MEDOFLORAN Tablet (2014)
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Περιεχόμενα
1. Name of the medicinal product
MEDOFLORAN 250 mg tablets.
2. Qualitative and quantitative composition
Each tablet contains terbinafine HCL equivalent to 250 mg terbinafine. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. For oral administration. White, round, flat, scored tablet, with diameter 10.5 mm. The tablet can be divided into equal doses.
4.1. Therapeutic indications
Fungal infections of the skin and nails caused by Trichophyton (eg, T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. Oral Medofloran is indicated ...
4.2. Posology and method of administration
Posology Adults 250 mg once daily. The duration of treatment varies according to the indication and the severity of the infection. Skin Infections Likely durations of treatment are as follows Tinea pedis ...
4.3. Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Liver Function Terbinafine is not recommended for patients with chronic or active liver disease. Before prescribing Medofloran, a liver function test should be performed and any pre-existing liver disease ...
4.5. Interaction with other medicinal products and other forms of interaction
Effect of other medicinal products on terbinafine The plasma clearance of terbinafine may be accelerated by drugs which induce metabolism and may be inhibited by drugs which inhibit cytochrome P450. Where ...
4.6. Fertility, pregnancy and lactation
Pregnancy Foetal toxicity and fertility studies in animals suggest no adverse effects. Since clinical experience in pregnant women is very limited, terbinafine tablets should not be used during pregnancy ...
4.7. Effects on ability to drive and use machines
No studies on the effects of terbinafine treatment on the ability to drive and use machines have been performed. Patients who experience dizziness as an undesirable effect should avoid driving vehicles ...
4.8. Undesirable effects
Side effects are generally mild to moderate, and transient. The following adverse reactions have been observed in the clinical trials or during post-marketing experience. Adverse reactions are ranked under ...
4.9. Overdose
Symptoms A few cases of overdose (up to 5g) have been reported, giving rise to headache, nausea, upper abdominal pain and dizziness. Management The recommended treatment of overdosage consists of eliminating ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Oral antifungal agent <b>ATC code:</b> D01BA02 Terbinafine is an allylamine which has a broad spectrum of antifungal activity. At low concentrations, terbinafine is fungicidal ...
5.2. Pharmacokinetic properties
Following oral administration, terbinafine is well absorbed (>70%) and the absolute bioavailability of terbinafine from terbinafine as a result of first-pass metabolism is approximately 50%. A single oral ...
5.3. Preclinical safety data
In long-term studies (up to 1 year) in rats and dogs no marked toxic effects were seen in either species up to oral doses of about 100mg/kg a day. At high oral doses, the liver and possibly also the kidneys ...
6.1. List of excipients
Sodium starch glycollate, HPMC E5, microcrystalline cellulose 101, colloidal silicon dioxide, magnesium stearate
6.2. Incompatibilities
None known.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions. Store in the original package.
6.5. Nature and contents of container
PVC-A1 blisters of 7 tablets each. Packs of 14 and 28 tablets are available. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
20373
9. Date of first authorization / renewal of the authorization
17/07/08
10. Date of revision of the text
11/2014
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