ALMOGRAN Film-coated tablet (2015)
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Περιεχόμενα
Name of the medicinal product
Almogran/Amignul/Almotrex 12.5 mg Film-coated tablet.
Qualitative and quantitative composition
Each tablet contains almotriptan 12.5 mg as almotriptan D,L-hydrogen malate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. White, circular, biconvex film-coated tablet with an A engraved on one side.
Therapeutic indications
Acute treatment of the headache phase of migraine attacks with or without aura.
Posology and method of administration
Almogran/Amignul/Almotrex should be taken with liquids as early as possible after the onset of migraine-associated headache but it is also effective when taken at a later stage. Almotriptan should not ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. As with other 5-HT<sub>1B/1D</sub> receptor agonists, almotriptan should not be used in patients with a history, ...
Special warnings and precautions for use
Almotriptan should only be used where there is a clear diagnosis of migraine. It should not be used to treat basilar, hemiplegic or ophthalmoplegic migraine. As with other acute migraine therapies, before ...
Interaction with other medicinal products and other forms of interaction
Interaction studies were performed with monoamine oxidase A inhibitors, beta-blockers, selective serotonin re-uptake inhibitors, calcium channel blockers or inhibitors of Cytochrome P450 isoenzymes 3A4 ...
Pregnancy and lactation
Pregnancy For almotriptan, very limited data on pregnant patients are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, ...
Effects on ability to drive and use machines
There are no studies on the effect of almotriptan on the ability to drive or operate machinery. However, since somnolence may occur during a migraine attack and has been reported as a side effect of treatment ...
Undesirable effects
Almogran/Amignul was evaluated in over 2700 patients for up to one year in clinical trials. The most common adverse reactions at the therapeutic dose were dizziness, somnolence, nausea, vomiting and fatigue. ...
Overdose
The most frequently reported adverse event in patients receiving 150 mg (the highest dose administered to patients) was somnolence. Overdose should be treated symptomatically and vital functions should ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antimigraine. Selective 5-HT1 receptor agonist ATC code: N02CC05 Mechanism of action Almotriptan is a selective 5-HT<sub>1B</sub> and 5-HT<sub>1D</sub> receptor agonist. These ...
Pharmacokinetic properties
Almotriptan is well absorbed, with an oral bioavailability of about 70%. Maximum plasma concentrations (C<sub>max</sub>) occur approximately between 1.5 and 3.0 hours after administration. The rate and ...
Preclinical safety data
In safety pharmacology, repeated dose toxicity and reproduction toxicity studies, adverse effects were observed only at exposures well above the maximum human exposure. Almotriptan did not show any mutagenic ...
List of excipients
Tablet core: Mannitol (E-421) Microcrystalline cellulose Povidone Sodium starch glycolate Sodium stearyl fumarate Coating material: Hypromellose Titanium dioxide (E-171) Macrogol 400 Carnauba wax
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Boxes containing aluminium foil blisters with 2, 3, 4, 6, 7, 9, 12, 14 or 18 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Almirall, S.A., Ronda General Mitre, 151, 08022, Barcelona, Spain
Marketing authorization number(s)
PL 16973/0005
Date of first authorization / renewal of the authorization
Date of last renewal: December 2009
Date of revision of the text
July 2015
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