PRIMOLUT N Tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Primolut N.
Qualitative and quantitative composition
Each tablet contains 5 milligrams of norethisterone BP. Excipient with known effect: Lactose. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White, uncoated tablets impressed with AN in a regular hexagon on one side.
Therapeutic indications
Metropathia haemorrhagica. Premenstrual syndrome. Postponement of menstruation. Endometriosis. Menorrhagia. Dysmenorrhoea.
Posology and method of administration
Posology Not intended for use in children. Metropathia haemorrhagica (dysfunctional uterine bleeding) 1 tablet 3 times daily for 10 days. Bleeding is arrested usually within 1-3 days. A withdrawal bleeding ...
Contraindications
Primolut N should not be used in the presence of any of the conditions listed below. Should any of the conditions appear during the use of Primolut N, the use of the product should be stopped immediately. ...
Special warnings and precautions for use
Medical Examination A complete personal and family medical history should be taken for each woman. Physical examination should be guided by this and by the contraindications (section 4.3) and warnings ...
Interaction with other medicinal products and other forms of interaction
Note: the prescribing information of concomitant medications should be consulted to identify interactions. Effects of other medicinal products on Primolut N Interactions can occur with drugs that induce ...
Pregnancy and lactation
Pregnancy The administration of Primolut N during pregnancy is contraindicated. Breast-feeding Primolut N can pass into breast milk and therefore should be avoided during lactation.
Effects on ability to drive and use machines
None known.
Undesirable effects
Undesirable effects are more common during the first months after start of intake of Primolut preparations, and subside with duration of treatment. The frequencies are based on reporting rates from postmarketing ...
Overdose
There have been no reports of ill-effects from overdosage and treatment is generally unnecessary. There are no special antidotes, and treatment should be symptomatic.
Pharmacodynamic properties
Pharmacotherapeutic group: sex hormones and modulators of the genital system, progestogens; Estren derivatives ATC Code: G03DC02 Norethisterone has progestational actions similar to those of progesterone, ...
Pharmacokinetic properties
Norethisterone is absorbed from the gastro-intestinal tract and its effects last for at least 24 hours. It is excreted in the urine. Metabolism Norethisterone is partly metabolised to ethinylestradiol ...
Preclinical safety data
Non-clinical data on norethisterone or its esters reveal no special risk for humans based on conventional studies of repeated dose toxicity, genotoxicity and carcinogenic potential which is not already ...
List of excipients
Lactose Maize starch Magnesium stearate
Incompatibilities
Not known.
Shelf life
5 years.
Special precautions for storage
Not applicable.
Nature and contents of container
30 tablets in aluminium/PVC blisters in a carton.
Special precautions for disposal and other handling
Keep out of the reach of children.
Marketing authorization holder
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Marketing authorization number(s)
PL 00010/0553
Date of first authorization / renewal of the authorization
1 May 2008
Date of revision of the text
13 December 2018
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