- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
FREEDERM® TREATMENT 4% w/w GEL
2. Qualitative and quantitative composition
Nicotinamide 4% w/w.For a full list of excipients, see List of excipient(s).
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
For the topical treatment of mild to moderate inflammatory acne vulgaris.
4.2 Posology and method of administration
Apply to the affected area twice daily after the skin has been thoroughly washed with warm water and soap. Enough gel should be used to cover the affected area.No difference in dose or dose schedule is recommended for adults, children or the elderly.For topical administration only.
Contraindicated in persons who have shown hypersensitivity to any of its components.
4.4 Special warnings and precautions for use
For external use only and to be kept away from the eyes and mucous membranes, including those of the nose and mouth. If excessive dryness, irritation or peeling occurs reduce the dosage to one application per day or every other day.
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
Vitamin B derivative requirements such as nicotinamide, are increased during pregnancy and infancy. Nicotinamide is excreted in breast milk. As with all medicines, care should be exercised during the first trimester of pregnancy.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
The most frequently encountered adverse effect reported is dryness of the skin. Other less frequent adverse effects include pruritus, erythema, burning sensation and irritation. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Niacin (nicotinic acid) is an essential B complex Vitamin (B3), whose deficiency results in the clinical syndrome known as pellagra. Nicotinic acid is converted in the body to nicotinamide adenine dinucleotide (NAD) or nicotinamide adenine dinucleotide phosphate (NADP), which function as coenzymes for a wide variety of vital oxidation-reduction reactions. Nicotinamide (niacinamide), the active ingredient, is the physiologically active form of niacin and is the chemical form of Vitamin B3 found in virtually all multivitamin products. Though nicotinic acid and nicotinamide are so closely related chemically, they differ somewhat in pharmacological properties. Nicotinic acid products exhibit moderately intense cutaneous vasodilation, resulting frequently in mild headaches and flushing or tingling of the skin, but such reactions have not been observed with nicotinamide. Nicotinic acid has also been used for its effect to lower plasma cholesterol, again a property not shared by nicotinamide.Nicotinamide has demonstrated beneficial effects on inflammatory acne. It is considered that these effects are related to its significant anti-inflammatory activity.
5.2 Pharmacokinetic properties
Following oral administration, nicotinamide is readily absorbed from the gastro- intestinal tract and widely distributed in the body tissues. The main route of metabolism is the conversion to N -methylnicotinamide and the 2-pyridone and 4-pyridone derivatives; nicotinuric acid is also formed. Small amounts of nicotinamide are excreted unchanged in the urine; this amount increases with larger doses.
5.3 Preclinical safety data
Nicotinic acid amide (nicotinamide) has been recognised since 1937 as an essential B complex vitamin whose deficiency results in the clinical syndrome known as pellagra. It is widely available, in tablets and in sterile solution in water for intravenous administration, for the prophylaxis and treatment of pellagra and nutritional deficiency.In the United States, nicotinamide is included in the Food and Drug Administration's listing of nutritional agents which are Generally Recognised As Safe (GRAS).
6. Pharmaceutical particulars
6.1 List of excipients
Aluminium Magnesium Silicate; Hypromellose; Citric Acid; Macrogol Lauryl Ether; Ethanol Anhydrous; Purified Water.
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Low density polyethylene or co-extruded low density polyethylene laminate 25 g tube with white polypropylene cap.
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
Diomed Developments LimitedTatmore Place, GosmoreHitchin, Herts SG4 7QR, UK.
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
15 January 2009.
10. Date of revision of the text
Diomed Developments Limited
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
+44 (0)1462 420 565
+44 (0)1462 458 866