Clarithromycin Sandoz 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Clarithromycin Sandoz 250 mg film-coated tablets EFG

Clarithromycin Sandoz 500 mg film-coated 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 or pharmacist.
• 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Clarithromycin Sandoz is and what it is used for

2. What you need to know before taking Clarithromycin Sandoz

3. How to take Clarithromycin Sandoz

4. Possible side effects

5. How to store Clarithromycin Sandoz

6. Contents of the pack and other information

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

Claritromicina is a medicine belonging to the macrolide group of antibiotics. Antibiotics stop the growth of certain bacteria.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not keep or reuse this medicine. If you have any medicine left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Claritromicina is used for the treatment in adults and adolescents (12 years of age and older) of infections caused by microorganisms sensitive to clarithromycin:

• infections of the throat and sinusitis,
• infections of the respiratory tract, such as bronchitis and pneumonia,
• infections of the skin and soft tissues,
• gastric ulcers caused by the bacterium Helicobacter pylori.

2. What you need to know before taking Claritromycin Sandoz

Do not take Claritromycin Sandoz

• if you are allergic to clarithromycin, to other macrolide antibiotics, or to any of the other ingredients of this medicine listed in section 6,
• if you or a family member have a history of certain abnormal heart rhythms (ventricular arrhythmia, including torsades de pointes) or electrocardiogram (ECG) abnormalities known as "long QT syndrome",
• if you have severe liver failure and kidney problems at the same time,
• if you have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia),
• if you are taking:
• ticagrelor, ivabradine, or ranolazine (for angina or to reduce the risk of myocardial infarction or stroke), ergotamine, dihydroergotamine (medicines for migraine),
• oral midazolam (for anxiety or to help sleep),
• cisapride and domperidone (gastric medicines),
• pimozide (an antipsychotic),
• terfenadine, astemizole (for hay fever, antihistamines),
• lovastatin, simvastatin (cholesterol-lowering medicines),
• a medicine containing lomitapide,
• colchicine (for the treatment of gout),
• other medicines known to cause serious disturbances in heart rhythm.

Warnings and precautions

Talk to your doctor or pharmacist before taking clarithromycin:

• if you are pregnant, think you may be pregnant, or are planning to become pregnant,
• if you have reduced liver or kidney function,
• if you have diabetes,
• if you develop severe or prolonged diarrhoea (pseudomembranous colitis) during or after taking clarithromycin, contact your doctor immediately. Inflammation of the colon (pseudomembranous colitis) has been reported with almost all antibacterial medicines, including clarithromycin,
• if you have heart problems.

Other medicines and Claritromycin Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take 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 Claritromycin Sandoz”).

Some medicines may affect the effectiveness of clarithromycin or vice versa. These medicines include:

Clarithromycin may increase the effect of the following medicines:

• ibrutinib (chronic lymphocytic leukaemia),
• alprazolam, triazolam, intravenous or oral (oromucosal) midazolam (for anxiety or to help sleep),
• digoxin, quinidine, disopyramide, amlodipine, diltiazem (heart medicines),
• theophylline (anti-asthma medicine),
• warfarin or other anticoagulants, e.g., dabigatran, rivaroxaban, apixaban, edoxaban (to thin the blood),
• other statins (not contraindicated with lovastatin and simvastatin) such as atorvastatin, rosuvastatin (cholesterol-lowering medicines),
• cyclosporine, sirolimus, tacrolimus (immunosuppressants),
• carbamazepine, phenytoin, or valproate (epilepsy medicines),
• cilostazol (used to improve leg circulation),
• insulin and other medicines for diabetes (such as nateglinide, pioglitazone, rosiglitazone, or repaglinide),
• methylprednisolone (a cortisone used to treat inflammation),
• omeprazole (a gastric medicine),
• sildenafil, tadalafil, vardenafil (medicines for erectile dysfunction),
• tolterodine (a medicine for overactive bladder syndrome),
• vinblastine (a cancer treatment medicine),
• medicines with risk of causing hearing problems, especially aminoglycosides such as gentamicin or neomycin (a group of antibiotics),

The effect of clarithromycin and the following medicines may be increased when taken together:

• atazanavir, saquinavir (HIV treatment medicines),
• itraconazole (a medicine for fungal infections).

If your doctor specifically recommends taking any of the above medicines at the same time as clarithromycin, your doctor should monitor you more closely.

The following medicines may reduce the effect of clarithromycin:

• rifampicin, rifabutin, rifapentine (antibiotics),
• efavirenz, etravirine, nevirapine (HIV treatment medicines),
• phenytoin, carbamazepine, phenobarbital (antiepileptics),
• St. John’s wort (a herbal preparation for depression).

This is also important if you are taking medicines called:

• 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, taken orally, by injection, or inhaled (used to suppress the immune system; useful in treating a wide range of conditions).

Please note that:

• ritonavir (antiviral) and fluconazole (a medicine for fungal infections) may increase the effect of clarithromycin,
• clarithromycin may reduce the effect of zidovudine (antiviral). To avoid this interaction, a 4-hour interval should be left between taking these medicines.
• using clarithromycin with digoxin, quinidine, disopyramide, or verapamil (heart medicines), or other macrolide antibiotics, may cause serious adverse effects,
• using clarithromycin together with disopyramide may cause low blood sugar levels (hypoglycaemia).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Clarithromycin generally does not affect the ability to drive or operate machinery, but it may cause adverse effects such as dizziness, confusion, and disorientation. If you feel affected, you should not drive, operate machinery, or engage in activities where you or others could be at risk. Visual disturbances and blurred vision may affect the patient’s ability to drive or operate machinery.

Claritromycin Sandoz contains sodium

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

3. How to take Claritromycin Sandoz

Follow exactly the instructions for use of this medicine as provided by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Dosage

Adults and adolescents (12 years of age and older)

The recommended dose is 1 tablet of clarithromycin 250 mg twice daily.

The dose may be increased to 2 tablets of clarithromycin 250 mg twice daily or 1 tablet of clarithromycin 500 mg twice daily.

Gastric ulcer caused by the bacterium Helicobacter pylori:

2 tablets of clarithromycin 250 mg twice daily or 1 tablet of clarithromycin 500 mg twice daily in combination with other appropriate antibiotics and medications used to treat excessive gastric acid production.

Children (under 12 years of age)

Use is not recommended in children under 12 years of age.

For these patients, other pharmaceutical forms are available, e.g., suspension.

Renal impairment

Your doctor may need to reduce the dose.

How to take Clarithromycin Sandoz

For oral use.

Take the medicine with a glass of water.

This medicine can be taken with or without food.

Duration of treatment

• The duration of treatment is generally 6 to 14 days. Treatment should be continued for at least 2 days after symptoms have disappeared.
• In case of streptococcal infections, the minimum duration of treatment is 10 days.
• Treatment of Helicobacter pylori-associated gastric ulcer should continue for 7 days.

If you take more Clarithromycin Sandoz than you should

If you have taken too many clarithromycin tablets at once, contact your doctor or go to the emergency room immediately. Symptoms of overdose include gastrointestinal symptoms.

If you have taken more clarithromycin than you should, contact your doctor, pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Clarithromycin Sandoz

If you forget to take clarithromycin, continue treatment with the next dose as recommended by your doctor. Do not take a double dose to make up for forgotten doses.

If you stop taking Clarithromycin Sandoz

It is important that you take your medicine according to your doctor's instructions. Do not stop treatment with clarithromycin suddenly without first consulting your doctor.

Otherwise, symptoms may 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.

Serious adverse effects:

If you experience any of the following symptoms of a severe allergic reaction, stop taking the medicine and contact your doctor immediately or go to the nearest hospital emergency department:

• sudden difficulty breathing, speaking or swallowing, swelling of the lips, face and neck,

• extreme dizziness or collapse,

• severe or itchy skin rashes, especially if blisters appear and there is pain in the eyes, mouth or genital organs.

• severe diarrhoea lasting for a prolonged period during or after treatment, or diarrhoea with blood, stomach pain or fever. This may be a sign of a serious inflammation of the intestine. Your doctor should stop treatment. Do not take medicines to reduce intestinal motility,

• liver problems with possible signs of:

• loss of appetite,

• yellowing of the skin or whites of the eyes (jaundice),

• unusually dark urine, pale stools,

• skin itching,

• abdominal pain.

• rapid or irregular heartbeat,

• inflammation of the pancreas causing severe pain in the abdomen and back,

• red, scaly rash with blisters and bumps under the skin (exanthematous pustulosis).

Other possible adverse effects:

Frequent adverse effects (may affect up to 1 in 10 people)

• insomnia,
• headache,
• changes in taste and smell (e.g. metallic or bitter taste),
• abdominal pain, dizziness or vomiting, diarrhoea, indigestion,
• abnormal liver function test results,
• rash,
• excessive sweating,
• dilation of blood vessels.

Uncommon (may affect up to 1 in 100 people)

• fungal infections (candidiasis), for example in the mouth,
• vaginal infections,
• low levels of white blood cells (leucopenia, neutropenia),
• increase in the number of certain white blood cells (eosinophilia),
• allergic reactions,
• anorexia, loss of appetite,
• anxiety, dizziness, drowsiness, tremors,
• sensation of dizziness,
• ear disturbance, ringing in the ears (tinnitus),
• changes in heart activity measured on ECG, known as "QT prolongation",
• awareness of heartbeat,
• inflammation of the stomach, mouth and tongue,
• gas, constipation, burping, bloated stomach and abdomen,
• dry mouth,
• impaired bile flow,
• malaise,
• feeling of general discomfort,
• weakness,
• chest pain,
• chills,
• fatigue,
• fainting,
• blistering dermatitis (see "Serious adverse effects" above).

Frequency not known (cannot be estimated from available data)

• inflammation of the intestine, from mild to severe (see "Serious adverse effects" above),

• certain skin and underlying tissue infections (erysipelas),

• severe decrease in certain white blood cells (agranulocytosis),

• reduced number of platelets in the blood: signs may include unusual bruising and bleeding,

• severe allergic reaction (anaphylactic reaction, see "Serious adverse effects" above),

• psychosis, a feeling of loss of identity,

• feeling detached from oneself, confusion,

• depression, abnormal sleep, disorientation, hallucinations, mania,

• seizures,

• changes in the sense of smell, loss of smell and taste,

• tingling or numbness,

• deafness,

• heart rhythm disorders including fatal cases (ventricular arrhythmia, torsades de pointes, see "Serious adverse effects" above),

• prolonged blood clotting time,

• acute inflammation of the pancreas (see "Serious adverse effects" above),

• discoloration of teeth and tongue,

• severe liver failure, including fatal cases (see "Serious adverse effects" above),

• yellowing of the skin or whites of the eyes (jaundice),

• serious skin diseases with malaise, redness, peeling and swelling (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, see "Serious adverse effects" above),

• acne,

• muscle pain or weakness,

• kidney inflammation, kidney failure,

• abnormal urine colour,

• vision problems (blurred vision),

• visual disturbances.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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 Clarithromycin Sandoz

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

Do not use this medicine after the expiry date stated on the blister pack and outer packaging, after EXP/CAD. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are in doubt, 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 Clarithromycin Sandoz

• The active substance is clarithromycin.

Clarithromycin Sandoz 250 mg film-coated tablets

Each tablet contains 250 mg of clarithromycin.

Clarithromycin Sandoz 500 mg film-coated tablets

Each tablet contains 500 mg of clarithromycin.

• The other components are:

Core: sodium croscarmellose (E 468), microcrystalline cellulose (E 460), povidone, magnesium stearate (E 572), anhydrous colloidal silica (E 551), talc (E 553b).

Coating: hypromellose (E 464), propylene glycol (E 1520), titanium dioxide (E 171), hydroxypropyl cellulose (E 463), sorbitan monoleate (E 494), quinoline yellow (E104), vanilla.

Appearance of the product and contents of the pack

Clarithromycin Sandoz 250 mg film-coated tablets are film-coated, dark yellow, capsule-shaped tablets (15.6 x 7.9 mm).

Clarithromycin Sandoz 500 mg film-coated tablets are film-coated, light yellow, oval-shaped tablets (18.8 x 8.8 mm).

Presented in PVC/PVDC/Aluminium blisters.

Pack sizes:

Clarithromycin Sandoz 250 mg film-coated tablets:

7, 10, 12, 14 or 21 film-coated tablets.

Clarithromycin Sandoz 500 mg film-coated tablets:

7, 10, 14 or 21 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova ulica 57

1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220

Lendava,

Slovenia

or

Lek S.A.

Ul. Domaniewska 50 C

02-672 Warszawa

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Novartis Pharmaceuticals S.R.L

Str. Livezeni nr. 7A

RO-540472 Targu-Mures

Romania

This medicinal product is authorized in the European Economic Area member states under the following names

Netherlands	Claritromycine Sandoz 250 mg, film-coated tablets Claritromycine Sandoz 500 mg, film-coated tablets
Belgium	Clarithromycine Sandoz 250 mg film-coated tablets Clarithromycine Sandoz 500 mg film-coated tablets
Bulgaria	Lekoklar 250 mg film-coated tablets Lekoklar 500 mg film-coated tablets
Poland	LEKOKLAR MITE, 250 MG, FILM-COATED TABLETS LEKOKLAR FORTE, 500 MG, FILM-COATED TABLETS
Lithuania	Lekoklar 500 mg film-coated tablets
Romania	Lekoklar 250 mg film-coated tablets Lekoklar 500 mg film-coated tablets
Slovakia	LEKOKLAR 250 mg film-coated tablets LEKOKLAR 500 mg film-coated tablets

Date of the last revision of this leaflet: May 2024

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