MYOPRIDIN Tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Myopridin 3 mg tablets.
2. Qualitative and quantitative composition
One tablet contains 3.02 mg pridinol (as 4 mg pridinol mesilate). <u>Excipient(s) with known effect:</u> One tablet contains 143.5 mg lactose (as monohydrate). For the full list of excipients, see section ...
3. Pharmaceutical form
Tablet. White, round tablet with a score line on one side. Diameter: 9.0 9.2 mm. Height: 2.5 2.7 mm. The tablet can be divided into equal doses.
4.1. Therapeutic indications
Central and peripheral muscle spasms: lumbar pain, torticollis, general muscle pain, in adults.
4.2. Posology and method of administration
Posology The recommended dose is 1.5-3 mg pridinol 3 times daily The duration of administration is decided by the treating doctor. Administration is independent of meals, with the onset of the effect being ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Glaucoma Prostate hypertrophy Syndrome with urinary retention Gastrointestinal obstructions Arrhythmia First trimester ...
4.4. Special warnings and precautions for use
The medicinal product must be used with caution in the elderly, and in patients with severe renal and/or hepatic insufficiency, because higher and/or longer-lasting blood levels must be expected. In patients ...
4.5. Interaction with other medicinal products and other forms of interaction
Myopridin potentiates the effect of anticholinergics such as atropine (see section 4.8).
4.6. Fertility, pregnancy and lactation
Pregnancy This medicinal product is contraindicated in the first trimester of pregnancy. During the further course of pregnancy, the medicinal product may only be used after a careful medical consideration, ...
4.7. Effects on ability to drive and use machines
Due to potential anticholinergic effects on eyesight (see section 4.8), greater caution is advised when driving vehicles and operating machines.
4.8. Undesirable effects
Assessment of adverse effects is based on the following frequencies: Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10,000, <1/1,000), Very rare (≥1/10,000), Not known ...
4.9. Overdose
In the event of overdose or accidental poisoning, symptoms that are typical for anticholinergics occur. When the severity of the symptoms requires it, intravenous physostigmine salicylate should be administered ...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: Muscle relaxants, centrally active agents; other centrally active agents ATC code: M03BX03 The active substance of Myopridin is pridinol as pridinol mesilate, a piperidin- polyalcohol ...
5.2. Pharmacokinetic properties
The kinetics of pridinol mesilate in humans have shown that, with oral administration, the maximum blood concentration is attained after about 1 hour and that there is a uniform distribution in the body. ...
5.3. Preclinical safety data
Acute toxicity was investigated in studies on various animal species. The LD50 was 250 mg/kg in mice after oral administration, 446 mg/kg in rats after subcutaneous administration. In a chronic 6-month ...
6.1. List of excipients
Lactose monohydrate Microcrystalline cellulose Hydrogenated castor oil Talc Povidone K30 Colloidal silicon dioxide Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
PVC//Al blisters. Packs with 20, 50 and 100 tablets. Hospital packs with 200 (10 20), 500 (10 50) and 1000 (10 100) tablets Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Mibe pharma UK Ltd, 4 Coleman Street, 6th Floor, London, EC2R 5AR, United Kingdom
8. Marketing authorization number(s)
PL 49452/0010
9. Date of first authorization / renewal of the authorization
28/05/2020
10. Date of revision of the text
28/05/2020
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