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XETININ XL 500MG PROLONGED RELEASE TABLETS

Active substance(s): CLARITHROMYCIN CITRATE

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Xetinin XL 500mg Prolonged Release Tablets
Clarithromycin

Read all of this leaflet carefully before you start taking
this medicine.
! 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. 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.
In this leaflet:
1. What Xetinin XL Tablets are and what they are used for
2. Before you take Xetinin XL Tablets
3. How to take Xetinin XL Tablets
4. Possible side effects
5. How to store Xetinin XL Tablets
6. Further information
1. WHAT XETININ XL TABLETS ARE AND WHAT THEY
ARE USED FOR
Xetinin XL 500mg Prolonged Release Tablets (Called Xetinin
XL Tablets in this leaflet) contain the active ingredient
clarithromycin citrate. Clarithromycin belongs to a group of
drugs called macrolide antibiotics which are used in the
treatment of:
1. chest infections such as bronchitis and pneumonia
2. sinus infection
3. skin and soft tissue infections (mild to moderate severity)
2. BEFORE YOU TAKE XETININ XL TABLETS
Do not take Xetinin XL Tablets if you
! are allergic to clarithromycin or other macrolide antibiotics
such as erythromycin or azithromycin.
! are taking the following, you should consult your doctor for
advice on alternative medicines:
, colchicine (for gout)
, ergotamine or dihydroergotamine tablets or use
ergotamine inhalers for migraine
, cisapride (for stomach disorders), pimozide (for some
mental illnesses), terfenadine and astemizole (for hay
fever or allergy) or other macrolide antibiotics, as
combining these drugs with clarithromycin can
sometimes cause serious disturbances in heart
rhythm. Consult your doctor for advice on alternative
medicines.
! have serious kidney or liver problems, consult your doctor
immediately.
! have or someone in your family is known to have an
abnormality of electrocardiogram (ECG) called 'long QT
syndrome'.
Take special care with XETININ XL Tablets
! if you have liver problems
! if you have kidney problems
! If you develop severe or prolonged diarrhoea during or
after taking Xetinin XL Tablets
! If your potassium levels are low (hypokalaemia).
If any of the above apply to you, please tell your doctor
immediately.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
! Digoxin, quinidine or disopyramide (heart drugs)
! Warfarin or other drugs to thin the blood
! Ergotamine, dihydroergotamine or eletriptan (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)
! Cilostazol (for poor circulation)

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Simvastatin or lovastatin (for high cholesterol)
Cisapride or omeprazole (for stomach disorders)
Itraconazole or fluconazole (for fungal infections)
Tolterodine (for overactive bladder)
Aprepitant (for preventing vomiting during chemotherapy)
Methylprednisolone (a corticosteroid)
Vinblastine (for treatment of cancer)
Sildenafil, tadalafil or vardenafil (for impotence)
Cyclosporin (immune suppressant)
Pimozide or ziprasidone (for psychiatric conditions)
Zidovudine, ritonavir, atazanavir, saquinavir, nevirapine or
efavirenz (anti-viral [anti-HIV] drugs)
Rifabutin or rifampicin (for treatment of some infections
such as tuberculosis)
Tacrolimus (for organ transplants).

Xetinin XL Tablets do not interact with oral contraceptives.
Taking Xetinin XL Tablets with food and drink
The tablets should be taken with food and must be swallowed
whole and not chewed.
Pregnancy and breast-feeding
Do not take Xetinin XL Tablets if you are pregnant or breast
feeding without consulting your doctor or pharmacist.
Driving and using machines
Do not drive or operate machinery if you feel dizzy, drowsy or
confused while taking this medicine.
Important information about some of the ingredients of
Xetinin XL Tablets
Xetinin XL Tablets contain lactose. If you have been told by
your doctor that you have intolerance to some sugars, contact
your doctor before taking this medicinal product.
3. HOW TO TAKE XETININ XL TABLETS
Always take Xetinin XL Tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if you
are not sure. The usual dose in:
Adults and children over 12 years: One (1) 500mg tablet
daily for seven (7) to fourteen (14) days. Your doctor may
increase the dose to two (2) 500mg tablets daily in severe
infections.
Children under 12 years: Not recommended.
If you take more Xetinin XL Tablets than you should
If you (or someone else) swallow a lot of tablets at the same
time, or you think a child may have swallowed any contact
your nearest hospital casualty department or tell your doctor
immediately.
If you forget to take Xetinin XL Tablets
Take the missed dose as soon as you remember, unless it's
nearly time for the next dose. Do not take two doses at the
same time to make up for forgotten individual doses.
If you stop taking Xetinin XL Tablets
Do not stop taking Xetinin XL Tablets because 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, clarithromycin can cause side effects,
although not everybody gets them.
Very common: Affects more than 1 people in 10.
Common: Affects 1 to 10 people in 100.
Uncommon: Affects 1 to 10 people in 1,000.
Rare: Affects 1 to 10 people in 10,000.
Very rare: Affects less than 1 people in 10,000.
Not known: Frequency cannot be estimated from the available
data.

If any of the following happen, stop taking Xetinin XL and tell
your doctor immediately or go to your nearest hospital
emergency department:
! Severe pain in the abdomen and back caused by
inflammation of the pancreas.
! Severe diarrhoea with blood in the stools during or after
taking Xetinin XL Tablets. Diarrhoea may occur over two
months after treatment with Xetinin XL Tablets.
! Dark urine, pale stools, jaundice (yellowing of the skin
and/or eyes), nausea, fever.
! Allergic reactions including rashes have been reported
with Xetinin XL Tablets. In very rare cases, difficulty in
breathing, fainting and swelling of the face and throat can
occur which may need emergency treatment. Allergic
rashes may range in severity from mild itchy skin eruptions
to a rarer, more serious condition called Stevens-Johnson
syndrome (which may cause ulceration of the mouth, lips
and skin) or toxic epidermal necrolysis (which causes
severe illness and sloughing of the skin).
! In the unlikely event that your infection has been caused
by a bug which Xetinin XL Tablets cannot treat, your
symptoms may get worse.
If this happens, you should consult your doctor.
Common side effects (Affects more than 1 people in 10)
include;
! feeling sick
, vomiting
, stomach pain
, indigestion
, diarrhoea
! headache
! changes in sense of taste or smell
Uncommon side effects (Affects 1 to 10 people in 1000)
include;
! Inflammation of the stomach and intestine, oral thrush,
rash, inflammation of the nose causing it to run, vaginal
thrush and vaginal infections.
! Low levels of white blood cells, anaemia, other white blood
cell disorders and an excessive level of platelets in the
blood (blood cells that help you stop bleeding) leading to
abnormal blood clotting or bleeding.
! Anorexia, increased appetite and other nutrition disorders
! Psychiatric disorders such as depression, difficulty
sleeping (insomnia), nervousness and feeling sleepy.
! Dizziness, headache and tremor.
! Conjunctivitis (inflammation of the eyes) and visual
disturbances.
! Ringing in the ears, vertigo and ear disorders.
! Vasodilation (flushing).
! Asthma, shortness of breath and other lung disorders.
! Bloating (excess gas in the stomach), constipation, dry
mouth, burping, passing gas, bleeding from the stomach,
inflammation of the corners of the mouth, tongue
discolouration, vomiting and other stomach and intestine
disorders.
! Yellowing of the skin and eyes (jaundice).
! Dry skin, eczema, itching of the skin, rash, hives, and
excessive perspiration.
! Back, joint or muscle pain.
! Kidney disorders including the presence of protein and
blood in urine, passing urine with pus (if you have a urine
test).
! Genital discharge.
! Lack of energy, chest pain, swelling of face, a feeling of
general discomfort, pain and thirst.
! If you have a blood test while taking (product name), it may
show raised liver enzymes and abnormal liver function test
results. The presence of protein in the urine and other
abnormalities may show the presence of kidney disorders.
A decrease in clotting factor, prothrombin time
prolongation (increased blood clotting time) and an
increase in other enzymes may also be detected.
Changes in laboratory test values such as chloride, uric
acid and calcium.
Very rare side effects: (Affects less than 1 people in
10,000) include;
! Tingling or numbness of limbs

Not known frequency of occurrence (frequency cannot
be estimated from the available data) include;
! Decrease in platelets (blood cells that help you stop
bleeding)
! Low blood sugar levels
! Psychiatric disorders such as abnormal dreams, anxiety,
confusional state, depersonalisation, disorientation,
hallucination (seeing things) and other psychotic
disorders
! Convulsions and change in the sense of smell
! Deafness
! Abnormal electric activity tracing of the heart (ECG),
changes in heart rhythm
! Inflammation of the tongue and tooth discolouration
! Liver failure, abnormal liver function or hepatitis
! Inflammation of the kidneys and
! Liver enzymes increased.
Inflammation of the colon (Pseudomembranous colitis) has
been reported with nearly all antibacterial medicines including
clarithromycin. Its symptoms include diarrhoea after taking
clarithromycin. Please inform your doctor immediately if you
suffer from diarrhoea.
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.
5. HOW TO STORE XETININ XL TABLETS
This medicinal product does not require any special storage
conditions.
Keep out of the reach and sight of children.
Do not use Xetinin 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 Xetinin XL Tablets contain
The active substance is clarithromycin citrate. Each
prolonged-release tablet contains clarithromycin citrate
equivalent to clarithromycin 500mg.
The other ingredients in the tablet core are Lactose
Monohydrate, Hypromellose, Hypromellose Phthalate, Talc,
Magnesium Stearate. The tablet coating contains
Hypromellose, Macrogol, Quinoline Yellow Aluminium Lake
(E104), Talc and Titanium Dioxide (E171)
What Xetinin XL Tablets looks like and contents of the
pack
Xetinin XL Tablets are yellow coloured, film coated, oblong
shaped, biconvex tablets, with both sides plain.
They are available in blister packs of 7, 10, 14, 20, 28, 30, 56,
60, 84, 90, 100 and 112 film coated tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road, Leicester
LE3 0PA, United Kingdom
Manufacturer
Morningside Pharmaceuticals Ltd
Pavilion Way, Loughborough,
LE11 5GW, United Kingdom
This medicinal product is authorised in the Member
States of the EEA under the following names:
UK: Xetinin XL
IE: Clorom XL
This leaflet was last approved in 02/2011

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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.

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