LOGYNON (SH B 264 AB) - patient leaflet, side effects, dosage

Patient leaflet - LOGYNON (SH B 264 AB)

Logynon®

Levonorgestrel

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 ‚Blood clots‘ in section 2).

► The Pill may reduceyour risk of cancer of the ovary and womb if used in the long term.

► The Pill will not protect you against sexually transmitted diseases.

► This medicine can increase your risk of problems such as blood clots and breast cancer.

► Some women should not take the Pill because of current medical problems or illnesses. Please read this leaflet to make sure Logynon is right for you.

► To prevent pregnancy it is important to take Logynon as instructed and start each pack on time. Please make surethatyou understand what to do if you miss a pill or if you thinkyou are pregnant.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

► If you have any further questions or need more advice, ask your doctor, family planning nurse 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, family planning nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Logynon is and what it is used for
2 Whatyou need to know beforeyou use Logynon
3. How to use Logynon
4. Possible side effects
5. How to store Logynon
6. Contents of the pack and other information

1. what logynon is and what it is used for

Logynon is a combined oral contraceptive pill (the Pill'). You take ittostopyou getting pregnant Logynon contains two types of female sex hormones, oestrogen (ethinylestradiol) and progestogen (levonorgestrel). These hormones stop you getting pregnant by working in three ways: by preventing an egg being released from your ovaries; by making the fluid (mucus) in your cervix thicker, 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 include: ► it is one of the most reliable reversible methods of contraception if used correctly

► it doesn't interrupt sex

► it usually makesyour periods regular, lighter and less painful

► it may help with pre-menstrual symptoms.

Logynon will not protect you against sexually transmitted infections, such as Chlamydia or HIV. Only condoms can help to do this.

Logynon needs to be taken as directed to prevent pregnancy.

2. what you need to know beforeyou use logynon

General notes

Beforeyou start using Logynonyou should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot – see ‚Blood clots‘ in section 2

It’s important that you understand the benefits and risks of taking the Pill beforeyou 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.

Tellyour doctor if you have any of the illnesses or risk factors mentioned in this leaflet

Before you start taki ng 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 checks, such as a breast examination, but only if these examinations are necessary for you, or if you have any special concerns.

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.

► Checkyour breasts and nipples every month for changes – tellyour doctor if you can see or feel anything odd, such as lumps or dimpling of the skin.

► If you need a blood test tell your doctor that you are taking the Pill, because the Pill can affect the results of some tests.

► If you’re going to have an operation, make sureyour doctor knows about it You may need to stop taking the Pill at least 4 weeks before the operation. This is to reduce the risk of a blood clot (see ‘Blood clots’ in section 2). Your doctor will tellyou when you can start taking the Pill again.

Whenyou 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 other form of birth control would be more appropriate.

Do not use Logynon

► If you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs

► If you know you have a disorder affecting your blood clotting – for instance, protein C deficiency, protein S deficiency, anti thrombin-lll deficiency, Factor V Leiden or antiphospholipid antibodies

► If you need an operation or if you are off your feet for a long time (see 'Blood clots’ in section 2)

► If you have ever had a heart attack or 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 dot in the arteries: t> severe diabetes with blood vessel damage t> very high blood pressure

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

t> a condition known as hyperhomocysteinaemia

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

► If you have or have ever had breast cancer

► If you have ever had a severe liver disease, and you have been told by your doctor that your liver function test results are notyet back to normal

► Ifyou have ever had liver tumours

► Ifyou are allergic (hypersensitive)to any of the ingredients in Logynon.

Do not use Logynon if you have hepatitis C and are taking medicinal products containing ombitasvir/ paritaprevir/ritonavir, dasabuvir, glecaprevir/ pi brentasvi r and sofosbuvirAelpatasvir/voxilaprevir (see also in section “Other medicines and Logynon").

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

Warnings and Precautions

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 clots' section below).

For a description of the symptoms of these serious side effects please go to “How to recognise a blood dot”.

Some of the conditions listed below can be made worse by taking the PilL Or they may mean it is less suitable for you. You may still be able to take Logynon but you need to take special care and have check-ups more often.

Tellyour doctor if any of the following conditions apply to you.

If the condition develops, or gets worse whileyou are using Logynon, you should also tellyour doctor.

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

► Ifyou have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)

► Ifyou have systemic lupus erythematosus (SLE -a disease affecting your natural defence system)

► Ifyou have haemolytic uraemic syndrome (HUS -a disorder of blood clotting causing failure of the kidneys)

► Ifyou have sickle cell anaemia (an inherited disease of the red blood cells)

► Ifyou have inflammation of the pancreas (pancreatitis)

► Ifyou have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)

► Ifyou need an operation, or you are off your feet for a long time (see ‘Blood clots’ section below)

► Ifyou 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

► Ifyou have an inflammation in theveins under the skin (superficial thrombophlebitis)

► Ifyou have varicose veins

► Ifyou have diabetes

► Ifyou oryourclose family have ever had problems with your heart, or circulation such as high blood pressure

► Ifyou oryourclose family have ever had problems with blood clotting

► Ifyou have the inherited disease called porphyria

► Ifyou are overweight (obese)

► Ifyou have migraines

► Ifyou have any illness that worsened during pregnancy or previous use of the Pill (see ‘Less serious side effects' in section 4)

Bloodclots

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 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 having a harmful blood clot due to Logynon is small.

HOW TO RECOGNISE A BLOOD CLOT

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

Areyou experiencing any of these signs?

What are you possibly suffering from?

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► swelling of one leg or along a vein in the leg or foot especially when accompanied by:

D> 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 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 may be mistaken for a milder condition such as a respiratory tract infection (e.g. a ‘common cold1).

Symptoms most commonly occur in one eye:

► immediate loss of vision or

► painless blurring of vision which can progress to loss of vision

► chest pain, discomfort, pressure, heaviness

► 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 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 extremity ► severe pain in your stomach (acute abdomen)

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

BLOOD CLOTS IN A VEIN

What can happenif 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 thevein (venous thrombosis). However, these side effects are rare. Most

Deep vein thrombosis

Pulmonary embolism

Retinalvein thrombosis (blood clot in the eye)

Heart attack

Stroke

Blood clots blocking other bloodvessels

frequently, they occur in the first year of use of a combined hormonal contraceptive.

► If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT).

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

► Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?

The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher ifyou 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 ifyou were not using a combined hormonal contraceptive.

When you stop Logynon 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 Logynon 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, such as Logynon, about 5–7 will develop a blood clot in a year.

► The risk of having a blood clot will vary according toyour personal medical history (see “Factors 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

Factorsthat increaseyour risk of a blood clot in a vein

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

► ifyou are very overweight (body mass index or BMIover 30kg/m2)

► if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50). In this case you could have a hereditary blood clotting disorder

► ifyou need to have an operation, or ifyou are off your feet for a long time because of an injury or illness, oryou haveyour leg in a cast. The use of Logynon may need to be stopped at least 4 weeks before surgery or while you are less mobile. Ifyou need to stop Logynon ask your doctor when you can start using it again.

► as you get older (particularly above about 35 years)

► ifyou 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 ifyou have some of the other factors listed.

It is important to tellyour doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that Logynon needs to be stopped.

If any of the above conditions change while you are using Logynon, for example a close family member experiences a thrombosis for no known reason, or you gain a lot of weight, tellyour doctor.

BLOOD CLOTS IN AN ARTERY

Whatcan happenif a blood clotforms 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 Logynon is very small but can increase:

► with increasing age (beyond about 35 years)

► ifyou smoke. When using a combined hormonal contraceptive like Logynon, 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

► ifyou are overweight

► ifyou 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

► ifyou, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides)

► ifyou get migraines, especially migraines with aura

► ifyou have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation)

► ifyou 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 whileyou 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, tell your doctor.

The Pill and cancer

While high dose Pills reduceyour risk of cancer of the ovary and womb if used in the long term, it is not clear whether lower dose Pills like Logynon also provide the same protective effects. However, it also seems that taking the Pill slightly increasesyour risk of cancer of the cervix – although this may 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 in women under the age of 40, the extra cases of breast cancer in current and recent Pill users is small. For example:

► Of 10,000 women who have never taken the Pill, about 16 will have breast cancer by the time they are 35 years old.

► Of 10,000 women who take the Pill for 5 years in their early twenties, about 17–18 will have breast cancer by the time they are 35 years old.

► Of 10,000 women who have never taken the Pill, about 100 will have breast cancer by the time they are 45 years old.

► Of 10,000 women who take the Pill for 5years in their early thirties, about 110 will have breast cancer by the time they are 45 years old.

Your risk of breast cancer is higher:

► if you have a close relative (mother, sister or grandmother) who has had breast cancer

► if you are seriously overweight

See a doctor as soon as possible ifyou notice any changes inyour breasts, such as dimpling of the skin, changes in the nipple or any lumps you can see orfeeL

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Ta ta n g the P i ll has also been linked to liver diseases, su ch as j a und ice an d n on- canc er li ve r tumou rs, but th is is rare. Very rarely, the Pill has also been tinted with some forms of liver ca ncer in women who have ta ten it for a long time.

See a da tor as soon as possible if you get severe pain inyour stoma ch, oryellow skin or ey e s fau ndice).Youmayneedtostoptaking Logy non.

Psychiatric disorders

Some women using hormonal contraceptives including Logy non have reported depression or depressed mood. Depress b n can be serio us and may sometimes lead tosu icidal thoug hts. If you ecperience mood changes and depressive symptomscontactyour do ctor for further medica ladvfceas soon as possible Other medicines and Locyron

If you ever need to take another medicine at the same time a s being on t he P ill, always tell you r doctor, ph anna cist or dentist th at yo u're taking Logyno n. Also check t he leaflets that come with all your medicines to see if they can be taken wth hormonal contraceptives.

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

► some me dicinesused to treat epilepsy

► some medidnesusedtotreatHIVand HepatitisCVirus infections (so-calied protease inhibitorsand non-nucleoside reverse transcriptase inhbitors)

► griseofutvin(an anti-fungal medicine)

► certain antibiotics

► certain sedatives(called barbiturates)

► St John’s Wort(a herbal remedy).

If you do need to take one of th ese med icines, Logynon may not be suitable for you or you may need to use ectra con traception for a w hile. Yo ur doctor, pharmacist or dentist can tellyou if this is necessary andfor how long.

Locynoncan also affect how well other medicines work. Your doctor may n eed to adju st the dose of your other med icine.

In addition,Logynon can also interferewth the resu Its of some blood tests, so alwaystel lyou r docto r th at you are taking Logynon if you have a blood test Donot use Logynon if you havehepatitisCand are ta Mng medicin al products conta ining ombtasvir/ pa ritap nevir/rito navir, dasa buvir, gleca previr/ pib re nta svir an d sofosbu vir/velpatasvir/voxilaprevir, as these prod ucts may cause in creases h liver fu net b n blood test resu Its (increa se in ALT liver e nzyme). You r docto r will p rescribe another type of contraceptive prior to startof the treatmentwith these med icinal products. Logynon can be restarted app roxima tely 2 weeks aft er comp letion of t his treat men t Se e se cti on “ Do no t u se Logy non Taking Locynon with food a nd drink

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

Preg nan cy a nd bre as t-f ee di ng

Do not use Logynon ifyou are pregnant. If you th ink you might be pregnant,do a pregnancy test to confirmthatyou arebeforeyou stoptakng Logynon. Ifyou arebreast-feeding,your doctor or family pla nning nurse may advise you not to take Logynon. They will be able to suggest alternative contraception. Breast-feeding may not stop you getting pregnant Driving and using machines

Logy nonhasnoknown effect o n the a bi lity to dri v e or use machines.

Logynon contains lactose and sucrose

If you have been told by your do ctor th at you have i rrt ole ran ceto some su gars, con tactyou r docto r before using Logynon.

3. how to use logynon

To prevent pregn ancy, always take Logynon as described below. C heck with your d octor or f amily pla nning nurse ifyou are not su re.

Take Logynon every cfay for21 (fays

Logynon comes instripsof 21 pills £ light brown, 5 w hite a nd 10 oc hre-co louredtablets), each ma rked with a day of the week.

► Takeyour pill at the same time every day.

► Start by ta tang pill number land markthat day oftheweek under the heading”! took my first pill on” by piereingt he smal I unn umbered foil disc This will re mind you on which day you started taking the course of pills.

► Follow the direction of the arrows on the str ip. Take one pill each day, until yo u h ave finished all 21 pills.

► Swallow each pill whois wit h wa ter if necessary. Do not chew the pill.

Then have seven pill-free days

After you have taken al 121 pills in the strip,you have seven days wh en you ta te no pills. So if you take t he last pil of one pack onaFriday, you will take t hefirst pill of you r next pack on the Sat urd ay of t he fol lowing week.

Within a few daysof taking the last pil If rom the strip, you should have a withd rawal bleed like a period. This bleed may not h ave fin ished wh en it is timeto sta rt your nect strip of pills.

You don't needto use extra contraception d uring these seven pill-free d ays – as Ion g as you have taken you r pills co rrect by and start t he nect st rip of pil Is on time

Then start your next strip

Sta rt taking your n ext strip of Logynon after the seven pill-free days-even ifyou are still bleeding. Always start the new strpontime

As longasyou take Logynon correctly, you will always starteach new str ip on the sa me day of the week

Starting Logynon

Asa newuserorsfartingthe Pill againaftera bre ak

It is best to ta te you r first Logynon pill on thefirstday of your ne<t period. By starting in this way,you will have con traceptive protection with your firstp ill.

Changing to Logynon from another contraceptive Pill

► Ifyou are currently taking a 21-day Pill: start Logynon the next day after the end of the p reviou s strip. You will have co ntrace ptive p rated ion wit h you r fr st pill. Yo u wiI In ot have a bleed until after your first str ip of Logynon.

► Ifyou are taking a 2 8-day Pill: start taking Logynon the day after your last active pill You will have cont racept ive p rated ion wit h you r frst p ill. You will not h ave a b leed u ntil after your first strip of Logynon.

► Or, ifyou are taking a progestogen-only Pill (POP or ‘miniPill): start Logynon onthefirstday of bleeding, even ifyou have already taten the p rag est oge n-on ly P i 11 for tha t d ay. You w i U h ave contraceptive cover straight away.

Starting Logynon after a mi scarriage or abortion Ifyou have had a rnisca rri a ge or an abort ion during the first three months of pregnancy, your dodor may tellyou to start taking Logynon straightaway. This means th at you will have contraceptive protection w ith your first pil L

Ifyou have had a rnisca rri a ge or an abort ion afte r the third m onth of pregn ancy, ask you r dod or for advice. You may need to use extra contraception, such as c ondo ms, for a shor t ti me.

Contraception after having a baby

Ifyou havejusthad a baby, your dodor may advise yo ut hat Logyno n s hou Id be sta rted 21 days after delivery provided th atyou a re fully mo bile. You donot haveto wait for a period. You wil I need to use anot her met hod of co ntr ace p ti on, su ch as a co ndom, un ti I you start Logynon and fort hefirst 7 days of pilltaking.

Amissedpill

Ifyou missa pill, follow these instructions:

If you have missed any of the pills i n a strip, and you do not bleed inthefirstpill-free break, you may be pregnant. Contact you doctor or family planning dinic, a do a pregnancy testyourself. Ifyou start anew strip of pillslate, or makeyour ‘week off’longer than seven cfays, you may not be protected from pregnancy. Ifyou hadsexinthe last sevend ays, ask you r dodor, femily plan ningn urse or pharmacist for advice. You may need to con sider emergency contraception. You should also use extra cont racept b n, su ch as a condo m, for seven days.

A lost pill

Ifyou lose a pill,

Either taketh e last p 11 of the stripin place of the lost pi 11. Th en take all th e oth er pi Us on th eir p roper days. Your cy de wi 11b e one day sh ort er th an no rmal, bu t you r cont racept ive p rated ion wo nt be affeded. After you r seve n pill-free days yo u willh ave a n ew starting day,oneday earlier tha n befo re.

Or f you donotwanttocha ngethe starting day of yourcycle, take a pill from a spa re st rip ifyou have one. Then take all the other pills from your cu rrent strip as usual You can then tee pt he opened spare strip in case you lose any mo rep Ils.

Ifyou are sick or have diarrhoea

If you a re sick (vomit) or have very ba d d iarr hoea with in 4 hou rs of taking t he P11 yo ur body may not get its usual dose of hormones from that pi 11. If you are better with in 12 hoursof taking Logynon, fol low the instruction sin section 3A lost pil, which describeshowto ta te another pill.

If you a re st ill sick or have diarrhoea more than 12 hoursafter taking Locynon, see h sedion 3.A missedpilL

Talk toyour dodor if you stomach 14)set carrie son or gets worse. Heorshemay reco nrnend an oth er form of cont racept ion.

Missed a period-couldyou be pregnant?

Occasionally, you may miss a withdrawalbleed. This could mean thatyou are preg nan t, but that is very u nlikely if you ha ve taken your p ills correctly. Sta rt your n extstrip at th e normal time. If you th ink that you might h ave put yourself at ris k of preg nan cy (for example, by missing pills or taking other medicines), or ifyou miss a second bleed,you should do a preg nancy test. You ca n b uy these fromthe chemist or get a free test atyour femily plan ning clinic or doctors surgery. Ifyou are pregn ant,stop taking Logynon a nd see you r dodor.

Taking more than one pill should not cause harm It is unlikely thattaking more than one pillwill do you any harm, but you may feel sick, vomit or have some vaginal bleed ing. Even girts who have not yet started to me nstr ua te bu t have accid en tally taken th is medicine may experience such bleeding. Talktoyour doctor if you ha ve a ny of t hese symptoms.

When you wantto get pregnant

Ifyou areplanningababy.it’sbesttouse another method of contraception after stopping Logynon until you have h ad a p roper period. You r dodor or midwife relies on the date of your lastnatural per bdtotel I you w hen you r baby is du e. However; it will n ot cause you or th e baby any harm if you get pregn ant str aigh t away.

4. possible side effects

Like all medicines, Logynon can cau se side effects, although noteverybodygetst hem. If you get any side effed.pa rticularly if severeandpersistent,or have any cha nge toyou r health t hat you th ink may be du e to Logynon, plea se tai k to your doctor.

An hcreased risk of blood clots in the veins (venous thromboembolism (VTE))or blood clots in the arteries (arterial thromboembolism (ATE))is present for all women using combined hormonal contraceptives. For more detailed information on t he different risks from ta Id n g c ombi ne d hor mona I c 0 ntr ace pti v es pl ea se see section 2 “What you need to know before you use Logynon”.

Tellyou (factor, pharmacist or family planning nurse if you are worrieda bout any side effeds w hich you th ink may be du e to Logy non.

Serious side effects-see a (to dor straight a way Rare side effeds (between land 10 h every lOjOOO users may be affected) ► harmful blood clots in a vein or artery for ecample:

t> in a leg or foot (i.e. DVT)

t> in a lung(i.e. PE)

t> heart attack t> stroke

t> min i-strote or te mporary st roke-like symptoms, known as a tran sient ischa emic attack (TIA)

t> b lood clots in the live 1; stomach/int estine, kidneys or eye.

5. how to store logynon

Keep th is medicine out of the s ig ht and rea ch of children.

Do not use Logynon after the expiry date which is stated on the str ip a fter EXR T he exp ry da te refe rs to the last day of tha tmo nth.

Do not th row away any medic ines via wastewater or household waste. Askyour pharmacist howtothrow away med icinesyou no to nger use. These measures will help protect the environment

6. contents of the pack and other information

What Logynon contains

The a dive substances are levo norgestrel and ethinylestradiol.

Each light brown tablet con tains 50 micrograms levonorgestrela nd 30 micrograms eth iny (estradiol.

Each white tab letcontahs 75 micrograms levonorgestrela nd 40 micrograms eth iny (estradiol Each ochre tablet con tain si 25 microgra ms levonorgestrela nd 30 micrograms eth iny (estradiol All ta blets are s ugar-coa ted.

The other ing redients are:

Lactose, maize starch, povidone, magnesium stearate (E 57 2), su erose, ma crog ol 600 0,

calcium carbonate (El 70) talc, glycolmontan ate, glycerin(E422), titanium dioxide (E171),ferric oxide pigment(red andyellow)(f 172).

W Lbt Logynon looks likeandcontentsof the pack Each box of Logyn on contains th ree strips of 21 coated tablets. Logynon is available in packs of one, t hree an d fifty. Not all pac k sizes may be marketed. Logynon tablets are contained in blister packs consisting of transparent films made of polyvhyl ch tor ide an d rreta Ilic foils made of alumin i urn.

E ach bl iste r pack c onta i ns 6 li gh t b row n tab lets, 5 white tab lets a nd 10 oc hre tablets.

Thecompany ttet holds the productlicence for

Logynon is:

Bayer plq 400South Oak Way, Reading, RG2 6AD

Logynon is made by:

Bayer AG, Mullerstrassel78,

13353 Berlin,Germany

Bayer Weimar GmbH & Co KG, Weimar, Germany.

This leaflet waslast revised in August? (E 0.

Bayer

8744434

Packaging Technology Berlin sqqwx ________ page 2 ____________________________ Bayer AG