Clarithromycin 250mg Film-Coated Tablets
Package leaflet: Information for the user Clarithromycin 250 mg film-coated tablets Clarithromycin 500 mg film-coated 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 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 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
The name of your medicine is Clarithromycin Tablets. Clarithromycin belongs to a group of medicines called macrolide ant biotics. Antibiotics stop the growth of bacteria that cause infections.
Clarithromycin is used in the treatment of the following infections:
• Chest infections such as bronchitis and pneumonia
• Throat and sinus infections
• Skin and tissue infections
• 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 if you;
• know that you are allergic (hypersensitive) to clarithromycin or other macrolide ant biotics (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 while taking Clarithromycin Tablets. Consult your doctor for advice on alternative medicines.
• are taking simvastatin (used to reduce cholesterol levels).
• are taking medicines called terfenadine or astemizole (widely taken for hay fever or allergies) or cisapride (for stomach disorders) or pimozide (for mental problems) while taking Clarithromycin Tablets, as combining these drugs can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines.
• are taking other medicines which are known to cause serious disturbances in heart rhythm.
• have abnormally low levels of potassium (hypokalaemia).
• or someone in your family has a history of heart rhythm disorders (ventricular cardiac arrhythmia, including torsade de pointes) or abnormality of electrocardiogram (ECG, electrical recording of the heart) called “long QT syndrome".
• have severe liver problems.
• 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 before taking Clarithromycin if you:
• have liver or kidney problems- your doctor may need to adjust the dose (see also under “Do not take Clarithromycin).
• have H. pylori infection - follow your doctor's advice strictly, because careless use of Clarithromycin may result in drug-resistant organisms.
• have or have had an allergic reaction to certain other antibiotics (lincomycin and clindamycin). There is a risk of an allergic reaction to Clarithromycin as well (cross-hypersensitivity).
• have heart problems (such as coronary vessel disease, slow or irregular heartbeat or a weak heart) or if medicinal products are used at the same time which may affect the heartbeat.
• have low blood values of potassium and/or magnesium. The rhythm of heartbeat may become affected in such cases.
• have myasthenia gravis (a disease affecting muscle functions), symptoms may become more severe if Clarithromycin is used.
• are taking colchicines (medicine used for the treatment of gout).
Important information about your medicine
If you have any of the following conditions (now or in the past,) speak to your doctor before using Clarithromycin:
• Tell your doctor immediately if you suffer from
severe or prolonged diarrhoea during or after use of Clarithromycin. Clarithromycin may cause a serious inflammation of the large intestine (pseudomembranous colitis) in very rare cases.
• Tell your doctor immediately if you suspect that during prolonged or repeated use of Clarithromycin you (or your child) have developed a new infection. This may be a superinfection by micro-organisms which are not suscept ble to Clarithromycin.
• This medicine contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate some sugars, contact your doctor before taking this medicine.
Other medicines and Clarithromycin Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If taken with Clarithromycin, the levels and therefore the effects of the following listed medicines may be increased:
• Digoxin, quinidine or disopyramide (heart drugs)
• Warfarin (blood thinner)
• Ergotamine or dihydroergotamine (used for migraine)
• Carbamazepine, valproate or phenytoin (drugs for epilepsy)
• Colchicine (for gout)
• Theophylline (helps breathing)
• Terfenadine or astemizole (for hay fever or allergy)
• Triazolam, alprazolam or midazolam (sedatives)
• Lovastatin or simvastatin (drugs for high cholesterol)
• Cisapride or omeprazole (for stomach disorders)
• Pimozide (an antipsychotic drug).
Clarithromycin may interact with anti-viral [HIV] drugs in the following manner:
• Zidovudine, Clarithromycin may lower the levels of zidovudine.
• Ritonavir may increase the levels of Clarithromycin.
• Atazanavir and Saquinavir: Taking these drugs with Clarithromycin may increase both the levels of Atazanavir (or Saquinavir) and Clarithromycin.
• Nevirapine and Efavirenz may lower the levels of Clarithromycin.
Other interactions include:
• Rifabutin (an antibiotic effective against some infections) may lower the levels of Clarithromycin.
• Itraconazole (an anti-fungal drug) taken together with Clarithromycin may increase the levels of both medicines.
• Fluconazole, another anti-fungal drug, may increase the level of Clarithromycin.
• Sildenafil, tadalafil or vardenafil (for treating erectile dysfunction). Taking these drugs with Clarithromycin may increase both their levels.
• Tolterodine (used to treat symptoms of overactive bladder syndrome). In certain patients, the levels of tolterodine may be increased when taken with Clarithromycin.
• Methylprednisolone (a corticosteroid used to treat inflammation).
• Vinblastine (a chemotherapy agent used to treat cancer).
• Ziprasidone (an antipsychotic drug).
• Eletriptan (used for migraine).
• Halofantrine (used to treat malaria).
• Aprepitant (used to prevent vomiting during chemotherapy).
• Cilostazol (used to improve circulation in the legs).
• Rifampicin (used to treat tuberculosis).
• Any beta-lactam antibiotics.
• Tacrolimus or cyclosporin (for organ transplants).
• St. John's Wort (a herbal product used to treat depression).
• Phenobarbital (drug for epilepsy).
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 for advice before taking this medicine.
Experience of treating pregnant women and nursing mother is limited. Pregnant women and nursing mothers should be treated only if the expected benefit outweighs the possible risks.
Driving and using machines
Do not drive or use machines if you suffer from one of the following side effects: dizziness, confusion or disorientation.
Clarithromycin Tablets contain lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Clarithromycin Tablets
Always take Clarithromycin Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Clarithromycin can be taken with or without food. The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water).
The recommended dose is given below:
Dosage in adults and adolescents (children over 12 years old):
The recommended dose is 250 mg twice daily. Your doctor may increase the dose to 500 mg twice daily in severe infections. Treatment will last for between 6 and 14 days. Your doctor will decide the duration of your treatment.
105319/4
Please be ready to give the following information:
|
Product name |
Reference number |
|
Clarithromycin 250 mg Film-Coated Tablets |
PL 29831/0476 |
|
Clarithromycin 500 mg Film-Coated Tablets |
PL 29831/0477 |
105319/4
222168
Use in H. pylori infections:
In adult patients with gastro-duodenal ulcers due to H. pylori infection, Clarithromycin as part of the “first line triple therapy” is given in a dosage of 500 mg twice daily.
Patients with kidney problems:
If you have severe kidney problems your doctor may need to reduce your dose by half, i.e. once daily and restrict treatment to 14 days at the most.
Use in children:
Do not give these tablets to children under 12 years. Your doctor will prescr be another suitable medicine for your child.
If you have the impression that the effect of Clarithromycin is too strong or too weak, talk to your doctor or pharmacist.
If you take more Clarithromycin Tablets than you should
If you (or some one else) swallow a lot of the tablets all together, contact your nearest hospital casualty department or your doctor immediately. 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.
An overdose is likely to cause vomiting and stomach pains.
If you forget to take Clarithromycin Tablets
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten tablet. Take the remaining doses at the correct time.
If you stop taking Clarithromycin Tablets
Do not stop taking your medicine because you are feeling better. If the use of Clarithromycin is stopped too early, possibly not all infective bacteria are killed and the infection may return.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
L ke all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor straight away if you or your child experience:
- allergic reactions ranging from skin rash, swollen itchy skin and skin eruption, difficulty in breathing and dizziness to shock (drop of blood pressure, restlessness, weak rapid pulse, clammy skin, reduced consciousness). Uncommon: may affect up to 1 in 100 people.
- severe prolonged diarrhoea. This may indicate a very rare inflammation of the large intestine (pseudomembranous colitis). Very rare: may affect up to 1 in 10,000 people.
- a severe hypersensitivity reaction involving mucous membranes, with (high) fever, red spotted skin, joint pain and/or inflammation of the eyes (Steven-Johnson syndrome) or if you or your child experience a severe sudden hypersensitivity reaction with fever and skin blisters/skin disintegration (toxic epidermal necrolysis). Very rare: may affect up to 1 in 10,000 people.
- liver or gall bladder problems, yellowing of the skin or eyes (jaundice). Uncommon: may affect up to 1 in 100 people.
- nausea, vomiting, abdominal pain and back pain (pancreatitis). Very rare: may affect up to 1 in 10,000 people.
- pain in your lower back, have difficulty passing urine, stop passing urine or if you have blood in your urine which may be signs of kidney problems. Very rare: may affect up to 1 in 10,000 people.
- ringing in the ears (tinnitus). Rare: may affect up to 1 in 1,000 people.
- hearing loss (usually revers ble on withdrawal of treatment). Very rare: may affect up to 1 in 10,000 people.
- reduction in blood cells (thrombocytopenia) with bruises and tendency to bleed. Very rare: may affect up to 1 in 10,000 people.
- fits (convulsions). Very rare: may affect up to 1 in 10,000 people.
Other possible side effects include:
Common side effects (may affect up to 1 in 10 people) include:
• Stomach problems such as nausea, vomiting, indigestion, stomach pains or diarrhoea.
• Change in sense of taste and smell.
• Inflammation of the mouth or tongue, tongue discolouration, thrush in the mouth (causing soreness of the mouth sometimes accompanied by white spots).
• Teeth discolouration (this can usually be corrected by professional cleaning).
• Headache.
• Changes in blood test levels.
• Difficulty sleeping.
Uncommon side effects (may affect up to 1 in 100 people) include:
• Joint and muscle pain.
• Decrease in the number of a type of blood cell (leucocytes), which makes infections more likely.
• Anxiety, nervousness.
• Chest pain or changes in heart rhythm such as palpitations.
Very rare side-effects (may affect up to 1 in 10,000 people) include:
• Bad dreams, hallucinations, disorientation.
• Confusion, depersonalisation, psychosis (a feeling of loss of identity), change in the sense of reality and feeling panicky.
• Depression.
• Dizziness, vertigo, numbness or pins and needles.
• Low blood sugar levels or a ‘hypo' in diabetic patients.
• Liver problems.
Not known (frequency cannot be estimated from the available data)
• Changes in heartbeat/rhythm.
Clarithromycin may worsen the symptoms of myasthenia gravis (a condition in which the muscles become weak and tire easily) in patients who already suffer from this condition.
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. Also, you can help make sure medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/ yellowcard alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday - Friday) or fill in a paper form available from your local pharmacy.
For patients in Malta, please contact the Medicines Authority, details as follows:
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens, GZR-1368 Gzira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
5. How to store Clarithromycin Tablets
Keep this medicine out of the sight and reach of children.
Do not use Clarithromycin Tablets after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product 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 Tablets contain
The active ingredient is clarithromycin.
Each Clarithromycin 250 mg Tablet contains 250 mg of clarithromycin.
Each Clarithromycin 500 mg Tablet contains 500 mg of clarithromycin.
The other ingredients are lactose monohydrate, cellulose microcrystalline, sodium starch glycolate (Type A), hydroxypropyl cellulose, colloidal silicon dioxide, talc, magnesium stearate, purified water, and Opadry Y-1-7000 white.
What Clarithromycin Tablets look like and the contents of the pack
Each Clarithromycin Tablet is a white to off white, oval shaped, film coated tablet.
Clarithromycin 250 mg Tablets are debossed with ‘W954' on one side and plain on the other side.
Clarithromycin 500 mg Tablets are debossed with ‘W949' on one side and plain on the other side.
Both 250 mg and 500 mg Clarithromycin Tablets are available in the following packs:
PVC-PVdC blister packs containing 14 tablets. The blisters are packaged in a carton.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only).
This is a service provided by the Royal National Institute of Blind People.
These medicinal products are authorised in the Member States of the EEA under the following names:
UK: Clarithromycin 250mg Film-Coated Tablets and Clarithromycin 500mg Film-Coated Tablets. Malta: Clarithromycin 250mg Film-Coated Tablets and Clarithromycin 500mg Film-Coated Tablets.
This leaflet was last revised in 07/2016.