BRENDA-35 ED 2MG-35MCG TABLETS (3 Month Pack)

Category: Prescription Drug

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Brenda-35 ED is a hormonal preparation used to treat the following androgen-dependent conditions in women:

• severe acne when other treatments have failed
• mild to moderate increased growth of facial or body hair (hirsutism).

Androgens are male sex hormones, produced by women in small amounts. If a woman`s body produces too much of these hormones or is overly sensitive, then androgen-dependent conditions occur. Brenda-35 ED works by blocking the action of these hormones.

Brenda-35 ED is also an effective oral contraceptive, commonly known as the “Pill” or “birth control pill”.

As a contraceptive, Brenda-35 ED prevents pregnancy by:

• preventing ovulation
• thickening the cervical mucus to act as a barrier to sperm
• making the lining of the uterus less suitable for implantation of the fertilised egg.

Oral contraceptives such as Brenda-35 ED may have the following theoretical benefits:

• a decrease in the amount of blood you lose each cycle during your period
• a decrease in anaemia
• a decrease in period pain
• a reduced risk of pelvic inflammatory disease
• a reduced risk of developing ovarian cysts
• an improvement in acne
• a reduced risk of tubal (ectopic) pregnancy
• a reduced risk of benign breast disease (breast lumpiness)
• a reduced risk of getting cancer of the uterus (womb) lining and ovaries.

Ask your doctor if you have any questions about why Brenda-35 ED has been prescribed for you.

Your doctor may have prescribed Brenda-35 ED for another reason.

Brenda-35 ED is not for use in men.

Brenda-35 ED does not protect against HIV infections (AIDS) or other sexually transmitted diseases (STDs).

• A barrier form of contraception such as a condom or diaphragm is needed.
• Brenda-35 ED is available only with a doctor`s prescription.

Follow all directions given to you by your doctor and pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist.

How much to take

Take one tablet each day, with some water.

When to take Brenda-35 ED

Brenda-35 ED can be taken with or without food.

Take your medicine at about the same time each day.

Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How to use Brenda-35 ED

The Brenda-35 ED pack contains 28 tablets. On the pack each tablet is marked with the day of the week on which it is to be taken. The ED in the name refers to the “every day” presentation where 7 white lactose tablets (placebos or sugar tablets) are also included in the pack so that a tablet is taken each day of the month instead of having a break.

Take your first tablet from the red section marked with the appropriate day of the week, e.g., if starting on Sunday – select SUN.

Follow the direction of the arrows on the pack until all 28 tablets have been taken.

Usually a menstrual period will start within 2 to 4 days after taking the last active tablet (i.e. while you are taking tablets from the last row of your pack).

Do not leave a gap between packs, i.e. start taking your next pack on the day after you have finished the current one, even if your period continues. This means that you will always start new packs on the same day of the week, and also that you have your withdrawal bleed on about the same days, each month.

Additional contraceptive methods

When additional contraceptive methods are required, either do not have sexual intercourse or use a barrier method such as a condom or diaphragm plus spermicide.

Rhythm methods are not advised as the Pill disrupts the cyclical changes associated with the natural menstrual cycle, e.g. changes in temperature and cervical mucus.

When to start Brenda-35 ED

After a natural cycle

Take the first tablet on the first day of your period from the red section of the pack. Additional contraceptive methods must be used for the next 14 days.

Switching from another combined oral contraceptive

Start Brenda-35 ED on the day after the last active tablet from the previous pill pack has been taken.

If your present pill pack contains placebo (sugar) tablets, you should throw away the placebo tablets and start Brenda-35 ED on the day after taking the last active tablet from your present pack (if you are not sure which this is, ask your doctor or pharmacist). This means no tablet free break. If you follow these instructions, it is not necessary to use an additional contraceptive method. A withdrawal bleed may not occur until the end of the first pack of Brenda 35 ED. This is not harmful.

Switching from progestagen-only contraceptives, e.g. minipill, implant, injectable or a progestogen-releasing intrauterine device (IUD)

Brenda-35 ED may be started on any day when switching from the minipill, or on the day when your implant or IUD is removed or next injection is due. Additional contraceptive methods must be used for the next 14 days.

After having a baby

Your doctor will advise you when it is best to start Brenda-35 ED. If you are breastfeeding, you should discuss this with your doctor first. Additional contraceptive methods must be used for the next 14 days.

After a miscarriage or abortion

Your doctor will advise you. Additional contraceptive methods must be used for the first 14 days.

How long to take Brenda-35 ED for

Keep taking Brenda-35 ED for as long as your doctor tells you to.

You will probably need to take Brenda-35 ED for about 6 months before you notice an improvement in your condition. To effectively treat your acne and excess hair you will probably need to take it for much longer. It is possible that acne and excess hair may return when treatment is stopped.

Repeat courses of Brenda-35 ED may be taken, however, it is recommended that you have a “pill-free” period.

If you forget to take Brenda-35 ED

If you forget to take Brenda-35 ED, it may not work as well in protecting you from becoming pregnant.

Additional contraceptive methods

When additional contraceptive methods are required, either do not have sexual intercourse or use a barrier method such as a condom or diaphragm plus spermicide.

If you are less than 12 hours late in taking a tablet, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.

Additional contraceptive measures are not necessary and contraceptive protection is not reduced.

If you are more than 12 hours late in taking an active (beige) tablet, take the missed tablet as soon as you remember, even if this means taking two tablets at the same time, then continue to take the next tablet at the normal time.

Additional contraceptive methods must be used for the next 7 days as there is an increased risk of becoming pregnant. If the 7 days include taking any of the non-active (white) tablets, discard the non-active tablets and continue with the small beige active tablets of the next pack. You are unlikely to have a period until you reach the red section of the second pack. This is not harmful.

See your doctor if you forget to take more than one active tablet in a pack or if you have missed one or more active tablets within the first week of the pack.

• There is an increased risk of becoming pregnant. An alternative method of contraception should be used until you are sure that you are not pregnant.
• If you have forgotten to take a non-active (white) tablet, discard the missed tablet and continue taking the tablets as you would normally.
• No additional contraceptive precautions are needed.
• If you are not sure what to do or have any questions, ask your doctor or pharmacist.

If you take too much Brenda-35 ED (overdose)

• Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Brenda-35 ED. Do this even if there are no signs of discomfort or poisoning.
• You may experience nausea, vomiting and vaginal bleeding.

Ingredients

The beige active tablets contain two active ingredients: cyproterone acetate 2 mg and ethinyloestradiol 35 mcg.

The white non-active tablets contain lactose. These are also known as placebos or “sugar tablets”.

The tablets also contain the following ingredients:

• lactose
• starch – maize
• povidone
• magnesium stearate
• sucrose
• macrogol 6000
• calcium carbonate
• talc – purified
• montanglycol wax
• glycerol
• titanium dioxide (E171)
• iron oxide yellow CI77492 (E172)
• water – purified.

The tablets do not contain gluten, tartrazine or any other azo dyes.