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CLARITHROMYCIN 250MG/5ML SUSPENSION

Active substance(s): CLARITHROMYCIN / CLARITHROMYCIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Clarithromycin 250 mg/5 ml Suspension

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

gentamicin or neomycin (group of antibiotics)

What Clarithromycin is and what it is used for

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).

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

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.

Clarithromycin is used to treat:
• Throat and sinus infections.
• Middle ear infections in children.
• Chest infections, such as bronchitis and pneumonia.
• Skin and soft-tissue infections.
• Gastric ulcers caused by the bacterium Helicobacter pylori.

2

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 Johnʼs Wort.

What you need to know before you take Clarithromycin

Please note
Ritonavir (antiviral) and fluconazole (medicine to treat fungal infections) may
increase the effect of 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, astemizole (antiallergics)
- lovastatin, simvastatin (medicines to lower cholesterol)
- colchicine (to treat gout).

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.

The use of Clarithromycin at the same time as disopyramide may cause low blood sugar
levels (hypoglycaemia).

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.

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 (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 suffer from myasthenia gravis, a rare disease which causes muscle weakness
• if you have diabetes
• if you have, or have had, heart problems
• if your magnesium level have previously been low
• if you have used Clarithromycin before on several occasions or for a long time.

Clarithromycin contains sucrose
This medicine contains 2.4 g sucrose per 5 ml ready-for-use suspension. This should
be taken into account in patients with diabetes mellitus. Patients with rare hereditary
problems of fructose intolerance, glucosegalactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.

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 much of this medicine you should take and how often
you should take. 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 well the
kidneys are working. Your doctor will explain this to you.

Other medicines and Clarithromycin
Tell your doctor or pharmacist if you are taking, 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:

Adults and adolescents:
The usual dose is 5 ml twice a day.
For severe infections or gastric ulcers caused by Helicobacter pylori the usual dose is
10 ml twice a day.

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)
• 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

Children 6 months to 12 years:
The daily amount is worked out according to the weight of the child.
The following table provides a guide to usual doses:
Body weight (in kg)

Age (years)

Dosage (in ml) given twice daily

20 – 29

4–8

3.75

12 – 19
30 – 40

8 – 12

2.5
5

Duration of treatment
Your doctor will tell you how long Clarithromycin should be used, normally between 5
and 14 days. Do not stop treatment on your own decision, e.g. because you or your
child feels better. If the use is stopped too early, the infection may return.

Method of use
Usually this medicine is given twice a day, once in the morning and again in the early
evening.
You may take this medicine with or without food.

Continued on the next page >>

The following information is intended for medical or healthcare
professionals only:






For the preparation of the suspension fill the bottle with following amounts of water
• For 50 ml bottle add 28.5 ml of water

For 60 ml bottle add 34.2 ml of water
For 70 ml bottle add 39.9 ml of water
For 80 ml bottle add 45.6 ml of water
For 100 ml bottle add 57.0 ml of water

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This medicine can cause a bitter aftertaste when remaining in the mouth. This can be
avoided by eating or drinking something immediately after the intake of the
suspension.











How to measure the dose
A 5 ml syringe marked at 2.5, 3.75 and 5 ml is provided with this medicine. It comes
with an adaptor which fits onto the bottle. To measure the medicine:
• Shake the bottle.
• Put the adaptor into the mouth of the bottle.
• Put the end of the syringe into the adaptor.
• Turn the bottle upside-down.
• Pull the plunger to measure the dose you need.
• Turn the bottle upright, remove the syringe, leave the adaptor on the bottle and
close the bottle.
Always remember to shake the bottle before measuring out each dose.

Frequency not known (frequency cannot be established from available data):
• discoloration of the teeth and tongue
• certain bacterial infections of the skin and underlying tissues
• disturbed sense of smell, loss of sense of smell or taste
• deafness
• acne
• depression
• pain or weakness in muscles
• abnormal urine colour
• nightmares, confusion, disorientation, seeing feeling or hearing things that are not
there, loss of contact with reality, a feeling of loss of identity
• convulsions, tingling and numbness of the skin
• bleeding
• liver failure
• kidney failure

Giving the medicine using the syringe:
• Make sure the child is supported in an upright position.
• Put the tip of the syringe carefully into the childʼs mouth. Point the tip of the syringe
towards the inside of the cheek.
• Slowly push down the plunger of the syringe: Do not squirt it out quickly.
• Allow the child time to swallow the medicine.

Alternatively, empty the measured dose from the pipette onto a spoon for your child to
take the medicine from.
How to prepare this medicine
A doctor or pharmacist will prepare this medicine for you. To open the medicine bottle,
you need to press the childproof top down and then turn it.

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.

If you need to prepare this medicine yourself, you should fill the bottle with cold water
to just under the measurement line marked on the bottle. Shake it well as soon as you
have done that.
Then put more water in right up to the measurement line marked on the bottle and
shake it again.

5

You only need to prepare the suspension once, at the beginning of your course.

If you take more Clarithromycin than you should
If you have taken too much of this medicine, contact your doctor or hospital as soon as
possible. Symptoms of overdosage may be gastrointestinal symptoms.

How to store Clarithromycin

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.

If you forget to take Clarithromycin
If you forget to take this medicine, continue treatment following the normal dosage,
recommended by your doctor. Do not take a double dose to make up for a forgotten dose.

Do not store above 25°C.
After reconstitution: Do not store above 25°C.
The suspension must be used within 14 days after preparation.

If you stop taking Clarithromycin
It is important that you take your medicine in accordance with the doctorʼs instructions.
Do not suddenly stop using this medicine without discussing it first with your doctor.
Otherwise symptoms may return.

4

loss or reduction of appetite
anxiety, nervousness, screaming
dizziness, tremor, somnolence
spinning sensation, impaired hearing, ringing in the ears (tinnitus)
feeling your heart beat
inflammation of the stomach lining, constipation, wind, dry mouth, belching
itching, hives, red raised rush
muscle spasms
fever, weakness

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Medicines should not be disposed of 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 contains
- The active substances is clarithromycin
- The other ingredients are poloxamer 188, povidone K 30, hypromellose, macrogol
6000, titanium dioxide (E171), methacrylic acid – ethyl acrylate copolymer (1:1),
triethyl citrate, glycerol monostearate, polysorbate 80, sucrose, maltodextrin, potassium
sorbate, colloidal anhydrous silica, xanthan gum, fruit punch flavouring (natural and
artificial flavouring substances including maltodextrin, modified starch and maltol).

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):
• 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
• irregular heart-beat (change in the electrical activity of the heart)
• risk of blood clotting, caused by a high level of blood platelets.

What Clarithromycin looks like and contents of the pack
60 ml, 120 ml and 240 ml white or beige granules in HDPE bottles with child resistant
PP-screw closures and an oral PE/PP-measuring syringe (5 ml) with filling marks at
2.5 ml, 3.75 ml and 5.0 ml.

Pack sizes:
1 bottle contains 34.1 g granules for oral suspension for 50 ml ready-for-use
suspension (required water amount: 28.5 g) or 41.0 g granules for oral suspension for
60 ml ready-for-use suspension (required water amount: 34.2 g) or 47.8 g granules for
oral suspension for 70 ml ready-for-use suspension (required water amount: 39.9 g) or
54.6 g granules for oral suspension for 80 ml ready-for-use suspension (required water
amount: 45.6 g) or 68.3 g granules for oral suspension for 100 ml ready-for-use suspension (required water amount: 57.0 g).
Double pack of 2 x 60 ml ready-for-use-suspension: 2 x 41.0 g granules for oral
suspension each for 2 x 60 ml ready-for-use suspension each (required water amount:
2 x 34.2 g each).

Serious side effect with unknown frequency:
• fever, sore throat, more frequent infections, caused by a serious shortage of white
blood cells (agranulocytosis)
• rash, fever, blood alterations (which may be a sign of hypersensitivity syndrome,
called DRESS)
• yellowing of the skin and eyes, nausea, loss of appetite, slightly yellow skin and
eyes, abnormal liver blood test results (signs of liver disorders)
• 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

1, 2, 5, 10, 20, 30, 40, 50, 100 bottles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer:
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia or
Sandoz S.R.L., Livezeni Street no 7A, Targu Mures, Romania or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany.

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:

This leaflet was last revised in 03/2014.

Common (may affect up to 1 in 10 people):
• headache
• changes in the senses of taste (for example metallic or bitter taste)
• abdominal pain, feeling or being sick, diarrhoea, indigestion
• difficulty in sleeping
• abnormal liver function test results
• rash
• excessive sweating.
Uncommon (may affect up to 1 in 100 people):
• low level of white blood cells
• increase of liver enzymes in the blood
• yeast infections (candidiasis)
• infections, for example of the vagina

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Shake the bottle well as soon as you have filled it with water. After reconstitution with
water the medicinal product results in a white to beige suspension.

SZ00000LT000

Artwork Proof Box
Ref: V032 - Update texts in line with P-RMS FAR - responses
Proof no.
012.1

Date prepared:
05/03/2014

Colours:
Black
Dimensions: 200 x 320 mm

Font size:
6.5pt
Fonts:
Helvetica

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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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