Femodette Film-coated Tablets (Pack of 3x21 Tablets)

Contraception Doctor Service

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

These pills like Gedarel and Marvelon or Mercilon help to stop you from getting pregnant, just as your natural hormones would stop you from conceiving again when you are already pregnant.

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

• Stop the ovary from releasing an egg each month (ovulation)
• Alter the lining of the womb to make it less likely to accept a fertilised egg
• Also thicken the fluid (at the neck of the womb making it more difficult for the sperm to reach the egg

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. 

The Benefits Of Taking Femodette Include:

• it usually makes your periods regular, lighter and less painful
• it is one of the most reliable reversible methods of contraception if used correctly
• oral contraceptive tablets doesn’t interrupt sex
• it may help with premenstrual symptoms.

Although it is not recommended for females who have an elevated risk of having thrombosis. 

• Femodette tablets are not recommended for use in adolescents under 18 years. The safety and efficacy of this contraceptive tablet in this age group has not been established. 

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

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 NHS Choices site on contraception.

What are the advantages of the Combined Oral Contraceptive?

• Can reduce the risk of some cancers
• Can improve acne symptoms (Dianette)
• 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 Combined Oral 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 Femodette can cause side effects, although not everybody gets them. While side effects are usually uncommon and mild in nature, it is best to be aware of any that may occur.

An increased risk of blood clots in your arteries is present for all women taking combined hormonal contraceptives. The risk of getting a blood clot is very small, but your doctor will check if you have certain risk factors before prescribing the pill.

Common side effects (between 100 and 1000 in every 10000 users may be affected)  - contact your doctor is these persist or are uncomfortable:

• 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 10000 users may be affected)

• Being sick and stomach upsets
• Fluid retention
• Migraine
• Loss of interest in sex
• Breast enlargement
• Skin rash which is itchy

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.
• 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 severe liver problems include: severe pain in your upper abdomen, yellow skin or eyes, inflammation of the liver, your whole body starts itching.

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 Femodette. 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 Femodette for a number of months. Chloasma may be reduced by avoiding too much sunlight and/or UV lamps.

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 Femodette Film-coated Tablets (Pack of 3x21 Tablets)

Important information about Combined Hormonal Contraceptives

• They are one of the most reliable reversible methods of contraceptives if used correctly.
• They slightly increase the risk of having a blood clot in their veins and arteries, especially in the first year 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 more information in the Patient Information Leaflet (referred to as how to recognise a blood clot).

Other medicines and Femodette

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use Mercilon. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so how long., or if you may need to change the dose of other medicines you use.

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 Femodette and can stop it from working properly – for example:

• some medicines used to treat epilepsy
• some medicines used to treat HIV and Hepatitis C Virus infections (so-called protease inhibitors and non nucleoside reverse transcriptase inhibitors)
• griseofulvin (an 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, Femodette 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.

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

Taking Femodette with food and drink: There are no special instructions about food and drink while on Femodette.

Femodette contains lactose and sucrose

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

Pregnancy and breast-feeding

Do not use Femodette if you are pregnant. If you think you might be pregnant, do a pregnancy test to confirm that you are before you stop taking Femodette.

If you are breast-feeding, your doctor or family planning nurse may advise you not to take Femodette. They will be able to suggest alternative contraception. Breast-feeding may not stop you getting pregnant.

Driving and using machines

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

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

How to store Femodette

• Do not use this medicine after the expiry date which is stated on the carton and the tube after EXP. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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.

Femodette tablet is for oral use only.

No clinical data on efficacy and safety are available in adolescents below 18 years.

Before you start taking the Femodette:

Your doctor will ask about you and your family’s medical problems and check your blood pressure. You may also need other checks, such as a breast examination.

While you’re on the Femodette:

• You will need regular check-ups with your doctor or family planning nurse, usually when you need another prescription of Femodette.
• 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 Femodette, 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 contraceptive tablets about 4–6 weeks before the operation. This is to reduce the risk of blood clots. Your doctor will tell you when you can start taking the Pill again.

Always use this medicine exactly as described in the patient information leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Each pack of Femodette contains 1 calendar strip of 21 coated tablets. The calendar strip has been designed to help you remember to take your tablet, and each tablet marked with the day of the week it should be taken on. 

Directions:

• 1. Swallow one tablet per day with water for 21 days. As a new user or starting the Pill again after a break take the first tablet on the first day of your period. By starting in this way, you will have contraceptive protection with your first pill. The first day of your cycle - the day when bleeding starts. Take a tablet marked for the day of the week (for example, if it is Tuesday when your period starts, take the tablet marked Tuesday on the pack). Follow the direction of the arrow and continue to take one tablet each day until the strip is empty.
  If you start on day 2-5 of your period, you should use another method of contraception as well, such as condom for the first seven tablet-taking days, but this is only for the first pack.

Try to take the pill at the same time each day. It can be taken at any time but taking it at the same time everyday will increase its effectiveness.

• 2. After 21 days, you will take a 7-day pill free break. During the break, you will have a withdrawal bleed, like your period. You will still be protected from pregnancy during the 7-day break if you took all the pills as instructed during the week before your break.
• 3. After the 7-day break, start your next strip on the day 8th - even if the bleeding has not ended yet.
  As long as you take Femodette correctly, you will always start each strip on the same day of the week, and you will always have your monthly period on the same day of the week in each month (in every 28 days). 

What happens if you miss a Femodette pill?

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 miss a pill and your strip ends within the next six days, you should skip your usual 7-day break and continue with the next strip of pills.

Can I take Femodette without a break?

Yes, you can take Gedarel without a break and this can reduce side effects in some women.

Warnings and precautions

• Talk to your doctor or pharmacist before taking Femodette tablets.

When should you contact your doctor or 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), heart attack or a stroke.

For a description of the symptoms of these serious side effects please read the Patient Information Leaflet. If you have any further questions, ask your doctor or pharmacist.

Tell your doctor if any of the following conditions apply to you:

If the condition develops, or gets worse while you are using Femodette, 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 Femodette
• 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

Femodette tablets are not recommended for use in adolescents under 18 years. The safety and efficacy of this contraceptive tablet in this age group has not been established.

Ingredients:

The active substances are desogestrel and ethinyl estradiol. Each box of Femodette contains 21 white sugar-coated tablets containing 75mg of the progestogen gestodene, and 20mg of the oestrogen ethinylestradiol.

The other ingredients are: lactose, maize starch, povidone, magnesium stearate, sucrose, macrogol 6000, calcium carbonate, talc, montan glycol wax.