Active ingredient
- estradiol valerate
- dienogest
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00010/0576.
Qlaira
Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Package leaflet: Information for the user
Qlaira film-coated tablets
Estradiol valerate/Dienogest
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Important things to know about combined hormonal contraceptives (CHCs):
What is in this leaflet:
1. What Qlaira is and what it is used for
2. What you need to know before you take Qlaira
When not to take Qlaira
Warnings and precautions
Blood clots
Qlaira and cancer
Bleeding between periods
What to do if no bleeding occurs on day 26 or the following day(s)
Other medicines and Qlaira
Qlaira with food and drink
Laboratory tests
Pregnancy and breast-feeding
Driving and using machines
Qlaira contains lactose
3. How to take Qlaira
Preparation of the wallet
When can you start with the first wallet?
If you take more Qlaira than you should
If you forget to take Qlaira
Use in children
What to do if you vomit or have severe diarrhoea
If you stop taking Qlaira
4. Possible side effects
5. How to store Qlaira
6. Contents of the pack and other information
1. What Qlaira is and what it is used for
2. What you need to know before you take Qlaira
General notes
Before you start using Qlaira you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot – see Section 2 “Blood clots”.
Before you can begin taking Qlaira, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure and, depending upon your personal situation, may also carry out some other tests.
In this leaflet, several situations are described where you should stop using Qlaira, or where the reliability of Qlaira may be decreased. In such situations you should either not have sex or you should take extra non-hormonal contraceptive precautions, e.g. use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because Qlaira alters the monthly changes of body temperature and cervical mucus.
Qlaira, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease
When not to take Qlaira
You should not use Qlaira if you have any of the conditions listed below. If you do have any of the conditions listed below, you must tell your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate.
Do not take Qlaira:
Warnings and precautions
When should you contact your doctor?
Seek urgent medical attention
For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”.
Tell your doctor if any of the following conditions apply to you.
In some situations you need to take special care while taking Qlaira or any other combined pill, and your doctor may need to examine you regularly. If the condition develops, or gets worse while you are using Qlaira, you should also tell your doctor.
Talk to your doctor before taking Qlaira.
Additional information on special populations
Use in children
Qlaira is not intended for use in females whose periods have not yet started.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Qlaira increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block blood vessels and cause serious problems.
Blood clots can develop
Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal.
It is important to remember that the overall risk of a harmful blood clot due to Qlaira is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms.
Are you experiencing any of these signs?
change in colour of the skin on the leg e.g. turning pale, red or blue
What are you possibly suffering from?
Deep vein thrombosis
Are you experiencing any of these signs?
If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g. a ‘common cold’).
What are you possibly suffering from?
Pulmonary embolism
Are you experiencing any of these signs?
Symptoms most commonly occur in one eye:
What are you possibly suffering from?
Retinal vein thrombosis (blood clot in the eye)
Are you experiencing any of these signs?
What are you possibly suffering from?
Heart attack
Are you experiencing any of these signs?
Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.
What are you possibly suffering from?
Stroke
Are you experiencing any of these signs?
What are you possibly suffering from?
Blood clots blocking other blood vessels
BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.
When you stop Qlaira your risk of a blood clot returns to normal within a few weeks.
What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.
The overall risk of a blood clot in the leg or lung (DVT or PE) with Qlaira is small.
Risk of developing a blood clot in a year
Women who are not using a combined hormonal pill and are not pregnant
About 2 out of 10,000 women
Risk of developing a blood clot in a year
Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate
About 5-7 out of 10,000 women
Risk of developing a blood clot in a year
Women using Qlaira
Not yet known.
Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Qlaira is small but some conditions will increase the risk. Your risk is higher:
The risk of developing a blood clot increases the more conditions you have.
Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed.
It is important to tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that Qlaira needs to be stopped.
If any of the above conditions change while you are using Qlaira, for example a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.
Factors that increase your risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke from using Qlaira is very small but can increase:
If you have more than one of these conditions or if any of them are particularly severe the risk of developing a blood clot may be increased even more.
If any of the above conditions change while you are using Qlaira, for example you start smoking, a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.
Qlaira and cancer
Breast cancer has been observed slightly more often in women using combined pills, but it is not known whether this is caused by the treatment itself. For example, it may be that more tumours are detected in women on combined pills because they are examined by their doctor more often. The risk of breast tumours becomes gradually less after stopping the combination hormonal contraceptives. It is important to regularly check your breasts and you should contact your doctor if you feel any lump.
In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been reported in contraceptive pill users. In isolated cases, these tumours have led to life-threatening internal bleeding. Contact your doctor if you have unusually severe abdominal pain.
Some studies suggest that long-term use of the pill increases a woman's risk of developing cervical cancer. However, it is not clear to what extent sexual behaviour or other factors such as Human Papilloma Virus (HPV) increases this risk.
Psychiatric disorders
Some women using hormonal contraceptives including Qlaira have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.
Bleeding between periods
During the first few months of taking Qlaira, you may have unexpected bleeding. Usually bleeding starts on day 26, the day you take the second dark red tablet, or the following day(s). The information provided by women in the diaries they kept during a clinical study of Qlaira shows that it is not unusual to experience unexpected bleeding in a given cycle (10-18 % of users). If unexpected bleeding occurs more than 3 months in a row, or if it begins after some months, your doctor will have to investigate the cause.
What to do if no bleeding occurs on day 26 or the following day(s)
The information provided by women in the diaries they kept during a clinical study of Qlaira shows that it is not unusual to miss your regular bleeding after day 26 (observed in about 15 % of cycles).
If you have taken all the tablets correctly, have not had any vomiting or severe diarrhoea and you have not taken any other medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not happen twice in a row or you have taken the tablets incorrectly, you may be pregnant. Contact your doctor immediately. Do not start the next wallet until you are sure that you are not pregnant.
Other medicines and Qlaira
Always tell your doctor which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist from whom you got the medicine) that you take Qlaira. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long.
Some medicines
These include:
Ask your doctor or pharmacist for advice before taking any medicine. Your doctor or pharmacist may advise on extra protective measures while you are taking other medication together with Qlaira.
Qlaira with food and drink
Qlaira may be taken with or without food, if necessary with a small amount of water.
Laboratory tests
If you need a blood test or other laboratory tests tell your doctor or the laboratory staff that you are taking the pill because oral contraceptives can affect the results of some tests.
Pregnancy and breast-feeding
Do not take Qlaira if you are pregnant. If you become pregnant while taking Qlaira, stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Qlaira at any time (see also “If you stop taking Qlaira”).
In general you should not take Qlaira while you are breast-feeding. If you want to take the pill while you are breast-feeding you should contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine when you are pregnant or breast-feeding.
Driving and using machines
There is nothing to suggest that the use of Qlaira affects driving or use of machines.
Qlaira contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Qlaira.
3. How to take Qlaira
Each wallet contains 26 coloured active tablets and 2 white inactive-tablets.
Take one tablet of Qlaira every day, if necessary with a small amount of water. You may take the tablets with or without food, but you should take the tablets at around the same time every day.
Preparation of the wallet
To help you keep track, there are 7 weekday sticker strips marked with the 7 days of the week.
Choose the weekday sticker strip that starts with the day you begin taking the tablets. For example, if you start on a Wednesday, use the weekday sticker strip that starts with “WED”.
Stick the weekday sticker strip along the top of the Qlaira wallet where it reads “Place weekday sticker strip here”, so that the first day is above the tablet marked “1”.
There is now a day shown above every tablet and you can see whether you have taken a pill on a particular day. Follow the direction of the arrow on the wallet until all 28 tablets have been taken.
Usually, so-called withdrawal bleeding starts when you are taking the second dark red tablet or the white tablets and may not have finished before you start the next wallet. Some women still experience bleeding after taking the first tablets of the new wallet.
Start the following wallet without a gap, in other words the day after you have finished your current wallet, even if the bleeding has not stopped. This means that you should start your following wallet on the same day of the week as the current wallet and that the withdrawal bleed should occur on the same weekdays each month.
If you use Qlaira in this manner, you are protected against pregnancy even during the 2 days when you take inactive tablets.
When can you start with the first wallet?
Ask your doctor what to do if you are not sure when to start.
If you take more Qlaira than you should
There are no reports of serious harmful effects of taking too many Qlaira tablets.
If you take several active tablets at once, you may feel sick or throw up. Young girls may have bleeding from the vagina.
If you have taken too many Qlaira tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.
If you forget to take Qlaira
Inactive tablets: If you miss a white tablet (2 tablets at the end of the wallet), you do not need to take it later because they do not contain any active substances. However, it is important that you discard the missed white tablet(s) to make sure that the number of days when you take tablets is not increased as this would increase the risk of pregnancy. Continue with the next tablet at the usual time.
Active tablets: Depending on the day of the cycle on which one active tablet has been missed, you may need to take additional contraceptive precautions, for example a barrier method such as a condom. Take the tablets according to the following principles. See also the ‘missed pill chart’ for details.
Do not take more than 2 active tablets on a given day.
If you have forgotten to start a new wallet, or if you have missed one or more tablets during days 3 - 9 of your wallet, there is a risk that you are already pregnant (if you had sex in the 7 days before forgetting the tablet). In that case, contact your doctor. The more tablets you have forgotten (especially those on days 3 – 24) and the closer they are to the inactive tablet phase, the greater the risk that the protection from pregnancy is reduced. See also the ‘missed pill chart’ for details.
If you have forgotten any of the active tablets in a wallet, and you have no bleeding at the end of a wallet, you may be pregnant. Contact your doctor before you start the next wallet.
Missed more than 1 coloured pill
Forgot to start a new wallet
Contact your doctor straight away
Only missed 1 pill (more than 12 hours late)
Day 1-9
Have had sex in the 7 days before forgetting?
YES
Contact your doctor straight away
Only missed 1 pill (more than 12 hours late)
Day 1-9
Have had sex in the 7 days before forgetting?
NO
Only missed 1 pill (more than 12 hours late)
Day 10-17
Only missed 1 pill (more than 12 hours late)
Day 18-24
Only missed 1 pill (more than 12 hours late)
Day 25-26
Only missed 1 pill (more than 12 hours late)
Day 27-28
Use in children
No data available in adolescents below 18 years.
What to do if you vomit or have severe diarrhoea
If you throw up within 3-4 hours of taking an active tablet or you have severe diarrhoea, there is a risk that the active substances in the pill are not fully absorbed by your body.
The situation is almost the same as forgetting a tablet. After throwing up or having diarrhoea, take the next tablet as soon as possible. If possible, take it within 12 hours of when you normally take your pill. If this is not possible or 12 hours have passed, you should follow the advice given under “If you forget to take Qlaira”. If you do not want to change your normal tablet-taking pattern take the corresponding tablet from another wallet.
If you stop taking Qlaira
You can stop taking Qlaira at any time. If you do not want to become pregnant, ask your doctor for advice about other reliable methods of birth control. If you want to become pregnant, stop taking Qlaira and wait for a menstrual period before starting to try to become pregnant. You will be able to calculate the expected delivery date more easily.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Qlaira can cause side effects, although not everybody gets them. If you get any side effect, particularly if severe and persistent, or have any change to your health that you think may be due to Qlaira, please talk to your doctor.
An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you take Qlaira”.
Serious side effects
Serious reactions associated with the use of the pill, as well as the related symptoms, are described in the following sections: “Blood clots” and “Qlaira and cancer". Please read these sections carefully and consult your doctor at once where appropriate.
Other possible side effects
The following side effects have been linked with the use of Qlaira:
Common side effects (between 1 and 10 in every 100 users may be affected):
Uncommon side effects (between 1 and 10 in every 1,000 users may be affected):
Rare side effects (between 1 and 10 in every 10,000 users may be affected):
Further information (taken from the diaries women kept during a Qlaira clinical trial) on the possible side effects “irregular bleeding (heavy irregular bleeding)” and “no periods” is given in the sections “Bleeding between periods” and “What to do if no bleeding occurs on day 26 or the following day(s)”.
Description of selected adverse reactions
Adverse reactions with very low frequency or with delayed onset of symptoms which are considered to be related to the group of combined oral contraceptives, and could also occur during use of Qlaira, are listed below (see also sections “When not to take Qlaira”, “Warnings and precautions”:
In case of disturbed liver function, it may be necessary to temporarily stop the use of combined oral contraceptive pills.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store.
Malta
5. How to store Qlaira
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the wallet after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Qlaira contains
The 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
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)
What Qlaira looks like and content of the pack
Qlaira 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 marked with the letters “DD” in a regular hexagon.
The medium red active tablet is round with biconvex faces, one side is marked with the letters “DJ” in a regular hexagon.
The light yellow active tablet is round with biconvex faces, one side is marked with the letters “DH” in a regular hexagon.
The dark red active tablet is round with biconvex faces, one side is marked with the letters “DN” in a regular hexagon.
The white inactive tablet is round with biconvex faces, one side is marked 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.
Marketing Authorisation Holder
Manufacturer
and
This medicinal product is authorised in the Member States of the EEA under the following names:
This leaflet was last revised in 12/2018.
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