Clarithromycin Unidia Kern Pharma 500 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Claritromycin Unidia Kern Pharma 500 mg modified-release tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Claritromicina Unidia Kern Pharma is and what it is used for

Claritromicina Unidia Kern Pharma is an antibiotic belonging to the macrolide group, active against microorganisms that cause infections of the respiratory tract or skin.

Clarithromycin is used for the treatment of infections caused by susceptible organisms in adults, adolescents aged 12 to 18 years, and children over 12 years of age:

• 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).
• Mild 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).

2. What you need to know before taking Claritromycin Unidia Pharma

Do not take Claritromycin Unidía Kern Pharma

• 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 you have a creatinine clearance less than 30 ml/min.
• If you have an irregular heartbeat.
• If you suffer from 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 (medicines 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 medicines 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, 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 sleep).
• 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 cardiac arrhythmia, including Torsade de Pointes) or abnormalities in the 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 medicines 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 Unidía Kern Pharma

• 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 hypoglycemic agents (medicines to lower blood sugar such as nateglinide, pioglitazone, rosiglitazone, repaglinide, sulfonylureas, or insulin), as clarithromycin may excessively lower blood glucose. Careful monitoring of glucose levels is recommended.
• If you are taking a medicine called warfarin or another anticoagulant, for example, dabigatran, rivaroxaban, apixaban, or edoxaban (used to thin the blood).
• If you have myasthenia gravis, a condition in which your muscles become weak 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 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.

Other medicines and Claritromycin Unidía Kern Pharma

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

Claritromycin Unidía Kern Pharma 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.

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 another anticoagulant such as dabigatran, rivaroxaban, apixaban, or 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 of the following medicines:

• 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 the treatment of certain infections).
• Tacrolimus or sirolimus (for organ transplants and severe eczema).
• Sildenafil, tadalafil, or vardenafil (to treat impotence in adult men or for 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 used 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 together 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 the treatment of a wide variety of diseases).

Taking Claritromycin Unidía Kern Pharma with food and drinks

Claritromycin Unidía Kern Pharma tablets should always be taken with food.

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 Unidía Kern Pharma contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Claritromycin Unidia Kern Pharma

Clarithromycin is administered orally.

Follow exactly the instructions for administration of clarithromycin given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Adults, adolescents aged 12 to 18 years, and children over 12 years: the usual recommended dose of clarithromycin for adults is 1 tablet of 500 mg once daily. The usual duration of treatment is 5 to 14 days, except for the treatment of community-acquired pneumonia and sinusitis, which require 6 to 14 days of therapy.

In severe cases, your doctor may instruct you to take 2 tablets (1 g) once daily.

Do not crush or chew the clarithromycin tablets.

Take the tablets always with food and with a glass of water. Remember to take your medication. Take the tablets at the same time every day.

Your doctor will determine the duration of your treatment with clarithromycin.

Renal impairment

In patients with renal impairment and a creatinine clearance of 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, clarithromycin should not be administered to this patient group. For patients with moderate renal function (creatinine clearance of 30 to 60 ml/min), a 50% reduction in dosage should be implemented, resulting in a maximum dose of one modified-release clarithromycin tablet per day.

If you take more Clarithromycin Unidia Kern Pharma 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 rapidly eliminate any clarithromycin not yet absorbed by your body. Hemodialysis or peritoneal dialysis are not effective.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Clarithromycin Unidia Kern Pharma

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

If you stop taking Clarithromycin Unidia Kern Pharma

Do not stop treatment early, as even if you feel better, your illness 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 Unidía Kern Pharma may produce adverse effects, although not everyone will experience 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 the available data).

The common and most common reactions related to treatment with clarithromycin, in both adults and children, are abdominal pain, diarrhoea, nausea, vomiting, and taste disturbance. 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 patients with or without pre-existing mycobacterial infections.

Summary of adverse effects

Adverse effects are described in order of decreasing 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 with all medicines containing clarithromycin (may affect up to 1 in 10 patients):

• 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 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 formulation), hypersensitivity (exaggerated allergic reaction to external agents).
• Eating 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 disorders: vertigo, hearing problems, tinnitus.
• Heart disorders: cardiac arrest and heart 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 heartbeats).
• Respiratory disorders: asthma (difficulty breathing, chest tightness, and nocturnal or early morning cough, only with the intravenous 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 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 prolonged-release tablets), gastric mucosal inflammation (gastritis), anal and rectal pain (only with prolonged-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 (a liver enzyme), aspartate aminotransferase (another liver enzyme), and gamma-glutamyltransferase (another liver enzyme, only with immediate-release tablets).
• Skin: bullous dermatitis (blistering rashes, only with the intravenous formulation), pruritus, urticaria (edematous, red, itchy skin lesions), maculopapular rash (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 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 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 latter two only with immediate-release tablets).

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

• Infections: pseudomembranous colitis (diarrhoea that may become severe), erysipelas (variable skin redness 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).
• Metabolism: decreased blood glucose concentration.
• 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 burning sensation in hands, feet, arms, or legs.
• Ear: deafness.
• Heart disorders: torsades de pointes (a type of ventricular tachycardia), ventricular tachycardia (accelerated heartbeat of more than 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.
• Liver disorders: liver function failure, hepatocellular jaundice (yellowing of the skin and eyes).
• Skin: Stevens-Johnson syndrome (widespread blistering 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 blistering and skin peeling, particularly around the mouth, nose, eyes, and genitals, causing widespread skin detachment (more than 30% of body surface), 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 types of 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 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 blood coagulation deficiency), 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 the concomitant use of clarithromycin and triazolam. Patient monitoring is advised.

In some reports of rhabdomyolysis (a muscle disease that may lead to renal failure), clarithromycin was administered concomitantly with statins, fibrates, colchicine, or allopurinol.

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 who do not experience improvement 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 itself or by other 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 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% receiving 1,000 mg or 2,000 mg daily of clarithromycin developed severely abnormal elevated transaminase levels, as well as abnormally low white blood cell and platelet counts. A smaller percentage of patients in both dosage groups 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 the 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clarithromycin Unidia Kern Pharma

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine 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 packaging at the Sigre Point located at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This way you can help protect the environment.

6. Contents of the pack and other information

Composition of Claritromycin Unidía Kern Pharma

• The active substance is clarithromycin. Each tablet contains 500 mg of clarithromycin (as clarithromycin citrate).
• The other components are: magnesium stearate, hypromellose, hypromellose phthalate, lactose monohydrate, talc, and Opadry II yellow (hypromellose, lactose monohydrate, polyethylene glycol, quinoline yellow, aluminium lake, titanium dioxide).

Appearance of the product and contents of the pack

Modified-release tablets, oval-shaped, biconvex, yellow in colour. Each pack contains 14 or 20 tablets (regular pack) and 500 tablets (hospital pack).

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

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

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