CLARITHROMYCIN FARMALIDER 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Claritromicina Farmalider 250 mg Film-Coated Tablets EFG

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

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

Contents of the Package Leaflet

1. What is Claritromicina Farmalider and what is it used for
2. What you need to know before taking Claritromicina Farmalider
3. How to take Claritromicina Farmalider
4. Possible side effects
5. Storage of Claritromicina Farmalider
6. Package contents and additional information

1. What is Claritromicina Farmalider and what is it used for

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

"Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or common cold.

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash."

Claritromicina Farmalider 250 mg film-coated tablets are used to treat infections caused by sensitive germs in adults and adolescents from 12 to 18 years old:

-Infections of the upper respiratory tract, such as pharyngitis (infection of the pharynx that causes sore throat), tonsillitis (infection of the tonsils), and sinusitis (infection of the paranasal sinuses that are around the forehead, cheeks, and eyes).

-Infections of the lower respiratory tract, such as acute bronchitis (infection and inflammation of the bronchi), exacerbation of chronic bronchitis (worsening of prolonged or recurrent lung inflammation), and bacterial pneumonia (inflammation of the lungs caused by bacteria) (see section 2 warnings and precautions).

-Infections of the skin and soft tissues, 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).

-Gastric and duodenal ulcers.

-And in the prevention and treatment of infections caused by mycobacteria.

2. What you need to know before taking Claritromicina Farmalider

Do not take Claritromicina Farmalider:

• If you are allergic to claritromicina, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other components of this medication (listed in section 6).
• 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 migraines while taking claritromicina. Consult your doctor for alternative medications.
• If you are taking medications called terfenadine, astemizole (medication for hay fever or allergies), cisapride, or domperidone (used for stomach problems) or pimozide (medication used to treat certain psychiatric disorders), as taking these medications with claritromicina can 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 pectoris).
• If you are taking other medications known to cause severe heart rhythm disturbances.
• If you are undergoing treatment with midazolam oral (for anxiety or to help fall asleep).
• If you have abnormally low potassium levels in your blood (hypokalemia).
• If you or a family member has a history of heart rhythm disorders (ventricular arrhythmia, including Torsade de Pointes) or electrocardiogram (ECG) abnormalities called "QT prolongation syndrome".
• If you are taking medications called lovastatin or simvastatin (to lower cholesterol levels), 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.
• If you have abnormally low potassium or magnesium levels in your blood (hypokalemia or hypomagnesemia).

Warnings and Precautions

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

• 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, or simvastatin.
• If you are diabetic and taking hypoglycemic agents (medications to lower blood sugar levels, such as nateglinide, pioglitazone, rosiglitazone, repaglinide, or sulfonylureas) or are being administered insulin, as it may lower blood sugar levels too much. Careful monitoring of blood sugar levels is recommended.
• If you are taking a medication called warfarin (blood thinner).
• If you have myasthenia gravis, a condition that causes muscle weakness and fatigue.
• If you develop severe or prolonged diarrhea during or after taking claritromicina, consult your doctor immediately.

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

Children and Adolescents

Do not administer this medication to children under 12 years old; other formulations are available for this age group (oral suspension granules).

Elderly Patients

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

Taking Claritromicina Farmalider with Other Medications:

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

Do not take claritromicina with ergot alkaloids, astemizole, 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 Farmalider").

This is especially important if you are taking medications for:

• Heart problems (such as digoxin, verapamil, quinidine, or disopyramide).
• Blood thinning (warfarin or other anticoagulants, such as dabigatran, rivaroxaban, apixaban, or edoxaban).
• Migraines (such as ergotamine or dihydroergotamine).
• Epilepsy or bipolar disorder (carbamazepine, valproate, phenobarbital, or phenytoin).
• High cholesterol (such as 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).
• Cyclosporine (immunosuppressant).
• Rifabutin (for the treatment of certain infections).
• Tacrolimus or sirolimus (for organ transplants and severe eczema).
• Sildenafil, tadalafil, or vardenafil (for treating impotence in adult men or for pulmonary arterial hypertension).
• Zidovudine (for treating viruses).
• St. John's Wort (a herbal product for treating depression).
• Phenobarbital (a medication for treating epilepsy).
• Nevirapine and efavirenz (antiviral medications used to treat HIV infection and AIDS) may decrease claritromicina levels.
• Rifampicin or rifapentine (for treating tuberculosis).
• Omeprazole (for treating stomach acid and stomach or intestinal ulcers).
• Ritonavir (an antiviral medication used to treat HIV infection) may increase claritromicina levels. The combination of atazanavir, etravirine, and saquinavir (also antiviral medications used to treat HIV infection) with claritromicina may increase both atazanavir (or saquinavir) and claritromicina levels.
• Itraconazole (an antifungal medication) taken with claritromicina may increase both medication levels.
• Fluconazole, another antifungal medication, may increase claritromicina levels.
• Tolterodine (for treating overactive bladder symptoms). In some patients, tolterodine levels may increase when taken with claritromicina.
• Quetiapine (for schizophrenia or other psychiatric conditions).
• Beta-lactam antibiotics (certain penicillins and cephalosporins).
• Aminoglycosides (used as antibiotics to treat infections).
• Calcium channel blockers (medications for treating high blood pressure).
• Hydroxychloroquine or chloroquine (used to treat diseases such as rheumatoid arthritis or to treat or prevent malaria). Taking these medications at the same time as claritromicina may increase the risk of abnormal heart rhythms and other severe side effects that affect the heart.
• Corticosteroids, administered orally, by injection, or inhaled (used to suppress the immune system; this is useful in treating a wide range of diseases)

Pregnancy, Breastfeeding, and Fertility

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.

The safety of claritromicina during pregnancy has not been established, so your doctor will carefully weigh the benefits against the potential risk, especially during the first three months of pregnancy.

Claritromicina passes into breast milk, so breastfeeding should be interrupted during treatment with claritromicina.

Driving and Using Machines

Since claritromicina can cause dizziness, vertigo, confusion, and disorientation, you should exercise caution when driving or using hazardous machinery during treatment with claritromicina.

Claritromicina Farmalider Contains Sodium

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

3. How to Take Claritromicina Farmalider

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Claritromicina Farmalider is available in film-coated tablets for oral administration. Take the tablets at the same time every day.

The recommended doses are:

Adults and Children Over 12 Years Old:

Patients with Respiratory Tract, Skin, and Soft Tissue Infections

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

Helicobacter pylori Eradication in Patients with Duodenal Ulcers (Adults):

In patients with peptic ulcers associated with Helicobacter pylori, the recommended treatments are: Triple therapy: two Claritromicina Farmalider 250 mg tablets twice a day, with 30 mg of lansoprazole twice a day and 1000 mg of amoxicillin twice a day for 10 days, or two Claritromicina Farmalider 250 mg tablets with 1000 mg of amoxicillin and 20 mg of omeprazole, all administered twice a day, for 7 to 10 days.

Elderly Patients

As for adults.

Patients with Mycobacterial Infections:

The recommended average dose for the prevention and treatment of mycobacterial infections is two Claritromicina Farmalider 250 mg tablets every 12 hours. The treatment duration should be determined by the doctor.

Patients with Renal Insufficiency:

In patients with renal insufficiency and a creatinine clearance of less than 30 ml/min, the claritromicina 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. 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 think the effect of Claritromicina Farmalider is too strong or too weak, inform your doctor or pharmacist.

Use in Children and Adolescents

There are suitable formulations with claritromicina for children from 6 months and adolescents under 12 years old (oral suspension granules).

If You Take More Claritromicina Farmalider Than You Should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the package leaflet and packaging to the healthcare professional. The most common symptoms accompanying an overdose are gastrointestinal disorders. Neither hemodialysis nor peritoneal dialysis is effective.

If You Forget to Take Claritromicina Farmalider

Do not take a double dose to make up for forgotten doses.

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

If You Interrupt Treatment with Claritromicina Farmalider

Do not stop treatment prematurely, as your illness may worsen or recur.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

Frequency not known: 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:

? It has been very frequently observed (with the intravenous injection formulation): phlebitis (inflammation of the vein) at the injection site.

(inflammation of the vein) at the injection site.

? With all medicines containing clarithromycin, the following have been frequently observed:

• Gastrointestinal 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 sweating.
• 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).

? Less frequently, the following have been observed:

• 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 oral suspension granules), 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 blood (only with oral suspension granules), 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 oral suspension granules).
• Nervous system: loss of consciousness and difficulty moving (both effects, only with the intravenous injection formulation), dizziness, somnolence, 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 may produce ventricular arrhythmias), extrasystoles (premature heartbeat, only with the intravenous injection formulation), palpitations (alterations in heartbeats).
• Respiratory disorders: asthma (difficulty breathing, chest oppression, and nocturnal or early morning cough, only with the intravenous injection formulation), nasal bleeding (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 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 (blistering 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 patch, only with oral suspension granules).
• Muscle disorders: muscle spasms (only with oral suspension granules), musculoskeletal stiffness (only with the intravenous injection formulation), muscle pain (only with prolonged-release tablets).
• Kidney disorders: increase in serum creatinine and 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).

? With unknown frequency, 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 sense of taste, alteration of sense of smell, loss or decrease of sense 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 (inflammation of the pancreas), tongue discoloration, tooth discoloration.
• 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 generalized skin peeling (more than 30% of the body surface), flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) [drug reaction with eosinophilia and systemic symptoms (DRESS)] and acne. If this type of reaction occurs, treatment with clarithromycin should be immediately discontinued and a doctor should be consulted to establish 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., somnolence and confusion) have been received with the simultaneous use of clarithromycin and triazolam. It is suggested to monitor the patient.

In some reports of rhabdomyolysis, clarithromycin was administered concomitantly with statins, fibrates, colchicine, or allopurinol (see Do not take Clarithromycin Farmalider and see 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 artificially expel intestinal waste 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 those caused by the disease or by 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 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 damage). Less frequently, difficulty breathing, insomnia, and dry mouth appeared. The incidences were similar in patients treated with 1,000 mg and 2,000 mg, but in general, they were 3 to 4 times more frequent in those who received a daily total dose of 4,000 mg of clarithromycin.

In these patients with a damaged immune system, 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 levels of urea (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 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 (pustular exanthematous). 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, www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Clarithromycin Farmalider

Keep this medicine out of sight and reach of children.

It does not require special storage conditions.

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 at the SIGRE point in the pharmacy. 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 Farmalider

The active ingredient is clarithromycin (D.O.E.). Each tablet contains 250 mg of clarithromycin.

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

Appearance of the Product and Package Contents

Clarithromycin Farmalider 250 mg is presented in the form of coated tablets in packages with 14 or 500 (clinical package) tablets.

It is possible that only some package sizes are marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

FARMALIDER, S.A.

C/ Aragoneses, 15

28108 Alcobendas

Spain

Manufacturer

KERN PHARMA, S.L.

Polígono Ind. Colón II

C/ Venus, 72

08228 Terrassa (Barcelona)

Date of the Last Revision of this Prospectus:March 2024

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/