Qlaira

1. What Qlaira is and what it is used for

Qlaira• Qlaira is a contraceptive pill and is used to prevent pregnancy.

• Qlaira is used for the treatment of heavy menstrual bleeding (not caused by any disease of the womb) in women who wish to use oral contraception.

• Each coloured, active tablet contains a small amount of female hormones, either estradiol valerate, or estradiol valerate combined with dienogest.

• The 2 white tablets contain no active substances and are called inactive tablets

• Contraceptive pills that contain two hormones are called “combined pills”.

2. How to store Qlaira

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

Do not use Qlaira after the expiry date which is stated on the wallet after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

3. Further information

What Qlaira contains

Qlaira BlisterThe active substances are estradiol valerate, or estradiol valerate combined with dienogest.

Each wallet (28 film-coated tablets) of Qlaira contains 26 active tablets in 4 different colours in rows 1, 2, 3 and 4, as well as 2 white inactive tablets in row 4.

Composition of the coloured tablets containing one or two active substances:

• 2 dark yellow tablets each containing 3 mg estradiol valerate

• 5 medium red tablets each containing 2 mg estradiol valerate and 2 mg dienogest

• 17 light yellow tablets each containing 2 mg estradiol valerate and 3 mg dienogest

• 2 dark red tablets each containing 1mg estradiol valerate 15

Composition of the white inactive tablets:

These tablets do not contain any active substances.

Other ingredients in the coloured active tablets are:

Tablet core: lactose monohydrate, maize starch, pregelatinised maize starch, povidone K25 (E1201), magnesium stearate (E572)

Tablet film-coating: hypromellose type 2910 (E464), macrogol 6000, talc (E553b), titanium dioxide (E171), iron oxide yellow (E172) and/or iron oxide red (E172)

Other ingredients in the white inactive tablets are:

Tablet core: lactose monohydrate, maize starch, povidone K25 (E1201), magnesium stearate (E572)

Tablet film-coating: hypromellose type 2910 (E464), talc (E553b), titanium dioxide (E171)

4. What Qlaira looks like and content of the pack

Qlaira Blister PackQlaira tablets are film-coated tablets; the core of the tablet is covered with a coating.

Each wallet (28 film-coated tablets) contains 2 dark yellow tablets in row 1, 5 medium red tablets in row 1, 17 light yellow tablets in rows 2, 3 and 4, 2 dark red tablets in row 4 as well as 2 white tablets in row 4.

The dark yellow active tablet is round with biconvex faces, one side is embossed with the letters “DD” in a regular hexagon.

The medium red active tablet is round with biconvex faces, one side is embossed with the letters “DJ” in a regular hexagon.

The light yellow active tablet is round with biconvex faces, one side is embossed with the letters “DH” in a regular hexagon.

The dark red active tablet is round with biconvex faces, one side is embossed with the letters “DN” in a regular hexagon.

The white inactive tablet is round with biconvex faces, one side is embossed with the letters “DT” in a regular hexagon.

Qlaira is available in packs of 1, 3, or 6 wallets each containing 28 tablets.

Not all pack sizes may be marketed.

5. Marketing Authorisation Holder

Bayer plc

Bayer House

Strawberry Hill

Newbury 16

Berkshire

RG14 1JA

Manufacturer

Bayer Weimar GmbH und Co. KG      and           Bayer Pharma AG

99427 Weimar                                                       13342 Berlin

Germany                                                                Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

• Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta,Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden,

United Kingdom: QLAIRA/Qlaira

• Italy: KLAIRA

Other contraceptive pills:

Ovranette

Micronor

Marvelon

Zoely