Ovestin vaginal cream contains the
active ingredient estriol, which is a naturally occuring form of the
main female sex hormone, oestrogen.
Womens’ ovaries gradually produce less
and less oestrogen in the period up to the menopause, and oestrogen
blood levels decline as a result. The declining levels of oestrogen can
cause distressing symptoms, and often affect the delicate lining of the
vagina. Oestrogen deficiency can cause vaginal dryness, inflammation or
itching, and this in turn can lead to sex being uncomfortable or
painful, and to an increased susceptibility to vaginal or urinary
infections.
Oestrogen can be given as a supplement
to replace the falling levels in the body and help reduce the
distressing symptoms of the menopause. This is known as hormone
replacement therapy (HRT). Oestrogen (in this case in the form of
estriol) can also be applied directly to the vagina in the form of
vaginal cream, in order to directly supplement the vaginal tissues with
oestrogen. This is known as topical HRT and is useful for relieving
just the vaginal symptoms of the menopause.
Ovestin cream is inserted into the
vagina using the applicator provided. It releases small amounts of
oestrogen locally into the vaginal tissues and is used short-term to
provide relief from the vaginal symptoms of the menopause, such as
dryness, itching and irritation.
Ovestin cream may also be used to treat the vaginal tissues before and after vaginal surgery, for example for vaginal prolapse.
Estriol from Ovestin cream is absorbed
from the vagina into the bloodstream, which means it may potentially be
associated with the same risks as other forms of HRT and so carries the
same warnings. These warnings are most relevent to repeated or
long-term use of the cream. You can read more about the risks and
benefits of HRT in the factsheet about the menopause linked below. To
minimise the absorption of this medicine, the lowest dose to control
symptoms should be used, and treatment should be stopped every two
three months for four weeks to see if it is still needed. Treatment
should be reviewed at least once a year with your doctor.
What is it used for?
Vaginal symptoms of the menopause (atrophic vaginitis)
Treating the vaginal tissues before and after vaginal surgery, eg for vaginal prolapse.
Warning!
Follow the instructions provided with your
vaginal cream carefully. The cream should be inserted into the vagina
using the applicator provided. It is usually best to do this before
going to bed at night.
Using oestrogen-only HRT tablets or patches
for a long time can increase the risk of cancer of the lining of the
womb (the endometrium). It is possible there may be a similar risk when
oestrogen creams, pessaries or rings are used in the vagina for
repeated treatments, or over a long period of time. If you experience
any vaginal bleeding or spotting, abnormal vaginal discharge or vaginal
discomfort during or after using Ovestin vaginal cream, you should
consult your doctor so that this can be investigated.
Women using any form of HRT should have
regular medical and gynaecological check-ups. Your need for continued
HRT should be reviewed with your doctor at least once a year.
It is important to be aware that women using
HRT have an increased risk of being diagnosed with breast cancer
compared with women who don't use HRT. This risk needs to be weighed
against the personal benefits to you of taking HRT. There is more
detailed information about the risks and benefits associated with HRT
in the factsheet about the menopause linked above. You should discuss
these with your doctor before starting HRT. Women on HRT should have
regular breast examinations and mammograms and should examine their own breasts regularly. Report any changes in your breasts to your doctor or nurse.
It is important to be aware that women using HRT have a slightly increased risk of stroke and of blood clots forming in the veins (eg deep vein thrombosis/pulmonary embolism)
compared with women who don't use HRT. The risk is higher if you have
existing risk factors (eg personal or family history, smoking, obesity,
certain blood disorders - see cautions below) and needs to be weighed
against the personal benefits to you of using HRT. There is more
detailed information about the risks and benefits associated with HRT
in the factsheet about the menopause linked above. Discuss these with
your doctor before starting treatment.
The risk of blood clots forming in the veins
(thromboembolism) while using HRT may be temporarily increased if you
experience major trauma, have surgery, or are immobile for prolonged
periods of time (this includes travelling for over five hours). For
this reason, your doctor may recommend that you stop using HRT for a
period of time (usually four to six weeks) prior to any planned
surgery, particularly abdominal surgery or orthopaedic surgery on the
lower limbs, or if you are to be immobile for long periods. The risk of
blood clots during long journeys may be reduced by appropriate exercise
during the journey and possibly by wearing elastic hosiery.
Discuss this with your doctor.
Stop using this medicine and inform your
doctor immediately if you experience any of the following symptoms
while using this medicine: stabbing pains or swelling in one leg; pain
on breathing or coughing; coughing up blood; breathlessness; sudden
chest pain; sudden numbness affecting one side or part of the body;
fainting; worsening of epilepsy; migraine or severe headaches; visual
disturbances; severe abdominal complaints; increased blood pressure;
itching of the whole body; yellowing of the skin or eyes (jaundice); or
severe depression.
There is a possibility that this cream may
damage latex condoms, diaphragms and caps, and the effectiveness of
these contraceptives may consequently be reduced. If you need to use
contraception to prevent pregnancy because you could still be fertile,
another non-hormonal method (eg contraceptive foam)
should be used. (A woman is considered fertile for two years after her
last menstrual period if she is under 50, or for one year if over 50.
This medicine should not be used by women who are pregnant.)
Use with caution in
Close family history of breast cancer (eg mother, sister or grandmother has had the disease)
History of an ear disorder that may cause hearing loss (otosclerosis)
History of irregular brown patches appearing
on the skin, usually of the face, during pregnancy or previous use of
hormone preparations such as contraceptive pills (chloasma).
Untreated overgrowth of the lining of the womb (endometrial hyperplasia)
Vaginal bleeding of unknown cause
Women with a blood clot in a vein of the leg (deep vein thrombosis) or in the lungs (pulmonary embolism), or a past history of these conditions where the cause is unknown
Women who have recently had a stroke caused by a blood clot
This medicine should not be used if you are
allergic to one or any of its ingredients. Please inform your doctor or
pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using
this medicine and inform your doctor or pharmacist immediately.
Pregnancy and Breastfeeding
Certain medicines should not be
used during pregnancy or breastfeeding. However, other medicines may be
safely used in pregnancy or breastfeeding providing the benefits to the
mother outweigh the risks to the unborn baby. Always inform your doctor
if you are pregnant or planning a pregnancy, before using any medicine.
This medicine should not be used by women who
are pregnant or breastfeeding. You should stop using this medicine and
consult your doctor immediately if you get pregnant during treatment.
A woman is considered fertile for two years
after her last menstrual period if she is under 50, or for one year if
over 50. HRT does not provide contraception for women who fall within
this group. If a potentially fertile women is using HRT and also
requires contraception, a non-hormonal method (eg contraceptive foam)
should be used. There is a possibility that this cream may damage latex
condoms, diaphragms or caps and the effectiveness of these
contraceptives may consequently be reduced.
Side effects
Medicines and their possible side
effects can affect individual people in different ways. The following
are some of the side effects that are known to be associated with this
medicine. Because a side effect is stated here, it does not mean that
all people using this medicine will experience that or any side effect.
Vaginal irritation or itching after applying the cream
Nausea and vomiting
Breast tenderness or pain
Breakthrough bleeding or spotting
Headache
Excessive production of cervical mucus
Gut disturbances, such as nausea, abdominal pain, bloating, flatulence, indigestion
Vaginal thrush
Depression
Dizziness
Changes in sex drive
Rise in blood pressure
Gall bladder disease
Swelling of the ankles due to to fluid retention (peripheral oedema)
Skin reactions such as rash and itch
Steepening of corneal curvature which may make contact lenses uncomfortable.
Premenstrual-like symptoms
Disturbance in liver function
Irregular brown patches on the skin, usually of the face (chloasma)
Blood clots in the blood vessels (eg, DVT, pulmonary embolism, heart attack, stroke - see warnings above)
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.
For more information about any other possible risks associated with
this medicine, please read the information provided with the medicine
or consult your doctor or pharmacist.
How can this medicine affect other medicines?
As the oestrogen from Ovestin
vaginal cream is absorbed into the bloodstream, it may interact with
other medicines being taken, eg by mouth or injection. It is important
to tell your doctor or pharmacist what medicines you are already
taking, including those bought without a prescription and herbal
medicines, before you start treatment with this medicine. Similarly,
check with your doctor or pharmacist before taking any new medicines
while using this one, to ensure that the combination is safe.
The following medicines may
potentially reduce the blood level and effect of this medicine, which
could result in recurrence of symptoms or irregular bleeding:
antiepileptic medicines such as carbamazepine, phenytoin, phenobarbital and primidone
barbiturates such as amobarbital
nevirapine or efavirenz for HIV infection
protease inhibitors for HIV infection such as ritonavir and nelfinavir
rifamycin antibiotics such as rifabutin and rifampicin
the herbal remedy St John's wort (Hypericum perforatum).
Oestrogens may increase the blood level of ropinirole used to treat Parkinson's disease.
Some women with diabetes may need
small adjustments in their dose of insulin or antidiabetic tablets
while using this medicine. You should monitor your blood sugar and seek
advice from your doctor or pharmacist if your blood sugar control seems
to be altered after starting this medicine.
If you need to use any other vaginal
medicines, for example pessaries or vaginal creams for thrush or other
vaginal infections, your doctor may want you to stop using Ovestin
cream during the treatment. Always check with your doctor.
