Amoxicillin (as trihydrate) Read all of this leaflet carefully before you start taking this medicine.

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1 PACKAGE LEAFLET: INFORMATION FOR THE USER [nationally completed name 125 mg/5 ml pharmaceutical form] [nationally completed name 250 mg/5 ml pharmaceutical form] [nationally completed name 500 mg/5 ml pharmaceutical form] Amoxicillin (as trihydrate) 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 [nationally completed name] is and what it is used for 2. Before you take [nationally completed name] 3. How to take [nationally completed name] 4. Possible side effects 5. How to store [nationally completed name] 6. Further information 1. What [nationally completed name]is and what it is used for [nationally completed name] 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. [nationally completed name] is used to treat: Infections of the ear, throat, nose or sinuses Chest infections such as bronchitis and pneumonia Infections of the bladder Prevention of heart infections during mouth or throat surgery 2. Before you take [nationally completed name] Do not take [nationally completed name]if: - You are allergic (hypersensitive) to amoxicillin, penicillins, cephalosporins or to any of the other ingredients of this medicine (See Further Information in Section 6). Take special care with [nationally completed name] Tell your doctor before taking [nationally completed name]if you have: - Kidney disease: your doctor may have to adjust the dose.

2 - 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. 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. Some medicines can cause problems if you take them with [nationally completed name]. 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 warfarin: the tendency to bleed may be increased. - Contraceptive pills: there is a risk of contraceptive pills not working to their greatest effect. Taking [nationally completed name] with food and drink: You can take [nationally completed name] either before, during or after meals. Pregnancy and breast-feeding: Ask your doctor for advice before taking any 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 quantities, therefore in some cases it may be necessary to stop breastfeeding. Driving and using machines: [nationally completed name] can have side effects and the symptoms may make you unfit to drive. Don t drive or operate machinery unless you are feeling well. Important information about some of the ingredients of this medicine [nationally completed name] contains the sweetener aspartame, a source of phenylalanine. This may be harmful for people with phenylketonuria. 3. How to take [nationally completed name] Always take [nationally completed name] exactly as your doctor has told you. You should check with your doctor or pharmacist, if you are not sure.

3 To reconstitute the suspension fill the bottle with fresh tap water approximately 1 cm below the filling mark, close and shake well at once. After the foam has settled, slowly add fresh tap water exactly to the filling mark. Shake vigorously again. The white to slightly yellowish suspension is now ready for use. Shake the bottle well before every withdrawal. Your doctor will tell you the exact dose (in millilitres or measuring spoon) you should take each day. The usual dose for children under 40 kg bodyweight is mg/kg/day in divided doses (up to a maximum of 60 mg/kg/day). The usual dose for adults and children over 12 years is 750 mg to 3000 mg daily in divided doses. In special cases (bronchitis), a dose of 1000 mg two times daily may be recommended. For the prevention of heart infections: In adults, 3000 mg are given in the hour before the surgery; for children a dose of 50 mg/kg is recommended. Your doctor will tell you how long you will need to keep taking your medicine. People with kidney disease Your doctor may have to lower the dose. If you take more [nationally completed name] 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, diarrhea, abdominal pain. If you forget to take [nationally completed name]: 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 [nationally completed name]: 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 product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, [nationally completed name] 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 (affect less than 1 out of 1000 people): Sudden difficulty in breathing, speaking and swallowing Painful swelling of lips, tongue, face or neck Extreme dizziness or collapse

4 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 (affect less than 1 out of 10,000 people): 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 (affect less than 1 out of 10 people): Nausea, vomiting, loss of appetite, disturbance of taste, dry mouth, eruptions in the mouth (enanthema), winds, diarrhoea 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. Urticaria, itching, fifth day skin rash, which resembles measles. Following side-effects are uncommon (affect less than 1 out of 100 people): Superinfections caused by resistant germs or yeasts (such as oral or vaginal thrush). Moderate rise in liver enzymes. Following side-effects are rare (affect less than 1 out of 1,000 people): 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 (affect less than 1 out of 10,000 people): 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. 5. How to store [nationally completed name] Keep out of the reach and sight of children. Do not store above 25 C. Keep the container tightly closed. Do not use [nationally completed name] after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Reconstituted suspension: Do not store above 25 C. The reconstituted suspension should be used within 14 days.

5 Medicines should be 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 [nationally completed name] contains The active substance is amoxicillin. 5 ml reconstituted suspension contain: Amoxicillin trihydrate corresponding to 125, 250 or 500 mg amoxicillin. Other ingredients are: Citric acid anhydrous (E330), Sodium Benzoate (E211), Aspartame (E951), Talc (E553b), Sodium citrate, anhydrous (E331), Guar galactomannan (E412), Silicon dioxide, precipitated (E551), Lemon flavouring, powdered, Peach-apricot flavouring, powdered, Orange flavouring, powdered. What [nationally completed name] looks like and contents of the pack Amber glass bottles containing 5.10 g, 6.6 g or 12 g powder for 60 ml oral suspension, respectively containing 8.50 g, 11 g or 20 g powder for 100 ml oral suspension with polypropylene screw closure (press + turn). The packaged measuring spoon with filling marks at 1.25 ml, 2.5 ml and 5.0 ml is made of polypropylene. Individual packs of 60 ml and 100 ml Hospital packs of 10x60 ml, 20x60 ml, 40x60 ml, 10x100 ml und 40x100 ml Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer This medicinal product is authorised in the Member States of the EEA under the following names: Austria: OSPAMOX 125 MG/5 ML - PULVER FÜR ORALE SUSPENSION OSPAMOX 250 MG/5 ML - PULVER FÜR ORALE SUSPENSION OSPAMOX 500 MG/5 ML - PULVER FÜR ORALE SUSPENSION Belgium: AMOXICILLINE SANDOZ 250MG/5ML, POEDER VOOR ORALE SUSPENSIE the Netherlands: AMOXICILLINE SANDOZ 125 MG/5 ML, POEDER FOR ORALE SUSPENSIE 125 MG/5 ML AMOXICILLINE SANDOZ FORTE 250 MG/5 ML, POEDER VOOR ORALE SUSPENSIE 250 MG/5 ML Norway: Portugal: ORAL AMOXICILLIN SANDOZ 100MG/ML OSPAMOX PÓ PARA SUSPENSÃO ORAL A 125 MG/5 ML AMOXICILINA SANDOZ 250 MG/5 ML PÓ PARA SUSPENSÃO

6 ORAL Sweden: SUSPENSION United Kingdom: AMOXICILINA SANDOZ 500 MG/5 ML PÓ PARA SUSPENSÃO AMOXICILLIN SANDOZ 100MG/ML PULVER TILL ORAL AMOXICILLIN 125 MG/5 ML SUSPENSION AMOXICILLIN 250 MG/5 ML SUSPENSION This leaflet was last approved in 11/2010 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: 125 mg/5ml For 60 ml bottle add 56ml of water For 100 ml bottle add 94 ml of water 250 mg/5 ml For 60 ml bottle add 55ml of water For 100 ml bottle add 92 ml of water 500 mg/ 5 ml For 60 ml bottle add 51ml of water For 100 ml bottle add 85 ml of water Shake vigorously again. The white to slightly yellowish suspension is now ready for use. Shake the bottle well before every withdrawal.