CLARITHROMYCIN 500MG TABLETS

Active substance: CLARITHROMYCIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Clarithromycin 250 mg & 500 mg Film-Coated Tablets

(Clarithromycin)

Read all of this leaflet carefully before you start taking 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.

In this leaflet:
1. What Clarithromycin is and what it is used for
2. Before you take Clarithromycin
3. How to take Clarithromycin
4. Possible side effects
5. How to store Clarithromycin
6. Further 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

Before you take Clarithromycin

Do not take Clarithromycin
• if you are allergic (hypersensitive) to clarithromycin, any
other macrolide antibiotics or to any of the other ingredients
in these tablets (see further information 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
- ergotamine, dihydroergotamine (medicines used for
migraines)
- cisapride (for heartburn)
- pimozide (used for schizophrenia)
- terfenadine (an antihistamine)
- astemizole (an antihistamine)
- lovastatin, simvastatin (medicines to lower cholesterol)

Take special care with Clarithromycin
Tell your doctor before taking this medicine
• if you have reduced liver or kidney function.
• if you are allergic to lincomycin or clindamycin (other
types of antibiotics).
• if you are using any antibacterial ear drops such as
gentamycin or neomycin.
• if you suffer from myasthenia gravis, a rare disease which
causes muscle weakness.
• if you have diabetes.
• if you have had, or have a history of heart problems, such
as slow or irregular heart beat or angina.
• if you have untreated electrolyte (blood salts) imbalance.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken, any other medicines, including medicines
obtained without a prescription (including any herbal remedies).

Clarithromycin may increase the effect of the following
medicines:
• Astemizole, terfenadine (an antihistamine), pimozide
(antipsychotic), cisapride (gastric medicine), ergotamine,
dihydroergotamine (migraine medicines), lovastatin,
simvastatin (medicines to lower cholesterol) (see “Do not
take Clarithromycin”)
• Theophylline (for asthma)
• Warfarin (for thinning the blood)
• Digoxin, verapamil (for the heart)
• Carbamazepine, phenytoin, valproate (for epilepsy)
• Cilostazol (used to improve circulation in the legs)
• Colchicine (to treat gout)
• Insulin and other medicines for the treatment of diabetes
(such as nateglinide, repaglinide, pioglitazone or
rosiglitazone)
• Sildenafil, tadalafil, vardenafil (medicines to treat erectile
dysfunction)

• Atorvastatin, rosuvastatin (cholesterol lowering agents)
• Alprazolam, triazolam, midazolam (used for sedation or anxiety)
• Ciclosporin, sirolimus, tacrolimus (medicines used after
organ transplants)
• Methylprednisolone (steroid for inflammation)
• Omeprazole (for ulcers)
• Vinblastine (for leukaemia or lymphomas)
• Tolterodine (to treat overactive bladder syndrome)
• 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, nevirapine (medicines to treat HIV)
• Phenytoin, carbamazepine, phenobarbitone (antiepileptic)
• St Johnʼs 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
Ask your doctor or pharmacist for advise before taking any
medicine.

If you are pregnant or breast-feeding do not take
Clarithromycin before consulting your doctor.

Driving or using machines
This medicine may cause side effects such as dizziness,
confusion or disorientation. This may make you less able to
do certain things, such as driving or using machines.

3

How to take Clarithromycin

Always take this medicine exactly as your doctor has told you.
You should 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.
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.

Continued on the next page >>

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 product,
ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, Clarithromycin tablets can have 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 (1 to 10 users in 1,000):
• allergic reactions such as sudden difficulty in breathing,
speaking and swallowing, swelling of the lips, face and
neck, extreme dizziness or collapse, itchy, raised skin rash
• yellowing of the skin and eyes, unusual tiredness or fever,
dark coloured urine (signs of inflamed liver)

Very rare serious side effects (less than 1 user in 10,000):
• diarrhoea that is serious, lasts a long time or has blood in
it, with stomach pain or fever. This can be a sign of a
serious bowel inflammation. Your doctor may discontinue
treatment. Do not take medicines that reduce bowel
movements.
• 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

Serious side effect with unknown frequency:
• fever, sore throat, more frequent infections, caused by a
lack of white blood cells
• 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 (affects 1 to 10 users in 100):
• oral thrush, inflammation of the mouth and tongue,
discoloration of the teeth and tongue (reversible when
treatment stops)
• headache
• changes in the senses of smell and taste (for example
metallic or bitter taste)
• abdominal pain, feeling or being sick, diarrhoea,
indigestion, heart burn
• increase in blood urea nitrogen.
• difficulty in sleeping
• abnormal liver function test results
• rash
• excessive sweating

Uncommon (affects 1 to 10 users in 1,000):
• low levels of white blood cells, increased number of certain
white blood cells
• increase of liver enzymes in the blood
• joint and muscle pain















yeast infections (candidiasis)
infections of the vagina
loss or reduction of appetite
anxiety
dizziness, tremor, spinning sensation
impaired hearing, ringing in the ears (tinnitus)
feeling your heart beat
inflammation of the stomach lining, constipation, wind, dry
mouth, belching, swelling or bloating of the abdomen
itching, hives
generally feeling unwell, weakness, tiredness
chest pain
chills

Very rare (affects less than 1 user in 10,000):
• nightmares, confusion, disorientation, hallucinations
(seeing things that are not there), psychosis (loss of
contact with reality), a felling of loss of identity, depression
• dizziness, convulsions, tingling and numbness of the skin
• difficulty hearing
• liver failure
• kidney failure
• low blood sugar level, especially after use of antidiabetics
and insulin at the same time

Frequency not known:
• certain bacterial infections of the skin and underlying
tissues
• disturbed sense of smell, loss of sense of smell or taste
• deafness
• acne
• pain or weakness in muscles
• abnormal urine colour.

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.

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.

5

How to store Clarithromycin

Keep out of the reach and sight of children.

Store in the original package.

Do not use Clarithromycin after the expiry date which is stated
on the carton after EXP. 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 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, 100x1.

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, 100x1, 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 approved in 05/2012.

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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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