|Main use||Active ingredient||Manufacturer|
|Vaginal symptoms of the menopause||Estriol||Janssen-Cilag|
How does it work?
Ortho-Gynest vaginal cream and pessaries both contain 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 inserted directly into the vagina in the form of vaginal cream or pessaries, 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.
Ortho-Gynest cream and pessaries are inserted into the vagina using the applicator provided. Both forms of Ortho-Gynest release small amounts of oestrogen locally into the vaginal tissues and are used short-term to provide relief from the vaginal symptoms of the menopause, such as dryness, itching and irritation.
Estriol from Ortho-Gynest 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 medicine. 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 three to six months 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)
- Follow the instructions provided with your medicine carefully. Ortho-Gynest cream and pessaries are for use in the vagina only. They 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 Ortho-Gynest, 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.
- Ortho-Gynest cream and pessaries 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 benign breast lumps (fibrocystic breast disease)
- History of fibroids in the womb
- History of endometriosis
- History of overgrowth of the lining of the womb (endometrial hyperplasia)
- Personal or family history of blood clots in the veins (venous thromboembolism, eg deep vein thrombosis or pulmonary embolism)
- Blood disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome, factor V Leiden
- Women taking medicines to prevent blood clots (anticoagulants), eg warfarin
- Long-term inflammation of skin and some internal organs (systemic lupus erythematosus)
- Personal or family history of recurrent miscarriage
- Severe obesity
- Varicose veins
- History of high blood pressure (hypertension)
- Raised levels of fats called triglycerides in the blood (hypertriglyceridaemia)
- History of liver disease, eg liver cancer
- Decreased kidney function
- Heart failure
- History of diabetes
- History of gallstones
- History of migraines or severe headaches
- History of epilepsy
- History of asthma
- 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).
Not to be used in
- Known, suspected, or past history of breast cancer
- Known or suspected cancer in which growth of the cancer is stimulated by oestrogen, eg cancer of the lining of the womb (endometrial cancer)
- 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
- Women who have recently had a heart attack
- Angina pectoris
- Active liver disease
- History of liver disease when liver function has not returned to normal
- Hereditary blood disorders known as porphyrias
- Ortho-Gynest cream contains arachis oil and should not be used by women with an allergy to peanuts or soya. This does not apply to the pessaries.
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.
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.
- Breast tenderness or pain
- Vaginal discharge or thrush
- Gut disturbances, such as nausea, abdominal pain, bloating, flatulence, indigestion
- Premenstrual-like symptoms
- Breakthrough bleeding or spotting
- 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.
- 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 Ortho-Gynest vaginal cream and pessaries 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 Ortho-Gynest during the treatment. Always check with your doctor.
Other medicines containing the same active ingredient
|Ovestin cream||Ovestin tablets|