ICHTHYOL-GESELLSCHAFT |
1. Name of the medicinal product
1. Name of the medicinal product
ICHTHRALETTEN® enteric-coated tablets
2. Qualitative and quantitative composition
Each enteric-coated tablet contains:
Active ingredient:
Sodium bituminosulphonate, dry substance (ICHTHYOL® sodium), 0.2 g
This product contains lactose and sucrose (sugar).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Enteric-coated tablets
4. Clinical particulars
4.1 Therapeutic indications
Inflammatory acne vulgaris, rosacea and seborrhoeic dermatitis.
4.2 Dosage and method of administration
Dosage:
In weeks 1 and 2, two enteric-coated tablets should be taken three times daily. From week 3 onwards: one tablet three times a day.
Method of administration:
Treatment should not be continued for more than six weeks.
4.3 Contraindications
Established hypersensitivity to sulphonated shale oils such as ammonium bituminosulphonate and/or sodium bituminosulphonate, or to any of the excipients.
4.4 Special warnings and precautions for use
ICHTHRALETTEN® should not be used by patients with rare hereditary galactose or fructose intolerance, lactase or sucrase-isomaltase deficiency or glucose-galactose malabsorption.
4.5 Interaction with other medicinal products and other forms of interaction
Concomitant use of tetracyclines (within three hours) inactivates both drugs.
4.6 Pregnancy and lactation
The data available about the use of ICHTHRALETTEN® during pregnancy are insufficient. The data obtained from animal studies regarding the effects of this product on pregnancy, foetal or postnatal development (see section 5.3) are insufficient. The potential risk of the use of ICHTHRALETTEN® by humans is unknown.
Thus, ICHTHRALETTEN® should be used in pregnancy only if clearly needed. In such cases, the lowest effective dose should be given and long-term treatment should be avoided.
It is not known whether the active ingredient of ICHTHRALETTEN® enters human milk and affects the infant. Therefore, the tablets should not be taken by nursing mothers. Breastfeeding should be stopped if treatment with ICHTHRALETTEN® is necessary.
4.7 Effects on ability to drive and use machines
ICHTHRALETTEN® have no influence on the ability to drive and use machines.
4.8 Undesirable effects
The evaluation of side-effects is based on the following incidence rates:
very frequently (≥ 1/10)
frequently (≥ 1/100 to < 1/10)
occasionally (≥ 1/1,000 to < 1/100)
rarely (≥ 1/10,000 to < 1/1,000)
very rarely (< 1/10,000)
Intolerance reactions such as mild GI disorders have rarely been seen. Erythema has been reported in isolated cases.
4.9 Overdose
a) Symptoms of overdosage
GI disorders may occur.
b) Countermeasures in case of massive overdose
There is no need to institute countermeasures.
6. Pharmaceutical Particulars
6.1 List of excipients
Kaolin, a-Lactose monohydrate, Copolyvidone, Glycerin, Stearic acid, highly dispersed silicon dioxide, Talc, acacia, Polyethyleneglycol-135, Sucrose, iron oxide and hydroxide (E 172), Montanglycol wax, Methacrylic acid-ethyl-acrylate copolymer (1:1).
6.2 Incompatibilities
Not applicable
6.3 Shelf life
Three years.
6.4 Special precautions for storage
For this medicinal product no special storage conditions are necessary.
6.5 Nature and contents of container
Blister pack with:
60 enteric-coated tablets.
6.6 Special precautions for disposal
No special requirements.
7. Marketing authorisation holder
ICHTHYOL-GESELLSCHAFT
Cordes, Hermanni & Co. (GmbH & Co.) KG
Sportallee 85
D-22335 Hamburg
Phone: + 49 40 50714-0
Fax: +49 40 50714-110
E-mail: info[at]ichthyol.de