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Orelox Paediatric (Cefpodoxime Proxetil)

What Orelox is and what it is used for

Orelox Paediatric 40mg/5ml Granules For Oral Suspension (called Orelox thoughout this leaflet) contains a medicine called cefpodoxime. This belongs to a group of antibiotics called ‘cephalosporins’.

Orelox Paediatric 40mg/5ml Granules For Oral Suspension is specially made for children.

The bottle contains granules which have been mixed with water by your pharmacist. The suspension is banana flavoured and is ready to use.

Orelox 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, pneumonia)
  • skin (such as an abscess, ulcer, infected wound, inflamed hair follicles, carbuncles, furuncles, infections around the finger nails, a type of skin infection called cellulitis)
  • urinary system (such as cystitis and kidney infections)

Before you give Orelox to your child

Do not give this medicine to your child if:

Your child is allergic (hypersensitive) to cefpodoxime, any other 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 any of the above apply to them. If you are not sure, talk to your child’s doctor or your pharmacist before giving Orelox.

Take special care with Orelox

Check with your child’s doctor or your pharmacist before giving this medicine if your child:

  1. Has ever had colitis
  2. Has kidney problems
  3. Is under 15 days old
  4. Has phenylketonuria (as this product contains a source of phenylalanine). It may be harmful to your child
  5. Your child cannot tolerate or digest some sugars (as this product contains sucrose and lactose)

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

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 Orelox can affect the way some other medicines work. Also some medicines can affect the way Orelox works.

In particular, tell your child’s doctor if they are taking any of the following:

  • antacids (used to treat indigestion)
  • medicines for treating ulcers (such as ranitidine or cimetidine)
  • water tablets or injections (diuretics) used to increase the flow of your water (urine)
  • aminoglycoside antibiotics (used to treat infections)
  • probenecid (used with a medicine called cidofovir to stop kidney damage)
  • coumarin anti-coagulants such as warfarin (used to thin the blood)
  • oestrogens such as in the contraceptive pill

Take antacids and medicines for ulcers 2-3 hours after Orelox. Your child’s doctor knows about this and will change the treatment if needed.

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 Orelox.

Important information about some of the ingredients of Orelox Paediatric 40mg/5ml Granules For Oral Suspension

If your child has been told by the doctor that he or she cannot tolerate or digest some sugars talk to your child’s doctor before they take this medicine. This is because Orelox contains sucrose and lactose (see also section ‘Take special care with Orelox’ on page 1).

Orelox contains a source of phenylalanine (aspartame). This may be harmful for people with something called ‘phenylketonuria’

How to give Orelox to your child

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

Taking this medicine

  • Give this medicine to your child by mouth
  • Give this medicine to your child with food

Orelox comes with a measuring spoon (5ml). Use this spoon to give your child the medicine

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

How much Orelox to give your child

Carefully read the label from the pharmacist. Ask your pharmacist if you are not sure about the dose to give. The amount of medicine given will depend on the weight and age of your child.

The dose will usually be given twice a day (morning and evening)

The medicine should be taken for the prescribed number of days. The pharmacist will usually give you the exact amount of medicine for this number of days

Blood tests

  1. If your child takes this medicine for more than 10 days, the doctor or nurse may do a blood test. This is routine and nothing to worry about.
  2. If your child has more Orelox than they should
  3. If your child has too much of this medicine, talk to your child’s doctor straight away.
  4. If you forget to give Orelox to your child
  5. If a dose is missed, do not worry. Just wait until the next dose is due. Do not give your child a double dose to make up for a forgotten dose.
  6. If you stop giving Orelox to your child

Do not stop giving your child the medicine without talking to your doctor. Your child should not stop taking Orelox 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.

Possible side effects

Like all medicines, Orelox 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 a severe allergic reaction. The signs include swelling in the neck, face or throat and difficulty breathing.

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’.

A severe infection of the lining of the bowel, characterised by diarrhoea, fever and abdominal pain. This may be something called ‘Pseudomembranous colitis’.

If your child develops flu-like symptoms, please talk to your child’s doctor for advice

This is because Stevens-Johnson syndrome and Toxic epidermal necrolysis often start with flu-like symptoms.

If your child develops any problems with their skin, they should stop taking Orelox. Talk to your child’s doctor straight away.

Tell your child’s doctor straight away if your child starts with:

  • a rash, itching or any other skin trouble
  • fever
  • joint pain.

These may be signs of an allergy to the medicine. Your child’s doctor will be able to advise you what to do.

Other side effects may include diarrhoea. If this becomes severe, stop giving your child this medicine and contact your child’s doctor.

Tell your child’s doctor straight away if  your child starts with:

  • being or feeling sick
  • stomach pains
  • headaches
  • feeling dizzy
  • ringing in the ears
  • feeling tired or weak
  • pins and needles
  • numbness or tingling feelings.

Tell your child’s doctor if any of the following side effects get serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet:

This medicine may affect your child’s blood or liver, although this is very unusual. It may cause them to feel tired or generally unwell.

If you think your child is reacting badly to the medicine or having any problems, then discuss it with the child’s doctor or your pharmacist.

How to store Orelox suspension

Keep out of the reach and sight of children.

After the granules have been mixed with water by the pharmacist, keep the bottles of medicine in the refrigerator.

Do not freeze.

After being mixed with water, Orelox suspension can be used for 10 days. Any liquid remaining after 10 days should be returned to your pharmacist.

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

If the doctor tells your child to stop taking this treatment, return any left over to the pharmacist.     Only keep it if your child’s doctor tells you to.

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.

Further information

What Orelox Paediatric 40mg/5ml Granules For Oral Suspension contains

Each 5ml spoonful of liquid contains 52mg of the active substance cefpodoxime proxetil (equivalent to 40mg cefpodoxime).

The other ingredients are lactose, aspartame, banana flavour, anhydrous colloidal silica, carboxymethylcellulose-calcium, carboxymethylcellulose-sodium, citric acid monohydrate, hydroxy propylcellulose, iron oxide yellow, monosodium glutamate, potassium sorbate, sodium chloride, sorbitan trioleate, sucrose and talc.

What Orelox Paediatric 40mg/5ml Granules For Oral Suspension looks like and content of the pack

Orelox Paediatric 40mg/5ml Granules For Oral Suspension is available in 50ml, 75ml, 100ml and 125ml bottles and comes with a measuring spoon (5ml). Not all pack sizes may be marketed.

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

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