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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
• 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
• 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
In 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
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
• 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.
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.

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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
• 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.
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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
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.
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 the 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 if 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.
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
• 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
• constipation, dry mouth, belching, flatulence (wind), bleeding from
stomach and intestines
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• 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
• 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.
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.
What Mycifor XL tablets contain
• The active ingredient is clarithromycin. Each tablet contains 500mg of
• 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
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
Quantum Generics, Crown House, 2-8 Gloucester Road, Redhill, Surrey,
Forum Products Ltd, Crown House, 2-8 Gloucester Road, Redhill, Surrey,
Kent Pharmaceuticals Ltd, Repton Road, Measham, DE 12 7DT
Revision Date: September 2014

16/09/2014 09:41

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.