ETHINYLESTRADIOL/DIENOGEST EXELTIS 0.03 MG / 2.0 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Package leaflet: Information for the user

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

• t he 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 think you may have symptoms of a blood clot (see section 2 “Blood clots”)

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 or pharmacist.

• – 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets is and what it is used for

• 2. What you need to know before you take Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets

• 3. How to take Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets

• 4. Possible side effects

• 5. How to store Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets

• 6. Contents of the pack and other information

1. what ethinylestradiol/dienogest exeltis 0.03 mg/2.0 mg film-coated tablets is and what it is used for

Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets contains the hormones ethinylestradiol and dieogenest. It belongs to a group called combined contraceptives (CHCs).

• Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets is a used:

o to prevent pregnancy (contraceptive pill).

LF.DIEEE.21.UK­.EXELTIS.-D47

o for treatment of women with moderate acne who agree to receive a contraceptive pill after failure of suitable local or oral antibiotic treatments.

• Each of the 21 tablets contains a small amount of ethinylestradiol. and dienogest
• „The Pills“ that contain two hormones are known as „combined oral contraceptives“

or „COCs“.

• In women in whom a pronounced effect of male hormones (so-called “androgens”) causes acne, clinical tests have proven that Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets relieves this condition.

2. what you need to know before you take ethinylestradiol/dienogest exeltis 0.03 mg/2.0 mg film-coated tablets

General notes

Before you start using Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets 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 begin taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets , your doctor can ask you some questions about your personal health history and that of your close relatives. The doctor can also measure your blood pressure and, depending upon your personal situation, also carry out some other tests.

In this leaflet, several situations are described where you should stop using Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets , or where the reliability of Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets 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 Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets alters the monthly changes of body temperature and cervical mucus.

Like all hormonal contraceptives, Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Your acne will usually improve between three and six months of treatment, and could continue to improve even after six months. You should discuss with your doctor the need to continue your treatment three to six months after the start and regularly thereafter.

When you should not use Ethinylestradiol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets :

You should not use Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated 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.

Do not take Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets

• 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:

-

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

-

• if you have (or have ever had) a type of migraine called ‘migraine with aura’;
• If you have (or have ever had) inflammation in the pancreas (pancreatitis) if together with a very high blood fat (lipid) levels (hypertriglyce­ridaemia).
• If you have or (have ever had) sever liver diseases, unless blood liver values function tests have returned to normal;
• If you have or (have ever had) benign or malign liver tumours.
• If you have, (have ever had) or if you are suspected of having malignant disease of the genital organs or breast cancer affected by sexual hormones. (e.g. cancer of the breast or womb lining)
• If you have any vaginal bleeding of unknown causes.
• If you are allergic to ethinylestradiol, dienogest or another ingredient of this medicine (listed in section 6).

If you have Hepatitis C and are taking the medicinal products containing ombitasvir/pa­ritaprevir/ri­tonavir and dasabuvir or glecaprevir / pibrentasvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme).

Your doctor will prescribe another type of contraceptive prior to start of the treatment with these medicinal products.

Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets can be restarted

approximately 2 weeks after completion of this treatment. See section “Do not take Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets ”.

If any of the above situations occur while taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets , you must stop taking the product immediately and consult your doctor. In the meantime, you should use a different, non-hormonal method of contraception. For further information, see also section “Warnings and precautions”.

Warnings and precautions

When you need to take special care with Ethinylestradiol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets

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’ section below).

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, special care is needed when taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets or any other combination pill and your doctor may need to examine you regularly.

If the condition develops, or gets worse while you are using Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets , you should also tell your doctor.

• 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 Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets ;
• if you have an inflammation in the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins.
• if you have a heart valve defect or cardiac arrhythmia
• if a close relative has or has ever had breast cancer
• if you have liver or gallbladder disease, gallstones;
• if you have jaundice or itching due to bile congestion;
• if you have patchy, yellow-brownish discoloration of the skin, especially on the face

(chloasma), or if you experienced this during an earlier pregnancy; in this case, strong sunlight and UV radiation must be avoided;

• if you have certain problems in haemoglobin formation (porphyria);
• if you have depression;
• if you have epilepsy;
• if you have St. Vitus’ dance (Sydenham Chorea);

if you have blistery rash during an earlier pregnancy (herpes gestationis);

if you have inner ear hearing loss (otosclerosis-related hearing loss).

if you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives potentially with difficulty breathing contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema..

BLOOD CLOTS

Using a combined hormonal contraceptive such as Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets 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 Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets is small.

HOW TO RECOGNISE A BLOOD CLOT

Seek urgent medical attention if you 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 Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets 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 Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets 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 dienogest and ethinylestradiol such as Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets between about 8 and 11 women will develop a blood clot in a yearThe 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

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

The risk of a blood clot with Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets 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 Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets ask your doctor when you can start using it again.
• as you are getting 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 Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets needs to be stopped.

If any of the above conditions change while you are using Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets , 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

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It is important to note that the risk of a heart attack or stroke from using Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets is very small but can increase:

• if you are getting older (beyond about 35 years);
• if you smoke. When using a combined hormonal contraceptive like Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets 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 Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets , 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.

Ethinylestradiol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets 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 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. See your doctor immediately if you have severe upper 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 (e.g. frequent change of partners) and other factors such as papilloma virus (HPV) increases this risk.

When should you consult your doctor?

Regular check-ups:

If you take the Pill, your doctor will request you are tested regularly. Normally, you should consult your doctor at least once a year.

Furthermore, consult your doctor immediately LF.DIEEE.21.UK­.EXELTIS.-D47

• if you notice any changes in your health, especially those mentioned in section “Do not take

Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets ”. Do not forget about illnesses affecting your family;

• if you feel a lump in your breast;
• if you are also taking other medicines (see also section “Other medicines and

Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets ”);

• if you are confined to bed for a prolonged period or about to undergo surgery (ask your

doctor at least four weeks in advance);

• if you have any unusual, severe vaginal bleeding between periods;
• if you have forgotten to take the coated tablets in the first week of Pill-taking and you had

sexual intercourse in the 7 days before;

• if you have missed two periods in a row despite taking the coated tablets regularly and you

suspect you are pregnant.

Psychiatric disorders:

Some women using hormonal contraceptives including Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets 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.

If you have unexpected bleeding between periods:

During the first few months of taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets , you may have unexpected bleeding. Irregular vaginal bleeding stops once your body has adjusted to taking the Pill (usually after about 3 tablet-cycles). If you experience heavier vaginal bleeding similar to a normal monthly period or slight vaginal bleeding lasting over several days, you should consult your doctor.

If you do not have your normal monthly period:

If you have been taking your tablets correctly, have had no vomiting or severe diarrhoea and have not been taking any other medicines, the probability that you are pregnant will be extremely low. Keep taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets as usual.

If you miss two periods in a row, or if you have not been taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets as directed before the missing period, there is a possibility of pregnancy. Consult your doctor immediately. Do not take Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets until your doctor has ruled out pregnancy.

Children and adolescents

Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets may only be used after the first menstrual period (menarche).

Other medicines and Ethinylestradiol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets

Tell your doctor or pharmacist if you are taking any other medicines, or have been taking recently, or plan to take, including medicines that you get without a prescription.

Some medicines can cause breakthrough bleedings and/or make Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets less effective in preventing pregnancy.

• Effect of other medicines on Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-

______

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) that you take Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long, or whether the use of another medicine you need must be changed.

Some medicines

• can have an influence on the blood levels of Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0

mg Film-coated tablets

• can make it less effective in preventing pregnancy
• can cause unexpected bleeding.

These include:

• medicines used for the treatment of:

o epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate)

o tuberculosis (e.g. rifampicin)

o HIV and Hepatitis C Virus infections (so-called protease inhibitors and nonnucleoside reverse transcriptase inhibitors)

o fungal infections (e.g. griseofulvin, ketokonazole)

o arthritis, arthrosis (etoricoxib)

• the herbal remedy St. John's wort

If you are being treated with any of the medicines listed above, you should also use a barrier method (e.g. a condom) temporarily or choose another method of contraception. Use additional local contraceptives while you are taking other medication together with Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets and also for 28 days after discontinuation of treatment with other medication.

If your treatment runs beyond the blister strip of Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets , start on the next Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets blister strip straight away, without take the rest period without tablets.

If prolonged treatment is required with any of the medicines listed above, you should choose another reliable non-hormonal method of contraception.

Interactions with Laboratory tests

The use of Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets can affect the results of certain laboratory tests, including values of liver, adrenal cortex, kidney and thyroid function, as well as the amount of certain proteins in the blood, e.g. proteins that affect fat digestion, carbohydrate metabolism or blood clotting and fibrinolysis. However, these changes generally remain within the normal range. Tell your doctor or the laboratory staff that you are taking the pill.

Ethinylestradiol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets with food and drink

Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets may be taken with or without food, if necessary with a small amount of water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.

Pregnancy

If you are pregnant, do not take Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets. If you become pregnant while taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets , stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets at any time (see also “If you stop taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets ”).

Breast-feeding

In general you should not take Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets while you are breast-feeding, as milk production may be reduced and small amounts of the active substance can pass into human milk.

Ask your doctor or pharmacist for advice before taking any medicine when you are pregnant or breastfeeding.

Driving and using machines

Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets has no effect on the ability to drive and use machines.

Ethinylestradiol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets contains lactose

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

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3. how to take ethinylestradiol/dienogest exeltis 0.03 mg/2.0 mg film-coated tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take one tablet of Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets every day, if necessary with a small amount of water and swallow it whole. You may take the tablets with or without food, but you should take the tablets at around the same time every day.

One blister strip contains 21 coated tablets.

Take one tablet marked with that day of the week. If, for example, you start on Friday, take a tablet with Fr (for Friday) next to it, by pressing it through the aluminium foil. Take one tablet every day, according to the sequence.

The time of day does not matter, but you should stick to this time once selected

Follow the direction of the arrows until you have finished the pack (that is, 21 consecutive days). The first tablet you should take is the one that corresponds to the day of the week in which you start taking the ‘pill’, as written on the blister pack (for example “Mo” for Monday).

After you have finished the pack, you need to allow a medicine-free interval for 7 days. During this tablet-free interval, bleeding should begin (so-called withdrawal bleeding). This usually starts on 2 to 4 days after you take last tablet.

Start a new blister pack on the 8th day, whether your bleeding has stopped or not. This means that you should start every blister pack on the same day of the week, and that the withdrawal bleed should occur on the same day every month.

If you use Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets in this manner, you will be protected against pregnancy during the tablet-free interval.

When do you start with the first blister?

• If you have not used any hormonal contraceptive during the previous month:

Start taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets on the first day of your cycle eg: on the first day of your monthly period.

• Switching from another combined hormonal contraceptive pill:

You should preferably start taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets on the day after taking the last active tablet of the previous pill, but by no later than on the day following the usual tablet-free interval or after taking the inactive tablets of the previous pill.

• If you are switching from a vaginal ring or a transdermal patch to Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets :

You should preferably start taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets on the day of removal of the last ring or patch of a cycle pack, but by no later than when the next application would be due.

• If you are switching from a progestogen-only product (mini-pill, implant, injection) or from a progestogen-releasing intrauterine system (IUS, hormonal coil) to Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets :

You may switch from the progestogen-only pill any day (from an implant or the 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 during the first 7 days of Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets use.

om).

• If you wish to use Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets

after a miscarriage in the first term (trimester) of pregnancy

Please talk to your doctor. In principle, you can start takingEthinyles­tradiol/Dieno­gest Exeltis 0.03 mg/2.0 mg Film-coated tablets immediately.

• If you wish to use Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets

after a miscarriage in the second term (trimester) of pregnancy or after childbirth:

If you wish to start taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets , your doctor will recommend you to start taking it between days 21 to 28 after a birth or second-trimester miscarriage. If taken at a later date, you must also use a barrier method (e.g. a condom) during the first 7 days of taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets.

However, if you already have had sexual intercourse, you must make sure that you are not pregnant before you start taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets , or else you must wait for your next monthly period.

• If you wish to breast-feed after the birth of a child and start taking

Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets :

Please read the section “Breast-feeding”.

If you take more Ethinylestradiol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets than you should:

There are no reports of serious harmful effects after taking too many Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets tablets.

If you have taken several tablets at once, then you may have symptoms of nausea and vomiting or bleeding from the vagina. Even girls who have not yet started to menstruate but have accidentally taken this medicine may experience such bleeding.

If you have taken too many Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets tablets, or you discover that a child has taken some ask your doctor or pharmacist for advice.

If you forget to take Ethinylestradiol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets

If you miss a white active tablet (tablets in the 1st, 2nd or 3rd rows), you must do the following:

• – 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 times.

• – 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 or at the end of the strip. Therefore, you should keep to the following rule

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 as usual time and use extra precaution for the next 7 days, for example condom. If you have had sex in the week before you 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 tablets at the usual times. The protection against pregnancy is not reduced, provided that the tablets have been taken correctly in the 7 days before forgetting the tablet, You do not need to use any additional barrier contraceptives. However, if you have missed more than 1 tablet, you must use additional protective measures for 7 days.

One 1 tablet forgotten in week 3:

You can choose between the following options without having to use additional contraceptives, provided you have been taking the Pill correctly on the 7 days before forgetting the tablet:

• 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 times. Skip the tablet-free interval, start taking the tablets from the next blister pack. It is unlikely that you will have a period at the end of the second blister strip; but, you may experience spotting or breakthrough bleeding on tablet taking days of the second strip.

OR

• 2: You can also stop taking tablets from the current blister strip immediately, and start the tablet-free interval of no more than 7 days (including the day you forgot the tablet ); then continue with tablets from the next blister strip. If you want to start a new blister strip on day you always start, make the tablet-free interval shorter than 7 days.

If you have forgotten any tablets in a strip and you do not have a bleeding during the tablet-free interval you may be pregnant.

Contact doctor before you start a new strip

What to do if you vomit or have severe diarrhoea

If you experience severe gastrointestinal disorders (e.g., vomiting or diarrhoea), the active ingredients of the tablet may not have been completely absorbed. The contraceptive protection may be reduced, the same way as if you forget to take a tablet. Additional barrier contraceptives are necessary. If you vomit within 3–4 hours after taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets , take a new (spare) tablet as soon as possible. The new tablet should be taken preferably within the first 12 hours of the usual intake-time. If more than 12 hours pass by, follow the advice for missed tablet. If you want to maintain your normal tablet-taking schedule, you may take a spare tablet from a new blister strip and keep the latter as spare strip in case you lose any more tablets.

Shifting the days of your period: What you need to know

Although it is not recommended, you can delay your monthly period by going straight to a new strip, without free-tablet interval You can continue to take the tablets until you want your period to start, but only until the second blister strip is over. You may experience light bleeding while using this second strip. After the following free-tablet interval days, you can continue taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets as usual..

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

Changing the day of the week when your monthly period starts: What you need to know

If you take the tablets as directed, you will have your monthly period every 4 weeks on roughly the same day. If you wish to change this day, simply shorten (never lengthen) the placebo-tablet (green tablets) interval. If your monthly period usually starts on a Friday and you want it to be on a Tuesday in future (3 days earlier), take only 4 free-tablet days and start the first tablet from the new blister strip three days earlier than usual. If you make the placebo-tablet interval very short (for example, 3 days or less) you may not have any bleeding during these days. You may then experience light bleeding.

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

If you want to stop taking Ethinylestradiol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets

You can stop taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets 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 Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets and wait for your menstrual bleeding before starting to try to become pregnant. You will be able to calculate the expected delivery date more easily.

Additional Information on special patient groups

Use in children and adolescents

Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets may only be used after the first menstrual period (menarche).

Elderly patients

Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets may only be used in women before the menopause.

Patients with impaired liver function

Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets must not be used in women with severe liver disorders (see section 2 “Do not take Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets ”).

Patients with impaired kidney function

The use of Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets in women with impaired kidney function has not been studied. Available data do not suggest any change in treatment for this patient group.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can have 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 Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets , 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 Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets ”.

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 “Ethinylestra­diol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets and cancer”. Please read these sections carefully and consult your doctor at once where appropriate.

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swollen face, tongue and/or throat and/or difficulty swallowing or hives potentially with difficulty breathing (see also section “Warnings and precautions”).

Other possible side effects

The following side effects have been linked with the use of Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets :

Common side effects (between 1 to 10 users in 100 users may be affected):

• – Headache

LF.DIEEE.21.UK­.EXELTIS.-D47

• – Painful Breast, including breast discomfort and breast tenderness

Uncommon side effects (between 1 to 10 users in 1,000 users may be affected):

• – Inflammation of the vagina and/or external genitalia (vaginitis/vul­vovaginitis), vaginal yeast infections (candidiasis, other vulvovaginal infections)

• – Increase in appetite

• – Depressed mood

• – Migraine, sensation of whirling(vertigo)

• – High blood pressure, low blood pressure

• – Abdominal pain (including bloating),

• – Nausea, vomiting,diarrhoea,

• – Acne

• – Hair loss (alopecia),

• – Skin rash

• – Itching

• – Abnormal periods including heavy periods (menorrhagia), light period (hypomenorrhoea), infrequent period (oligomenorrhoea) and no period (amenorrhea),

• – Bleeding between periods consisting of vaginal hemorrhage and irregular bleeding between periods metrorrhagia

• – Painful bleeding (dysmenorrhea),

• – Genital/vaginal discharge, fluid-filled structures (cysts) in the ovaries, pain in the internal sex organs,

• – breast enlargement breast oedema,

• – Tiredness, weakness, feeling unwell

• – Weight increased

Rare side effects (between 1 to 10 users in 10,000 users may be affected):

• – Inflammation of the fallopian tubes urinary tract infection, bladder inflammation (cystitis), mammary gland inflammation (mastitis),

• – Inflammation of the cervix lining (cervicitis). Fungal infections (e.g. Candida), viral infections (e.g. cold sores), flu (influenza), bronchitis, inflamed sinuses (sinusitis), infections of the upper airways

–

• – Benign growths in the womb (fibroids), benign growths in fatty breast tissue (breast lipomas)

• – Decreased number of red blood cells (anaemia)

• – Allergic reactions

• – Masculinisation (virilism)

• – Loss of appetite (anorexia)

• – Depression, psychiatric disorders, sleeplessness, sleep disorders,aggres­sion

• – Stroke, blood circulation problems in the brain or heart; muscle disorders which, for example, may cause abnormal body posture (dystonia)

• – Dry or irritated eyes, eye problems, blurred vision

• – Sudden of hearing loss, ringing or other noise in the ears (tinnitus), dizziness, hearing impairment

• – Rapid heart rhythm

• – Inflammation of the veins high diastolic blood pressure, dizziness or fainting when standing up from sitting or lying down (orthostatic dysregulation), hot flushes

• – Varicose veins (varicosis) vein disorders, painful veins

• – 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)

• – Asthma, rapid or deep breathing (hyperventilation)

• – Inflammation of the stomach lining (gastritis), intestinal inflammation (enteritis), upset stomach (dyspepsia)

• – Allergic inflammation of the skin (dermatitis), skin rash (e.g. neurodermatitis), skin disease with thickened patches of red skin (psoriasis), heavy sweating (hyperhidrosis), changes or disorders in the colour of the skin (e.g. chloasma), overproduction of fat by the sebaceous glands (seborrhoea), dandruff, skin lesions, orangepeel skin (cellulite) , web-like collection of blood vessels with a central red spot on the skin (spider naevi)

• – Back pain, pain in the bones, joints and muscles (e.g. myalgia), pain in the arms and legs

• – Abnormal cell growth on the surface of the cervix (cervical dysplasia), pain or fluid-filled

structures in the fallopian tubes and ovaries, fluid-filled structures in the breast, pain/spasms during sexual intercourse (dyspareunia), breast milk-like secretion from the mammary glands (galactorrhoea), menstrual complaints

• – Chest pain, swelling of the hands, ankles or feet (peripheral oedema), flu-like symptoms, inflammation, fever, irritability

• – Elevated blood fat levels (raised triglyceride and cholesterol levels), weight loss, weight fluctuations

• – Swelling of congenital, extra mammary glands outside the breast area (accessory breasts)

Other side effects observed in users of Ethinylestradiol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets , but whose exact frequency is not known, are

– Changing moods, increased or decreased sex drive (libido), contact lens intolerance, hives; skin and/or mucous membrane reactions with rash, nodules, blistering or death of tissue (erythema nodosum or multiforme), breast discharge, build-up of fluid in the body (oedema).

Tumors

• – The incidence of breast cancer diagnosis is slightly increased with the use of “Ethinylestra­diol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets ”. As breast cancer rarely occurs in women under 40 years of age, the risk of developing breast cancer in relation to the overall risk is low. For further information, see section “Ethinylestra­diol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets and cancer”.

• – Liver tumors (benign and malignant)

• – Cervical cancer

Other conditions

• – Women with hypertriglyce­ridemia (increased blood fats resulting in an increased risk of pancreatitis when using combined oral contraceptives)

• – High blood pressure

• – Occurrence or worsening of conditions for which a link to combined oral contraceptives is not definite:

jaundice and/or itching related to cholestasis (blocked bile flow); gallstone formation; a metabolic condition called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); hemolytic uremic syndrome (a blood clotting disease); a neurological condition called Sydenham’s chorea; herpes gestationis (a type of skin condition that occurs during pregnancy); otosclerosis-related hearing loss

• – Disturbed liver function

• – Changes in glucose tolerance or effect on peripheral insulin resistance

• – Crohn’s disease, ulcerative colitis

• – Chloasma

Interactions

Unexpected bleeding and/or contraceptive failure may result from interactions of other drugs with oral contraceptives (e.g. the herbal remedy St. John’s wort, or drugs for epilepsy, tuberculosis, HIV infections and other infections). See section ‘Effect of other medicines on Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets ’.

Other serious reactions to taking Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets , as well as related symptoms, are described in the section “Warnings and precautions”.

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 national reporting system via Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store ethinylestradiol/dienogest exeltis 0.03 mg/2.0 mg film-coated tablets

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 box and blister strip, after “EXP”. The expiry date refers to the last day of that month.

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

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- the active substances are dienogest and ethinylestradiol. one coated tablet contains 2.0 mg of dienogest and 0.03 mg of ethinylestradiol.

• – The other ingredients are:

What Ethinylestradiol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets looks like and contents of the pack

Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets is a white, round, biconvex film-coated tablet.

Ethinylestradi­ol/Dienogest Exeltis 0.03 mg/2.0 mg Film-coated tablets is available in packages containing 21, 3×21 and 6×21 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Exeltis Healthcare, S.L.

Avda Miralcampo 7-Poii'gono Industrial Miralcampo

19200 Azuqueca de Henares – Guadalajara

Manufacturer:

Laboratorios Leon Farma SA

La Vallina s/n, Pol. Ind. Navatejera,

Navatejera-24008 Leon Spain

This leaflet was last revised in 02/2022

LF.DIEEE.21.UK­.EXELTIS.-D47