Femodene - 63 Tablets (3-month course)

Contraception Doctor Service

Femodene is a Combined Oral Contraceptive (COC) tablet also called "Pill". It contains two types of female hormones in a low dose - a progestogen: gestodene and an oestrogen: ethinylestradiol.

These help to stop you from getting pregnant, just as your natural hormones would stop you conceiving again when you are already pregnant.

The COC pill protects you against getting pregnant in three ways: 

• 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;
• Preventing an egg being released from your ovaries;
• Preventing the lining of your womb thickening enough for an egg to grow in it

Femodene is a 21-day pill – you take one each day for 21 days, followed by 7 days when you take no pills. This combined contraceptive pill can be prescribed for females who experience painful or irregular menstruation in order to ease the pain and regulate the period. 

You can order Femodene tablets from our UK registered online pharmacy and doctor service. To see if you are suitable for this treatment, complete the online assessment and checkout. Our UK registered doctors will review the order and after approval pass the prescription to the Pharmacy team. We will then dispense and dispatch your order to your chosen address.

• Femodene is not intended for use in females whose periods have not yet started.
• Femodene is not intended for use after the menopause.
• This medicine is not recommended for females who have an elevated risk of having thrombosis. 

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 makes your periods regular, lighter and less painful,
• it may help with premenstrual symptoms.

A good self care guide and information for contraceptives is available on the NHS website.

NHS - Contraception

Femodene tablets, like other hormonal contraceptives, do not protect against HIV infection (AIDS) or any other sexually transmitted disease.

What are the side effects of the Contraceptive Pill? 

While side effects are usually uncommon and mild in nature, it is best to be aware of any that may occur. Some of the most common side effects include mood swings, headaches nausea, breast tenderness. For a full list of side effects and more information, you can read the Patient Information Leaflet of the medication.

What are the Advantages of the Combined Oral Contraceptive?

• Can reduce the risk of some cancers
• Can improve acne symptoms 
• Can reduce menopausal symptoms

What are the disadvantages of the Combined Oral Contraceptive?

• Can cause headaches, breast tenderness and mood changes
• Can increase blood pressure
• Can experience breakthrough bleeding

What are the advantages of Progesterone only contraceptives?

• Reduced likelihood of side effects associated with combined pill
• Can be used during breastfeeding
• Can help with premenstrual symptoms

What are the disadvantages of Progesterone only contraceptives?

• Can cause irregular periods
• Can cause periods to be more frequent, or stop altogether
• Must be taken at the same time each day

Which pill is right for me?

Prescribers will take a thorough medical history before choosing the right contraceptive pill for you. For most people, the combined contraceptive pill works best. For those who are over 35, smoke, suffer from migraine or have other risk factors your doctor will look into, the Progesterone-only pill may be more suitable.

Am I protected straight away?

Some pills, if taken correctly, will provide protection immediately, while others take time to provide contraceptive cover. Refer to your patient information leaflet to find out when you are protected on your pill.

Do I still need to use a condom?

Although you will be covered against pregnancy with the pill, it is always advised to use a condom. This is to reduce the risk of sexually transmitted diseases such as chlamydia and gonorrhoea.

I forgot to take my pill – what should I do?

You should always take your pill around the same time each day to ensure maximum contraceptive cover. Different pills vary in the amount of time you can delay your dose. Always refer to your prescribed medication’s patient information leaflet to find more detailed information relating to missed doses.

Like all medicines, Femodene can cause side effects, although not everybody gets them. If you get any side effects, particularly if severe and persistent, or have any change to your health that you think may be due to Femodene, 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. 

The following is a list of the side effects that have been linked with the use of Femodene:

Serious side effects – See a doctor straight away

Rare side effects (between 1 and 10 in every 10,000 users may be affected)

• harmful blood clots in a vein or artery for example:
• in a leg or foot (i.e. DVT)
• in a lung (i.e. PE)
• heart attack
• stroke
• mini-stroke or temporary stroke-like symptoms, known as a transient
• ischaemic attack (TIA)
• 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. For more information, please read the Patient Information Leaflet.

Signs of a severe allergic reaction or worsening of hereditary angioedema:
▪ swelling of the hands, face, lips, mouth, tongue or throat. A swollen tongue/throat may lead to difficulty swallowing and breathing
▪ a red bumpy rash (hives) and itching.

Signs of 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 smells and/or contains blood
▪ unusual vaginal bleeding
▪ pelvic pain
▪ painful sex.

Signs of severe liver problems include:
▪ severe pain in your 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 Femodene.

Less serious side effects

Common side effects (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 painful breasts.

Uncommon side effects (between 10 and 100 in every 10,000 users may be affected)

• being sick and stomach upsets
• fluid retention
• migraine
• loss of interest in sex
• breast enlargement
• skin rash, which may be itchy.

Rare side effects (between 1 and 10 in every 10,000 users may be affected)

• poor tolerance of contact lenses
• losing weight
• increase of interest in sex
• vaginal or breast discharge.

Other side effects reported

• Bleeding and spotting between your periods can sometimes occur for the first few months but this usually stops once your body has adjusted to Femodene. If it continues, becomes heavy or starts again, contact your doctor.
• Chloasma (yellow brown patches on the skin). This may happen even if you have been using Femodene ED 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
• Ulcerative colitis
• Conditions that may worsen during pregnancy or previous use of the Pill:

- yellowing of the skin (jaundice)

- persistent itching (pruritus)

- kidney or liver problems

- gallstones

- certain rare medical conditions such as systemic lupus erythematosus

- blister-like rash (herpes gestationis) whilst pregnant

- an inherited form of deafness (otosclerosis)

- a personal or family history of a form of sickle cell disease

- swelling of body parts (hereditary angioedema)

- an inherited disease called porphyria

- cancer of the cervix

- Crohn’s disease

For a full list of side effects, read the Patient Information Leaflet.

If you get any side effects, talk to your doctor, our Rightdose pharmacists or nurse. This includes any possible side effects not listed in this leaflet.

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Before taking any medication, it is important to read the Patient Information Leaflet. You can find information leaflets for your medicines by typing them into the search bar at medicines.org, or by contacting us.

Patient Information Leaflet Femodene (Packs of 3x21 Tablets)

Before you start taking the Pill

Your doctor will ask about you and your family’s medical problems and 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.
• 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.
• 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 sure your 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. Your doctor will tell you when you can start taking the Pill again.

Other medicines and Femodene 

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 Femodene. 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 Femodene 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 (socalled protease inhibitors and non nucleoside reverse transcriptase inhibitors)
• griseofulvin (an antifungal medicine)
• certain antibiotics
• certain sedatives (called barbiturates)
• St. John’s Wort (a herbal remedy).

If you do need to take one of these medicines, Femodene 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.

Femodene can also affect how well other medicines work. Your doctor may need to adjust the dose of your other medicine. In addition, Femodene can also interfere with the results of some blood tests, so always tell your doctor that you are taking Femodene if you have a blood test.

Pregnancy and breastfeeding

Do not use Femodene if you are pregnant. If you think you might be pregnant, do a pregnancy test to confirm that you are before you stop taking Femodene. If you are breastfeeding, your doctor or family planning nurse may advise you not to take Femodene. They will be able to suggest alternative contraception. Breastfeeding may not stop you getting pregnant.

Driving and using machines

Femodene has no known effect on the ability to drive or use machines.

Taking Femodene with food and drink

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

Femodene contains lactose and sucrose

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

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

How to store Femodene

• Do not use Femodene after the expiry date shown on the strip.
• Do not store above 25°C and protect from light.
• 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.

Keep all medicines out of the sight and reach of children.

Before using any medication, it is important to read the Patient Information Leaflet. You can find information leaflets for your medicines by typing them into the search bar at medicines.org, or by contacting us.

Femodene tablet is for oral use only.

How to take Femodene

• Take Femodene every day for 21 days. Femodene comes in strips of 21 pills, each marked with a day of the week.
• Take your pill at the same time every day. Start by taking a pill marked with the correct day of the week. Follow the direction of the arrows on the strip. Take one pill each day, until you have finished all 21 pills.
• Swallow each pill whole, with water if necessary. Do not chew the pill.
• Then have seven pill-free days. After you 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 will take the first pill of your next pack on the Saturday of the following week.
• Within a few days of taking the last pill from 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 Femodene after the seven pill-free days – even if you are still bleeding. Always start the new strip on time. As long as you take Femodene correctly, you will always start each new strip on the same day of the week.

Starting Femodene 

As a new user or starting the Pill again after a break. It is best to take your first Femodene 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 Femodene from another contraceptive Pill

• If you are currently taking a 21-day Pill: start Femodene 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 Femodene.
• If you are currently taking a 28-day Pill: start taking Femodene 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 Femodene.
• Or, if you are taking a progestogen-only Pill (POP or ‘mini Pill’): start Femodene 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 Femodene 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 Femodene straight away. This means that you will have contraceptive protection with your first pill. If you have had a miscarriage or an abortion after the third month of pregnancy, ask your doctor for advice. You may need to use extra contraception, such as condoms, for a short time.

Starting Femodene after having a baby

If you have just had a baby, your doctor may advise you that Femodene should be started 21 days after delivery provided that you are fully mobile. You do not have to wait for a period. You will need to use another method of contraception, such as a condom, until you start Femodene and for the first 7 days of pill taking.

If you take more Femodene than you should

It is unlikely that taking more than one pill will do you any harm, but you may feel sick, vomit or bleed from the vagina. 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.

If you want to stop taking Femodene

If you are planning a baby, it’s best to use another method of contraception after stopping Femodene 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.

If you miss one pill and are less than 12 hours late then your protection from pregnancy will not be reduced. You should take the missed tablet as soon as you remember even if it means taking two in one day. Take the following pills at your usual time.

If you are more than 12 hours late taking your pill, your protection from pregnancy may be reduced. Continue to take your pill as normal but you should avoid unprotected sex for 7 days. If you have already had unprotected sex (after your missed pill), you will need to use emergency contraception.

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

Do not use Femodene

You should not use Femodene 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.

• 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, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies
• If you need an operation or if you are off your feet for a long time 
• 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 clot in the arteries:

- severe diabetes with blood vessel damage
- very high blood pressure
- a very high level of fat in the blood (cholesterol or triglycerides)
- 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 not yet back to normal
• If you have ever had liver tumours
• If you are allergic (hypersensitive) to any of the ingredients in Femodene.

Do not use Femodene if you have hepatitis C and are taking the medicinal products containing ombitasvir / paritaprevir / ritonavir and dasabuvir or glecaprevir / pibrentasvir.

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.
For a description of the symptoms of these serious side effects please read the Patient Information Leaflet.

Blood Clots

Using a combined hormonal contraceptive such as Femodene 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);

Warnings and precautions

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 Femodene 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 Femodene, you should also tell your doctor.

• If you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
• If you have systemic lupus erythematosus (SLE – a disease affecting your natural defence system)
• If you have haemolytic uraemic syndrome (HUS – a disorder of blood clotting causing failure of the kidneys)
• If you have sickle cell anaemia (an inherited disease of the red blood cells)
• If you have inflammation 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
• 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 Femodene 
• 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 your heart, 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 Pill.

What Femodene contains

Each box of Femodene contains three strips of 21 tablets.

Each strip of Femodene contains 21 white tablets containing 75 micrograms of the progestogen gestodene and 30 micrograms of the oestrogen ethinylestradiol.

Femodene also contains the inactive ingredients: Lactose, maize starch, povidone, magnesium stearate (E572), sodium calcium edetate, sucrose, macrogol 6000, calcium carbonate (E170), talc, montan glycol wax.