CLARITHROMYCIN 250MG FILM COATED TABLETS

Active substance: CLARITHROMYCIN

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CLARITHROMYCIN 250 mg AND 500 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier. We must receive a copy of any 3rd Party Suppliers Proof before approval to print will be granted.

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier. We must receive a copy of any 3rd Party Suppliers Proof before approval to print will be granted.

01 February 2013

PANTONE GREEN C

01 February 2013

PANTONE GREEN C

BLACK

IN THIS LEAFLET:

Please refer to the latest version of the full base material specification: 92653, 92655, 92651

1

WHAT CLARITHROMYCIN IS AND WHAT IT IS USED FOR

231-30-14274-B.LEA CLARITHROMYCIN A/S TAB TUK
PL 00289/1549-50. TEVA UK Limited Licence (Post Licence Regulatory Team), Packed at Debrecen. Text update.

231-30-14274-B.LEA CLARITHROMYCIN A/S TAB TUK
PL 00289/1549-50. TEVA UK Limited Licence (Post Licence Regulatory Team), Packed at Debrecen. Text update.

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 Please tell your doctor or pharmacist if you skin and soft tissue infections are taking or have recently taken any other Helicobacter pylori infection associated medicines, including medicines obtained with duodenal ulcer. without a prescription.

Please refer to the latest version of the full base material specification: 92653, 92655, 92651

Colours: (PANTONE is a registered trademark of Pantone, Inc.)

Colours: (PANTONE is a registered trademark of Pantone, Inc.)

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

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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.

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 Johns 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, methylprednisolone.

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. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. POSSIBLE SIDE EFFECTS 4 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 STOP TAKING 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 StevensJohnson 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.

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Child:

Child:

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360 mm 160 mm

360 mm 160 mm

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HOW TO STORE CLARITHROMYCIN

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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. 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.

Dimensions:

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BEFORE YOU USE CLARITHROMYCIN

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. Important information about some of the ingredients of Clarithromycin This product contains Tartrazine lake (E102) and Allura Red lake (E129) which may cause allergic reactions.

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Keep out of the reach and sight of children. Do not store above 25C. 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 how to dispose of medicines no longer required. These measures will help to protect the environment.

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175336

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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 Pallagi t 13, Debrecen, H-4042, Hungary This leaflet was last revised: January 2013. PL 00289/1549 PL 00289/1550

231-10-03257-8 123 (111100) To be added by 3rd party Univers 9 Pt

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HOW TO 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 Taking other medicines: severe infections. The usual duration of DO NOT take Clarithromycin if you are taking: treatment is 7 to 14 days. ergotamine or dihydroergotamine (to treat migraines) For the treatment of Helicobacter pylori terfenadine or astemizole (used to treat hay infection associated with duodenal ulcers: fever and other allergies) Clarithromycin should be taken in a dose of pimozide (used to treat mental disorders) 500 mg twice daily in combination with cisapride (used to treat stomach problems) other medicines to treat Helicobacter pylori. simvastatin or lovastatin (used to lower Your doctor will decide on the best treatment cholesterol) combination for you. If you are at all unsure as colchicine (to treat gout). to which medicine to take and when to take the medicine you must speak to your doctor. Talk to your doctor if you are taking any of the following: Patients with liver or kidney problems coumarin anticoagulants used to thin your If you have liver or severe kidney problems blood, e.g. warfarin your doctor may need to reduce your dose. medicines used to treat an abnormal heart Clarithromycin should not be taken for more beat, e.g. disopyramide or quinidine than 14 days if you have these problems.

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231-10-03257-8 123 (111100) To be added by 3rd party Univers 9 Pt

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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