CLARITHROMYCIN

Main information

  • Trade name:
  • CLARITHROMYCIN
  • Dosage:
  • 250 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLARITHROMYCIN
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • clarithromycin

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Marketed
  • Authorization number:
  • PA2050/002/001
  • Authorization date:
  • 20-10-2006
  • Last update:
  • 12-12-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Clarithromycin Tabs PIL

PI size : 140 x 580 mm

Market : Ireland

SPIL/PKGDEV - CG18/Dec/2017-V01, CG19/Dec/2017-V02,

CG26/Feb/2018-V03, CG06/Jul/2018-V04

What is in this leaflet

What Clarithromycin Film-coated Tablets are and

what they are used for

What you need to know before you take

Clarithromycin Film-coated Tablets

How to take Clarithromycin Film-coated Tablets

Possible side effects

How to store Clarithromycin Film-coated Tablets

Contents of the pack and other information

1.

What Clarithromycin Film-coated Tablets are

and what they are used for

Clarithromycin is a macrolide antibiotic which is

highly effective in the treatment of a variety of

infections including:

Throat and sinus infections

Chest infections such as bronchitis and

pneumonia

Skin and soft tissue infections

Helicobacter pylori infections associated with

duodenal ulcers.

Clarithromycin film-coated tablets are indicated in

adults and children 12 years and older.

2.

What you need to know before you take

clarithromycin film-coated tablets

Do not take Clarithromycin Film-coated Tablets if:

you are allergic to clarithromycin, other

macrolide antibiotics such as erythromycin or

azithromycin, or any of the other ingredients

of this medicine (listed in section 6)

you have abnormally low levels of potassium in

your blood (hypokalaemia)

you have severe liver disorders combined with

kidney disorders

someone in your family has a history of heart

rhythm disorders (ventricular cardiac

arrhythmia, including torsades de pointes) or

abnormality of electrocardiogram (ECG,

electrical recording of the heart) called “long

QT syndrome”

you are taking:

medicines called terfenadine or astemizole

(for hay fever or allergies) or cisapride (for

stomach disorders) 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.

other medicines which are known to cause

serious disturbances in heart rhythm

medicines called ergot alkaloid tablets (e.g.

ergotamine or dihydroergotamine) or use

ergotamine inhalers (for migraine)

lovastatin or simvastatin (treatments to

lower cholesterol [a type of fat] in blood)

ticagrelor (for stroke or heart attack)

ranolazine (for chest pain)

colchicine (for gout)

oral midazolam (a sedative)

If any of the above applies to you, consult your

doctor for advice on alternative medicines.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Clarithromycin Film-coated Tablets:

if you have a liver or kidney disorder

if you are resistant to other antibiotics such as

clindamycin, lincomycin

if you have heart problems (e.g. heart disease,

heart failure, an unusually slow heart rate, or

low levels of magnesium in the blood)

if you have hypomagnesaemia (low blood

magnesium)

if you take anticoagulants, e.g. warfarin

(medicines to thin your blood). Your

prothrombin time should be monitored

frequently

if you take medicines, which can impair hearing,

especially aminoglycosides (group of

medicine to treat some infections). Your

doctor should check your ability to hear, if

necessary

if you take medicines to lower your blood sugar.

Their effect might be increased by

Clarithromycin

if you have pneumonia, as the causing bacteria

(Streptococcus pneumoniae) might be

resistant against clarithromycin

if you have, or are prone to, fungal infections

(e.g. thrush)

if you are pregnant or breast feeding

If any of the above applies to you, consult your

doctor before taking Clarithromycin Film-coated

Tablets.

Stop taking Clarithromycin Film-coated Tablets and

tell your doctor, if you:

develop severe diarrhoea during or after

treatment with Clarithromycin Film-coated

Tablets. Medicines that prevent peristalsis

(bowel movement) such as antidiarrhoeal

treatments should be avoided

develop 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.

develop another infection.

Clarithromycin Film-coated tablets are not suitable

for use in children under 12 years of age.

Other medicines and Clarithromycin Film-coated

Tablets

Tell your doctor or pharmacist if you are taking, have

recently taken or might take any other medicines.

You should not use Clarithromycin Film-coated

Tablets if you are taking any one of the following

medicines (see section 'Do not take

Clarithromycin Film-coated Tablets if')

astemizole or terfenadine (for hay fever or

allergy)

cisapride (for stomach disorders)

pimozide (for mental disorders)

lovastatin or simvastatin (treatments to lower

cholesterol [a type of fat] in blood)

ticagrelor (for stroke or heart attack)

ranolazine (for chest pain)

colchicine (for gout)

quetiapine (for bipolar disorder and

schizophrenia)

oral midazolam (a sedative).

Your doctor may need to control blood levels or

effects, or to adjust the dosage, or to interrupt (for

some time) the treatment if Clarithromycin Film-

coated Tablets are used at the same time with

medicines containing one of the substances listed

below:

digoxin (for heart failure)

quinidine or disopyramide (for heartbeat disorders)

intravenous or oromucosal midazolam

(sedatives/sleeping pills)

triazolam (sleeping pills)

alprazolam (for anxiety)

cilostazol (for poor circulation)

verapamil, amlodipine and diltiazem (medicine

against high blood pressure)

tolterodine (medicine to treat urinary incontinence)

St. John's wort (herbal product used for depression)

cyclosporin, tacrolimus or sirolimus (help prevent

rejection after transplant)

theophylline (used in patients with breathing

difficulties such as asthma)

efavirenz, nevirapine, ritonavir, etravirine,

zidovudine, atazanavir or saquinavir (HIV

treatments)

rifampicin, rifabutin or rifapentine (antibiotics

used in the treatment of certain bacterial

infections)

fluconazole, itraconazole (antifungal medicine)

warfarin (blood thinner)

atorvastatin, rosuvastatin (cholesterol-lowering

drugs). Statins can cause rhabdomyolosis (a

condition which causes the breakdown of

muscle tissue which can result in kidney

damage). Signs of myopathy (muscle pain or

muscle weakness) should be monitored.

omeprazole antacid (for heartburn or ulcers)

unless your doctor has prescribed it for you to

treat Helicobacter pylori infection associated

with stomach or duodenal ulcers

methylprednisolone (a corticosteroid)

vinblastine (for treatment of cancer)

phenytoin, carbamazepine, valproate or

phenobarbital (for epilepsy)

insulin or other diabetes medicines, e.g.

pioglitazone, rosiglitazone, repaglinide and

nateglinide (used to lower blood glucose

levels)

sildenafil, tadalafil and vardenafil (for impotence

in adult males or for use in high blood

pressure in the blood vessels of the lungs)

aminoglycosides (a group of antibiotic to treat

certain bacteria for example gentamicin,

neomycin)

gliclazide or glimiperide (sulphonylureas used in

the treatment of type II diabetes)

quetiapine or other antipsychotic medicines

other macrolide medicines

lincomycin and clindamycin (lincosamides – a

type of antibiotic)

Please tell your doctor if you are taking oral

contraceptive pills and diarrhoea or vomiting occurs

as you may need to take extra contraceptive

precautions such as using a condom.

It may still be all right for you to be given

Clarithromycin Film-coated tablets and your doctor

will be able to decide what is suitable for you.

Clarithromycin Film-coated Tablets with food and

drink

Clarithromycin Film-coated Tablets may be taken with

or without 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 or pharmacist before taking this

medicine as the safety of Clarithromycin Film-

coated Tablets in pregnancy and breast-feeding is

not known. Your doctor will decide if it is ok for

you to take Clarithromycin Film-coated Tablets.

Ask your doctor or pharmacist for advice before

taking any medicine.

Driving and using machines

Clarithromycin Film-coated Tablets may cause

dizziness, vertigo (spinning sensation), confusion or

disorientation (not knowing where you are). If

affected, you should not drive or operate machines.

3.

How to take Clarithromycin Film-coated

Tablets

Always take this medicine exactly as your doctor or

pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

Adults, older people and children over 12 years

For chest infections, throat or sinus infections and

skin and soft tissue infections:

The usual dose is 250 mg twice daily. This may be

increased to 500 mg twice daily for severe

infections.

For the treatment of Helicobacter pylori as part of a

treatment for duodenal ulcers:

There are a number of effective treatment

combinations available to treat Helicobacter pylori

in which clarithromycin tablets are taken together

with one or two other drugs.

These combinations include the following and are

usually taken for 6 to 14 days:

One Clarithromycin 500 mg tablet taken twice a

day together with amoxycillin, 1000 mg taken

twice a day plus lansoprazole, 30 mg twice a

day.

One Clarithromycin 500 mg tablet taken twice a

day together with metronidazole, 400 mg taken

twice a day plus lansoprazole, 30 mg twice a

day.

One Clarithromycin 500 mg tablet taken twice a

day together with amoxycillin, 1000 mg taken

twice a day or metronidazole, 400 mg taken

twice a day plus omeprazole, 40 mg a day.

One Clarithromycin 500 mg tablet taken twice a

day together with amoxycillin, 1000 mg taken

twice a day plus omeprazole, 20 mg taken

once a day.

The treatment combination that you receive may differ

slightly from the above. Your doctor will decide

which treatment combination is the most suitable

for you. If you are unsure which tablets you should

be taking or how long you should be taking them

for, please consult your doctor for advice.

Use in renal impairment

Patients with a severe kidney disorder may need a

reduced dose and their treatment should not be

longer than 14 days.

ergotamine or dihydroergotamine (for migraine)

Black

Clarithromycin 500 mg Film-coated Tablets can be

divided into equal doses.

Clarithromycin Film-coated tablets should be

swallowed with at least half a glass of water.

Clarithromycin film-coated Tablets may be taken with

or without food.

Clarithromycin Film-coated Tablets are not

suitable for children less than 12 years of age.

They should receive Clarithromycin granules

for oral suspension.

Duration of treatment

The usual length of treatment is 6 to 14 days.

If you take more Clarithromycin Film-coated

Tablets than you should

If you accidentally take more Clarithromycin Film-

coated Tablets in one day than your doctor has

told you to, or if a child accidentally swallows

some tablets, contact your doctor, pharmacist or

nearest hospital emergency department

immediately. An overdose of Clarithromycin is

likely to cause vomiting and stomach pains.

If you forget to take Clarithromycin Film-coated

Tablets

If you miss, a dose take it as soon as possible.

However if it is nearly time for your next dose, skip

the missed dose and carry on as before. Do not

take a double dose to make up for a forgotten dose.

If you stop taking Clarithromycin Film-coated

Tablets

Do not stop taking Clarithromycin Film-coated

Tablets, even if you feel better. It is important to

take the tablets 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.

Serious side effects

If you suffer from any of the following at any time

during your treatment stop taking your tablets and

contact your doctor immediately.

Uncommon (may affect up to 1 in 100 people):

any sudden wheeziness, difficulty in breathing,

swelling of the eyelids, face or lips, rash or

itching. This is a sign that you may have

developed an allergic reaction.

Frequency not known (frequency cannot be

estimated from the available data):

contact a doctor immediately if you experience a

serious skin reaction; a red, scaly rash with

bumps under the skin and blisters

(exanthematous pustulosis)

severe form of skin rash with flushing, fever,

blisters or ulcers (Stevens Johnson syndrome),

severe rash involving reddening, peeling and

swelling of the skin that resembles severe

burns (toxic epidermal necrolysis)

rash fever, abnormal blood count and

inflammation of internal organs. These may be

symptoms of drug reaction with eosinophilia

and systemic symptoms (DRESS).

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 (see also 'Warnings and

precautions').

jaundice (yellowing of the skin or eyes), skin

irritation, pale stools, dark urine, tender

abdomen or loss of appetite. These may be

signs that your liver may not be working

properly.

Tell your doctor immediately or go to the casualty

department at your nearest hospital if any of the

following happens:

Common (may affect up to 1 in 10 people):

abnormal liver test results

Uncommon (may affect up to 1 in 100 people):

heart attack, dangerously fast heartbeat, ECG

changes, extra heart beats, palpitations

blood clot in the lungs which causes chest pain

and breathlessness

Frequency not known (frequency cannot be

estimated from the available data):

changes in heartbeat rhythm (torsades de

points), increased heart rate (tachycardia)

inflammation of the pancreas (combined with

severe pain in the upper abdominal region

radiating to the back, along with nausea and

vomiting)

inflammation of kidneys (combined with blood in

the urine, fever, and pain in the sides)

hypoglycaemia (abnormally low blood sugar

indicated by feeling hungry, sweating,

dizziness, heart palpitation) particularly after

taking anti-diabetic medicine

muscle weakness, tenderness or pain and

particularly, if at the same time, you feel

unwell or have a high temperature it may be

caused by an abnormal muscle breakdown,

which can lead to kidney problems

(rhabdomyolysis)

Other side effects

Tell your doctor as soon as possible if any of the

following develops:

Common (may affect up to 1 in 10 people):

rash

sleeplessness (insomnia)

headache

feeling sick (nausea), vomiting, stomach pain,

indigestion, diarrhoea

change in the sense of taste, altered taste (for

example metallic or bitter taste)

increased sweating (hyperhidrosis)

widening of blood vessels.

Uncommon (may affect up to 1 in 100 people):

inflammation of the skin with blisters (dermatitis

bullous), itching of the skin, skin rash and

hives (urticaria), rash characterized by a flat,

red area on the skin that is covered with small

confluent bumps (rash maculo-papular)

hot, tender and red skin, sometimes with fever

and chills (cellulitis)

oral or vaginal 'thrush' (a fungal infection)

mild to severe nausea, vomiting, cramps,

diarrhoea. These symptoms may be due to

inflammation of the stomach and intestines,

usually caused by a virus

a burning sensation in the chest rising up to the

throat, also known as heartburn

inflammation of the food pipe (oesophagitis),

stomach (gastritis), in the mouth or the tongue

constipation, dry mouth, winds, abdominal

distension, belching

bile disorder (cholestasis)

fever, generally feeling unwell, feeling of

weakness, chest pain, chills, tiredness, pain in

muscles, muscle stiffness, muscle spasms or

loss of muscle tissue. If you suffer from

myasthenia gravis (a condition in which the

muscles become weak and tired easily)

clarithromycin may worsen these symptoms

decreased appetite, loss of appetite (anorexia)

anxiety, screaming, nervousness

loss of consciousness, uncontrollable twitching,

jerking or writhing movements (dyskinesia),

dizziness, drowsiness, tremors or shaking

hearing impaired

spinning sensation (vertigo), ringing in the ears

(tinnitus)

frequent infections such as fever, severe chills,

sore throat or mouth ulcers. These symptoms

may be due to low count of white blood cells

increase in some white blood cells

increase platelet count (thrombocythemia)

raised blood urea nitrogen or creatinine (waste

products)

changed blood levels of albumin, globulin and

diverse enzymes (alkaline phosphatase,

lactate dehydrogenase)

breathlessness, wheezing, a cough sometimes

brought on by exercise, and a feeling of

tightness in the chest (asthma)

nose bleed

pain in the rectum

decrease in neutrophils (neutropenia)

Frequency not known (frequency cannot be

estimated from the available data):

inflammation of the colon

bacterial infections of the skin (erysipelas)

abnormal urine colour

tongue discoloration, tooth discoloration

severely reduced kidney function (renal

failure)

deafness

depression, hallucinations, abnormal thoughts

(psychosis), not knowing where you are

(disorientation), out of body feeling

(depersonalization), bad dreams, confusion

and mania (feeling of elation or over-

excitement)

numbness and tingling in arms and legs

(paraesthesia)

convulsions (fits)

loss of taste functions of the tongue (ageusia)

change in the sense of smell (parosmia), inability

to perceive smells (anosmia)

abnormally low counts of blood platelets (which

may cause bruising of the skin or increased

tendency to bleed)

acne

loss of blood (haemorrhage),

long bleeding and blood clotting time

Reporting of side effects

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. You can also

report side effects directly via HPRA

Pharmacovigilance, Earlsfort Terrace, IRL - Dublin

2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

By reporting side effects you can help provide more

information on the safety of this medicine.

5.

How to store Clarithromycin Film-coated

Tablets

Keep this medicine out of the sight and reach of

children.

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.

This medicine does not require any special

temperature storage conditions. Store in the

original package in order to protect from moisture.

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 Film-coated Tablets contain

Each film-coated tablet contains clarithromycin

250mg or 500mg.

The other ingredients are microcrystalline cellulose,

croscarmellose sodium, povidone, magnesium

stearate, talc, colloidal anhydrous silica, stearic

acid and the coating material Opadry 20H 52875

containing hypromellose, hydroxypropylcellulose,

propylene glycol, vanillin, titanium dioxide, talc

and quinoline yellow lake (E104)

What Clarithromycin Film-coated Tablets look

like and contents of the pack

Clarithromycin 250mg Film-coated Tablets are light

yellow, oval, biconvex film coated tablets

embossed with 'C1' on one side.

Clarithromycin 500mg Film-coated Tablets are light

yellow, oval, biconvex film coated tablets with 'C'

and '2' embossed on either side of the breakline

on one side and notched on both sides. The

tablet can be divided into equal doses.

Clarithromycin Film-coated Tablets are available in

blister strips of 1, 2, 10, 12, 14, 15, 20, 21, 30, 42,

50, 56 or 100 tablets. Not all pack sizes may be

marketed.

Marketing Authorisation Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132 JH, Hoofddorp,

The Netherlands

Manufacturer

Terapia S.A.,

124 Fabricii Street,

400 632 Cluj-Napoca,

Romania

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132 JH, Hoofddorp,

The Netherlands

This medicinal product is authorised in the

Member States of the EEA under the following

names:

Ireland:

Clarithromycin 250mg, 500mg Film-

coated Tablets

Italy:

Claritromicina Ranbaxy Italia 250mg,

500mg compresse rivestite con film

Lithuania:

Klabax 250mg, 500mg plėvele

dengtos tabletės

Poland:

Klabax 250mg, 500mg tabletki

powlekane

UK:

Clarithromycin 250mg, 500mg Film-

coated tablets

This leaflet was last revised in: February 2018

Font Size : 9 pt.

Package leaflet: Information for the user:

Clarithromycin 250mg

Film-coated Tablets

Clarithromcyin 500mg

Film-coated Tablets

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.