Informations for option: Logynon (Sh B 264 Ab), show other option

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1. Logynon (Sh B 264 Ab)
2. Logynon (Sh B 264 Ab)

Levonorgestrel

Ethinylestradiol

A 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

^ Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 23'Blood clots').

^ The Pill may reduce your risk of cancer of the ovary and womb if used in the long term.

^ The Pill wi J not protect you against sexually transmitted diseases.

^ Thi s m edicin e can increase your risk of problem s such as blood clots and breast cancer.

^ Some women should not take the Pillbecause of current medical problems or illnesses. Please read this leaf let to make sure Logynon is right for

^ To prevent pregnancy it is important to take Logynon as instructed and start each pad! on time. Please make sure that you understand what to do if you miss a pill or if you think you are pregnant.

Read all of this leaflet carefully before you start taking this medicine.

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

^ If you have any questions orneed more advice, ask your doctor, family planning nurse or pharmacist.

^ This medicine has been prescribed foryou. Do not pass it on to others. It may harm them.

^ If any of the side effects gets severe, or if you notice any not listed in this leaflet, please tell your doctor, family planning nurse or pharmacist.

1.    What Logynon does

Logynon is a combined oral contraceptive pillfthe Pill)- You take it to stop you getting pregnant.

This contraceptive contains two types of female sex hormones, oestrogen and progestogen. These hormones stop you getting pregnant by working in three ways: by preventing an egg being releasedfrom your ovaries; by making the fluid (mucus) in your cervixthicker, which makes it more difficult for sperm to enter the womb; and by preventing the lining of your womb thickening enough for an egg to grow in it. Logynon is a 21-day pill - you take one each day for 21 days, followed by 7 days when you take no pills. The benefits of taking the Pill i nclu de:

^ it is one of the most reliable reversible methods of contraception if used correctly ^ it doesn’t interrupt sex ^ it usually makes your periods regular, lighter and less painful

^ it may help with pre-menstrualsymptoms. Logynon willnot protect you against sexually transmitted infections, such as Chlamydia or HIV. Only

Logynon needsto betaken as directed to prevent pregnancy.

2.    What you need to know before you use Logynon

General notes

Before you start using Logynon you should read the information on blood dots in section 2. It is particularly important to read the symptoms of a blood clot - see Section 23 'Blood ciots'.

It’s important that you understand the benefits and risks of taking the Pill before you start taking it, or when deciding whether to carry' on taking it. Although the Pill is suitable for most healthy women it isn’t suitable for everyone.

*■* Tell your doctor if you have any of the illnesses orrislc factors mentioned in this leaflet.

Bef oreyou start taking the Pill ^ Your doctor will ask about you and your family’s medical problems, check your blood pressure and exclude the likelihood of you being pregnant. You may also need other chedts, such as a breast examination, but only if these examinations are necessary for you, or if you have any special

While you’re on the Pill ^ You will need regular check-ups with your doctor or family planning nurse, usually when you need another prescription of the Pill.

^ You should go for regular cervical smear tests. ^ Check your breasts and nipples every month for changes - tellyour doctor if you can see or feel anything odd, such as lumps or dimpling of the

^ If you need a blood test tell your doctor that you are taking the Pi 1, because the Pill can affect the results of sometests.

^ If you’re going to have an operation, m ake sure your doctor knows about it. You may need to stop taking the Pill about 4-6 weeks before the operation. This is to reduce the risk of a blood dot (see section 23). Your doctor will tellyou when you can start taking the Pillagain.

2.1 Wh en you should not use Logynon You should not use Logynon if you have any of the conditions listed below. If you do have any of the conditions listed below, you must tellyour doctor. Your doctor will discuss with you what otherform of birth control would be more appropriate.

Do not take Logynon:

^ If you have (or have ever had) a blood clot in a blxiod 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-lll deficiency, Factor'/Leiden or anti phospholipid antibodies ^ If you need an operation or if you are off your feet for a long time (see section 23 ‘Blood clots’) ► If you have ever had a heart attack or stroke ^ If you have (or have ever had) angina pectoris (a

be a first sign of a heart attack) ortransient ischaemicattackfTIA-temporary stroke symptoms)

^ If you have any of the following diseasesthat may increase your risk of a clot in the arteries:

0 severe diabetes with blood vessel damage 0 very high blood pressure

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

hyperhomocysteinaemia

^ If you have (or have ever had) a type of migraine called ‘migraine with aura’

^ If you have ever had a severe liver disease, and you have been told by your doctorthat your liver function test results are not yet bade to normal ^ If you have ever had liver tumours ^ If you are allergic [nypersenstave] to any of the ingredients in Logynon.

Tellyour doctor or family planning nurse if you have any medical problems or illnesses.

2.2 Wh en to take special care with Logynon When should you contact your doctor?

Seek urgent medical attention ^ if you notice possible signs of a blood clot th at may mean you are suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot i n the lung (i .e. pulmon ary embolism), a heart attadt or a stroke (see‘Blood clots’

(chronic inflammatory bowel disease)

^ If you have systemic lupus erythematosus (SLE -a disease affecting your natural defence system) ^ If you have haemolyticuraemic syndromejHUS-a disorder of blood clotting causing failure of the kidney's)

^ If you have sidde cellanaemia (an inherited disease of the red blood cells)

^ If you have inflamm ati on of the pancreas (pancreatitis)

^ 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 23 ‘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 Logynon

^ If you have an inflammation in the veins under the skin (superficial thrombophlebitis)

^ If you have varicose veins

^ If you have diabetes

^ If you or your close family have ever had

problems with yourheart, or circulation such as high blood pressure

^ If you or your close family have ever had problems with blood clotting ^ If you have the inherited disease called porphyria ^ If you are overweight [obese)

^ If you have migraines ^ If you have any illness that worsened during pregnancy or previous use of the Pi 1 (see section 4.2)

2.3 Blood clots

Using a combined hormonal contraceptive such as Logynon increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block vessels and cause serious problems. Blood dots can develop:

^ in vein s (referred to as a ‘ven ou s throm bosi s’, “venous thromboembolism’or VTE);

^ in the arteriesjreferred to as an ‘arterial

thrombosis’, ‘arterial thromboembolism’ or ATE). Recoveryfrom 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 having a harmful blood clot dueto Logynon is

HOW TO RECOGNISEA BLOOD CLOT

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

mu

See a doctor as soon as possible. Do not take any more Logynon untilyour doctor says you can. Use another method of contraception, such as condoms, in the meantime.

BLOOD CLOTS IN A VEIN

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

^ The use of combined hormonal contraceptives

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 combi ned h orm onal contraceptive.

►    If a blood clot forms in a vein in the leg orfoot it can cause a deep vein thrombosis (D'/T).

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

^ Very rarely a clot may form in a vein in another organ such as the eyejretinal 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 contraceptivejthe 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 horm on al contraceptive.

When you stop Logynon your risk of a blood clot returnsto normal within afew weeks.

What is the risk of developing a blood clot?

The risk depends on your naturalrisk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (D'/T or PE) with Logynon is small.

^ Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 willdevelop a blood clot in a

^ Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, such as Logynon, about 5-7 will develop a blood clot in a year.

^ The ri sk of havi ng a blood clot will vary according to your personal medical history (see“F actors that increase your risk of a blood clot in a vein” below).

Risk of developing a blood clot in a year

Women who are not About 2 out of 10,000 using a combined    women

hormonal pill and are not pregnant

Women using a combined    About 5-7 out of

hormonal contraceptive    10,000 women

pill containing levonorgestrel

Women using Logynon    About 5-7 out of

10,000 women

Factors that increase your risk of a blood clot in a

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

^ if you are very overwei ght (body m ass in dex or BMI over 30kg/m²)

^ if one of your immediate family has had a blood dot in the leg, king or other organ at ayoung age (e.g. below the age of about 50). In this case you could ha\'ea hereditary'blood dotting disorder

^ if you need to have an operation, or if you are off your feet fora longtime because of an injury' or illness, or you have your leg in a cast. The use of Logynon may need to be stopped several weeks before surgery' or while you are less mobile. If you need to stop Logynon ask your doctor when you

^ as you get older (particularly above about 35

^ 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 tel your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may dedde that Logynon needs to be stopped. If any of the above conditions change while you are using Logynon, for example a dose family member experiences a thrombosis for no known reason, or you gain a lot of weight, tellyour doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an

Like a blood clot in a vein, a dot in an artery' can cause serious problems. For example, it can cause a heart

Factors that increaseyour risk of a blood clot in

It is important to note that the risk of a heart attack or stroke from using Logynon is very'small but can increase:

^ with increasing age (beyond about 35 years)

^ if you smoke. When usi ng a comb ined h ormonal contraceptive like Logynon, you are advised to stop smoking. If you are unableto 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 agefless 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, espedally migraines with

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

^ if you have diabetes.

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 Logynon, for example you start smoking, a close family member experiences a thrombosis for no known reason, or you gain a lot of weight, tellyour

2A The Pill and cancer

While high dose Pills reduce your risk of cancer of the ovary and womb if used in the long term, it is not dear whether lower dose Pills like Logynon also provide the same protective effects. However, it also seems that taking the Pill slightly increases your risk of cancer of the cervix- although th is m ay be due to having sex without a condom, rather than the Pill. All women should have regular smear tests.

If you have breast cancer, or have had it in the past, you should not take the Pill. The Pill slightly increases your risk of breast cancer. This risk goes up the longer you’re on the Pill, but returns to normal within about 10 years of stopping it. Because breast cancer is rare

Your risk of breast cancer is higher:

^ if you have a dose relative (mother, sister or grandmother) who has had breast cancer ^ if you are seriously overweight.

*+ See a doctor as soon as possible if you notice any changes in your breasts such as dimpling of the skin, changes in the nipple or any lumps you can see or feel.

Taking the Pill has also been linked to liver diseases, such as jaundice and non-cancer liver tumours, but this is rare. Very rarely, the Pillhas also been linked with some forms of liver cancer in women who have taken it for a long time.

*+ See a doctor as soon as possible if you get severe pain in your stomach, or yellow skin or

eyes(/aurafte). You may need to stop taking Logynon.

2.5    Taking other medicines

If you ever need to take another medicine at the same time as being on the Pill, always tellyour doctor, pharmacist or dentist that you’re taking Logynon.

Also check the leaflets that come with all your medicines to see if they can betaken with hormonal contraceptives.

Some medicines can have an influence on the blood levels of Logynon and can stop it from working properly - for example:

^ some medicines used to treat epilepsy ^ some medicines used to treat HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors)

^ griseofulvin(an anti-fungalmedicine)

^ certain antibiotics ^ certain sedatives (called barbiturates)

^ St. John’s Wort (a herbal remedy).

If you do need to take one of these medicines,

Logynon may not be suitable fory'ou or you mayneed to use extra contraception for a while. Your doctor, pharmacist or dentist can tell you if this is necessary and for how long.

Logynon can also affect how well other medicines work. Your doctor may need to adjust the dose of your other medicine.

In addition, Logynon can also interfere with the results of some blood tests, so always tell your doctor that you are taking Logynon if you have a blood test.

2.6    Taking Logynon with food and drink

There are no special instructions about food and drink while on Logynon.

2.7    Pregnancy and breast-feeding

Do not use Logynon if you are pregnant. If you think you might be pregnant, do a pregnancytestto confirm that you are before you stop taking Logynon. If you are breast-feeding, your doctor or family plan nin g n urse may advise you n ot to take Logynon. They will be able to suggest alternative contraception. Breast-feeding may not stop you getting pregnant.

2.8    Driving and using machines

Logynon has no known effect on the ability to drive or

2.9    Logynon contains lactose and sucrose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before using Logynon.

3. Taking Logynon

3.1 How to take it

To prevent pregnancy, always take Logynon as described below. Check with your doctor or family plan nin g n urse if you are not su re.

Take Logynon every day for 21 days Logynon comes in strips of 21 pills (6 light brown, 5 white and 10 ochre-coloured tablets), each marked with a day of the week.

^ Take your pi Hat the same timeevery day.

^ Start by taking pill number 1 and mark that day of the week under the heading “I took my first pill on” by piercing the small unnumbered foildisc This will remind you on which day you started taking the course of pills.

^ Follow the direction of the arrows on the strip. Take one pill each day, untilyou havefinished all 21 pills.

^ Swallow each pill whole, with water if necessary.

Donot chewthe pill.

Then have seven pill-free days Afteryou have taken all 21 pills in the strip, you have seven days when you take no pills. So if you take the last pill of one pack on a Friday, you willtake the first pill of your next pack on the Saturday of the following

Within a few days of taking the last pillfrom the strip, you should have a withdrawal bleed like a period. This bleed may not have finished when it is time to start your next strip of pills.

You don't need to use extra contraception during these seven pill-free days - as long as you have taken your pills correctly and start the next strip of pills on time. Then start your next strip Start taking your next strip of Logynon after the seven pill-free days - even if you are still bleeding. Always

3.3 A missed pill

If you miss a pill, follow these instructions:

•    Takethe delayed pill straight away and further pills as usual. This may mean taking two pills in one day.

•    Don’t worry, your contraceptive protection should notbereduced.

| 7 or more pills left in the pack~|

If you have missed any of the pills in a strip, and you do not bleed in thefirst pill-free break,you may be pregnant. Contact your doctor or family planning clinic, or do a pregnancy test yourself.

If you start a new strip of pills late, or make your ‘week off’ longer than seven days, you may not be protected from pregnancy. If you had set in the last seven days, ask your doctor, family planning nurse or pharmacist for advice. You may need to consider emergency contraception. You should also use extra contraception, such as a condom, for seven days.

3.4 A lost pill If you lose a pill,

Either takethe last pill of the strip in place of the Lost pill. Then take allthe other pills on their proper days. Your cycle willbe one day shorter than normal, but your contraceptive protection won’t be affected. After your seven pill-free days you will have a new starting day, one day earlier than before.

►    Don’t forget to use extra precautionsforthenext

►    When you finish the strip of pills, start the next strip the next day without a break.

►    Ifyou donot have a withdrawal bleed afteryou have finished the second strip, do a pregnancy' test before starting another strip.

►    Ifyou have missed one or more pills from the first week of your strip (days 1 to 7) and you had sex in that week, you could become pregnant. Contact you r doctor, family plan ning nurse or pharmatist for advice as soon as possible.

Or if you do not want to change the starting day of your cycle, take a pill from a spare strip if you have one. Then take allthe other pills from your current strip as usual. You can then keep the opened spare strip in case you lose any more pills.

3.3 If you are sick or have diarrhoea If you are sickjvomit) or have very'bad diarrhoea within 4 hours of taking the Pill, your body may not get its usual dose of hormones from that pill. If you are better within 12 hours of taking Logynon, follow the instructions in section 3A A lost pill, which describes how to take another pill.

If you are still sick or have diarrhoea morethanl2 hours after taking Logynon, see section 3.3,71 missed pill.

*■* Talk to your doctor if your stomach upset

carries on or gets worse. He or she may

recommend another form of contraception.

3.6    Missed a period - could you be pregnant?

Occasionally, you may miss a withdrawal bleed. This couW mean that you are pregnant, but that is very' unlikely if you have taken your pills correctly. Start your next strip at the normal time. If you think that you might have put yourself at risk of pregnancy (for example, by missing pills or taking other medicines), or if you miss a second bleed, you should do a pregnancy test. You can buy these from the chemist or get a free test at your family planning clinic or doctors surgery'. If you are pregnant, stop taking Logynon and see your doctor.

3.7    Taking more than one pill should not cause

It is unlikely that taking morethan one pill will do you any harm, but you may feel siclt, vomit or have some vaginal bleeding. Talk to your doctor if you have any of these symptoms.

3.8    When you want to get pregnant

If you are planning a baby, it’s best to use another method of contraception after stopping Logynon until you have had a proper period. Your doctor or midwife relies on the date of your last natural period to tell you when your baby is due. However, it will not cause you or the baby any harm if you get pregnant straight

4. Possible side effects

risks from beforeyou use

planning nurse if you are worried about any sit effects which you think may be due to Logynon.

a doctor straight

ck(TIA)

0 blood clots in the liver, stomach/intestine, kidneys or eye.

The chance of having a blood clot may be higher if you ha\'e any' other conditions that increasethis risk (see section 2.3 for more information on the conditions that increase risk for blood dots and the symptoms of a blood clot).

Signsof a blood clot (see section 2.3 ’Blood clots') Signs of a severe allergic reaction or worsening of hereditary angioedema:

^ swelling of the hands, face, lips, mouth, tongue or throat. A swollen tongueAhroat may lead to difficulty swallowing and breathing ^ a red bumpy rash [hives) and itching.

Signsof breast cancer include:

^ dimpling of the skin ^ changes in the nipple ^ any lumps you can see or feel.

Signs of cancer of the cervix include:

^ vaginal discharge that sm ells and/or contai ns

^ unusual vaginal bleeding ^ pelvic pain ^ painful sex.

Signsof severe liver problems include:

^ severe pain inyour upper abdomen ^ yellow skin or eyes (jaundice)

► inflammation of the liver [hepatitis)

^ your whole body starts itching.

If you think you may have any of these, see a doctor straight away. You may need to stop taking Logynon.

4.2 Less serious side effects

Common sideeffects (between 100 and 1000 in

every 10,000 users may be affected)

^ feeling sick ^ stomach ache ^ putting on weight ^ headaches

^ depressive moods or mood swings ^ sore or painfulbreasts Uncommon side effects (between 10 and 100 in every 10,000 users may be affected)

^ b eing sick and stomach u psets ^ fluid retention ^ migraine

^ breast enlargement

^ skin rash, which may be itchy

Rare side effectsjbetween 1 and 10 in every 10,000

users may be affected)

^ poortolerance of contact lenses ^ losing weight ^ increase of interest in sex ^ vaginalor breast discharge Other side effects repotted ^ Bleeding and spotting between your periods can sometimes occur for the first few months but this usually stops once your body has adjusted to

again, contact your doctor (see section 4.3)

► Chloasma (yellow brown patches on the skin). This may happen even if you have been using Logynon for a number of months. Chloasma may be reduced by avoiding too much sunlight and/or UV lamps

^ Occurrence or deterioration of the movement disorder chorea

^ Crohn’s disease or ulcerative colitis ^ Conditions that may worsen during pregnancy or previous use of the Pill:

0 yellowing of the skin [jaundice)

0 persistent itching [pruritus)

|> kidney or liver problems |> gall stones

0 certain rare medical conditions such as systemic lupus erythematosus 0 blister-like rash [herpes gestations) whilst pregnant

0 an inherited form of deafness [otosclerosis)

0 a personal or family history' of a form of sickle cell disease

0 swelling of body parts [hereditary angioedema)

0 an i nherited disease called porphyria |> cancer of the cervix Tellyour doctor, pharmacist or family planning nurse if you are worried about any side effects which you think may' be due to Logynon. AlsoteJthem if any existing conditionsget worse while you are taking Logynon.

4.3 Bleeding between periods should not last long Afew women have a little unexpected bleeding or spotting while they are taking Logynon, especially during thefirst few months. Normally, this bleeding is nothing to worry' about and will stop after a day or two. Keep taking Logynon as usual. The problem should disappear after the first few strips.

You may also have unexpected bleeding if you are not taking your pills regularly, so try' to take your pill at the same time every'day. Also, unexpected bleeding

*+ Make an appointmentto see your doctor if you get breakthrough bleeding or spotting that: ^ carries on for more th an the fi rst few m onths ^ starts after you’ve been taking Logynon for a

^ carries on even afteryouVe stopped taking Logynon.

Repotting of side effects

If you get any side effects, talk to your doctor, ph armacist or nu rse. This in dudes any possi ble si de effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more i nformati on on th e safety of th is m edici ne.

5.    How to store Logynon

Keep allmedicines out of the sight and reach of children.

Do not use Logynon after the expiry' date shown on

Do not throw away any medicines down a drain or into a bin. Ask your pharmacist what to do with any medicines you do not want. This will help to protect the environment.

6.    What is in Logynon and who makes it

What is in Logynon

Each box of Logynon containsthree strips of 21 tablets.

Each strip of Logynon contains:

6 light brown tablets containing 50 micrograms levonorgestrel and 30 micrograms ethinylestradiol 5 whitetabljetscontaining 75 micrograms levonorgestrel and 40 micrograms ethinylestradiol 10 ochretabljets containing 125 micrograms levonorgestrel and 30 micrograms ethinylestradiol AIJ, tablets are sugar-coated.

Let'onorgestrel is a progestogen and ethinylestradiol is an oestrogen.

Logynon also containsthe inactive ingredients: Lactose, maize starch, povidone, magnesium stearate (E572), sucrose, polyethylene glycol 6000, calcium carbonate (E170), talc, montan glycol wax, glycerin (E422), titanium dioxide (El71), ferric oxide pigment (red and yellow) (E172).

The company that holds the product licence for Logynon is:

Bayer pic, Bayer House, Strawberry'Hill, Newbury' Berkshire, RG141J A.