Package leaflet: Information for the user

2 mg / 0.03 mg film-coated tablets

(Chlormadinone acetate and Ethinylestradiol)

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

Read all of the 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. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See the section 4.

What is in this leaflet 1. What Chlormadinone acetate /Ethinylestradiol is and what it is used for 2. What you need to know before you use Chlormadinone acetate /Ethinylestradiol 3. How to take Chlormadinone acetate /Ethinylestradiol 4. Possible side effects 5. How to store Chlormadinone acetate /Ethinylestradiol 6. Contents of the pack and other information

1. WHAT CHLORMADINONE ACETATE /ETHINYLESTRADIOL IS AND WHAT IT IS USED FOR:

Chlormadinone acetate /Ethinylestradiol is a hormonal contraceptive. Hormonal contraceptives that contain two hormones, like Chlormadinone acetate /Ethinylestradiol, are also known as combined hormonal contraceptives (CHC). The 21 film-coated tablets in one calendar pack contain equal quantities of both hormones. Chlormadinone acetate /Ethinylestradiol is thus also referred to as a “single phase” preparation.

Hormonal contraceptives like Chlormadinone acetate /Ethinylestradiol do not protect against AIDS (HIV infection) or other sexually transmitted diseases. Only condoms are useful for this purpose.

1 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CHLORMADINONE ACETATE /ETHINYLESTRADIOL:

General notes Before you start using Chlormadinone acetate /Ethinylestradiol 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 take Chlormadinone acetate /Ethinylestradiol, your doctor will carry out a thorough general examination and a gynecological examination to rule out pregnancy and to assess whether Chlormadinone acetate /Ethinylestradiol is suitable for you, taking the contraindications and precautionary measures into account. This examination should be carried out annually whilst you are taking Chlormadinone acetate /Ethinylestradiol

Do not use Chlormadinone acetate /Ethinylestradiol

You should not use Chlormadinone acetate /Ethinylestradiol if you 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 are hypersensitive (allergic) to the active substances, ethinylestradiol or chlormadinone acetate, or to any of the other ingredients of this medicine (listed in section 6);  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 notice the early stages or first signs of a blood clot, inflammation of the veins or an embolism such as transient stinging, pain or a tight chest;  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 suffer from sugar diabetes (Diabetes mellitus) with severe uncontrollable changes in blood glucose levels;  If you suffer from high blood pressure which is difficult to control or high increases in blood pressure (values that regularly exceed 140/90 mmHg);  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),

2 – a condition known as hyperhomocysteinaemia;  If you have (or have ever had) a type of migraine called ‘migraine with aura’;  If you suffer from inflammation of the liver (e.g. virus-induced) or jaundice and your liver values have still not returned to normal;  If you are suffering from pruritus (itching) throughout your body or have an impaired bile flow, especially if this has occurred in conjunction with an earlier pregnancy or oestrogen treatment;  If you have high bilirubin (a decomposition product of haemoglobin) levels in your blood due to a congenital excretion disorder (Dubin-Johnson’s syndrome or Rotor syndrome);  If you have or have had a liver tumour;  If you experience severe pain in the upper abdomen or liver enlargement or notice signs of abdominal bleeding;  If you experience porphyria for the first time or recurring porphyria (metabolic disorder of haemoglobin);  If you are suffering from malignant, hormone-dependent tumours such as breast cancer or carcinoma of the uterus or a corresponding disease or if this type of disease is suspected;  If you suffer from serious metabolic disorders;  If you have or have had pancreatitis associated with a sharp rise in blood lipid values (triglycerides);  If headaches are unusually frequent, persistent or severe;  If sensory disorders (visual disturbances or hearing loss) develop;  If movement disorders (especially signs of paralysis) appear;  If you suffer from epileptic seizures and these suddenly become more frequent;  If you suffer from severe depression;  If you have a certain type of hearing disorder (otosclerosis), which became worse during pregnancy;  If your period stops for any unknown reason;  If you notice pathogenic proliferation of the uterine mucosa (endometrial hyperplasia)  If you notice vaginal bleeding of unknown origin.

If you develop any of these conditions whilst taking Chlormadinone acetate /Ethinylestradiol, please stop medication immediately.

You must not take Chlormadinone acetate /Ethinylestradiol or should stop taking the medication immediately if a serious risk factor or several risk factors for blood clots exist(s) or develop(s) (see section 2. “Take special care with Chlormadinone acetate /Ethinylestradiol”).

Do not use Chlormadinone acetate /Ethinylestradiol if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also in section Other medicines and Chlormadinone acetate /Ethinylestradiol).

3 Warnings and precautions: Talk to your doctor or pharmacist before using Chlormadinone acetate /Ethinylestradiol.

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 recognize a blood clot”.

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

- If you smoke. Smoking increases the risk of serious cardiovascular side effects during administration of combined hormonal contraceptives. This risk increases with age and cigarette consumption. This applies in particular to women over 35 years of age. Female smokers over 35 years of age should use other methods of contraception.

If the condition develops, or gets worse while you are using Chlormadinone acetate /Ethinylestradiol, you should also tell your doctor:

- If you have high blood pressure, abnormally high blood liver values, are overweight or if you suffer from diabetes (see also “Do not use Chlormadinone acetate /Ethinylestradiol” and “Other diseases” under “Take special care with Chlormadinone acetate /Ethinylestradiol”). In these cases, you are at greater risk of developing adverse side effects of combined hormonal contraceptives (e.g. heart attack, embolism, stroke or liver tumours). - 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 Chlormadinone acetate /Ethinylestradiol;

4 - If you have an inflammation in the veins under the skin (superficial thrombophlebitis); - If you have varicose veins.

BLOOD CLOTS Using a combined hormonal contraceptive such as Chlormadinone acetate /Ethinylestradiol 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 Chlormadinone acetate /Ethinylestradiol is small.

HOW TO RECOGNISE A BLOOD CLOT

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

Are you experiencing any of these signs? What are you possibly suffering from? • swelling of one leg or along a vein in the leg or foot Deep vein thrombosis especially when accompanied by: • pain or tenderness in the leg which may be felt only when standing or walking • increased warmth in the affected leg • change in colour of the skin on the leg e.g. turning pale, red or blue • sudden unexplained breathlessness or rapid Pulmonary embolism breathing; • sudden cough without an obvious cause, which may bring up blood; • sharp chest pain which may increase with deep breathing; • severe light headedness or dizziness; • rapid or irregular heartbeat; • severe pain in your stomach

If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath

5 may be mistaken for a milder condition such as a respiratory tract infection (e.g. a ‘common cold’). Symptoms most commonly occur in one eye: Retinal vein thrombosis • immediate loss of vision or (blood clot in the eye) • painless blurring of vision which can progress to loss of vision • chest pain, discomfort, pressure, heaviness; Heart attack • sensation of squeezing or fullness in the chest, arm or below the breastbone; • fullness, indigestion or choking feeling; • upper body discomfort radiating to the back, jaw, throat, arm and stomach; • sweating, nausea, vomiting or dizziness; • extreme weakness, anxiety, or shortness of breath; • rapid or irregular heartbeats • sudden weakness or numbness of the face, arm or Stroke leg, especially on one side of the body; • sudden confusion, trouble speaking or understanding • sudden trouble seeing in one or both eyes; • sudden trouble walking, dizziness, loss of balance or coordination; • sudden, severe or prolonged headache with no known cause; • loss of consciousness or fainting with or without seizure

Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke. • swelling and slight blue discolouration of an Blood clots blocking other extremity; blood vessels • severe pain in your stomach (acute abdomen)

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).

6  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 Chlormadinone acetate /Ethinylestradiol 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 Chlormadinone acetate /Ethinylestradiol 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.  It is not yet known how the risk of a blood clot with Chlormadinone acetate /Ethinylestradiol compares to the risk with a combined hormonal contraceptive that contains levonorgestrel.  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 About 2 out of 10,000 women hormonal pill/patch/ring and are not pregnant Women using a combined hormonal About 5-7 out of 10,000 women contraceptive pill containing levonorgestrel, norethisterone or norgestimate Women using Chlormadinone acetate Not yet known /Ethinylestradiol

Contact your doctor as quickly as possible if you experience more frequent or more intense migraines whilst taking Chlormadinone acetate /Ethinylestradiol as this could

7 indicate a disruption in the blood flow to the brain. Your doctor may advise you to stop taking Chlormadinone acetate /Ethinylestradiol immediately.

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

The risk of a blood clot with Chlormadinone acetate /Ethinylestradiol is small but some conditions will increase the risk. Your risk is higher: 2 - if you are very overweight (body mass index or BMI over 30kg/m ); - 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 Chlormadinone acetate /Ethinylestradiol may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop Chlormadinone acetate /Ethinylestradiol 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 Chlormadinone acetate /Ethinylestradiol needs to be stopped. If any of the above conditions change while you are using Chlormadinone acetate /Ethinylestradiol, 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 Chlormadinone acetate /Ethinylestradiol is very small but can increase:

- with increasing age (beyond about 35 years); - if you smoke. When using a combined hormonal contraceptive like Chlormadinone acetate /Ethinylestradiol 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;

8 - 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 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 Chlormadinone acetate /Ethinylestradiol, 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.

Development of Cancer:

Some studies show that women whose cervix uteri is infected with a certain sexually transmitted virus (human papilloma virus) are at risk of developing cervical cancer if they take hormonal contraceptives in the long term. The extent to which this outcome is affected by other factors (e.g. differences in the number of sexual partners or the use of mechanical contraceptive methods) is, however, unclear.

Studies indicate a slightly higher risk of breast cancer in women currently taking CHCs. This value gradually reverts to the age-related background risk within 10 years of discontinuing CHCs. Since breast cancer seldom develops in women under 40 years of age, the number of additional breast cancer diagnoses in women either taking or who have taken CHCs is small compared with the overall risk of breast cancer.

Benign liver tumours can occasionally occur and malignant liver tumours even more rarely following the use of contraceptives. These tumours can cause life-threatening internal bleeding. Contact your doctor immediately if you experience severe upper abdominal pain that does not regress spontaneously.

Other diseases:

A slight increase in blood pressure values has been recorded in many women taking hormonal contraceptives. If your blood pressure increases whilst taking Chlormadinone acetate /Ethinylestradiol, your doctor will advise you to stop taking the medication immediately and will prescribe an antihypertensive drug (to lower your blood pressure). As soon as your blood pressure values have reverted to normal, you can restart Chlormadinone acetate /Ethinylestradiol.

9 If you suffered herpes during an earlier pregnancy, this may recur whilst taking a hormonal contraceptive.

The risk of pancreatitis is increased if you or your family suffers from abnormal blood lipid values (hypertriglyceridaemia). In the event of acute or chronic impaired liver function, your doctor may advise you to stop taking Chlormadinone acetate /Ethinylestradiol until the liver function values return to normal. If you suffered from jaundice during an earlier pregnancy or when previously taking sex hormones, and this recurs, you must stop taking Chlormadinone acetate /Ethinylestradiol.

If you are a diabetic or your blood glucose levels are under control, and you take Chlormadinone acetate /Ethinylestradiol, your doctor will carefully monitor you whilst you are taking the medication. You may have to change your diabetes treatment.

Brown patches (chloasma) can sometimes appear on the skin, especially if this occurred during a previous pregnancy. If you are prone to this condition, you should not expose yourself directly to sunlight or ultraviolet light (e.g. sun bed) whilst taking Chlormadinone acetate /Ethinylestradiol.

• Diseases that are adversely affected Close medical monitoring is also required in the following cases: - If you suffer from epilepsy; - If you suffer from multiple sclerosis; - If you suffer from severe muscle spasms (tetany); - If you suffer from migraines (see also section 2, “Do not use Chlormadinone acetate /Ethinylestradiol”); - If you suffer from asthma; - If you have heart failure or impaired kidney functions (see also section 2, “Do not use Chlormadinone acetate /Ethinylestradiol”); - If you suffer from St. Vitus’ dance (Chorea minor); - If you are a diabetic (see also “Do not use Chlormadinone acetate /Ethinylestradiol” and “Other diseases” under “Take special care with Chlormadinone acetate /Ethinylestradiol”); - If you have a liver disease (see also section 2, “Do not use Chlormadinone acetate /Ethinylestradiol”); - If you have a metabolic disorder (see also section 2, “Do not use Chlormadinone acetate /Ethinylestradiol”); - If you are suffering from diseases affecting the immune system (including lupus erythematosus); - If you are severely overweight; - If you suffer from high blood pressure (see also section 2. “Do not use Chlormadinone acetate /Ethinylestradiol”); - If benign proliferation of the uterine mucosa (endometriosis) has been diagnosed see also section 2. “Do not use Chlormadinone acetate /Ethinylestradiol”);

10 - If you have varicose veins or are suffering from inflammation of the veins (see also section 2. “Do not use Chlormadinone acetate /Ethinylestradiol”); - If you are suffering from blood coagulation disorders (see also section 2., “Do not use Chlormadinone acetate /Ethinylestradiol”); - If a benign tumour (myoma) is detected in the uterus; - If you are suffering from a disease affecting the mammary glands (mastopathy); - If you developed herpes of pregnancy during a previous pregnancy; - If you suffer from depression (see also section 2. “Do not use Chlormadinone acetate /Ethinylestradiol”); - If you are suffering from chronic inflammatory intestinal diseases (Crohn’s disease and ulcerated colitis).

Talk to your doctor if you are currently experiencing or have experienced one of the afore-mentioned diseases or if such a disease develops whilst you are taking Chlormadinone acetate /Ethinylestradiol.

Efficacy

The effect of a contraceptive can be adversely affected if you do not take the medication regularly, if you experience vomiting or diarrhoea after taking the contraceptive (see section 3. “What to do if vomiting or diarrhoea occurs whilst taking Chlormadinone acetate /Ethinylestradiol”), or if you are taking certain other medicines concomitantly (see section 2 “Using other medicines”). The contraceptive can very occasionally be affected by metabolic disorders.

However, even if used correctly, a hormonal contraceptive cannot give 100% protection against pregnancy.

Irregular bleeding

Irregular bleeding (spotting and breakthrough bleeding) can occur with all hormonal contraceptives, especially during the first few months of use. Please contact your doctor if this irregular bleeding persists after 3 months or if it recurs after or before a regular cycle.

Intermenstrual bleeding is also an indication of reduced contraceptive efficacy.

Withdrawal bleeding may not occur in some users during the tablet-free interval. If Chlormadinone acetate /Ethinylestradiol has been taken as described in “How to take Chlormadinone acetate /Ethinylestradiol” it is unlikely that you are pregnant. If, however, the medication has not been taken as directed before the first withdrawal bleeding-free period, pregnancy must be ruled out before continuing Chlormadinone acetate /Ethinylestradiol.

Other medicines and Chlormadinone acetate /Ethinylestradiol:

11 Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do not use Chlormadinone acetate /Ethinylestradiol if you have Hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir 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. Chlormadinone acetate /Ethinylestradiol can be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Chlormadinone acetate /Ethinylestradiol”.

The contraceptive efficacy of Chlormadinone acetate /Ethinylestradiol may be adversely affected by the concomitant administration of other substances. This includes medicines to treat epilepsy (such as carbamazepine, phenytoin and topiramate), tuberculosis (e.g. rifampicin, rifabutin)and griseofulvin, barbiturates, barbexaclone, primidone, modafinil, medicines to treat HIV infections (e.g. ritonavir) and preparations containing St. John’s Wort. Preparations that stimulate intestinal movement (e.g. metoclopramide) and active charcoal can adversely affect the absorption of the active substances contained in Chlormadinone acetate /Ethinylestradiol.

Medicines containing St. John’s Wort should not be taken concomitantly with Chlormadinone acetate /Ethinylestradiol.

If you are taking or are starting to take one of the aforementioned active substances (apart from St. John’s Wort), you can continue to take Chlormadinone acetate /Ethinylestradiol. You must, however, use other mechanical methods of contraception (e.g. condoms) whilst taking this medication. With some medicines, these additional measures should be followed not only during concomitant administration but for up to 7 to 28 days afterwards, depending on the medicinal product in question. If long-term treatment with one of the aforementioned active substances is required, you should not use hormonal contraceptives. Ask your doctor or pharmacist for advice.

If the concomitant medication continues after you have taken the last tablet in the CHC blister pack, you should start the next CHC blister pack immediately, without leaving a tablet-free interval.

Inform your doctor if you are taking insulin or any other medicine to lower your blood glucose levels. The dose of this medication may have to be altered.

The excretion of diazepam, cyclosporin, theophylline and prednisolone may be reduced during the administration of hormonal contraceptives. These active substances could thus have a greater prolonged effect. Reduced efficacy is anticipated if preparations containing clofibrate, paracetamol, morphine and lorazepam are administered concomitantly.

12 Please note that this information also applies if you have taken one of these active substances shortly before starting Chlormadinone acetate /Ethinylestradiol.

Some laboratory tests to check liver, adrenal cortex and thyroid gland function, some blood proteins, carbohydrate metabolism and blood coagulation may be affected by Chlormadinone acetate /Ethinylestradiol. Please tell your doctor that you are taking Chlormadinone acetate /Ethinylestradiol before having a blood test.

Pregnancy and breast-feeding

Chlormadinone acetate /Ethinylestradiol is not indicated during pregnancy. If you become pregnant whilst taking Chlormadinone acetate /Ethinylestradiol, you must stop the medication immediately. The previous administration of Chlormadinone acetate /Ethinylestradiol is, however, no reason to terminate pregnancy.

If taking Chlormadinone acetate /Ethinylestradiol whilst breast-feeding, it should be noted that milk production may be reduced and its consistency adversely affected. The smallest quantities of active substance can diffuse into breast milk. Hormonal contraceptives such as Chlormadinone acetate /Ethinylestradiol should therefore be taken only after breast-feeding has ended.

Driving and using machines:

Combined hormonal contraceptives are not known to have an adverse effect on driving or using machines.

Chlormadinone acetate /Ethinylestradiol contains lactose.

This medicinal product contains lactose. Do not take Chlormadinone acetate /Ethinylestradiol without consulting your doctor if you know that you are intolerant to certain sugars.

3. HOW TO TAKE CHLORMADINONE ACETATE /ETHINYLESTRADIOL

Always take Chlormadinone acetate /Ethinylestradiol exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Method of administration For oral administration

How to and when to take Chlormadinone acetate /Ethinylestradiol Remove the first film-coated tablet marked with the relevant day of the week, (e.g. “Su” for Sunday) from the calendar pack, and swallow whole. Continue taking one tablet a day, following the direction of the arrows. If possible, take at the same time of day, preferably in the evening. The interval between two doses should always be 24

13 hours if at all possible. By removing the tablet for the relevant day of the week from the pack, you can check every day whether you have taken the tablet for the day in question.

Take one film-coated tablet per day for 21 consecutive days. This is followed by a break of 7 days. Withdrawal bleeding, similar to a period, should generally begin two to four days after the last dose. After the 7-day break, continue to take Chlormadinone acetate /Ethinylestradiol from the next pack, regardless of whether bleeding has stopped or still persists.

When to start taking Chlormadinone acetate /Ethinylestradiol

If you have not taken any hormonal contraceptive before (in the last monthly cycle):

Take your first Chlormadinone acetate /Ethinylestradiol tablet on the 1st day of your next monthly period.

Protection begins on the first day of administration and also continues during the 7-day break.

If your monthly period has already started, take the first tablet between the 2nd and 5th day of your period, regardless of whether or not bleeding has already stopped. In this case, however, you must use an additional mechanical method of contraception for the first 7 days of administration (7-day rule).

If your monthly period started more than 5 days previously, wait until your next period before starting Chlormadinone acetate /Ethinylestradiol.

If you have taken another combination hormonal contraceptive in the past:

You should continue to take all of the tablets in the old pack on a regular basis. After the usual treatment-free interval or after taking the last active substance-free tablet in the previous pack of combination hormonal contraceptives, start taking Chlormadinone acetate /Ethinylestradiol immediately on the next day.

If you have previously taken a hormonal contraceptive containing purely gestagen:

Withdrawal bleeding similar to your monthly period may not occur with preparations containing purely gestagen. Take your first Chlormadinone acetate /Ethinylestradiol tablet on the day after completing the medication containing only gestagen. You must then use an additional mechanical method of contraception for the first 7 days.

If you have previously received a contraceptive hormone injection or a contraceptive implant

14 Take your first Chlormadinone acetate /Ethinylestradiol tablet on the day on which the implant was removed or on which the next injection was planned. You must then use additional methods of contraception for the first 7 days.

If you had a miscarriage or pregnancy termination during the first trimester of pregnancy:

You can start to take Chlormadinone acetate /Ethinylestradiol immediately after a miscarriage or pregnancy termination. No additional methods of contraception are required in this case.

nd If you gave birth or had a miscarriage during the 2 trimester of pregnancy:

If you are not breast-feeding, you can start to take Chlormadinone acetate /Ethinylestradiol 21 to 28 days after delivery. No additional mechanical methods of contraception are required in this case.

If more than 28 days have elapsed since delivery, you must use additional mechanical methods of contraception for the first 7 days.

If you have already had intercourse before starting to take Chlormadinone acetate /Ethinylestradiol, you must rule out pregnancy or wait until your next monthly period before starting Chlormadinone acetate /Ethinylestradiol.

Please note that you should not take Chlormadinone acetate /Ethinylestradiol whilst breast-feeding (see section entitled “Pregnancy and breast-feeding”).

For how long can you take Chlormadinone acetate /Ethinylestradiol?

You can take Chlormadinone acetate /Ethinylestradiol for as long as you wish to use a hormonal method of contraception and provided that it is not contraindicated by medical risks (see section 2, “Do not take Chlormadinone acetate /Ethinylestradiol” and “Warnings and precautions”). The start of your next monthly period may be delayed by approximately one week after stopping Chlormadinone acetate /Ethinylestradiol.

What to do if vomiting or diarrhoea occurs whilst you are taking Chlormadinone acetate /Ethinylestradiol

If vomiting or diarrhoea occurs within 4 hours of taking the film-coated tablet, the active substances contained in Chlormadinone acetate /Ethinylestradiol may not be completely absorbed by your body. This situation is similar to that of a forgotten tablet and you must immediately take a new tablet from a new blister pack. If possible, take this new tablet within 12 hours of the last dose and continue to take Chlormadinone acetate /Ethinylestradiol at the usual time. If this is not possible or if more than 12 hours have already elapsed since the last dose, follow the instructions given in the section entitled, “If you forget to take Chlormadinone acetate /Ethinylestradiol” or ask your doctor.

15 If you take more Chlormadinone acetate /Ethinylestradiol than you should

There is no evidence to suggest that single administration of more tablets will trigger serious signs of poisoning. Nausea, vomiting and slight vaginal bleeding may occur, especially in young girls. Seek medical advice in such cases. If need be, your doctor will test your salt and water balance as well as your liver function.

If you forget to take Chlormadinone acetate /Ethinylestradiol

If you forget to take the film-coated tablet at the usual time, you must take it within the next 12 hours. In this case, no additional methods of contraception are required and you can continue to take the tablets as usual.

However, if more than 12 hours elapse since the last dose, the contraceptive effect of Chlormadinone acetate /Ethinylestradiol is no longer guaranteed. In this instance, take the forgotten film-coated tablet immediately and continue to take Chlormadinone acetate /Ethinylestradiol at the usual time. This may mean that you take two tablets on one day. You must, however, use additional methods of mechanical contraception (e.g. condoms) for the next 7 days. If you finish your current pack during this 7-day period, start immediately with the next pack, i.e. do not take a break between packs (7-day rule). The usual withdrawal bleeding will probably not appear until you finish the new pack; so- called spotting may, however, occur after starting the new pack.

The more tablets you forget to take at the usual time, the greater the risk of diminished contraceptive effect. If you forget one or more tablets during the 1st week of the cycle and have intercourse the week before you start to take the forgotten tablets, you may become pregnant. The same applies if withdrawal bleeding does not appear during the tablet-free interval after forgetting to take your tablets. Please consult your doctor in such cases.

Altering the timing of your menstrual cycle

Although it is not recommended, your period (withdrawal bleeding) can be delayed by taking the first tablet from the second pack of Chlormadinone acetate /Ethinylestradiol without any break between packs and by continuing to take the pack up until the last tablet, as usual. Spotting may occur whilst you are taking the second calendar pack. Then continue the next pack after the standard tablet-free interval of 7 days. Seek medical advice before deciding to alter the timing of your menstrual cycle.

Bringing your period forward

If you take the tablets as directed, menstruation/withdrawal period will occur during the one-week tablet-free interval. If this day is brought forward, the treatment-free interval may be shortened (but never prolonged!). If, for instance, the treatment-free interval begins on Friday but should start on a Tuesday in future (i.e. 3 days earlier),

16 start to take the new pack 3 days earlier than usual. If you keep the treatment-free interval very short (e.g. 3 days or less), no bleeding may occur during this break. Spotting (spots or flecks of blood) may, however appear. If you are unsure about what to do next, please ask your doctor for advice.

If you stop taking Chlormadinone acetate /Ethinylestradiol

If you stop taking Chlormadinone acetate /Ethinylestradiol, the ovaries will quickly become fully functional again and you may become pregnant.

4. POSSIBLE SIDE EFFECTS:

Like all medicines, Chlormadinone acetate /Ethinylestradiol 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 Chlormadinone acetate /Ethinylestradiol, 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 Chlormadinone acetate /Ethinylestradiol”.

The frequency of side effects can be defined as follows:

Very common: More than 1 user in 10 Nausea, vaginal discharge, pain during monthly period, absence of monthly period, spotting, headaches, discomfort in the chest.

Common: 1 to 10 users in 100 Depressive moods, irritability, nervousness, dizziness, migraine (and/or more intense migraines) visual disturbances, vomiting, acne, lower abdominal pain, fatigue, sensation of heavy legs, accumulation of water, weight gain, increase in blood pressure,

Uncommon: 1 to 10 users in1,000 Abdominal pain, hypersensitivity to the medication including allergic skin reactions, flatulence, diarrhoea, impaired pigmentation, brown patches on the face, hair loss, dry skin, backache, muscle pain, discharge from the mammary glands, benign connective tissue changes in the breast, fungal vaginal infections, diminished sex drive, tendency to sweat, changes in blood lipid values including elevated triglyceride levels.

Rare: 1 to 10 users in10,000 Conjunctivitis, pain on wearing contact lenses, sudden deafness, ringing in the ears, high blood pressure, low blood pressure, circulatory collapse, formation of varicose veins. Harmful blood clots in a vein or artery for example:

17 o in a leg or foot (i.e. DVT) o in a lung (i.e. PE) o heart attack o stroke o mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA) o 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).

Nettle rash, skin rash (eczema), redness of the skin, itching, exacerbation of existing psoriasis, increased body and facial hair, breast enlargement, inflammation of the vagina, prolonged and/or more intense monthly period, premenstrual syndrome (physical and mental discomfort before the period starts), increased appetite.

Very rare: Less than 1 user in 10, 000 Erythema nodosum.

Combined hormonal contraceptives have also been associated with an increased risk of serious diseases and side effects. - Risk of occlusion of venous and arterial blood vessels (see section 2., “Take special care with Chlormadinone acetate /Ethinylestradiol ”), - Risk of bile duct disorders (see section 2., “Take special care with Chlormadinone acetate /Ethinylestradiol ”), - Risk of tumour formation (e.g. liver tumours, which, in some cases have led to life- threatening bleeding in the abdominal cavity as well as uterine and breast cancer, see section 2. “Take special care with Chlormadinone acetate /Ethinylestradiol”). - Deterioration in chronic-inflammatory intestinal diseases (Crohn’s disease and ulcerative colitis, see section 2. “Diseases that are adversely affected”).

Please carefully read the information given in see section 2, “Warnings and precautions” and, if need be, seek medical advice immediately.

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

5. HOW TO STORE CHLORMADINONE ACETATE /ETHINYLESTRADIOL:

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

18 Do not use this medicine after the expiry date stated on the blister / carton after ‘{EXP}’. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage condition.

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 Chlormadinone acetate / Ethinylestradiol contains.

The active substances are Chlormadinone acetate 2.0 mg and Ethinylestradiol 0.03 mg.

The other ingredients are

Tablet core: lactose monohydrate, lactose anhydrous, all-rac-α-Tocopherol, maize starch, povidone K-25, magnesium stearate

Tablet coating: opadry pink (03G540005) (Composition: HPMC 2910/ Hypromellose 6 cp (E464), Titanium Dioxide (E171), Macrogol /PEG (MW 6000) (E1521), Propylene glycol (E1520), Talc (E553b) and Iron oxide Red (E172))

What Chlormadinone acetate/ Ethinylestradiol looks like and contents of the pack

The tablet is round, pink, biconvex, film-coated debossed ‘I’ on one side and other side plain.

Each box contains 1, 3 and 6 blisters of 21 tablets each. Each carton contains blisters packed separately in an aluminium laminated sachet. Not all pack sizes may be marketed.

Marketing Authorization Holder Manufacturer

PHARMADOX HEALTHCARE LTD. KW20A Kordin Industrial Park, Paola, PLA 3000

19 Malta

Wessling Hungary Kft Fóti út 56., Budapest, 1047, Hungary

This medicinal product is authorized in the Member States of the EEA under the following names:

DE: Chlormadinonacetat/Ethinylestradiol Famy Care 2 mg/0,03 mg Filmtabletten ES: Clormadinona acetato/ Etinilestradiol Aristo 2 mg / 0,03 mg comprimidos recubiertos con película EFG

This leaflet was last revised in 05/2017

20