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MYCIFOR XL 500MG PROLONGED RELEASE TABLETS

Active substance(s): CLARITHROMYCIN CITRATE

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Aw. No.: 20000XXXX

Mycifor XL Leaf

Front

Back

PATIENT INFORMATION LEAFLET ON

500mg PROLONGED RELEASE TABLETS
(Clarithromycin)
medicine because it contains important information for you.

• 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.
See section 4.
1. What Mycifor XL tablets are and what they are used for
2. What you need to know 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. Contents of the pack and other information
1. What Mycifor XL tablets are and what they are used for
Mycifor XL 500mg prolonged release tablets, referred to as Mycifor
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 infections such as:
• Chest infections such as bronchitis and pneumonia
• Throat and sinus infections
• Pharyngitis and tonsillitis
• Mild to moderate skin and tissue infections e.g. cellulitis,
folliculitis or erysipelas.
Mycifor XL Tablets are used in adults and children 12 years and
older.
2. What you need to know before taking Mycifor XL tablets
Do not take Mycifor XL tablets:
• 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)
• if you are taking medicines called ergot alkaloid tablets (e.g.
ergotamine or dihydroergotamine) or use ergotamine
inhalers for migraine
• if you are taking medicines called terfenadine or astemizole
(widely taken for hay fever or allergies) or cisapride (for
stomach problems) or pimozide (for mental health problems)
as combining these drugs can sometimes cause serious
disturbances in heart rhythm
• if you are taking other medicines which are known to cause
serious disturbances in heart rhythm
• if you 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)
• if you are taking oral midazolam (a sedative)
• if you have low levels of potassium in the blood (a condition
known as hypokalaemia)
• if you have severe liver disease with kidney disease
• if you have an irregular heart rhythm
• if you are taking medicines called ticagrelor or ranolazine (for
heart attack, chest pain or angina)
• if you or someone in your family has a history of heart rhythm
disorders (ventricular cardiac arrhythmia, including torsades
de pointes) or abnormality of electrocardiogram (ECG, electrical
recording of the heart) called “long QT syndrome”
• if you are taking colchicine (usually taken for gout).
Take special care with Mycifor XL tablets
• If you have abnormally low levels of magnesium in your blood
(hypomagnesaemia) consult your doctor before taking these
tablets.
Mycifor XL tablets are not suitable for use in children under
12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Mycifor XL tablets
• if you have any liver or kidney problems

K

3. How to take Mycifor XL tablets
Do not give these tablets to children under 12 years. Your doctor
will prescribe another suitable medicine for your child.
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 for adults and children over 12 years is
one 500 mg tablet once a day for 7 to 14 days.
Your doctor may increase the dose to two 500 mg tablets daily in
severe infections. Mycifor XL tablets should be taken with food and
must be swallowed whole and not chewed.
If you take more Mycifor XL tablets than you should
If you accidentally take more Mycifor XL 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 Mycifor XL tablets is likely
to cause vomiting and stomach pains.

Front

Dimension : 170 x 285mm
Paper should be Maplitho (60 GSM)
iQ/MYC/500/P/V2/P3

Packaging Development

• if you have heart problems (e.g. heart disease, heart failure, an
unusually slow heart hate, or low levels of magnesium in the
blood)
• if you have, or are prone to, fungal infections (e.g. thrush)
• if you are pregnant or breast-feeding
• if you have an intolerance to any sugars as Mycifor XL tablets
contain lactose.
Other medicines and Mycifor XL 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
asthma)
• triazolam, alprazolam or intravenous or oromucosal
midazolam (sedatives)
• cilostazol (for poor circulation)
• omeprazole (for treatment of indigestion and gastric ulcers)
• 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)
, itraconazole
• rifabutin, rifampicin, rifapentine,
(used in the treatment of certain bacterial infections)
• tolterodine (for overactive bladder)
• verapamil, amlodipine, diltiazem (for high blood pressure)
,
and
(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)
• quetiapine or other antipsychotic medicines.
Mycifor 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 Mycifor XL tablets in
pregnancy and breast-feeding is not known.
Driving and Using Machines:
Mycifor XL 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.
Mycifor XL tablets contains Lactose
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicine.

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Regulatory Affairs

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Quality Assurance

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If you forget to take Mycifor XL tablets
If you forget to take a dose of Mycifor XL tablets, take it as soon
as you remember. 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 Mycifor XL tablets
Do not stop taking Mycifor XL 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, this medicine 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

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 are 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 (may affect up to 1 in 10 people) include:

• changes in sense of taste
• headache
• widening of blood vessels
• stomach problems such as feeling sick, vomiting, stomach pain,
indigestion, diarrhoea
• a change in the way your liver works
• skin rash
• increased sweating.
Uncommon side effects (may affect up to 1 in 100 people)
include:
• high temperature
• swelling, redness or itchiness of the skin
• oral or vaginal ‘thrush’ (a fungal infection)

• decrease of the levels of blood platelets (blood platelets help
stop bleeding)
• decrease in white blood cells (leukopenia)
• decrease in neutrophils (neutropenia)
• stiffness
• chills
• increase of eosinophils (white blood cells involved in immunity)
• exaggerated immune response to a foreign agent
• lack or loss of appetite
• anxiety, nervousness
• drowsiness, tiredness, dizziness or shaking
• involuntary muscle movements
• vertigo
• ringing in the ears or hearing loss
• chest pain or changes in heart rhythm such as palpitations or an
irregular heartbeat
• asthma: lung disease associated with tightening of air passages,
• nose bleed
• blood clot that causes sudden blockage in a lung artery
(pulmonary embolism)

the stomach
• anal pain

• bloating, constipation, wind, burping
• dry mouth




duodenum (cholestasis)

• muscle spasms, 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
• raised abnormal kidney and liver function blood test and raised
blood tests
• feeling weak, tired and having no energy.
Not known side effects (frequency cannot be estimated from
the available data):

• bacterial infection of the outer layers of the skin
• reduction in the level of certain blood cells (which can make
infections more likely or increase the risk of bruising or bleeding)
• swelling of the lips and eyes
• confusion, loss of bearing, hallucinations (seeing things), change
in sense of reality or panicking, depression, abnormal dreams
or nightmares and mania (feeling of elation or over-excitement)

• paraesthesia, more commonly known as ‘pins and needles’
• loss of taste or smell or inability to smell properly
• type of heart rhythm disorder (Torsade de pointes, ventricular
tachycardia)
• loss of blood (haemorrhage)

• discolouration of the tongue or teeth

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)
• Stevens-Johnson syndrome: skin condition that causes painful
blisters and sores of the skin and mucous membranes,
especially in the mouth
• rare allergic skin reactions which cause severe illness with
ulceration of the mouth, lips and skin which causes severe
(DRESS)
• acne
• change in the levels of products produced by the kidney,
face, abdomen, thighs or ankles or problems with urination).
• Contact a doctor immediately if you experience a serious skin
reaction: a red, scaly rash with bumps under the skin and blisters
(exanthematous pustulosis).
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card on
Google Play or Apple App Store.
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Mycifor XL Tablets
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
This medicinal product does not require any special temperature
storage conditions. Store in the original packaging. Do not use this
medicine after the expiry date which is stated on the carton. The
expiry date refers to the last day of that month.
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 Mycifor XL tablets contains
• The active substance is clarithromycin. Each tablet contains
500mg of clarithromycin.
• The other ingredients are: lactose monohydrate, hypromellose,
hypromellose phthalate, magnesium stearate, talc, macrogol
400, 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
Elara Pharmaservices Ltd, Derby, DE74 2QD

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Further information

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