Clarithromycin Normon 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clarithromycin Normon 500 mg film-coated tablets EFG

Package leaflet:

1. What Claritromycin Normon is and what it is used for
2. What you need to know before taking Claritromycin Normon
3. How to take Claritromycin Normon
4. Possible side effects
5. How to store Claritromycin Normon
6. Contents of the pack and other information

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

Clarithromycin is an antibiotic that belongs to the macrolide group and works by killing bacteria.

Claritromicina Normon is used to treat infections caused by susceptible microorganisms in adults and adolescents aged 12 to 18 years:

• Infections of the upper respiratory tract, such as pharyngitis (infection of the pharynx causing sore throat), tonsillitis (infection of the tonsils), and sinusitis (infection of the paranasal sinuses located around the forehead, cheeks, and eyes).
• Infections of the lower respiratory tract, such as acute bronchitis (infection and inflammation of the bronchi), acute exacerbation of chronic bronchitis (worsening of long-term or recurrent lung inflammation), 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 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 starting to take Claritromycin Normon

Do not take Claritromycin Normon

• If you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or to any of the other ingredients of Claritromycin Normon (listed in section 6).
• If your creatinine clearance is less than 30 ml/min.
• 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 migraine while taking clarithromycin. Consult your doctor for advice on alternative medications.
• If you are taking medications known as terfenadine, astemizole (a medicine for hay fever or allergies), cisapride or domperidone (used for stomach problems), or pimozide (a medicine used to treat certain psychiatric conditions), as taking these with clarithromycin may cause serious disturbances in heart rhythm. Consult your doctor for advice on 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 myocardial infarction or stroke).
• If you are taking other medicines known to cause serious disturbances in heart rhythm.
• If you are undergoing treatment with oral midazolam (for anxiety or to help you sleep).
• If you have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia).
• If you or a family member has a history of heart rhythm disorders (ventricular arrhythmia, including Torsade de Pointes) or abnormalities on electrocardiogram (ECG, electrical recording of the heart) known as "QT prolongation syndrome".
• If you are taking medications called lovastatin or simvastatin (to lower cholesterol levels), as combining these with clarithromycin may increase the risk of adverse effects. Consult your doctor for advice on alternative medications.
• If you are taking colchicine (for gout).
• If you are taking a medicine containing lomitapide.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Claritromycin Normon

• 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 medicines known as colchicine, triazolam, midazolam (for anxiety or insomnia), lovastatin, or simvastatin.
• If you are diabetic and taking hypoglycaemics (medicines to lower blood sugar such as nateglinide, pioglitazone, rosiglitazone, repaglinide, sulfonylureas, or insulin), as clarithromycin may excessively lower blood glucose levels. Careful monitoring of glucose is recommended.
• If you are taking a medicine called warfarin (a blood thinner).
• If you have myasthenia gravis, a condition in which your muscles become weak and tire easily.
• If you develop severe or prolonged diarrhoea 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 give this medicine to children under 12 years of age.

Elderly patients

Since clarithromycin is eliminated through the liver and kidneys, caution should be exercised in patients with hepatic impairment, moderate or severe renal impairment, and in elderly patients.

Taking Claritromycin Normon with other medicines

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

Claritromycin Normon must not be taken with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, certain medicines used to treat high cholesterol, or medicines known to cause serious disturbances in heart rhythm (see Do not take Claritromycin Normon).

This is especially important if you are taking medicines for:

• Heart problems (e.g., digoxin, verapamil, quinidine, or disopyramide).
• Thinning the blood (e.g., warfarin or other anticoagulants 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., lovastatin or simvastatin).

Or if you are taking any medicine 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 (an immunosuppressant).
• Rifabutin (for treating certain infections).
• Tacrolimus or sirolimus (for organ transplants and severe eczema).
• Sildenafil, tadalafil, or vardenafil (to treat impotence in adult men or pulmonary arterial hypertension (high blood pressure in the blood vessels of the lungs)).
• Zidovudine (to treat viruses).
• St. John’s wort (a herbal product used to treat depression).
• Phenobarbital (a medicine to treat epilepsy).
• Nevirapine and efavirenz may decrease levels of clarithromycin.
• Rifampicin or rifapentine (to treat tuberculosis).
• Omeprazole (to treat stomach acidity and stomach or intestinal ulcers).
• Ritonavir (an antiviral medicine used in the treatment of HIV infection) may increase levels of clarithromycin. Concomitant use of atazanavir, etravirine, and saquinavir (also antiviral medicines used in the treatment of HIV infection) with clarithromycin may increase levels of both atazanavir (or saquinavir) and clarithromycin.
• Itraconazole (an antifungal) taken with clarithromycin may increase levels of both medicines.
• Fluconazole, another antifungal medicine, may increase levels of clarithromycin.
• Tolterodine (to treat symptoms of overactive bladder syndrome). In some patients, levels of tolterodine may increase when taken with clarithromycin.
• Quetiapine (for schizophrenia or other psychiatric conditions).
• Beta-lactam antibiotics (certain penicillins and cephalosporins).
• Aminoglycosides (used as antibiotics to treat infections).
• Calcium channel blockers (medicines to treat high blood pressure).
• Hydroxychloroquine or chloroquine (used to treat diseases such as rheumatoid arthritis, or to treat or prevent malaria). Taking these medicines together with clarithromycin may increase the risk of abnormal heart rhythms and other serious adverse effects affecting the heart.
• Corticosteroids administered orally, by injection, or by inhalation (used to suppress the immune system; this is useful in treating a wide range of diseases).

Taking Claritromycin Normon with food and drinks

Claritromycin Normon tablets may be taken before, during, or after meals, as the presence of food in the digestive tract does not alter the activity of the medicine.

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 medicine.

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

Clarithromycin passes into breast milk, so breastfeeding should be discontinued during treatment with clarithromycin.

Driving and using machines

Since clarithromycin may cause dizziness, vertigo, confusion, and disorientation, you should exercise extreme caution when driving or operating dangerous machinery during treatment with clarithromycin.

Claritromycin Normon contains sodium

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

3. How to take Claritromycin Normon

Claritromycin Normon is administered orally.

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and children over 12 years of age:

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

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

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

For patients with peptic ulcer associated with Helicobacter pylori, the recommended treatments are:

Triple therapy: one 500 mg clarithromycin tablet twice daily, together with 30 mg of lansoprazole twice daily and 1,000 mg of amoxicillin twice daily for 10 days.

Or one 500 mg clarithromycin tablet with 1,000 mg of amoxicillin and 20 mg of omeprazole, all administered twice daily, for 7 to 10 days.

Elderly patients:

Same as for adults.

Patients with mycobacterial infections:

The recommended average dose for prevention and treatment of mycobacterial infections is one 500 mg clarithromycin tablet every 12 hours. The duration of treatment should be determined by the physician.

Patients with renal impairment:

In patients with renal impairment and a creatinine clearance of less than 30 ml/min, the clarithromycin dose should be reduced by half, i.e., 250 mg once daily, or 250 mg twice daily in more severe infections. In these patients, treatment should be discontinued after 14 days. Since the tablet cannot be halved, the daily dose cannot be less than 500 mg/day; therefore, Clarithromycin Normon 500 mg tablets should not be administered to this patient group.

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

Remember to take your medicine. Take the tablets at the same time each day. Your doctor will advise you on the duration of your treatment.

Use in children and adolescents

Other commercial formulations containing the same active substance as oral suspension granules at 25 and 50 mg/ml are available and suitable for children from 6 months of age and adolescents under 12 years of age.

If you take more Claritromycin Normon than you should

If you have taken more clarithromycin than you should, gastrointestinal disturbances may be expected. Contact your doctor or pharmacist immediately, as they will need to eliminate the clarithromycin that has not yet been absorbed by your body. Hemodialysis and peritoneal dialysis are not effective. You may also call the Toxicology Information Service (Tel. 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Claritromycin Normon

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

Take the tablet as soon as possible, and continue taking it at the same time each day.

If you stop treatment with Claritromycin Normon

Do not discontinue treatment prematurely, as even if you feel better, your condition could worsen or recur. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Claritromycin Normon may cause adverse effects, although not everyone experiences them.

Adverse effects are classified as very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), and frequency not known (cannot be estimated from available data).

Common and very common adverse reactions associated with clarithromycin treatment, in both adults and children, include abdominal pain, diarrhoea, nausea, vomiting, and altered taste. These adverse reactions are usually mild in intensity and consistent 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 patient populations with or without pre-existing mycobacterial infections.

Summary of adverse effects

Adverse effects are listed in decreasing order of severity within each body system:

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

• Frequently observed (may affect up to 1 in 10 patients) with all medicines containing clarithromycin:

• Gastrointestinal system: diarrhoea, vomiting, gastric discomfort impairing digestion (dyspepsia), nausea, abdominal pain.

• Nervous system: altered taste sensation, headache, taste disturbance.

• 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.

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

• Uncommonly observed (may affect up to 1 in 100 patients):

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

• Blood 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, increased red and white blood cells in blood (only with granules for oral suspension), increased eosinophils (a type of white blood cell, only with immediate-release tablets).

• Immune system disorders: anaphylactoid reaction (generalized allergic reaction, only with the intravenous formulation), hypersensitivity (exaggerated allergic reaction to external agents).

• Nutritional disorders: anorexia, decreased appetite.

• Psychiatric disorders: anxiety and nervousness (the latter only with granules for oral suspension).
• Nervous system: loss of consciousness and difficulty moving (both effects, only with the intravenous formulation), dizziness, somnolence, tremors.
• Ear and balance: vertigo, hearing problems, tinnitus.
• Cardiac disorders: cardiac arrest and cardiac rhythm disturbance (atrial fibrillation) (both effects, only with the intravenous formulation), QT interval prolongation (an ECG indicator of potential ventricular arrhythmias), extrasystoles (premature heartbeat relative to normal heart rate, only with the intravenous formulation), palpitations (irregular heartbeat).
• Respiratory disorders: asthma (difficulty breathing, chest tightness, and nocturnal or early morning cough, only with the intravenous formulation), epistaxis (nosebleeds, only with extended-release tablets), pulmonary embolism (blockage of the pulmonary artery causing one-sided chest pain, cough, and breathing difficulty, only with the intravenous formulation).
• Gastrointestinal disorders: oesophagitis (only with the intravenous formulation), gastroesophageal reflux disease (damage to the oesophagus causing burning sensation, chronic cough, shortness of breath, and difficulty swallowing, only with extended-release tablets), gastric mucosal inflammation (gastritis), anal and rectal pain (only with extended-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 (liver enzyme), aspartate aminotransferase (another liver enzyme), and gamma-glutamyltransferase (another liver enzyme, only with immediate-release tablets).
• Skin: bullous dermatitis (blistering rash, only with the intravenous formulation), pruritus, urticaria (edematous, red, itchy skin lesions), maculopapular eruption (skin lesion with a papule or wart-like bump on a patch, only with granules for oral suspension).
• Musculoskeletal disorders: muscle spasms (only with granules for oral suspension), musculoskeletal rigidity (only with the intravenous formulation), muscle pain (only with extended-release tablets).
• Renal disorders: increased serum creatinine and serum urea (both effects, indicating impaired kidney function, only with the intravenous formulation).
• General disorders: malaise (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 formulation), increased serum alkaline phosphatase and increased blood lactate dehydrogenase (the last two only with immediate-release tablets).

• Frequency not known (frequency cannot be estimated from available data):

• Infections: pseudomembranous colitis (diarrhoea that may become severe), erysipelas (skin redness of variable extent that may cause pain, itching, and fever).

• Blood disorders: decreased number of neutrophils (a type of white blood cell), decreased platelets.

• Immune system disorders: anaphylactic reaction (generalized allergic reaction), angioedema (swelling beneath the skin).

• Psychiatric disorders: psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, hypnagogic hallucinations (attenuated perception of external stimuli).

• Nervous system: seizures, decreased or loss of taste sensation, altered sense of smell, loss or decreased sense of smell, tingling, numbness, or pins and needles sensation in hands, feet, arms, or legs.

• Ear: deafness.

• Cardiac disorders: torsades de pointes (a type of ventricular tachycardia), ventricular tachycardia (accelerated heartbeat with more than 100 beats/minute with at least 3 consecutive irregular beats).

• Vascular disorders: haemorrhage.

• Gastrointestinal disorders: acute pancreatitis (acute inflammation of the pancreas), tongue discoloration, tooth discoloration.

• Liver disorders: liver function failure, hepatocellular jaundice (yellowing of the skin and eyes).

• Skin: Stevens-Johnson syndrome (widespread rash with blisters and skin peeling, mainly affecting genital, oral, and trunk areas), acute generalized exanthematous pustulosis (widespread scaly red rash with bumps under the skin and blisters, accompanied by fever; mainly localized in skin folds, trunk, and upper limbs), and toxic epidermal necrolysis (widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals, causing widespread skin shedding (more than 30% of body surface area), flu-like symptoms with skin rash, fever, lymph node swelling, and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) [drug reaction with eosinophilia and systemic symptoms (DRESS)], acne. If any of these reactions occur, discontinue treatment with clarithromycin immediately and consult your doctor for appropriate management.

• Musculoskeletal disorders: rhabdomyolysis (muscle breakdown that may cause kidney damage), myopathy (muscle disease of multiple causes).

• Renal disorders: kidney function failure, interstitial nephritis (inflammation of renal tubules).

• Laboratory tests: increased international normalized ratio (calculation to detect blood coagulation), prolonged prothrombin time (indicates impaired blood coagulation), and abnormal urine colour.

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 marketing of the medicine, reports of central nervous system effects (e.g. somnolence and confusion) have been received with concomitant use of clarithromycin and triazolam. Patient monitoring is recommended.

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

Rarely, there have been reports of prolonged-release clarithromycin tablets appearing in faeces. Many of these cases occurred in patients with gastrointestinal anatomical disorders [including ileostomy or colostomy (surgery to divert intestinal waste artificially from the ileum or colon)] or functional disorders (disorders caused by a bodily defect) with shortened gastrointestinal transit time. In several reports, tablet residues appeared in the context of diarrhoea. Patients who notice tablet residues in their faeces and who do not experience improvement are advised to switch to another formulation of clarithromycin (e.g. suspension) or to 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 immunocompromised patients treated with high doses of clarithromycin over long periods for mycobacterial infections, it is often difficult to distinguish adverse effects possibly associated with clarithromycin administration from those caused by the disease or other comorbid conditions associated with AIDS.

In adult patients treated with total daily doses of 1,000 mg and 2,000 mg of clarithromycin, the most frequently reported adverse reactions were: nausea, vomiting, taste disturbance, abdominal pain, diarrhoea, skin rash, flatulence, headache, constipation, hearing disturbances, and elevated transaminases (which may indicate liver, pancreas, heart, or muscle involvement). Less frequently reported were respiratory difficulty, insomnia, and dry mouth. Incidences were similar in patients treated with 1,000 mg and 2,000 mg, but were generally 3 to 4 times more frequent in those receiving a total daily dose of 4,000 mg of clarithromycin.

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

Contact a doctor as soon as possible if you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this adverse effect is considered not known (cannot be estimated from available data).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clarithromycin Normon

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

No special storage conditions are required.

Do not use Clarithromycin Normon after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clarithromycin Normon

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

• The other components are: Core: croscarmellose sodium, 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 contents of the pack

Clarithromycin Normon 500 mg is presented as yellow, elongated biconvex coated tablets, in packs containing 14 or 21 coated tablets in PVC/aluminum blisters or clinical packaging containing 500 coated tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the most recent revision of this leaflet: June 2024

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging.

You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/64825/P_64825.html.