NORIDAY Tablet (2019)
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Περιεχόμενα
1. Name of the medicinal product
Noriday 350 microgram tablets.
2. Qualitative and quantitative composition
Each tablet contains 350 micrograms norethisterone. <u>Excipient(s) with known effect:</u> Each tablet contains 62.25 mg lactose (as monohydrate). For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. White, flat, circular, bevel-edged tablet inscribed SEARLE on one side and NY on the other side.
4.1. Therapeutic indications
Noriday is a progestogen-only oral contraceptive. It is particularly useful for women for whom oestrogens may not be appropriate.
4.2. Posology and method of administration
Posology Starting on the first day of menstruation, one pill every day without a break in medication for as long as contraception is required. Additional contraceptive precautions (such as a condom) should ...
4.3. Contraindications
The contraindications for progestogen-only oral contraceptives are: known, suspected, or a past history of breast, genital or hormone dependent cancer acute or severe chronic liver diseases including past ...
4.4. Special warnings and precautions for use
Assessment of women prior to starting oral contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. Physical examination should be guided ...
4.5. Interaction with other medicinal products and other forms of interaction
The herbal remedy St Johns wort (Hypericum perforatum) should not be taken concomitantly with this medicine as this could potentially lead to a loss of contraceptive effect. Some drugs may modify the metabolism ...
4.6. Pregnancy and lactation
Pregnancy Noriday is not indicated during pregnancy. If pregnancy occurs during medication with Noriday, treatment should be withdrawn immediately. Like all norethisterone derivatives used for contraception, ...
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
The incidence of side effects in clinical trials was lower than that experienced with oestrogen-containing oral contraceptives. Side effects which did occur included some cycle irregularity during the ...
4.9. Overdose
Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may be manifested by nausea, vomiting, breast enlargement and vaginal ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> sex hormones and modulators of the genital system, progestogens <b>ATC code:</b> G03DC02 Norethisterone administration increases the protein and sialic acid content of ...
5.2. Pharmacokinetic properties
Norethisterone is rapidly and completely absorbed after oral administration, peak plasma concentrations occurring in the majority of subjects between 1 and 3 hours. Due to first-pass metabolism, blood ...
5.3. Preclinical safety data
The toxicity of norethisterone is very low. Reports of teratogenic effects in animals are uncommon. No carcinogenic effects have been found even in long-term studies. In subacute and chronic studies only ...
6.1. List of excipients
Maize starch Polyvidone Magnesium stearate Lactose monohydrate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Do not store above 25°C. Keep the blister in the outer carton in order to protect from light and moisture.
6.5. Nature and contents of container
Noriday tablets are supplied in pvc/foil blister packs of 28 and 84 tablets. Blister packaging consists of 250 micron PVC and 20 micron aluminium foil. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
8. Marketing authorization number(s)
PL 00057/1019
9. Date of first authorization / renewal of the authorization
26<sup>th</sup> July 2002
10. Date of revision of the text
08/2019
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