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CLARITHROMYCIN 250MG FILM COATED TABLETS

Active substance(s): CLARITHROMYCIN / CLARITHROMYCIN

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Clarithromycin 250 mg Film-Coated Tablets • pimozide (used to treat mental disorders)
Clarithromycin 500 mg Film-Coated Tablets • cisapride (used to treat stomach problems)
• simvastatin or lovastatin (used to lower
Clarithomycin
Package leaflet: Information for the user

Read all of this leaflet carefully before you start
using 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.

cholesterol)
• colchicine (usedto treat gout)
• ticagrelor (a blood-thinning drug)
• ranolazine (used to treat angina)

Talk to your doctor if you are taking any of the
following
• coumarin anticoagulants used to thin your
blood, e.g. warfarin
• medicines used to treat an abnormal heart
beat, e.g. disopyramide or quinidine
• medicines used to treat heart failure,
e.g. digoxin
• medicines used to treat epilepsy,
e.g. phenytoin or carbamazepine
• theophylline, used to treat asthma
• benzodiazepines used as medicines that make
What is in this leaflet
you sleepy, e.g. midazolam, triazolam or
1. What Clarithromycin is and what it is used for
alprazolam
2. What you need to know before you use
• phenobarbital, used as a sedative and
Clarithromycin
anti-convulsant
3. How to use Clarithromycin
• rifabutin or rifampicin, rifapentine or
4. Possible side effects
aminoglycosides (e.g. gentamicin) used to
5. How to store Clarithromycin
treat some infections
6. Contents of the pack and other information
• ciclosporin, tacrolimus or sirolimus, used
following organ transplant
Clarithromycin is and what it is
1 What
• medicines used to lower cholesterol,
used for
e.g. atorvastatin or rosuvastatin
• Clarithromycin belongs to a group of drugs
• efavirenz, nevirapine, atazanvir, saquinavir,
called macrolide antibiotics.
ritonavir, zidovudine or etravirine, used to
• Clarithromycin is used in the treatment of the
treat HIV infected patients
following infections:
• St John’s Wort, used to treat depression.
• bronchitis and pneumonia
• fluconazole, itraconazole or ketoconazole,
• throat and sinus infections: sinusitis and
used to treat fungal infections
pharyngitis
• sildenafil, tadalafil or vardenafil, used to treat
• skin and soft tissue infections
sexual dysfunction in men, and high blood
• Helicobacter pylori infection associated with
pressure.
duodenal ulcer.
• tolteridone, used to treat incontinence

omeprazole, for the treatment of gastric ulcers
you need to know before you
2 What
• medicines used to treat diabetes, e.g. insulin,
use Clarithromycin
glibenglamide, repaglinide nateglinide
Do not take Clarithromycin
• valproate, used to treat bipolar disorder
• if you are allergic to Clarithromycin , other
• eletriptan, aprepitant, halofantrine, ziprasidone,
macrolide antibiotic (e.g. erythromycin,
vinblastine, cilostazol, methylprednisolone
azithromycin) or any of the other ingredients
• verapamil, amlodipine or diltiazem, used to
of this medicine (listed in section 6)
treat heart problems.
• if you are taking medicines called terfenadine
Clarithromycin with food and drink
or astemizole (for hay fever or allergies) or
cisapride (for stomach disorders) or pimozide • You can take Clarithromycin either with or
without food, whichever you prefer
(for mental illness) tablets as combining these











drugs can sometimes cause serious
disturbances in heart rhythm. Consult your
doctor for advice on alternative medicines.
if you have been told by your doctor that you
have abnormally low levels of potassium in
your blood (hypokalaemia)
if you or someone in your family has a history
of heart rhythm disorders (ventricular cardiac
arrhythmia, including torsade de pointes) or
abnormality of electrocardiogram (ECG,
electrical recording of the heart) called “long
QT syndrome”
if you are taking ergotamine-like drugs
(usually used for migraine)
if you if you are taking simvastatin or
lovastatin (to reduce cholesterol)
if you have severe liver disease with kidney
disease
if you are taking ticagrelor (a blood-thinning
drug)
if you are taking ranolazine (used to treat
angina)
if you are taking colchicine (used to treat gout)

Warnings and precautions
Talk to your doctor or pharmacist before taking
Clarithromycin if you
• have liver problems
• have kidney problems
• have heart problems, in particular heart
rhythm problems (e.g. long QT syndrome)
• if you have, or are prone to, fungal infections
(e.g. thrush)
• if you have abnormally low levels of
magnesium in your blood (hypomagnesaemia).
• if you are taking other medicines which are
known to cause serious disturbances in heart
rhythm (for the medicines terfenadine,
astemizole, cisapride, and pimozide: see ‘Do
not take Clarithromycin’).
Other medicines and Clarithromycin
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
DO NOT take Clarithromycin if you are taking:
• ergotamine or dihydroergotamine (to treat
migraines)
• terfenadine or astemizole (used to treat hay
fever and other allergies)

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 for advice before
taking this medicine
Clarithromycin should not be given to pregnant
or breast-feeding mothers unless the benefits to
the mother outweigh the risks to the baby. Ask
your doctor or pharmacist for advice before
taking any medicine.
Small amounts of clarithromycin can pass into
breast milk.
Driving and using machines
• Your tablets may make you feel sleepy, dizzy
or confused. DO NOT drive or operate
machinery if you are affected.
Clarithromycin contains
• This medicine contains Tartrazine lake (E102)
and Allura Red lake (E129) which may cause
allergic reactions.

3

How to use Clarithromycin

Always use this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
The tablets should be swallowed preferably with
a glass of water.
The recommended dosage instructions are
given below:
Adults including the Elderly and children over
12 years old:
• For chest infections, throat or sinus infections
and skin and soft tissue infections:
The recommended dose is 250 mg twice a day.
Your doctor may increase the dose to 500 mg
twice a day in severe infections. The usual
duration of treatment is 6 to 14 days.
• For the treatment of Helicobacter pylori
infection associated with duodenal ulcers:
Clarithromycin should be taken in a dose of
500 mg twice daily in combination with other
medicines to treat Helicobacter pylori.
Your doctor will decide on the best treatment
combination for you. If you are at all unsure
as to which medicine to take and when to take
the medicine you must speak to your doctor.

Patients with liver or kidney problems
If you have liver or severe kidney problems your
doctor may need to reduce your dose.
Clarithromycin should not be taken for more
than 14 days if you have these problems.
Children under 12 years old
Clarithromycin is not recommended for use in
children under 12 years of age.
If you take more Clarithromycin than you should
If you (or someone else) swallow a lot of the tablets
all together, or if you think a child has swallowed
any of the tablets, contact your nearest hospital
casualty department or your doctor immediately.
An overdose is likely to cause vomiting and
stomach pains.
Please take this leaflet, any remaining tablets and
the container with you to the hospital or doctor
so that they know which tablets were consumed.
If you forget to take Clarithromycin
If you forget to take a tablet, take one as soon as
you remember, unless it is nearly time to take
the next one.
Do not take a double dose to make up for a
forgotten tablet.
If you stop taking Clarithromycin
DO NOT stop taking your medicine because you
are feeling better. It is important that you
complete your prescribed course of treatment,
otherwise the problem may come back and this
medicine may be less effective next time.
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.
• a rash, difficulty breathing, fainting or swelling
of the face and 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 may be 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).
• torsade de pointes, a life threatening
irregular heart beat.
These are very serious but rare side effects. You
may need urgent medical attention or
hospitalisation.

Not known (frequency cannot be estimated from
available data):
• swelling, redness or itchiness of the skin.
• angioedema (swelling of the face, lips and
tongue)
• acne
• inflammation of the pancreas
• confusion, loss of bearings, hallucinations
(seeing things), change in sense of reality or
panicking, depression, abnormal dreams or
nightmares, mania
• convulsion (fits)
• pins-and-needles (paraesthesia)
• bleeding
• discolouration of the tongue or teeth
• loss of taste or smell or inability to smell
properly
• hearing loss
• 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
• 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), or kidney failure
Reporting of side effects
If you get 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
By reporting side effects you can help provide
more information on the safety of this medicine.

5

How to store Clarithromycin

Keep this medicine out of the sight and reach of
children.
Do not store above 25°C.
Do not use this medicine after the expiry date
which is stated on the blister and carton after EXP.
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 to
protect the environment.

6

Contents of the pack and other
information

What Clarithromycin Film-coated Tablets contains
• The active ingredient is clarithromycin. Each
tablet contains either 250 mg or 500 mg of
Clarithromycin.
• The other ingredients are sodium starch
glycolate, microcrystalline cellulose, povidone
(PVP K-30), magnesium hydroxide,
croscarmellose sodium, anhydrous colloidal
silica, stearic acid, magnesium stearate,
hypromellose (E464), titanium dioxide (E171),
The following side effects have been reported at
macrogol 400, tartrazine lake (E102), allura red
the approximate frequencies shown:
AC lake (E129), indigo carmine lake (E132) and
Common (may affect up to 1 in 10 people)
vanillin.
• headache
What
Clarithromycin looks like and contents of
• difficulty sleeping
the pack
• changes in sense of taste
• Each tablet contains either 250 mg or 500 mg
• stomach problems such as feeling sick,
of Clarithromycin.
vomiting, stomach pain, indigestion, diarrhoea
• abnormal liver function (seen in blood results) • The 250 mg tablet is a yellow, oval shaped
film-coated tablet marked with “93” on one
• skin rash
side and “7157” on the other.
• increased sweating

The
500 mg tablet is a light yellow, oval
Uncommon (may affect up to 1 in 100 people)
shaped film-coated tablet marked with “93”
• oral or vaginal ‘thrush’ (a fungal infection),
on
one
side and “7158” on the other.
vaginal bacterial infection
• The 250 mg product is available in pack sizes
• reduction in the level of certain blood cells
of
8,
10,
12, 14, 14 calendar pack, 16, 20, 30,
(which can make infections more likely or
100 and 120 tablets.
increase the risk of bruising or bleeding)
• The 500 mg product is available in pack sizes
• loss of appetite, heartburn, bloating,
of 8, 10, 14, 14 calendar pack, 16, 20, 21, 30, 42
constipation, wind
and 100 tablets.
• anxiety, nervousness, drowsiness,
Not all pack sizes may be marketed.
tiredness, weakness, dizziness, tremor or
shaking, or a general feeling of being unwell
ringing in the ears or hearing loss
vertigo
inflammation of the mouth or tongue
dry mouth
joint pain
chest pain or changes in heart rhythm such
as palpitations
• a change in the levels of products made by
the liver, inflammation of the liver, an
inability of the liver to function properly or
liver failure (you may notice yellowing of
the skin, dark urine, pale stools or itchiness
of the skin)
• abnormal blood test results







Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer:
Teva Pharmaceutical Works Private Limited
Company
Pallagi út 13
Debrecen, H-4042
Hungary
This leaflet was last revised February 2017
PL 00289/1549
PL 00289/1550

14274-D

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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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