Ovesse Cream

Ovesse 1 mg/g Vaginal Cream

What is Ovesse cream used for?

Ovesse vaginal cream is used to treat menopausal symptoms. After menopause, oestrogen levels drop naturally, which can cause the vaginal wall to become thinner, drier and less elastic. In medical terms, this is known as Genitourinary Syndrome of Menopause (GSM).

Symptoms of GSM include:

• Vaginal dryness
• Soreness or irritation
• Itching or burning sensation
• Painful sexual intercourse

How does Ovesse cream work?

Ovesse contains estriol, a naturally occurring oestrogen. When applied inside the vagina using the included applicator, it replaces the oestrogen that your body no longer produces after menopause. This helps restore moisture and elasticity to the vaginal tissues, relieving dryness, irritation and discomfort.

Because Ovesse is a local treatment applied directly to the vagina, very little oestrogen is absorbed into the bloodstream. This makes it different from systemic HRT treatments such as tablets, patches or gels, which work throughout the whole body.

Who can use Ovesse vaginal cream?

Ovesse vaginal oestrogen cream is suitable for postmenopausal women aged 50 and over who have not had a period for at least 1 year and are experiencing vaginal symptoms due to oestrogen deficiency.

Do not use Ovesse if you:

• Are allergic to estriol or any of the other ingredients
• Have or have ever had breast cancer, or are suspected of having it
• Have or have ever had womb or ovarian cancer, or have unexplained symptoms such as vaginal bleeding or pelvic pain you have not discussed with your doctor
• Have had any vaginal or genital bleeding since your periods stopped
• Have recent or suspected endometrial hyperplasia
• Have any change in the look or feel of the vulval area, such as thickening, a lump, shrinking or scarring
• Have previously been treated with oestrogen-only systemic HRT and have not had your womb removed (hysterectomy)
• Have a condition called vulval dermatoses, or any genital skin disorders such as severe vaginal itching, itchy patches or rash
• Have a current vaginal infection
• Have or have ever had a blood clot in a vein (thrombosis), such as deep vein thrombosis or pulmonary embolism
• Have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina
• Have a blood clotting disorder (such as protein C, protein S or antithrombin deficiency)
• Have or have ever had a liver disease where liver function has not returned to normal
• Have a rare inherited blood problem called porphyria
• Are pregnant or breastfeeding

Speak to your doctor or pharmacist before using Ovesse if you:

• Are already receiving systemic HRT (tablets or patches) that circulates in the blood
• Have a history of endometriosis or endometrial hyperplasia
• Are switching from another vaginal oestrogen HRT

How to Use Ovesse Cream

Ovesse comes with a reusable plastic applicator. You will need to fill the applicator from the tube yourself before each use. A good time to apply the cream is just before going to bed.

1. Remove the cap from the tube and turn it upside down. Use the sharp point on the cap to pierce and open the tube
2. Screw the end of the applicator onto the tube
3. Squeeze the tube to fill the applicator with cream up to the red ring mark. The plunger will stop automatically at the correct dose
4. Unscrew the applicator from the tube and replace the cap
5. Lie down and gently insert the applicator deep into your vagina
6. Slowly push the plunger all the way in to release the cream
7. Remove the applicator

After use, pull the plunger out of the barrel and wash both parts in warm, soapy water. Rinse well with clean water. Do not use detergents and do not put the applicator in boiling water.

Ovesse Cream Dosage

Initial dose: 1 applicator daily for 2 weeks.

Maintenance dose: 1 applicator twice a week, with 3 to 4 days between doses.

Treatment can be started on any day. If you miss a dose, use it as soon as you remember. Do not use a double dose to make up for a forgotten one.

Side Effects of Ovesse Cream

Like all medicines, Ovesse can cause side effects, though not everyone experiences them. Because Ovesse is a local treatment with a low dose of oestrogen, side effects are generally less common than with systemic HRT.

Side effects can include:

• Vaginal irritation or itching, particularly when you first start using Ovesse (this usually settles after a few weeks)
• Increased vaginal discharge, bleeding or spotting
• Breast swelling, tenderness or pain
• Headaches
• Nausea or vomiting
• Flu-like symptoms
• Skin rash or sensitivity to the sun
• Gallbladder problems

For a full list of side effects, read the patient information leaflet.

Stop using Ovesse and seek urgent medical attention if you experience signs of a serious allergic reaction, such as sudden sweating, difficulty breathing, rapid heartbeat or dizziness.

Ovesse Cream Ingredients

Active ingredient: Estriol 1 mg per gram of cream

Other ingredients: Chlorhexidine dihydrochloride, octyldodecanol, cetyl palmitate, glycerin, cetyl alcohol, stearyl alcohol, polysorbate 60, sorbitan stearate, lactic acid, sodium hydroxide and purified water.

Cetyl alcohol and stearyl alcohol may cause local skin reactions in some people.

Important Information

• Keep out of the sight and reach of children
• Do not use after the expiry date shown on the packaging
• Store below 25°C and do not freeze
• Ovesse is for vaginal use only
• Do not use if you are pregnant or breastfeeding
• Stop using Ovesse and contact your doctor if you develop any new vaginal bleeding, spotting or itching during treatment
• If you are due to have surgery, tell your surgeon you are using Ovesse. You may need to stop using it 4 to 6 weeks before your operation to reduce the risk of a blood clot