Leaflet: information for the user

Clarithromycin Normon 500 mg coated tablets

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

Claritromicina Normon is used for the treatment of infections caused by sensitive germs in adults and adolescents aged 12 to 18 years:

• Upper respiratory tract infections, such as pharyngitis (infection of the pharynx that causes 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 or repeated inflammation of the lungs) and bacterial pneumonias (inflammation of the lungs 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 inflammation of the skin) and erysipelas (a type of skin infection) (see section 2Warnings and precautions).
• Peptic ulcer and duodenal ulcer.
• And in 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 ingredients 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 dihydroergotamineor using ergotamine inhalersfor migrainewhile 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 that are known to cause severe heart rhythm disturbances.
• If you are being treated with midazolam oral (for anxiety or to help you fall asleep).
• If you have abnormally low levels of potassium or magnesium in your blood (hypokalemia or hypomagnesemia).
• If you or a family member has a history of heart rhythm disorders (ventricular arrhythmia, including Torsade de Pointes) or abnormal electrocardiogram (ECG) 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 monitoring of blood sugar 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 affect 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 failure, moderate or severe renal failure, and in elderly patients.

Taking Claritromicina Normon with other medications

Inform your doctor or pharmacist if you are taking or have recently taken, 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 cholesterol-lowering medications, 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. digoxin, verapamil, quinidine, or disopyramide).
• Thinning the blood (e.g. warfarin or other anticoagulants, e.g. dabigatran, rivaroxaban, apixaban, edoxaban).
• Migraine (e.g. ergotamine or dihydroergotamine).
• Epilepsy or bipolar disorder (carbamazepine, valproate, phenobarbital, or phenytoin).
• 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).
• Cyclosporine (immunosuppressant).
• Rifabutin (for the treatment of certain infections)
• Tacrolimus or sirolimus(for organ transplants and severe eczema).
• Sildenafil, tadalafil, or vardenafil (to treat erectile dysfunction in adult men or for pulmonary hypertension).
• Zidovudine (for viruses).
• St. John's Wort (herbal product for depression).
• Phenobarbital (medication for epilepsy).
• Nevirapine and efavirenz may decrease clarithromycin levels.
• Rifampicin or rifapentine (for tuberculosis).
• Omeprazole (fortreating stomach acid and ulcers or intestinal ulcers).
• Ritonavir (antiviral medication used in the treatment of HIV infection) may increase clarithromycin levels. The concomitant use ofatazanavir, etravirina, and saquinavir (also antiviral medications used in the treatment ofthe HIV infection) with clarithromycin may increase both atazanavir (or saquinavir) and clarithromycin levels.
• Itraconazole (an antifungal) taken with clarithromycin may increase both medications' levels.
• Fluconazole, another antifungal, may increase clarithromycin levels.
• Tolterodine (for 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 diseases such as rheumatoid arthritis, or to treat or prevent malaria). Taking these medications at the same time as clarithromycin may increase the risk of abnormal heart rhythms and other severe adverse effects 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, think you may be pregnant, or plan to become 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 risk, especially during the first three months of pregnancy.

Claritromycin 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 of 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 withrespiratory 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 duration of treatment is 5 to 14 days, excluding community-acquired pneumonia and sinusitis that require 6 to 14 days of therapy.

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

In patients with peptic ulcer associated withHelicobacter pylorithe 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 all twice a day, for 7 to 10 days.

Older patients:

As adults.

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 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 twice a day in more severe infections. In these patients, treatment should be discontinued after 14 days. Since the tablet cannot be dosed to half, the daily dose cannot be less than 500 mg/day, so Clarithromycin Normon 500 mg tablets should not be administered in this group of patients.

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 childrenand 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 the treatment withClarithromycin Normon

Do not discontinue 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 can cause side effects, although not everyone will experience them.

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

The most common and more common adverse reactions related to treatment with clarithromycin, both in adults and children, are abdominal pain, diarrhea, nausea, vomiting, and 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 were observed in the incidence of these gastrointestinal adverse reactions during clinical trials between patients with or without pre-existing mycobacterial infections.

Summary of side effects

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

• Very common (can 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 (can affect up to 1 in 10 patients) frequency:

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

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

• Infections: cellulitis (only with the intravenous 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 formulation), hypersensitivity (exaggerated allergic reaction to external agents).

Food disorders: anorexia, decreased appetite.

• Psychiatric disorders: anxiety and nervousness (the latter only with oral suspension granules).
• Nervous system: loss of consciousness and difficulty moving (both effects, only with intravenous formulation), dizziness, somnolence, tremors.
• Auditory and balance: vertigo, hearing problems, ringing in the ears.
• Cardiac disorders: cardiac arrest and altered heart rhythm (fibrillation of the auricle) (both effects, only with intravenous formulation), prolongation of the QT interval (electrocardiogram indicator of potential ventricular arrhythmias), extrasystoles (premature heartbeat, only with intravenous formulation), palpitations (alterations in heartbeats).
• Respiratory disorders: asthma (difficulty breathing, 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 that causes 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 that causes burning sensation, chronic cough, lack of air, and difficulty swallowing, only with prolonged-release tablets), gastritis (inflammation of the stomach lining), anal and rectal pain (only with prolonged-release tablets), oral mucosa inflammation, tongue inflammation, abdominal distension (only with immediate-release tablets), constipation, dry mouth, belching, flatulence.
• Liver disorders: decreased or suppressed bile flow to the intestine and liver inflammation (hepatitis) (both effects, only with immediate-release tablets), increased alanine aminotransferase (liver enzyme), increased aspartate aminotransferase (another liver enzyme), and increased gamma-glutamyltransferase (another liver enzyme, only with immediate-release tablets).
• Skin: dermatitis bullous (vesicular eruptions, only with intravenous formulation), itching, urticaria (edematous, red, and itchy skin lesions), maculopapular eruption (skin lesion with a papule or wart on a patch, only with oral suspension granules).
• Musculoskeletal disorders: muscle spasms (only with oral suspension granules), musculoskeletal rigidity (only with intravenous formulation), muscle pain (only with prolonged-release tablets).
• Renal disorders: increased serum creatinine and urea (both effects, indicating impaired renal 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 (frequency cannot be determined 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).
• 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, and somnambulism (attenuated perceptions of external stimuli).
• Nervous system: convulsions, decreased or lost sense of taste, altered sense of smell, lost or decreased sense of smell, paresthesia, numbness, or acorchamiento in hands, feet, arms, or legs.
• Auditory: deafness.
• Cardiac disorders: torsades de pointes (a type of ventricular tachycardia), ventricular tachycardia (acceleration of heartbeats with more than 100 beats per minute with at least 3 irregular consecutive beats).
• Vascular disorders: hemorrhage.
• Gastrointestinal disorders: acute pancreatitis (inflammation of the pancreas), tongue discoloration, tooth discoloration.
• Liver disorders: liver function failure, icterus hepatocelular (yellowing of the skin and eyes).
• Skin: Stevens-Johnson syndrome (generalized eruption with blisters and skin peeling, mainly affecting genital, oral, and trunk areas), generalized acute exanthematous pustulosis (generalized scaly eruption of red color with subcutaneous nodules and blisters, accompanied by fever, mainly located in 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 generalized skin peeling (more than 30% of the body surface) 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 any of these 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: renal function failure, interstitial nephritis (inflammation of the renal tubules).
• Laboratory tests: increased international normalized ratio (calculation to detect blood coagulation), prolonged prothrombin time (indicates a coagulation disorder), and abnormal urine color.

Specific side effects

Flebitis at the injection site, pain at the injection site, pain at the venipuncture site, and inflammation at the injection site are specific to the intravenous formulation of clarithromycin.

After marketing, reports have been received of central nervous system effects (e.g., somnolence and confusion) with the simultaneous use of clarithromycin and triazolam. It is suggested to monitor the patient.

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

Rarely, reports have been received of prolonged-release tablets of clarithromycin appearing in the stool, 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, the residues of tablets have appeared in the context of diarrhea. It is recommended that patients who present tablet residues in the stool and do not experience any improvement, switch to another formulation of clarithromycin (e.g., suspension) or another antibiotic.

Side effects in children and adolescents

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

Immunocompromised patients

In patients with AIDS and in other patients with damaged immune systems, treated with high doses of clarithromycin for long periods of time for mycobacterial infections, it is often difficult to distinguish side effects possibly associated with clarithromycin administration from those caused by the disease or other diseases that 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 adverse reactions that appeared were: nausea, vomiting, altered taste, abdominal pain, diarrhea, skin rash, flatulence, headache, constipation, hearing abnormalities, and elevated transaminases (which can indicate liver, pancreas, heart, or muscle damage). With lower frequency, difficulty breathing, insomnia, and dry mouth appeared. Incidences were similar in patients treated with 1,000 mg and 2,000 mg, but generally 3 to 4 times more frequent in those who received a daily total dose of 4,000 mg of clarithromycin.

In these immunocompromised patients, around 2% to 3% who received daily

1,000 mg or 2,000 mg of clarithromycin presented severely abnormal elevated transaminases, as well as abnormally low white blood cell and platelet counts. A smaller percentage of patients in both dosing groups had elevated blood urea nitrogen levels (which can 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 subcutaneous nodules and blisters (pustular exanthema). 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, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse 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 unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Claritromicina Normon

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

• The other components are:Core: sodium croscarmellose, microcrystalline cellulose (E 460), povidone, magnesium stearate, stearic acid, talc (E 553b), colloidal silica.Covering: 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 500 mg is presented in the form of coated tablets, yellow in color, elongated biconvex shape, in packaging with 14 or 21 coated tablets in a PVC/aluminum blister or a 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)

Last review date of this leaflet: June 2024

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