Synalar Forte 2 mg/g cream
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Synalar forte 2 mg/g cream
Fluocinolone acetonide
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Synalar forte is and what it is used for
- What you need to know before using Synalar forte
- How to use Synalar forte
- Possible adverse effects
- How to store Synalar forte
- Contents of the pack and other information
1. What Synalar forte is and what it is used for
The active substance of Synalar forte is fluocinolone acetonide. This medicine belongs to a group of drugs known as topical corticosteroids (for external use) that work by reducing inflammation, itching, and cell proliferation.
Synalar forte is used in adults and children over 2 years of age to treat a wide variety of inflammatory, pruritic, and allergic skin lesions, such as: eczema, dermatitis, psoriasis, lichen planus, and discoid erythematosus lupus.
2. What you need to know before you start using Synalar forte
Do not use Synalar forte
- if you are allergic to the active substance or to any of the other components of this medicinal product (listed in section 6).
- in primary skin infections and tuberculosis, syphilis or viral infections (e.g., herpes or varicella).
- if you have lesions infected by bacteria, viruses, or fungi, do not apply this cream to infected lesions.
- on areas of skin affected by facial red/pink inflammation (rosacea), ulcers or wounds, inflammation of sebaceous glands (acne), or skin conditions associated with skin thinning (atrophy).
- in skin inflammation occurring around the mouth (perioral dermatitis).
- on areas of skin showing a vaccine reaction, i.e., redness or inflammation following administration of a vaccine.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Synalar forte.
- If a skin infection develops, your doctor will prescribe appropriate treatment for the fungal or bacterial infection. If the infection does not respond to treatment, your doctor may discontinue treatment until the infection is under control.
- This cream should be used at the lowest possible dose, especially in children, and only for the minimum time necessary to relieve the skin condition.
- Prolonged use of topical corticosteroids, or use in skin folds (such as the groin or armpits), as well as application under occlusive dressings (dressings that do not allow air circulation, or, for example, areas covered by a diaper), may cause atrophy of the skin, mucous membranes, and subcutaneous tissue.
- Prolonged use, excessive amounts of medication, or application over large areas may lead to systemic effects (those occurring when the medication is absorbed into the bloodstream), especially in children.
- If the medication causes irritation, you should discontinue use and consult your doctor.
- Avoid contact of the cream with the eyes or around the eyes, on open wounds, or with mucous membranes (such as the mouth or genital area).
- If you are being treated for psoriasis, your doctor should monitor your condition frequently to detect any possible worsening.
- Inform your doctor if you experience blurred vision or other visual disturbances.
Paediatric population
Chronic administration in children may interfere with growth and development; therefore, treatment should be limited to short periods and the minimum effective amount of medication.
Use in athletes
Athletes are advised that this medicinal product contains a component, fluocinolone, which may produce a positive result in doping control tests.
Other medicines and Synalar forte
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
You should not apply other topical preparations to the treated area together with this cream.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicinal product.
As a general rule, this cream should not be used during the first trimester of pregnancy.
Do not use this medicine for prolonged periods, over large areas, or under occlusive dressings if you are pregnant. Its use should be reserved for cases where the therapeutic benefit outweighs the potential risk.
Similarly, caution is advised if this medicine must be used during breastfeeding. Do not apply the cream on the breasts and avoid contact between the infant and treated areas.
Driving and use of machines
This medicinal product has no effect on the ability to drive and/or use machinery.
Synalar forte contains methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), cetyl alcohol, stearyl alcohol, and propylene glycol (E-1520).
This medicine may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).
This medicine may cause local skin reactions (such as contact dermatitis) because it contains stearyl alcohol and cetyl alcohol.
This medicine contains 150 mg of propylene glycol (E-1520) in each gram of cream.
Propylene glycol may cause skin irritation.
Do not use this medicine in infants under 4 weeks of age with open wounds or large areas of damaged skin (such as burns) without first consulting your doctor or pharmacist.
3. How to use Synalar forte
Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Adults and children aged 2 years and older:
May be applied in open treatment, as a thin layer on the affected area of skin, two to three times daily, gently rubbed in until completely absorbed.
Must not be used for occlusive dressings, for example, bandages.
Your doctor will determine the duration of your treatment; usually one week.
Depending on the severity of the condition, treatment may be extended from 1 to 4 weeks. If there is no improvement within this time, your doctor should re-evaluate the treatment.
Treatment must not exceed 2 months.
Use in children
Use is not recommended in children under 2 years of age.
Must not be used for occlusive dressings, for example, in the diaper area.
In children, treatment should be limited to short periods, and the smallest effective amount of medicine should be used. If applied to the face, treatment should not exceed 5 days, and generally one week at most on other body areas.
If you use more Synalar forte than you should
Excessive use of the cream may cause adrenal suppression (leading to disruption of normal hormone production). In such cases, treatment must be discontinued and your doctor should monitor your adrenal hormonal axis function.
Accidental ingestion may cause episodes of tachycardia (accelerated heart rate) and occasional increases in blood pressure, which resolve without requiring medical treatment.
If you have used more of this medicine than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91-562 04 20, indicating the medicine and the amount used.
If you forget to use Synalar forte
Do not apply a double dose to make up for missed doses.
If you forget to apply the cream at the scheduled time, do so as soon as you remember, then continue as before.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Rare adverse effects (may affect up to 1 in 1,000 people):
- Cutaneous atrophy with thinning of the epidermis (often irreversible)
- Telangiectasia (dilation of small blood vessels on the skin surface)
- Purpura (appearance of red patches and spots on the skin)
- Skin striae (stretch marks)
- Acneiform eruptions (acne-like rashes)
- Perioral dermatitis (small red papules around the mouth)
- Skin depigmentation (loss of skin color)
- Dermatitis and eczema, including contact dermatitis
- Burning sensation
- Rebound effect.
Very rare adverse effects (may affect up to 1 in 10,000 people):
- Adrenal suppression, leading to disruption of normal hormone production.
Frequency not known (cannot be estimated from available data):
- Hypersensitivity (allergic reactions)
- Pruritus (itching)
- Dry skin
- Miliaria (a condition caused by blockage of sweat ducts, resulting in white or red bumps appearing on various parts of the body) or rash
- Skin maceration
- Hypertrichosis (excessive hair growth)
- Folliculitis (inflammation of one or more hair follicles)
- Secondary infection.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines:
www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Synalar forte
Keep this medicine out of the sight and reach of children.
Do not use after the expiry date which is stated on the carton and tube.
The expiry date refers to the last day of that month.
No special storage conditions are required.
After opening, the product can be stored for up to 12 months.
Do not use the medicine after this period.
Dispose of unused medicine. Do not dispose of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.
Keep the tube in the outer carton to protect from light.
Store below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Synalar forte
- The active substance is fluocinolone acetonide. Each gram of cream contains 2 mg of fluocinolone acetonide.
- The other components are: cetyl alcohol, stearyl alcohol, sorbitan stearate,
polysorbate 60 (E-435), liquid paraffin, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), propylene glycol (E-1520), anhydrous citric acid (E-330), and purified water.
Appearance of Synalar forte and contents of the pack
Homogeneous white cream packed in aluminium tubes with a polyethylene (HDPE) screw cap. Available in tubes containing 15 and 30 grams of cream.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Tora Laboratories, S.L.U.
Avenida de Oporto, 60
28019 Madrid, Spain
Manufacturer
Temmler Italia S.R.L.
Via delle Industrie, 2 - 280061 Carugate – Milan - Italy
Date of the most recent revision of this summary: October 2020
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/