Gedarel 20/150mcg - 63 Tablets (3-month course)

Contraception Doctor Service

Gedarel is a Combined Oral Contraceptive (COC) tablet also called pill. It contains two types of female hormones in a low dose: a progestogen, 150 micrograms desogestrel and an oestrogen, 20 micrograms ethinylestradiol in a low dose.

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: These hormones:

• Alter the lining of the womb to make it less likely to accept a fertilised egg
• Stop the ovary from releasing an egg each month (ovulation)
• 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 safety and efficacy in adolescents below 18 years has not been established.
• This medicine is not recommended for females who have an elevated risk of having thrombosis. 

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

NHS - Contraception

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 (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 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 Gedarel 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 or blood clots in your arteries is present for all women taking combined hormonal contraceptives.

Very common (may affect more than 1 in 10 people)

• irregular bleeding.

Common side effects (may affect up to 1 in 10 people)

• depression, mood altered, nervousness, headache, dizziness, acne, abdominal pain, nausea, menstruation pain, absence of menstruation, tender breasts, breast pain, painful menstruation, weight gain.

Uncommon side effects (may affect up to 1 in 100 people) 

• fluid retention, decreased sexual desire, migraine, impaired hearing, high blood pressure, diarrhoea, breast enlargement.

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 Gedarel 20/150mcg Film-coated Tablets (Packs 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.

Other medicines and Gedarel

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 Gedarel. 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.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you are pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You must not use Gedarel when you are pregnant. If you become or you think you might be pregnant, stop taking Gedarel and talk to your doctor immediately.

Gedarel should not be taken during breastfeeding. If you are breastfeeding and want to take the pill, you should discuss this with your doctor.

Driving and using machines

You can drive or operate machinery while taking Gedarel.

Gedarel contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Keep this medicine out of the sight and reach of children.

How to store Gedarel tablets

• 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 30°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.

Gedarel tablet is for oral use only.

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 Gedarel contains 1 calendar strip of 21 coated tablets or 3, 6, 13 calendar strips 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. Take the first tablet on the first day of your period. 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 Gedarel 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 Gedarel 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 pilland 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 Gedarel 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 Gedarel 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 Gedarel, 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 elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition.
• If you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots’).
• If you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking Gedarel.
• If you have an inflammation in the veins under the skin (superficial thrombophlebitis).
• If you have varicose veins.
• If a close relative has or has had breast cancer.
• If you have a disease of the liver or the gallbladder.
• If you have diabetes.
• If you have depression.
• If you have epilepsy (see “Other medicines and Gedarel”).
• If you have a disease that first appeared during pregnancy or earlier use of sex hormones (for example, hearing loss, porphyria (a disease of the blood), gestational herpes (skin rash with vesicles during pregnancy), Sydenham’s chorea (a disease of the nerves in which sudden movements of the body occur)).
• If you have or have ever had chloasma (golden brown pigment patches, so-called “pregnancy patches”, especially on the face). If this is the case, avoid direct exposure to sunlight or ultraviolet light.
• If you have hereditary angioedema, products containing estrogens may induce or worsen symptoms of angioedema. You should see your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and/or pharynx and/or difficulty swallowing or hives together with difficulty breathing.

Ingredients:

The active substances are desogestrel and ethinylestradiol. One film-coated tablet contains 20 micrograms  ethinylestradiol and 150 micrograms desogestrel.

The other ingredients are:

Tablet core: Potato starch, stearic acid, all-rac-alpha-tocopherol, lactose monohydrate, magnesium stearate, silica colloidal, anhydrous, povidone K 30, quinoline yellow (E104).

Tablet coating: Hypomellose, macrogol 6000, propylene glycol.

What Gedarel tablets looks like and contents of the pack

Slightly yellow, round shaped, biconvex film-coated tablets of about 6 mm diameter with P9 sign on one side and RG sign on other side.