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Claritromycine Sandoz 250 mg/5 ml, granulaat voor orale suspensie

RegistratienummerRVG 108083
ProcedurenummerNL/H/2100/002
Farmaceutische vormGranulaat voor orale suspensie
ToedieningswegOraal gebruik
ATCJ01FA09 - Clarithromycin
AfleverstatusUitsluitend recept
Registratiedatum20 januari 2012
Registratiehouder
Veluwezoom 22
1327 AH ALMERE
Werkzame stof(fen)
Hulpstof(fen)COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1)
FRUIT-PUNCH SMAAKSTOFPOEDER
GLYCEROLMONOSTEARAAT (E 471)

KALIUMSORBAAT (E 202)

MALTODEXTRINE
MALTOL (E 636)
NATRIUMZETMEELOCTENYLSUCCINAAT (E 1450)
POLOXAMEER 188
POLYSORBAAT 80 (E 433)
POVIDON K 30 (E 1201)

SILICIUMDIOXIDE (E 551)
TITAANDIOXIDE (E 171)
TRIETHYLCITRAAT (E 1505)
XANTHAANGOM (E 415)
Download: Bijsluiter PDF


1.3.1.3 Package Leaflet 
 
 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

 
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 Claritromycine Sandoz 250 mg/5 ml is and what it is used for 
2.  Before you take Claritromycine Sandoz 250 mg/5 ml 
3.  How to take Claritromycine Sandoz 250 mg/5 ml 
4.  Possible side effects 
5.  How to store Claritromycine Sandoz 250 mg/5 ml 
6. Further 
information 
 
 
1.  What Claritromycine Sandoz 250 mg/5 ml 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. 
 
Claritromycine Sandoz 250 mg/5 ml 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 

 
 

2.  Before you take Claritromycine Sandoz 250 mg/5 ml 
 
Do not take Claritromycine Sandoz 250 mg/5 ml 
•  if you are allergic (hypersensitive) to clarithromycin, other macrolide antibiotics or to 
any of the other ingredients of Claritromycine Sandoz 250 mg/5 ml (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 to treat migraine), 
•  cisapride (gastric medicine), 
•  (antipsychotic), 
•  or 
•  astemizole (antiallergics) 
•  (medicines to lower cholesterol). 
 
Take special care with Claritromycine Sandoz 250 mg/5 ml 
Tell your doctor before taking this medicine 
•  if you have reduced liver or kidney function 
•  if you are allergic to lincomycin or clindamycin (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, or have had, heart problems or 
•  if your blood potassium and 
 
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. 
 
Certain other medicines may affect the effectiveness of Claritromycine Sandoz 250 mg/5 ml 
or vice-versa. Such medicines include: 
 
Claritromycine Sandoz 250 mg/5 ml may increase the effect of the following medicines: 

medicine), ergotamine, dihydroergotamine (migraine medicines), lovastatin, simvastatin 
(medicines to lower cholesterol) (see “Do not take Claritromycine Sandoz 250 mg/5 mlâ€) 


•  Theophylline (antiasthmatic) 

•  Warfarin (blood thinning medicine) 


•  Carbamazepin, phenytoin, valproate (medicines to treat epilepsy) 
•  Cilostazol (used to improve circulation in the legs) 
•  Colchicine (to treat gout) 


•  Methylprednisolone (a cortisone to treat inflammation) 
•  Omeprazole (gastric medicine) 

•  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 Claritromycine Sandoz 250 mg/5 ml and the effect of the following 
medicines may be increased when taken together: 

• 

• 
Itraconazole (medicine to treat fungal infections) 
 
If your doctor has specifically recommended to take Claritromycine Sandoz 250 mg/5 ml 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 Claritromycine Sandoz 250 mg/5 ml: 
•  Rifampicin, rifabutin, rifapentine (antibiotics) 


•  St John’s Wort 
 
Please note 
(antiviral) and  (medicine to treat fungal infections) may increase the 
effect of Claritromycine Sandoz 250 mg/5 ml. 
 
Claritromycine Sandoz 250 mg/5 ml may weaken the effect of (antiviral). In 
order to avoid this you should leave a 4 hour interval between taking these medicines. 
 
The use of Claritromycine Sandoz 250 mg/5 ml at the same time as digoxinquinidine, 
or verapamil (heart medicines), or other macrolide antibiotics may cause 
cardiac arrhythmia. 
 
Pregnancy and breast-feeding 


Ask your doctor or pharmacist for advice before taking any medicine. 
 
If you are pregnant or breast-feeding do not take Claritromycine Sandoz 250 mg/5 ml before 
consulting your doctor. 
 
Driving and using machines 
Claritromycine Sandoz 250 mg/5 ml 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. 
 
Important information about some of the ingredients of Claritromycine Sandoz 250 
mg/5 ml 
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.  
If you have been told by your doctor that you have an intolerance to some sugars, contact 
your doctor before taking this medicinal product. 
 
3.  How to take Claritromycine Sandoz 250 mg/5 ml 
 
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. 
 
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. 
 
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 
12 – 19 
2 – 4 
2.5 
20 – 29 
4 – 8 
3.75 
30 – 40 
8 – 12 

 
Duration of treatment 

Your doctor will tell you how long Claritromycine Sandoz 250 mg/5 ml 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. 
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. 
 
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 child’s 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. 
 

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

If you take more of this medicine 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. 
 
If you forget to take this medicine 
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. 
 
If you stop taking this medicine 
It is important that you take your medicine in accordance with the doctor’s instructions. Do 
not suddenly stop using this medicine without discussing it first with your doctor. Otherwise 
symptoms may return. 
 
If you have any further questions on the use of this product, 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 (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) 
•  risk of blood clotting, caused by a high level of blood platelets 
 
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 serious shortage 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 (1 to 10 users in 100): 
•  oral thrush, inflammation of the mouth and tongue, discoloration of the teeth and tongue 
•  headache 
•  changes in the senses of smell and taste (for example metallic or bitter taste) 
•  abdominal pain, feeling or being sick, diarrhoea, indigestion 
•  abnormal kidney function test results 
•  difficulty in sleeping 
•  abnormal liver function test results 
•  rash 
•  excessive sweating 
 
Uncommon 
(1 to 10 users in 1,000): 
•  low level of white blood cells 
•  liver disorders, increase of liver enzymes in the blood 
•  joint and muscle pain 
•  yeast infections (candidiasis) 
•  infections, for example of the vagina 
•  loss or reduction of appetite 
•  anxiety, nervousness, screaming 
•  dizziness, tremor, spinning sensation 
•  impaired hearing, ringing in the ears (tinnitus) 
•  feeling your heart beat 

•  itching, hives, red raised rush 
•  muscle spasms 
•  fever, weakness 
 
Very rare (less than 1 user in 10,000): 
•  nightmares, confusion, disorientation, seeing feeling or hearing things that are not there, 
loss of contact with reality, a feeling of loss of identity 
•  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 
•  depression 
•  pain or weakness in muscles 
•  abnormal urine colour. 
 
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 Claritromycine Sandoz 250 mg/5 ml 
 
Keep out of the reach and sight of children. 
 
Do not use Claritromycine Sandoz 250 mg/5 ml after the expiry date which is stated on the 
carton and bottle after EXP:. The expiry date refers to the last day of that month. 
 
Do not store above 25°C. 
After reconstitution: Do not store above 25°C. 
 
The suspension must be used within 14 days after preparation. 
 
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 Claritromycine Sandoz 250 mg/5 ml 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).  
 

What Claritromycine Sandoz 250 mg/5 ml 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  
47.8 g granules for oral suspension for 70 ml ready-for-use suspension (required water 
amount: 39.9 g) or 
68.3 g granules for oral suspension for 100 ml ready-for-use suspension (required water 
amount: 57.0 g). 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder 
Sandoz B.V., Veluwezoom 22, Almere, Nederland 
Correspondentie: Postbus 10332, 1301 AH Almere 
 
Manufacturer 

VerovÅ¡kova 57 
1526 Ljubljana 
Slovenië 
 
Salutas Pharma GmbH 
Otto-von-Guericke Allee 1 
39179 Barleben 
Duitsland  
 
LEK S.A. 
ul. Domaniewska 50 C 
02-672 Warschau 
Polen 
 
S.C. Sandoz, S.R.L. 
Str. Livezeni nr. 7A 
RO-540472 Targu-Mures 
Roemenië 
 
MA-number: 
RVG 108083 
 


This medicinal product is authorised in the Member States of the EEA under the 
following names:
 
Netherlands  
Claritromycine Sandoz 250 mg/5 ml, granulaat voor orale suspensie 
Ireland 
Clarithromycin 250mg/5ml Granules for Oral Suspension 
 
  
Deze bijsluiter is goedgekeurd in januari 2012. 
 
 
The following information is intended for medical or healthcare professionals only: 
 
For the preparation of the suspension fill the bottle with the following amount of water: 
•  For 70 ml bottle add 39.9 ml of water 
•  For 100 ml bottle add 57.0 ml of water 
 
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. 
 





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