Clarithromycin 500mg Tablets
PATIENT INFORMATION LEAFLET ON
Klaricid® 500mg 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 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 symptoms 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 the leaflet. See section 4.
• The name of your medicine is Klaricid 500mg tablets but will be referred to as Klaricid tablets throughout the remainder of this leaflet.
• Klaricid tablets are also available in other strengths.
What is in this leaflet:
1) What Klaricid tablets are and what they are used for
2) What you need to know before you take Klaricid tablets
3) How to take Klaricid tablets
4) Possible side effects
5) How to store Klaricid tablets
6) Contents of the pack and other information
1) WHAT KLARICID TABLETS ARE AND WHAT THEY ARE USED FOR
Each Klaricid tablet contains 500mg 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) WHAT YOU NEED TO KNOW BEFORE YOU TAKE 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.
• are taking medicines called ticagrelor or ranolazine (for heart attack, chest pain or angina).
• are taking colchicine (usually taken for gout).
Klaricid tablets are not suitable for use in children under 12 years of age.
Other medicines and Klaricid 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:
• 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). Statins can cause rhabdomyolosis (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.
• 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, amlodipine, diltiazem (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)
• aminoglycosides (a group of antibiotic to treat certain bacteria for example gentamicin, neomycin)
Klaricid does 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 this medicine 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) HOW TO TAKE 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. 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 250mg twice daily for 6 to 14 days, e.g. one 250mg tablet in the morning and one in the early evening. Your doctor may increase the dose to 500mg twice daily in severe infections.
Klaricid tablets should be swallowed with at least half a glass of water.
Warnings and precautions
Talk to your doctor or pharmacist before taking 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.
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 500mg tablet taken twice a day together with amoxicillin, 1000mg taken twice a day plus lansoprazole, 30mg twice a day.
b) One Klaricid 500mg tablet taken twice a day together with metronidazole, 400mg taken twice a day plus lansoprazole, 30mg twice a day.
c) One Klaricid 500mg tablet taken twice a day together with amoxicillin, 1000mg taken twice a day or metronidazole, 400mg taken twice a day plus omeprazole, 40mg a day.
d) One Klaricid 500mg tablet taken twice a day together with amoxicillin, 1000mg taken twice a day plus omeprazole, 20mg taken once a day.
e) One Klaricid 500mg tablet taken three times a day together with omeprazole 40mg 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.
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.
If you stop taking Klaricid tablets
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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).
• muscle pain or weakness known as rhabdomyolysis (a condition which causes the breakdown of muscle tissue which can result in kidney damage).
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 the liver works
• skin rash
• increased sweating
Other less common side effects include:
• swelling, redness or itchiness of the skin.
• acne
• 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)
• a change in the levels of certain cells or products found in the blood.
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. By reporting side effects, you can help provide more information on the safety of this medicine.
5) HOW TO STORE KLARICID TABLETS
• Keep out of the 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.
• Store in a dry place and protect from light.
• Do not store above 30oC.
• 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) CONTENTS OF THE PACK AND OTHER INFORMATION
What Klaricid tablets contain
Each film-coated tablet contains 500mg clarithromycin.
The other ingredients are:
Croscarmellose sodium, microcrystalline cellulose, silicon dioxide, povidone, stearic acid, magnesium stearate, talc, hypromellose, hydroxypropylcellulose, propylene glycol, sorbitan monooleate, titanium dioxide (E171), sorbic acid, vanillin and quinoline yellow (E104).
What Klaricid tablets look like and contents of the pack Klaricid tablets are plain, yellow, oval film-coated tablets.
Klaricid tablets are supplied in packs containing 14 tablets.
Manufactured by Abbott S.r.l., Campoverde di Aprilia (LT), Italy.
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: 33532/0410 Klaricid® 500mg tablets
Leaflet date 08th January 2015 Leaflet code: xxxxxxxxxxxxxxx
Klaricid® is a registered trademark of Abbott Laboratories.
POM
Clarithromycin 500mg tablets
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 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 symptoms 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 the leaflet. See section 4.
• The name of your medicine is Clarithromycin 500mg tablets but will be referred to as Clarithromycin tablets throughout the remainder of this leaflet.
• Clarithromycin tablets are also available in other strengths.
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 500mg 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:
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
Clarithromycin Tablets are indicated in adults and children 12 years and older.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLARITHROMYCIN TABLETS
Do not take Clarithromycin 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.
• are taking medicines called ticagrelor or ranolazine (for heart attack, chest pain or angina).
• are taking colchicine (usually taken for gout).
Clarithromycin tablets are not suitable for use in children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Clarithromycin 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.
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:
• 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). Statins can cause rhabdomyolosis (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.
• 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, amlodipine, diltiazem (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)
• aminoglycosides (a group of antibiotic to treat certain bacteria for example gentamicin, neomycin)
Clarithromycin does 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 this medicine as the safety of Clarithromycin tablets in pregnancy and breastfeeding is not known.
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
Do not give these tablets to children under 12 years. Your doctor will prescribe another suitable medicine for your child.
Always take Clarithromycin tablets exactly as your doctor has told you. 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 Clarithromycin tablets for adults and children over 12 years is 250mg twice daily for 6 to 14 days, e.g. one 250mg tablet in the morning and one in the early evening. Your doctor may increase the dose to 500mg twice daily in severe infections.
Clarithromycin 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 Clarithromycin 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 Clarithromycin 500mg tablet taken twice a day together with amoxicillin, 1000mg taken twice a day plus lansoprazole, 30mg twice a day.
b) One Clarithromycin 500mg tablet taken twice a day together with metronidazole, 400mg taken twice a day plus lansoprazole, 30mg twice a day.
c) One Clarithromycin 500mg tablet taken twice a day together with amoxicillin, 1000mg taken twice a day or metronidazole, 400mg taken twice a day plus omeprazole, 40mg a day.
d) One Clarithromycin 500mg tablet taken twice a day together with amoxicillin, 1000mg taken twice a day plus omeprazole, 20mg taken once a day.
e) One Clarithromycin 500mg tablet taken three times a day together with omeprazole 40mg 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 Clarithromycin tablets than you should
If you accidentally take more Clarithromycin 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 Clarithromycin tablets is likely to cause vomiting and stomach pains.
If you forget to take Clarithromycin tablets
If you forget to take a Clarithromycin tablet, take one as soon as you remember. Do not take more tablets in one day than your doctor has told you to.
If you stop taking Clarithromycin tablets
Do not stop taking Clarithromycin 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.
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 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).
• muscle pain or weakness known as rhabdomyolysis (a condition which causes the breakdown of muscle tissue which can result in kidney damage).
Common side effects of Clarithromycin 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 the liver works
• skin rash
• increased sweating
Other less common side effects include:
• swelling, redness or itchiness of the skin.
• acne
• 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)
• a change in the levels of certain cells or products found in the blood. 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. By reporting side effects, you can help provide more information on the safety of this medicine.
5) HOW TO STORE CLARITHROMYCIN TABLETS
• Keep out of the 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.
• Store in a dry place and protect from light.
• Do not store above 30oC.
• 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) CONTENTS OF THE PACK AND OTHER INFORMATION
What Clarithromycin tablets contain
Each film-coated tablet contains 500mg clarithromycin.
The other ingredients are:
Croscarmellose sodium, microcrystalline cellulose, silicon dioxide, povidone, stearic acid, magnesium stearate, talc, hypromellose, hydroxypropylcellulose, propylene glycol, sorbitan monooleate, titanium dioxide (E171), sorbic acid, vanillin and quinoline yellow (E104).
What Clarithromycin tablets look like and contents of the pack
Clarithromycin tablets are plain, yellow, oval film-coated tablets. Clarithromycin tablets are supplied in packs containing 14 tablets.
Manufactured by Abbott S.r.l., Campoverde di Aprilia (LT), Italy.
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: 33532/0410 Clarithromycin 500mg tablets
Leaflet date 08th January 2015 Leaflet code: xxxxxxxxxxxxxxx
POM