Clarithromycin 500 Mg Film-Coated Tablets
Package leaflet: Information for the patient
Clarithromycin 500 mg film-coated tablets
(Clarithromy cin)
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 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 is and what it is used for
2. What you need to know before you take Clarithromycin
3. How to take Clarithromycin
4. Possible side effects
5. How to store Clarithromycin
6. Contents of the pack and other information
1. What Clarithromycin is and what it is used for
Clarithromycin contains the active substance clarithromycin which belongs to a group of medicines called macrolide antibiotics.
Antibiotics stop the growth of certain bacteria which cause infections.
Clarithromycin is used to treat infections in adults and adolescents 12 years and older, such as:
• bronchitis and community acquired pneumonia
• Throat and sinus infections
• Skin and tissue infections (e.g. impetigo, erysipelas, erythrasma)
• in combination with appropriate ulcer healing Helicobacter pylori infection associated with duodenal ulcer (restricted to adults only).
2. What you need to know before you take Clarithromycin DO NOT take Clarithromycin if:
• you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients of this medicine (listed in section 6.)
• you are taking
- ergotamine-like medicinal products (medicines for the treatment of acute migraine attacks)
- astemizole or terfenadine (medicines for the treatment of hay fever or allergies)
- cisapride (medicine used for the treatment of digestive problems)
- pimozide (medicine for the treatment of psychoses)
- colchicine (medicine for the treatment of gout)
- lovastatin, simvastatin or atorvastatin (medicines to reduce cholesterol levels (a certain type of fat) in the blood)
- other medicines which are known to cause serious disturbances in heart rhythm
• you have low levels of potassium or magnesium in your blood (a condition known as hypokalaemia or hypomagnesaemia)
• you have severe liver disease in combination with kidney disease
• you have an irregular heart rhythm.
Warnings and precautions
Talk to your doctor or pharmacist before taking Clarithromycin if:
• you are allergic to the antibiotics lincomycin or clindamycin
• you have any liver or kidney problems
• you have heart problems, in particular heart rhythm problems (e.g. long QT syndrome)
• you have or are prone to fungal infections (e.g., thrush)
• you have diabetes
• you are pregnant or breast-feeding
• you develop severe diarrhea while taking Clarithromycin, or even several weeks after you have stopped taking it
Children under 12 years of age
Clarithromycin is not suitable for use in children under 12 years of age.
Other medicines and Clarithromycin Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:
• ergotamine, dihydroergotamine (medicines for the treatment of migraine)
• terfenadine or astemizole (medicines for the treatment of hay fever or allergies)
• cisapride (medicine for the treatment of digestive problems)
• pimozide (medicines for the treatment of psychiatric disorders)
• colchicine (medicine for the treatment of gout)
• simvastatin or lovastatin (medicines used to lower cholesterol)
• ticagrelor or ranolazine (medicines for the treatment of heart problem)
Care is needed if you are taking
• digoxin, disopyramide or quinidine (medicines for the treatment of various heart conditions)
• cilostazol (medicine for the treatment of poor blood circulation)
• methylprednisolone (a corticosteroid)
• oral anticoagulants (e.g., warfarin; used to thin the blood)
• nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (medicines to lower blood glucose levels)
• sildenafil, vardenafil and tadalafil (medicines for the treatment of impotence in adult males or to treat high blood pressure in the blood vessels of the lungs)
• vinblastine (medicine for the treatment of cancer)
• valproate, carbamazepine, phenobarbital or phenytoin (medicines for the treatment of epilepsy)
• theophylline (medicine for the treatment of breathing problems)
• omeprazole (medicine for the treatment of indigestion and gastric ulcers) unless your doctor has prescribed it for you to treat Helicobacter pylori infection associated with duodenal ulcer)
• ciclosporin, sirolimus or tacrolimus (used to prevent organ rejection after transplant)etravirine, efavirenz, nevirapine, atazanavir, saquinavir, zidovudine or ritonavir (medicines used for the treatment of human immunodeficiency virus [HIV]infection)
• rifampicin, rifapentine, fluconazole, itraconazole or rifabutin (medicines used for the treatment of certain infections)
• tolterodine (medicine for the treatment of an overactive bladder)
• verapamil (medicine for the treatment of high blood pressure)
• St John’s wort (a herbal product used to treat depression)
• benzodiazepine drugs such as midazolam, triazolam and alprazolam used as sedatives
Clarithromycin does not interact with oral contraceptives.
Clarithromycin with food and drink
Clarithromycin tablets may be taken with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, do not take Clarithromycin without consulting your doctor first.
Driving and using machines
Clarithromycin may make you feel sleepy, dizzy or confused. DO NOT drive or operate machinery if you are affected.
3. How to take Clarithromycin
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults and adolescents (aged 12 years and older)
For chest infections, throat or sinus infections and skin and soft tissue infections:
Clarithromycin 500 mg film-coated tablets:
For doses not realisable / practicable with this strength another strength of this medicinal product is available.
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.
Use in children and adolescents
Clarithromycin is not recommended for use in children under 12 years of age. For these patients other pharmaceutical forms e.g. suspensions are available.
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
Method of administration
Clarithromycin tablets should be swallowed preferably with a glass of water.
If you take more Clarithromycin 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.
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 dose. DO NOT take more tablets in one day than your doctor has told you to Do not take a double dose to make up for a forgotten dose.
If you stop taking Clarithromycin
DO NOT stop taking Clarithromycin because you are feeling better. It is important to take the tablets for as long as the doctor has told you to, otherwise symptoms may return.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
If you suffer from any of the following at any time during your treatment STOP TAKING
Clarithromycin and contact your doctor immediately:
• a rash, difficulty breathing, fainting or swelling of the face and throat. This is a sign that you may have developed an allergic reaction.
• 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).
Other side effects that may occur:
If you experience any of the following symptoms, contact with your doctor as soon as
possible:
• 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.
• 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.
fast or irregular heart beat
severe pain in the abdomen and back, caused by inflammation of the pancreas.
Common side effects (may affect up to 1 in 10 people) 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 (may affect up to 1 in 100 people) 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, dizziness, tremor or shaking, or a general feeling of being unwell
• ringing in the ears or hearing loss
• vertigo
• 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 or 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.
Side effects for which the frequency is not known (cannot be estimated from the available data) include:
• swelling, redness or itchiness of the skin. Sometimes brown scales may appear
• small palpable bleedings in the skin, often with joint and adominal pain (Henoch-Schonleins purpura)
• 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
Reporting of 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 national reporting system 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
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 film-coated tablets contain
- The active substance is clarithromycin.
Each film-coated tablet contains 500 mg clarithromycin.
- The other ingredients are:
microcrystalline cellulose, croscarmellose sodium, povidone K29/32, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E171) and macrogol 400.
What Clarithromycin film-coated tablets look like and contents of the pack
Clarithromycin 500 mg film-coated tablets are white or almost white capsular shaped film-coated tablets, debossed with “S20” on one side and blank on the other side. The tablet size is 19*8mm.
Pack sizes:
10, 14, 16, 20, 42 or 100 tablets in white PVC/PVDC /ALU blister.
Not all pack sizes may be marketed
Marketing Authorisation Holder
HEC Pharm GmbH
Gabriele-Tergit-Promenade 17, 10963 Berlin
10963
Germany
Manufacturer
Formula Pharmazeutische und chemische Entwicklungs GmbH
Goerzallee 305b, D-14167 Berlin
14167
Germany