Clarithromycin 500mg Film-Coated Tablets

Document: leaflet MAH GENERIC_PL 40378-0010 change

Package Leaflet: Information for the user

Clarithromycin 250 mg and 500 mg Film-coated Tablets (Clarithromycin)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

- Keep this leaflet. You may need to read it again.

- If you have any further questions, ask your doctor or your 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.

What is in this leaflet

1. What Clarithromycin tablets are and what they are used for

2. What you need to know before you take Clarithromycin tablets

3. How to take Clarithromycin tablets

4. Possible side effects

5. How to store Clarithromycin tablets

6. Contents of the pack and other information

1. What Clarithromycin tablets are and what they are used for

Each Clarithromycin tablet contains 250 mg of the active ingredient clarithromycin Each Clarithromycin tablet contains 500 mg of the active ingredient clarithromycin.

Clarithromycin belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria (bugs) which cause infections.

Clarithromycin tablets are used to treat infections such as:

• Chest infections such as bronchitis and pneumonia

• Throat and sinus infections

• Mild to moderate skin and tissue infections, e.g. cellulitis, folliculitis or erysipelas

• Mycobacterial infections

• Helicobacter pylori infection associated with duodenal ulcer

2. What you need to know before you take Clarithromycin tablets Do not take Clarithromycin tablets if you:

• are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or to any of the other ingredients in the tablets (see section 6).

• are taking medicines called ergotamine or dihydroergotamine tablets or use ergotamine inhalers for migraine.

• are taking medicines called terfenadine or astemizole (for hay fever or allergies) or cisapride or pimozide tablets as combining these drugs can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines.

• are taking lovastatin or simvastatin (HMG_CoA reductase inhibitors, commonly known as statins, used to lower levels of cholesterol (a type of fat) in the blood).

• or someone in your family has a history of heart rhythm disorders (ventricular cardiac arrhythmia, including torsades de pointes) or abnormality of electrocardiogram (ECG, electrical recording of the heart) called “long QT syndrome”.

• have abnormally low levels of potassium in your blood (hypokalaemia).

• have severe liver disease with kidney disease

• have an irregular heart rhythm.

• are taking medicines called ticagrelor or ranolazine (for heart attack, chest pain or angina).

• are taking colchicine (usually taken for gout).

Warnings and precautions

Talk to your doctor or pharmacist before taking Clarithromycin tablets if you:

• are pregnant or breast-feeding (see section ‘Pregnancy and breast-feeding’)

• have any liver or kidney problems

• have heart problems (such as coronary artery disease or severe cardiac insufficiency)

• have a slow heart beat (bradycardia)

• have low magnesium levels in your blood (hypomagnesaemia)

• have, or are prone to, fungal infections (e.g. thrush)

Children

Clarithromycin tablets are not recommended for use in children younger than 12 years of age.

Other medicines and Clarithromycin tablets

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines as your dose may need to be changed or you may need to have regular tests performed.

Consult your doctor if you are taking any of the following medicines:

• medicines for epilepsy (e.g. carbamazepine, valproate, phenobarbital or phenytoin)

• theophylline (used in patients with breathing difficulties such as asthma)

• warfarin or other anticoagulants (blood thinners)

• ergotamine or dihydroergotamine (for migraine)

• triazolam, alprazolam or midazolam (sedatives)

• disopyramide, digoxin, quinidine or verapamil (for heart problems)

• atorvastatin, rosuvastatin (HMG-CoA reductase inhibitors, commonly known as statins, and used to lower levels of cholesterol (a type of fat) in the blood). Statins can cause rhabdomyolysis (a condition which causes the breakdown of muscle tissue which can result in kidney damage) and signs of myopathy (muscle pain or muscle weakness) should be monitored.

• pimozide (for some mental illnesses)

• fluconazole, itraconazole, rifabutin, rifampicin, rifapentine

• medicines for HIV (e.g. etravirine, efavirenz, nevirapine, zidovudine, atazanavir, saquinavir or ritonavir)

• ciclosporin, sirolimus or tacrolimus (for organ transplants)

• terfenadine or astemizole (for hay fever or allergy)

• cisapride or omeprazole (for stomach disorders, for treatment of indigestion and gastric ulcers)

• colchicine (for gout)

• nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (used to lower blood glucose levels)

• St John’s wort (herbal remedy used to treat depression)

• cilostazol (for poor circulation)

• methylprednisolone (for inflammatory disorders)

• sildenafil, tadalafil or vardenafil (for erectile dysfunction or for use in pulmonary arterial hypertension (high blood pressure in the blood vessels of the lung))

• vinblastine (to treat some cancers)

• tolterodine (used to improve bladder control)

• verapamil, amlodipine, diltiazem (for high blood pressure)

• aminoglycosides (a group of antibiotic to treat certain bacteria for example gentamicin, neomycin)

• atypical antipsychotics (e.g. quetiapine)

Clarithromycin tablets do not interact with oral contraceptives.

Pregnancy and breast-feeding

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 Clarithromycin tablets as the safety of Clarithromycin tablets

in pregnancy and breast-feeding is not known.

Your doctor will carefully weigh the benefits against risk when prescribing this medicine, especially during the first three months of pregnancy.

Driving and using machines

Clarithromycin tablets may make you feel dizzy or drowsy. If they affect you in this way do not drive, operate machinery or do anything that requires you to be alert.

3. How to take Clarithromycin tablets

Always take Clarithromycin tablets exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.

Clarithromycin tablets are for use in adults and children 12 years and older.

The recommended dose is one 250 mg tablet in the morning and one in the evening. In severe infections, your doctor may increase the dose to 500 mg twice daily. The usual length of treatment is between 6 and 14 days. Clarithromycin tablets should be taken with food and must be swallowed whole and not chewed.

If you have kidney problems or certain infections, your doctor may give you a different dose.

Use in children

Clarithromycin tablets are not recommended for use in children younger than 12 years. Other forms of this medicine may be more suitable for children younger than 12 years; ask your doctor or pharmacist.

If you take more Clarithromycin tablets than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.

An overdose of Clarithromycin tablets is likely to cause vomiting and stomach pains.

If you forget to take Clarithromycin tablets

If you forget to take a dose, take another as soon as you remember. Do not take more tablets in one day than your doctor has told you. Do not take a double dose to make up for a forgotten dose.

If you stop taking Clarithromycin tablets

Do not stop taking Clarithromycin tablets because 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Clarithromycin tablets can cause side effects although not everybody gets them.

If any of the following side effects occur, stop taking Clarithromycin tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

• allergic reactions including rashes have been reported with clarithromycin. Allergic rashes may range in severity from mild itchy skin eruptions to rarer more serious skin eruptions. Difficulty in breathing, fainting and swelling of the face and throat can occur which may need emergency treatment.

• severe skin reactions such as blistering of the skin, mouth, lips, eyes and genitals (symptoms of a

rare allergic reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis).

• kidney failure (symptoms of this include an increased need to urinate at night, muscle twitching and cramps, loss of appetite, feeling or being sick, unpleasant taste in mouth).

• liver failure (symptoms of this include feeling generally unwell, yellow skin and/or eyes, pale stools with dark urine, loss of appetite, itching, tender abdomen).

• severe or prolonged diarrhoea, which may have blood or mucus in it, during or after taking Clarithromycin tablets.

• Muscle pain or weakness known as rhabdomyolysis (a condition which causes the breakdown of muscle tissue which can result in kidney damage).

Tell your doctor if any of the following side effects occur:

Common: may affect up to 1 in 10 people:

• difficulty sleeping

• changes in sense of taste

• headache

• diarrhoea

• feeling or being sick

• indigestion

• stomach pain

• changes in liver function

• skin rash

• increasing sweating

Other less common side effects: may affect up to 1 in 100 people

• fungal infections

• vaginal infections

• changes in some blood cells (if you notice that you are bruising easily or have frequent nose bleeds, or you have more sore throats and infections than usual tell your doctor who may want to give you a blood test)

• decreased appetite, heartburn, bloating, constipation and indigestion, wind (flatulence)

• eructation

• anxiety, nervousness, drowsiness, tiredness, dizziness, tremor or shaking

• ‘spinning’ sensation

• difficulty hearing

• 'ringing' in the ears

• changes in heart rhythm (palpitations, an abnormally fast, slow, or irregular pulse)

• gastritis (feeling or being sick, diarrhoea)

• swollen tongue, mouth or stomach

• dry mouth

• gall bladder disorders

• a change in the levels of products made by the liver, inflammation of the liver or an inability of the liver to function properly (you may notice yellowing of the skin, dark urine, pale stools or itchiness of the skin)

• feeling unwell

• weakness

• chest pain

• chills

• changes in levels of chemicals in the blood (seen in blood tests)

• swelling, redness or itchiness of the skin (anaphylactic reaction)

• rectal pain

• nose bleeds

• muscle spasms and myalgia

• fever

Not known: frequency cannot be estimated from the available data

• inflammation of the gut with severe diarrhoea called Pseudomembranous colitis

• saint Anthony’s fire (erysipelas), acne

• several reduction of white blood cells associated with sudden high fever, severe sore throat and mouth ulcers (agranulocytosis)

• unusual bruising or bleeding caused by low blood platelets

• serious allergic reaction which causes swelling of the face or throat (angioedema)

• psychosis, a feeling of loss identity

• confusion, change in sense of reality or panicking

• depression, nightmares, disorientation, hallucinations

• convulsions

• disturbed sense of smell, loss of sense of smell or taste

• deafness

• tingling or numbness in the hands or feet

• difficulty with your blood clotting

• discolouration of the teeth and tongue

• muscle pain or loss of muscle tissue. If you suffer from myasthenia gravis (a condition in which the muscles become weak and tire easily) or rhabdomyolysis (a condition which causes the breakdown of muscle tissue), clarithromycin may worsen these symptoms

• a change in levels of products produced by the kidney, inflammation of the kidney or an inability of the kidney to function properly (you may notice tiredness, swelling or puffiness in the face, abdomen, thighs or ankles or problems with urination)

• changes in urine colour

• leaking of blood from blood vessels (haemorrhage)

• inflammation of the pancreas

• mania

Reporting side effects

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/yellow. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Clarithromycin tablets

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

Do not store above 30 °C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Clarithromycin tablets contain

The active ingredient (the ingredient that makes the medicine work) is clarithromycin. Each tablet either contains 250 mg or 500 mg of the active ingredient.

The other ingredients are microcrystalline cellulose, starch pregelatinised, croscarmellose sodium, povidone, talc, magnesium stearate, silica colloidal anhydrous, titanium dioxide (E171), polydextrose (E1200), hypromellose (E464), triacetin (E1518), macrogol, quinoline yellow (E104).

What Clarithromycin tablets look like and contents of the pack

Clarithromycin 250 mg tablets are yellow, oval, biconvex, film-coated tablets, ‘250’ on one side and ‘CL’ on the other side. They are available in the following pack sizes:

Blister packs: 12 and 14 tablets Bottles: 100 tablets

Clarithromycin 500 mg tablets are yellow, oval, biconvex, film-coated tablets, ‘500’ on one side and ‘CL’ on the other side. They are available in the following pack sizes:

Blister packs: 14 and 20 tablets Bottles: 100 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Aptil Pharma Limited,

Unit 4, Charlwood Court,

County Oak Way, Crawley West Sussex, RH11 7XA,

United Kingdom

This leaflet was last revised in September 2016.

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