QLAIRA Film-coated tablet (2018)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Qlaira, film-coated tablets.

2. Qualitative and quantitative composition

Each wallet (28 film-coated tablets) contains in the following order: 2 dark yellow tablets each containing 3 mg estradiol valerate 5 medium red tablets each containing 2 mg estradiol valerate and 2 mg ...

3. Pharmaceutical form

Film-coated tablet (tablet). Dark yellow film-coated tablet, round with biconvex faces, one side is marked with the letters DD in a regular hexagon. Medium red film-coated tablet, round with biconvex faces, ...

4.1. Therapeutic indications

Oral contraception. Treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception. The decision to prescribe Qlaira should take into consideration the individual ...

4.2. Posology and method of administration

Method of administration Oral use. Posology How to take Qlaira Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. Tablet taking is continuous. ...

4.3. Contraindications

Combined hormonal contraceptives (CHCs) should not be used in the following conditions. Should any of the conditions appear for the first time during CHC use, the product should be stopped immediately. ...

4.4. Special warnings and precautions for use

Warnings If any of the conditions or risk factors mentioned below is present, the suitability of Qlaira should be discussed with the woman. In the event of aggravation, or first appearance of any of these ...

4.5. Interaction with other medicinal products and other forms of interaction

Note: The prescribing information of concomitant medications should be consulted to identify potential interactions. Interaction studies have only been performed in adults. The following interactions have ...

4.6. Fertility, pregnancy and lactation

Pregnancy Qlaira should not be used during pregnancy. If pregnancy occurs during use of Qlaira, further intake must be stopped. However, extensive epidemiological studies with ethinylestradiol containing ...

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. No effects on ability to drive and use machines have been observed in users of COCs.

4.8. Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions with Qlaira when used as an oral contraceptive or in the treatment of heavy menstrual bleeding in women without organic pathology ...

4.9. Overdose

There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in case of taking an overdose of active tablets are: nausea, vomiting and, in young girls, slight vaginal ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: progestogens and estrogens, sequential preparations ATC code: G03AB08 In clinical trials performed with Qlaira in the European Union and in the USA/Canada the following ...

5.2. Pharmacokinetic properties

Dienogest Absorption Orally administered dienogest is rapidly and almost completely absorbed. Maximal serum concentrations of 90.5 ng/ml are reached at about 1 hour after oral administration of the Qlaira ...

5.3. Preclinical safety data

Preclinical data reveal no special risks for humans based on conventional studies of repeated dose toxicity, genotoxicity, and toxicity to reproduction. A carcinogenicity study with dienogest in mice and ...

6.1. List of excipients

Active film-coated tablets Tablet core: Lactose monohydrate Maize starch Pregelatinized maize starch Povidone K25 (E1201) Magnesium stearate (E572) Tablet coating: Hypromellose type 2910 ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Transparent PVC/Aluminium blister in a cardboard wallet Presentation Pack sizes: 1 28 film-coated tablets 3 28 film-coated tablets 6 28 film-coated tablets Each wallet (28 film-coated tablets) ...

6.6. Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading, RG2 6AD

8. Marketing authorization number(s)

PL00010/0576

9. Date of first authorization / renewal of the authorization

First Authorisation: 08.12.2008 Renewal of Authorisation: 03.11.2013

10. Date of revision of the text

17.12.2018

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