Clarithromycin 250mg Tablets
PATIENT INFORMATION LEAFLET ON
Klaricid® 250mg tablets Clarithroymcin 250mg tablets (clarithroymcin)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or your 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.
• Your medicine is available using either of the above names but will be referred to as Klaricid tablets throughout the remainder of this leaflet.
• Klaricid tablets are also available in other strengths.
In this leaflet:
1) What Klaricid tablets are and what they are used for
2) Before taking Klaricid tablets
3) Taking Klaricid tablets
4) Possible side effects
5) How to store Klaricid tablets
6) Further information
1) WHAT KLARICID TABLETS ARE AND WHAT THEY ARE USED FOR
Each Klaricid tablet contains 250 mg or 500 mg of the active ingredient clarithromycin.
Klaricid belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria (bugs) which cause infections.
Klaricid tablets are used to treat infections such as:
1. Chest infections such as bronchitis and pneumonia
2. Throat and sinus infections
3. Skin and tissue infections
4. Helicobacter pylori infection associated with duodenal ulcer Klaricid Tablets are indicated in adults and children 12 years and older.
2) BEFORE TAKING KLARICID TABLETS Do not take Klaricid tablets if you;
• know that you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients in the tablets.
• are taking medicines called ergotamine or dihydroergotamine tablets or use ergotamine inhalers for migraine.
• are taking medicines called terfenadine or astemizole (widely taken for hay fever or allergies) or cisapride (for stomach disorders) or pimozide (for mental health problems) as combining these drugs can sometimes cause serious disturbances in heart rhythm.
• 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).
• have low levels of potassium in the blood (a condition known as hypokalaemia).
• have severe liver disease with kidney disease.
• have an irregular heart rhythm.
Klaricid tablets are not suitable for use in children under 12 years of age.
Take special care with Klaricid tablets;
• if you have any liver or kidney problems
• if you have, or are prone to, fungal infections (e.g. thrush)
• if you are pregnant or breast feeding
If any of these apply to you, consult your doctor before taking Klaricid tablets.
Taking other medicines
You should not take Klaricid tablets if you are taking any of the medicines listed in the section above “Do not take Klaricid tablets if you;”
Tell your doctor if you are taking any of the following medicines as your dose may need to be changed or you may need to have regular tests performed:
• digoxin, quinidine or disopyramide (for heart problems)
• warfarin (for thinning the blood)
• carbamazepine, valproate, phenobarbital or phenytoin (for epilepsy)
• atorvastatin, rosuvastatin (HMG-CoA reductase inhibitors, commonly known as statins, and used to lower levels of cholesterol (a type of fat) in the blood)
• colchicine (usually taken for gout)
• nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (used to lower blood glucose levels)
• theophylline (used in patients with breathing difficulties such as asthma)
• triazolam, alprazolam or midazolam (sedatives)
• cilostazol (for poor circulation)
• omeprazole (for treatment of indigestion and gastric ulcers) unless your doctor has prescribed it for you to treat Helicobacter pylori infection associated with duodenal ulcer
• methylprednisolone (a corticosteroid)
• vinblastine (for treatment of cancer)
• ciclosporin, sirolimus and tacrolimus (immune suppressants)
• etravirine, efavirenz, nevirapine, ritonavir, zidovudine, atazanavir, saquinavir (anti-viral drugs used in the treatment of HIV)
• rifabutin, rifampicin, rifapentine, fluconazole, itraconazole (used in the treatment of certain bacterial infections)
• tolterodine (for overactive bladder)
• verapamil (for high blood pressure)
• sildenafil, vardenafil and tadalafil (for impotence in adult males or for use in pulmonary arterial hypertension (high blood pressure in the blood vessels of the lung))
• St John's Wort (a herbal product used to treat depression)
Klaricid does not interact with oral contraceptives.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, or if you are breastfeeding, consult your doctor before taking Klaricid tablets as the safety of Klaricid tablets in pregnancy and breast-feeding is not known.
Driving and Using Machines:
Klaricid 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) TAKING KLARICID TABLETS
Do not give these tablets to children under 12 years. Your doctor will prescribe another suitable medicine for your child.
Always take Klaricid tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is;
For chest infections, throat or sinus infections and skin and soft tissue infections:
Usual dose of Klaricid tablets for adults and children over 12 years is 250 mg twice daily for 6 to 14 days, e.g. one 250 mg tablet in the morning and one in the early evening. Your doctor may increase the dose to 500 mg twice daily in severe infections.
Klaricid tablets should be swallowed with at least half a glass of water.
For the treatment of Helicobacter pylori infection associated with duodenal ulcers:
There are a number of effective treatment combinations available to treat Helicobacter pylori in which Klaricid tablets are taken together with one or two other drugs.
These combinations include the following and are usually taken for 6 to 14 days:
a) One Klaricid 500 mg tablet taken twice a day together with amoxycillin, 1000 mg taken twice a day plus lansoprazole, 30 mg twice a day.
b) One Klaricid 500 mg tablet taken twice a day together with metronidazole, 400 mg taken twice a day plus lansoprazole, 30 mg twice a day.
c) One Klaricid 500 mg tablet taken twice a day together with amoxycillin, 1000 mg taken twice a day or metronidazole, 400 mg taken twice a day plus omeprazole, 40 mg a day.
d) One Klaricid 500 mg tablet taken twice a day together with amoxycillin, 1000 mg taken twice a day plus omeprazole, 20 mg taken once a day.
e) One Klaricid 500 mg tablet taken three times a day together with omeprazole 40 mg taken once a day.
The treatment combination that you receive may differ slightly from the above. Your doctor will decide which treatment combination is the most suitable for you. If you are unsure which tablets you should be taking or how long you should be taking them for, please consult your doctor for advice.
If you take more Klaricid tablets than you should
If you accidentally take more Klaricid tablets in one day than your doctor has told you to, or if a child accidentally swallows some tablets, contact your doctor or nearest hospital emergency department immediately. An overdose of Klaricid tablets is likely to cause vomiting and stomach pains.
POM
If you forget to take Klaricid tablets
If you forget to take a Klaricid tablet, take one as soon as you remember. Do not take more tablets in one day than your doctor has told you to.
Do not stop taking Klaricid 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.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Klaricid tablets 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 Stevens-Johnson syndrome/toxic epidermal necrolysis).
• Henoch-Schonlein purpura (a rash which appears as purple spots on the skin).
Common side effects of Klaricid tablets include;
• headache
• difficulty sleeping
• changes in sense of taste
• stomach problems such as feeling sick, vomiting, stomach pain, indigestion, diarrhoea
• a change in the way your liver works
• skin rash
• increased sweating
Other less common side effects include:
• swelling, redness or itchiness of the skin. Sometimes brown scales may appear
• acne
• Henoch-Schonlein purpura (a rash which appears as purple spots on the skin).
• 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
• inflammation of the pancreas
• anxiety, nervousness, drowsiness, tiredness, dizziness, tremor or shaking
• confusion, loss of bearings, hallucinations (seeing things), change in sense of reality or panicking, depression, abnormal dreams or nightmares
• convulsion (fits)
• ringing in the ears or hearing loss
• vertigo
• paraesthesia, more commonly known as ‘pins and needles'
• leaking of blood from blood vessels (haemorrhage)
• inflammation of the mouth or tongue
• discolouration of the tongue or teeth
• dry mouth
• loss of taste or smell or inability to smell properly
• joint pain
• 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
• 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 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)
• a change in the 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)
• low blood sugar levels
• a change in the levels of certain cells or products found in the blood.
Consult your doctor immediately if you develop any of these problems or have any other unexpected or unusual symptoms.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
5) HOW TO STORE KLARICID TABLETS
• Keep out of sight and reach of children.
• Do not use these tablets after their use-by (exp) date that is printed on the box and on the blister label.
• Do not store above 25C.
• Store in the original package
• Store in a dry place and protect from light.
• If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
• 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.
6) FURTHER INFORMATION
What Klaricid tablets contain
Each film-coated tablet contains 250 mg clarithromycin.
The other ingredients are:
croscarmellose sodium, starch pregelatinised, cellulose microcrystalline, povidone, colloidal silicon dioxide, stearic acid, magnesium stearate, talc, quinoline yellow (E104), hypromellose, hydroxypropylcellulose, propylene glycol, sorbitan monooleate, vanillin, titanium dioxide (E171) and sorbic acid.
What Klaricid tablets look like and contents of the pack
Klaricid tablets are yellow, ovaloid film-coated tablets, plain on both sides.
Klaricid tablets are supplied in calendar packs containing 14 tablets. Manufactured by Abbott S.r.l., 104010 Campoverde di Aprilia, Italy.
It is procured from within the EU by PL Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER
Repackaged by MPT Pharma Ltd.
PL: 33532/0461 Klaricid® 250mg tablets
Clarithroymcin 250mg tablets
Leaflet date 9th March 2014 Leaflet code: xxxxxxxxxxxxxxx
Klaricid is a registered trade mark of XXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXX.
By reporting side effects, you can help provide more information on the safety of this medicine.