Klacid 500 mg film-coated tablets

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

KLACID 500 mg film-coated tablets

Clarithromycin

Please read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Klacid 500 mg film-coated tablets are and what they are used for
2. What you need to know before taking Klacid 500 mg film-coated tablets
3. How to take Klacid 500 mg film-coated tablets
4. Possible adverse effects
5. How to store Klacid 500 mg film-coated tablets
6. Contents of the pack and other information

1. What Klacid 500 mg film-coated tablets are and what they are used for

Clarithromycin is an antibiotic belonging to the macrolide group and works by eliminating bacteria.

Klacid 500 mg tablets are used for the treatment of infections caused by sensitive organisms 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 pneumonia (lung inflammation caused by bacteria). (see section 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 Warnings and precautions)

• Gastric and duodenal ulcer

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

2. What you need to know before taking Klacid 500 mg film-coated tablets

Do not take Klacid 500 mg film-coated tablets

• If you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or to any of the other ingredients of this medicine (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 medicines 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, used in heart attacks and other heart conditions), ivabradine, or ranolazine (for angina).
• If you are taking other medicines known to cause serious disturbances in heart rhythm.
• If you are being treated 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 medicines 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 taking Klacid:

• 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 have diabetes and are taking hypoglycaemic agents (medicines to lower blood sugar such as nateglinide, pioglitazone, rosiglitazone, repaglinide, sulphonylureas, or insulin), as clarithromycin may lower blood glucose too much. Careful monitoring of blood 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 via the liver and kidneys, caution should be exercised in patients with hepatic impairment, moderate or severe renal impairment, and in elderly patients.

Taking Klacid 500 mg film-coated tablets 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.

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

This is especially important if you are taking medicines for:

• Heart problems (e.g. digoxin, verapamil, quinidine, or disopyramide).
• Blood thinning (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. simvastatin or lovastatin).

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 erectile dysfunction 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 for treating epilepsy).

• Nevirapine and efavirenz may decrease clarithromycin levels.

• Rifampicin or rifapentine (for treating tuberculosis).

• Omeprazole (to treat stomach acidity and stomach or intestinal ulcers).

• Ritonavir (an antiviral medicine used in the treatment of HIV infection) may increase clarithromycin levels. Concomitant use of atazanavir, etravirine, and saquinavir (also antiviral medicines used in HIV treatment) with clarithromycin may increase levels of both atazanavir (or saquinavir) and clarithromycin.

• Itraconazole (an antifungal) taken together with clarithromycin may increase levels of both medicines.

• Fluconazole, another antifungal medicine, may increase clarithromycin levels.

• Tolterodine (to treat symptoms of 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 to treat infections).

• Calcium channel blockers (medicines for treating high blood pressure).

• Hydroxychloroquine or chloroquine (used to treat conditions 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).

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 is not recommended 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.

Klacid 500 mg film-coated tablets contain sodium. This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Klacid 500 mg film-coated tablets

Klacid 500 mg tablets are administered orally.

Follow exactly the instructions for use of Klacid 500 mg tablets 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, except for community-acquired pneumonia and sinusitis, which require 6 to 14 days of therapy.

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

In patients with peptic ulcer associated with Helicobacter pylori, the recommended regimens are:

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

Or one tablet of Klacid 500 mg 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 tablet of Klacid 500 mg 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 less than 30 ml/min, the dose of clarithromycin 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 divided, the daily dose cannot be less than 500 mg/day; therefore, Klacid once-daily 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

The appropriate formulations for children from 6 months of age and adolescents under 12 years of age are: Klacid 25 mg/ml granules for oral suspension and Klacid 50 mg/ml granules for oral suspension.

If you think that the effect of Klacid 500 mg tablets is too strong or too weak, consult your doctor or pharmacist.

If you take more Klacid 500 mg film-coated tablets than you should

If you have taken more Klacid 500 mg tablets than prescribed, gastrointestinal disturbances may occur. Contact your doctor or pharmacist immediately, as steps should be taken to rapidly eliminate any clarithromycin not yet absorbed by your body. Hemodialysis and peritoneal dialysis are ineffective.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Klacid 500 mg film-coated tablets

Do not take a double dose to make up for the missed dose. Take the tablet as soon as possible and continue taking it at the same time each day.

If you stop taking Klacid 500 mg film-coated tablets

Do not discontinue treatment prematurely, as even if you feel better, your illness may 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, this medicine can 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).

Frequent and very frequent adverse reactions associated with clarithromycin treatment in both adults and children are 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 order of decreasing severity within each body system:

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

? The following have been 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).
• Hepatic disorders: abnormal liver function tests.
• Administration site reactions: pain and inflammation at the injection site (only with the intravenous injection formulation).

? Uncommonly observed (may affect up to 1 in 100 patients) are the following:

• Infections: cellulitis (only with the intravenous injection formulation), candidiasis (fungal infection), gastroenteritis (only with prolonged-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 injection 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 injection formulation), dizziness, somnolence, tremor.
• Ear and balance disorders: vertigo, hearing problems, tinnitus.
• Cardiac disorders: cardiac arrest and arrhythmia (atrial fibrillation) (both effects, only with the intravenous injection formulation), QT interval prolongation (an ECG indicator of potential ventricular arrhythmias), extrasystoles (premature heartbeat compared to normal heart rate, only with the intravenous injection formulation), palpitations (irregular heartbeats).
• Respiratory disorders: asthma (difficulty breathing, chest tightness, and nocturnal or early morning cough, only with the intravenous injection formulation), epistaxis (only with prolonged-release tablets), pulmonary embolism (blockage of the pulmonary artery causing one-sided chest pain, cough, and breathing difficulty, only with the intravenous injection formulation).
• Gastrointestinal disorders: oesophagitis (only with the intravenous injection formulation), gastro-oesophageal reflux disease (damage to the oesophagus causing burning sensation, chronic cough, shortness of breath, and difficulty swallowing, only with prolonged-release tablets), gastric mucosal inflammation (gastritis), anal and rectal pain (only with prolonged-release tablets), oral mucosal inflammation, glossitis, 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 (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 injection formulation), pruritus, urticaria (edematous, red, itchy skin lesions), maculopapular eruption (skin lesion with a papule or bump on a discoloured spot, only with granules for oral suspension).
• Musculoskeletal disorders: muscle spasms (only with granules for oral suspension), musculoskeletal rigidity (only with the intravenous injection formulation), muscle pain (only with prolonged-release tablets).
• Renal disorders: increased serum creatinine and serum urea (both effects indicating impaired kidney function, only with the intravenous injection 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 injection formulation), increased serum alkaline phosphatase and increased blood lactate dehydrogenase (the last two only with immediate-release tablets).

? With frequency not known (frequency cannot be estimated from available data), the following have been observed:

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

• Blood disorders: decreased neutrophil count (a type of white blood cell), decreased platelet count.

• 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 in hands, feet, arms, or legs.

• Ear: deafness.

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

• Vascular disorders: haemorrhage.

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

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

• Skin: Stevens-Johnson syndrome (widespread rash with blisters and skin peeling, primarily affecting genital, oral, and trunk areas), acute generalized exanthematous pustulosis (widespread scaly red rash with subcutaneous bumps and blisters accompanied by fever, mainly localized in skin folds, trunk, and upper limbs), and toxic epidermal necrolysis (widespread blistering and skin peeling, particularly around the mouth, nose, eyes, and genitals, leading to widespread skin shedding (more than 30% of body surface area), flu-like symptoms with skin rash, fever, glandular swelling, and abnormal blood tests (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, treatment with clarithromycin must be stopped immediately and you should consult your doctor for appropriate management.

• Musculoskeletal disorders: rhabdomyolysis (muscle breakdown that may lead to kidney damage), myopathy (muscle disease of various causes).

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

• Laboratory tests: increased international normalized ratio (INR, a calculation to detect blood coagulation), prolonged prothrombin time (indicating 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.

Following 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 advised.

In some reports of rhabdomyolysis, clarithromycin was administered concomitantly with statins, fibrates, colchicine, or allopurinol (see Do not take Klacid 500 mg film-coated tablets 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 artificially divert intestinal waste from the ileum or colon)] or functional disorders (conditions caused by a bodily defect) with shortened gastrointestinal transit time. In several reports, tablet residues appeared in the context of diarrhoea. It is recommended that patients who notice tablet residues in their faeces and do not experience improvement should 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 underlying 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 frequent 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 observed were dyspnoea, insomnia, and dry mouth. Incidence rates were similar in patients receiving 1,000 mg and 2,000 mg, but were generally 3 to 4 times higher in those receiving a total daily dose of 4,000 mg of clarithromycin.

In these immunocompromised patients, approximately 2% to 3% receiving 1,000 mg or 2,000 mg of clarithromycin daily developed severely abnormal elevations in transaminases, as well as abnormally low white blood cell and platelet counts. A smaller percentage of patients in both dosage groups also had elevated blood urea nitrogen levels (indicating reduced renal function). Patients receiving 4,000 mg daily showed slightly higher incidences of abnormal values across all parameters, except white blood cell count.

Contact a doctor as soon as possible if you experience a serious 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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Klacid 500 mg film-coated tablets

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

No special storage conditions are required. Do not use Klacid 500 mg film-coated tablets after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Klacid 500 mg film-coated tablets

The active substance in Klacid 500 mg film-coated tablets is clarithromycin. Each tablet contains 500 mg of clarithromycin.

The other components (excipients) are: sorbic acid, sodium croscarmellose, microcrystalline cellulose, silicon dioxide, povidone, stearic acid, magnesium stearate, talc, hypromellose, hydroxypropylcellulose, propylene glycol, sorbitan monooleate, titanium dioxide, vanillin, and quinoline yellow aluminium lake (E104).

Appearance of the medicinal product and contents of the pack

Film-coated oval tablets, pale yellow in colour. Each pack contains 14 or 21 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer: AbbVie S.r.l. – SR 148 Pontina, Km 42, 04011 Campoverde di Aprilia, Italy

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

Date of the most recent review of this leaflet: March 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/”