Package Insert: Information for the User

Claritromycin SUN 500 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.

• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Claritromicina SUN is a macrolide antibiotic. Antibiotics prevent the growth of certain bacteria.

Claritromicina SUN is used for the treatment of infections caused by sensitive germs 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,
• Ulcers caused by the Helicobacter pylori bacteria

Do not take Claritromicina SUN

• ?If you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other components of this medication (listed in section 6).
• If you have a creatinine clearance of less than 30 ml/min.
• If you have an irregular heart rhythm.
• If you have severe kidney and liver problems.
• If you are taking ergotamine or dihydroergotamine or using inhalers of ergotamine for migraines while taking clarithromycin. Consult your doctor for alternative medications..
• If you are taking medications called terfenadine, astemizol (for hay fever or allergies), cisaprida, or domperidona (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 or to reduce the risk of heart attack or stroke).
• If you are taking other medications that are 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 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 in the 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 are taking colchicina (for gout).
• If you are taking a medication with lomitapida.

Warnings and precautions

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

• 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 medications known as colchicina, 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. It is recommended to have careful control of blood sugar levels.
• If you are taking a medication called warfarina (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 you are taking a medication called cloroquina (antiparasitic medication for malaria).

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

Use of Claritromicina SUN with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

The medications listed below should not be taken with Claritromicina SUN:

?astemizol and terfenadine (for allergies), cisaprida, domperidona (for stomach problems) and pimozida (for psychiatric disorders), as these medications if taken with clarithromycin may increase the risk of severe heart problems.

• lovastatina and simvastatina (to lower cholesterol levels), as taking these medications with clarithromycin may cause muscle problems.
• ergotamine or dihydroergotamine, as taking these medications with clarithromycin may cause acute toxicity characterized by vasospasm (contraction of blood vessel walls that makes it difficult for blood to pass through them) and ischemia (lack of oxygen) of extremities and other tissues, including the central nervous system.
• Midazolam oral.
• Ticagrelor or ranolazina
• Colchicina

The following medications should be taken with caution during treatment with clarithromycin and consult your doctor beforehand as it may affect the activity of these medications, clarithromycin, or both. It may be necessary to change the dose and have close monitoring:

?Anticoagulants: acenocumarol, warfarina, or other anticoagulants, for example dabigatrán, rivaroxabán, apixabán, edoxabán (used to thin the blood). It may increase the risk of bleeding. Your doctor should monitor you.

?Cholesterol-lowering medications such as atorvastatina and rosuvastatina. It may increase the risk of muscle problems. Your doctor may need to lower the dose of these medications or change them temporarily.

• Aminoglycoside antibiotics.?Antiepileptic medications: phenitoína, carbamazepina, valproato. They may reduce the action of clarithromycin and increase the adverse effects of antiepileptic medications.

?Digoxina, quinidina, or disopiramida (for heart problems)

?Theophylline (for asthma).

?Some immunosuppressants, used for example after organ transplantation: ciclosporina, tacrolimus, and sirolimus.

?Ibrutinib or vinblastina, for cancer treatment.

?Benzodiazepines, for anxiety and insomnia: alprazolam, triazolam, or midazolam intravenously or oromucously.

• Medications for the treatment of angina and hypertension, such as verapamilo, amlodipino, and diltiazem.

?Antifungal medications, for fungal infections: fluconazol, itraconazol.

?Antiretrovirals, for HIV infection: zidovudina, ritonavir, atazanavir, saquinavir, nevirapina, etravirina, or efavirenz. Consult your doctor on how to take these medications if you start treatment with clarithromycin. Do not interrupt them unless your doctor tells you to.

?Prednisolone (corticosteroid), cilostazol (for intermittent claudication)

?Rifampicina, rifabutina, and rifapentina (antibiotics used to treat some infections).

•Sildenafilo, tadalafilo, and vardenafilo (medications for erectile dysfunction and pulmonary hypertension) and tolterodina (to alleviate urinary difficulties

• Medications for diabetes (used to reduce blood sugar levels) such as insulin, glibenclamida, nateglinida, or repaglinida. Abnormally low blood sugar levels may occur.

?Omeprazol (for digestive disorders such as ulcers and gastroesophageal reflux).

• Quetiapina (for schizophrenia or other psychiatric conditions)

• St. John's Wort or hypericum (for depression).

Inform your doctor or pharmacist if you are using or have used recently other medications, including those purchased without a prescription.

This is also important if you take medications called:

•hydroxychloroquine or cloroquina (used to treat diseases such as rheumatoid arthritis, or to treat or prevent malaria). Taking these medications at the same time as clarithromycin may increase the risk of abnormal heart rhythms and other severe adverse reactions affecting the heart.

•corticosteroids, administered orally, by injection, or inhaled (used to suppress the immune system; this is useful in the treatment of a wide variety of diseases)

Taking Claritromicina SUN with food and drinks

Claritromicina SUN 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

• The safety of clarithromycin use during pregnancy has not been established. If you are pregnant or think you may be pregnant, do not take Claritromicina SUN without consulting your doctor and they will decide if you should take it or not.
• The safety of clarithromycin use during breastfeeding has not been established. Clarithromycin passes into breast milk. If you are breastfeeding, do not take this medication.
• If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication,

Driving and operating machinery

Clarithromycin may cause drowsiness, dizziness, or confusion. If you experience any of these symptoms, do not drive vehicles or operate machinery.

Claritromicina SUN 500 mg coated tablets contain sodium

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

Claritromicina SUN is administered orally.

Claritromicina can be taken independently of meals.

Follow exactly the administration instructions of this medication indicated 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 withHelicobacter pylorithe recommended treatments are:

• Triple therapy: one tablet ofClaritromicina SUNtwice a day, with 1,000 mg of amoxicillin twice a day and 20 mg of omeprazole once a day, for 10 days, or one tablet ofClaritromicina SUNwith 1,000 mg of amoxicillin and 20 mg of omeprazole, administered all twice a day, for 7 days.
• Double therapy: one tablet ofClaritromicina SUN, three times a day, with 40 mg of omeprazole, once a day, for 2 weeks. To ensure healing in patients with duodenal ulcer with poor therapeutic response, treatment can be prolonged with 40 mg of omeprazole for up to 4 weeks.

The recommended average dose for the prevention and treatment of infections caused by mycobacteria is one tablet ofClaritromicina SUN, every 12 hours. The duration of treatment should be established by the doctor.

In the treatment of respiratory, skin, and soft tissue infections, the duration of treatment should be established by the doctor and depends on the severity and type of infection. It ranges from 6 to 14 days. The patient should strictly follow the doctor's instructions even if symptoms disappear. The usual recommended dose for adults may be one tablet ofClaritromicina250 mg orClaritromicina SUN500 mg, every 12 hours, depending on the type and severity of the infection.

Use in children

Children under 12 years:Claritromicina tablets are not recommended for children under 12 years. The pediatric suspension formulation should be used.

Elderly patients:The same dosage as adults.

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

Your doctor will indicate the duration of your treatment. Do not stop treatment before, as your disease may worsen or recur.

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

If you take more Claritromicina SUN than you should

If you have taken more Claritromicina SUN than you should, gastrointestinal disturbances can be expected, and you should consult your doctor or pharmacist immediately, as they will try to quickly eliminate the clarithromycin that your body has not yet absorbed. Hemodialysis or peritoneal dialysis is not effective.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Claritromicina SUN

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

If you interrupt treatment withClaritromicinaSUN

Do not stop treatment before, as your disease may worsen or recur. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Claritromicina SUN may cause side effects, although not everyone will experience them.

Side effects are classified as very common (may affect more than 1 in 10 patients), common (may affect up to 1 in 10 patients), uncommon (may affect up to 1 in 100 patients), rare (may affect up to 1 in 1,000 patients), and unknown frequency (cannot be estimated from available data).

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

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

Summary of side effects

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

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

? With all clarithromycin-containing medicines, the following have been observed with common (may affect up to 1 in 10 patients) frequency:

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

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

• Infections: cellulitis (only with the intravenous injection formulation), candidiasis (infection by a type of fungus), gastroenteritis (only with prolonged-release tablets), infection (only with oral suspension granules), 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, 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 injection 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 injection 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 injection formulation), prolongation of the QT interval (electrocardiogram indicator of potential ventricular arrhythmias), extrasystoles (premature heartbeat, only with intravenous injection formulation), palpitations (alterations in heartbeats).
• Respiratory disorders: asthma (difficulty breathing, chest tightness, and nocturnal or morning cough, only with intravenous injection 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 injection formulation).
• Gastrointestinal disorders: esophagitis (inflammation of the esophagus, only with intravenous injection 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), gastritis (inflammation of the stomach lining), anal and rectal pain (only with prolonged-release tablets), oral mucosa inflammation, tongue inflammation, abdominal distension (only with immediate-release tablets), constipation, dry mouth, belching, flatulence.
• Liver disorders: decreased or suppressed bile flow to the intestine and liver inflammation (hepatitis) (both effects, only with immediate-release tablets), increased alanine aminotransferase (liver enzyme), increased aspartate aminotransferase (another liver enzyme), and increased gamma-glutamyltransferase (another liver enzyme, only with immediate-release tablets).
• Skin: dermatitis bullous (bullous eruptions, only with intravenous injection formulation), pruritus, urticaria (edematous, red, and itchy skin lesions), maculopapular eruption (skin lesion with a papule or wart on a patch, only with oral suspension granules).
• Musculoskeletal disorders: muscle spasms (only with oral suspension granules), musculoskeletal rigidity (only with intravenous injection formulation), muscle pain (only with prolonged-release tablets).
• Renal disorders: increased serum creatinine and urea (both effects, indicating impaired kidney function, only with intravenous injection formulation).
• General disorders: malaise (only with immediate-release tablets), chest pain, chills, and fatigue (the latter three, only with immediate-release tablets).
• Laboratory tests: abnormal albumin-globulin ratio (only with intravenous injection formulation), increased serum alkaline phosphatase, and increased lactate dehydrogenase in blood (both effects, only with immediate-release tablets), increased urea in blood, increased creatinine in blood.

? With unknown frequency (cannot be determined from available data) the following have been observed:

- Infections: pseudomembranous colitis (diarrhea that can be severe), erysipelas (skin redness of variable extent that can cause pain, itching, and fever).

- Blood disorders: 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, illusions (attenuated perceptions of external stimuli).

- Nervous system: convulsions, decreased or lost sense of taste, altered sense of smell, lost or decreased sense of smell, paresthesia (tingling, numbness, or burning sensation in hands, feet, arms, or legs).

- Auditory disorders: hearing loss.

- Cardiac disorders: torsades de pointes (a type of ventricular tachycardia), ventricular tachycardia (acceleration of heartbeats with more than 100 beats per minute with at least 3 irregular consecutive beats).

- Vascular disorders: hemorrhage.

- Gastrointestinal disorders: acute pancreatitis (inflammation of the pancreas), tongue discoloration, tooth discoloration.

- Liver disorders: liver function failure, icteric hepatitis (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 blisters under the skin and fever, primarily located in skin folds, trunk, and upper limbs), toxic epidermal necrolysis (generalized eruption with blisters and skin peeling, particularly around the mouth, nose, eyes, and genital areas, causing generalized skin peeling (more than 30% of body surface area) and 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 kidney damage), myopathy (muscle disease of multiple causes).

- Renal disorders: kidney function failure, interstitial nephritis (inflammation of renal tubules).

- Laboratory tests: increased international normalized ratio (calculation to detect blood coagulation), prolonged prothrombin time (indicates a deficiency in blood coagulation), 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 of the reports of rhabdomyolysis, clarithromycin was administered concomitantly with statins, fibrates, colchicine, or allopurinol (see Do not take Claritromicina SUN 500 mg film-coated tablets EFG and Warnings 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 or functional gastrointestinal disorders (including ileostomy or colostomy (surgery to expel intestinal waste artificially from the ileum or colon)) or 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 switch to another clarithromycin formulation (e.g., suspension) or another antibiotic.

Side effects in children and adolescents:

The frequency, type, and severity of adverse reactions in children are expected to be the same as in adults.

Immunocompromised patients

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

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

In these immunocompromised patients, around 2% to 3% who received daily 1,000 mg or 2,000 mg of clarithromycin presented severely abnormal elevated transaminases, as well as abnormally low white blood cell and platelet counts. A smaller percentage of patients in both dosing groups had elevated blood urea nitrogen levels (which may 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 blisters under the skin and blisters (pustular exanthema). The frequency of this side effect is considered unknown (cannot be estimated from available data).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of 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 Claritromycin SUN 500 mg tablets

The active ingredient is Claritromycin. Each tablet contains 500 mg of claritromycin.

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), yellow quinoline (E 104).

Appearance of the product and content of the container

Claritromycin SUN 500 mg tablets are oval, biconvex, light yellow in color, scored on both sides and engraved with “C” and “2” on each side of the score on one of the faces.

The tablets are presented in thermoformable PVC/PVdC blisters united to an aluminum foil. This medicine is presented in containers of 14 and 21 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

Responsible for manufacturing:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

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

Last review date of this leaflet: February2024

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