Clarithromycin 500 Mg Film-Coated Tablets
CLARITHROMYCIN 250 mg AND 500 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FORTHE USER
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Read all of this leaflet carefully before you
start using this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Clarithromycin is and what it is used for
2. Before you use Clarithromycin
3. How to use Clarithromycin
4. Possible side effects
5. How to store Clarithromycin
6. Further information
OWHAT CLARITHROMYCIN IS AND WHAT IT IS USED FOR
Clarithromycin belongs to a group of drugs called macrolide antibiotics.
Clarithromycin is used in the treatment of
- the following infections:
• bronchitis and pneumonia • throat and sinus infections: sinusitis and pharyngitis
• skin and soft tissue infections • Helicobacter pylori infection associated with duodenal ulcer.
BEFOREYOU USE CLARITHROMYCIN
DO NOT take Clarithromycin if you:
• are allergic (hypersensitive) to Clarithromycin or any of the other ingredients of this medicine
• are allergic (hypersensitive) to any other macrolide antibiotic e.g. erythromycin, azithromycin
• have been told by your doctor that you have low blood potassium levels
• are taking ergotamine-like drugs (usually used for migraine)
• are taking cisapride (for stomach disorders)
• are taking pimozide (for mental illness)
• are taking terfenadine or astemizole (for hayfever or allergy)
• if you are taking simvastatin or lovastatin (to reduce cholesterol)
• have severe liver disease with kidney disease
• have an irregular heart rhythm.
• medicines used to treat heart failure, e.g. digoxin
• medicines used to treat epilepsy, e.g. phenytoin or carbamazepine
• theophylline, used to treat asthma
• benzodiazepines used as medicines that make you sleepy, e.g. midazolam, triazolam or alprazolam
• phenobarbital, used as a sedative and anti-convulsant
• rifabutin or rifampicin, used to treat some infections
• ciclosporin, tacrolimus or sirolimus, used following organ transplant
• medicines used to lower cholesterol, e.g. atorvastatin or cerivastatin
• efavirenz, nevirapine, atazanvir, saquinavir, ritonavir or zidovudine, used to treat HIV infected patients
• St John's Wort, used to treat depression
• fluconazole, itraconazole or ketoconazole, used to treat fungal infections
• sildenafil, tadalafil or vardenafil, used to treat sexual dysfunction in men, and high blood pressure
• tolteridone, used to treat incontinence
• omeprazole, for the treatment of gastric ulcers
• medicines used to treat diabetes, e.g. insulin, glibenglamide, repaglinide
• valproate, used to treat bipolar disorder
• eletriptan, aprepitant, halofantrine, ziprasidone, vinblastine, cilostazol, methyl prednisolone.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Clarithromycin with food and drink
• You can take Clarithromycin either with or without food, whichever you prefer.
Pregnancy and breast-feeding
Clarithromycin should not be given to pregnant or breast-feeding mothers unless the benefits to the mother outweigh the risks to the baby. Ask your doctor or pharmacist for advice before taking any medicine.
Small amounts of clarithromycin can pass into breast milk.
If you are pregnant or breast-feeding do not take clarithromycin without consulting your doctor first.
Driving and using machines
• Your tablets may make you feel sleepy, dizzy or confused. DO NOT drive or operate machinery if you are affected.
Take special care with Clarithromycin Tell your doctor before you start to take this medicine if you:
• are allergic to the antibiotics lincomycin or clindamycin
• have liver problems
• have kidney problems
• have heart problems, in particular heart rhythm problems (e.g. long QT syndrome)
• have muscle problems known as myasthenia gravis
• have low potassium levels and/or magnesium levels
• take or have recently taken a drug called colchicine (usually taken for gout) as this can cause very serious side effects
• if you have, or are prone to, fungal infections (e.g. thrush).
If any of the above applies to you, tell your doctor before receiving clarithromycin.
Taking other medicines:
DO NOT take Clarithromycin if you are taking:
• ergotamine or dihydroergotamine (to treat migraines)
• terfenadine or astemizole (used to treat hay fever and other allergies)
• pimozide (used to treat mental disorders)
• cisapride (used to treat stomach problems)
• simvastatin or lovastatin (used to lower cholesterol)
• colchicine (to treat gout).
Talk to your doctor if you are taking any of the following:
• coumarin anticoagulants used to thin your blood, e.g. warfarin
• medicines used to treat an abnormal heart beat, e.g. disopyramide or quinidine
Important information about some of the ingredients of Clarithromycin
• This product containsTartrazine lake (E102) and Allura Red lake (E129) which may cause allergic reactions.
Q HOWTO USE CLARITHROMYCIN
Always use Clarithromycin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The tablets should be swallowed preferably with a glass of water.
The usual dosage instructions are given below: Adults including the Elderly and children over 12 years old:
• For chest infections, throat or sinus infections and skin and soft tissue infections: 250 mg twice a day. Your doctor may increase the dose to 500 mg twice a day in severe infections. The usual duration of treatment is 7 to 14 days.
• For the treatment of Helicobacter pylori infection associated with duodenal ulcers: Clarithromycin should be taken in a dose of 500 mg twice daily in combination with other medicines to treat Helicobacter pylori.
Your doctor will decide on the best treatment combination for you. If you are at all unsure as to which medicine to take and when to take the medicine you must speak to your doctor.
Patients with liver or kidney problems
If you have liver or severe kidney problems your doctor may need to reduce your dose. Clarithromycin should not be taken for more than 14 days if you have these problems.
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Children under 12 years old Clarithromycin is not recommended for use in children under 12 years of age.
If you take more Clarithromycin than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
An overdose is likely to cause vomiting and stomach pains.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Clarithromycin
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining doses at the correct time.
If you stop taking Clarithromycin
DO NOT stop taking your medicine because you are feeling better. It is important that you complete your prescribed course of treatment, otherwise the problem may come back and this medicine may be less effective next time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Q POSSIBLE SIDE EFFECTS
Like all medicines. Clarithromycin can cause side effects, although not everybody gets them.
If you suffer from any of the following at any time during your treatment STOPTAKING your tablets and contact your doctor immediately:
• severe or prolonged diarrhoea, which may have blood or mucus in it. Diarrhoea may occur over two months after treatment with clarithromycin, in which case you should still contact your doctor
• a rash, difficulty breathing, fainting or swelling of the face and throat. This is a sign that you may have developed an allergic reaction
• yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, tender abdomen or loss of appetite.These may be signs that your liver may not be working properly
• 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)
• torsades de pointes, a life threatening irregular heart beat.
Common side effects (affects 1 to 10 users in 100) include:
• headache
• difficulty sleeping
• changes in sense of taste
• stomach problems such as feeling sick, vomiting, stomach pain, indigestion, diarrhoea
• abnormal liver function (seen in blood results)
• skin rash
• increased sweating
Uncommon side effects (affects 1 to 10 users in 1000) include:
• oral or vaginal 'thrush' (a fungal infection)
• reduction in the level of certain blood cells (which can make infections more likely or increase the risk of bruising or bleeding)
• loss of appetite, heartburn, bloating, constipation, wind
• anxiety, nervousness, drowsiness, tiredness, weakness, dizziness, tremor or shaking, or a general feeling of being unwell
• ringing in the ears or hearing loss
• vertigo
• bleeding
• inflammation of the mouth or tongue
• dry mouth
• joint pain
• chest pain or changes in heart rhythm such as palpitations
• a change in the levels of products made by the liver, inflammation of the liver, an inability of the liver to function properly or liver failure (you may notice yellowing of the skin, dark urine, pale stools or itchiness of the skin)
• abnormal blood test results
Other side effects that have been seen (frequency cannot be estimated from available data):
• swelling, redness or itchiness of the skin. Sometimes brown scales may appear.
• acne
• inflammation of the pancreas
• confusion, loss of bearings, hallucinations (seeing things), change in sense of reality or panicking, depression, abnormal dreams or nightmares
• convulsion (fits)
• bleeding
• discolouration of the tongue or teeth
• loss of taste or smell or inability to smell properly
• deafness
• muscle pain or loss of muscle tissue. If you suffer from myasthenia gravis (a condition in which the muscles become weak and tire easily) clarithromycin may worsen these symptoms
• low blood sugar levels
• 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), or kidney failure.
If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet.
HOWTO STORE CLARITHROMYCIN
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Clarithromycin after the expiry date that is stated on the blister and carton.The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist howto dispose of medicines no longer required.These measures will help to protect the environment.
FURTHER INFORMATION
What Clarithromycin Film-coated Tablets contain
• The active ingredient is clarithromycin.
• Other ingredients are sodium starch glycolate, microcrystalline cellulose, povidone (PVP K-30), magnesium hydroxide, croscarmellose sodium, anhydrous colloidal silica, stearic acid, magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol 400, tartrazine lake (E102), allura red AC lake (E129), indigo carmine lake (E132) and vanillin.
Contents of the pack:
• Each tablet contains either 250 mg or 500 mg of Clarithromycin.
• The 250 mg tablet is a yellow, oval shaped film-coated tablet marked with "93" on one side and "7157" on the other.
• The 500 mg tablet is a light yellow, oval shaped film-coated tablet marked with "93" on one side and "7158" on the other.
• The 250 mg product is available in pack sizes of 8, 10, 12, 14,14 calendar pack, 16, 20, 30, 100 and 120 tablets.
• The 500 mg product is available in pack sizes of 8, 10, 14,14 calendar pack, 16, 20, 21,30, 42 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer:
TEVA UK Ltd,
Brampton Road, Hampden Park, Eastbourne East Sussex, BN22 9AG, England
or
Teva Pharmaceutical Works Private Limited Company
Pa Magi ut 13, Debrecen, H-4042, Hungary
This leaflet was last revised: January 2013.
PL 00289/1549 PL 00289/1550
TEVA UK LIMITED
14274-B