• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Clarithromycin Film-Coated Tablets are and what they are used for
2. What you need to know before you take Clarithromycin Film-Coated Tablets
3. How to take Clarithromycin Film-Coated Tablets
4. Possible side effects
5. How to store Clarithromycin Film-Coated Tablets
6. Contents of the pack and other information

• you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients of this medicine (listed in section 6)
• you are taking ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, to treat migraines) or oral midazolam (a medicine used to treat anxiety and insomnia).
• you are taking medicines which may cause serious disturbances in heart rhythm.
• you are taking astemizole or terfenadine (medicines used to treat allergy), cisapride or domperidone (a medicine used to treat gastrointestinal tract disorders), pimozide (a medicine used to treat mental disorders), because they may cause serious disturbances in heart rhythm when taken together with Clarithromycin Film-Coated Tablets.
• you are taking ticagrelor (a medicine that inhibits platelets aggregation) or ranolazine (a cardiac medicine).
• you have been diagnosed with low level of potassium or magnesium in the blood (hypokalaemia or hypomagnesaemia).
• you are taking lovastatin or simvastatin (statin medicines used to lower blood cholesterol).
• you have been diagnosed with severe liver failure with concurrent kidney failure.
• you have or anyone in your family has had a history of heart rhythm disturbances(ventricular cardiac arrhythmias, including torsades de pointes) or abnormal electrocardiogram results (ECG, measurement of the electrical activity of the heart) called “QT interval prolongation syndrome”.
• you are taking colchicine (a medicine used to treat gout).
• you are taking medicine containing lomitapide.

Talk to your doctor or pharmacist before you start taking Clarithromycin Film-Coated Tablets:

• if you are pregnant or you think that you may be pregnant
• if you have a liver or kidney disorder
• if you have been diagnosed with coronary artery disease, severe heart failure or slowed heart rate
• if you are taking any of the medicines listed under section “Other medicines and Clarithromycin Film-Coated Tablets ”

If you experience any of the situations described below while taking Clarithromycin Film-Coated Tablets, you should tell your doctor about it.

• Severe hypersensitivity reactions, such as maculopapular rash, utricaria, ecchymosis, swelling of the larynx , bronchospasm. Immediately report to a doctor who will introduce appropriate treatment.
• Diarrhoea, especially acute or prolonged. Talk to your doctor as soon as possible. If necessary, the doctor will prescribe appropriate treatment. Do not use anti-diarrheal medicines.
• Symptoms indicating hepatic dysfunction, such as lack of appetite, jaundice, dark urine colour, pruritus or painful stomach. Stop treatment and report to the doctor.
• New infection (superinfection) with clarithromycin-resistant bacteria or fungi, especially during prolonged antibiotic use. The doctor will prescribe appropriate treatment.

Moreover, while taking Clarithromycin Film-Coated Tablets you may experience:

• cross-resistance of bacteria (clarithromycin-resistant bacteria may be also resistant to other macrolide antibiotics as well as lincomycin and clindamycin);
• drug-resistance of bacteria (e.g. the treatment of Helicobacter pylori infection may lead to the occurrence of drug-resistant microorganisms).

If the symptoms indicating acoustic organ or labyrinth damage (see section 4) occur, appropriate follow-up examinations are recommended after the end of treatment.

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

You must inform your doctor, if you are taking one of the following medicines, as it is contraindicated to use them with Clarithromycin Film-Coated Tablets:

• ergot alkaloids, such as ergotamine or dihydroergotamine (medicines used, among others, to treat migraines)
• astemizole or terfenadine (medicines used to treat allergy)
• cisapride or domperidone (a medicine used to treat gastrointestinal tract disorders)
• pimozide (a medicine used to treat mental disorders)
• ticagrelor, ranolazine (a medicine used to treat heart and circulatory diseases)
• colchicine (a medicine used to treat gout)
• statins – lovastatin, simvastatin (medicines used to lower blood cholesterol)
• midazolam administered orally (a medicine used to treat anxiety or insomnia)

Tell your doctor if you are taking any of the following medicines, as it is necessary to take special care while using them with Clarithromycin Film-Coated Tablets:

• rifampicin, rifapentine, rifabutin (antibiotics used to treat tuberculosis)
• fluconazole, itraconazole (antifungal medicines)
• atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used to treat HIV infection)
• digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used to treat heart disturbances or arterial hypertension)
• alprazolam, triazolam, midazolam administered intravenously or oromucosally (medicines used to treat anxiety or insomnia)
• warfarin or any other anticoagulant e.g. dabigatran, rivaroxaban, apixaban
• quetiapine or another atypical antipsychotic drug
• carbamazepine, valproate, phenytoin (antiepileptic drugs)
• methylprednisolone (an anti-inflammatory medicine)
• omeprazole (a medicine reducing the secretion of gastric acid)
• cilostazol (a medicine used to treat intermittent claudication which manifests as muscle pain of lower extremities during effort resolving after short rest)
• cyclosporine, tacrolimus, sirolimus (medicines used, among others, after transplants)
• sildenafil, tadalafil, vardenafil (medicines used to treat erectile dysfunction)
• ibrutinib or vinblastine (medicines used in cancer chemotherapy)
• theophylline (a medicine used to treat asthma)
• tolterodine (a medicine used to treat urinary incontinence)
• phenobarbital (an anti-seizure medicine)
• St. John’s wort (a herbal medicine used to treat mild depression)
• sulfonylurea, nateglinide, repaglinide, insulin (medicines used in diabetes)
• ototoxic medicines (which damage hearing), especially aminoglycoside antibiotics used in bacterial infections
• hydroxychloroquine and chloroquine (medicines used to treat autoimmune diseases).

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before taking this medicine as the safety of clarithromycin in pregnancy and breast-feeding is not known. Clarithromycin Film-Coated Tablets may only be used during pregnancy when in the opinion of the physician the benefits for the mother outweigh the potential risk for the foetus.

Clarithromycin is excreted in human milk, so breastfeeding women should take special care when taking Clarithromycin Film-Coated Tablets.

This medicine may cause dizziness, vertigo, confusion and disorientation, which can affect the ability to drive and use machines. If affected, you should not drive or operate machines.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

If you take more than the recommended dose of Clarithromycin Film-Coated Tablets contact your doctor or pharmacist immediately.

Taking more Clarithromycin Film-Coated Tablets than the dose recommended by your doctor may cause gastrointestinal tract symptoms (vomiting, stomach pain).

If you miss a dose, take it as soon as possible, and take another dose at the specified time.

Do not take a double dose to make up for a forgotten dose.

Do not stop taking Clarithromycin Film-Coated Tablets, even if you feel better. It is important to take the tablets for as long as the doctor has told you to, otherwise the problem might come back.

The following side effects (occur in 1 to 10 patients out of 100) were often reported in clinical studies and in post-marketing experience with clarithromycin:

• insomnia
• taste disturbances, headache
• diarrhoea, vomiting, indigestion, nausea, abdominal pain
• abnormal liver function results
• excessive sweating

Uncommon side effects (occur in 1 to 10 patients in 1000):

• candidiasis (fungal infection), vaginal infection
• decrease in white blood cells, decrease in neutrophils and increase of eosinophils
• anorexia, decreased appetite
• restlessness
• dizziness, sleepiness, shaking
• balance disorder, hearing loss, ringing in the ears
• palpitations, ECG trace changes (QT interval prolongation)
• inflammation of the stomach, inflammation of the mouth, inflammation of the tongue, bloating, constipation, dry mouth, burping, wind
• increased liver enzymes activity: alanine aminotransferase, increased aspartate aminotransferase activity, increased gamma-glutamyl transferase activity
• malaise, asthenia (weakness, lack of energy), chest pain, chills, fatigue
• increased blood enzyme activity: alkaline phosphatase and lactate dehydrogenase

The frequency of the side effects listed below is not known (the frequency cannot be estimated from the available data); they were reported in post-marketing experience with Clarithromycin Film-Coated Tablets in the form of tablets and suspension:

• erysipelas
• agranulocytosis (reduction in the number of white blood cells in the blood), thrombocytopenia (decreased platelet count)
• acne
• psychotic disorders, confusional state, depersonalization, depression, disorientation, hallucinations, abnormal dreams, mania
• seizures, lack of taste, change in the sense of smell (parosmia), loss of smell, paraesthesia(numbness, tingling)
• deafness
• type of heart rhythm disorder (Torsade de pointes, ventricular tachycardia, ventricular fibrillation)
• haemorrhage
• acute inflammation of the pancreas, discolouration of the tongue or teeth
• myopathy (a muscle disease involving muscle strength reduction)
• renal failure, interstitial nephritis
• change in diagnostic test results (increased international normalized ratio [INR], prolonged prothrombin time, abnormal urine colour)

Immunosuppressed patients

Apart from the symptoms related to the disease course, the following side effects were observed in adult immunosuppressed patients:

• nausea, vomiting, altered taste, constipation, abdominal pain, diarrhoea, bloating with passing winds, dry mouth
• headache, hearing disorders
• rash
• dyspnoea, insomnia
• abnormal laboratory test results: increased aspartate aminotransferase activity (AspAT) and alanine aminotransferase (AlAT), increased blood urea nitrogen and decreased platelet count and white blood cell count

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine

Each film-coated tablet contains clarithromycin 250mg.

The other ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate, talc, colloidal anhydrous silica, stearic acid and the coating material Opadry 20H 52875 containing: hypromellose, hydroxypropylcellulose, propylene glycol, vanillin, titanium dioxide, talc and quinoline yellow lake (E 104)

Clarithromycin 250mg Film-coated Tablets are light yellow, oval, biconvex film coated tablets embossed with ‘C1’ on one side.

Clarithromycin Film-Coated Tablets are available in blister strips of 1, 2, 10, 1x10, 12, 14, 1x14, 15, 20, 42, 50, 56 or 100 tablets. Not all pack sizes may be marketed.