0.025% cream, ointment, gel
fluocinolone acetonide
What Synalar is and what it is used for
Synalar is a cortisone preparation. It counteracts certain skin inflammations and itching.
Cortisone preparations for external use are divided into four classes depending on the strength: I – mild action, II – medium action, III – strong action, and IV – extra strong action. Synals belong to class III.
Synalar ointment and cream are used for the treatment of various skin diseases, eg eczema, psoriasis , and inflammation of the external auditory canal. Synalar gel is particularly suitable for use on the scalp or other hairy areas.
Fluocinolone acetonide found in Synalar may also be approved to treat 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.
What you need to know before using Synalar
Do not use Synalar
- if you are allergic to fluocinolone acetonide or any of the other ingredients of this medicine (listed in section 6).
- as the only preparation for infected skin diseases.
- against acne, diaper rash, or itching around the anal opening or genitals.
- with rashes around the mouth (perioral dermatitis ) or with blisters and visible blood vessels in the nose ( rosacea ).
Warnings and precautions
Talk to your doctor before using Synalar.
Synalar should not normally be used on the face, armpits, or groin. Avoid getting Synalar in or around the eyes.
Tight dressings ( occlusion dressings ) should not be used on children or infected eczema only on adults and according to a doctor’s prescription.
Do not use more Synalar than prescribed by your doctor or for longer than prescribed. Excessive use can cause streaks in the skin or thin skin. Getting used to it can happen after a long time of use. Synalar is not normally used for the treatment of widespread psoriasis as this may worsen or side effects may occur.
Children
Synalar should not be used for children under 1 year, without a doctor’s prescription. Older children should not normally be treated for more than 5 days unless otherwise prescribed by the doctor.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you are pregnant or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.
There is a risk that the fetus will be affected. Therefore, always consult a doctor before using Synalar during pregnancy.
It is unknown whether fluocinolone acetonide passes into breast milk. Therefore, consult a doctor before regular use during breastfeeding. Do not use Synalar on the breast before breastfeeding
Driving ability and use of machinery
Synalar cream contains propylene glycol which can cause skin irritation and cetostearyl alcohol which can cause local skin reactions (e.g. contact dermatitis).
Synalar ointment contains propylene glycol which can cause skin irritation and lanolin which can cause local skin reactions (e.g. contact dermatitis).
Synalar gel contains propylene glycol which can cause skin irritation.
How to use Synalar
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose is a small amount of Synalar on the affected skin area 1-3 times per day.
Rub it gently but thoroughly into the skin (ointment and cream ), or into the scalp or other hairy body parts ( gel ). To facilitate the application of gel en, an applicator is included in the package. This is screwed onto the tube opening.
Try to apply Synalar at the same time each day.
Do not stop treatment until your doctor prescribes it, even if the skin condition seems to have improved.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. When treating large areas of the body for a long time or when treating with cover dressings, the risk of side effects increases.
Uncommon (may affect up to 1 in 100 people): Irritation where Synalar has been applied. Long-term use or too high a dosage can cause streaks in the skin, fragile blood vessels, or thin skin. Acne- and rosacea-like rashes.
Rare (may affect up to 1 in 1,000 users): Allergic reaction to Synalar (increased itching, redness, skin irritation). Increased hair growth. Inhibition of adrenal cortex function.
During long and vigorous treatment, some of the active substances can be absorbed by the body, and side effects such as the swollen face, muscle atrophy, and edema can occur. In such cases, your doctor may decide to stop the treatment.
How Synalar should be stored
Store at a maximum of 25ºC.
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is fluocinolone acetonide 0.25 mg/g.
- Other ingredients are:
- Ointment: propylene glycol, lanolin, citric acid, white vaseline.
- Cream: propylene glycol, sorbitan monostearate, polysorbate 60, cetostearyl alcohol, liquid paraffin, benzyl alcohol ( preservative ), citric acid, water
- Gel: propylene glycol, denatured ethanol, sodium edetate, citric acid, met again ( preservative E218), propagation ( preservative E216), carboxy polymethylene, triethanolamine, water.
Appearance and package sizes of the medicine
Ointment: Pale yellow, translucent. 30g and 100g.
Cream: White. 30g and 100g.
Gel: Colorless, transparent. 30g.
Bioglan AB, Box 50310, 202 13 Malmö