Alegria 100 / 20 Microgram Film-Coated Tablets
Package leaflet: Information for the patient
Alegria 100/20 microgram film-coated tablets
Levonorgestrel/Ethinylestradiol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Alegria is and what it is used for
2. What you need to know before you take Alegria
3. How to take Alegria
4. Possible side effects
5. How to store Alegria
6. Contents of the pack and other information
1. What Alegria is and what it is used for
Alegria is a combined oral contraceptive pill and it is used to prevent pregnancy.
Each pink t ablet c ontains a s mall a mount o f two female s ex hor mones, oestrogen and progestogen. White tablets do not contain active substances and are placebo tablets.
This m edicine co ntains l evonorgestrel and et hinylestradiol and because i t c ontains two hormones, it is called a ‘combined hormonal contraceptive’. Alegria is also called a ‘low-dose’ contraceptive pi ll b ecause i t con tains on ly a sm all am ount of these hormones. The hormones prevent an egg being released from your ovaries so you cannot get pregnant.
Alegria is a 28-day Pill - you take one tablet each day for 28 days.
2. What you need to know before you take Alegria
It is important that you understand the benefits and risks of taking Alegria before you start taking it, or when deciding whether to carry on taking it. Although Alegria is suitable for most healthy women it is not suitable for everyone.
Tell your doctor if you have any of the illnesses or risk factors mentioned in this leaflet.
Do not take Alegria:
• if you are allergic to lenonorgestrel, ethinylestradiol or any of the other ingredients in this medicine (listed in section 6)
• if y ou ha ve (or ha ve e ver ha d) a b lood c lot (thrombosis) in your legs (deep vein thrombosis or DVT), or lungs (pulmonary embolism) or another part of your body
• if you have (or have ever had) a heart attack or a type of chest pain called ‘angina’
• if you have (or have ever had) a stroke or a disease that can be an indicator of a stroke (for example, a passing slight stroke with no residual effects)
• if you are breast feeding and your baby is less than 6 weeks old
• if you have high blood pressure (160/100 mmHg or above)
• if you have an illness which runs in your family which affects fat levels in your blood (called dyslipoproteinemia)
• if you have an illness which runs in your family which affects the clotting of your blood (such as ‘protein C deficiency’ or ‘protein S deficiency’)
• if y ou have ha d diabetes for m ore than 20 years o r have di abetes w ith sec ondary problems
• if you have any conditions which make you more at risk of a blood clot (thrombosis), such as having an operation and being off your feet for a long time
• if you have an irregular heartbeat (atrial fibrillation), problems with heart valves or heart failure
• if you have ever had bad headaches with neurological symptoms such as changes in vision or numbness in any part of your body (migraine with focal aura)
• if you have or have recently had severe liver disease
• if you have a tumour in the liver
• if you have ever had or suspect you have breast cancer or cancer of the womb, cervix or vagina
• if you know or suspect that you are pregnant
• if you have (or have ever had) an inflammation of the pancreas (pancreatitis)
• if your period has not yet started (girls in puberty)
Medical check-ups
Before using Alegria you will need to see your doctor for a medical check-up. Your doctor will ask about you and your family’s medical problems and check your blood pressure. You may also need other checks, such as a breast examination but only if these are necessary for you or you have any special concerns.
• You will need regular check-ups with your doctor or family planning nurse, usually when you need another prescription of Alegria.
• You should go for regular cervical smear tests.
• Check your breasts and nipples every month for changes - tell your doctor if you can see or feel anything odd, such as lumps or dimpling of the skin.
• If you need a blood test tell your doctor that you are taking Alegria, because it can affect the results of some tests.
• If you’re going to have an operation, make sure your doctor knows about it. You may need to stop taking Alegria about 4-6 weeks before the operation. This is to reduce the risk of a blood clot. Your doctor will tell you when you can start taking Alegria again.
Warnings and precautions
In some situations you need to take special care while using Alegriaor any other combined pill, and it may be necessary that you are regularly checked by your doctor. If any of the following conditions applies to you, you must inform your doctor before starting to use Alegria.
Talk to your doctor or pharmacist before taking Alegria if you have any of the following or they happen or get worse while using this medicine:
• as you get older
• if you are seriously overweight (you weigh 90 kg ,which is 14 stone 2 lb) or more
• if you smoke
• if you are off your feet for a long time because of major surgery, injury or illness
• if you have an irregular heartbeat (atrial fibrillation), problems with heart valves or heart f ailure, or if y ou or someone i n y our close family has had a h eart attack or stroke at a young age
• if you have a hearing loss
• if you have a blood problem called porphyria
• if y ou ha ve a pr oblem of t he ne rvous s ystem i nvolving s udden m ovements of t he body called ‘Sydenham’s chorea’
• if a close relative has or has ever had breast cancer
• if y ou ha ve l iver p roblems i ncluding y ellowing of the s kin a nd w hites of the e ye (jaundice)
• if you have diabetes
• if you have gallstones
• if you had a skin rash with blisters during pregnancy (called ‘herpes gestationis’)
• if you have depression
• if you have Crohn’s disease or inflammatory bowel disease (ulcerative colitis)
• if you have a blood disease called HUS (haemolytic uraemic syndrome) that causes kidney damage
• if you have epilepsy
• if y ou have a di sease of t he i mmune sy stem called SLE (systemic l upus erythematosus), an illness causing generalised skin disorders
• if you have ever had golden brown pigment patches (chloasma), so called “pregnancy patches”, especially on the face.
• if you have an intolerance to lactose or are on a lactose-free diet
• if y ou ha ve he reditary a ngioedema ( rapid s welling of t he s kin, m ucosal t issues, internal organs o r brain); products c ontaining oe strogens may c ause or w orsen the symptoms. If you experience symptoms of angioedema such as swollen face, tongue, throat/neck area, difficulty swallowing or hives together with difficulty in breathing, you should see your doctor immediately.
• if you have a high level of fat in your blood (cholesterol or triglycerides) or someone in your family has had this
• if you have high blood pressure or your blood pressure gets higher..
• if you have any disturbance of blood clotting (for example, protein C deficiency)
• if you suffer from migraine
• if you think you might be pregnant.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Alegria.
Other medicines and Alegria
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
Certain medicines and herbal remedies may stop Alegria from working properly. If this happens you could get pregnant.
Tell your doctor if you are taking:
• Medicines for HIV infection (such as ritonavir, nevirapine)
• Medicines for infection -called antibiotics (such as rifampicin and griseofulvin)
• Medicines for epilepsy ( such as t opiramate, phenytoin sodium, carbamazepine, primidone, oxcarbamazepine and felbamate)
• Medicine for tuberculosis (rifampicin)
• Medicine for relaxation and difficulty in sleeping (sedatives such as barbiturates)
St. John’s Wort - a herbal remedy used for depression.
Alegria can also affect other medicines- for example:
• ciclosporin (to prevent transplant rejection and for rheumatoid arthritis or some skin problems)
• lamotrigine (for epilepsy)
Talk to your doctor before taking Alegria if you are taking any of these medicines. Your doctor may have to change how much of these medicines you are taking.
Risks of using combined hormonal contraceptives
The following information is based on information about combined birth control tablets. As Alegria contains similar hormones to those used in combined birth control tablets, it is likely to have the same risks. All combined birth control tablets have risks, which may lead to disability or death.
Alegria and venous and arterial blood clots
The use of any combination pill, including Alegria, increases a woman’s risk of developing a venous blood clot (venous thrombosis) compared with women who do not take any contraceptive pill. The risk of developing a venous blood clot is highest during the first year a woman initially starts using the pill. It is possible that the risk of blood clots in the legs and/or lungs with Alegria is higher than the risk associated with the use of other combined birth control tablets.
The risk of venous blood clots in users of combination pills increases:
• with increasing age
• if you are overweight
• if on e of y our c lose r elatives e ver ha d a b lood clot i n the leg, l ung ( pulmonary embolism), or other organ at a young age
• if y ou have t o have surg ery, if y ou have ha d a serious a ccident or if y ou ar e immobilized for a long time. It is important to tell your doctor that you are using Alegria, as you may have to stop taking it. Y our doctor will tell you when to start again. This is usually about two weeks after you are back on your feet.
A blood clot in the veins may travel to the lungs and may block blood vessels (called a lung embolus). Formation of blood clots in the veins may be fatal in 1-2% of cases.
The level of risk may vary according to the type of pill you take. Discuss with your doctor the available options.
The use of combination pills has been connected with an increase of the risk of an arterial blood clot (arterial thrombosis), for example, in the blood vessels of the heart (heart attack) or the brain (stroke).
The risk of an arterial blood clot in users of combination pills increases:
• if you smoke. You are strongly advised to stop smoking when you use Alegria, especially if you are older than 35 years.
• if the fat content of your blood is increased (cholesterol or triglycerides)
• if you are overweight
• if one of your close relatives ever had a heart attack or stroke at a young age
• if you have high blood pressure
• if you suffer from migraine
• if you have a problem with your he art (valve di sorder, a di sturbance of the cardiac rhythm)
Stop taking Alegria and contact your doctor immediately if you notice possible signs of a blood clot, such as:
• severe pain and/or swelling in one of your legs
• sudden severe pain in the chest which may reach the left arm
• sudden breathlessness
• sudden cough without an obvious cause
• any unusual, severe or long-lasting headache or worsening of migraine
• partial or complete blindness or double vision
• difficulty in speaking or inability to speak
• giddiness or fainting
• weakness, strange feeling, or numbness in any part of the body Combined hormonal contraceptives and cancer
Breast cancer
Breast cancer has been found more often in women who take combined hormonal contraceptives. However, it is possible that the combined hormonal contraceptive is not the cause of more women having breast cancer. It may be that women taking the combined hormonal contraceptive are examined more often. This might mean that there is a better chance of the breast cancer being noticed. The increased risk gradually goes down after stopping the combined hormonal contraceptive. After 10 years, the risk is the same as for people who have never used the combined hormonal contraceptive.
Cervical cancer
Cervical cancer also has been found more often in women taking combined hormonal contraceptives. However, this may be due to other causes. These include more sexual partners and sexually transmitted disease.
Liver cancer
In rare cases, liver tumours which are not cancer have been found in women taking combined hormonal contraceptives. Even more rarely, liver tumours which are cancer have been found. This can cause bleeding inside the body with very bad pain in the stomach area.
If this happens to you, talk to your doctor immediately.
Alegria with food and drink
Alegria may be taken with or without food, if necessary with a small amount of water.
Pregnancy and breast-feeding
Do not start taking Alegria if you are pregnant. If you think you might be pregnant while taking Alegria, do a pregnancy test to confirm that you are before you stop taking your tablets.
If you are breast-feeding, your doctor or nurse may advise you not to take <Product Name and advise you on alternative contraception. Taking this medicine while breast-feeding may not stop you from becoming pregnant.
Driving and using machines
Alegriahas no known effect on the ability to drive or use machines.
Sexually transmitted disease
Alegria will not protect you against sexually transmitted infections, such as Chlamydia or HIV. Only condoms can help to do this.
Alegriacontains lactose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.
3. How to take Alegria
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Each blister strip contains 28 tablets (21 pink and 7 white ones). Within the carton a sticker pad is available which contains the days of the week. This should be stuck on the blister on the weekday that the blister is started. For example, if you start to take the tablets on a Tuesday, then select the sticker strip which starts with "TUE" and stick this on top of the first row of the blister where it is written: “Place the sticker strip that coincides with the start date”. Take the first tablet of the first row under the word “Start”. Take the tablets every day in the order shown by the arrows.
Take one pink (active) tablet of Alegria every day for 21 days, with water if necessary. You may take the tablets with or without food, but you should take the tablets every day around the same time.
Once you have finished all 21 pink tablets, you will take the placebo (white) tablets. You have to take a tablet every day and there is not an interval without taking any tablet. Your period (withdrawal bleed) will start during these 7 days, usually 2-3 days after taking the last pink Alegria tablet.
You don’t need to use extra contraception during these seven placebo-taking days-as long as you have taken your tablets correctly and start the next strip of active tablets on time.
Start the next blister pack after taking the 4th row, with white tablets (placebo) even if your period continues. This way you will always start a new pack on the same day of the week, and the withdrawal bleed will occur roughly at the same time each month.
When can you start with the first strip?
• If you have not used a contraceptive with hormones in the previous month
Begin taking Alegria on the first day of the cycle (that is, the first day of your period). If you start Alegria on this day you are immediately protected against pregnancy. You may also begin on da y 2 -5 of your cycle, but you must use extra protective measures (for example, a condom) for the first 7 days.
• Changing from another combined hormonal contraceptive, or vaginal ring or patch Start taking Alegria preferably on the day after the last active tablet (the last tablet containing active substances) of your previous pill but at the latest,after the last placebo tablet of your previous pill.
When changing f rom a c ombination c ontraceptive vaginal r ing or patch, follow the advice of your doctor.
• Changing from a progestogen-only-method (progestogen-only pill, injection, implant or a progestogen-releasing intrauterine system IUS).
You may switch on any day from a progestogen-only pill (from an implant or an IUS on the day of its removal, from an injectable when the next injection would be due) but in all of these cases you must use extra protective measures (for example, a condom) for the first 7 days of tablet-taking.
• After miscarriage
Follow the advice of your doctor.
• After having a baby
You can start Alegria between 21 and 28 days after having a baby. If you start later than day 28, you must use an additional barrier method (for example, a condom) during the first 7 days of Alegria use.
If, after having a baby, you have had sex before starting Alegria (again), be sure that you are not pregnant or wait until your next period.
• If you are breast-feeding and want to start Alegria (again) after having a baby
Read the section on “Breast-feeding”. Ask your doctor what to do if you are not sure when to start.
If you forget to take Alegria
Tablets at the fourth row are placebo tablets. If you forget to take one placebo tablet, the effect of Alegria will not be affected. Discard the placebo tablet you have forgotten.
If you forget a tablet from row 1, 2 or 3, you will have to follow the next instructions:
If you are less than 12 hours late taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets again at the usual time.
If you are more than 12 hours late taking a tablet, the protection against pregnancy may be reduced. The greater the number of tablets that you have forgotten, the greater is the risk of becoming pregnant.
The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning of a strip (1st row) or at the end of week 3 (3rd row of the blister strip). Therefore, you should keep to the following rules (see the diagram below).
More than one tablet forgotten in this strip
Contact your doctor.
One tablet forgotten in week 1
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time and use extra precautions for the next 7 days, for example, a condom. If you have had sex in the week before forgetting the tablet you may be pregnant. In that case, contact your doctor.
One tablet forgotten in week 2
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time. The protection against pregnancy is not reduced, and you do not need to take extra precautions.
One tablet forgotten in week 3
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time. Instead of taking the placebo tablet, start the next strip.
Most likely, you will have a period at the end of the second strip but you may have light or menstruation-like bleeding during the second strip.
2. You can also stop taking the pink active tablets and go directly to the placebo tablets period of 7 days (record the day on which you forgot your pink tablet). Then continue with the next strip. If you want to start a new strip on the day you always start, make the placebo period less than 7 days.
If you follow one of these two recommendations, you will remain protected against pregnancy.
If you have forgotten any of the tablets in a strip, and you do not have a bleeding during the first placebo tablet period, you may be pregnant. Contact your doctor before you start the next strip.
If you start a new strip of tablets late, you may not be protected from pregnancy. If you had sex in the last seven days, ask your doctor, nurse or pharmacist for advice. You may need to consider emergency contraception. You should also use extra contraception, such as a condom, for seven days.
If you lose a tablet
If you lose a tablet, just take a tablet from a spare strip. Then take all the other tablets from your current strip as usual. You can then keep the opened spare strip in case you lose any more tablets.
What to do in the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking a pink tablet or you have severe diarrhoea, there is a risk that the active substances in the pill will not be fully taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea, take another 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, follow the advice given under “If you forget to take Alegria”.
If you have absence of bleeding
Occasionally, you may miss a withdrawal bleed. This could mean that you are pregnant, but that is very unlikely if you have taken your tablets correctly. Start your next strip at the normal time. If you think that you might have put yourself at risk of pregnancy (for example, by missing tablets or taking other medicines), or if you miss a second bleed, you should do a pregnancy test.
If you are pregnant, stop taking Alegria and see your doctor.
If you take more Alegria than you should
It is unlikely that taking more than one tablet will do you any harm, but you may feel sick, vomit or have some vaginal bleeding. Talk to your doctor if you have any of these symptoms.
If you want to delay a period
If you want to delay having a period, finish the strip of active tablets you are taking. Take an active tablet from the next strip the next day without a break or taking any placebo tablets. Tablet taking should then continue as usual.
When you use the second strip, you may have some unexpected bleeding or spotting on the days that you take the medicine, but do not worry. Take the next strip after the usual 7 day break or placebo taking period even if you are still bleeding or spotting.
If you want to get pregnant
If you are planning a baby, it is best to use another method of contraception after stopping Alegria until you have had a proper period. Your doctor relies on the date of your last natural period to tell you when your baby is due. However, it will not cause you or the baby any harm if you get pregnant straight away.
If you stop taking Alegria
You may get irregular, little or no bleeding. This usually happens in the first 3 months and especially if your periods were not regular before you started using Alegria.
Use in children and adolescent
Alegria should not be used by girls in puberty that have not had their first period yet.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them. Tell your doctor, pharmacist or nurse if you are worried about any side effects which you think may be due to Alegria. This includes any side effects not listed in this leaflet.
Common (may affect up to 1 in 10 people):
• mood swings, depression
• headache
• nausea, abdominal pain
• breast pain or tenderness
• weight increase
Uncommon (may affect up to 1in 100 people)
• decreased interest in sex
• skin rash
• migraine
• vomiting, diarrhoea
• itching or raised bumps on the skin
• swollen breasts
• fluid retention
Rare (may affect up to 1 in 1,000 people)
• contact lens intolerance
• allergic reactions
• increased interest in sex
• breast or vaginal discharge
• red skin lesions or nodules
• skin redness or blotchiness
• weight decrease
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme; Website: www.mhra.gov.uk/vellowcard
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Alegria
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton “EXP”. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask you pharmacist how to throw away medicines you no longer use. The measures will help protect the environment.
6. Contents of the pack and other information What Alegria contains
Active film-coated tablets:
- The active substances are: levonorgestrel and ethinylestradiol
- Each film coated tablet contains 100 microgram levonorgestrel and 20 microgram ethinylestradiol.
- The other ingredients are:
- Tablet core: Lactose monohydrate, Polacrilin potassium, Microcrystalline cellulose, Magnesium stearate.
- Tablet coating: Opadry II Pink, consisting of: Macrogol 3350, Titanium dioxide (E171), Polyvinyl alcohol, Talc (E553b), Iron oxide red (E172), Iron oxide yellow (E172).
Placebo film-coated tablets:
- Tablet core: Lactose monohydrate, Polacrilin potassium, Microcrystalline cellulose, Magnesium stearate.
- Tablet coating: Opadry II White, consisting of: Macrogol 3350, Titanium dioxide (E171), Polyvinyl alcohol, Talc (E553b).
What Alegria looks like and the contents of the pack
Active tablets:
Pink, cylindrical, biconvex, film coated tablet of 6 mm approximately.
Placebo tablets:
White, cylindrical, biconvex, film coated tablet of 6 mm approximately.
Alegria is packed in PVC/PVDC/Aluminium blister packs of 28 tablets consisting of 21 active and 7 placebo tablets per blister.
Alegria is available in the following pack sizes: 28 and 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Cyndea Pharma, S.L.
Poligono Industrial Emiliano Revilla Sanz Av. de Agreda 31, 42110 Olvega (Soria),
Spain
This medicines product is authorised in the Member States of the EEA under the following names:
Italy: Poehme
Germany: Carisa 100 / 20 microgram Filmtabletten
Spain: Carisa 100 / 20 microgram Comprimidos recubiertos con pelicula EFG
United Kingdom: Alegria 100 / 20 microgram film - coated tablets