PACKAGE LEAFLET: INFORMATION FOR THE USER

Cimizt 150/30 Tablets

Desogestrel 150 micrograms & Ethinylestradiol 30 micrograms

Read all of this leaflet carefully before you start taking this medicine because it

contains important information foryou.

• Keep this leaflet. You may need to read it again.

• If you have any furtherquestions.askyourdoctoror pharmacist.

• This medicine has been prescribed foryou 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 or pharmacist. This includes any possible side effects not listed in this leaflet.

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception if used correctly.

• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks.

•    Please be alert and see your doctor if you thinkyou may have symptoms of a blood clot (see section 2 “Blood Clots”).

What is in this leaflet

1.    What Cimizt Tablets are and what they are used for

2.    What you need to know before you take Cimizt Tablets

3.    Howto take Cimizt Tablets

4.    Possible side effects

5.    HowtostoreCimiztTablets

6.    Contents of the pack and other information

1. WHAT CIMIZT TABLETS ARE AND WHAT THEY ARE USED FOR

Cimizt tablet is a combined oral contraceptive, also called the pill. Each tablet contains a small amount of two types of female hormones, namely, a progestogen, desogestrel and an oestrogen, ethinylestradiol.

These help to stop you from getting pregnant, just as your natural hormones would stop you conceiving again when you are already pregnant.

The combined contraceptive pill protects you against getting pregnant in three ways. These hormones:

1.    stop the ovary from releasing an egg each month (ovulation),

2.    thicken the fluid at the neck of the womb making it more difficult for the sperm to reach the egg,

3.    alterthe lining of the womb to make it less likely to accept afertilised egg.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CIMIZT TABLETS

Do not take tablets

You should not use Cimizt Tablets 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) orotherorgans;

•    if you know you have a disorder affecting your blood clotting - for instance, protein C deficiency, protein S deficiency, antithrombin-lll 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 liverfunction is still not normal;

•    if you have (or 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 or desogestrel, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

In some situations you need to take special care while using Cimizt Tablets or any other combination pill, and your doctor may need to examine you regularly.

Tell your doctor if any of the following conditions apply to you.

If any of the following conditions applies to you, tell your doctor before starting to use Cimizt Tablets. Also if any of the following applies or if any of the conditions develops or worsens while you are using Cimizt Tablets consult your doctor:

•    ifacloserelativehasorhaseverhad breastcancer;

•    ifyou haveadiseaseoftheliverorthegallbladder;

•    ifyou have diabetes;

•    ifyou have depression;

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

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

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

•    ifyou have epilepsy (see “Other medicines and Cimizt Tablets”);

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

•    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);

•    ifyou need an operation, or you are off your feet for a long time (see in section 2 'Blood Clots');

•    ifyou have just given birth. In this case you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking Cimizt;

•    ifyou have an inflammation in the veins underthe skin (superficial thrombophlebitis);

•    ifyou have varicose veins;

•    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);

•    ifyou 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. In this case products containing oestrogens may cause or worsen symptoms. You should see your doctor immediately ifyou experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives together with difficulty in breathing.

Blood Clots

Using a combined hormonal contraceptive such as Cimizt 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 Cimizt is small.

How to recognise a blood clot

Seek urgent medical attention ifyou notice any of the following signs or symptoms.

Blood clots in a vein

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 Cimizt 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 riskofa blood clot in the leg or lung (DVT or PE) with Cimizt 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 Cimizt, about 9-12 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 riskofa 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 Cimizt	About 9-12 out of 10,000 women

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

The risk of a blood clot with Cimizt 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 years). 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 Cimizt may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop Cimizt askyour doctor when you can start using it again;

•    as you get older (particularly above the age of 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 Cimizt needs to be stopped.

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

• with increasing age (beyond the age of about 35 years);

•    if you smoke. When using a combined hormonal contraceptive like Cimizt 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 than about the age of 50 years); 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 ortriglycerides);

• 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 Cimizt, for example you start smoking, a close family member experiences a thrombosis for no known reason, or you gain a lot of weight, tell yourdoctor.

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 yourdoctor 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 unusually severe abdominal pain.

Bleeding between periods

During the first few months that you are taking Cimizt Tablets, 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, yourdoctor must find out what is wrong.

What you must do if no bleeding occurs in 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.

Other medicines and Cimizt Tablets_

Always tell the doctor which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you use Cimizt Tablets. 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 Cimizt Tablets less effective in preventing pregnancy, or can cause unexpected bleeding. These include:

•    Medicines used forthe treatment of:

■    epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbamazepine);

■    tuberculosis (e.g. rifampicin);

■    HIV infections (ritonavir, nevirapine) or other infections (antibiotics such as griseofulvin, penicillin, tetracycline);

•    The herbal remedy St. John's wort;

Cimizt Tablets 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.

Cimizt Tablets with food and drink

Cimizt Tablets may be taken with orwithoutfood, 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

If you are pregnant, do not take Cimizt Tablets. If you become pregnant while taking Cimizt Tablets stop immediately and contact your doctor. If you want to become pregnant, you can stop taking the pill at any time.

Askyour doctor or pharmacist for advice before taking any medicine.

Breast-feeding

Use of Cimizt Tablets is generally not advisable when a woman is breast-feeding. If you want to take the pill while you are breastfeeding you should contact your doctor.

Askyour doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

Cimizt Tablets contain lactose

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before you take this product.

3. HOW TO TAKE CIMIZT TABLETS

Take one tablet of Cimizt Tablets 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. 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 is so-called “withdrawal bleeding” usually starts on the 2^nd or 3"¹ day of the gap week.

On the 8*¹ day after the last tablet of Cimizt (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 occuron the same days each month.

If you use Cimizt Tablets 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 with Cimizt on the first day of the cycle (that is the first day of your period). If you start Cimizt on the first day of your period you are immediately protected against pregnancy. You may also begin on day 2-5 of the cycle, but then you must use extra protective measures (forexample, acondom)forthefirst7 days.

The following serious 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 Cimizt Tablets, 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 10in every 10,000 users maybe 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 characterized 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 or 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:

•    inalegorfoot(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).

Before you have any blood tests

Tell your doctor or the laboratory staff that you are taking the pill, because oral contraceptives can affect the results of some tests.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. HOWTO STORE CIMIZT TABLETS

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

Do not store above 25°C. Store in the original package in order to protect from moisture and 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 dayofthatmonth.

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 PACKAND OTHER INFORMATION

What Cimizt Tablets contain

The active substances are desogestrel and ethinylestradiol.

The other ingredients are:

All-rac-alpha-tocopherol, potato starch, povidone (E1201), stearic acid (E570), silica colloidal anhydrous (E551) and lactose anhydrous.

What Cimizt tablets look like and contents of the pack

Each tablet is round, white to off-white, uncoated, biconvex, debossed with '142' on one side and otherside plain.

Each strip of Cimizt Tablets contains 21 white tablets.

Each box of Cimizt Tablets contains 1,3 or 6 strips of 21 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Morningside Healthcare Ltd,

115 Narborough Road, Leicester, LE3 OPA, United Kingdom.

Manufacturer

Morningside Pharmaceuticals Ltd,

5 Pavilion Way, Castle Business Park, Loughborough, Leicestershire,

LE115GW, United Kingdom.

This leaflet is available in large font or audio format upon request.

This leaflet was last revised in March 2014.