CLARITHROMYCIN SUN 500 mg FILM-COATED TABLETS

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 sensitive germs in adults and adolescents (12 years of age and older)

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

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

Do not take Claritromicina SUN

• If you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or to 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 ergotamine inhalers for migraine while taking clarithromycin. Consult your doctor for alternative medications.
• If you are taking medications called terfenadine, astemizole (for hay fever or allergies), cisapride, or domperidone (used for stomach problems) or pimozide (a medication used to treat certain psychiatric disorders), as taking these medications with clarithromycin can cause serious 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), ivabradine, or ranolazine (for angina pectoris or to reduce the risk of heart attack or stroke).
• If you are taking other medications that are known to cause serious heart rhythm disturbances.
• If you are undergoing treatment 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 have a history of heart rhythm disorders (ventricular arrhythmia, including Torsade de Pointes) or abnormalities in the electrocardiogram (ECG, electrical recording of the heart) called "QT prolongation syndrome".
• If you are taking medications called lovastatin or simvastatin (to lower cholesterol), as the combination of these medications can increase the risk of side effects. Consult your doctor for alternative medications.
• If you are taking colchicine (for gout).
• If you are taking a medication with lomitapide.

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 (such as thrush).
• If you are pregnant or breastfeeding
• If you are taking medications known as colchicine, triazolam, midazolam (for anxiety or insomnia), lovastatin, simvastatin.
• If you are diabetic and taking hypoglycemic agents (medications to lower blood sugar levels) such as nateglinide, pioglitazone, rosiglitazone, and repaglinide, sulfonamides, or insulin, and clarithromycin may lower blood sugar levels too much. Careful monitoring of blood sugar levels is recommended.
• If you are taking a medication called warfarin (blood anticoagulant).
• 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 chloroquine (antiparasitic, such as antimalarial)

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

Using Claritromicina SUN with Other Medications

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

The following medications should not be taken with Claritromicina SUN

Astemizole and terfenadine (for allergies), cisapride, domperidone (for gastrointestinal problems), and pimozide (for psychiatric disorders), as these medications, when administered with clarithromycin, can increase the risk of serious heart problems.

• Lovastatin and simvastatin (to lower cholesterol), as the combination of these medications with clarithromycin can cause muscle problems.
• Ergotamine or dihydroergotamine, as taking them with clarithromycin can cause acute toxicity characterized by vasospasm (contraction of the walls of the arteries that makes it difficult for blood to pass through them) and ischemia (lack of oxygen) of the extremities and other tissues, including the central nervous system.
• Oral midazolam.
• Ticagrelor or ranolazine
• Colchicine

The following medications should be taken with caution during treatment with clarithromycin, and you should consult your doctor before taking them, as the activity of these medications, clarithromycin, or both may be affected. A dose change 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.

Cholesterol-lowering medications such as atorvastatin and rosuvastatin. The risk of muscle problems increases. Your doctor may need to lower the dose of these medications or temporarily change them.

• Aminoglycoside antibiotics.
• Antiepileptics, used to treat epilepsy: phenytoin, carbamazepine, valproate. They may reduce the effect of clarithromycin and increase the side effects of antiepileptics.

Digoxin, quinidine, or disopyramide (for heart problems)

Theophylline (for asthma)

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

Ibrutinib or vinblastine, for cancer treatment.

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

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

Antifungals, for fungal infections: fluconazole, itraconazole.

Antiretrovirals, for HIV infection: zidovudine, ritonavir, atazanavir, saquinavir, nevirapine, etravirine, 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.

Methylprednisolone (corticosteroid), cilostazol (for intermittent claudication)

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

• Sildenafil, tadalafil, and vardenafil (medications for impotence and pulmonary hypertension) and tolterodine (for urinary difficulties)

• Diabetes medications (used to lower blood sugar levels) such as insulin, glibenclamide, nateglinide, or repaglinide. Abnormally low blood sugar levels may occur.

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

• Quetiapine (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 recently used other medications, including those purchased without a prescription.

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 first, and they will decide whether 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 or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Using Machines

Claritromicina may cause drowsiness, dizziness, or confusion. If this occurs, do not drive vehicles or use machinery.

Claritromicina SUN 500 mg film-coated tablets contain sodium

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

3. How to Take Claritromicina SUN 500 mg Tablets

Claritromicina SUN is administered orally.

Claritromicina can be administered independently of meals.

Follow your doctor's instructions for administration of this medication exactly. If in 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 Claritromicina SUN tablet twice a day, with 1000 mg of amoxicillin twice a day and 20 mg of omeprazole once a day, for 10 days, or one Claritromicina SUN tablet with 1000 mg of amoxicillin and 20 mg of omeprazole, all administered twice a day, for 7 days.
• Double therapy: one Claritromicina SUN tablet, 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 with 40 mg of omeprazole may be extended up to 4 weeks.

The recommended average dose for the prevention and treatment of mycobacterial infections is one Claritromicina SUN tablet every 12 hours. The duration of treatment should be determined by your doctor.

In the treatment of respiratory tract, skin, and soft tissue infections, the duration of treatment should be determined by your 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 the discomfort disappears. The usual recommended dose for adults may be one Claritromicina 250 mg or Claritromicina SUN 500 mg tablet every 12 hours, depending on the type and severity of the infection.

Use in Children

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

Elderly patients: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 could worsen or reappear.

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, you can expect the appearance of digestive disorders, and 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 Toxicology 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 make up for forgotten doses. Take the tablet as soon as possible and continue taking it every day at the same time.

If You Interrupt Treatment with Claritromicina SUN

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

4. Possible Adverse Effects

Like all medicines, Clarithromycin SUN can have adverse effects, although not all people suffer from them.

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

The frequent and very frequent adverse reactions related to treatment with clarithromycin, in both adults and children, are abdominal pain, diarrhea, nausea, vomiting, and alteration of taste. These adverse reactions are usually mild and coincide 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 the patient population with or without pre-existing mycobacterial infections.

Summary of Adverse Effects

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

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

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

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

Infrequently observed (may affect up to 1 in 100 patients) are the following:

• Infections: cellulitis (only with the intravenous injection formulation), candidiasis (infection caused by a type of fungus), gastroenteritis (only with prolonged-release tablets), infection (only with the oral suspension granule), vaginal infection.
• Blood disorders: decrease in white blood cells, decrease in neutrophils (a type of white blood cell, only with immediate-release tablets), increase in platelets and, to a lesser extent, red and white blood cells in the blood (only with the oral suspension granule), increase in eosinophils (a type of white blood cell, only with immediate-release tablets).
• Immune system: anaphylactoid reaction (generalized allergic reaction, only with the intravenous injection formulation), hypersensitivity (exaggerated allergic reaction to external agents).
• Eating disorders: anorexia, decreased appetite.
• Psychiatric disorders: anxiety and nervousness (the latter only with the oral suspension granule).
• Nervous system: loss of consciousness and difficulty moving (both effects, only with the intravenous injection formulation), dizziness, drowsiness, tremors.
• Ear and balance: vertigo, hearing problems, tinnitus.
• Heart disorders: cardiac arrest and alteration of heart rhythm (atrial fibrillation) (both effects, only with the intravenous injection formulation), prolongation of the QT interval (indicator of the electrocardiogram that arrhythmias may occur), extrasystoles (premature heartbeat, only with the intravenous injection formulation), palpitations (alterations in heartbeats).
• Respiratory disorders: asthma (difficulty breathing, chest oppression, and nocturnal cough, only with the intravenous injection formulation), nasal bleeding (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 the intravenous injection formulation).
• Gastrointestinal disorders: esophagus inflammation (only with the intravenous injection formulation), gastroesophageal reflux disease (damage to the esophagus that causes a burning sensation, chronic cough, shortness of breath, and difficulty swallowing, only with prolonged-release tablets), stomach mucosa inflammation (gastritis), pain in the anus and rectum (only with prolonged-release tablets), oral mucosa inflammation, tongue inflammation, abdominal distension (only with immediate-release tablets), constipation, dry mouth, belching, flatulence.
• Liver disorders: decrease or suppression of bile flow to the intestine and liver inflammation (hepatitis) (both effects, only with immediate-release tablets), increase in alanine aminotransferase (liver enzyme), aspartate aminotransferase (another liver enzyme), and gamma-glutamyltransferase (another liver enzyme, only with immediate-release tablets).
• Skin: bullous dermatitis (bullous rashes, only with the intravenous injection formulation), itching, urticaria (edematous, red, and very itchy skin lesions), maculopapular rash (skin lesion with a papule or wart on a spot, only with the oral suspension granule).
• Muscle disorders: muscle spasms (only with the oral suspension granule), musculoskeletal stiffness (only with the intravenous injection formulation), muscle pain (only with prolonged-release tablets).
• Kidney disorders: increase in serum creatinine and serum urea (both effects, which indicate poorer kidney function, only with the intravenous injection formulation).
• General disorders: discomfort (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 injection formulation), increase in serum alkaline phosphatase and increase in lactate dehydrogenase in blood (the last two, only with immediate-release tablets), increase in blood urea, increase in blood creatinine.

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

• Infections: pseudomembranous colitis (diarrhea that can become severe), erysipelas (redness of the skin of variable extent that can cause pain, itching, and fever).
• Blood disorders: decrease in neutrophils (a type of white blood cell), decrease in platelets.
• Immune system: anaphylactic reaction (generalized allergic reaction), angioedema (swelling under the skin).
• Psychiatric disorders: psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, daydreaming (attenuated perceptions of external stimuli).
• Nervous system: convulsions, decrease or loss of taste, alteration of smell, loss or decrease of smell, sensation of tingling, numbness, or prickling in hands, feet, arms, or legs.
• Ear: deafness.
• Heart disorders: torsades de pointes (a type of ventricular tachycardia), ventricular tachycardia (acceleration of heartbeats with more than 100 beats/minute with at least 3 consecutive irregular beats).
• Vascular disorders: hemorrhage.
• Digestive disorders: acute pancreatitis (acute inflammation of the pancreas), discoloration of the tongue, discoloration of the teeth.
• Liver disorders: liver failure, hepatocellular jaundice (yellowing of the skin and eyes).
• Skin: Stevens-Johnson syndrome (generalized rash with blisters and peeling of the skin, mainly affecting genital, oral, and trunk areas), acute generalized exanthematous pustulosis (generalized scaly red rash with bumps and blisters under the skin, accompanied by fever, mainly located in skin folds, trunk, and upper limbs) and toxic epidermal necrolysis (generalized rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals, causing widespread skin peeling (more than 30% of the body surface) with flu-like symptoms, skin rash, fever, inflammation of glands, and abnormal blood test results (such as increased leukocytes (eosinophilia) and elevated liver enzymes) [drug reaction with eosinophilia and systemic symptoms (DRESS)] acne. If such reactions occur, treatment with clarithromycin should be discontinued immediately and a doctor consulted for appropriate treatment.
• Muscle disorders: rhabdomyolysis (muscle breakdown that can cause kidney damage), myopathy (muscle disease of multiple causes).
• Kidney disorder: kidney failure, interstitial nephritis (inflammation of the renal tubules).
• Laboratory tests: increase in international normalized ratio (calculation to detect blood coagulation), prolongation of prothrombin time (indicates a deficit in 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.

After the marketing of the medicine, reports of effects on the central nervous system (e.g., drowsiness and confusion) with the simultaneous use of clarithromycin and triazolam have been received. 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 SUN 500 mg film-coated tablets EFG and Warnings and precautions).

There have been rare reports that prolonged-release clarithromycin tablets appear in the feces; many of these cases have occurred in patients with gastrointestinal anatomical disorders [including ileostomy or colostomy (surgery to expel intestinal waste artificially from the ileum or colon)] or functional 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 with tablet residues in the feces and who do not experience any improvement change to another formulation of clarithromycin (e.g., suspension) or to another antibiotic.

Adverse Effects in Children and Adolescents:

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 a damaged immune system, treated with the highest doses of clarithromycin for long periods of time for mycobacterial infections, it is often difficult to distinguish adverse effects possibly associated with the administration of clarithromycin from the effects caused by the disease or by other diseases that the patient may have along 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 that appeared were: nausea, vomiting, alteration of taste, abdominal pain, diarrhea, skin rash, flatulence, headache, constipation, hearing disturbances, and elevations in transaminases (which may indicate liver, pancreas, heart, or muscle involvement). Less frequently, respiratory difficulty, insomnia, and dry mouth appeared. The incidences were similar in patients treated with 1,000 mg and 2,000 mg, but in general were 3 to 4 times more frequent in those who received a total daily dose of 4,000 mg of clarithromycin.

In these immunocompromised patients, around 2% to 3% who received 1,000 mg or 2,000 mg of clarithromycin daily presented severely abnormal elevated transaminase levels, as well as abnormally low white blood cell and platelet counts. A smaller percentage of patients in both dosage groups had increased blood urea nitrogen levels (which may indicate decreased renal function). In patients who received 4,000 mg daily, slightly higher incidences of abnormal values were observed in all parameters, except for the white blood cell count.

Contact a doctor as soon as possible if you experience a severe skin reaction: a red and scaly rash with bumps and blisters under the skin. 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Clarithromycin SUN 500 mg tablets

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Clarithromycin SUN 500 mg tablets

The active ingredient 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 Package Contents

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

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

Marketing Authorization Holder and Manufacturer

Holder:

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

Manufacturer:

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

Date of the last revision of this prospectus: February2024

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