUN is used to treat infections caused by susceptible organisms in adults and adolescents (12 years of age and older):

• Throat infections and sinusitis
• Respiratory tract infections, such as bronchitis and pneumonia
• Skin and soft tissue infections
• Gastric ulcers caused by the bacterium Helicobacter pylori

2. What you need to know before taking Claritromycin SUN 500 mg coated tablets

Do not take Claritromycin SUN

• If you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or to any of the other ingredients of this medicine (listed in section 6).
• If your creatinine clearance is less than 30 ml/min.
• If you have an irregular heartbeat.
• If you have severe kidney or liver problems.
• If you are taking ergotamine or dihydroergotamine, or using ergotamine inhalers for migraine while taking clarithromycin. Consult your doctor for alternative treatment options.
• If you are taking medicines known as terfenadine, astemizole (medicines for hay fever or allergies), cisapride or domperidone (used for stomach problems), or pimozide (a medicine used to treat certain psychiatric conditions), as taking these with clarithromycin may cause serious disturbances in heart rhythm. Consult your doctor for alternative treatment options.
• If you are taking ticagrelor (to prevent blood clots in your veins, used in heart attacks and other heart conditions), ivabradine, or ranolazine (for angina or to reduce the risk of myocardial infarction or stroke).
• 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 have abnormally low levels of potassium or magnesium in your blood (hypokalemia or hypomagnesemia).
• 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 treatment options.
• 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 Claritromycin SUN if:

• You have heart, kidney, or liver problems.
• You have or are prone to fungal infections (e.g. oral thrush).
• You are pregnant or breastfeeding.
• You are taking medicines known as colchicine, triazolam, midazolam (for anxiety or insomnia), lovastatin, or simvastatin.
• You have diabetes and are taking antidiabetic medicines (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.
• You are taking a medicine called warfarin (a blood thinner).
• You have myasthenia gravis, a condition in which your muscles become weak and tire easily.
• You develop severe or prolonged diarrhea during or after taking clarithromycin; consult your doctor immediately.
• You are taking a medicine called chloroquine (an antiparasitic agent, such as an antimalarial).

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

Taking Claritromycin SUN with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

The following medicines must not be taken together with Claritromycin SUN:

• Astemizole and terfenadine (for allergies), cisapride, domperidone (for gastrointestinal problems), and pimozide (for psychiatric disorders), as these medicines, when taken with clarithromycin, may increase the risk of serious heart problems.

• Lovastatin and simvastatin (to lower cholesterol), as taking them with clarithromycin may cause muscle problems.

• Ergotamine or dihydroergotamine, as taking them with clarithromycin may lead to acute toxicity characterized by vasospasm (contraction of artery walls making blood flow difficult) and ischemia (lack of oxygen) in the limbs and other tissues, including the central nervous system.

• Oral midazolam.

• Ticagrelor or ranolazine.

• Colchicine.

The following medicines should be taken with caution during treatment with clarithromycin, and you should consult your doctor beforehand, as their activity, or that of clarithromycin, or both, may be affected. Dose adjustments and close monitoring may be necessary:

• Oral anticoagulants: acenocoumarol, warfarin, or other anticoagulants such as dabigatran, rivaroxaban, apixaban, edoxaban (used to thin the blood). The risk of bleeding may increase. Your doctor should monitor you regularly.

• Cholesterol-lowering medicines such as atorvastatin and rosuvastatin. The risk of muscle problems increases. Your doctor may need to reduce your dose or temporarily switch your treatment.

• Aminoglycoside antibiotics.

• Antiepileptic medicines used to treat epilepsy: phenytoin, carbamazepine, valproate. These may reduce the effect of clarithromycin and increase adverse effects of the antiepileptics.

• Digoxin, quinidine, or disopyramide (to treat heart problems).

• Theophylline (for asthma).

• Certain immunosuppressants, used, for example, after organ transplantation: cyclosporine, tacrolimus, and sirolimus.

• Ibrutinib or vinblastine, used in cancer treatment.

• Benzodiazepines, for anxiety and insomnia: alprazolam, triazolam, or intravenous or oromucosal midazolam.

• Medicines for angina and hypertension, such as verapamil, amlodipine, and diltiazem.

• Antifungal medicines for fungal infections: fluconazole, itraconazole.

• Antiretroviral medicines for HIV infection: zidovudine, ritonavir, atazanavir, saquinavir, nevirapine, etravirine, or efavirenz. Consult your doctor on how to take these medicines if you start clarithromycin treatment. Do not stop taking them unless instructed by your doctor.

• Methylprednisolone (a corticosteroid), cilostazol (to treat intermittent claudication).

• Rifampicin, rifabutin, and rifapentine (antibiotics used to treat certain infections).

• Sildenafil, tadalafil, and vardenafil (medicines to treat erectile dysfunction and pulmonary hypertension) and tolterodine (to relieve urinary difficulties).

• Medicines for diabetes (used to lower blood glucose levels), such as insulin, glibenclamide, nateglinide, or repaglinide. Abnormally low blood glucose levels may occur.

• Omeprazole (for digestive disorders such as ulcers and gastroesophageal reflux).

• Quetiapine (for schizophrenia or other psychiatric conditions).

• St. John’s wort (Hypericum perforatum) (for depression).

Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription.

This is also important if you are taking medicines called:

• Hydroxychloroquine or chloroquine (used to treat conditions such as rheumatoid arthritis, or to treat or prevent malaria). Taking these 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 conditions).

Taking Claritromycin SUN with food and drink

Claritromycin SUN 500 mg coated tablets can be taken before, during, or after meals, as the presence of food in the digestive tract does not affect the medicine’s activity.

Pregnancy and breastfeeding

• The safety of clarithromycin use during pregnancy has not been established. If you are pregnant or think you may be pregnant, do not take Claritromycin SUN without first consulting your doctor, who will decide whether you should take it.

• The safety of clarithromycin use during breastfeeding has not been established. Clarithromycin passes into breast milk. If you are breastfeeding, do not take this medicine.

• 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.

Driving and using machines

Claritromycin may cause drowsiness, dizziness, or confusion. If this occurs, do not drive or operate machinery.

Claritromycin SUN 500 mg coated tablets contain sodium

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

3. How to take Claritromycin SUN 500 mg tablets

Claritromycin SUN is administered orally.

Claritromycin may be taken independently of meals.

Follow exactly the instructions for use of this medicine provided by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults and adolescents (12 years of age and older): in patients with peptic ulcer associated with Helicobacter pylori, the recommended treatments are:

• Triple therapy: one tablet of Claritromycin SUN twice daily, together with 1,000 mg of amoxicillin twice daily and 20 mg of omeprazole once daily for 10 days, OR one tablet of Claritromycin SUN with 1,000 mg of amoxicillin and 20 mg of omeprazole, all administered twice daily for 7 days.
• Dual therapy: one tablet of Claritromycin SUN three times daily, together with 40 mg of omeprazole once daily for 2 weeks. To ensure healing in patients with duodenal ulcer with poor therapeutic response, treatment with 40 mg of omeprazole may be prolonged up to 4 weeks.

The recommended average dose for prevention and treatment of infections caused by mycobacteria is one tablet of Claritromycin SUN every 12 hours. The duration of treatment must be determined by the physician.

For treatment of respiratory tract, skin, and soft tissue infections, the duration must be determined by the physician and depends on the severity and type of infection. It ranges between 6 and 14 days. The patient must strictly follow the doctor's instructions, even if symptoms disappear. The usual recommended dose for adults may be one tablet of Claritromycin 250 mg or Claritromycin SUN 500 mg every 12 hours, depending on the type and severity of the infection.

Use in children

Children under 12 years: The use of Claritromycin tablets is not recommended in children under 12 years of age. The pediatric suspension formulation of Claritromycin should be used instead.

Elderly patients: Same dosage as for adults.

Remember to take your medicine. Take the tablets at the same time every day.

Your doctor will determine how long your treatment should last. Do not stop treatment early, as even if you feel better, your illness could worsen or recur.

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

If you take more Claritromycin SUN than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Claritromycin SUN

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

If you stop treatment with Claritromycin SUN

Do not stop treatment early, as even if you 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, Claritromycin SUN may have adverse effects, although not everyone experiences 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), rare (may affect up to 1 in 1,000 people), and frequency not known (cannot be estimated from available data).

Common and very common adverse 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 patient populations 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 commonly observed (may affect more than 1 in 10 patients, with the intravenous formulation): phlebitis (vein inflammation) at the injection site.

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

• 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 intravenous formulation).

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

• Infections: cellulitis (only with 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 intravenous formulation), hypersensitivity (exaggerated allergic reaction 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 intravenous formulation), dizziness, somnolence, tremor.
• Ear and balance disorders: vertigo, hearing problems, tinnitus.
• Cardiac disorders: cardiac arrest and cardiac rhythm disturbances (atrial fibrillation) (both effects only with intravenous formulation), QT interval prolongation (an ECG indicator suggesting risk of ventricular arrhythmias), extrasystoles (premature heartbeat relative to normal heart rate, only with intravenous formulation), palpitations (irregular heartbeats).
• Respiratory disorders: asthma (difficulty breathing, chest tightness, and nocturnal or early morning cough, only with intravenous formulation), epistaxis (only with prolonged-release tablets), pulmonary embolism (blockage of the pulmonary artery causing unilateral chest pain, cough, and breathing difficulty, only with intravenous formulation).
• Gastrointestinal disorders: oesophagitis (only with intravenous formulation), gastro-oesophageal reflux disease (damage to the oesophagus causing heartburn, 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: 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 rash, only with intravenous formulation), pruritus, urticaria (edematous, red, itchy skin lesions), maculopapular rash (skin lesion with a papule or wart-like bump on a flat discolored area, only with granules for oral suspension).
• Musculoskeletal disorders: muscle spasms (only with granules for oral suspension), musculoskeletal rigidity (only with intravenous formulation), muscle pain (only with prolonged-release tablets).
• Renal disorders: increased serum creatinine and serum urea (both indicating impaired kidney function, only with intravenous formulation).
• General disorders: malaise (only with immediate-release tablets), chest pain, chills, and fatigue (the last three only with immediate-release tablets).
• Laboratory findings: abnormal albumin-globulin ratio (only with intravenous formulation), increased serum alkaline phosphatase and increased blood lactate dehydrogenase (both only with immediate-release tablets), increased blood urea, increased blood creatinine.

? With frequency not known (frequency cannot be estimated from available data), the following have been observed:

• Infections: pseudomembranous colitis (diarrhoea that may become severe), erysipelas (variable skin redness causing pain, itching, and fever).
• Blood disorders: decreased neutrophil count (a type of white blood cell), thrombocytopenia (decreased platelets).
• Immune system disorders: anaphylactic reaction (generalized allergic reaction), angioedema (subcutaneous swelling).
• Psychiatric disorders: psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, daydreaming (attenuated perception of external stimuli).
• Nervous system: seizures, decreased or loss of taste, olfactory disturbance, 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.
• Hepatic disorders: liver failure, hepatocellular jaundice (yellowing of 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 subcutaneous bumps and blisters, accompanied by fever, mainly localized in skin folds, trunk, and upper limbs), toxic epidermal necrolysis (widespread blistering and skin peeling, particularly around mouth, nose, eyes, and genitals, leading to widespread skin shedding involving more than 30% of body surface), drug reaction with eosinophilia and systemic symptoms (DRESS) (flu-like symptoms with skin rash, fever, lymphadenopathy, and abnormal blood tests such as increased leukocytes (eosinophilia) and elevated liver enzymes), acne. If any of these reactions occur, treatment with clarithromycin should be stopped immediately and medical advice sought for appropriate management.
• Musculoskeletal disorders: rhabdomyolysis (muscle breakdown that may lead to kidney damage), myopathy (muscle disease of various causes).
• Renal disorders: kidney dysfunction, interstitial nephritis (inflammation of renal tubules).
• Laboratory findings: increased international normalized ratio (INR, a test to monitor blood coagulation), prolonged prothrombin time (indicating impaired blood coagulation), and abnormal urine color.

Specific adverse effects

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

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

In some rhabdomyolysis reports, clarithromycin was administered concomitantly with statins, fibrates, colchicine, or allopurinol (see Do not take Claritromycin SUN 500 mg film-coated tablets EFG 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 gastrointestinal anatomical disorders [including ileostomy or colostomy (surgery to artificially divert intestinal waste from the ileum or colon)] or functional disorders (conditions caused by bodily defects) with shortened gastrointestinal transit time. In several reports, tablet residues appeared in the context of diarrhoea. Patients who notice tablet residues in their faeces and experience no clinical improvement should consider switching 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 underlying disease or 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 frequently reported 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 dyspnoea, 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 daily of clarithromycin developed severely abnormal elevations in transaminases, 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 (indicating possible 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly 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 SUN 500 mg tablets

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 is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and any unused medicines at the SIGRE collection point located at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Clarithromycin SUN 500 mg tablets

The active substance is Clarithromycin. Each tablet contains 500 mg of clarithromycin.

The other components (excipients) are: microcrystalline cellulose, sodium croscarmellose, povidone, magnesium stearate, talc, anhydrous colloidal silica, stearic acid, hypromellose, propylene glycol, vanillin, titanium dioxide (E 171), hydroxypropylcellulose (E 463), quinoline yellow (E 104).

Appearance of the product and contents of the pack

Claritromycin SUN 500 mg tablets are oval, biconvex, light yellow in colour, scored on both sides, and engraved with "C" and "2" on either side of the score line on one of the faces.

The tablets are presented in thermoformed blisters made of PVC/PVdC sealed with an aluminium foil. This medicinal product is available in packs of 14 and 21 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

The Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

The Netherlands

Terapia S.A.

Str. Fabricii nr. 124,

Cluj, Napoca,

Romania

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona,

Spain

Tel.: +34 93 342 78 90

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

Detailed and up-to-date 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/ .