Package Leaflet: Information for the User

Claritromicina Normon 250 mg Coated Tablets

Claritromicina is an antibiotic that belongs to the group of macrolides and acts by eliminating bacteria.and acts by eliminating bacteria.

Claritromicina Normon is

used for the treatment of 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 (tonsil infection) 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 or repeated inflammation of the lungs) and bacterial pneumonias (lung inflammation caused by bacteria) (see section 2 Warnings and precautions).
• Skin and soft tissue infections, such as folliculitis (infection of one or more hair follicles), cellulitis (acute skin inflammation) and erysipelas (a type of skin infection) (see section 2 Warnings and precautions).
• Gastric and duodenal ulcers.
• And for the prevention and treatment of infections caused by mycobacteria.

Do not take Claritromicina Normon

• If you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or to any of the other components of Claritromicina Normon (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), 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 known to cause severe heart rhythm disturbances.
• If you are being treated with midazolam oral (for anxiety or to help 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 abnormal 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 colchicine (for gout).
• If you are taking a medication with lomitapida.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Claritromicina Normon

• If you have heart, kidney, or liver problems.
• If you have or are prone to fungal infections (e.g. mouth ulcers).
• If you are pregnant or breastfeeding.
• If you are taking medications known as colchicine, triazolam, midazolam (for anxiety or insomnia), lovastatina, simvastatina.
• If you are diabetic and taking hypoglycemic medications (medications to lower blood sugar such as nateglinida, pioglitazona, rosiglitazona, and repaglinida, sulfonilureas, or insulin) and clarithromycin may lower blood sugar too much. Careful glucose control is recommended.
• If you are taking a medication called warfarin (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 any of these situations apply to you, consult your doctor before taking clarithromycin.

Children and adolescents

Do not administer this medication to children under 12 years old.

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 elderly patients.

Taking Claritromicina Normon with other medications

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

Do not take Claritromicina Normon with ergot alkaloids, astemizol, terfenadine, cisaprida, domperidona, pimozida, ticagrelor, ranolazina, colchicine, certain medications for high cholesterol, and medications known to cause severe heart rhythm disturbances (see Do not take Claritromicina Normon).

This is especially important if you are taking medications for:

• Heart problems (e.g. digoxina, verapamilo, quinidina, or disopiramida).
• Thinning the blood (e.g. warfarin or other anticoagulants, e.g. dabigatrán, rivaroxabán, apixabán, edoxabán).
• Migraine (e.g. ergotamine or dihydroergotamine).
• Epilepsy or bipolar disorder (carbamazepina, valproato, fenobarbital, or phenitoína).
• High cholesterol (e.g. lovastatina or simvastatina).

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).
• Ciclosporina (immunosuppressant).
• Rifabutina (for the treatment of some infections)
• Tacrolimus or sirolimus (for organ transplants and severe eczema).
• Sildenafil, tadalafilo, or vardenafilo (to treat erectile dysfunction in adult men or for pulmonary hypertension).
• Zidovudina (to treat viruses).
• St. John's Wort (herbal product for depression).
• Fenobarbital (medication for epilepsy).
• Nevirapina and efavirenz may decrease clarithromycin levels.
• Rifampicina or rifapentina (for tuberculosis).
• Omeprazol (for stomach acid and ulcers).

• Ritonavir (antiviral medication used in HIV treatment) may increase clarithromycin levels. The combination of atazanavir, etravirina, and saquinavir (also antiviral medications used in HIV treatment) with clarithromycin may increase both atazanavir (or saquinavir) and clarithromycin levels.
• Itraconazol (antifungal medication) taken with clarithromycin may increase both medication levels.
• Fluconazol, another antifungal medication, may increase clarithromycin levels.
• Tolterodina (for overactive bladder syndrome). In some patients, tolterodina levels may increase when taken with clarithromycin.
• Quetiapina (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 the treatment of a wide variety of diseases).

Taking Claritromicina Normon with food and drinks

Claritromicina Normon tablets can be taken before, during, or after meals, as the presence of food in the digestive tract does not alter the activity of the medication.

Pregnancy, breastfeeding, and fertility

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

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.

Clarithromycin passes into 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, during treatment with clarithromycin, you should exercise extreme caution when driving or operating hazardous machinery.

Claritromicina Normon contains sodium

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

Clarithromycin Normon is administered orally.

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults and children over 12 years old:

Patients with respiratory tract, skin, and soft tissue infections:

The usual dose is 250 mg 2 times a day for 7 days, although in more severe infections, the dose may be increased to 500 mg 2 times 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.

Eradiation of Helicobacter pylori in patients with duodenal ulcers (adults):

In patients with peptic ulcers associated withHelicobacter pylorithe recommended treatments are:

Triple therapy: two tablets of clarithromycin 250 mg tablets 2 times a day, with 30 mg of lansoprazole 2 times a day and 1,000 mg of amoxicillin 2 times a day for 10 days.

Or two tablets of clarithromycin 250 mg with 1,000 mg of amoxicillin and 20 mg of omeprazole, administered all 2 times a day, for 7 to 10 days.

Patients of advanced age:

As adults.

Patients with infections caused by mycobacteria:

The recommended average dose for the prevention and treatment of infections caused by mycobacteria is two tablets of clarithromycin 250 mg, every 12 hours. The duration of treatment should be established by the doctor.

Patients with renal insufficiency:

In patients with renal insufficiency and a creatinine clearance of less than 30 ml/min, the dose of clarithromycin should be reduced to half, i.e., 250 mg once a day, or 250 mg 2 times 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 other indications.

Remember to take your medication. Take the tablets at the same time every day. Your doctor will indicate the duration of your treatment.

Use in children and adolescents

There are other commercial presentations with the same active ingredient in granulated form for oral suspension of 25 and 50 mg/ml suitable for children from 6 months, and adolescents under 12 years old.

If you take more Clarithromycin Normon than you should

If you have taken more clarithromycin than you should, you can expect the appearance of digestive disorders and consult your doctor or pharmacist immediately, as they should try to quickly eliminate the clarithromycin that your body has not yet absorbed. Hemodialysis or peritoneal dialysis is not effective. You can also call the Toxicological Information Service (Tel. 91 562 04 20), indicating the medication and the amount ingested.

If you forgot to take Clarithromycin Normon

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 withClarithromycin Normon

Do not stop treatment prematurely, as, although you may already be feeling better, your disease could worsen or recur. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Claritromicina Normon 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), and unknown frequency (cannot be estimated from available data).

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

There were no significant differences in the incidence of these gastrointestinal side effects 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 formulation): phlebitis (inflammation of the vein) at the injection site.

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

-Gastrointestinal system: diarrhea, vomiting, dyspepsia (digestive disorder), nausea, abdominal pain.

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

-Skin: mild skin eruptions, excessive sweating.

-Psychiatric disorders: insomnia.

-Vascular disorders: vasodilation.

-Hepatic disorders: abnormal liver function tests.

-Administration site reactions: pain and inflammation at the injection site (only with the intravenous formulation).

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

-Infections: cellulitis (only with the intravenous formulation), candidiasis (fungal infection), gastroenteritis (only with prolonged-release tablets), infection (only with oral suspension granules), vaginal infection.

-Haematological 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 formulation), hypersensitivity (exaggerated allergic reaction to external agents).

-Metabolic and nutritional disorders: anorexia, decreased appetite.

-Psychiatric disorders: anxiety and nervousness (the latter only with oral suspension granules).

-Nervous system disorders: loss of consciousness and difficulty moving (both effects, only with intravenous formulation), dizziness, somnolence, tremors.

-Auditory and vestibular disorders: vertigo, hearing problems, tinnitus.

-Cardiac disorders: cardiac arrest and alteration of heart rhythm (fibrillation) (both effects, only with intravenous formulation), prolongation of the QT interval (electrocardiogram indicator of possible ventricular arrhythmias), extrasystoles (premature heartbeat, only with intravenous formulation), palpitations (abnormal heartbeats).

-Respiratory disorders: asthma (breathing difficulty, chest tightness, and nocturnal or morning cough, only with intravenous formulation), nasal hemorrhages (only with prolonged-release tablets), pulmonary embolism (blockage of the pulmonary artery causing chest pain on one side, cough, and difficulty breathing, only with intravenous formulation).

-Gastrointestinal disorders: esophagitis (inflammation of the esophagus, only with intravenous formulation), gastroesophageal reflux disease (damage to the esophagus causing 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.

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

-Skin disorders: pemphigus (blistering skin eruptions, only with intravenous formulation), pruritus, urticaria (hives), 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 stiffness (only with intravenous formulation), muscle pain (only with prolonged-release tablets).

-Renal disorders: increased serum creatinine and urea (both effects, indicating impaired kidney function, only with intravenous 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 formulation), increased serum alkaline phosphatase, and increased lactate dehydrogenase in the blood (both effects, only with immediate-release tablets).

• Unknown frequency (cannot be estimated from available data) have been observed the following:

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

-Haematological disorders: decreased neutrophils (a type of white blood cell), decreased platelets.

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

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

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

-Auditory disorders: hearing loss.

-Cardiac disorders: torsades de pointes (a type of ventricular tachycardia), ventricular tachycardia (accelerated heart rate 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.

-Hepatic disorders: liver failure, icteric hepatitis (yellowing of the skin and eyes).

-Skin disorders: Stevens-Johnson syndrome (generalized blistering skin eruptions with peeling, primarily affecting genital, oral, and trunk areas), generalized acute exanthematous pustulosis (generalized scaly skin eruption with blisters and fever, primarily affecting skin folds, trunk, and upper limbs), toxic epidermal necrolysis (generalized blistering skin eruptions with peeling, primarily affecting mouth, nose, eyes, and genital areas, causing widespread skin peeling (more than 30% of body surface area), systemic symptoms such as fever, glandular inflammation, and abnormal laboratory tests (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 failure, interstitial nephritis (inflammation of the renal tubules).

-Laboratory tests: increased international normalized ratio (calculation to detect blood coagulation), prolonged prothrombin time (indicating a coagulation disorder), 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. Monitoring of the patient is suggested.

In some reports of rhabdomyolysis, clarithromycin was administered concomitantly with statins, fibrates, colchicine, or allopurinol (see Do not take Claritromicina Normon and Warnings and precautions).

Rarely, reports have been received of prolonged-release tablets appearing in the feces, many of these cases have occurred in patients with anatomical or functional gastrointestinal disorders (including ileostomy or colostomy) 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 feces and do not experience any improvement switch to another clarithromycin formulation (e.g. suspension) or to another antibiotic.

Side effects in children and adolescents

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

Immunocompromised patients

In patients with AIDS and in other patients with impaired 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 those caused by the disease or other diseases the patient may have in addition to AIDS.

In adult patients treated with daily total doses of 1,000 mg and 2,000 mg of clarithromycin, the most common side effects that appeared were: nausea, vomiting, taste alteration, abdominal pain, diarrhea, skin rash, flatulence, headache, constipation, hearing problems, and elevated transaminases (indicating 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 (indicating 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 peeling (pustular exanthema). The frequency of this side effect is considered unknown (cannot be estimated from available data).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 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 Claritromicina Normon after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Claritromicina Normon

• The active ingredient is clarithromycin. Each coated tablet contains 250 mg of clarithromycin.
• The other components are:Core: sodium croscarmellose, microcrystalline cellulose (E 460), povidone, magnesium stearate, stearic acid, talc (E 553b), colloidal silica.Coating: talc, hydroxypropyl methylcellulose (hypromellose), titanium dioxide (E 171), macrogol 6000, and quinoline yellow (E 104).

Appearance of the product and content of the packaging

Claritromicina Normon 250 mg is presented in the form of coated tablets of yellow color, round, biconvex shape, in packaging with 14 coated tablets in PVC/aluminum blister or clinical packaging of 500 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet:June2024

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