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Cefradine Capsules 250mg

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Document: leaflet MAH BRAND_PL 13606-0167 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nicef Capsules 250mg and 500mg

(Cefradine)

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 Nicef is and what it is used for

2.    Before you take Nicef Capsules

3.    How to take Nicef Capsules

4.    Possible side effects

5.    How to store Nicef Capsules

6.    Further information

1. WHAT NICEF IS AND WHAT IT IS USED FOR

This medicine is called Nicef Capsules. Nicef Capsules contain the active substance cefradine, which belongs to a group of medicines called cephalosporin antibiotics.

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

2. BEFORE YOU TAKE NICEF CAPSULES Do not take Nicef Capsules

-    if you are allergic (hypersensitive) to any cephalosporin antibiotic, such as cefalexin, cefuroxime, cefradine or cefaclor

-    if you are allergic to any of the other ingredients of Nicef Capsules

Talk to your doctor before taking this product if either of the above apply to you. Take special care with Nicef Capsules

-    if you are allergic to any penicillin antibiotic, such as penicillin, ampicillin, amoxicillin or flucloxicillin

-    if you suffer from any kidney problems

-    if you are on kidney dialysis

-    if you are diabetic (cefradine can interfere with some urine sugar tests)

If any of the above apply to you, it is important that you tell your doctor or pharmacist before taking Nicef Capsules and they will decide what to do. It may still be safe for you to take Nicef Capsules.

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

Taking other medicines

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

In particular, tell your doctor if you are taking:

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

-    probenecid (used to treat gout).

It may still be safe for you to take Nicef Capsules; your doctor or pharmacist will be able to advise you further.

Pregnancy and breast-feeding

If you are pregnant, think you might be pregnant, or are breast-feeding, you should ask your doctor or pharmacist for advice before taking Nicef or any other medicine.

Driving and using machines

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

Important information about some of the ingredients of Nicef Capsules

Nicef Capsules contain lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE NICEF CAPSULES

Always take Nicef Capsules exactly as your doctor has told you. You should check

with your doctor or pharmacist if you are not sure.

Nicef Capsules should be taken by mouth (orally).

The usual dose for adults and the elderly will depend on the type of infection being

treated:

-    For urinary tract infections the usual dose is 500mg four times a day or 1g twice a day. In more severe infections the dosage may be increased.

-    For respiratory tract (chest) infections the usual dose is 250mg to 500mg four times a day or 500mg to 1g twice a day, depending on the site and severity of the infection.

-    For skin and soft tissue infections the usual dose is 250mg to 500mg four times a day or 500mg to 1g twice a day, depending on the site and severity of the infection.

The usual dose for children will depend on the child’s weight and the site and severity of the infection.

For patients suffering from kidney disease, your doctor will tailor your dosing schedule and dose amount to suit your condition.

It is important to read the label on your medicine, as it will tell you precisely what dose to take.

If you take more Nicef Capsules than you should

If you take too many capsules contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Take this leaflet and any remaining capsules with you.

If you forget to take Nicef Capsules

If you forget to take your medicine, just take your normal dose as soon as you remember and then continue as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Nicef Capsules

Keep taking the medicine until you have finished the full course of treatment that your doctor has prescribed for you. Do not stop taking the medicine, even if you feel better. This will make sure that the infection has completely cleared.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Nicef Capsules can cause side effects, although not everybody gets them.

If you get any of the following side effects you should stop taking Nicef and tell your doctor immediately or go to the casualty department of your nearest hospital, as these may be signs of a serious allergic reaction:

■    a skin rash resembling hives or nettle rash

■    itchy and/or scaly skin

■    red or purple patches on the skin

■    joint pain

■    difficulty breathing or wheezing

■    fever

■    swelling of the tongue, face, lips or throat

■    feeling faint accompanied by one or some of the other reactions above

Tell your doctor immediately if you notice the following as you may require urgent medical attention:

■    diarrhoea which becomes severe or contains blood or mucus

Other side effects of Nicef Capsules include:

■    diarrhoea

■    feeling sick or being sick

■    stomach pain

■    heartburn tightness in the chest

■    irritation or inflammation of the vagina

■    vaginal discharge

■    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.

5. HOW TO STORE NICEF CAPSULES

Keep out of the reach and sight of children.

Do not use Nicef Capsules after the expiry date, which is stated on the carton and blister foil. The expiry date refers to the last day of that month.

Store your capsules below 25oC. Store in the original packaging in order to protect the capsules from light and moisture.

Do not use Nicef Capsules if you notice that the pack or any of the capsules are damaged.

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.

What Nicef Capsules contain

The active substance in Nicef Capsules is called cefradine. The capsules contain either 250mg or 500mg of cefradine. The other ingredients are sodium lauryl sulphate, povidone, colloidal silicon dioxide, magnesium stearate and lactose monohydrate. The 250mg capsule shells are made of gelatin and contain sunset yellow (E110), FD & C Blue 2 (E132) and titanium dioxide (E171) as colouring agents. The 500mg capsule shells are made of gelatin and contain FD & C Blue 2 (E132) and titanium dioxide (E171) as colouring agents. The printing ink on the capsule shells contains shellac, black iron oxide (E172) and propylene glycol.

What Nicef Capsules look like and the contents of the pack

Nicef Capsules 250mg are blue and orange hard gelatin capsules with ‘CEPHR 250’ printed in black ink.

Nicef Capsules 500mg are blue hard gelatin capsules with ‘CEPHR 500’ printed in black ink.

Nicef Capsules 250mg and 500mg are available in packs containing 2, 4, 10, 14, 20, 28, 30, 50, 56, 60, 84, 100, 500 and 1000 capsules. Not all pack sizes may be marketed. (Delete this section as appropriate.)

Marketing Authorisation Holder

Co-pharma Limited Unit 4, Metro Centre Tolpits Lane Watford Herts

UK, WD18 9SS Manufacturer

Almac Pharma Services Limited

Almac House

20 Seagoe Industrial Estate

Craigavon

BT63 5QD

UK

This leaflet was last revised in November 2015.