Claritromycine Sandoz 125 mg/5 ml, granulaat voor orale suspensie

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

Claritromycine Sandoz 125 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
• Gastric ulcers caused by the bacterium Helicobacter pylori.

Do not take Claritromycine Sandoz 125 mg/5 ml

• if you are allergic (hypersensitive) to clarithromycin, other macrolide antibiotics or to any of the other ingredients of Claritromycine Sandoz 125 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),
  • pimozide (antipsychotic),
  • terfenadine or
  • astemizole (antiallergics)
  • lovastatin, simvastatin (medicines to lower cholesterol).

Take special care with Claritromycine Sandoz 125 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 magnesium level have previously been low.

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 125 mg/5 ml or vice-versa. Such medicines include:

Claritromycine Sandoz 125 mg/5 ml 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) (see “Do not take Claritromycine Sandoz 125 mg/5 ml”)
• Alprazolam, triazolam, midazolam (hypnotics)
• Digoxin, verapamil (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)
• Colchicine (to treat gout)
• Insulin and other medicines for the treatment of diabetes (such as nateglinide, repaglinide, pioglitazone or rosiglitazone)
• 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 Claritromycine Sandoz 125 mg/5 ml 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 Claritromycine Sandoz 125 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 125 mg/5 ml:

• Rifampicin, rifabutin, rifapentine (antibiotics)
• Efavirenz, 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 Claritromycine Sandoz 125 mg/5 ml.

Claritromycine Sandoz 125 mg/5 ml 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 Claritromycine Sandoz 125 mg/5 ml at the same time as digoxin, quinidine, disopyramide 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 125 mg/5 ml before consulting your doctor.

Driving and using machines

Claritromycine Sandoz 125 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 125 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.

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 10 ml twice a day.

For severe infections or gastric ulcers caused by Helicobacter pylori the usual dose is 20 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
8 – 11	1 – 2	2.5
12 – 19	2 – 4	5
20 – 29	4 – 8	7.5
30 – 40	8 – 12	10

Children who weigh less than 8 kg should be given a dose of 0.3 ml/kg twice a day.

Duration of treatment

Your doctor will tell you how long Claritromycine Sandoz 125 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.

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.

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.

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
• inflammation of the stomach lining, constipation, wind, dry mouth, belching
• 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.

Keep out of the reach and sight of children.

Do not use Claritromycine Sandoz 125 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.

What Claritromycine Sandoz 125 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 125 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.

1 bottle contains 47.8 g granules for oral suspension for 70 ml ready-for-use suspension (required water amount: 41.3 ml) or

68.3 g granules for oral suspension for 100 ml ready-for-use suspension (required water amount: 59.0 ml) or

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

Lek Pharmaceuticals d.d. Verovškova 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

Clarithromycin 125mg/5ml Granules for Oral Suspension Claritromycine Sandoz 125 mg/5 ml, granulaat voor orale suspensie

MA-number:

RVG 108082

This medicinal product is authorised in the Member States of the EEA under the following names:

Ireland Netherlands

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 41.3 ml of water
• For 100 ml bottle add 59.0 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.