Ovranette

You can choose Ovranette to help treat:

• painful periods
• premenstrual symptoms (PMS)
• periods with heavy bleeding
• irregular periods
• endometriosis

Your doctor can help you decide if Ovranette is right for you.

You can take Ovranette if you do:

• are not pregnant or breastfeeding
• do not get blood clots
• do not have high blood pressure
• do not have irregular heartbeats or heart valve conditions
• do not have migraines with aura
• do not have diabetes
• do not have systemic lupus erythematosus (SLE)
• do not have liver disease, liver cancer, jaundice or hepatitis C
• do not have breast cancer or ovarian cancer
• do not have unexplained vaginal bleeding
• are not allergic to any of the ingredients in Ovranette

If you’re unsure about taking Ovranette, speak to your doctor or pharmacist. You can also check your patient information leaflet in your pack of Ovranette.

To take Ovranette, you follow the days and arrows labelled on the back of the foil blister strips. Each Ovranette blister strip has 21 pills.

• You take 1 Ovranette pill each day for 21 days in a row. To make sure you are protected from pregnancy, do not miss any pills.
• At the end of 21 days, you should have a 7 day break. If you have not missed any pills, you will stay protected during your 7 day break. It is normal to have a withdrawal bleed during this week.
• The day after your 7 day break, you should start a new strip of Ovranette pills, even if you are still bleeding.

When you take Ovranette pills:

• take 1 pill at the same time each day
• swallow the pill with water
• do not chew the pill

You will need to see your doctor for regular blood pressure checks while you are taking Ovranette.

When do I start taking Ovranette?

You start taking Ovranette between the first and fifth day of your period. Then you will be protected from pregnancy straight away.

If you start taking Ovranette on any other day of your period, use condoms for 7 days. Keep taking your Ovranette pill each day to continue being protected.

What do I do if I forget to take Ovranette?

If you miss a pill it might affect your contraception. A pill counts as being missed if you have taken it more than 24 hours after you should have taken it.

• If you have only missed one pill, take it as soon as you remember, even if you have to take 2 pills at once. Continue to take the rest of your pack as usual. You’ll still be protected against pregnancy.
• If you have missed 2 or more pills, take the most recently missed pill as soon as you remember and leave any previous pills in the strip. This may mean taking two pills at once. Continue to take the rest of your pack as usual. But if you have fewer than 7 pills left in the pack, start a new pack without taking a pill free break. You will need to use extra contraception such as condoms for seven days as you may be at risk of pregnancy.

If you have missed more than 2 pills in the first week of your pack you may need to use emergency contraception. Speak to your doctor or pharmacist for advice if you are unsure. You can also message one of our doctors through your account.

Try to remember to take your pill with an activity you do every day like brushing your teeth. Or you can set a daily alarm to remind you.

What do I do if I take Ovranette twice?

You may vomit or have a vaginal bleed if you take too many Ovranette pills. If this happens, talk to your doctor or pharmacist for advice. You should still take your pills as normal for contraceptive protection.

Can pregnant or breastfeeding women take Ovranette?

You should not take Ovranette if you’re pregnant. You have to stop taking Ovranette if you find out you are pregnant.

If you’re breastfeeding, you might be able to take Ovranette, but this will depend on when you gave birth. Your doctor might recommend a progesterone only pill or mini pill for contraception instead.

What should I watch out for if I want to stop taking Ovranette?

When you stop taking Ovranette, you will no longer be protected from pregnancy. Use condoms to protect yourself from pregnancy and sexually transmitted infections.

You will have a withdrawal bleed after your last Ovranette pill.

When you take Ovranette, you might get some side effects. Most side effects, like breakthrough bleeding between periods, clear up within a few months. If they do not, speak to your doctor as soon as possible.

Common side effects of Ovranette include:

• vaginal infections such as thrush
• nausea or vomiting
• stomach pain or cramps
• change in body weight
• mood changes

Uncommon side effects of Ovranette include:

• diarrhoea
• rash
• chloasma (brown patches of skin)
• hives
• fluid retention
• increase in blood pressure
• increase in blood cholesterol levels

Rare side effects of Ovranette include:

• changes in skin colour or texture
• changes in your period
• vaginal discharge
• systemic lupus erythematosus getting worse
• gallbladder problems
• breast cancer or cancer of the cervix
• blood clots
• liver tumour

Any side effects can be reported using the MHRA Yellow Card Scheme in the Google Play or Apple App Store.

Does the risk of thrombosis increase?

Ovranette can increase your risk of getting a blood clot, or thrombosis.

Stop taking Ovranette and call 999 if you have:

• leg pain or swelling
• chest pain
• breathing difficulties

A blood clot can come up in your:

• leg (deep vein thrombosis)
• lungs (pulmonary embolism)
• eyes (retinal vein thrombosis)
• brain (stroke)
• heart (heart attack)

Ovranette can interact with other medicines. This means Ovranette may not work as you expect.

These include treatments for:

• epilepsy such as carbamazepine, barbiturates, primidone, phenytoin, topiramate, oxcarbazepine
• tuberculosis such as rifampicin, rifabutin
• HIV such as ritonavir, nevirapine
• fungal infections such as griseofulvin
• sleep disorders such as modafinil
• inflammation such as phenylbutazone, dexamethasone
• bacterial infections such as rifampicin, rifabutin
• low mood such as St. John’s wort, a herbal remedy

If you are taking any other medicines, speak to your doctor before you start Ovranette.

The active ingredients in Ovranette are levonorgestrel (150 micrograms) and ethinylestradiol (30 micrograms).

The other ingredients in Ovranette are lactose monohydrate, maize starch, povidone 25, magnesium stearate, talc, purified water, sucrose, polyethylene glycol 6000, calcium carbonate, white wax and wax carnauba.

If you have lactose intolerance, please speak to your doctor for advice before taking Ovranette.

How should Ovranette be stored?

Store Ovranette in its original pack to avoid damage by light or water. Keep Ovranette pills in a place below 25°C and away from children or pets.

How must Ovranette be disposed of?

To dispose of Ovranette pills, take them to a pharmacy. Do not throw Ovranette pills into your household bin or down the drain.

What does Ovranette look like?

Ovranette is a white round pill.

In which pack sizes is Ovranette available?

Ovranette is available in a pack size of 1 or 3 blister strips. Each blister strip of Ovranette contains 21 pills.

Information on the manufacturer

The marketing authorisation holder for Ovranette is Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom.

Ovranette is manufactured by Haupt Pharma Münster GmbH, Schleebrüggenkamp 15, D-48159 Münster, Germany and Pfizer Ireland Pharmaceuticals, Little Connell, Newbridge, Co. Kildare, Ireland.