CLARITHROMYCIN 250MG FILM COATED TABLETS

Active substance: CLARITHROMYCIN

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If you are pregnant or breast-feeding do not
take clarithromycin without consulting your
doctor first.
Driving and using machines
• Your tablets may make you feel sleepy,
dizzy or confused. DO NOT drive or operate
machinery if you are affected.
Important information about some of the
ingredients of Clarithromycin
• This product contains Tartrazine lake (E102)
and Allura Red lake (E129) which may cause
allergic reactions.

3

HOW TO USE CLARITHROMYCIN

Always use Clarithromycin exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
The tablets should be swallowed preferably
with a glass of water.

The usual 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:
250 mg twice a day. Your doctor may
increase the dose to 500 mg twice a day in
Taking other medicines:
severe infections. The usual duration of
DO NOT take Clarithromycin if you are taking:
treatment is 7 to 14 days.
• ergotamine or dihydroergotamine (to treat
migraines)
• For the treatment of Helicobacter pylori
• terfenadine or astemizole (used to treat hay
infection associated with duodenal ulcers:
fever and other allergies)
Clarithromycin should be taken in a dose of
• pimozide (used to treat mental disorders)
500 mg twice daily in combination with
• cisapride (used to treat stomach problems)
other medicines to treat Helicobacter pylori.
• simvastatin or lovastatin (used to lower
Your doctor will decide on the best treatment
cholesterol)
combination for you. If you are at all unsure as
• colchicine (to treat gout).
to which medicine to take and when to take
the medicine you must speak to your doctor.
Talk to your doctor if you are taking any of
the following:
Patients with liver or kidney problems
• coumarin anticoagulants used to thin your If you have liver or severe kidney problems
blood, e.g. warfarin
your doctor may need to reduce your dose.
• medicines used to treat an abnormal heart Clarithromycin should not be taken for more
beat, e.g. disopyramide or quinidine
than 14 days if you have these problems.

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

BLACK

PANTONE® GREEN C

360 mm
160 mm
L:
W:

175346

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)
Dimensions:

231-10-03257-8
123 (111100)
To be added by 3rd party
Univers
9 Pt

Small amounts of clarithromycin can pass
into breast milk.

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

Take special care with Clarithromycin
Tell your doctor before you start to take this
medicine if you:
• are allergic to the antibiotics lincomycin or
clindamycin
• have liver problems
• have kidney problems
• have heart problems, in particular heart
rhythm problems (e.g. long QT syndrome)
• have muscle problems known as
myasthenia gravis
• have low potassium levels and/or
magnesium levels
• take or have recently taken a drug called
colchicine (usually taken for gout) as this
can cause very serious side effects
• if you have, or are prone to, fungal
infections (e.g. thrush).
If any of the above applies to you, tell your
doctor before receiving clarithromycin.

Pregnancy and breast-feeding
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.

F. P. Code:
Pharma Code:
Third party code:
Fonts:
Base Font Size:

DO NOT take Clarithromycin if you:
• are allergic (hypersensitive) to Clarithromycin
or any of the other ingredients of this medicine
• are allergic (hypersensitive) to any other
macrolide antibiotic e.g. erythromycin,
azithromycin
• have been told by your doctor that you
have low blood potassium levels
• are taking ergotamine-like drugs (usually
used for migraine)
• are taking cisapride (for stomach disorders)
• are taking pimozide (for mental illness)
• are taking terfenadine or astemizole (for
hayfever or allergy)
• if you are taking simvastatin or lovastatin
(to reduce cholesterol)
• have severe liver disease with kidney disease
• have an irregular heart rhythm.

Taking Clarithromycin with food and drink
• You can take Clarithromycin either with or
without food, whichever you prefer.

PL 00289/1549-50. TEVA UK Limited Licence (Post Licence Regulatory Team),
Packed at Debrecen.
Text update.

BEFORE YOU USE CLARITHROMYCIN

PL Number(s),
MA Holder & Packer:
Reason for revision:

2

Child:

• Clarithromycin belongs to a group of drugs
called macrolide antibiotics.
• Clarithromycin is used in the treatment of
the following infections:
• bronchitis and pneumonia
• throat and sinus infections: sinusitis and
pharyngitis
Please tell your doctor or pharmacist if you
• skin and soft tissue infections
are taking or have recently taken any other
• Helicobacter pylori infection associated
medicines, including medicines obtained
with duodenal ulcer.
without a prescription.

175336

WHAT CLARITHROMYCIN IS AND
WHAT IT IS USED FOR

Trackwise Parent:

1

1

1. What Clarithromycin is and what it is used for
2. Before you use Clarithromycin
3. How to use Clarithromycin
4. Possible side effects
5. How to store Clarithromycin
6. Further information

Version:

IN THIS LEAFLET:

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.
01 February 2013

Read all of this leaflet carefully before you
start using 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.

Children under 12 years old
Clarithromycin is not recommended for use
in children under 12 years of age.

231-30-14274-B.LEA CLARITHROMYCIN A/S TAB TUK
IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

BLACK

360 mm
160 mm
L:
W:

Dimensions:

231-10-03257-8
123 (111100)
To be added by 3rd party
Univers
9 Pt
F. P. Code:
Pharma Code:
Third party code:
Fonts:
Base Font Size:

Trackwise Parent:

PL 00289/1549-50. TEVA UK Limited Licence (Post Licence Regulatory Team),
Packed at Debrecen.
Text update.
PL Number(s),
MA Holder & Packer:
Reason for revision:

1
Version:

175336

231-30-14274-B.LEA CLARITHROMYCIN A/S TAB TUK Ref:

Child:

175346

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C

01 February 2013

PACKAGE LEAFLET: INFORMATION FOR THE USER

• 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
you sleepy, e.g. midazolam, triazolam or
alprazolam
• phenobarbital, used as a sedative and
anti-convulsant
• rifabutin or rifampicin, used to treat some
infections
• ciclosporin, tacrolimus or sirolimus, used
following organ transplant
• medicines used to lower cholesterol, e.g.
atorvastatin or cerivastatin
• efavirenz, nevirapine, atazanvir, saquinavir,
ritonavir or zidovudine, used to treat HIV
infected patients
• St John’s Wort, used to treat depression
• fluconazole, itraconazole or ketoconazole,
used to treat fungal infections
• sildenafil, tadalafil or vardenafil, used to
treat sexual dysfunction in men, and high
blood pressure
• tolteridone, used to treat incontinence
• omeprazole, for the treatment of gastric ulcers
• medicines used to treat diabetes, e.g.
insulin, glibenglamide, repaglinide
• valproate, used to treat bipolar disorder
• eletriptan, aprepitant, halofantrine,
ziprasidone, vinblastine, cilostazol,
methylprednisolone.

Ref:

CLARITHROMYCIN 250 mg AND
500 mg FILM-COATED TABLETS

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. Never take two doses together.
Take the remaining doses at the correct time.
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.

Other side effects that have been seen
(frequency cannot be estimated from
available data):
• swelling, redness or itchiness of the skin.
Sometimes brown scales may appear.
• acne
• inflammation of the pancreas
• confusion, loss of bearings, hallucinations
(seeing things), change in sense of reality
or panicking, depression, abnormal dreams
or nightmares
• convulsion (fits)
• bleeding
• discolouration of the tongue or teeth
• loss of taste or smell or inability to smell
properly
• deafness
• 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
• low blood sugar levels
• 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.

If you have any further questions on the use
of this product, ask your doctor or pharmacist. If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
POSSIBLE SIDE EFFECTS
4
Like all medicines, Clarithromycin 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 StevensJohnson syndrome/toxic epidermal necrolysis)
• torsades de pointes, a life threatening
irregular heart beat.
Common side effects (affects 1 to 10 users in
100) include:
• headache
• difficulty sleeping
• changes in sense of taste
• stomach problems such as feeling sick,
vomiting, stomach pain, indigestion, diarrhoea
• abnormal liver function (seen in blood results)
• skin rash
• increased sweating
Uncommon side effects (affects 1 to 10 users
in 1000) include:
• oral or vaginal ‘thrush’ (a fungal infection)
• reduction in the level of certain blood cells
(which can make infections more likely or
increase the risk of bruising or bleeding)
• loss of appetite, heartburn, bloating,
constipation, wind
• anxiety, nervousness, drowsiness,
tiredness, weakness, dizziness, tremor or
shaking, or a general feeling of being unwell
• ringing in the ears or hearing loss
• vertigo
• bleeding
• 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

5

HOW TO STORE CLARITHROMYCIN

Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Clarithromycin after the expiry date
that is stated on the blister and 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 Clarithromycin Film-coated Tablets
contain
• The active ingredient is clarithromycin.
• 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), macrogol 400,
tartrazine lake (E102), allura red AC lake (E129),
indigo carmine lake (E132) and vanillin.
Contents of the pack:
• Each tablet contains either 250 mg or 500 mg
of Clarithromycin.
• The 250 mg tablet is a yellow, oval shaped
film-coated tablet marked with “93” on one
side and “7157” on the other.
• The 500 mg tablet is a light yellow, oval
shaped film-coated tablet marked with “93”
on one side and “7158” on the other.
• The 250 mg product is available in pack
sizes of 8, 10, 12, 14, 14 calendar pack, 16,
20, 30, 100 and 120 tablets.
• The 500 mg product is available in pack
sizes of 8, 10, 14, 14 calendar pack, 16, 20,
21, 30, 42 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer:
TEVA UK Ltd,
Brampton Road, Hampden Park, Eastbourne
East Sussex, BN22 9AG, England
or
Teva Pharmaceutical Works Private Limited
Company
Pallagi út 13, Debrecen, H-4042, Hungary
This leaflet was last revised: January 2013.
PL 00289/1549
PL 00289/1550

14274-B

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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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