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XETININ XL 500MG PROLONGED RELEASE TABLETS

Active substance(s): CLARITHROMYCIN CITRATE / CLARITHROMYCIN CITRATE / CLARITHROMYCIN CITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Severe prolonged diarrhoea, which may have blood or
!
depression, abnormal dreams or nightmares and mania

mucus in it. Diarrohea may occur over two months after
(feeling of elation or over-excitement).
treatment with clarithromycin, in which case you should
Convulsion (fits).
!
Xetinin XL 500mg Prolonged Release Tablets
still contact your doctor.
Paraesthesia, more commonly known as 'pins and
!
Clarithromycin
Dark urine, pale stools, jaundice (yellowing of the skin
!
needles'.
and/or eyes), skin irritations, nausea, fever, tender
!
Loss of taste or smell or inability to smell properly.
abdomen
or
loss
of
apetite.
These
are
signs
that
your
liver
!
Loss
of blood (haemorrhage).
!
Nategilinide,
pioglitzone,
repaglinide,
rosiglitazone
or
Read all of this leaflet carefully before you start taking
may not be working properly.
!
Inflammation of the pancreas.
insulin (used to lower blood glucose levels).
this medicine because it contains important information
Allergic reactions including rashes have been reported.
!
!
Discolouration of the tongue or teeth.
!
Gliclazide or glimepiride (sulfonylureas used in tretament
for you.
A rash, difficulty in breathing, fainting and swelling of the
!
!
Change in the levels of products made by the liver,
of type II diabetes).
!
Keep this leaflet. You may need to read it again.
face
and
throat.
This
is
a
sign
that
you
may
have
inflammation
of the liver or an inability of the liver to
!
Colchicine
(for
gout).
!
If you have any further questions, ask your doctor or
developed an allergic reactions.Severe reactions such as
function properly (you may notice yellowing of the skin,
!
Theophylline (used in patients with breathing difficulties
pharmacist.
blistering of the skin, mouth, lips, eyes and genitals
dark urine, pale stools or itchiness of the skin).
such as asthma).
!
This medicine has been prescribed for you only. Do not
(symptoms of rare allergic reaction called Stevens!
Stevens - Johnson syndrome: skin condition that causes
!
Terfenadine or astemizole (for hay fever or allergy).
pass it on to others. It may harm them, even if their signs of
Johnson syndrome/toxic epidermal necrolysis.
painful blisters and sores of the skin and mucous
!
Triazolam, alprazolam or intravenous or oromucosal
illness are the same as yours.
In the unlikely event that your infection has been caused
!
membranes, especially in the mouth.
midazolam (sedatives).
!
If you get any side effects talk to your doctor or pharmacist.
by a bug which Xetinin XL Tablets cannot treat, your
!
Acne.
!
Cilostazol (for poor circulation).
This includes any possible side effects not listed in this
symptoms may get worse.
!
Change in the levels of products produced by the kidney,
!
Simvastatin or lovastatin (for high cholesterol).
leaflet. See section 4.
Muscle pain or weakness known as rhabdmyolysis (a
!
inflammation of the kidney or an inability of the kidney to
!
Cisapride or omeprazole (for stomach disorders).
condition which causes the breakdown of muscle tissue
function properly (you may notice tiredness, swelling or
!
Itraconazole or fluconazole (for fungal infections).
What is in this leaflet
which can result in kidney damage).
puffiness in the face, abdomen, thighs or ankles or
!
Tolterodine (for overactive bladder).
1. What Xetinin XL Tablets are and what they are used for
Reduction in the level of certain blood cells (which can
!
problems with urination.
!
Verapamil, amlodipine, diltiazem (for high blood
2. What you need to know before you take Xetinin XL Tablets
make infections more likely or increase the risk of bruising
!
Change in normal urine colour.
pressure).
3. How to take Xetinin XL Tablets
or bleeding).
!
Decrease in platelets (blood cells that help you stop
!
Aprepitant (for preventing vomiting during chemotherapy).
4. Possible side effects
Type of heart rhythm disorder (Torsade de pointes,
!
bleeding).
!
Methylprednisolone (a corticosteroid).
5. How to store Xetinin XL Tablets
ventricular tachycardia).
!
Low blood sugar levels.
!
Vinblastine (for treatment of cancer).
6. Contents of the pack and other information
Rare allergic skin reactions which causes severe illness
!
!
Change in the sense of smell.
!
Sildenafil, tadalafil are vardenafil (for impotence in adult
with ulceration of the mouth, lips and skin which causes
!
Deafness.
males or for use in pulmonary arterial hypertension (high
1. What Xetinin XL Tablets are and what they are used
severe illness with rash, fever and inflammation of internal
!
Abnormal electric activity tracing of the heart (ECG),
blood pressure in the blood vessels in the lung)).
for
organs (DRESS).
changes in heart rhythm.
!
Cyclosporin, sirolimus and tacrolimus (immune
!
Inflammation of the tongue.
suppressants).
Xetinin XL 500mg Prolonged Release Tablets (Called Xetinin
Common (may affect up to 1 in 10 people):
!
Liver failure, abnormal liver function or hepatitis.
!
St John's Wort (a herbal prduct used to treat depression).
XL Tablets in this leaflet) contain the active ingredient
Difficulty sleeping.
!
!
Inflammation of the kidneys.
!
Quetiapine or other antipsychotic medicines.
clarithromycin citrate. Clarithromycin belongs to a group of
Widening of blood vessels.
!
!
Liver enzymes increased.
!
Other macrolide medicines.
medicines called macrolide antibiotics. Antibiotics stop the
Stomach problems such as feeling sick, vomiting,
!
!
Lincomycin and clindamycin (lincosamides - a type of
growth of bacteria (bugs) which cause infections. Xetinin XL
stomach pain, indigestion, diarrhoea.
Inflammation of the colon (Pseudomembranous colitis) has
antibiotic).
Tablets are used to treat infections such as:
A change in the way liver works.
!
been reported with nearly all antibacterial medicines including
!
Pimozide or ziprasidone (for psychiatric conditions).
1. Chest infections such as bronchitis and pneumonia
Skin rash.
!
clarithromycin. Its symptoms include diarrhoea after taking
!
Zidovudine, ritonavir, atazanavir, saquinavir, etravirine,
2. Throat and sinus infection
Increased sweating.
!
clarithromycin. Please inform your doctor immediately if you
nevirapine or efavirenz (anti-viral drugs used in treatment
3. Mild to moderate skin and tissue infections, e.g. cellulitis,
Headache.
!
suffer
from diarrhoea.
of
HIV).
folliculitis or erysipelas.
Changes in sense of taste or smell.
!
!
Rifabutin, rifampicin, rifapentine, fluconazole,
Xetinin XL Tablets are used in adults and children 12 years
Clarithromycin may worsen the symptoms of myasthenia
itraconazole (for treatment of some bacterial infections
and older.
gravis (a condition in which the muscles become weak and tire
Uncommon (may affect up to 1 in 100 people):
such as tuberculosis).
easily) in patients who already suffer from this condition.
!
Tacrolimus (for organ transplants).
High temperature.
!
2. What you need to know before you take Xetinin XL
Swelling, redness, or itchiness of the skin.
!
Tablets
Reporting of side effects
Xetinin XL Tablets do not interact with oral contraceptives.
Inflammation of the stomach and intestine, oral thrush,
!
If you get any side effects, talk to your doctor or pharmacist.
rash, inflammation of the nose causing it to run, vaginal
Do not take Xetinin XL Tablets
This
includes any possible side effects not listed in this leaflet.
Xetinin
XL
Tablets
with
food
and
drink
thrush
and
vaginal
infections.
!
If you are allergic to clarithromycin or other macrolide
You can also report side effects directly via the Yellow Card
The tablets should be taken with food and must be swallowed
Low levels of white blood cells, anaemia, other white blood
!
antibiotics such as erythromycin or azithromycin or any of
Scheme at: www.mhra.gov.uk/yellowcard.
whole and not chewed.
cell disorders and an excessive level of platelets in the
the other ingredients of this medicine (listed in section 6).
By reporting side effects you can help provide more
blood (blood cells that help you stop bleeding) leading to
!
If you are taking medicines called ergot alkaloid tablets
information on the safety of this medicine.
Pregnancy and breast-feeding
abnormal blood clotting or bleeding.
(e.g. ergotamine or dihydroergotamine) or use ergotamine
If you are pregnant or breast-feeding, think you may be
Decrease in neutrophils (neutropenia).
!
inhalers for migraine.
5. How to store Xetinin XL Tablets
pregnant or are planning to have a baby, ask your doctor or
Stiffness.
!
!
If you are taking medicines called terfenadine or
pharmacist before taking this medicine as the safety of Xetinin
Chills.
!
astemizole (widely taken for hay fever or allergies) or
Keep out of the sight and reach of children.
XL Tablets in pregnancy and breast-feeding is not known.
Increase in number of eosinophills (white blood cells
!
cisapride (for stomach problems) or pimozide (for mental
involved in immunity).
health problems) as combining these drugs can
This medicinal product does not require any special storage
Driving and using machines
Exaggerated immune response to a foreign agent.
!
sometimes cause serious disturbances in heart rhythm.
conditions.
Xetinin XL Tablets may make you feel dizzy or drowsy. If they
Lack or loss of apetite.
!
Consult your doctor for advice on alternative medicines.
affect you in this way do not drive, operate machinery or do
Anxiety, nervousness.
!
!
If you are taking other medicines which are known to
Do not use Xetinin XL Tablets after the expiry date which is
anything that requires you to be alert.
Drowsiness, tirednes, dizziness or shaking.
!
cause serious disturbances in heart rhythm.
stated on the carton. The expiry date refers to the last day of
!
Involuntary muscle movements.
!
If you are taking lovastatin or simvastatin (HMG-CoA
that month.
Xetinin XL Tablets contain lactose
!
Blood clot that causes sudden blockage in a lung artery
reductase inhibitors, commonly known as statins, used to
Xetinin XL Tablets contain lactose. If you have been told by
(pulmonary embolism).
lower levels of cholesterol (a type of fat) in the blood).
Do not throw away any medicines via wastewater or
your doctor that you have an intolerance to some sugars,
!
Psychiatric disorders such as depression, difficulty
!
If you are taking oral midazolam (an oral sedative).
household waste. Ask your pharmacist how to throw away
contact your doctor before taking this medicinal product.
sleeping (insomnia), nervousness and feeling sleepy.
!
If you have abnormally low levels of potassium or
medicines you no longer use. These measures will help
!
Conjunctivitis (inflammation of the eyes) and visual
magensium in your blood (hypokalemia or
protect the environment.
3. How to take Xetinin XL Tablets
disturbances.
hypomagnesaemia).
Ringing in the ears, vertigo and ear disorders.
!
!
If you have severe liver disease with kidney disease.
6. Contents of the pack and other information
Do not give Xetinin XL Tablets to children under 12 year. Your
Asthma: lung disease associated with tightening of air
!
!
If you or someone in your family has a history of heart
doctor will prescribe another suitable medicine for your child.
passages, making breathing difficult, shortness of breath
rhythm disorders (ventricular cardiac arrythmia inclduing
What Xetinin XL Tablets contain
and other lung disorders.
torsades de pointes) or abnormality cardiogram (ECG,
The active substance is clarithromycin citrate. Each
Always take this medicine exactly as your doctor has told you.
!
Nose bleed.
electrical recording of the heart) called “long QT
prolonged-release tablet contains clarithromycin citrate
Check with your doctor or pharmacist if you are not sure.
!
Bloating (excess gas in the stomach), constipation, dry
syndrome”.
equivalent to clarithromycin 500mg.
mouth, wind, burping, passing gas, bleeding from the
!
If you are taking medicines called ticagrelor or ranolzaline
The usual dose of Xetinin XL Tablets for adults and children
stomach, inflammation of the corners of the mouth, tongue
(for heart attack. chest pain or angina).
The other ingredients in the tablet core are lactose
over 12 years is one 500 mg tablet once a day for 6 to 14 days.
discolouration and lips, vomiting and other stomach and
!
If you are taking colchicine (usually taken for gout).
monohydrate, hypromellose, hypromellose phthalate, talc,
intestine disorders.
magnesium stearate. The tablet coating contains
Your doctor may increase the dose to two 500 mg tablets daily
!
Inflammation of the lining of the gullet (oesophagus) and
Take special care with Xetinin XL Tablets
hypromellose, macrogol, quinoline yellow aluminium lake
in severe Infections. Xetinin XL Tablets should be taken with
lining of the stomach.
!
If you have abnormally low levels of magnesium in your
(E104), talc and titanium dioxide (E171).
food and must be swallowed whole and not chewed.
!
Situation where the bile (fluid made by the liver and stored
blood (hypomagnesaemia) consult your doctor before
in the gall bladder) cannot flow from the gall bladder to the
taking these tablets.
What Xetinin XL Tablets looks like and contents of the
If you take more Xetinin XL Tablets than you should
duodenum (cholestasis).
!
If you have liver problems.
pack
If you accidentally take more Xetinin XL Tablets in one day
!
Inflammation of the liver.
!
If you have kidney problems.
Xetinin XL Tablets are yellow coloured, film coated, oblong
than your doctor has told you to, or if a child accidentally
!
Inflammation of the skin characterized by the presence of
!
If you develop severe or prolonged diarrhoea during or
shaped, biconvex tablets, with both sides plain.
swallow some tablets, contact your doctor or nearest hospital
bullae which are filled with fluid, itchy and painful rash.
after taking Xetinin XL Tablets.
emergency department immediately. An overdose of Xetinin
!
Muscle spasms, muscle pain or loss of muscle tissue. If
!
If your potassium levels are low (hypokalaemia).
They are available in blister packs of 7, 10, 14, 20, 28, 30, 56,
XL Tablets is likely to cause vomiting and stomach pains.
you suffer from mysthenia gravis (a condition in which
60, 84, 90, 100 and 112 film coated tablets.
muscle becomes weak and tire easily), clarithromycin may
If any of the above apply to you, please tell your doctor
If you forget to take Xetinin XL Tablets
worsen these symptoms.
immediately.
Not all pack sizes may be marketed.
If you forget to take a dose of Xetinin XL Tablets, take it as
!
Raised abnormal kidney and liver function blood test and
soon as you remember. Do not take more tablets in one day
raised blood tests.
Xetinin XL Tablets are not suitable for use in children under 12
Marketing Authorisation Holder
unless your doctor has told you to. Do not take a double dose
!
Feeling weak, tired and having no energy.
years of age.
Morningside Healthcare Ltd
to make up for a forgotten dose.
!
Anal pain.
115 Narborough Road
!
Yellowing of the skin and eyes (jaundice).
Warning and precautions
Leicester
If you stop taking Xetinin XL Tablets
!
Dry skin, eczema, itching of the skin, rash, hives, and
Talk to your doctor or pharmacist before taking Xetinin XL
LE3 0PA
Do not stop taking Xetinin XL Tablets, even if you feel better. It
excessive perspiration.
Tablets
United Kingdom
is Important to take the tablet for as long as the doctor has told
!
Back, joint or muscle pain.
!
If you have heart problems (e.g. heart diasease, heart
you to, otherwise the problem might come back.
!
Kidney disorders including the presence of protein and
failure, an unusually slow heart rate, or low levels of
Manufacturer
blood in urine, passing urine with pus (if you have a urine
magnesium in the blood).
Morningside Pharmaceuticals Ltd
If you have any further questions on the use of this medicine,
test).
!
If you have any liver or kidney problems.
Pavilion Way, Loughborough,
ask your doctor or pharmacist.
!
Genital discharge.
!
If you have, or are prone to, fungal infections (e.g. thrush).
LE11 5GW
!
Lack of energy, chest pain or changes in heart rhythm
!
If you are pregnant or breast-feeding.
United Kingdom
4. Possible side effects
such as palpitation or an irregular heartbeat, swelling of
!
If you have an intolerance to any sugars as Xetinin XL
face, a feeling of general discomfort, pain and thirst.
Tablets contain lactose.
This medicinal product is authorised in the Member
Like all medicines, this medicine can cause side effects,
!
If you have a blood test while taking (product name), it may
States of the EEA under the following names:
although not everybody gets them.
show raised liver enzymes and abnormal liver function test
Other medicines and Xetinin XL Tablets
UK: Xetinin XL
results. The presence of protein in the urine and other
Please tell your doctor or pharmacist if you are taking or have
IE: Clorom XL
Very common: may affect more than 1 in 10 people
abnormalities may show the presence of kidney disorders.
recently taken or might take any other medicines, including
Common: may affect up to 1 in 10 people
A decrease in clotting factor, prothrombin time
medicines obtained without a prescription.
This leaflet was last revised in June 2017.
Uncommon: may affect up to 1 in 100 people
prolongation (increased blood clotting time) and an
!
Digoxin, quinidine or disopyramide (for heart problems).
Rare:
may
affect
1
in
1,000
people
increase
in
other
enzymes
may
also
be
detected.
!
Warfarin or other drugs (for thinning the blood).
Very rare: may affect up to 1 in 10,000 people
Changes in laboratory test values such as chloride, uric
!
Ergotamine, dihydroergotamine or eletriptan (for
Not known: frequency cannot be estimated from the available
acid and calcium.
migraine).
data.
!
Carbamazepine, valproate or phenytoin (for epilepsy).
Not known (frequency cannot be estimated from the
!
Atorvastatin, rosuvastatin (HMG-CoA reductase
If any of the following happen, stop taking Xetinin XL Tablets
available data):
inhibitors, commonly known as statins, used to lower
and tell your doctor immediately or go to your nearest hospital
!
Inflammation of the colon.
levels of cholesterol (a type of fat) in the blood. Statins can
emergency department:
!
Bacterial infection of the outer layer of the skin.
cause rhabdomyolysis (a condition which causes
!
Severe pain in the abdomen and back caused by
!
Swelling of the lips and eyes.
breakdown of muscle tissue which can result in kidney
inflammation of the pancreas.
!
Confusion, loss of bearings, hallucinations (seeing
damage) and signs of myopathy (muscle pain or muscle
things), change in sense of reality or panicking,
weakmess) should be monitored.

Expand Transcript

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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