Logynon ED tablets

Main information

  • Trade name:
  • Logynon ED tablets
  • Pharmaceutical form:
  • Not applicable
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Never Valid To Prescribe As A VMP
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Logynon ED tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 07030100; GTIN: 5016703004127

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 00010/0541
  • Last update:
  • 11-07-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

This area must be identical on both sides!

Levonorgestrel

Ethinylestradiol

!

Important things to know about

combined hormonal

contraceptives (CHCs):

R They are one of the most reliable reversible

methods of contraception if used correctly.

R 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.

R Please be alert and see your doctor if you

think you may have symptoms of a blood

clot (see section 2.3 ‘Blood clots’).

R The Pill may reduce your risk of cancer of

the ovary and womb if used in the long

term.

R The Pill will not protect you against sexually

transmitted diseases.

R This medicine can increase your risk of

problems such as blood clots and breast

cancer.

R Some women should not take the Pill

because of current medical problems or

illnesses. Please read this leaflet to make

sure Logynon ED is right for you.

R To prevent pregnancy it is important to take

Logynon ED as instructed and start each

pack 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.

R Keep this leaflet. You may need to read it

again.

R If you have any questions or need more

advice, ask your doctor, family planning

nurse or pharmacist.

R This medicine has been prescribed for you.

Do not pass it on to others. It may harm

them.

R 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.

In this leaflet:

1. What Logynon ED does

2. What you need to know before you use

Logynon ED

3. Taking Logynon ED

3.3 A missed pill

4. Possible side effects

5. How to store Logynon ED

6. What is in Logynon ED and who makes it

1. What Logynon ED does

Logynon ED is a combined oral contraceptive

pill (‘the 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 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 ED is taken every day without a break.

You take an ‘active pill’ each day for 21 days,

followed by an ‘inactive pill’ each day for 7

days.

The benef

its of taking the Pill include:

R it is one of the most reliable reversible

methods of contraception if used correctly

R it doesn’t interrupt sex

R it usually makes your periods regular,

lighter and less painful

R it may help with pre-menstrual symptoms.

Logynon ED will not protect you against sexually

transmitted infections, such as Chlamydia or HIV.

Only condoms can help to do this.

Logynon ED needs to be taken as directed to

prevent pregnancy.

2. What you need to know

before you use Logynon ED

General notes

Before you start using Logynon ED you should

read the information on blood clots in section

2.3. It is particularly important to read the

symptoms of a blood clot – see Section

2.3 ‘Blood clots’.

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 or risk factors mentioned in this

leaflet.

Before you start taking the Pill

R 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

R You will need regular check-ups with your

doctor or family planning nurse, usually

when you need another prescription of

the Pill.

R You should go for regular cervical smear

tests.

R Check your breasts and nipples every

month for changes – tell your doctor if you

can see or feel anything odd, such as lumps

or dimpling of the skin.

R 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.

R If you’re going to have an operation,

make sure your doctor knows about it.

You may need to stop taking the Pill about

4–6 weeks bef

ore the operation. This is to

reduce the risk of a blood clot (see section

2.3). Your doctor will tell you when you can

start taking the Pill again.

2.1

When you should not use Logynon ED

You should not use Logynon ED if you have any

of the conditions listed below. If you do have

any of the conditions listed below, you must tell

your doctor. Your doctor will discuss with you

what other form of birth control would be more

appropriate.

Do not use Logynon ED:

R 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

R 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

R If you need an operation or if you are off

your feet for a long time (see section

2.3 ‘Blood clots’)

R If you have ever had a heart attack or stroke

R 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)

R If you have any of the following diseases

that may increase your risk of a clot in the

arteries:

P severe diabetes with blood vessel

damage

P very high blood pressure

P a very high level of fat in the blood

(cholesterol or triglycerides)

P a condition known as

hyperhomocysteinaemia

R If you have (or have ever had) a type of

migraine called ‘migraine with aura’

R If you have or have ever had breast cancer

R If you have ever had a severe liver disease,

and you have been told by your doctor that

your liver function test results are not yet

back to normal

R If you have ever had liver tumours

R If you are allergic (hypersensitive) to any of

the ingredients in Logynon ED.

Do not use Logynon ED if you have hepatitis C

and are taking the medicinal products

containing ombitasvir/paritaprevir/ritonavir and

dasabuvir (see also in section “Taking other

medicines”).

. Tell your doctor or family planning nurse

if you have any medical problems or

illnesses.

2.2

When to take special care with

Logynon ED

When should you contact your doctor?

Seek urgent medical attention

R 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 clot”.

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 ED but you need to take special

care and have check-ups more often.

Tell your doctor if any of the following

conditions apply to you.

If the condition develops, or gets worse while

you are using Logynon ED, you should also tell

your doctor.

R If you have Crohn’s disease or ulcerative

colitis (chronic inflammatory bowel disease)

R If you have systemic lupus erythematosus

(SLE – a disease affecting your natural

defence system)

R If you have haemolytic uraemic syndrome

(HUS – a disorder of blood clotting causing

failure of the kidneys)

R If you have sickle cell anaemia (an inherited

disease of the red blood cells)

R If you have inflammation of the pancreas

(pancreatitis)

R 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)

R If you need an operation, or you are off your

feet for a long time (see in section 2.3 ‘Blood

clots’)

R 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 ED

R If you have an inflammation in the veins

under the skin (superficial thrombophlebitis)

R If you have varicose veins

R If you have diabetes

R If you or your close family have ever had

problems with your heart, or circulation

such as high blood pressure

R If you or your close family have ever had

problems with blood clotting

R If you have the inherited disease called

porphyria

R If you are overweight (obese)

R If you have migraines

R If you have any illness that worsened during

pregnancy or previous use of the Pill (see

section 4.2)

2.3

Blood clots

Using a combined hormonal contraceptive such

as Logynon ED 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:

R in veins (referred to as a ‘venous thrombosis’,

‘venous thromboembolism’ or VTE);

R 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 ED 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?

R swelling of one leg or

along a vein in the leg or

foot especially when

accompanied by:

P pain or tenderness in

the leg which may be

felt only when

standing or walking

P increased warmth in

the affected leg

P change in colour of

the skin on the leg

e.g. turning pale, red

or blue

Deep vein

thrombosis

R sudden unexplained

breathlessness or rapid

breathing

R sudden cough without an

obvious cause, which may

bring up blood

R sharp chest pain which

may increase with deep

breathing

R severe light headedness

or dizziness

R rapid or irregular

heartbeat

R 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 cold’).

Pulmonary

embolism

Symptoms most commonly

occur in one eye:

R immediate loss of vision

R painless blurring of vision

which can progress to

loss of vision

Retinal vein

thrombosis

(blood clot in

the eye)

R chest pain, discomfort,

pressure, heaviness

R sensation of squeezing or

fullness in the chest, arm

or below the breastbone

R fullness, indigestion or

choking feeling

R upper body discomfort

radiating to the back, jaw,

throat, arm and stomach

R sweating, nausea,

vomiting or dizziness

R extreme weakness,

anxiety, or shortness of

breath

R rapid or irregular

heartbeats

Heart attack

R sudden weakness or

numbness of the face,

arm or leg, especially on

one side of the body

R sudden confusion, trouble

speaking or

understanding

R sudden trouble seeing in

one or both eyes

R sudden trouble walking,

dizziness, loss of balance

or coordination

R sudden, severe or

prolonged headache with

no known cause

R 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.

Stroke

R swelling and slight blue

discolouration of an

extremity

R severe pain in your

stomach (acute abdomen)

Blood clots

blocking

other blood

vessels

. See a doctor as soon as possible. Do not

take any more Logynon ED until your

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?

R 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.

R If a blood clot forms in a vein in the leg or

foot it can cause a deep vein thrombosis

(DVT).

R If a blood clot travels from the leg and

lodges in the lung it can cause a pulmonary

embolism.

R 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 Logynon ED 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 ED is small.

R 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.

R Out of 10,000 women who are using a

combined hormonal contraceptive that

contains levonorgestrel, such as Logynon

ED, about 5-7 will develop a blood clot in a

year.

R 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 in a vein” below).

Risk of developing a

blood clot in a year

Women who are not

using a combined

hormonal pill and are

not pregnant

About 2 out of

10,000 women

Women using a

combined hormonal

contraceptive pill

containing

levonorgestrel

About 5-7 out of

10,000 women

Women using

Logynon ED

About 5-7 out of

10,000 women

Factors that increase your risk of a blood clot

in a vein

The risk of a blood clot with Logynon ED is small

but some conditions will increase the risk. Your

risk is higher:

R if you are very overweight (body mass index

or BMI over 30kg/m

R 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

R 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 Logynon ED may need to be

stopped several weeks before surgery or

while you are less mobile. If you need to

stop Logynon ED ask your doctor when you

can start using it again.

R as you get older (particularly above about

35 years)

R 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 Logynon ED needs

to be stopped.

If any of the above conditions change while you

are using Logynon ED, 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 Logynon ED is very

small but can increase:

R with increasing age (beyond about 35 years)

R if you smoke. When using a combined

hormonal contraceptive like Logynon ED,

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

R if you are overweight

R if you have high blood pressure

R 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

R if you, or someone in your immediate family,

have a high level of fat in the blood

(cholesterol or triglycerides)

R if you get migraines, especially migraines

with aura

R if you have a problem with your heart (valve

disorder, disturbance of the rhythm called

atrial fibrillation)

R 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 Logynon ED, 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.

2.4

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 clear whether lower dose Pills like

Logynon ED also provide the same protective

effects. However, it also seems that taking the

Pill slightly increases your 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:

R Of 10,000 women who have never taken

the Pill, about 16 will have breast cancer

by the time they are 35 years old.

R 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.

R Of 10,000 women who have never taken

the Pill, about 100 will have breast cancer

by the time they are 45 years old.

R Of 10,000 women who take the Pill for 5

years in their early thirties, about 110

will have breast cancer by the time they are

45 years old.

Y

our risk of breast cancer is higher:

R if you have a close relative (mother, sister or

grandmother) who has had breast cancer

R 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 Pill has

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 (jaundice). You may

need to stop taking Logynon ED.

2.5

Psychiatric disorders

Some women using hormonal contraceptives

including Logynon ED have reported depression

or depressed mood. Depression can be serious

and may sometimes lead to suicidal thoughts. If

you experience mood changes and depressive

symptoms contact your doctor for further

medical advice as soon as possible.

2.6

Taking other medicines

If you ever need to take another medicine at the

same time as being on the Pill, always tell your

doctor, pharmacist or dentist that you’re taking

Logynon ED. Also check the leaflets that come

with all your medicines to see if they can be

taken with hormonal contraceptives.

Some medicines can have an influence on the

blood levels of Logynon ED and can stop it from

working properly – for example:

R some medicines used to treat epilepsy

R some medicines used to treat HIV

and Hepatitis C Virus infections (so-called

protease inhibitors and non-nucleoside

reverse transcriptase inhibitors)

R griseofulvin (an anti-fungal medicine)

R certain antibiotics

R certain sedatives (called barbiturates)

R St. John’s Wort (a herbal remedy).

If you do need to take one of these medicines,

Logynon ED may not be suitable for you or

you may need to use extra contraception for a

while. Your doctor, pharmacist or dentist can

tell you if this is necessary and for how long.

Logynon ED can also affect how well other

medicines work. Your doctor may need to

adjust the dose of your other medicine.

In addition, Logynon ED can also interfere with

the results of some blood tests, so always tell

your doctor that you are taking Logynon ED if

you have a blood test.

Do not use Logynon ED 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. Logynon ED can

be restarted approximately 2 weeks after

completion of this treatment. See section “Do

not use Logynon ED”.

2.7

Taking Logynon ED with food and drink

There are no special instructions about food and

drink while on Logynon ED.

2.8

Pregnancy and breast-feeding

Do not use Logynon ED if you are pregnant.

If you think you might be pregnant, do a

pregnancy test to confirm that you are before

you stop taking Logynon ED.

If you are breast-feeding, your doctor or

family planning nurse may advise you not to

take Logynon ED. They will be able to suggest

alternative contraception. Breast-feeding may

not stop you getting pregnant.

2.9

Driving and using machines

Logynon ED has no known effect on the ability

to drive or use machines.

2.10 Logynon ED contains lactose and

sucrose

you have been told by your doctor that you

have intolerance to some sugars, contact your

doctor before using Logynon ED.

3. Taking Logynon ED

3.1

How to take it

To prevent pregnancy, always take Logynon ED

as described below. Check with your doctor or

family planning nurse if you are not sure.

This pack is designed to help you remember

to take your pills. Your pack contains 3 foil

memo strips with 3 sets of

7 self-adhesive

strips showing the days of the week. Each foil

memo strip contains 28 tablets: 21 small active

tablets in 3 rows (6 red, 5 white and 10 ochre-

coloured tablets) and 7 larger, white, inactive

tablets in the last row.

Take Logynon ED every day for 28 days

R Find the set of self-adhesive strips. Each

strip starts with a different day of the

week. Peel off a strip that starts with your

starting day

R For instance, if you start the tablets on a

Wednesday, use a strip that starts with

‘Wed’.

R Stick the strip along the top of the foil

memo-strip so that the first day is above

the pill marked ‘start’.

R You can now see on which day you have to

take each tablet.

R Take your pill at the same time every day.

R Follow the direction of the arrows on the

strip. Take one pill each day, until you have

finished all 28 pills.

R Swallow each pill whole, with water if

necessary. Do not chew the pill.

Then start your next strip

Start taking your next strip of Logynon ED the

next day. Do not leave a gap between packs.

As long as you take Logynon ED correctly, you

will always start each new strip on the same

day of the week.

3.2

Starting Logynon ED

As a new user or starting the Pill again after

a break

It is best to take your first Logynon ED pill on the

first day of your next period. By starting in this

way, you will have contraceptive protection with

your first pill.

Changing to Logynon ED from another

contraceptive Pill

R If you are currently taking a 21-day Pill:

start Logynon ED the next day after the end

of the previous strip. You will have

contraceptive protection with your first pill.

You will not have a bleed until after your

first strip of Logynon ED.

R If you are taking a 28-day Pill: start taking

Logynon ED the day after your last active

pill. You will have contraceptive protection

with your first pill. You will not have a bleed

until after your first strip of Logynon ED.

R Or, if you are taking a progestogen-only

Pill (POP or ‘mini Pill’): start Logynon ED on

the first day of bleeding, even if you have

already taken the progestogen-only Pill for

that day. You will have contraceptive cover

straight away.

Starting Logynon ED after a miscarriage or

abortion

If you have had a miscarriage or an abortion

during the first three months of pregnancy,

your doctor may tell you to start taking Logynon

ED straight away. This means that you will have

contraceptive protection with your first pill.

Package leaflet: Information for the user

Logynon

ED

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1.3.2

86672553

A missed pill

If you miss a pill, follow these instructions:

What kind of pill did you miss?

Active (small)

Inactive (large)

When were you due to take the missed pill?

More than 12 hours ago,

or you have missed

more than one pill.

Complete your pack as usual

before starting the next one

If you 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 your doctor, family planning

nurse or pharmacist for advice as

soon as possible. They may

recommend you use emergency

contraception.

When you finish the active pills,

throw away the large

inactive tablets and start the next strip the next day.

You may see some bleeding on the days you take the active

pills, but do not worry.

If you do not have a period after the second pack, you must

talk to your doctor before you start the next pack.

If you 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 your doctor, family

planning nurse or pharmacist for advice as soon as possible.

Take the most recently missed pill straight away.

Leave any earlier missed pills in the strip.

Take your further pills as usual. This may mean taking

two pills in one day.

Use extra precautions (condoms for instance) for

the next 7 days.

Check how many active pills are left in the strip

after the most recently missed pill.

Take the 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 not be reduced.

Less than 12 hours ago

7 or more active pills left

Fewer than 7 active pills left

If you have missed any of the pills in a strip, and

you do not bleed while taking the large inactive

pills, 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, you may not

be protected from pregnancy. If you had sex 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

condoms, for seven days.

3.4

A lost pill

If you lose an active pill,

Either take the last active pill of the strip in place

of the lost pill. Then take all the other pills on their

proper days. Your cycle will be one day shorter than

normal, but your contraceptive protection won’t be

affected. After taking the large white inactive pills

you will have a new starting day, one day earlier

than before.

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 all the other pills from your current

strip as usual. You can then keep the opened spare

strip in case you lose any more pills.

If you lose an inactive pill, don’t worry, just

continue taking the remaining tablets at the

correct time. Your contraceptive protection won’t

be affected.

3.5

If you are sick or have diarrhoea

If you are sick (vomit) 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 ED,

follow the instructions in section 3.4 A lost pill,

which describes how to take another pill.

If you are still sick or have diarrhoea more than 12

hours after taking Logynon ED, see section 3.3, A

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 could 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 ED and see your

doctor.

3.7

Taking more than one pill should not cause

harm

It is unlikely that taking more than one pill will do

you any harm, but you may feel sick, vomit or have

some vaginal bleeding. Even girls who have not yet

started to menstruate but have accidentally taken

this medicine may experience such 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

ED 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 away.

4. Possible side effects

Like all medicines, Logynon ED 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 Logynon ED, please talk to

your doctor.

An increased 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

the different risks from taking combined hormonal

contraceptives please see section 2 “What you need

to know before you use Logynon ED”.

. Tell your doctor, pharmacist or family

planning nurse if you are worried about any

side effects which you think may be due to

Logynon ED.

4.1

Serious side effects – see a doctor straight

away

Rare side effects (between 1 and 10 in every

10,000 users may be affected)

R harmful blood clots in a vein or artery for

example:

P in a leg or foot (i.e. DVT)

P in a lung (i.e. PE)

P heart attack

P stroke

P mini-stroke or temporary stroke-like

symptoms, known as a transient ischaemic

attack (TIA)

P 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 2.3 for more information on the

conditions that increase risk for blood clots and the

symptoms of a blood clot).

Signs of a blood clot (see section 2.3 ‘Blood clots’)

Signs of a severe allergic reaction or worsening

of hereditary angioedema:

R swelling of the hands, face, lips, mouth,

tongue or throat. A swollen tongue/throat

may lead to difficulty swallowing and

breathing

R a red bumpy rash (hives) and itching.

Signs of breast cancer include:

R dimpling of the skin

R changes in the nipple

R any lumps you can see or feel.

Signs of cancer of the cervix include:

R vaginal discharge that smells and/or contains

blood

R unusual vaginal bleeding

R pelvic pain

R painful sex.

Signs of severe liver problems include:

R severe pain in your upper abdomen

R yellow skin or eyes (jaundice)

R inflammation of the liver (hepatitis)

R 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 ED.

4.2

Less serious side effects

Common side effects (between 100 and 1000 in

every 10,000 users may be affected)

R feeling sick

R stomach ache

R putting on weight

R headaches

R depressive moods or mood swings

R sore or painful breasts

Uncommon side effects (between 10 and 100 in

every 10,000 users may be affected)

R being sick and stomach upsets

R fluid retention

R migraine

R loss of interest in sex

R breast enlargement

R skin rash, which may be itchy

Rare side effects (between 1 and 10 in every

10,000 users may be affected)

R poor tolerance of contact lenses

R losing weight

R increase of interest in sex

R vaginal or breast discharge

Other side effects reported

R Bleeding and spotting between your periods

can sometimes occur for the first few months

but this usually stops once your body has

adjusted to Logynon ED. If it continues,

becomes heavy or starts again, contact your

doctor (see section 4.3)

R Chloasma (yellow brown patches on the skin).

This may happen even if you have been using

Logynon ED for a number of months.

Chloasma may be reduced by avoiding too

much sunlight and/or UV lamps

R Occurrence or deterioration of the movement

disorder chorea

R Crohn’s disease or ulcerative colitis

R Conditions that may worsen during

pregnancy or previous use of the Pill:

P yellowing of the skin (jaundice)

P persistent itching (pruritus)

P kidney or liver problems

P gall stones

P certain rare medical conditions such as

systemic lupus erythematosus

P blister-like rash (herpes gestationis) whilst

pregnant

P an inherited form of deafness (otosclerosis)

P a personal or family history of a form of

sickle cell disease

P swelling of body parts (hereditary

angioedema)

P an inherited disease called porphyria

P cancer of the cervix

. Tell your doctor, pharmacist or family

planning nurse if you are worried about any

side effects which you think may be due to

Logynon ED. Also tell them if any existing

conditions get worse while you are taking

Logynon ED.

4.3

Bleeding between periods should not last

long

A few women have a little unexpected bleeding or

spotting while they are taking Logynon ED,

especially during the first few months. Normally,

this bleeding is nothing to worry about and will

stop after a day or two. Keep taking Logynon ED 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 can sometimes be caused by other

medicines.

. Make an appointment to see your doctor if

you get breakthrough bleeding or spotting

that:

R carries on for more than the first few months

R starts after you’ve been taking Logynon ED for

a while

R carries on even after you’ve stopped taking

Logynon ED.

Reporting of side effects

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. You can also

report side effects directly via the Yellow Card

Scheme at: www.mhra.gov.uk/yellowcard or search

for MHRA Yellow Card in the Google Play or Apple

App Store.

By reporting side effects you can help provide more

information on the safety of this medicine.

5. How to store Logynon ED

Keep all medicines out of the sight and reach of

children.

Do not use Logynon ED after the expiry date shown

on the strip.

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 ED and

who makes it

What is in Logynon ED

Each box of Logynon ED contains three strips of 28

tablets (21 active tablets and 7 larger inactive

tablets).

Each memo strip of Logynon ED contains:

6 red tablets containing 50 micrograms

levonorgestrel and 30 micrograms ethinylestradiol

5 white tablets containing 75 micrograms

levonorgestrel and 40 micrograms ethinylestradiol

10 ochre tablets containing 125 micrograms

levonorgestrel and 30 micrograms ethinylestradiol

7 larger, white, inactive tablets. All tablets are

sugar-coated. Levonorgestrel is a progestogen and

ethinylestradiol is an oestrogen.

Logynon ED also contains the inactive ingredients:

Lactose, maize starch, povidone, magnesium

stearate (E572), sucrose, polyethylene glycol 6000,

calcium carbonate (E170), talc, montan glycol wax,

glycerin (E422), titanium dioxide (E171), ferric

oxide pigment (red and yellow) (E172).

The company that holds the product licence for

Logynon ED is:

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

Logynon ED is made by:

Bayer AG, Mullerstrasse 178,

13353 Berlin, Germany

Bayer Weimar GmbH & Co KG, Weimar, Germany

This leaflet was last revised in

December 2018.

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12/13/2018 8:16:56 AM

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