Patient Information Leaflet
Please read this carefully before you start to take your tablets. This leaflet provides only a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
What's in your tablets?
The name of your medicine is Ovranette.
Ovranette is supplied in a carton containing 3 blister packs of tablets.
Each blister pack of Ovranette contains 21 beige, shiny, sugar-coated tablets, each containing 150 micrograms of levonorgestrel and 30 micrograms of ethinyloestradiol. Ovranette tablets also contain lactose maize starch povidone, magnesium stearate, talc, sucrose, polyethylene glycol, calcium carbonate, glycerin, titanium dioxide, iron oxide yellow pigment (E172) and wax. Ovranette is an oral contraceptive.
The product licence is held by:
John Wyeth and Brother Limited
trading as Wyeth Laboratories
Huntercombe Lane South
Berks SL6 0PH
The manufacturer is:
Wyeth Medical Ireland
Republic of Ireland
How the female reproductive system works
Once a month, an egg (or ovum) is released from one of the ovaries and passes along the fallopian tube to the womb. Fertilisation, (the joining together of the male's sperm with the female's egg) usually takes place while the egg is still in the fallopian tube. The fertilised egg embeds itself in the wall of the womb, which has been specially prepared to receive it, and it grows into a baby.
If fertilisation does not take place, then the egg b shed in the next menstrual period.
What do your tablets do?
Ovranette is a combined oral contraceptive, and belongs to a group of products often referred to as the Pill. Your doctor may also prescribe it for some other conditions, such as premenstnual tension, or heavy, painful or irregular bleeding. It contains different amounts of two types of hommone: an oestrogen (ethinyloestradiol) and a progestogen (levonorgestrel). These hormones stop the ovary from releasing an egg each month (ovulation). They also thicken the fluid (mucus) at the neck of the womb (cervix) making it more difficult for the sperm to reach the egg, and alter the lining of the womb to make it less likely to accept a fertilise egg.
Medical research and vast experience have shown that, if taken correctly, the Pill is an effective reversible form of contraception.
BEFORE YOU TAKE YOUR TABLETS
Reasons for not taking Ovranette
You should not take these tablets:
You should not take these tablets:
What you should know before you take the Pill
Women who take the Pill have an increased risk of developing a blood clot which can block a vein or artery (thrombosis) and can have severe effects. This risk is considered to be less with pills such as Ovranette which contain lower doses of contraceptive hormone. Women who smoke or who are overweight and those who have diabetes, varicose veins, migraine, heart disease or high blood pressure are at an increased risk of thrombosis. If you have any of these conditions, you should discuss the matter fully with your doctor.
The Pill is not recommended for older women who smoke because the risk of developing thrombosis is greater Fit women who are not overweight and who do not smoke may continue to use a modern low-dose Pill. It is important that you have regular check-ups, including having your blood pressure taken, to make sure you can continue to take the Pill. Cancer of the liver has rarely been reported in long term users of the Pill. Non malignant liver tumours have also been linked with Pill usage.
Information linking the use of the Pill and breast cancer remains unclear. Some studies suggest an increased risk of breast cancer in women who have taken the Pill for a long time. However, this risk is likely to be small,
You can take your pill at any time but you should take it about the same time each day. You may find it easiest to
second pack If you do not have a withdrawal bleed then, consult your doctor before starting the next pack. This advice can be summarised by following the diagram below:
If you have a stomach upset
If you have been sick or had diarrhoea, the Pill may not work. Continue to take it, but you may not be protected from the first day of vomiting or diarrhoea. Use another method such as a condom for any intercourse during the stomach upset and for the next seven days. In addition, if you have more than seven pills left in the pack, continue as normal. Then start your next pack as you would normally do after the usual gap between packs. But if you have fewer than seven pills left in the pack, start the next pack as soon as you have finished the present one, without having a gap between packs. Then continue as normal. This will mean you may not have a period until the end of two packs, but this will not harm you. Nor does it matter if you have some bleeding on pill-taking days.
If you do not have a period at the end of the second pack, see your doctor to make sure you are not pregnant.
Using Ovranette for something other than contraception
Your doctor may have prescribed Ovranette for some reason other than contraception and at a different daily dose. The doses which are usual for each different use of Ovranette are: Painful menstruation (dysmenorrhoea) or pre-menstrual tension - the same dosage is used as that described for oral contraception (1 tablet daily for 21 days then a 7 day break before starting the next pack).
Endometriosis - continuous treatment, taking 2 tablets every day.
Bleeding of the womb (uterus) - as for oral contraception (treatment for 21 days followed by a 7 day break) but taking 2 tablets per day (for the first month or two your doctor may ask you to take 4 or 5 tablets a day). If bleeding from your womb is more serious your doctor may ask you to take 4 tablets immediately and then 4-8 tablets daily until the bleeding is controlled.
THINGS TO BE AWARE OF WHILST TAKING YOUR TABLETS
If you have bleeding while you are taking the tablets
You may at first have some breakthrough bleeding, or spotting, while you are taking your tablets, but your periods should settle down after a few months. However if the bleeding is heavy, continual or keeps returning, see your doctor.
Ovranette may cause side-effects, most of which are not serious and you need only tell your doctor if the symptoms become troublesome These include:
Occasionally some side-effects could be more serious. TELL YOUR DOCTOR STRAIGHT AWAY IF YOU GET ANY OF THESE SYMPTOMS AFTER TAKING YOUR TABLETS:
Your doctor will probably stop you taking these tablets if:
Tell your doctor or pharmacist if you get any other unwanted effect not mentioned here.
Storing your tablets
Do not use your pack of Ovranette after the expiry date on the pack.
Store your tablets at or below room temperature. Keep your tablets in a safe place where children cannot reach them. Your tablets could harm them. Return any unused tablets to your pharmacist Only keep them if your doctor tells you to.
REMEMBER these tablets are only for you. Only a doctor can prescribe them for you. Never give these tablets to others. They may harm them.
Last revision: November 1995