Patient Information Leaflet

Claritromycin Kern Pharma 500 mg Film-Coated Tablets EFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Claritromycin Kern Pharma and what it is used for

2.What you need to know before taking Claritromycin Kern Pharma

3.How to take Claritromycin Kern Pharma

4.Possible side effects

5Storage of Claritromycin Kern Pharma

6.Contents of the pack and additional information

Claritromicina is a medication that belongs to the group of macrolide antibiotics and acts by eliminating bacteria.

Claritromicina is used to treat infections caused by susceptible pathogens in:

Adults and adolescents aged 12 to 18 years:

• 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).
• Lower respiratory tract infections, such as acute bronchitis (infection and inflammation of the bronchi), exacerbation of chronic bronchitis (prolonged and recurring inflammation of the lungs), and bacterial pneumonias (inflammation of the lungs caused by bacteria). (See warnings and precautions section)
• Skin and soft tissue infections, such as folliculitis (infection of one or more hair follicles), cellulitis (acute inflammation of the skin), and erysipelas (a type of skin infection). (See section 2 Warnings and precautions)
• Peptic ulcers or duodenal ulcers
• Prevention and treatment of infections caused by mycobacteria (a type of bacteria).

Do not take Claritromicina Kern Pharma

• 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 migraine while taking clarithromycin. Consult your doctor for alternative medications.
• If you are taking medications called terfenadine, astemizol (allergy medication), cisapride, or domperidone (used for stomach problems) or pimozide (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), ivabradine, or ranolazine (for angina or to reduce the risk of heart attack or stroke).
• If you are taking other medications known to cause severe heart rhythm disturbances.
• If you are taking midazolam oral (for anxiety or to help 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 "prolonged QT syndrome."
• If you are taking medications called lovastatin or simvastatin (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 colchicine (for gout)
• If you are taking a medication with lomitaprida.
• If you have abnormally low levels of potassium or magnesium in your blood (hypokalemia or hypomagnesemia).

Warnings and precautions

Consult your doctor or pharmacist before starting to take clarithromycin

• 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 colchicine, triazolam, midazolam (for anxiety or insomnia), lovastatin, simvastatin.
• If you are diabetic and taking hypoglycemic medications (medications to lower blood sugar such as nateglinide, pioglitazone, rosiglitazone, and repaglinide, sulfonylureas, or insulin) as clarithromycin may lower blood sugar levels too much. Careful glucose control is recommended.
• If you are taking a medication called warfarin or another anticoagulant, such as dabigatran, rivaroxaban, apixaban, edoxaban (used to thin the blood).
• 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 affect you, consult your doctor before taking clarithromycin.

Children and adolescents

Do not administer this medication to children under 12 years old, as there are other presentations available for this age group (oral suspension granules).

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 older patients.

Claritromicina Kern Pharma with other medications

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription.

Do not take clarithromycin with ergot alkaloids, astemizol, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, certain medications for high cholesterol, and medications known to cause severe heart rhythm disturbances (see Do not take Claritromicina Kern Pharma).

This is especially important if you are taking medications for:

• Heart problems (e.g., digoxin, verapamil, quinidine, or disopyramide).
• Thinning the blood (e.g., warfarin or any other anticoagulant, such as dabigatran, rivaroxaban, apixaban, edoxaban).
• Migraine (e.g., ergotamine or dihydroergotamine).
• Epilepsy or bipolar disorder (carbamazepine, valproate, phenobarbital, or phenytoin).
• High cholesterol (e.g., simvastatin or lovastatin).

Or if you are taking any 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).
• Ciclosporin (immunosuppressant).
• Rifabutin (for treating certain infections).
• Tacrolimus or sirolimus (for organ transplants and severe eczema).
• Sildenafil, tadalafil, or vardenafil (for treating erectile dysfunction in adult men or for pulmonary hypertension).
• Zidovudine (for treating viruses).
• St. John's Wort (herbal product for treating depression).
• Phenobarbital (medication for treating epilepsy).
• Nevirapine and efavirenz may decrease clarithromycin levels.
• Rifampicin or rifapentine (for treating tuberculosis).
• Omeprazole (for treating stomach acid and ulcers or intestinal ulcers).
• Ritonavir (antiviral medication used in HIV treatment) may increase clarithromycin levels. The concomitant use of atazanavir, etravirine, and saquinavir (also antiviral medications used in HIV treatment) with clarithromycin may increase both atazanavir (or saquinavir) and clarithromycin levels.
• Itraconazole (antifungal medication) taken with clarithromycin may increase both medication levels.
• Fluconazole, another antifungal medication, may increase clarithromycin levels.
• Tolterodine (for treating overactive bladder syndrome). In some patients, tolterodine levels may increase when taken with clarithromycin.
• Quetiapine (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 reactions 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).

Pregnancy, lactation, and fertility

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

Pregnancy

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.

Lactation

Clarithromycin is excreted in 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.

Warnings about excipients

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

Follow these instructions unless your doctor has given you different instructions. If in doubt, consult your doctor or pharmacist again.

Clarithromycin is presented in oral tablets. Take the tablets at the same time every day.

Recommended doses are:

Adults and children over 12 years old:

Patients with respiratory tract, skin, and soft tissue infections

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

This pharmaceutical form is not suitable for doses lower than 250 mg or for patients with swallowing problems.

Helicobacter pylori eradication in patients with duodenal ulcers (adults):

In patients with peptic ulcers associated with Helicobacter pylori, the recommended treatments are: Triple therapy: one tablet of clarithromycin 500 mg twice a day, with 30 mg of lansoprazole, twice a day, and 1,000 mg of amoxicillin twice a day for 10 days. Or one tablet of clarithromycin 500 mg with 1,000 mg of amoxicillin and 20 mg of omeprazole, administered twice a day, for 7 to 10 days.

Patients with infections caused by mycobacteria:

The recommended dose for the prevention and treatment of infections caused by mycobacteria is one tablet of clarithromycin 500 mg, every 12 hours. The duration of treatment should be established by the doctor.

Patients with kidney insufficiency:

In patients with kidney insufficiency and a creatinine clearance of less than 30 ml/min, the clarithromycin dose should be reduced to half, i.e., 250 mg once a day, or 250 mg twice a day in more severe infections. In these patients, treatment should be discontinued after 14 days.

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

Since Clarithromycin Kern Pharma 500 mg cannot be split, use the 250 mg presentation.

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

Your doctor will indicate the duration of your treatment.

If you estimate that the action of clarithromycin is too strong or too weak, inform your doctor or pharmacist.

Older patients

Like adults.

Use in children and adolescents

There are presentations suitable for children, from 6 months, and adolescents under 12 years old (oral suspension granules)

If you take more Clarithromycin Kern Pharma than you should

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. It is recommended to bring the leaflet and the packaging to the healthcare professional. The most frequent symptoms that accompany an overdose are gastrointestinal disturbances. Neither hemodialysis nor peritoneal dialysis is effective.

If you have taken more clarithromycin than you should, you can expect gastrointestinal disturbances and consult your doctor or pharmacist immediately, as they will try to quickly eliminate the clarithromycin that your body has not yet absorbed.

If you forgot to take Clarithromycin Kern Pharma

Do not take a double dose to compensate for the missed doses.

Take the tablet as soon as you remember and continue to respect the 12-hour interval between doses.

If you interrupt treatment with Clarithromycin Kern Pharma

Your doctor will indicate the duration of your treatment with clarithromycin. Do not discontinue treatment prematurely, as although you may feel better, your disease could worsen or recur.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, clarithromycin can cause side effects, although not everyone will experience them.

The frequencies have been defined as follows:

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

Unknown frequency: cannot be estimated from available data

The common and very common adverse reactions related to treatment with clarithromycin, both in adults and children, are abdominal pain, diarrhea, nausea, vomiting, and altered taste. 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 in clinical trials between patients 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:

? It has been observedvery frequently(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 medications, the following have been observed frequently(may affect up to 1 in 10 patients):

- Digestive system: diarrhea, vomiting, gastrointestinal disorder that makes digestion difficult (dyspepsia), nausea, abdominal pain.

- Nervous system: altered taste, headache, altered taste.

- 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 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 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: anaphylactoid reaction (generalized allergic reaction, only with intravenous injection formulation), hypersensitivity (exaggerated allergic reaction to external agents).

- Eating 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.

- Ear and balance: vertigo, hearing problems, ringing in the ears.

- Heart disorders: cardiac arrest and altered heart rhythm (fibrillation of the auricle) (both effects, only with intravenous injection formulation), prolonged QT interval (indicator of the electrocardiogram that arrhythmias may occur), 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) and, 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: esophageal inflammation (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), gastric mucosal inflammation, 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.

- Liver disorders: decreased or suppressed bile flow to the intestine and liver inflammation (hepatitis) (both effects, only with immediate-release tablets), increased alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyltransferase (another liver enzyme, only with immediate-release tablets).

- Skin: dermatitis herpetiformis (vesicular 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).

- Muscular disorders: muscle spasms (only with oral suspension granules), musculoskeletal rigidity (only with intravenous injection formulation), muscle pain (only with prolonged-release tablets).

- Kidney 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).

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

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

- Blood abnormalities: decreased neutrophils (a type of white blood cell), decreased platelets.

- Immune system: anaphylactic reaction (generalized allergic reaction), angioedema (swelling under the skin).

- Psychiatric disorders: psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, daydreaming (perceptions of external stimuli that are attenuated).

- Nervous system: convulsions, decreased or lost sense of taste, altered sense of smell, lost or decreased sense of smell, paresthesia, numbness, or tingling 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 per minute with at least 3 consecutive irregular beats).

- Vascular disorders: hemorrhage.

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

- 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 patches, blisters, and fever, primarily affecting skin folds, trunk, and upper limbs), and toxic epidermal necrolysis (generalized eruption with blisters and skin peeling, particularly around the mouth, nose, eyes, and genital areas, causing widespread 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.

- Muscular disorders: rhabdomyolysis (muscle breakdown that can cause kidney damage), myopathy (muscle disease of multiple causes).

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

- Laboratory tests: increased international normalized ratio (calculation to detect blood coagulation), prolonged prothrombin time (indicating a deficiency in blood coagulation), and abnormal urine color.

Specific adverse 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 the medication, reports have been received of effects on the central nervous system (e.g., somnolence and confusion) with the simultaneous use of clarithromycin and triazolam. Monitoring of the patient is suggested.

In some of the reports of rhabdomyolysis, clarithromycin was administered concomitantly with statins, fibrates, colchicine, or allopurinol (seeDo not take clarithromycinandWarnings and precautions).

Rarely, reports have been received 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 improvement switch to another clarithromycin formulation (e.g., suspension) or 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 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 effects possibly associated with clarithromycin administration from effects caused by the disease or other diseases that the patient may have 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, altered taste, abdominal pain, diarrhea, skin rash, flatulence, headache, constipation, hearing abnormalities, and elevated transaminases (which may 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 levels of urea nitrogen (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 adverse effect is considered unknown (cannot be estimated from available data).

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 30°C.

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 the 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 the packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Claritromicina Kern Pharma

-The active ingredient is clarithromycin. Each coated tablet contains 500 mg of clarithromycin.

-The other components (excipients) are: pregelatinized cornstarch, sodium croscarmellose, povidone K 25, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, hydroxypropylmethylcellulose, titanium dioxide (E-171), talc, and propylene glycol (E 1520).

Appearance of the product and contents of the packaging

Claritromicina Kern Pharma is presented in the form of coated tablets in packaging with 14 or 21 tablets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:February 2024

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