Suprax Powder 100mg/5ml Paediatric For Oral Suspension

PACKAGE LEAFLET: INFORMATION FOR THE USER

Suprax Paediatric 100mg/5ml Powder for Oral Suspension

Cefixime

SANOFlO

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Read all of this leaflet carefully before giving

your child this medicine.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your child’s doctor or your pharmacist.

• This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child’s.

• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your child’s doctor or your pharmacist.

In this leaflet:

1. What Suprax Powder is and what it is used for

2. Before you give Suprax Powder to your child

3. How to give Suprax Powder to your child

4. Possible side effects

5. How to store Suprax Powder

6. Further information

1. What Suprax Paediatric is and what it is used for

Suprax Paediatric 100mg/5ml Powder for Oral Suspension (called Suprax Paediatric in this leaflet) contains a medicine called cefixime.

This belongs to a group of antibiotics called ‘cephalosporins’.

Suprax Paediatric is specially made for children. The bottle contains powder which has been mixed with water by your pharmacist. The suspension is strawberry flavoured and is ready to use.

Suprax is used to treat infections caused by bacteria. These include infections of the:

• Ear

• Nose, sinuses (such as sinusitis)

• Throat (such as tonsillitis, pharyngitis)

• Chest and lungs (such as bronchitis and pneumonia)

• Urinary system (such as cystitis and kidney infections)

2. Before you give Suprax Paediatric to your child

S Do not give this medicine to your child and tell their doctor if:

X Your child is allergic (hypersensitive) to cefixime, any other cephalosporin antibiotics including penicillin or to any of the other ingredients of this medicine (see Section 6: Further information).

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat and tongue. Do not give this medicine to your child if the above applies to them. If you are not sure, talk to your child’s doctor or your pharmacist before giving Suprax.

Take special care with Suprax Paediatric Check with your child’s doctor or your pharmacist before giving this medicine if your child:

a Has ever had colitis a Has severe kidney problems a Is under 6 months

If you are not sure if any of the above apply to your child, talk to your doctor or pharmacist before giving this medicine.

3 Taking other medicines

Please tell your child’s doctor or your pharmacist if your child is taking or has recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Suprax Paediatric can affect the way some other medicines work. Also some medicines can affect the way Suprax Paediatric works.

In particular, tell your child’s doctor if they are taking:

• Medicines to thin the blood such as warfarin

Pregnancy and breast-feeding

This medicine is specially made for children. However, if you are taking this medicine as an adult, you should talk to your doctor before taking this medicine if:

• You are pregnant, might become pregnant or think you may be pregnant

• You are breast-feeding or planning to breast feed

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Tests

If your child requires any tests (such as blood or urine tests) while taking this medicine, please make sure your child’s doctor knows that your child is taking Suprax Paediatric.

Important information about some of the ingredients of Suprax Paediatric Suprax Paediatric contains:

• Sucrose: This is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars talk to your doctor before taking this medicine.

3. How to give Suprax Paediatric to your child

Having this medicine

Always use Suprax Paediatric exactly as your child’s doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The amount of medicine given will depend on the weight and age of your child

• Give this medicine to your child by mouth

• Suprax comes with a measuring spoon that can measure 3.75ml to 5ml. Use this spoon to give your child the medicine

• The dose can be given in one go or the dose can be divided into two and given at different times

• If you feel the effect of the medicine is too weak or too strong, do not change the dose yourself, but ask your child’s doctor

Carefully read the label from the pharmacist. Ask

your pharmacist if you are not sure about the_

dose to give. The medicine should be Turn

taken for the prescribed number of days.

How much to give

The usual dose is:

Adults, Elderly and Children over 10 years or weighing more than 50kg

• 10ml to 20ml each day, depending on the infection

Children 5 to 10 years old

• 10ml each day Children 1 to 4 years old

• 5ml each day

Children 6 months to 1 year old

• 3.75ml each day

If your child has more Suprax Paediatric than they should

If your child has too much of this medicine, talk to your child’s doctor straight away.

If you forget to give Suprax Paediatric to your child

If you forget to give your child a dose, give it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.

Do not give a double dose to make up for a forgotten dose

If you stop giving Suprax Paediatric to your child

Do not stop giving your child the medicine without talking to your doctor. Your child should not stop taking Suprax just because he or she feels better. This is because the infection may come back or get worse again.

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

4. Possible side effects

Like all medicines, Suprax Paediatric can cause side effects, although not everybody gets them.

Tell your doctor straight away or go to the

nearest hospital casualty department if you

notice any of the following serious side effects -

your child may need urgent medical treatment:

• If your child has an allergic reaction. The signs may include: a rash, joint pain, swallowing or breathing problems, swelling of your lips, face, throat or tongue

• Blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like symptoms and fever. This may be something called ‘Stevens-Johnson syndrome’.

• Severe blistering rash where layers of the skin may peel off to leave large areas of raw exposed skin over the body. Also a feeling of being generally unwell, fever, chills and aching muscles. This may be something called ‘Toxic epidermal necrolysis’

• If your child gets a skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly or filled with fluid. The rash may appear especially on the palms or soles of your feet. These could be signs of a serious allergy to the medicine called ‘erythema multiforme’

• If your child get infections more easily than usual. This could be because of a blood disorder. This normally gets better after stopping the medicine

• If your child bruises or bleeds more easily than normal. This could be because of a blood disorder. This normally gets better after stopping the medicine

• If your child gets nose bleeds, bleeding gums, chills, tiredness, pale skin (often with a yellow tinge), shortness of breath. This may be due to haemolytic anaemia.

• Changes in the way the kidneys are working or blood in your child's urine

Stop giving your child this medicine and contact the child’s doctor without delay if they get:

• Severe watery diarrhoea that will not stop and your child is feeling weak and has a fever. This may be something called ‘Pseudomembranous colitis’

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days

• Feeling sick (nausea) or being sick (vomiting)

• Stomach pains, indigestion or wind

• Headaches

• Feeling dizzy

• Feeling itchy in the genital or vaginal area Blood tests

Suprax Paediatric can cause blood clots or small changes to the way the liver and kidney work.

This would be shown up in blood tests. This is not common and goes back to normal after stopping this medicine.

Reporting of side effects

If your child gets any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 Suprax Paediatric

Keep out of the reach and sight of children. After the powder has been mixed with water by the pharmacist, keep the bottles of medicine at room temperature (below 25°C).

Do not freeze.

After being mixed with water, Suprax Paediatric can be used for 14 days. Any liquid remaining after 14 days should be returned to your pharmacist.

Do not use this medicine after the expiry date which is stated on the bottle.

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.

6. Further information

What Suprax Paediatric 100mg/5ml Powder for Oral Suspension contains

• Each 5ml spoonful of liquid contains 100mg of the active substance cefixime

• The other ingredients are sucrose, xantham gum, sodium benzoate and strawberry flavour.

What Suprax Paediatric looks like and content of the pack

Suprax Paediatric is available in 50ml and 100ml bottles and comes with a measuring spoon that can measure 3.75ml to 5ml. Not all pack sizes may be marketed.

The bottle contains powder which will have been mixed with water by your pharmacist, to form a strawberry flavour medicine ready for use.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Sanofi, One Onslow Street Guildford, Surrey, GU1 4YS, UK Tel: 0845 372 7101 email:

uk-medicalinformation@sanofi.com

Manufacturer

Merck S.L., Poligono Merck, 08100 Mollet del Valles (Barcelona), Spain.

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

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