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FLAMAZINE CREAM 1% - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - FLAMAZINE CREAM 1%

FLAMAZINE™

Cream 1.0% w/w

Silver Sulfadiazine 10mg/g

Read all of this leaflet carefully before you start using this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, please 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

  • 1. What FLAMAZINE Cream is and what it is used for.

  • 2. Before you use FLAMAZINE Cream.

  • 3. How to use FLAMAZINE Cream.

  • 4. Possible side effects.

  • 5. How to store your FLAMAZINE Cream.

  • 6. Further information.

1. what flamazine cream 1.0% is and what it is used for

FLAMAZINE Cream contains silver sulfadiazine as the active ingredient. (This is the new name for silver sulphadiazine). It works by killing bacteria or stopping their growth.

FLAMAZINE Cream is a sterile antibacterial cream used to:

  • prevent or treat bacterial infections in burns.
  • treat bacterial infections in leg ulcers or pressure sores for short periods of time.
  • prevent bacterial infections in skin graft donor sites and large abrasions.
  • treat finger-tip injuries where nail loss or partial loss of the end of the finger has occurred.

2. before you use flamazine cream

Do not use FLAMAZINE Cream if:

  • you are allergic to silver sulfadiazine or any of the ingredients such as cetyl alcohol and propylene glycol (see section 6 Further information).
  • you are pregnant or breast-feeding

Do not use your medicine on premature babies or on newborn babies within the first few months of life.

Take special care with FLAMAZINE Cream Consult your doctor, pharmacist or nurse before using your medicine if any of the following apply to you:

  • if you know you are allergic to sulphonamide treatment.
  • if you suffer from kidney or liver problems.
  • if you suffer from a deficiency of the enzyme known as glucose-6-phosphate dehydrogenase?
  • if you are taking tablets prescribed by your doctor to control epilepsy or diabetes.
  • if you are using a biological product to remove dead tissue from the leg ulcer or wound before using your medicine.

Using other medicines

The effects of using other medication may be altered where large areas of burns are treated. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using FLAMAZINE Cream with food, drink and alcohol

There are no known effects of food, drink or alcohol on the use of FLAMAZINE Cream.

Pregnancy and breast-feeding

Do not use If you are pregnant, thinking of becoming pregnant, or breast feeding. Ask your doctor or pharmacist before taking or using any medicines.

Driving and using machines

There are no known effects.

3. how to use flamazine cream

It is unlikely that you will apply this medicine to yourself. A nurse or a doctor will normally apply the cream in which case the following directions apply:

Burns:

  • – The burn should first be cleaned.

  • – Apply a 3–5 mm layer of your medicine to the burned area using a sterile glove or spatula.

  • – Cover the area with a non-stick dressing.

  • – Your medicine should be re-applied to the burn at least every day.

Hand Burns:

  • – Once your medicine has been applied as above, the hand may be enclosed in a plastic bag or glove, which is then closed at the wrist.

  • – The hand and fingers should be moved as much as possible.

  • – Your medicine should be re-applied to the burn when an excessive amount of fluid has built up in the bag and at least every day.

  • – Fill the cavity of the ulcer or sore with medicine to a depth of 3–5mm and cover the wound with an absorbent pad.

  • – The doctor or nurse may tell you to apply a pressure bandage over the pad.

  • – Dressings should normally be changed at least every 1–2 days. Before re-applying your medicine, the ulcer or sore should be cleaned and the dead tissue removed.

Finger-tip Injuries:

  • – Before applying the 3–5mm layer of your medicine, ensure that the injured finger has

stopped bleeding.

  • – Cover the finger-tip with the finger of a plastic or non sterile surgical glove and fix in place with waterproof tape.

  • – Your medicine should be re-applied every 2–3 days.

If you use more FLAMAZINE Cream than you should

When used as directed an overdose is not likely. Do not use your medicine for a period longer than that prescribed by your doctor.

If you forget to use FLAMAZINE Cream

In the event of a missed treatment, contact your doctor as soon as possible.

Important : Always keep the contents of one tube or pot for the treatment of one person only.

4. possible side effects

Like all medicines, FLAMAZINE Cream can cause side effects, although not everyone gets them. The following side effects may happen with this medicine:

Common (less than 1 per 10 but more than

1 per 100);

  • Irritation.
  • Rashes around the wound area (including eczema and contact dermatitis).
  • Decreased white blood cells (leukopenia). This can lead to an increased risk of infection. This usually returns to normal within a few days; however a doctor will need to closely monitor you to ensure that the count returns to normal.
  • Discolouration of the skin (due to absorption of silver over prolonged periods).
  • Kidney failure. Inform your doctor if you have difficulty in passing urine, passing a greater or smaller amount of urine than usual, or if you notice any blood or cloudiness in your urine. This may be a sign that your kidneys are not working properly.

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:

5. how to store flamazine cream

  • Keep out of the reach and sight of children.
  • Store your medicine below 25°C. Protect from the light.
  • The expiry date is printed on the base of the tube or on the jar label. Do not use your medicine after this date.
  • Do not use if you notice any visible signs of deterioration such as the cream being dark brown or black. Return it to your pharmacist and obtain fresh supplies.
  • If you are using pots, discard any remaining cream 24 hours after opening.
  • If you are using tubes, then you may use the cream for up to 7 days after opening.

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 protect the environment.

  • 6. Further information

  • The active substance is silver sulfadiazine. Each 100g of cream contains 1g of silver sulfadiazine.
  • FLAMAZINE Cream: the other ingredients are polysorbates, glycerol monostearate, cetyl alcohol, liquid paraffin, propylene glycol and purified water.

What FLAMAZINE Cream looks like and the contents of the pack

FLAMAZINE Cream is a white to off-white, sterile cream.

It is available in tubes containing 20g and 50g and pots containing 250g and 500g.

Marketing Authorisation Holder

Smith & Nephew Pharmaceuticals Ltd, 101 Hessle Road, Hull HU3 2BN, England.

Marketing Authorisation (PL 13374/0006).

Manufacturer

Recipharm Parets S.L.U

Carrer Ramon i Cajal 08150 Parets del Valles Barcelona, Spain.

Date of Preparation: August

2019 ™Trade Mark of Smith &

Nephew

48321

Sources: Original (products.mhra.gov.uk)