PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SZ00000LT000

Amoxicillin 125 mg/5 ml Powder for Oral Suspension Amoxicillin 250 mg/5 ml Powder for Oral Suspension

Amoxicillin (as trihydrate)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Amoxicillin is and what it is used for

2.    What you need to know before you take Amoxicillin

3.    How to take Amoxicillin

4.    Possible side effects

5.    How to store Amoxicillin

6.    Contents of the pack and other information

What Amoxicillin is and what it is used for

Amoxicillin 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.

Amoxicillin 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.

What you need to know before you take Amoxicillin

Do not take Amoxicillin if:

• You are allergic to amoxicillin, penicillins, cephalosporins or to any of the other ingredients of this medicine (listed in Section 6). Warnings and precautions Talk to your doctor or pharmacist before taking Amoxicillin if you have:

• Contraceptive pills: there is a risk of contraceptive pills not working to their greatest effect.

Amoxicillin with food and drink:

You can take Amoxicillin 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 or pharmacist 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 quantities, therefore in some cases it may be necessary to stop breast-feeding.

Driving and using machines:

Amoxicillin can have side effects and the symptoms may make you unfit to drive. Don't drive or operate machinery unless you are feeling well. Amoxicillin contains the sweetener aspartame, a source of phenylalanine. This may be harmful for people with phenylketonuria.

•    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 Amoxicillin Tell your doctor or pharmacist, if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Some medicines can cause problems if you take them with Amoxicillin.

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

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3 How to take Amoxicillin

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

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 40 - 90 mg/kg/day in two to three divided doses.

The usual dose for adults and children over 40 kg bodyweight is 750 mg to 3,000 mg daily in divided doses.

In special cases (bronchitis), a dose of 1,000 mg two times daily may be recommended.

For the prevention of heart infections: In adults, 3,000 mg are given in the hour before the surgery; for children a dose of 50 mg/kg is recommended.

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For the preparation of the suspension fill the bottle with the following amount of water:

125 mg/5ml

• For 60 ml bottle add 56 ml of water

•    For 100 ml bottle add 94 ml of water.

250 mg/5 ml

•    For 60 ml bottle add 55 ml of water

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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 Amoxicillin 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 Amoxicillin:

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 Amoxicillin:

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 or pharmacist.

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.

Reporting of side effects 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 Yellow Card Scheme: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Amoxicillin

4 Possible side effects

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 (may affect up to 1 in 1,000 people):

•    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 (may affect up to1 in 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 (may affect up to 1 in 10 people):

•    Nausea, vomiting, loss of appetite, disturbance of taste, dry mouth, eruptions in the mouth (enanthema), wind, 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 (may affect up to 1 in 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 (may affect up to 1 in 1,000 people):

•    Increase in certain white blood cells (eosinophilia), abnormal breakdown of red blood cells (haemolytic anaemia)

•    Drug fever

•    Dizziness, hyperactivity, convulsions

•    Superficial tooth discolouration. The discolouration 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 (may affect up to 1 in 10,000 people):

•    Changes in blood count (decrease of red or

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•    For 100 ml bottle add 92 ml of water.

Shake vigorously again.

The white to slightly yellowish suspension is now ready for use.

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

Do not store above 25°C. Keep the bottle tightly closed in order to protect from moisture.

Do not use this medicine 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: Store in a refrigerator (2°C - 8°C). The reconstituted suspension should be used within 14 days.

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 protect the environment.

Contents of the pack and other information

What Amoxicillin contains

The active substance is amoxicillin.

5 ml reconstituted suspension contains: Amoxicillin trihydrate corresponding to 125 or 250 mg amoxicillin.

Other ingredients are: Citric acid anhydrous (E330); Sodium Benzoate (E211); Aspartame (E951); Talc (E553b); Sodium citrate, anhydrous (E331); Guar (E412); Silicon dioxide, precipitated (E551); Lemon flavouring, powdered; Peach-apricot flavouring, powdered; Orange flavouring, powdered.

What Amoxicillin looks like and contents of the pack

White to slightly yellowish powder.

Amber glass bottles containing 5.10 g or 6.6 g powder for 60 ml oral suspension, respectively containing 8.50 g or 11 g powder for 100 ml oral suspension with polypropylene screw closure (press + turn) and sealing membrane.

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 10 x 60 ml, 20 x 60 ml,

40 x 60 ml,

10 x 100 ml and 40 x 100 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Sandoz GmbH, Biochemiestrasse 10,

6250 Kundl, Austria.

This leaflet was last revised in 06/2015.

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Shake the bottle well before taking each dose.

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