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CLARITHROMYCIN 250MG TABLETS

Active substance(s): CLARITHROMYCIN / CLARITHROMYCIN

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

Clarithromycin 250 mg & 500 mg Film-Coated 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 Clarithromycin is and what it is used for
2. What you need to know before you take Clarithromycin
3. How to take Clarithromycin
4. Possible side effects
5. How to store Clarithromycin
6. Contents of the pack and other information

1

What Clarithromycin is and what it is
used for

Clarithromycin is an antibiotic which belongs to the group of
macrolide antibiotics. It stops the growth of certain bacteria.

Clarithromycin is used to treat:
• Infections of the respiratory tract (nose, throat and lungs)
such as pneumonia, bronchitis, sinusitis and pharyngitis.
• Mild to moderate skin and soft tissue infections.
• It can also be used, in combination with other antibacterials
and appropriate ulcer healing agents, to eradicate
H. pylori infections.

2

What you need to know before you
take Clarithromycin

Do not take Clarithromycin
• if you are allergic to clarithromycin, other macrolide
antibiotics or to any of the other ingredients of this
medicine (listed in section 6).
• if you have a history of certain abnormal heart rhythms
(ventricular arrhythmia, including torsades de pointes) or
changes in the heart activity as measured in the
electro-cardiogram called “QT prolongation”.
• if you suffer from severe liver failure and kidney problems
at the same time.
• if your blood potassium level is low.
• if you are taking
- ticagrelor (to prevent blood clotting)
- ranolazine (used to treat angina pectoris)
- ergotamine, dihydroergotamine (medicines to treat migraine)
- cisapride (gastric medicine)
- pimozide (antipsychotic)
- terfenadine or astemizole (antiallergics)
- lovastatin, simvastatin (medicines to lower cholesterol)
- colchicine (to treat gout).

Warnings and precautions
Talk to your doctor or pharmacist before taking Clarithromycin
• if you have reduced liver or kidney function.
• if you are allergic to lincomycin or clindamycin (other
types of antibiotics).
• if you develop severe or prolonged diarrhoea
(pseudomembranous colitis) during or after taking
Clarithromycin, consult your doctor immediately. Inflammation
of the colon (Pseudomembranous colitis) has been reported
with nearly all antibacterial medicines including clarithromycin.
• if you have, or have had, heart problems or
• if your magnesium level has previously been low
• if you have used clarithromycin before on several
occasions or for a long time.
Other medicines and Clarithromycin
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.
Certain other medicines may affect the effectiveness of
Clarithromycin or vice-versa. Such medicines include:

Clarithromycin may increase the effect of the following
medicines:
• Astemizole, terfenadine (antiallergic), pimozide
(antipsychotic), cisapride (gastric medicine), ergotamine,
dihydroergotamine (migraine medicines), lovastatin,
simvastatin (medicines to lower cholesterol), ticagrelor (to
prevent blood clotting), ranolazine (used to treat angina
pectoris), colchicine (to treat gout) (see “Do not take
Clarithromycin”)
• Alprazolam, triazolam, midazolam (hypnotics)
• Digoxin, verapamil, amlodipine, diltiazem (heart medicines)
• Theophylline (antiasthmatic)
• Warfarin (blood thinning medicine)
00000000 000

• Atorvastatin, rosuvastatin (cholesterol lowering agents)
• Cyclosporine, sirolimus, tacrolimus (immunosuppressants)
• Carbamazepin, phenytoin, valproate (medicines to treat
epilepsy)
• Cilostazol (used to improve circulation in the legs)
• Insulin and other medicines for the treatment of diabetes
(such as nateglinide or repaglinide)
• Methylprednisolone (a cortisone to treat inflammation)
• Omeprazole (gastric medicine)
• Sildenafil, tadalafil, vardenafil (medicines to treat erectile
dysfunction)
• Tolterodine (to treat overactive bladder syndrome)
• Vinblastine (medicine for cancer therapy)
• Medicines with the risk to affect hearing, especially
aminoglycosides, such as gentamicin or neomycin (group
of antibiotics)
Both, the effect of Clarithromycin and the effect of the
following medicines may be increased when taken
together:
• Atazanavir, saquinavir (medicines to treat HIV)
• Itraconazole (medicine to treat fungal infections)

If your doctor has specifically recommended to take
Clarithromycin and any of the above mentioned medicines at
the same time, your doctor may need to monitor you more
closely.
The following medicines may weaken the effect of
Clarithromycin:
• Rifampicin, rifabutin, rifapentine (antibiotics)
• Efavirenz, etravirine, nevirapine (medicines to treat HIV)
• Phenytoin, carbamazepine, phenobarbitone (antiepileptic)
• St John’s Wort

Please note
Ritonavir (antiviral) and fluconazole (medicine to treat fungal
infections) may increase the effect of Clarithromycin.
Clarithromycin may weaken the effect of zidovudine
(antiviral). In order to avoid this you should leave a 4 hour
interval between taking these medicines.

The use of Clarithromycin at the same time as digoxin,
quinidine, disopyramide or verapamil (heart medicines) or
other macrolide antibiotics may cause cardiac arrhythmia.

Taking Clarithromycin with food and drink
Clarithromycin Tablets can be taken before, with or after food.
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 for advice before taking this medicine.

Driving and using machines
Clarithromycin has generally no effect on the ability to drive or
use machines but may cause side effects such as dizziness,
confusion and disorientation. If you feel affected you should
not drive, operate machinery or take part in activities where
you may put yourself or others at risk.

3

How to take Clarithromycin

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The dispensing label will tell you how much of this medicine
you should take and how often you should take it. Please read
it carefully. The dose your doctor prescribes depends on the
type of infection and how bad the infection is. It also depends
on how your kidneys are working. Your doctor will explain this
to you.
Continued on the next page >>

Adults and children over 12 years:
The usual dose is one 250 mg tablet twice a day for 6 to 14 days.
For some infections, you may be instructed to take two
250 mg tablets or one 500 mg tablet twice a day.
For Helicobacter Pylori Infections:
One 500 mg tablet (or two 250 mg tablets) twice a day in
combination with 1000 mg amoxicillin and 20 mg omeprazole
twice a day for 7 days.
Patients with kidney problems:
Depending on your kidney function, your doctor may need to
give you a lower dose than the normal adult dose.

Children (under 12 years old):
Clarithromycin Tablets are not recommended. Clarithromycin
Suspension will usually be given.

If you take more of this medicine than you should
If you have taken too many Clarithromycin Tablets, or if
someone else has taken your Clarithromycin Tablets, you/they
should contact your doctor or your nearest hospital accident
and emergency department immediately. Please take any
remaining medicine with you in the carton in which it came so
that the doctor or hospital staff will know what has been taken.
If you forget to take this medicine
Take it as soon as you remember. Then continue as before.
Do not take any more tablets in one day than your doctor has
prescribed. Do not stop taking the tablets until the end of the
prescribed course even if you feel better.
If you stop taking this medicine
Do not stop taking Clarithromycin Tablets before the end of
the course, even if you think the infection is better. Stopping
early can mean that the infection quickly comes back. If you
are not sure about anything, ask your doctor or pharmacist.

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.

Serious side effects
If any of the following happens, stop taking this medicine and
tell your doctor immediately or go to the casualty department
at your nearest hospital.
Uncommon serious side effects (may affect up to 1 in 100
people):
• fever, sore throat or mouth ulcers due to infections
(signs of low level of white blood cells)
• rash, itching, hives, breathlessness or difficult breathing,
wheezing or coughing, light-headedness, dizziness,
changes in levels of consciousness, hypotension, with or
without mild generalized itching, skin reddening,
facial/throat swelling, blue discoloration of the lips, tongue
or skin (signs of severe allergic reaction)
• irregular heart-beat (change in the electrical activity of the
heart)
• yellow skin and eyes, nausea, loss of appetite, dark urine

Serious side effects with unknown frequency (frequency
cannot be estimated from the available data):
• diarrhoea, abdominal pain, fever (signs of inflammation of
the colon
• severe pain in the abdomen and back, caused by pancreas
inflammation
• high or low urine output, drowsiness, confusion, and
nausea caused by kidney inflammation
• severe or itchy skin rash, especially if this shows blistering
and there is soreness of the eyes, mouth or genital organs
• unusual bruising or bleeding caused by low blood platelets
• fast or irregular heart beat
• severe bleeding
• abnormal breakdown of muscle, causing pain, fever,
red-brown urine
• severely decreased urine output
• rash, fever, blood alterations (which may be a sign of
hypersensitivity syndrome, called DRESS).
These are all serious side effects. You may need urgent
medical attention.
Other possible side effects
Tell your doctor if any of the following side effects bother you.
Common (may affect up to 1 in 10 people):
• difficulty falling asleep
• headache
• changes in the senses of taste (for example metallic or
bitter taste)
• abdominal pain, feeling or being sick, diarrhoea,
indigestion, heart burn
• abnormal liver function test results
• rash
• excessive sweating.

Uncommon (may effect up to 1 in 100 people):
• yeast infections (candidiasis)
• infections of the vagina
• low levels of white blood cells, increased number of certain
white blood cells
• loss or reduction of appetite














anxiety
dizziness, drowsiness, tremor
impaired hearing
spinning sensation
ringing in the ears (tinnitus)
inflammation of the stomach lining, constipation, wind, dry
mouth, belching, swelling or bloating of the abdomen
increase of liver enzymes in the blood
generally feeling unwell, weakness, tiredness
chest pain
chills
abnormal blood test result - high level of an enzyme called
alkaline phosphatase in the blood that gives information
about the health of bones or high level of an enzyme called
blood lactate dehydrogenase in the blood that gives
information about the health of certain organs

Frequency not known (frequency cannot be estimated
from the available data)
• nightmares, confusion, disorientation, hallucinations
(seeing things that are not there), psychosis (loss of
contact with reality), a feeling of loss of identity, depression
• convulsions, loss of sense of taste or smell, tingling and
numbness of the skin
• deafness
• certain bacterial infections of the skin and underlying tissues
• disturbed sense of smell, loss of sense of smell or taste
• tongue discolouration, tooth discoloration
• hemorrhage
• acne
• pain or weakness in muscles
• abnormal blood test results - prolonged blood clotting time
• urine colour abnormal.
Clarithromycin may also affect some laboratory tests. If you
have to go to hospital or doctors for a blood test it is important
that you tell the doctor or nurse that you are taking clarithromycin.

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 (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.

Store in the original package in order to protect from moisture.

Do not use this medicine after the expiry date which is stated
on the 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 protect the
environment.

6

Contents of the pack and other
information

What Clarithromycin Tablets contain:
The active substance is clarithromycin.

• Each film-coated tablet contains 250 mg or 500 mg of the
active ingredient clarithromycin
• The other ingredients include: croscarmellose sodium,
microcrystalline cellulose, povidone, magnesium stearate,
colloidal anhydrous silica, talc, hypromellose, propylene
glycol, titanium dioxide (E171), hydroxypropylcellulose,
sorbitan monooleate, quinolin yellow (E104), vanillin.

What Clarithromycin Tablets look like and the contents of
the pack
Clarithromycin 250 mg Tablets are dark yellow, film-coated,
capsule-shaped tablets and are available in
PVC/PVDC/Aluminium blister packs of 8, 10, 12, 14, 15, 16,
20, 21, 24, 49, 50, 100, 100 x 1.

Clarithromycin 500 mg Tablets are light yellow, film-coated,
oval shaped tablets and are available in
PVC/PVDC/Aluminium blister packs of 5, 6, 7, 8, 10, 12, 14,
15, 16, 20, 21, 30, 42, 50, 60, 100, 100 x 1, 140.
Not all pack sizes may be marketed.
Marketing Authorisation Holders and Manufacturer
The marketing authorisation holder is:
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
The manufacturer is:
Sandoz S.R.L., Livezeni Street no. 7A, RO-540472,
Targu Mures, Romania.
The leaflet was last revised in 01/2016.

SZ00000LT000
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draft: 990340, 990341, 44043716
laetus code: 000
mat.no.: 00000000

Artwork Proof Box
Ref: V026: Update texts to the current QRD version 3 + RFI
Proof no.
006.1

Date prepared:
14/01/2016

Colours:
Black
Black 20%
Dimensions: 160 x 320 mm

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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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