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XETININ XL 500MG PROLONGED RELEASE TABLETS

Active substance(s): CLARITHROMYCIN CITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Xetinin XL

500mg Prolonged Release Tablets

Clarithromycin

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 Xetinin XL Tablets are and what they are used for
2. What you need to know 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. Contents of the pack and other 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 medicines called
macrolide antibiotics. Antibiotics stop the growth of bacteria
(bugs) which cause infections. Xetinin XL Tablets are used to treat
infections such as:
1. Chest infections such as bronchitis and pneumonia
2. Throat and sinus infection
3. Mild to moderate skin and tissue infections, e.g. cellulitis,
folliculitis or erysipelas.
Xetinin XL Tablets are used in adults and children 12 years and
older.
2. What you need to know 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 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. Consult your doctor for advice on
alternative medicines.
• 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 (an oral sedative).
• If you have abnormally low levels of potassium in your blood
(hypokalemia).
• If you have severe liver disease with kidney disease.
• If you or someone in your family has a history of heart rhythm
disorders (ventricular cardiac arrythmia inclduing torsades de
pointes) or abnormality cardiogram (ECG, electrical recording of
the heart) called “long QT syndrome”.
• If you are taking medicines called ticagrelor or ranolzaline (for
heart attack. chest pain or angina).
• If you are taking colchicine (usually taken for gout).
Warning and precautions
Talk to your doctor or pharmacist before taking Xetinin XL Tablets
• If you have heart problems (e.g. heart diasease, heart failure,
an unusually slow heart rate, or low levels of magnesium in the
blood also called hypomagnesaemia).
• If you have any liver or kidney problems.
• 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 Xetinin XL Tablets
contain lactose.
Children under 12 years
Xetinin XL Tablets are not suitable for use in children under 12 years
of age.
Other medicines and Xetinin XL Tablets
Please tell your doctor or pharmacist if you are taking or have
recently taken or might take any other medicines, including
medicines obtained without a prescription.
Do not take Xetinin XL Tablets if you are taking any of the
medicines listed in the section “Do not take Xetinin XL Tablets”
above.
Tell your doctor if you are taking any of the following medicines as
the dose may need to be changed or you may need to have regular
tests performed:
• Digoxin, quinidine or disopyramide (for heart problems).
• Warfarin or other drugs (for thinning the blood).
• Carbamazepine, valproate or phenytoin (for epilepsy).
• Atorvastatin, rosuvastatin (HMG-CoA reductase inhibitors,
commonly known as statins, used to lower levels of cholesterol
(a type of fat) in the blood. Statins can cause rhabdomyolysis (a
condition which causes breakdown of muscle tissue which can
result in kidney damage) and signs of myopathy (muscle pain or
muscle weakmess) should be monitored.
• Nategilinide, pioglitzone, repaglinide, rosiglitazone or insulin
(used to lower blood glucose levels).
• Gliclazide or glimepiride (sulfonylureas used in tretament of
type II diabetes).

• Theophylline (used in patients with breathing difficulties such as
asthma).
• Triazolam, alprazolam (sedatives).
• Cilostazol (for poor circulation).
• Omeprazole (for stomach disorders).
• Itraconazole or fluconazole (for fungal infections).
• Tolterodine (for overactive bladder).
• Verapamil, amlodipine, diltiazem (for high blood pressure).
• Aprepitant (for preventing vomiting during chemotherapy).
• Methylprednisolone (a corticosteroid).
• Vinblastine (for treatment of cancer).
• Sildenafil, tadalafil are vardenafil (for impotence in adult males
or for use in pulmonary arterial hypertension (high blood
pressure in the blood vessels in the lung)).
• Cyclosporin, sirolimus and tacrolimus (immune suppressants).
• St John’s Wort (a herbal prduct used to treat depression).
• Quetiapine or other antipsychotic medicines.
• Lincomycin and clindamycin (lincosamides - a type of
antibiotic).
• Ziprasidone (for psychiatric conditions).
• Zidovudine, ritonavir, atazanavir, saquinavir, etravirine,
nevirapine or efavirenz (anti-viral drugs used in treatment of
HIV).
• Rifabutin, rifampicin, rifapentine, fluconazole, itraconazole (for
treatment of some bacterial infections such as tuberculosis).
• Tacrolimus (for organ transplants).
Xetinin XL Tablets do not interact with oral contraceptives.
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
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 Xetinin XL Tablets in pregnancy
and breast-feeding is not known.
Driving and using machines
Xetinin 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.
Xetinin XL Tablets contain lactose
Xetinin XL Tablets contain lactose. 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 Xetinin XL Tablets
Do not give Xetinin XL Tablets to children under 12 year. Your doctor
will prescribe another suitable medicine for your child.
Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
The usual dose of Xetinin XL Tablets for adults and children over 12
years is one 500 mg tablet once a day for 6 to 14 days.
Your doctor may increase the dose to two 500 mg tablets daily in
severe Infections. Xetinin XL Tablets should be taken with food and
must be swallowed whole and not chewed.
If you take more Xetinin XL Tablets than you should
If you accidentally take more Xetinin XL Tablets in one day than your
doctor has told you to, or if a child accidentally swallow some tablets,
contact your doctor or nearest hospital emergency department
immediately. An overdose of Xetinin XL Tablets is likely to cause
vomiting and stomach pains.
If you forget to take Xetinin XL Tablets
If you forget to take a dose of Xetinin XL Tablets, take it as soon
as you remember. Do not take more tablets in one day unless your
doctor has told you to. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Xetinin XL Tablets
Do not stop taking Xetinin XL Tablets, even if you feel better. It is
Important to take the tablet 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 any of the following happen, stop taking Xetinin XL Tablets 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.
• Inflammation of the colon (Pseudomembranous colitis) has
been reported with nearly all antibacterial medicines including
clarithromycin. Its symptoms include diarrhoea or severe
prolonged diarrhoea, which may have blood or mucus in it.
Diarrohea may occur over two months after treatment with
clarithromycin, in which case you should still contact your
doctor.
• Dark urine, pale stools, jaundice (yellowing of the skin and/or
eyes), skin irritations, nausea, fever, tender abdomen or loss
of apetite. These are signs that your liver may not be working
properly.
• Allergic reactions including asthma: lung disease associated
with tightening of air passages, making breathing difficult,
shortness of breath and other lung disorders.
• A rash, difficulty in breathing, fainting and swelling of the face

and throat. This is a sign that you may have developed an
allergic reactions. Severe reactions such as blistering of the
skin, mouth, lips, eyes and genitals (symptoms of rare allergic
reaction called Stevens-Johnson syndrome/toxic epidermal
necrolysis) or a red, scaly rash with bumps under the skin and
blisters (exanthematous pustulosis).
• Muscle pain or weakness known as rhabdmyolysis (a condition
which causes the breakdown of muscle tissue which can result
in kidney damage).
• Reduction in the level of certain blood cells (which can
make infections more likely or increase the risk of bruising or
bleeding).
• Abnormal electric activity tracing of the heart (ECG), type
of heart rhythm disorder (Torsade de pointes, ventricular
tachycardia).
• Rare allergic skin reactions which causes severe illness with
ulceration of the mouth, lips and skin which causes severe
illness with rash, fever and inflammation of internal organs
(DRESS).
OTHER SIDE EFFECTS:
Common (may affect up to 1 in 10 people):
• Difficulty sleeping.
• Widening of blood vessels.
• Increased sweating.
• Headache.
• Changes in sense of taste or smell.
Uncommon (may affect up to 1 in 100 people):
• High temperature.
• Inflammation of the stomach and intestine, oral thrush, rash,
inflammation of the nose causing it to run, vaginal thrush and
vaginal infections.
• Stiffness.
• Chills.
• Increase in number of eosinophills (white blood cells involved in
immunity).
• Exaggerated immune response to a foreign agent.
• Lack or loss of apetite.
• Anxiety, nervousness.
• Drowsiness, tirednes, dizziness or shaking.
• Involuntary muscle movements.
• Blood clot that causes sudden blockage in a lung artery
(pulmonary embolism).
• Psychiatric disorders such as depression and feeling sleepy.
• Conjunctivitis (inflammation of the eyes) and visual
disturbances.
• Ringing in the ears, vertigo and ear disorders.
• Nose bleed.
• Bloating (excess gas in the stomach), constipation, dry mouth,
wind, burping, passing gas, bleeding from the stomach,
inflammation of the corners of the mouth, tongue discolouration
and lips, vomiting and other stomach and intestine disorders.
• Inflammation of the lining of the gullet (oesophagus) and lining
of the stomach.
• Situation where the bile (fluid made by the liver and stored in the
gall bladder) cannot flow from the gall bladder to the duodenum
(cholestasis).
• Inflammation of the liver.
• Muscle spasms, muscle pain or loss of muscle tissue. If you
suffer from mysthenia gravis (a condition in which muscle
becomes weak and tire easily), clarithromycin may worsen
these symptoms.
• Raised abnormal kidney and liver function blood test and raised
blood tests.
• Anal pain.
• Dry skin, eczema.
• Joint pain.
• Kidney disorders including the presence of protein and blood in
urine, passing urine with pus (if you have a urine test).
• Genital discharge.
• Chest pain, pain and thirst.
• If you have a blood test while taking Xetinin XL, 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.
Not known (frequency cannot be estimated from the available
data):
• Bacterial infection of the outer layer of the skin.
• Confusion, loss of bearings, hallucinations (seeing things),
change in sense of reality or panicking, depression, abnormal
dreams or nightmares and mania (feeling of elation or overexcitement).
• Convulsion (fits).
• Paraesthesia, more commonly known as ‘pins and needles’.
• Loss of blood (haemorrhage).
• Discolouration of the teeth.
• Acne.
• Change in the levels of products produced by the kidney,
inflammation of the kidney or an inability of the kidney to
function properly (you may notice tiredness, swelling or
puffiness in the face, abdomen, thighs or ankles or problems
with urination.
• Change in normal urine colour.
• Low blood sugar levels.
• Deafness.
• Inflammation of the tongue.
• Liver failure, abnormal liver function or hepatitis.
• Liver enzymes increased.
In the unlikely event that your infection has been caused by a bug
which Xetinin XL Tablets cannot treat, your symptoms may get
worse.

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. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
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 Xetinin XL Tablets
Keep out of the sight and reach of children.
This medicinal product does not require any special storage
conditions.
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.
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 Xetinin XL Tablets contain
The active substance is clarithromycin citrate. Each prolongedrelease 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
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 revised in January 2018.

M0177LAMUKNAB1-S-001

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