ACNAMINO MR Capsule, hard (2014)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Acnamino MR 100mg Capsules.
Qualitative and quantitative composition
Each capsule contains 100mg minocycline (as minocycline hydrochloride). For excipients, see section 6.1.
Pharmaceutical form
Capsules, hard. Minocycline 100 mg is a hard gelatin capsule, with an opaque-buff body and an opaque-brown cap, containing one pink film-coated tablet, and one peach enteric-coated tablet.
Therapeutic indications
Minocycline 100 mg capsules are indicated for the treatment of acne. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology and method of administration
Posology Adults One 100 mg capsule every 24 hours. Children over 12 years One 100 mg capsule every 24 hours. Children under 12 years Minocycline is not recommended. Elderly Dose selection for an elderly ...
Contraindications
Hypersensitivity to minocycline or to any other of the tetracyclines or to any of the capsule excipients. Pregnancy and lactation. Children of less than 12 years of age. Renal failure.
Special warnings and precautions for use
Minocycline should be used with caution in patients with hepatic dysfunction and in conjunction with alcohol and other hepatotoxic drugs. It is recommended that alcohol consumption should remain within ...
Interaction with other medicinal products and other forms of interaction
Tetracyclines depress plasma prothrombin activity and reduced doses of concomitant anticoagulants may be necessary. Diuretics may aggravate nephrotoxicity by volume depletion. Minocycline should not be ...
Pregnancy and lactation
Pregnancy Minocycline is contraindicated in pregnancy. Results of animal studies indicate that tetracyclines cross the placenta, are found in foetal tissues and can have toxic effects on the developing ...
Effects on ability to drive and use machines
Headache, light-headedness, dizziness, tinnitus and vertigo (more common in women) and, rarely, impaired hearing have occurred with minocycline. Patients should be warned about the possible hazards of ...
Undesirable effects
Adverse reactions are listed in the Table in CIOMS frequency categories under MedDRA system/organ classes: Common ≥1%, Uncommon ≥0.1% and <1%, Rare ≥0.01% and <0.1%, Very Rare <0.01%. Infections and Infestations ...
Overdose
Dizziness, nausea and vomiting are the adverse effects most commonly seen with overdose. There is no specific antidote. In cases of overdose, discontinue medication; treat symptomatically with gastric ...
Pharmacodynamic properties
Therapeutic classification: Antibacterial for Systemic Use ATC code: J01AA08 Minocycline Capsules contain the active ingredient minocycline as minocycline hydrochloride, a semi-synthetic derivative of ...
Pharmacokinetic properties
After a single 100 mg dose of Minocycline Capsules administered to fasting male subjects a maximum concentration of 608 (± 162) ng/ml was achieved at 3.2 (± 1.1) hours after dosing and was eliminated with ...
Preclinical safety data
There is no other relevant information from pre-clinical studies that has not already been mentioned in the preceding sections.
List of excipients
Microcrystalline cellulose, Croscarmellose sodium, Povidone, Red iron oxide, Ferric oxide yellow, Silica colloidal anhydrous, Magnesium stearate, Hypromellose phthalate, Triethyl citrate, Carnauba wax, ...
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
Store in the original package.
Nature and contents of container
The capsules are presented in aluminium/aluminium blisters, strips of which are contained within a printed cardboard carton. Each carton contains 56 capsules.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Dexcel-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
Marketing authorization number(s)
PL 14017/0062
Date of first authorization / renewal of the authorization
12/04/2010
Date of revision of the text
11/12/2014
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
