Alenini 150/20micrograms Film-coated Tablets

Desogestrel/Ethinylestradiol

2. What you need to know before you take Alenini

Do not take Alenini

You should not use Alenini 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.

•    if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs;

•    if you know you have a disorder affecting your blood clotting - for instance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;

•    if you need an operation or if you are off your feet for a long time (see section 'Blood clots');

•    if you have ever had a heart attack or a stroke;

•    if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA -temporary stroke symptoms);

•    if you have any of the following diseases that may increase your risk of a clot in the arteries:

•    severe diabetes with blood vessel damage

•    very high blood pressure

•    a very high level of fat in the blood (cholesterol or triglycerides)

•    a condition known as hyperhomocysteinaemia

•    if you have (or have ever had) a type of migraine called 'migraine with aura';

•    if you have (or have ever had) an inflammation of the pancreas (pancreatitis)

•    if you have (or have ever had) a liver disease and your liver function is still not normal.

•    if you have (of have ever had) a tumour in the liver.

•    if you have (or have ever had) or if you are suspected to having breast cancer or cancer of the genital organs.

•    if you have any unexplained bleeding from the vagina.

•    if you are allergic to ethinylestradiol, desogestrel or any of the other ingredients of this medicine (listed in section 6). This can be recognised by itching, rash or swelling

•    if you are allergic to peanut or soya.

If any of these circumstances appear for the first time while you are taking the pill, stop taking it and consult your doctor immediately. Meanwhile, use non-hormonal contraceptives.

When to take special care with Alenini

When should you contact your doctor?

Seek urgent medical attention

•    if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see 'Blood clot' (thrombosis) section below.

For a description of the symptoms of these serious side effects please go to "How to recognise a blood clot".

In some situations you need to take special care while using Alenini or any other combination pill, and your doctor may need to examine you regularly. If any of the following conditions applies to you, inform your doctor before start to take Alenini. Also if any of the following applies or if any of the conditions develops or gets worse while you are using Alenini, you should also tell your doctor:

•    if a close relative has or has ever had breast cancer

•    if you have a disease of the liver or the gallbladder

•    if you have diabetes

•    if you have depression

•    if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);

•    if you have systemic lupus erythematosus (SLE -; a disease affecting your natural defence system);

•    if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys);

•    if you have sickle cell anaemia (an inherited disease of the red blood cells);

•    if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);

•    if you need an operation, or you are off your feet for a long time (see in section 2 'Blood clots').

•    if you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking Alenini.

•    if you have an inflammation in the veins under the skin (superficial thrombophlebitis).

•    if you have varicose veins.

•    if you have epilepsy (see "Other medicines and Alenini")

•    if you have a disease that first appeared during pregnancy or earlier use of sex hormones (for example, hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy (gestational herpes), a nerve disease causing sudden movements of the body (Sydenham's Chorea)

•    if you have or have ever had chloasma (a discoloration of the skin especially of the face or neck known as "pregnancy patches". If so, avoid direct sunlight or ultraviolet light.

•    if you have hereditary angioedema, products containing estrogens may cause or worsen symptoms. You should see your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives together with difficulty breathing.

Talk to your doctor or pharmacist before taking Alenini.

The pill and venous arterial blood clots (thrombosis)

BLOOD CLOTS

Using a combined hormonal contraceptive such as Alenini 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

•    in veins (referred to as a 'venous thrombosis, 'venous thromboembolism' or VTE)

•    in the arteries (referred to as an 'arterial thrombosis, 'arterial thromboembolism' or ATE).

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 Alenini is small.

HOW TO RECOGNISE A BLOOD CLOT

What can happen if a blood clot forms in a vein?

•    The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous thrombosis). However, these side effects are rare. Most frequently, they occur in the first year of use of a combined hormonal contraceptive.

•    If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT).

•    If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism.

•    Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).

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 Alenini 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 Alenini is small.

•    Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.

•    Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a blood clot in a year.

•    Out of 10,000 women who are using a combined hormonal contraceptive that contains desogestrel, such as Alenini, between about 9 and 12 women will develop a blood clot in a year.

•    The risk of having a blood clot will vary according to your personal medical history (see "Factors that increase your risk of a blood clot" below)

	Risk of developing a blood clot in a year
Women who are not using a combined hormonal pill/patch/ ring and are not pregnant	About 2 out of 10,000 women
Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 out of 10,000 women
Women using Alenini	About 9-12 out of 10,000 women

Factors that increase your risk of a blood clot in a vein

The risk of a blood clot with Alenini is small but some conditions will increase the risk. Your risk is higher:

•    if you are very overweight (body mass index or BMI over 30kg/m²);

•    if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50). In this case you could have a hereditary blood clotting disorder;

•    if you need to have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a cast. The use of Alenini may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop Alenini ask your doctor when you can start using it again.

•    as you get older (particularly above about 35 years);

•    if you gave birth less than a few weeks ago

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 Alenini needs to be stopped.

If any of the above conditions change while you are using Alenini, 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 Alenini is very small but can increase:

•    with increasing age (beyond about 35 years);

•    if you smoke. When using a combined hormonal contraceptive like Alenini you are advised to stop smoking. If you are unable to stop smoking and are older than 35 your doctor may advise you to use a different type of contraceptive;

•    if you are overweight;

•    if you have high blood pressure;

•    if a member of your immediate family has had a heart attack or stroke at a young age (less then about 50). In this case you could also have a higher risk of having a heart attack or stroke;

•    if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides);

•    if you get migraines, especially migraines with aura;

•    if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation)

•    if you have diabetes.

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 Alenini, 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.

The pill and cancer

Breast cancer has been observed slightly more often in women using combination pills, but it is not known whether this is caused by the treatment. For example it may be that more tumours are detected in women on combination pills because they are examined by their doctor more often. The occurrence 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 pill users. Contact your doctor if you have unusual severe abdominal pain.

Bleeding between periods

During the first few months that you are taking Alenini, you may have unexpected bleeding (bleeding outside the gap week). If this bleeding occurs for more than a few months, or if it begins after some months, your doctor find out what is wrong.

What to do if no bleeding occurs during the gap week

If you have taken all the tablets correctly, have not had 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 succession, you may be pregnant. Contact your doctor immediately. Do not start the next strip until you are sure that you are not pregnant.

Children and adolescents

No clinical data on efficacy and safety are available in adolescents below 18 years. Other medicines and Alenini

Always tell your doctor which medicines or herbal products you are already using, have recently used or might use. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you use Alenini. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long.

•    Some medicines can make Alenini less effective in preventing pregnancy, or can cause unexpected bleeding.

These include:

•    medicines used for the treatment of

•    epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)

•    tuberculosis (e.g. rifampicin)

•    HIV infections (ritonavir, nevirapin) or other infections (antibiotics such as g riseofulvin, penicillin, tetracycline)

•    the herbal remedy St., John's wort.

•    Alenini may influence the effect of other medicines, e.g.

•    medicines containing cyclosporin

•    the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures).

Ask your doctor or pharmacist for advice before taking any medicine.

Alenini with food and drink

Alenini may be taken with or without food, if necessary with a small amount of water.

Laboratory tests

If you need a blood test, tell your doctor or the laboratory staff that you are taking the pill, because hormone contraceptives can affect the results of some tests.

Pregnancy and breast-feeding Pregnancy

If you are pregnant, do not take Alenini. If you become pregnant while taking Alenini stop immediately and contact your doctor. If you want to become pregnant, you can stop taking the pill at any time (see also "If you want to stop taking Alenini"). Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

Use of Alenini is generally not advisable when a woman is 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.

Driving and using machines

There is no information suggesting that use of Alenini affects driving or use of machines.

Alenini contains lactose and soybean oil

If you have been told by your doctor that can not tolerate certain sugars, contact your doctor before taking this product.

If you are allergic to peanut or soya, do not use this medicinal product.

You might ask your doctor for advice before deciding to delay your menstrual period.

Change of the first day of your menstrual period: what you must know

If you take the tablets according to the instructions, then your period will begin during the tablet-free week. If you have to change this day, you do this by making the tablet-free period shorter (but never longer!). For example, if your tablet-free period begins on a Friday, and you want to change this to a Tuesday (3 days earlier) you must start a new strip 3 days earlier than usual. If you make the tablet-free period very short (for example, 3 days or less) then it may be that you do not have any bleeding during this tablet-free period. You may light or menstruation-like bleeding.

If you are not sure what to do, consult your doctor.

If you want to stop taking Alenini

You can stop taking Alenini whenever you want. 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 Alenini and wait for a period before trying 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Take one tablet of Alenini 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 every day around the same time.

The strip contains 21 tablets. Next to each tablet is printed the day of the week that it should be taken. Start by taking a tablet from the first row marked with the correct day of the week. If, for example you start on a Wednesday, take a tablet with "WED" next to it. Follow the direction of the arrow on the strip until all 21 tablets have been taken.

Then take no tablets for 7 days. In the course of these 7 tablet-free days (otherwise called a stop or gap week) bleeding should begin. This so-called "withdrawal bleeding', usually starts on the 2nd or 3rd day of the gap week.

On the 8th day after the last Alenini tablet (that is, after the 7-day gap week), you should start with the following strip, whether your bleeding has stopped or not. This means that you should start every strip on the same day of the week and that the withdrawal bleed should occur on the same days each month.

If you use Alenini in this manner, you are also protected against pregnancy during the 7 days when you are not taking a tablet.

When can you start with the first strip?

•If you have not used a contraceptive with hormones in the previous month

Begin Alenini on the first day of the cycle (that is the first day of your period). If you start Alenini on the first day of your period you are immediately protected against pregnancy. You may also start on days 2-5 of your cycle, but in that case make sure you also use an additional contraceptive method (barrier method) for the first 7 days of tablet-taking in the first cycle.

•Changing from another combination hormonal contraceptive, or combination contraceptive vaginal ring or patch

You can start Alenini preferably on the day after taking the last active tablet (the last tablet containing active substances) of your previous pill, but at the latest on the day after the tablet-free days of your previous pill (or after the last inactive tablet of your previous pill). When changing from a combination contraceptive vaginal ring or patch, follow the advice of your doctor.

•Changing from a progestogens-only-method (progestogen-only-pill, injection, implant or a progestogen-releasing IUD)

You may switch any day from the progestogen-only pill (from an implant or an IUD 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 a miscarriage

Follow the advice of your doctor.

•After having a baby

You can start Alenini between 21 and 28 days after having a baby. If you start later than day 28, use a so-called barrier method (for example, a condom) during the first seven days of Alenini use. If after having a baby, you have had sex before starting Alenini (again), be sure that you are not pregnant or wait until your next period.

•If you are breastfeeding and want to start Alenini (again) after having a baby.

Read the section "Breast-feeding".

Ask your doctor what to do if you are not sure when to start.

If you take more Alenini than you should

There are no reports of serious harmful results of taking to many Alenini tablets.

If you take several tablets at once then you may have symptoms of nausea or vomiting. Young girls may have bleeding from the vagina. If you have taken too many Alenini tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

What to do if you forget to take Alenini

•    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 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 or the end of the strip. Therefore, you should adhere to the following rules (see also 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 this means that you have to take two tablets at the same time. Continue taking the tablets at the usual 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 or you have forgotten to start a new strip after the tablet-free period, 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 the tablet-free period go straight on to the next strip.

Most likely, you will have a period at the end of the second strip buy you may also have light or menstruation -like bleeding during the second strip.

2. You can also stop the strip and go directly to the tablet-free period of 7 days (record the day on which you forgot your tablet). If you want to start a new strip on your fixed start day, make the tablet-free period less than 7 days.

If you follow one of these two recommendations, you will remain protected against pregnancy.

Like all medicines, Alenini 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 Alenini 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 use Alenini'.

Serious reactions

More serious reactions associated with combined hormonal contraceptive pills are detailed above in section 2 under "The pill and venous and arterial blood clots (thrombosis)" and "The pill and cancer'. Please read these subsections carefully, and if you have any questions, ask your doctor.

The following side effects have been reported in women using the pill: Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases), systemic lupus erythematosus (SLE, a disease of the connective tissue), epilepsy, the rash known as herpes gestationis, chorea (a movement disease), a blood disorder called haemolytic uraemic syndrome - HUS (a disorder where blood clots cause the kidneys to fail), brown patches on the face and body (chloasma), movement disorder called Sydenham's chorea, yellowing of the skin, gynaecological disorders (endometriosis, uterine myoma).

Other possible side effects

The following side effects have been reported in women using the pill, which can occur in the first few months after starting Alenini, but they usually stop once your body has adjusted to the pill. The most commonly reported side effects (more than 1 in every 10 users may be affected) are irregular bleeding and weight gain.

Common or uncommon (between 1 and 100 in every 1,000 users may be affected): none or reduced bleeding, tender breasts, breast enlargement, breast pain, decreased sexual desire, depression, headache, nervousness, migraine, dizziness, nausea, vomiting, acne, rash, nettle-rash (urticaria), fluid retention, high blood pressure.

Rare (between 1 and 10 in every 10,000 users may be affected): vaginal candidiasis (fungal infection), impaired hearing (otosclerosis), thromboembolism, hypersensitivity, increased sexual desire, eye irritation due to contact lens, loss of hair (alopecia), itching, skin disorders (erythema nodosum - a skin disease associated with joint pain, fever, hypersensitivity, or infection, and characterised by small, painful, pink to blue nodules under the skin and on the shins that tend to recur, erythema multiforme - a skin disease characterized by solid raised spots on the skin on fluid-filled blisters lesions and reddening or discoloration of the skin often in concentric zones about the lesions, vaginal discharge, breast discharge, harmful blood clots in a vein or artery, for example: in a leg or foot (i.e. DVT), in a lung (i.e. PE), heart attack, stroke, mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA), blood clots in the liver, stomach/ intestine, kidneys or eye.

The chance of having a blood clot may be higher if you have any other conditions that increase this risk (See section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot)

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 via the Yellow Card Scheme, Website:www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Alenini

Keep this medicine out of the sight and reach of children.

Do not store this medicine above 30°C. Store in the original package in order to protect from light.

Expiry Date

Do not use this medicine after the expiry date which is stated on the package, after 'EXP. The expiry date refers to the last day of that month.

Do not use Alenini if you notice a change of colour, broken tablets or any other visible signs of deterioration.

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 Alenini contains

•    The active substances are desogestrel and ethinylestradiol. Each white tablet contains 150 micrograms desogestrel and 20 micrograms ethinylestradiol.

•    The other ingredients are: lactose monohydrate, maize starch, povidone K-30 (1201), rrr-alpha-tocopherol (E307), soybean oil, silica colloidal hydrated (E551), silica colloidal anhydrous (E551), stearic acid (E570), hypromellose 2910 (E464), macrogol 400, titanium dioxide (E171).

What Alenini looks like and contents of the pack

•    Each film-coated tablet is white and rounded. Each tablet is coded on one side "C" and on the reverse side "5'.

•    Alenini is available in blisters of 21 tablets.

Pack sizes are 3 strips, each strip with 21 tablets.

Marketing Authorisation Holder

Actavis Group PTC ehf. Reykjavikurvegi 76-78 220 HafnarfjorSur Iceland

Manufacturer

Laboratorios Leon Farma, S.A.

C/ La Vallina s/n, Pol. Ind. Navatejera. 24008 - Navatejera, Leon.

Spain

• If you have forgotten any of the tablets in a strip, and you do not have bleeding in the first tablet-free period, you may be pregnant. Contact your doctor before you start the next strip.

If you would like a leaflet with larger text, please contact 01271 385257.

What to do in case of vomiting or severe diarrhoea

If you vomit within 3-4 hours of taking a tablet or you have severe diarrhoea, there is a risk that the active substances in the tablet are not fully absorbed into your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea, take another tablet from a reserve strip 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 Alenini'.

Delay of menstrual period: what you need to know

Even though is not recommended, you can delay your menstrual period by going straight to a new strip of Alenini instead of the tablet-free period, and finishing it. You may experience light or menstruation-like bleeding while using this second strip. After the usual tablet-free period of 7 days, start the next strip.

^actavis