Claritromycine Sandoz 500 mg, filmomhulde tabletten

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

Claritromycine Sandoz is used to treat:

• throat and sinus infections
• 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

• if you are allergic (hypersensitive) to clarithromycin, other macrolide antibiotics or to any of the other ingredients of Claritromycine Sandoz (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

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.

Tell your doctor:

• if you develop severe diarrhea while you are taking Claritromycine Sandoz, or even several weeks after you have stopped taking it (see further information in section 4).
• if you experience any evidence of infection (e.g. fever, sore throat).

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 or vice-versa. Such medicines include:

Claritromycine Sandoz 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”)
• 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 glibenclamide, 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)
• aprepitant (used to prevent vomiting during chemotherapy)
• eletriptan (migraine medicine)
• halofantrine (medicine to treat malaria)
• ziprasidone (an antipsychotic drug)

Both, the effect of Claritromycine Sandoz 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 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:

• 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.
• Claritromycine Sandoz 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 at the same time as digoxin, quinidine or disopyramide or verapamil (heart medicines), or other macrolide antibiotics may cause serious side effects.

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 before consulting your doctor.

Driving and using machines

Clarithromycin has generally no effect on the ability to drive or use machines. Do not drive or use machines, if you feel dizzy, drowsy or confused while taking this medicine.

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults including the elderly and adolescents (children over 12 years)

The usual dose is 250 mg twice a day.

For severe infections or gastric ulcers caused by Helicobacter pylori the usual dose is 500 mg twice a day.

Children under 12 years

Use for children under the age of 12 years (under 30 kg bodyweight) is not recommended. For these patients other pharmaceutical forms e.g. suspensions are available.

For children with a body weight of more than 30 kg, the same dose as for adults is used.

Kidney problems

If you have severe kidney problems your doctor may need to reduce your dose by half, i.e. once daily and restrict treatment to 14 days at the most.

How to take this medicine

For oral use.

Take a glass of water with the medicine.

The medicine may be taken with or without food.

Duration of treatment

Your doctor will tell you how long Claritromycine Sandoz should be used, normally between 6 and 14 days. Do not stop treatment on your own decision.

If you take more Claritromycine Sandoz than you should

If you have taken too much of this medicine, contact your doctor or nearest hospital emergency department as soon as possible. Take the container and any remaining tablets with you. Symptoms of overdose include feeling or being sick, diarrhoea, indigestion or stomach pains and there is the possibility of allergic reactions.

If you forget to take Claritromycine Sandoz

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 Claritromycine Sandoz

It is important that you take your medicine in accordance with the doctor’s instructions. Do not suddenly stop using Claritromycine Sandoz 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 (affects 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
• yellowing of the skin and eyes, unusual tiredness or fever, dark coloured urine (signs of inflamed liver)

Very rare serious side effects (affects 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
• 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

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, reversible 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 and liver function test results
• difficulty sleeping
• rash
• excessive sweeting.

Uncommon (affects 1 to 10 users in 1,000):

• low level 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
• prolongation of a specific interval in the electro-cardiogram (ECG) called QT prolongation
• 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):

• unusual bruising or bleeding caused by low blood platelets
• irregular or rapid heartbeat
• nightmares, confusion, disorientation, hallucinations, psychosis, a feeling of loss of identity
• convulsions, tingling and numbness of the skin
• difficulty hearing
• severe 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
• bleeding
• disturbed sense of smell, loss of sense of smell or taste
• deafness
• acne
• rash, fever, blood alterations (which may be a sign of hypersensitivity syndrome, called DRESS).
• depression
• pain or weakness in muscles
• abnormal urine colour.

Clarithromycin may worsen the symptoms of myasthenia gravis (a condition in which the muscles become weak and tire easily) in patients who already suffer from this condition.

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 after the expiry date which is stated on the pack after ‘EXP’. The expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions.

Store in the original carton in order to protect from light.

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 contains

The active substance is clarithromycin. Claritromycine Sandoz 250 mg:

1 film coated tablet contains 250 mg clarithromycin. Claritromycine Sandoz 500 mg:

1 film coated tablet contains 500 mg clarithromycin.

The other ingredients are:

Tablet core: croscarmellose sodium (E 468), microcrystalline cellulose (E 460), povidone, magnesium stearate (E 572), colloidal anhydrous silica (E 551), talc (E 553b).

Coating: hypromellose (E 464), propylene glycol (E 1520), titanium dioxide (E171), hydroxypropylcellulose (E 463), sorbitan monooleate (E 494), quinolin yellow (E104), vanillin.

What Claritromycine Sandoz looks like and contents of the pack

Claritromycine Sandoz 250 mg: dark yellow, film-coated, capsule shaped tablets (15.6 x 7.9 mm). Claritromycine Sandoz 500 mg: light yellow, film-coated, oval shaped tablets (18.8 x 8.8 mm).

PVC/PVDC aluminium blister

Pack sizes:

Claritromycine Sandoz 250 mg: 7, 10, 12, 14, 21 film-coated tablets.

Claritromycine Sandoz 500 mg: 7, 10, 14, 21 film-coated tablets.

Not all pack sizes may be marketed.

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

Lek Pharmaceuticals d.d. Trimlini 2D

9220 Lendava Slovenië

Claritromycine Sandoz 250 mg, filmomhulde tablettenClaritromycine Sandoz 500 mg, filmomhulde tablettenClaritromicina Salutas 250 mg comprimidos recubiertos con película EFG Claritromicina Salutas 500 mg comprimidos recubiertos con película EFG

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-numbers

RVG 107884

RVG 107885

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

The Netherlands

Spain

This leaflet was last approved in september 2011