Amoxicilline DSM Sinochem Pharmaceuticals 250 mg capsules, hard

Amoxicilline DSM Sinochem Pharmaceuticals is an antibiotic. It belongs to a group of antibiotics called penicillins. It is used to treat infections caused by bacteria which are sensitive to amoxicillin.

Amoxicilline DSM Sinochem Pharmaceuticals is used to treat:

• Infections of the ear, throat, nose and sinuses
• Infections of the lower respiratory tract such as bronchitis and pneumonia
• Infections of the bladder
• Prevention of heart infections during mouth or throat surgery
• Early Lyme disease (from a tick bite)
• Stomach ulcers caused by the bacterium Helicobacter pylori

Do not take Amoxicilline DSM Sinochem Pharmaceuticals

• if you are allergic (hypersensitive) to amoxicillin, penicillins, cephalosporins or to any of the other ingredients of this medicine listed in section 6 of this leaflet.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Amoxicilline DSM Sinochem Pharmaceuticals, if you have:

• Kidney disease: your doctor may have to adjust the dose.
• Infectious mononucleosis (a viral infection) or leukaemia: you may have a higher risk of skin reactions.
• Fits (epilepsy): you may have a higher risk of seizures (fits)
• A bladder catheter. If so, drink plenty of liquid to prevent the forming of crystals in your urine.

This medicine can also alter the results of urine tests or blood tests for sugar. If you have diabetes and routinely test your urine or your blood, tell your doctor. This is because other tests may have to be used.

Other medicines and Amoxicilline DSM Sinochem Pharmaceuticals

Tell your doctor or pharmacist, if you are taking, have recently taken or might take any other medicines.

Take care with the following medicines:

• Allopurinol (used to treat gout): you may have a higher risk of skin reactions.
• Methotrexate (used to treat arthritis): the toxicity of methotrexate may be increased.
• Digoxin (used to treat certain heart diseases): the absorption of digoxin may be increased.
• Anticoagulants (to prevent blood clotting) such as coumarin: the tendency to bleed may be increased.
• Contraceptive pills: there is a risk of contraceptive pills not working to their greatest effect.
• Probenecid: if you are taking probenecid (used for gout), your doctor may decide to adjust your dose of amoxicillin.
• Other antibiotics such as tetracyclines, macrolids, sulfonamids, chloramphenicol or aminoglycosides: the effect of amoxicillin might change.

Amoxicilline DSM Sinochem Pharmaceuticals with food, drink and alcohol

You can take Amoxicilline DSM Sinochem Pharmaceuticals either before, during or after meals.

Pregnancy, breast-feeding and fertility

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.

Data on a limited number of exposed pregnancies indicate no adverse effects of amoxicillin on pregnancy or on the health of the foetus or newborn child. As a precautionary measure, amoxicillin should only be used during pregnancy if in the judgement of the physician the potential benefits outweigh the possible hazards. This medicine passes into breast milk in small quantity, therefore in some cases it may be necessary to stop breastfeeding.

Driving and using machines

This medicine has no known influence on the ability to drive and use machines.

This medicinal product contains allura red (E129).

This may cause allergic reactions.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist, if you are not sure.

Swallow your capsules whole with a drink of water.

The recommended dose for adults and children over 12 years is 750 mg to 3000 mg daily in two to three divided doses.

For the prevention of heart infections: In adults, 2000-3000 mg is given in the hour before the surgery; for children a dose of 50 mg/kg is recommended.

People with kidney disease

Your doctor may have to lower the dose.

If you take more Amoxicilline DSM Sinochem Pharmaceuticals than you should

If you take too much of this medicine (overdose), talk to your doctor or go to a hospital straight away, and show them the pack. The most likely signs of overdose are: nausea, vomiting, diarrhoea, abdominal pain.

If you forget to take Amoxicilline DSM Sinochem Pharmaceuticals

If you forget to take your dose of this medicine, take the forgotten dose as soon as you remember. Do not take a double dose to make up for forgotten individual doses.

If you stop taking Amoxicilline DSM Sinochem Pharmaceuticals

Always keep taking this medicine until the course is finished, even if you feel better. If you stop taking this medicine too soon, the infection may come back. Also, the bacteria may become resistant to the medicine.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, talk to your doctor immediately or go to a hospital straight away:

Following serious side-effects are rare (affects 1 to 10 users in 10,000):

• Sudden difficulty in breathing, speaking and swallowing
• Painful swelling of lips, tongue, face or neck
• Extreme dizziness or collapse
• Severe or itchy skin rashes, especially if this shows blistering and there is soreness of the eyes, mouth or genital organs
• Yellowing of the skin or whites of the eyes, or urine getting darker and stools paler. This is a sign of liver problems.

Following side-effects are very rare (affects less than 1 user in 10,000):

• Diarrhoea that is serious, lasts a long time or has blood in it. This can be a sign of serious bowel inflammation.

Other possible side-effects during treatment:

Following side-effects are common (affects 1 to 10 users in 100):

• Nausea, vomiting, loss of appetite, disturbance of taste, dry mouth, eruptions in the mouth (exanthema), winds, diarrhea or soft stools. These effects are mostly mild and disappear during treatment or very soon after completion of therapy. They can be reduced by taking this medicine with food.
• Skin rash with severe itching and hives (urticaria), “fifth day” skin rash, which resembles measles.

Following side-effects are uncommon (affects 1 to 10 users in 1,000):

• Super infections caused by resistant germs or yeasts (such as oral or vaginal thrush).
• Moderate rise in liver enzymes.

Following side-effects are rare (affects 1 to 10 users in 10,000):

• Increase in certain white blood cells (eosinophilia), abnormal breakdown of red blood cells (haemolytic anemia).
• Drug fever.
• Dizziness, hyperactivity, convulsions.
• Superficial tooth discoloration. The discoloration can be removed by teeth brushing.
• Hepatitis and cholestatic jaundice.
• Inflammation of the kidneys (interstitial nephritis), crystals in the urine.

Following side-effects are very rare (affects less than 1 user in 10,000):

• Changes in blood count (decrease of red or white blood cells and of platelets), prolongation of bleeding time. These may cause symptoms such as fever, a sore throat, rash, nose bleeds or bruising. These effects are reversible after stopping the treatment.
• Black tongue.

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 Nederlands Bijwerkingen Centrum Lareb, www.lareb.nl

By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not store above 25oC.

Do not use this medicine after the expiry date which is stated on the carton and blister foil after the letters EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines 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.

What Amoxicilline DSM Sinochem Pharmaceuticals contains:

The active substance is amoxicillin.

• Each Amoxicilline DSM Sinochem Pharmaceuticals 250 mg hard capsule contains amoxicillin trihydrate equivalent to 250 mg amoxicillin.
• Each Amoxicilline DSM Sinochem Pharmaceuticals 500 mg hard capsule contains amoxicillin trihydrate equivalent to 500 mg amoxicillin.

The other ingredients are:

Capsule contents: Talc, magnesium stearate.

Capsule shell: Gelatin, quinoline yellow (E104), allura red (E129), titanium dioxide (E171), silicon dioxide, sodium laurilsulfate, glacial acetic acid, glycerol.

What Amoxicilline DSM Sinochem Pharmaceuticals looks like and contents of the pack

Amoxicilline DSM Sinochem Pharmaceuticals 250mg hard capsule:

Hard gelatin capsule with red cap and white body, cylindrical, with rounded ends, opaque and, filled with white to off white granular powder.

Pack size of 21 capsules in PVC/aluminium blisters.

Amoxicilline DSM Sinochem Pharmaceuticals 500mg hard capsule:

Hard gelatin capsule with red cap and white body, cylindrical, with rounded ends, opaque and, filled with white to off white granular powder.

Pack size of 12, 21 and 24 capsules in PVC/aluminium blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

DSM Sinochem Pharmaceuticals Netherlands B.V.

Alexander Fleminglaan 1

2613 AX Delft

Nederland

Manufacturer

Antibiotice S.A.

1 Valea Lupului

Iasi 707410

Roemenië

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

Frankrijk: Amoxicilline DSM Sinochem Pharmaceuticals 500 mg, gélule

Ierland: Amoxicillin DSM Sinochem Pharmaceuticals 250 mg & 500 mg hard capsules

Deze bijsluiter is voor het laatst goedgekeurd in juli 2013

Other sources of information

Detailed information on this medicine is available on the website of the College ter Beoordeling van Geneesmiddelen www.cbg-meb.nl