ROACCUTANE 10MG SOFT CAPSULES

Active substance: ISOTRETINOIN

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Roaccutane

®

isotretinoin

Contraception advice for
fo
®
people taking Roaccutane

© 2004 F. Hoffmann-La Roche AG; All rights reserved. Unauthorised copying prohibited.
UK-BP-01 - MEDI00057 - Feb 2009

This booklet should only be given to patients who
have been prescribed Roaccutane®

Your guide to contraception
Contraception and isotretinoin

There are many different contraceptive methods available and different methods suit

Isotretinoin is an effective treatment for severe acne. However, it is well known that

decide on the method of contraception most suited to you both. It shows all the

isotretinoin can cause severe birth defects in babies born to mothers taking

available methods, explains how they work, how effective they are and the main

isotretinoin. There is also an increased risk of miscarriage.

advantages and disadvantages. You can ask your GP practice nurse or family planning

people at different times of their lives. This leaflet will help you and your partner to

clinic for more information on any method you are interested in.
It is vital that you do not start isotretinoin treatment if you are pregnant, may become
The figures quoted in this leaflet for how well each method works are based on

will need to have at least one negative pregnancy test just before starting treatment,

extensive independent research. Most contraceptives need to be prescribed. If your GP

your doctor may require you to have a pregnancy test each month during your

does not provide all the methods they should be able to tell you of the nearest GP or

treatment, as well as 5 weeks after the end of treatment.

family planning clinic that does. If you would prefer not to see your own GP about
contraception you can sometimes go to another GP for contraception only. Many sexual

You must use at least one effective method of contraception, for 1 month before

health clinics offer contraception.

starting treatment, throughout the treatment period and for 1 month after treatment

Contraception

has finished. The most highly effective methods include contraceptive injections,

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You can buy male condoms and spermicides without going to a doctor or clinic.

implants, intra-uterine devices with copper or hormone and combined contraceptive

Spermicides on their own are not recommended as a reliable contraceptive.

Contraception

pregnant during treatment, or in the first month after treatment. This means that you

pills and patches when used carefully. Preferably you should use two methods of
contraception including a barrier method such as the male condom, as no method is
100% safe on its own. Barrier methods on their own are not recommended. It is vital
that both you and your sexual partners understand the importance of this and what
the consequences may be if you become pregnant whilst on isotretinoin. Contraception
must be used even if you are not currently sexually active, unless in your doctor’s
opinion there are compelling reasons for assuming that there is no risk of pregnancy.
This leaflet discusses the different types of contraception, how to use them and how
effective they are. Any method of contraception, however effective, may fail, and by
using two methods at once you will minimise the risk of pregnancy.
This leaflet is intended as an aid only – it won’t replace medical advice given by a
healthcare professional. You will need to discuss your contraceptive options with your
doctor or nurse before you begin treatment with isotretinoin.

Using contraception
How effective any contraceptive is depends on how old you are, how often you have
sex and whether you follow the instructions. If 100 sexually active women don’t use any
contraception 80 to 90 of them will become pregnant in a year. The methods shown in
this brochure are divided into two types:
No user failure: do not depend on you remembering to take or use contraception.
These are long acting methods: contraceptive injection, implant, intrauterine system
(IUS), intrauterine device (IUD), female sterilisation, male sterilisation (vasectomy).
User failure: methods you have to use and think about each day or each time you have
sex. For these methods to be effective you must use them according to the instructions
given: Combined pill, the contraceptive patch, progestogen-only pill, male condom,
diaphragm/cap with spermicide, female condom and natural family planning (the
female condom and natural family planning are not recommended as contraception
methods in patients taking isotretinoin and are not discussed further in this brochure).

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Some facts about contraception

Contraceptive injection

There are a lot of myths around about contraception. These are the facts.

Effectiveness

A woman can still get pregnant:

Over 99% effective. Less than 1 woman in 100 will get pregnant in a year.



if it is the first time she has sex



if she does not have an orgasm



if a man pulls out of her vagina before he comes



if she has sex when she has a period



if she is fully breastfeeding

Advantages



if she douches (squirts water into the vagina). This can be harmful to women



Lasts for 12 weeks (Depo-Provera) or 8 weeks (Noristerat).



whatever position the couple have sex in



May protect against cancer of the womb and some protection from pelvic

How it works
Releases the hormone progestogen slowly into the body. This stops ovulation and
thickens cervical mucus to prevent sperm meeting an egg.

Contraception
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Contraception

inflammatory disease.

Disadvantages


Periods may be irregular or stop.



Regular periods and fertility may take a year or more to return after stopping
the injections.



Some women gain weight.



Other possible side-effects include headaches, acne, mood changes and
tender breasts.

Comments
The injection cannot be removed from the body so any side-effects may continue for as
long as it works and for some time afterwards.

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Effectiveness

Effectiveness

Over 99% effective. Less than 1 woman in 100 will get pregnant in a year.

Over 99% effective. Less than 1 woman in 100 will get pregnant in a year.

How it works

How it works

Small flexible tube placed under the skin of the inner upper arm. Releases the hormone

A small plastic device which releases the hormone progestogen is put into the womb. It

progestogen into the bloodstream to stop ovulation and thickens cervical mucus to

thickens cervical mucus to stop sperm meeting an egg. It may stop an egg settling in

prevent sperm meeting an egg.

the womb or stop ovulation.

Advantages

Advantages



Works for three years but can be taken out at any time.



Works for five years but can be taken out at any time.



Contraception

Intrauterine system (IUS)

When the implant is removed normal level of fertility will return immediately.



Periods will be much lighter, shorter and usually less painful.

Disadvantages

Disadvantages



Periods are often irregular, very long or stop for at least the first year.



Irregular light bleeding is common for the first three months and sometimes longer.



Some women gain weight.



May be temporary side-effects such as headaches, acne and tender breasts.



Other possible side-effects include headaches, acne, mood changes and tender

Contraception

Implant

Comments

breasts.

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Comments


Implant is usually put in under a local anaesthetic and no stitches are needed. The
area may be tender for a day or two with bruising and some swelling.



Most women can feel the implant with their fingers, but it can’t be seen.



Minor surgery necessary to take the implant out.

Women are taught to check the IUS is in place by feeling the threads high in their
vagina.



Very useful for women with very heavy or painful periods.

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Effectiveness

98% to over 99% effective depending on the type of IUD. Less than 1 to 2 women in

Over 99% effective. The lifetime failure rate is about 1 in 200, depending on the

100 will get pregnant in a year.

method used.

How it works

How it works

A small plastic and copper device is put into the womb. It stops sperm meeting an egg

The fallopian tubes are cut or blocked so the egg cannot travel down them to meet

or may stop an egg settling in the womb.

sperm.

Advantages

Advantages



Works as soon as it is put in.





Contraception

Effectiveness

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Female sterilisation

Can stay in 3 to 10 years depending on type, but can be taken out at any time.

Disadvantages

It is permanent and has no known long-term side-effects.

Disadvantages



The fallopian tubes may rejoin so the woman is fertile again.



Periods may be heavier or longer and more painful.



Contraception must be used up to the time you are sterilised and until you have had



Not suitable for women at risk of getting a sexually transmitted infection.

Contraception

Intrauterine device (IUD)

your first period after sterilisation.

Comments

Comments



If fitted after the age of 40 it can stay in until the menopause.



Should not be chosen if in any doubt and counselling is important.



Women are taught to check the IUD is in place by feeling the threads high in their



Time in hospital varies from one to three days depending on the type of operation.

vagina.



A few days rest needed afterwards.

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Male sterilisation (vasectomy)

Combined pill

Effectiveness

Effectiveness

Over 99% effective. The lifetime failure rate is 1 in 2,000.

Over 99% effective if taken according to instructions. Less than 1 woman in 100 will get
pregnant in a year.

How it works
How it works
Contains two hormones – oestrogen and progestogen – which stop ovulation.

Advantages

Advantages



It is permanent and has no known long-term side-effects.



Often reduces bleeding, period pain and pre-menstrual tension.



Minor operation takes 10-15 minutes and can be done at a doctor’s surgery or clinic.



Protects against cancer of the ovary and womb and some pelvic infections.

Disadvantages



Suitable for healthy non-smokers up to the menopause.



It usually takes a few months for all the sperm to disappear from the semen.

Disadvantages



Contraception must be used until there are two negative semen tests



Not suitable for all women.

(no sperm seen).



Rare but serious side-effects may include blood clots (thrombosis), breast cancer and

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Comments



cervical cancer.

The tubes may rejoin so the man is fertile again. This is not common.


Can be temporary minor side-effects.



Not suitable for smokers over 35.



Should not be chosen if in any doubt and counselling is important.



Likely to be bruising, swelling and some discomfort or pain for a short time after

Comments

the operation.



Not effective if taken over 12 hours late or after vomiting or severe diarrhoea.

Rest for 24-36 hours and avoid strenuous exercise for at least a week.



Some drugs or herbal medicines such as St John’s wort may stop the pill working.



Pill users should not smoke.



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ejaculated when the man ‘comes’.

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The tubes carrying the sperm are cut, so sperm are not present in the semen that is

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The contraceptive patch
(Evra contraceptive patch)

Progestogen-only pill (POP)
Effectiveness
99% effective if taken according to instructions. 1 woman in 100 will get pregnant in

Effectiveness
Over 99% effective when used correctly and according to the instructions.

a year.

How it works
The hormone progestogen, taken at the same time each day, thickens cervical mucus to

A constant daily dose of hormones are released into the bloodstream through the skin. Its

prevent sperm meeting an egg or an egg settling in the womb. In some women it

main action is the same as the combined oral contraceptive pill; it stops the ovaries from

prevents ovulation.

releasing an egg each month (ovulation).

Advantages

Contraception

Advantages

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• Useful for older women who smoke or who cannot use the combined pill.



Contraception

How it works

Disadvantages

You don’t have to remember to take it every day; you only have to remember to replace
the patch once each week.



As the hormones do not need to be absorbed by the stomach, they are not affected by
vomiting or diarrhoea.

Disadvantages

• May be minor side-effects.
• Periods may be irregular, with some bleeding in between, or be missed.
• May be less effective in women who weigh over 70kg (11 stone).



It may be visible.

Comments



For a small number of women it may cause skin irritation.

• Not effective if taken over three hours late or after vomiting or severe diarrhoea.



Side-effects are similar to those seen with combined oral contraceptive pill.

• Some drugs may stop the pill working but antibiotics do not affect POPs.

Comments


Some drugs or herbal medicines such as St John’s wort may stop the patch working.



Women who are unable to use the combined oral contraceptive pill cannot use the
patch.



The effectiveness of the patch is reduced in women who weigh 90kg (14 stone) or over.



Patch users should not smoke.

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Effectiveness

98% effective if used according to instructions. 2 women in 100 will get pregnant in a

92% to 96% effective if used according to instructions. Between 4 and 8 women in 100

year.

will get pregnant in a year.

How it works

How it works

Made of very thin latex (rubber) or polyurethane it is put over the erect penis and stops

A flexible rubber or silicone device used with spermicide, is put into the vagina to cover

sperm from entering the woman’s vagina.

the cervix. Must be specially fitted to make sure it is the right size.

Advantages

Advantages



Free from family planning clinics and also sold widely.



Can be put in any time before sex.



Contraception

Effectiveness

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Diaphragm/cap with spermicide

May protect both partners from sexually transmitted infections, including HIV.



May protect against some sexually transmitted infections and cancer of the cervix.



A wide variety of types to choose from.



A variety of types to choose from.

Disadvantages

Disadvantages



Putting it on can interrupt sex.



Putting it in can interrupt sex.



May slip off or split if not used correctly.



Extra spermicide is needed if you have sex again.



Man needs to withdraw as soon as he has ejaculated and be careful not to spill any



Cystitis can be a problem for some diaphragm users.

Contraception

Male condom

semen.

Comments

Comments


Fitting should be checked every 12 months and if you gain or lose more than 3kg



Men can take responsibility for contraception.



Use a new condom each time.



Silicone caps come in disposable and reusable varieties.



Must be put on before the penis touches the woman’s vagina.



Should be removed 6 hours after intercourse.



Use a condom with a BSI Kitemark (BS EN 600) and CE Mark on the pack and check
the expiry date.



Oil based products damage latex condoms, but can be used with polyurethane
condoms.

(7lbs), or have a baby, miscarriage or abortion.

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Emergency Contraception

Sexually transmitted infections

If you have had sex without using contraception or think your method might have

Male and female condoms can help protect against sexually transmitted infections.

failed there are two emergency methods you can use.

Male latex condoms should carry the BSI Kitemark (BS EN 600) and European CE mark.



Emergency pills – must be started up to three days (72 hours) after sex. They are
more effective the earlier they are started after sex (preferably within 12 hours).



An IUD – must be fitted within five days after sex.

isotretinoin, you should contact your doctor, nurse or family planning clinic

How do I find a family planning
doctor or clinic?

immediately if you have had unprotected sex.
Contraception is free through the NHS.


You can get lists of GPs from libraries, advice centres, helplines, health authorities or

Contraception

health boards.


Contraception

As it is vitally important that you do not become pregnant when you are taking

Diaphragms and caps may also protect against some sexually transmitted infections.

You can get details of your nearest family planning or sexual health clinic from your
telephone directory, health centre, hospital, midwife or health visitor, advice centre,
helpline, health authority or health board.



Young people can phone Brook on 0808 802 1234 or Sexwise on 0800 282930 for
details of the nearest young people’s clinic.



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You can find out all about all clinics from fpa’s helpline on 0845 122 8690 or visit the
web-site at www.fpa.org.uk.



NHS Direct on 0845 46 47 also gives information on local family planning services
in England.

What if I become pregnant?
If you become pregnant while on isotretinoin therapy or during the month after
treatment has stopped, immediately stop taking the medicine and contact your doctor.

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Information in this brochure

Remember

This brochure can only give you basic information about contraception. The



Isotretinoin can cause severe birth defects - it is vital that you do not start

information is based on the evidence and medical opinion available at the time this

isotretinoin treatment if you are pregnant or are not on at least one effective form

leaflet was printed. Different people may give you different advice on certain points.

of contraception.

Remember – contact your doctor or family planning clinic if you are worried or unsure



You must not begin isotretinoin treatment whilst pregnant, or become pregnant
during isotretinoin treatment. It is very important that you use at least one and

about anything.

preferably two effective forms of contraception, including one barrier method, for



No method of contraception, other than having no sex at all, works 100% of the
time. Even if you use one of the recommended methods properly, there is still a
small but real risk of getting pregnant.



There are many different types of contraception. Long-acting contraceptives such as

Contraception

monthly injections or the coil do not depend on your remembering to take or use

Contraception

one month before, during, and one month after treatment.

them and there is hardly any ‘user failure’. If you use other methods, such as the pill
and the condom, you have to remember to use them each day or just before having
sex. Whatever methods you use, you must use them according to the instructions
given in order for these methods to be effective.


Make sure you explain to your partner the importance of contraception one month
before, during and for one month after treatment with isotretinoin. It is important

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that your sexual partner also understands the facts about contraception and the
risks of birth defects occurring in babies born to women taking isotretinoin. Explain
what you and he must do: choose (together with your doctor or nurse) and use at
least one, but preferably two effective forms of contraception for one month
before, during and for one month after isotretinoin treatment.


As it is vitally important that you do not become pregnant when you are taking
isotretinoin, you should contact your doctor, nurse or family planning clinic
immediately if you have had unprotected sex.



If you think you are pregnant, stop taking isotretinoin immediately and contact
your doctor or nurse.

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Acknowledgement
The information on contraception in this brochure is adapted from the fpa leaflets
‘Your Guide to Contraception’ (Your guide Nov 01) and ‘The Contraceptive Patch’
(August 2003).
You can obtain further information from the fpa by contacting:

3rd Floor, Ascot House

EC1Y 8QU

24 - 31 Shaftesbury Square

Phone 0845 122 8690

Belfast

(9am - 6pm Mon - Fri)

Contraception

Belfast

London

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fpa Northern Ireland

50 Featherstone Street

BT2 7DB

fpa Scotland

Derry

Unit 10

3rd Floor

Firhill Business Centre

67 Carlisle Rd

76 Firhill Road

Derry

Glasgow

BT48 6JL

G20 7BA

Northern Ireland Helpline 0845 122 8687

Phone 0141 948 1179

(9am - 5pm Mon - Thurs, 9am - 4.30pm Fri)

fpa Wales

Website: www.fpa.org.uk

Contraception

fpa England

Suite D1
Canton House
435-451 Cowbridge Road East
Cardiff
Phone 029 20 0644 034

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Contraception

Contraception
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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