Ovestin Cream

Ovestin is a vaginal cream which is used for treatment of symptoms of vaginal atrophy (dryness, burning and/or itching of the vagina, pain, bleeding or discomfort during sex, recurring urine infections) due to oestrogen deficiency in postmenopausal women. Ovestin cream contains 1mg estriol in 1g cream. It is an oestrogen only product for intravaginal use. The cream is administered high up in the vagina by a reusable applicator which is included in the pack. The cream delivers oestrogen to areas of the vagina which reduce the symptoms of vaginal dryness or discomfort.

Ovestin is ideal for menopausal women who find vaginal symptoms troublesome but do not experience other symptoms like hot flushes or mood changes. Vaginal dryness is common in menopausal women however some have more severe symptoms which interfere with their daily life routines. As the oestrogen is administered directly into the vagina patients tend to see faster results with lower risk of systemic side effects. You will notice an improvement in symptoms within 2-3 weeks. However if you feel like your symptoms have not improved over 4 weeks use then you should consult your GP.

The usual dose is 1 applicator up to the ring (0.5 mg estriol in 0.5 g of cream) a day for the first 2 to 3 weeks (maximally 4 weeks). Then the dose is 1 applicator up to the ring twice a week. The clinician will prescribe you the lowest dose that relieves your symptoms. It is recommended that you to stop from time to time (every 2 to 3 months for a period of 4 weeks). This is to check if you still need treatment.

Ovestin comes in a pack together with a clear plastic applicator.Use the applicator to apply the cream in the vagina. A good time to do this is before going to bed. The applicator has a ring marked on the body. Fill the applicator up to the ring mark with Ovestin cream to get the correct dose.

1. Remove the cap from the tube and turn the cap upside down. Then use the sharp point to open the tube.
2. Screw the end of the applicator onto the tube.
3. Squeeze the tube to fill the applicator with the cream up to the red ring mark (the plunger will stop at the red ring mark).
4. Unscrew the applicator from the tube and put the cap back on the tube.
5. To apply the cream, lie down, put the end of the applicator deep into your vagina and slowly push the plunger all the way in.

Cleaning the applicator

• After use, pull the plunger out of the barrel.
• Wash the plunger and barrel in hand hot, soapy water.
• Do not use detergents. Rinse well with clean water afterwards.
• Do not put the applicator in boiling water.

Ovestin is easy to remove with water.

If you forget to use Ovestin

• Apply the missed dose when you remember, unless you are more than 12 hours late.
• If you are more than 12 hours late just skip the missed dose.

Like all medicines, Ovestin can cause side effects, although not everybody gets them

See your doctor straight away, if you notice any of the following serious side effects –your doctor may decide to stop you using the cream:

• your blood pressure rises
• your skin or the whites of your eyes go yellow (jaundice)
• you suddenly have migraine-type headaches
• you have signs of a blood clot

These side effects are rare.

Other side effects include:

• irritation or itching of the skin in or around your vagina when you start to use Ovestin. This usually gets better after a few weeks.
• increased vaginal discharge, bleeding or spotting
• gall bladder problems
• skin problems such as a rash or an allergy to the sun
• breasts become swollen, tender or painful
• headaches
• feeling sick or being sick.
• flu-like symptoms

If you have any of these side effects tell your doctor. They may decide to stop your treatment for a while. The list above isn’t exhaustive. If you experience serious side effects or side effects lasting longer than 3 months then you should consult your doctor immediately.

Make sure you read the patient information leaflet for a full list of side effects, cautions and contraindications. You should only take HRT once you have understood all the warnings and precautions as HRT may increase your chances of getting certain cancers or cardiovascular disease. If you are concerned discuss this with your doctor or The Family Chemist clinician.

Do not use Ovestin:

• If you have or have ever had breast cancer, or if you are suspected of having it
• If you have cancer which is sensitive to estrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it
• If you have any unexplained vaginal bleeding
• If you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated
• If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism)
• If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency)
• If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina
• If you have or ever have had a liver disease and your liver function tests have not returned to normal
• If you have a rare blood problem called “porphyria” which is passed down in families (inherited)
• If you are allergic (hypersensitive) to estriol or any of the other ingredients of Ovestin

If any of the above conditions appear for the first time while using Ovestin, stop taking it at once and consult your doctor immediately.

Warnings and precautions

Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Ovestin. If so, you should see your doctor more often for check-ups:

• fibroids inside your womb
• growth of womb lining outside your womb (endometriosis) or a history of excessive
• growth of the womb lining (endometrial hyperplasia)
• increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”)
• increased risk of getting an estrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
• high blood pressure
• a liver disorder, such as a benign liver tumor
• diabetes
• gallstones
• migraine or severe headaches
• a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
• epilepsy
• asthma
• a disease affecting the eardrum and hearing (otosclerosis)
• fluid retention due to cardiac or kidney problems

Tell your doctor if you have Hepatitis C and you are taking the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. Taking the combination of these drugs with some oestrogen-containing products may cause increases in liver function blood test results (increase in ALT liver enzyme); the risk of this happening with Ovestin is currently unknown.

Ovestin contains cetyl alcohol and stearyl alcohol. This may cause local skin reactions (e.g.contact dermatitis).

Stop using Ovestin and see a doctor immediately If you notice any of the following when taking HRT:

• any of the conditions mentioned in the ‘DO NOT take Ovestin’ section
• yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
• a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
• migraine-like headaches which happen for the first time
• if you become pregnant
• if you notice signs of a blood clot, such as:
  • painful swelling and redness of the legs
  • sudden chest pain
  • difficulty in breathing

• https://www.medicines.org.uk/emc/files/pil.5384.pdf
• https://www.womens-health-concern.org/
• https://patient.info/medicine/oestrogen-and-progestogen-for-hrt
• https://www.nhs.uk/conditions/menopause/
• https://www.nhs.uk/conditions/hormone-replacement-therapy-hrt/