1% hydrocortisone ointment 

What Ficortril is and what it is used for

Ficortril contains the active substance hydrocortisone and is a mild cortisone ointment (mild steroid ) that has an anti-inflammatory and antipruritic effect. It is used to treat mild eczema caused by, for example, soap, detergent, cosmetics, or strong sunburn.

Ficortril ointment can also be prescribed by a doctor for other ailments such as chronic eczema or itching in the anal/genital area. Hydrocortisone contained in Ficortril may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Ficortril

Do not use Ficortril

  • if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).
  • in case of skin infections caused by bacteria, fungi, or parasites.

Warnings and cautions

Eczema that is around the eyes should always be treated by a doctor. Avoid getting the ointment in your eyes.

Contact a doctor if eczema is infected with bacteria or fungi because then the treatment must be combined with medicines for infection.

Contact a doctor if you experience blurred vision or other visual disturbances.

Children and young people

Children under 2 years of age should only be treated according to a doctor’s prescription.

Pregnancy, breastfeeding, and fertility

Pregnancy

No adverse effects on the fetus have been demonstrated.

Breast-feeding

Hydrocortisone passes into breast milk but is unlikely to affect breastfed infants. However, consult your doctor if you are taking Ficortril more than temporarily while breast-feeding.

Driving and using machines

No effect on the ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Ficortril ointment contains propylene glycol (E 1520), cetyl alcohol, stearyl alcohol, methyl parahydroxybenzoate (E 218), and sodium lauryl sulfate

This medicine contains 118.8 mg of propylene glycol per gram of ointment. Propylene glycol may cause skin irritation. Do not use the medicine for newborns (younger than 4 weeks) with open wounds or large areas with damaged skin (such as burns), without consulting a doctor or pharmacist.

Cetyl alcohol and stearyl alcohol may cause local skin reactions (eg contact dermatitis).

Methyl parahydroxybenzoate may cause an allergic reaction (possibly delayed).

This medicine contains 9.9 mg sodium laurilsulfate per gram ointment. Sodium lauryl sulfate may cause local skin reactions (stinging or burning) or increase skin reactions caused by other products used on the same skin surface.

3. How to use Ficortril

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Recommended dose and duration of treatment

Adults and children from 2 years:

Lubricate the ointment in a thin layer 2-3 times a day or as prescribed by a doctor. After improvement, the ointment does not need to be lubricated more than once a day or every other day. Ficortril ointment should be used for a maximum of 1 week without a doctor’s prescription. You need to talk to a doctor if you do not feel better or if you feel worse after a week.

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

nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon (may affect up to 1 in 100 people):

  • Skin irritation and contact allergy in the form of increased itching, redness, and irritation.

Has been reported (occurs in an unknown number of users):

  • Dimsyn.

5. How to store Ficortril

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

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. Contents of the packaging and other information

Content declaration

  • The active substance is hydrocortisone . 1 gram of ointment contains 10 mg of hydrocortisone .
  • The other ingredients are sodium lauryl sulphate, propylene glycol (E 1520), stearyl alcohol, cetyl alcohol, cholesterol , white petrolatum, liquid paraffin, methyl parahydroxybenzoate ( preservative E 218), purified water (see section 2 “Ficortril ointment, propylene alkyl parole glycol); ).

What the medicine looks like and contents of the pack

Ointment. Tube 15 g, 50 g.

Marketing Authorization Holder and Manufacturer

Pfizer AB, 191 90 Sollentuna

Tel: 08 – 550 520 00

Email: eumedinfo@pfizer.com

Muhammad Nadeem

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