LOESTRIN PATIENT INFORMATION LEAFLET

INSTRUCTIONS FOR USE OF 21-TABLET PACKS

This leaflet is designed to help you use correctly Parke-Davis 21-tablet combined oral contraceptive (combination of two hormones) and to answer many of the questions that you may have about the pill. It cannot tell you everything about the pill because this requires explanation by your doctor as much of it may not apply to your particular circumstances.

The pill has been extensively researched, and vast experience has confirmed that it can be safely used by the majority of women. Nevertheless, it is important to recognise that, however wide medical experience of a product becomes, its complete safety in all users can never be guaranteed, since every person is unique, and that with the pill, or with any other medicinal product, some risk must be accepted. The pill is available to you only on prescription because your doctor’s professional knowledge and judgment are required to supervise its use. Therefore, the leaflet is not intended to take the place of his information and instructions to you, but to reinforce them. Ask him to explain anything that you do not understand, and do not hesitate to consult him if you have any doubts or anxieties about your use of the pill or the effect it may be having on you.

THE BENEFITS OF COMBINED ORAL CONTRACEPTIVES

Pills of this type are highly effective reversible forms of contraception. In addition, they have advantages not provided by other methods. Generally, irregular periods are replaced by regular bleeding, and heavy periods by lighter bleeding. Painful periods are in most cases abolished. The symptoms that often make the last few days before a period so unpleasant a part of every month (known as the premenstnual syndrome) are commonly eliminated. Finally, because of the combined pill’s outstanding reliability, all the risks that result from failure of contraception - in other words from pregnancy - are much less than with other methods.

HOW PREGNANCY IS PREVENTED

From the beginning of sexual maturity until the change of life, the ovaries normally release an egg cell (ovulate) every month. If it is fertilized by a man’s sperm, it becomes embedded in the womb and begins to grow. From then on, the ovaries produce increased amounts of hormone to maintain the pregnancy and to prevent further egg cells from developing. Thus, in pregnancy, development of egg cells is inhibited by the body’s own hormones.

Combined oral contraceptives contain similar hormones, and therefore ad in a similar way, so that normally when an oral contraceptive is taken no egg cells are released for fertilization. In addition, the fluid present in the neck of the womb remains thick, so that it is more difficult for sperms to enter the womb. Also, the lining of the womb is not prepared sufficiently for a fertilised egg to grow in it. A combined oral contraceptive thus offers protection against pregnancy in several ways.

BEFORE STARTING THE PILL

There are certain medical conditions that nub out the use of this type of pill, which are listed later under ‘Contra-indications’. There are certain other conditions that, while not ruling out the pill, indicate the need for careful consideration before a decision is taken to use the pill, and which require supervision during its use. These conditions are referred to under ‘Warnings and Precautions’. Your doctor will have considered whether or not any of the conditions referred to under those headings apply to you, but before you start taking the pill, d you are in any doubt, discuss the matter with him again.

HOW TO TAKE THE PILL

About the pack

This memo-pack has been specially designed to help your memory; in fact, it does the counting for you. Each pill is placed in a section marked with the day of the week on which it should be taken. If, at any time, you are in doubt whether you have taken your pill, a glance at the appropriate day on the memo-pack will tell you.

Taking your first course

If you are having as usual, count the first day of bleeding of your next period as day 1, and take your first pill on that day. Choose a pill marked with the correct day of the week. One Loestrin tablet should be taken daily for three weeks. Following the direction of the arrows, take a pill each day until the pack is empty.

2

If you have just had a baby, it is usual to wait until your first period before starting the pill, but you should realise that it is possible to get pregnant before the first period, and use some other form of contraception in the meantime. If you are breastfeeding, or want to start the pill earlier, you should get your doctor’s advice.

After a miscarriage or abortion within the first twelve weeks of pregnancy, oral contraceptives can normally be started at once.

If you are changing from another oral contraceptive, leave whatever break is appropriate between courses of that contraceptive before starting the new one.

If the starting day was not the first day of menstrual bleeding, you should use an additional contraceptive for the first 7 days of the first pack in addition to taking the tablets. Suitable methods are sheaths. cap plus spermicide, and intra-uterine devices. The rhythm, temperature and cervical-mucus methods cannot be used.

Additional precautions are not needed subsequently. except when special circumstances reduce the reliability of the pill, as described under ‘Reduced protection’. Except in those circumstances, the protection provided by the pill is continuous, and this includes the weeks between the courses of pill when you are taking no tablets.

Subsequent courses

Allow an interval of one tablet-free week before commencing the second and subsequent courses of tablets. Each new course of tablets is always started on the same day of the week.

IRREGULAR BLEEDING

If bleeding is missed

If, as may occasionally happen, you should have no bleeding at all in the seven days after a course of pills, and you have taken the tablets correctly, it is very unlikely that you are pregnant, but the possibility should be ruled out by your doctor before you start a new course of pills.

If bleeding starts while you are taking tablets

If bleeding occurs during the three weeks in which you are taking the pills do not stop taking them. The bleeding should stop in a day or two. However, if the bleeding is troublesome, very heavy, prolonged or recurrent, you should consult your doctor. Bleeding while the pills are being taken does not mean that the pill does not suit you, nor does it necessarily mean that contraceptive protection is lost (but see ‘Interaction with other medicines’). If bleeding does occur during pill-taking, it is usually only in the first two or three months, while your body is adjusting itself to the pill.

REDUCED PROTECTION

If you forget to take your pill

If you forget to take a pill at the usual time, it must be taken as soon as possible and the next tablet taken at the normal time. If the delay exceeds twelve hours, additional contraception (which must be a sheath, or cap and spermicide) should be used for the next seven days, while the next seven tablets are being taken; then continue as usual according to instructions. If your period fails to occur, consult your doctor immediately before starting your next course. If pills have been missed during the last seven days of the pack, there should be no break before the next pack is started.

If you have a stomach upset

Vomiting and diarrhoea may interfere with absorption of the pill and reduce its contraceptive effect. If you do get such a stomach upset, continue to take the pills, but you should use another method of contraception, which must be a sheath or cap plus spermicide, during and for seven days after the upset. If those seven days overrun the end of the pack, the next pack should be started without a break.

Interaction with other medicines

Some medicines may reduce the effectiveness of oral contraceptives when taken at the same time. They include certain sedatives, antibiotics and anti-epileptic drugs. Suspicion that the reliability of an oral contraceptive is reduced in this way is sometimes raised by occurrence of irregular bleeding. If you are taking any medicines at all while you are also taking an oral contraceptive, be sure to tell your doctor, who can advise you whether or not you should take additional contraceptive precautions.

By law, certain information must appear in any leaflet of this kind, and must be kept separate from the rest of the contents. That information comprises the remainder of this leaflet.