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Cefradine Syrup 250mg/5ml

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Document: leaflet MAH BRAND_PL 13606-0166 change

NICEF SYRUP 250MG/5ML

(CEFRADINE)

PATIENT INFORMATION LEAFLET

This leaflet has been provided to help you understand about Nicef and the way in which it should be taken to ensure that you gain most benefit from the product. Please read it carefully and follow the instructions given. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The Name of Your Medicine is Nicef Syrup


What is Nicef?

Nicef contains cefradine, one of a group of antibiotics called cephalosporins. It is available as a powder for the preparation of a cherry flavoured syrup. When prepared by the pharmacist, each bottle of syrup contains 100ml.

Each 5ml spoonful of Nicef Syrup contains 250mg of cefradine. The other ingredients are methylcellulose, sodium citrate, anhydrous citric acid, cherry flavour and sucrose.

The Marketing Authorisation holder is Co-pharma Ltd, Unit 4 Metro Centre, Tolpits Lane, Watford, Hertfordshire, WD1 8SS. The product is manufactured by PDMS, Almac House, 20 Seagoe Industrial Estate, Craigavon, BT63 5QD, UK.

What Does Nicef Syrup Do?


It is used to kill bacteria which cause infections in your body. These include throat, chest and ear infections, sinus infections, infections of skin and soft tissue and urinary tract infections.

Before Taking Your Medicine


Before taking this product, please answer the following question:

- Have you had any allergic reaction (e.g. rash, itching, shortness of breath) to any cephalosporin antibiotic in the past (e.g. cefalexin, cefuroxime or cefaclor) or to other antibiotics known as penicillins?

If you answer YES to this question you should NOT take this product. Speak to your doctor.

Now answer these questions:

-    Are you pregnant or breast feeding?

-    Do you suffer from kidney disease?

-    Are you on kidney dialysis?

-    Are you diabetic? (Cefradine can interfere with some urine sugar tests.)

If the answer to any of these questions is YES, it is important that you tell your doctor or pharmacist before taking this medicine. It may still be safe for you to take cefradine. Ask your doctor or pharmacist’s advice.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.

In particular, tell your doctor if you are taking:

-    diuretics or ‘water tablets’ e.g. furosemide

-    probenecid (used to treat gout).

If you are having a blood test, it is important that you tell your doctor that you are taking this medicine as it may affect the result.

Other warnings:    Each 5ml spoonful contains 17.59mg of sodium. If this product

is taken in high doses it may be harmful to people on a low sodium diet. If you are on a low sodium diet please seek your doctor or pharmacist’s advice before taking this product.

Each 5ml spoonful contains 2.45grams of sucrose. As a result this product is unsuitable for patients with hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency. If you suffer from any of the above conditions you should NOT take this product.

Nicef Syrup may cause dizziness. If you experience dizziness while taking this medicine, do not drive or operate machinery.

Taking Your Medicine


How much should I take and how often?

This product should be taken orally (by mouth).

The usual adult dose is 250mg (one 5ml spoonful) four times daily or 500mg (two 5ml spoonfuls) twice daily but this may be increased for severe infections. The usual dose for children will depend on the child’s weight.

Doctors may sometimes prescribe different doses to these. It is important to read the label on your bottle as it will tell you exactly what dose to take.

Keep taking your Nicef Syrup until you have finished the full course of treatment that your doctor has prescribed for you. This will make sure that the infection is completely cleared. Do not stop taking the medicine just because you feel better.

What should I do if I forget to take a dose ?

If you forget to take a dose of your medicine, take it as soon as you remember and then continue as before.

What should I do if I take too much?

It is always important to follow the dose recommended on the label. If you accidentally take too much, contact your doctor or pharmacist who will recommend what steps to take.

After Taking Your Medicine


Are there any side effects?

Some people find that cefradine makes them feel sick or vomit. It may also cause heartburn, abdominal pain or diarrhoea. If you develop diarrhoea which becomes severe or contains blood or mucus you should tell your doctor. Sometimes this product may cause vaginal discharge or irritation.

Tell your doctor immediately if you start suffering from a rash or any other skin trouble (especially if there are numerous red/purple patches on the skin or if skin shedding occurs), itching, joint pain or if you have difficulty breathing. These may be signs of an allergy and you should stop taking this product at once and contact your doctor if this happens to you. You should also tell your doctor if you start to feel weak or if you develop a sore throat or your tongue becomes swollen or inflamed while taking this product.

Other side effects include:

-    headache

-    confusion

-    dizziness

-    nervousness

-    difficulty sleeping

-    hyperactivity

-    sore tongue or mouth

-    kidney inflammation, which could cause reduced urine output, cloudy or bloody urine, swelling and pain

-    temporary liver problems which can cause dark urine, pale stools, fever, yellowing of your eyes and skin

-temporary blood disorders which could cause you to have more infections than usual and can also make your skin pale and cause weakness, breathlessness and tiredness.

Reporting of side effects

If you get 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.

Storing Your Medicine


How should I store Nicef Syrup?

Nicef Syrup should be stored in the fridge (between 2 and 8oC) where children cannot reach it. Syrup which has been kept in the fridge may be used for fourteen days. Throw away any medicine that has not been used after fourteen days.

Keep the lid tightly closed and do not use after the expiry date shown on the label.

If your doctor tells you to stop your treatment, return any left over medicine to the pharmacist. Only keep it if the doctor tells you to.

Remember - As with all medicines, do NOT share this product with any other person. Date of Revision: March 2015