Mycifor Xl 500mg Prolonged Release Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYCIFOR XL
500mg PROLONGED RELEASE TABLETS
(Clarithromycin)
Please read this leaflet carefully before you start to take this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please 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.
I n this leaflet:
1. What Mycifor XL tablets are and what they are used for
2. Before you take Mycifor XL tablets
3. How to take Mycifor XL tablets
4. Possible side effects
5. How to store Mycifor XL tablets
6. Further information
1. WHAT MYCI FOR XL TABLETS ARE AND WHAT THEY ARE USED FOR
Mycifor XL 500mg prolonged release tablets, referred to as Mycifor XL tablets throughout this leaflet, contain the active ingredient clarithromycin. This medicine is an antibiotic belonging to a group called the macrolides. Antibiotics stop the growth of bacteria (bugs) which cause infections.
Mycifor XL tablets are used to treat bacterial infections such as:
• Chest infections such as bronchitis and pneumonia (infection of the lungs)
• Sinusitis (infection of the sinuses)
• Pharyngitis and tonsillitis (infection of the throat or tonsils)
• Skin and soft tissue infections that are mild to moderate in severity Mycifor XL tablets are prolonged release tablets which means that the active ingredient is released slowly from the tablet so that you only have to take them once a day.
2. BEFORE YOU TAKE MYCIFOR XL TABLETS
Do not take Mycifor XL tablets
Tell your doctor before taking Mycifor XL tablets if you think any of these apply to you:
• If you are allergic (hypersensitive) to clarithromycin or any other macrolide antibiotics such as erythromycin or azithromycin or any of the other ingredients in Mycifor XL tablets (see section 6).
• If you are taking the following medications. Consult your doctor for advice on alternative medicines or ask if you are not sure:
- Ergotamine or dihydroergotamine tablets or use
ergotamine inhalers (medicines used to treat migraines). Combining these with Mycifor XL tablets may cause your blood vessels to narrow. This will lead to a decrease of blood supply to tissues.
- Cisapride (to treat stomach disorders), pimozide (to treat some mental illnesses), terfenadine or astemizole (to treat hay fever or allergy). Combining these medicines with Mycifor XL tablets can cause serious changes in your heart rhythm.
- Lovastatin or simvastatin (HMG-CoA reductase inhibitors, commonly known as statins, used to lower levels of cholesterol (a type of fat) in the blood).
• If your potassium levels are low (hypokalaemia)
• If you have severe liver disease with kidney disease
• If you have an irregular heart rhythm.
Take special care with Mycifor XL tablets Tell your doctor or pharmacist if you:
• Have any kidney problems
• Have liver problems
• Have, or are prone to, fungal infections (such as thrush)
• Are pregnant or breast-feeding.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription or if you are taking herbal remedies.
You should not take Mycifor XL tablets if you are taking any of the following medicines (see ‘Do not take Mycifor XL tablets'):
• Cisapride (to treat stomach disorders)
• Pimozide (to treat mental illness)
• Terfenadine or astemizole (to treat hay fever or allergies)
• Ergotamine or dihydroergotamine (to treat migraines)
• Lovastatin or simvastatin (to treat high cholesterol)
Tell your doctor if you are taking any of the following medicines. Because of the possibility of reactions your doctor will decide if you can still take Mycifor XL tablets:
• Colchicine (usually taken for gout). This may increase your risk of side effects and lead to potential toxicity.
• Digoxin (to treat heart failure). It may cause irregular heart beat and may also increase your risk of side effects.
• Quinidine or disopyramide (to treat abnormal heart rhythm). This may cause you to experience seriously irregular heart beat.
• Warfarin or acenocoumarol (to thin the blood). These medicines may change the rate at which your blood clots. This might result in toxic effects.
• Triazolam, alprazolam or midazolam (sedatives).
These medicines may cause sleepiness and confusion.
• Rosuvastatin, atorvastatin (to treat high cholesterol). These medicines may lead to pain or weakness in muscles, or abnormal muscle breakdown. This can lead to kidney problems.
• Zidovudine (anti-viral agent). This may change the effectiveness of zidovudine.
• Rifabutin, rifampicin, rifapentin (to treat some infections). These medicines may change the effectiveness of Mycifor XL tablets.
• Efavirenz, nevirapine (HIV treatments). These medicines may change the effectiveness Mycifor XL tablets.
Taking the following medicines with Mycifor XL tablets may increase your risk of side effects. Tell your doctor if you are taking any of the following:
• Carbamazepine, valproate, phenobarbital or phenytoin
(to treat epilepsy)
• Cilostazol (to treat poor circulation)
• Methylprednisolone (to treat inflammation)
• Sildenafil, tadalafil, vardenafil (to treat erection problems)
• Vinblastine (to treat cancer)
• Tolterodine (to treat urinary frequency)
• Omeprazole (to treat indigestion)
• Cyclosporin, tacrolimus, sirolimus (to help prevent rejection after a transplant)
• Theophylline (to treat asthma)
• Itraconazole or fluconazole (to treat fungal infections)
• Etavirine, ritonavir, atazanavir, saquinavir (anti-viral and anti-HIV medicines)
• Nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (to treat diabetes)
• Verapramil (to treat high blood pressure)
• St John’s Wort (a herbal product)
Taking Mycifor XL tablets with food and drink Mycifor XL tablets should be taken with food.
Pregnancy and breast-feeding
Do not take Mycifor XL tablets if you are pregnant without consulting your doctor first. Your doctor will determine if the benefits to you outweigh the risk to the baby.
Do not take Mycifor XL tablets if you are breast-feeding without consulting your doctor first. This is because small amounts of this medicine can pass into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant; intend to become pregnant or are breast-feeding.
Driving and using machines
Mycifor XL tablets may cause dizziness or a spinning feeling (vertigo) as a possible side effect. If you experience these effects you should not drive or operate machines.
Important information about some of the ingredients of Mycifor XL tablets
Mycifor XL tablets contain lactose (a kind of sugar). If you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE Mycifor XL TABLETS
Always take Mycifor XL tablets exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
How to take
Mycifor XL tablets should be taken with food and must be swallowed whole and not chewed.
Dosage
The usual dose of Mycifor XL for adults and children over 12 years of age is 500mg once daily for 7 to 14 days. Your doctor may increase t he dose to two 500mg tablets daily to treat severe infections.
Use in children
This medicine is not suitable for children under 12 years of age. Your doctor can advise you of other medicines which may be more suitable for younger children.
If you take more Mycifor XL than you should
If you accidentally take more than two Mycifor XL tablets in one day, or i f a child accidentally swallows some tablets, seek medical advice immediately. An overdose of Mycifor XL tablets is likely to cause vomiting and stomach pains and there is a possibility of allergic reactions.
If you forget to take Mycifor XL
If you forget to take a Mycifor XL 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 Mycifor XL
Do not stop taking Mycifor XL because you feel better. It is important to take the tablets for as long as your doctor has told you to, otherwise the infection might come back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Mycifor XL tablets can have side effects, although not everyone gets them.
Stop taking Mycifor XL tablets and contact your doctor immediately if any of the following side effects occur:
• Allergic reactions such as:
- swelling of the face, lips, throat or tongue
- difficulty breathing or swallowing
- skin flushing and/or dizziness or fainting You may need emergency treatment.
• Severe or prolonged diarrhoea, which may have blood or mucus in it (pseudomembranous colitis)
• Blistering of the skin, mouth, eyes or genitals (Stevens-Johnson syndrome)
• Henoch-Schonlein purpura (a rash which appears as purple spots on the skin)
• Yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, tender abdomen or loss of appetite (signs of liver problems)
These side effects listed above are rare but serious.
Tell your doctor if any of the following side effects occur: Common side effects
• increased levels of urea in the blood (detected in laboratory tests)
• change in sense of taste, headache
• abdominal pain, diarrhoea, indigestion, feeling sick, vomiting, bloating
• difficulty sleeping
• skin rash
• increased sweating
Other less common side effects
• presence of protein, blood or white blood cells in the urine, changes in liver or kidney function tests or blood tests, prothrombin time prolongation (increased blood clotting time)
• leucopenia (reduction in the number of white blood cells, which makes infections more likely), anaemia (decrease in red blood cells, which can make the skin pale and cause weakness and breathlessness), eosinophilia (blood disorder), thrombocythaemia (increase in blood platelets, which increases the risk of bleeding or blood clots)
• dizziness, tremor (shaking)
• tinnitus (ringing in the ears) or hearing loss, vertigo (spinning sensation)
• constipation, dry mouth, belching, flatulence (wind), bleeding from stomach and intestines redness of skin, scaling, itching, rash, rash with raised bumps, rash with pus, dry skin or eczema
• Henoch-Schonlein purpura (a rash which appears as purple spots on the skin)
• back, joint or muscle pain
• if you suffer from myasthenia gravis (a condition in which the muscles become weak and tire easily) clarithromycin may worsen these symptoms
• gastroenteritis (inflammation of the stomach and intestines), oral thrush, vaginal bacterial or fungal infection
• allergic reactions ranging from urticaria (nettle rash), mild skin eruptions and angioedema (swelling of the hands and face) to anaphylaxis (severe allergic reaction)
• liver dysfunction or hepatitis (inflammation of the liver), cholestasis (obstruction of bile), jaundice (yellowing of the skin and whites of the eyes), hyperbilirubinaemia (increase of bilirubin in blood)
• depression, sleepiness or difficulty in sleeping, nervousness
• anorexia (loss of appetite)
• widening of blood vessels
• shortness of breath or other problems with breathing including asthma
• feeling of weakness or discomfort, lethargy, fatigue, thirst, water retention in face (oedema), general feeling of being unwell, chest pain or any other pain
• loss of taste or smell or inability to smell properly
• discolouration of the tongue or teeth
• inflammation of the mouth or tongue
• heart rhythm disturbances or palpitations
• hypoglycaemia (low blood sugar)
• life-threatening irregular heart beat
• thrombocytopenia (reduction in blood platelets, which increases the risk of bleeding or bruising)
• tingling or numbness of limbs, convulsions (fits)
• pancreatitis (inflammation of the pancreas), pseudomembranous colitis (infection of the bowel)
• kidney failure, interstitial nephritis (inflammation of the kidneys)
• Steven-Johnson syndrome or toxic epidermal necrolysis (severe peeling and blistering of the skin)
• liver failure
• bad dreams, anxiety, confusion, depersonalisation (out of body feeling), disorientation (not knowing where you are), hallucinations, psychosis (mental illness)
• acne
• deafness
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.
5. HOW TO STORE MYCIFOR XL TABLETS
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Keep Mycifor XL tablets in the original packaging. Do not use Mycifor XL tablets after the expiry date which is stated on the 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.
6. FURTHER INFORMATION
What Mycifor XL tablets contain
• The active ingredient is clarithromycin. Each tablet contains 500mg of clarithromycin.
• The other ingredients are: lactose monohydrate, hypromellose, hypromellose phthalate, magnesium stearate, talc, macrogol 4000, titanium dioxide (E171) and quinoline yellow (E104b).
What Mycifor XL tablets look like and the contents of the pack
Mycifor XL tablets are yellow, oblong-shaped, biconvex tablets. They are available in blister packs containing 7 (1x7) or 14 (2x7) tablets.
Marketing Authorisation Holder
IQ Pharma Limited, Westbourne, Gorse Bank Lane,
Baslow, Derbyshire, DE45 1SG, United Kingdom Manufacturer/Importer
Forum Products Ltd, Crown House, 2-8 Gloucester Road,
Redhill, Surrey, RH1 1FH
Distributor
Kent Pharmaceuticals Ltd, Repton Road, Measham, DE 12 7DT Revision Date: September 2014 UK003
2
