Clarithromycin 250 mg film-coated tablets - Patient Information Leaflet (PIL) (2023)

• Keep this brochure. You may have to read it again.
• If you are still not sure, talk to your doctor or pharmacist.
• This medicine has been specially prescribed for you. Do not pass this on to other people. It can hurt them even if the symptoms are the same as yours.
• If you notice any side effects, tell your doctor or pharmacist. This includes any possible side effects not mentioned 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 Accord
3. How to take clarithromycin film-coated tablets
4. Possible side effects
5. How to store Clarithromycin film-coated tablets
6. Package content and other information

• if 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 migraine headaches) or oral midazolam (a medicine used to treat anxiety and insomnia).
• you are taking medicines that can cause serious heart rhythm disturbances.
• if you are taking astemizole or terfenadine (medicines used to treat allergies), cisapride or domperidone (a medicine used to treat gastrointestinal disorders), pimozide (a medicine used to treat mental disorders), as these may cause serious heart rhythm disturbances when taken together with clarithromycin film-coated tablets.
• you are taking ticagrelor (a medicine that inhibits platelet aggregation) or ranolazine (a heart medicine).
• you have been diagnosed with a low level of potassium or magnesium in your 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 concomitant renal failure.
• you have or someone in your family has had a history of heart rhythm disorders (ventricular cardiac arrhythmias, includingtorsades of points) or abnormal results from an electrocardiogram (ECG, a measurement of the heart's electrical activity) called "long QT syndrome."
• you are taking colchicine (a medicine used to treat gout).
• you are taking medicines containing lomitapide.

Talk to your doctor or pharmacist before taking clarithromycin film-coated tablets:

• if you are pregnant or think you may be pregnant
• if you have a liver or kidney disorder
• if you have been diagnosed with coronary heart disease, severe heart failure or a slow heart rate
• if you are taking any of the medicines listed in the section “Other medicines and clarithromycin film-coated tablets”

If you experience any of the conditions described below while taking clarithromycin film-coated tablets, please tell your doctor.

• Serious hypersensitivity reactions such as macular rash, urticaria, ecchymosis, laryngeal edema, bronchospasm.Immediatelyinform a doctor who will introduce the appropriate treatment.
• Diarrhoea, especially acute or prolonged. Talk to your doctor as soon as possible. If necessary, the doctor will prescribe the appropriate treatment. Do not use anti-diarrheal medicines.
• Symptoms that indicate liver dysfunction, such as loss of appetite, jaundice, dark urine, itching, or stomach pain. Discontinue treatment and inform the doctor.
• New infection (superinfection) with clarithromycin-resistant bacteria or fungi, especially during prolonged use of antibiotics. The doctor will prescribe the appropriate treatment.

Besides,during downloadClarithromycin film-coated tablets that you can feel:

• bacterial cross-resistance (bacteria resistant to clarithromycin may also be resistant to other macrolide antibiotics, as well as lincomycin and clindamycin);
• bacterial resistance to drugs (for example, the treatment ofHelicobacter pyloriinfection can lead to the emergence of drug-resistant microorganisms).

If symptoms suggesting damage to the auditory or labyrinthine organs occur (see section 4), appropriate follow-up testing is recommended after completion of treatment.

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

You should tell your doctor if you are taking any of the following medicines, as their use with clarithromycin film-coated tablets is contraindicated:

• ergot alkaloids such as ergotamine or dihydroergotamine (medicines used, among others, to treat migraine)
• astemizole or terfenadine (medicines used to treat allergies)
• cisapride or domperidone (a medicine used to treat gastrointestinal disorders)
• pimozide (a medicine used to treat mental disorders)
• ticagrelor, ranolazine (a medicine used to treat heart and circulation problems)
• colchicine (a medicine used to treat gout)
• statins: lovastatin, simvastatin (medicines used to lower blood cholesterol)
• oral midazolam (a medicine used to treat anxiety or insomnia)

Tell your doctor if you are taking any of the following medicines, as special care is needed when using them with clarithromycin film-coated tablets:

• rifampicin, rifapentine, rifabutin (antibiotics used to treat tuberculosis)
• fluconazole, itraconazole (antifungal drugs)
• atazanavir, efavirenz, etravirine, nevirapine, ritonavir, saquinavir, zidovudine (used to treat HIV infection)
• digoxin, quinidine, disopyramide, verapamil, amlodipine, diltiazem (used to treat heart disease or high blood pressure)
• alprazolam, triazolam, midazolam given intravenously or orally (medicines used to treat anxiety or insomnia)
• warfarin or any other anticoagulant, e.g. dabigatran, rivaroxaban, apixaban
• quetiapine or other atypical antipsychotic medication
• carbamazepine, valproate, phenytoin (antiepileptic drugs)
• methylprednisolone (an anti-inflammatory drug)
• omeprazole (a medicine that reduces the secretion of stomach acid)
• cilostazol (a medicine used to treat intermittent claudication manifested as muscle pain in the lower extremities when you strain to take a step back after a short rest)
• ciclosporin, tacrolimus, sirolimus (medicines used, among others, after transplants)
• sildenafil, tadalafil, vardenafil (medicines used to treat erectile dysfunction)
• ibrutinib or vinblastine (drugs used in cancer chemotherapy)
• theophylline (a medicine used to treat asthma)
• tolterodine (a medicine used to treat urinary incontinence)
• phenobarbital (an anti-seizure medication)
• St. John's Wort (an herbal medicine used to treat mild depression)
• Sulfonylurea, nateglinide, repaglinide, insulin (drugs used in diabetes)
• Ototoxic (hearing-damaging) drugs, 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, talk to your doctor or pharmacist before using this medicine, as the safety of clarithromycin during pregnancy and breast-feeding is unknown. Clarithromycin film-coated tablets can only be used during pregnancy when, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the foetus.

Clarithromycin is excreted in human milk, therefore lactating women should be especially careful when taking clarithromycin film-coated tablets.

This medicine can cause dizziness, lightheadedness, confusion and disorientation, which may affect your ability to drive and use machines. If you are affected, you should not drive or use machinery.

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, ie 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 symptoms (vomiting, stomach pain).

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

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

Do not stop taking clarithromycin, even if you feel better. It is important to take the pills for as long as your doctor tells you, otherwise the problem may come back.

The following side effects (occurring in between 1 and 10 patients in 100) have beenmany timesReported in clinical studies and post-marketing experience with clarithromycin:

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

unusual side effects(occurs in 1 to 10 patients in 1,000):

• yeast infection (yeast infection), vaginal infection
• Decreased white blood cells, decreased neutrophils, and increased eosinophils.
• anorexia, decreased appetite
• worry
• dizziness, drowsiness, tremors
• balance disorder, hearing loss, ringing in the ears
• palpitations, changes in the ECG tracing (QT prolongation)
• inflammation of the stomach, inflammation of the mouth, inflammation of the tongue, bloating, constipation, dry mouth, belching, wind
• increased activity of liver enzymes: increased alanine aminotransferase activity, increased aspartate aminotransferase activity, increased γ-glutamyl transferase activity
• malaise, weakness (weakness, lack of energy), chest pain, chills, tiredness
• increased activity of blood enzymes: alkaline phosphatase and lactate dehydrogenase

The frequency of side effects listed below isa stranger(Frequency cannot be estimated from the available data.) Reported from post-marketing experience with clarithromycin film-coated tablets and suspension:

• erysipelas
• agranulocytosis (reduced number of white blood cells in the blood), thrombocytopenia (reduced number of platelets)
• acne
• psychotic disorders, confusional state, depersonalization, depression, disorientation, hallucinations, abnormal dreams, mania
• seizures, lack of taste, changes in smell (parosmia), loss of smell, paraesthesia (numbness, tingling)
• deafness
• type of heart rhythm disorder (twisted ends, ventricular tachycardia, ventricular fibrillation)
• bleeding
• acute inflammation of the pancreas, discoloration of the tongue or teeth;
• myopathy (a muscle disease involving decreased muscle strength)
• renal failure, interstitial nephritis
• change in test results (increased international normalized ratio [INR], prolonged prothrombin time, abnormal urine color)

Immunocompromised patients

In addition to symptoms related to the course of the disease, the following side effects have been observed in immunocompromised adult patients:

• nausea, vomiting, taste disturbances, constipation, abdominal pain, diarrhoea, flatulence, dry mouth
• headache, hearing disorders
• rash
• shortness of breath, insomnia
• Abnormal laboratory test results: increased aspartate aminotransferase (AspAT) and alanine aminotransferase (AlAT) activity, increased blood urea nitrogen, and decreased platelet and white blood cell counts.

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

You can also report adverse reactions directly through the Yellow Card scheme at: www.mhra.gov.uk/amarillocard or search for MHRA Yellow Card on Google Play or the Apple App Store. Reporting side effects can help provide more information about the safety of this medication.

Each film-coated tablet contains 250 mg clarithromycin.

The other ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate, talc, colloidal anhydrous silica, stearic acid and Opadry 20H 52875 coating material containing: hypromellose, hydroxypropylene yellow, propylene vanoxide, propylene and propylene. I (E 104)

Clarithromycin 250 mg film-coated tablets are pale yellow, oval, biconvex, film-coated tablets debossed “C1” on one side.

Clarithromycin film-coated tablets are available in blisters of 1, 2, 10, 1x10, 12, 14, 1x14, 15, 20, 42, 50, 56 or 100 tablets. Not all packages can be published.

Ranbaxy (UK) Limited
5th walk
Oh Hyde Park
Hayes 3
11 Millington Road
Hayes
UB3 4AZ
United Kingdom

Sun Pharmaceutical Industries Europe B.V.
87 Polarisa Avenue
2132 JH Hoofddorp
Netherlands

Terapia S.A.
factory street
124, Cluj-Napoca
Cluj
400632
Rumania