Zulima 150/30 microgram, filmomhulde tabletten

• Zulima 150/30 microgram, filmomhulde tabletten is a contraceptive pill and it is used to prevent pregnancy.
• Each tablet contains a small amount of two different female hormones, namely levonorgestrel and ethinylestradiol.
• Contraceptive pills that contain two hormones are called “combination” pills.

General notes

Before you can begin taking Zulima 150/30 microgram, filmomhulde tabletten, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure, and depending upon your personal situation, may also carry out some other tests.

In this leaflet, several situations are described where you should stop using Zulima 150/30 microgram, filmomhulde tabletten, or where the reliability of the Zulima 150/30 microgram, filmomhulde tabletten may be decreased. In such situations you should either not have intercourse or you should take extra non- hormonal contraceptive precautions, for example use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because Zulima 150/30 microgram, filmomhulde tabletten alters the monthly changes of the body temperature and of the cervical mucus.

Zulima 150/30 microgram, filmomhulde tabletten, like other hormonal contraceptives, does not protect you against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take Zulima 150/30 microgram, filmomhulde tabletten

• if you have (or have ever had) a blood clot in a blood vessel of the leg (thrombosis), lung (pulmonary embolism) or other organs
• if you have (or have ever had) a heart attack or stroke;
• if you have (or have ever had) a disease that can be an indicator of a heart attack (for example, angina pectoris, which causes severe pain in the chest) or of a stroke (for example, a passing slight stroke with no residual effects);
• if you have a disease that may increase the risk of a clot in the arteries. This applies to the following diseases:
  • diabetes with damaged blood vessels;
  • very high blood pressure;
  • a very high level of fat in the blood (cholesterol or triglycerides);
• if you have a disturbance of blood clotting (for example, protein C deficiency);
• if you have (or have ever had) a liver disease and your liver function is still not normal;
• if you have (or have ever had) a tumour in the liver;
• if you have (or have ever had) or if you are suspected of having breast cancer or cancer of the genital organs;
• if you have any unexplained bleeding from the vagina;
• if you have (or have ever had) a certain form of migraine (with so-called focal neurological symptoms);
• if you are allergic to ethinylestradiol, levonorgestrel or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause itching, rash or swelling.

Warnings and precautions

In some situations you need to take special care while using Zulima 150/30 microgram, filmomhulde tabletten or any other combination pill, and it may be necessary that you are regularly checked by your doctor. If any of the following conditions applies to you, inform your doctor before starting to take Zulima 150/30 microgram, filmomhulde tabletten.

Also if any of the following conditions develops or worsens while you are using Zulima 150/30 microgram, filmomhulde tabletten, you must consult your doctor:

• if a close relative has or has ever had breast cancer;
• if you have a disease of the liver or the gallbladder;
• if you have diabetes;
• if you have depression;
• if you have Crohn’s disease or inflammatory bowel disease (ulcerative colitis);
• if you have a blood disease called HUS (haemolytic uraemic syndrome) which causes kidney damage);
• if you have a blood disease called sickle cell anaemia;
• if you have epilepsy (see section “Other medicines and Zulima 150/30 microgram, filmomhulde tabletten”);
• if you have a disease of the immune system called SLE (systemic lupus erythematosus)
• if you have a disease that first appeared during pregnancy or earlier use of sex hormones (for example hearing loss), a blood disease called porphyria, skin rash with blisters during pregnancy (gestational herpes), a nerve disease causing sudden movements of the body (Sydenham’s chorea);
• if you have or have ever had chloasma (a discoloration of the skin especially of the face or neck known as “pregnancy patches”). If so, avoid direct exposure to sunlight or ultraviolet light

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

Talk to your doctor or pharmacist before taking Zulima 150/30 microgram, filmomhulde tabletten.

Zulima 150/30 microgram, filmomhulde tabletten and venous and arterial blood clots

The use of any combination pill, including Zulima 150/30 microgram, filmomhulde tabletten, increases a woman’s risk of developing a venous blood clot (venous thrombosis) compared with women who do not take any contraceptive pill.

The risk of venous blood clots in users of combination pills increases:

• with increasing age;
• if you are overweight;
• if one of your close relatives ever had a blood clot in the leg, lung (pulmonary embolism), or other organ at a young age;
• if you have to have surgery, if you have had a serious accident or if you are immobilised for a long time. It is important to tell your doctor that you are using Zulima 150/30 microgram, filmomhulde tabletten as you may have to stop taking it. Your doctor will tell you when to start using it again. This is usually about two weeks after you are back on your feet.

Your chances of having a blood clot are increased by taking the pill.

• Of 100,000 women who are not on the pill and not pregnant, about 5-10 may have a blood clot in a year.
• Of 100,000 women taking a pill like Zulima 150/30 microgram, filmomhulde tabletten, 30-40 may have a blood clot in a year, the exact number is unknown.
• Of 100,000 women who are pregnant, around 60 may have a blood clot in a year.

A blood clot in the veins may travel to the lungs and may block blood vessels (called a lung embolus). Formation of blood clots in the veins may be fatal in 1-2% of cases.

The level of risk may vary according to the type of pill you take. Discuss with your doctor the available options.

The use of the combination pill has been connected with an increase of the risk of an arterial blood clot (arterial thrombosis), for example, in the blood vessels of the heart (heart attack) or the brain (stroke).

The risk of arterial blood clot in users of combination pills increases:

• if you smoke. You are strongly advised to stop smoking when you use Zulima 150/30 microgram, filmomhulde tabletten, especially if you are older than 35 years.
• if the fat content of your blood is increased (cholesterol or triglycerides);
• if you are overweight;
• if one of your close relatives ever had a heart attack or stroke at a young age;
• if you have high blood pressure;
• if you suffer from migraine;
• if you have a problem with your heart (valve disorder, a disturbance of the cardiac rhythm).

Stop taking Zulima 150/30 microgram, filmomhulde tabletten and contact your doctor immediately if notice possible signs of a blood clot, such as:

• severe pain and/or swelling in one of your legs;
• sudden severe pain in the chest which may reach the left arm;
• sudden breathlessness;
• sudden cough without an obvious cause;
• any unusual, severe or long-lasting headache or worsening of migraine;

• partial or complete blindness or double vision;
• difficulty in speaking or inability to speak;
• giddiness or fainting;
• weakness, strange feeling, or numbness in any part of the body.

Zulima 150/30 microgram, filmomhulde tabletten 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 using the pill because they see the doctor more often.

The occurrence of breast tumours becomes gradually less after stopping the combination hormonal contraceptives. It is important to regularly check your doctor if you feel any lump.

In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been reported in pill users. Contact your doctor if you have unusually severe abdominal pain.

Bleeding between periods

During the first few months that you are taking Zulima 150/30 microgram, filmomhulde tabletten, you may have unexpected bleeding (bleeding outside the gap week). If this bleeding occurs for more than a few months, or if it begins after some months, talk to your doctor, who will find out what is wrong.

What to do if no bleeding occurs during the gap week

If you have taken all the tablets correctly, have not had vomiting or severe diarrhoea and you have not taken any other medicines, it is highly unlikely that you are pregnant.

If the expected bleeding does not happen twice in a row, you may be pregnant. Contact your doctor immediately. Do not start the next strip until you are sure that you are not pregnant.

Other medicines and Zulima 150/30 microgram, filmomhulde tabletten

Always tell your doctor, who prescribes Zulima 150/30 microgram, filmomhulde tabletten, if you are using, have recently used or might use any other medicines, including herbal products. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you take Zulima 150/30 microgram, filmomhulde tabletten. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long.

Some medicines can make Zulima 150/30 microgram, filmomhulde tabletten less effective in preventing pregnancy, or can cause unexpected bleeding. These include

• medicines used for the treatment of: o epilepsy (for example primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine); o tuberculosis (for example rifampicin); o HIV infections (ritonavir, nevirapin) or other infections (antibiotics such as griseofulvin, penicillin, tetracycline); o high blood pressure in the blood vessels in the lungs (bosentan);
• the herbal remedy St. John’s wort.

Zulima 150/30 microgram, filmomhulde tabletten may influence the effect of other medicines, for example:

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

Zulima 150/30 microgram, filmomhulde tabletten with food and drink

Zulima 150/30 microgram, filmomhulde tabletten may be taken with or without food, if necessary with a small amount of water.

Laboratory tests

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

Pregnancy and breast-feeding

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

Pregnancy

If you are pregnant, do not take Zulima 150/30 microgram, filmomhulde tabletten. If you become pregnant while taking Zulima 150/30 microgram, filmomhulde tabletten stop using the pill immediately and contact your doctor. If you want to become pregnant, you can stop taking the pill at any time (see also “If you want to stop taking Zulima 150/30 microgram, filmomhulde tabletten”).

Breast-feeding

Use of Zulima 150/30 microgram, filmomhulde tabletten is generally not advisable when a woman is breast- feeding. If you want to take the pill while you are breast-feeding, contact your doctor.

Driving and using machines

There is no information suggesting that the use of Zulima 150/30 microgram, filmomhulde tabletten affects driving or use of machines.

Zulima 150/30 microgram, filmomhulde tabletten contains lactose

This medicine contains lactose. If you cannot tolerate certain sugars, contact your doctor before you take Zulima 150/30 microgram, filmomhulde tabletten.

Always take Zulima 150/30 microgram, filmomhulde tabletten exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Remember to take Zulima 150/30 microgram, filmomhulde tabletten as prescribed because missing tablets could reduce the effectiveness of the medicine.

How and when should Zulima 150/30 microgram, filmomhulde tabletten be used:

Each strip contains 21 tablets.

Take one Zulima 150/30 microgram, filmomhulde tabletten tablet every day, if necessary with a small amount of water. You should take the tablets every day around the same time.

Next to each tablet is printed the day of the week when it should be taken. Start by taking a tablet from the first row marked with the correct day of the week. If, for example, you start on a Wednesday, take a tablet with "WED" next to it. Follow the direction of the arrows on the strip until you have taken all 21 tablets. Then take no tablets for 7 days. In the course of these 7 tablet-free days (otherwise called a stop or gap week)

bleeding should begin. This so-called “withdrawal bleeding” usually starts on the 2nd or 3rd day of the gap week.

On the 8th day after the last Zulima 150/30 microgram, filmomhulde tabletten tablet (that is, after the 7-day gap week), you should start with the following strip, whether your bleeding has stopped or not. This means that you should start every strip on the same day of the week and that the withdrawal bleed should occur on the same days each month.

If you use Zulima 150/30 microgram, filmomhulde tabletten in this manner, you are also protected against pregnancy during the 7 days when you are not taking tablets.

When to can you start taking Zulima 150/30 microgram, filmomhulde tabletten

• If you have not used any contraceptive with hormones in the previous month Start taking Zulima 150/30 microgram, filmomhulde tabletten on the first day of the cycle (that is, on the first day of your menstrual period). If you start Zulima 150/30 microgram, filmomhulde tabletten on the first day of your menstruation, you are immediately protected against pregnancy. You may also begin on days 2-5 of the cycle, but then you must use extra protective measures (for example, a condom) for the first 7 days.
• If you are changing from a combination hormonal contraceptive, vaginal ring or a patch

You can start Zulima 150/30 microgram, filmomhulde tabletten preferably on the day after the last active tablet (the last tablet containing active substances) of your previous pill, but at the latest on the day after the tablet-free days of your previous pill).

When changing from a combination contraceptive vaginal ring or patch, follow the advice of your doctor.

• If you are changing from a progestogen-only-method (progestogen-only–pill, injection, implant or progestogen releasing intrauterine device - IUD)

You may switch any day from the progestogen-only pill (from an implant or an IUD on the day of its removal, from an injectable when the next injection would be due) but in all the cases use extra protective measures (for example, a condom) for the first 7 days of tablet-taking.

• If you had a miscarriage

Follow the advice of your doctor.

• After having a baby You can start taking Zulima 150/30 microgram, filmomhulde tabletten between 21 and 28 days after having a baby. If you start later than day 28, use a barrier contraceptive method (for example, a condom) during the first seven days.

If, after having a baby, you have had sex before starting to take Zulima 150/30 microgram, filmomhulde tabletten (again), be sure that you are not pregnant or wait until the next menstrual period before taking this medicine.

• While breast-feeding If you are breast-feeding and want to start taking Zulima 150/30 microgram, filmomhulde tabletten (again) after having a baby, read the section “Pregnancy and breast-feeding”.

Ask your doctor what to do if you are not sure when to start taking Zulima 150/30 microgram, filmomhulde tabletten.

If you take more Zulima 150/30 microgram, filmomhulde tabletten than you should

There are no reports of serious harmful results of taking too many Zulima 150/30 microgram, filmomhulde tabletten.

If you take several tablets at once then you may have symptoms of nausea or vomiting. Young girls may have bleeding from the vagina.

If you have taken too many Zulima 150/30 microgram, filmomhulde tabletten, or you discover that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take Zulima 150/30 microgram, filmomhulde tabletten

• If you are less than 12 hours late taking a tablet, the protection from pregnancy is not reduced. Take the tablet as soon as you remember and then continue to take the following tablets at the usual time (even if this means taking two tablets the same day). In this case you do not need to use any additional method of contraception.
• If you are more than 12 hours late taking a tablet, the protection from pregnancy may be reduced. The greater the number of tablets you have forgotten, the greater is the risk of becoming pregnant.
• The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or the end of the strip.

Follow the instructions below if you have forgotten to take a tablet:

• If you forgot more than one tablet in this strip Contact your doctor.
• If you forgot one tablet in week 1

Take the forgotten tablet as soon as you remember, even if that means taking two tablets at the same time. Continue taking the tablets at the usual time and use extra contraceptive barrier methods for the next 7 days, for example, a condom. If you have had sex in the week before forgetting the tablet, you may be pregnant. In that case, contact your doctor.

 If you forgot one tablet in week 2

Take the forgotten tablet as soon as you remember, even if that means taking two tablets at the same time. Continue taking the tablets at the usual time. The contraceptive effect of the medicine is not reduced, and you do not need to take extra precautions.

 If you forgot one tablet in week 3

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if that means taking two tablets at the same time. Continue taking the tablets at the usual time. Instead of the tablet-free period, start the next strip.

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

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

If you follow any of the above recommendations, you will remain protected against pregnancy.

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

More than 1 tablet forgotten in 1 strip

in week 1

only 1 tablet

forgotten in week 2 (taken more

than 12 hours late)

in week 3

Ask your doctor for advice

Yes

Had sex in the previous week before forgetting?

No

• Take the forgotten tablet
• Use a barrier method (condom) for the following 7 days and
• Finish the strip
• Take the forgotten tablet and

 Finish the strip

• Take the forgotten tablet and
• Finish the strip

 Instead of the gap week  Start the next strip

Or

• Stop the strip immediately
• Begin the gap week (not longer than 7 days, including the forgotten tablet)

 Then, start the next strip

What to do if you vomit or have severe diarrhoea

If you vomit within 3-4 hours after taking a tablet or you have severe diarrhoea, there is a risk that the active substances in the tablet are not fully absorbed in your body. The situation is almost the same as forgetting a tablet. After vomiting or having diarrhoea, take another tablet from a reserve strip as soon as possible. If possible take it within 12 hours of when you normally take your tablets. If this is not possible or 12 hours have passed, follow the advice given under “If you forget to take Zulima 150/30 microgram, filmomhulde tabletten”.

Delaying your period: what you need to know

Even though it is not recommended, you can delay your period by going straight to a new strip of Zulima 150/30 microgram, filmomhulde tabletten (and finishing it) instead of the tablet-free period. You may experience light or menstruation-like bleeding while taking the tablets from this second strip. After the usual tablet-free period of 7 days, start the next strip.

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

Changing the first day of your period: what you need to know

If you take the tablets according to the instructions, then your period will begin during the tablet-free week. If you want to change this day, reduce the number of tablet-free days (but never increase them – 7 is the maximum!). For example, if your tablet-free days normally begin on a Friday, and you want to change this to a Tuesday (3 days earlier) start a new strip 3 days earlier than usual. If you make the tablet-free interval very short (for example, 3 days or less) you may not have any bleeding during these days. You may then experience light or menstruation-like bleeding.

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

If you want to stop taking Zulima 150/30 microgram, filmomhulde tabletten

You can stop taking Zulima 150/30 microgram, filmomhulde tabletten whenever you want. If you do not want to become pregnant, ask your doctor for advice about other reliable methods of birth control. If you want to become pregnant, stop taking Zulima 150/30 microgram, filmomhulde tabletten and wait for a menstrual period before trying to become pregnant. You will be able to calculate the expected delivery date more easily.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following is a list of the side effects that have been linked with the use of Zulima 150/30 microgram, filmomhulde tabletten:

Common (may affect up to 1 in 10 people ):

• nausea
• abdominal pain
• increased weight
• headache
• depressed mood
• altered mood
• breast tenderness
• breast pain

Uncommon (may affect up to 1 in 100 people):

• vomiting
• diarrhoea

• fluid retention
• migraine
• decreased libido
• breast enlargement
• rash
• hives (urticaria)

Rare (may affect up to 1 in 1,000 people):

• contact lens intolerance
• hypersensitivity
• decreased weight
• increased libido
• breast discharge
• vaginal discharge
• a type of skin inflammation resulting in reddish, painful, tender lumps (erythema nodosum)
• a skin disorder that causes red, target-shaped or ”bulls-eye” patches or sores (erythema multiforme)

Oral contraceptive use has been associated with:

• Increased risk of blood clots in arteries and veins and disorders caused by a blood clot that breaks loose, including heart attack, blood clot in a vein and blood clot in the lung (see "Warnings and precautions" section).
• Increased risk of changes in the surface of the neck of the uterus (intraepithelial neoplasia) and cancer of the neck of the uterus.
• Increased risk of breast cancer diagnosis (see "Warnings and precautions" section).

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.

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

Do not store above 30ºC.

Do not use this medicine after the expiry date which is stated on the carton and strip after “EXP”. The expiry date refers to the last day of that month.

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.

What Zulima 150/30 microgram, filmomhulde tabletten contains

• The active ingredients are levonorgestrel and ethinylestradiol. Each tablet contains 0.15 mg of levonorgestrel and 0.03 mg of ethinylestradiol.
• The other ingredients are:

Tablet core: lactose monohydrate, povidone K30, crospovidone type A and magnesium stearate.

Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b) and iron oxide yellow (E172)

What Zulima 150/30 microgram, filmomhulde tabletten looks like and contents of the pack

• Each strip of Zulima 150/30 microgram, filmomhulde tabletten contains 21 yellow film-coated tablets.
• Zulima 150/30 microgram, filmomhulde tabletten are film-coated tablets. The tablets are yellow, round, with a diameter of 6 mm and thickness less than 4 mm approximately.
• Zulima 150/30 microgram, filmomhulde tabletten is available in packs of 1, 3, 6 or 13 strips, each strip with 21 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios León Farma, S.A.

Polígono Industrial Navatejera, La Vallina S/N

24008 Navatejera (Leon) - Spanje

Manufacturer

Laboratorios León Farma, S.A.

Polígono Industrial Navatejera, La Vallina S/N

24008 Navatejera (Leon) - Spanje

In het register ingeschreven onder RVG 111873.

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

This leaflet was last revised in October 2013.