Ovesse 1mg/g Vaginal Cream - 15g Tube + Applicator

Product features

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• Contains estriol, a gentle form of oestrogen for effective local Hormone Replacement Therapy (HRT)
• Specifically targets vaginal dryness, soreness and irritation caused by menopause
• Restores vaginal elasticity and moisture by replenishing natural oestrogen levels

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Product description

Ovesse 1 mg/g Vaginal Cream helps relieve vaginal discomfort caused by changes during menopause.

The name of your medicine is Ovesse 1 mg/g vaginal cream. Ovesse contains a medicine called estriol. Ovesse belongs to a group of medicines called local vaginal Hormone Replacement Therapy (HRT).

It is used to relieve menopausal symptoms in the vagina such as dryness or irritation. In medical terms this is known as ‘Genitourinary Syndrome of Menopause’. It is caused by a drop in the levels of oestrogen in your body. This happens naturally after the menopause.
The drop in oestrogen may cause the vaginal wall to become thinner, drier and less elastic and can cause symptoms in the vagina such as dryness, soreness or irritation, itching or burning sensation, and painful sexual intercourse. 

Ovesse works by replacing the oestrogen which is normally produced in the ovaries of women. It is inserted into your vagina, so the hormone is released where it is needed. This may relieve discomfort in the vagina

Features of Ovesse 1mg/g Vaginal Cream - 15g Tube + Applicator

• Provides localised relief directly where it’s needed without affecting the whole body
• Helps ease discomfort during sexual intercourse by improving vaginal tissue health
• Clinically designed for postmenopausal women aged 50 and above to relieve symptoms of oestrogen deficiency

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Specifications

• Product: Ovesse 1mg/g Vaginal Cream
• Package includes: 15g tube, applicator

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Warnings and cautions

The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it. Before you start (or restart) using Ovesse, your pharmacist will ask about your own and your family’s medical history. They may also ask you about your menopause and what symptoms you have had. This is to make sure that Ovesse is suitable for you and that you do not need to see your doctor before using Ovesse or if any other treatments may be more suitable.

Once you have started on Ovesse you should review your treatment regularly with your
pharmacist. Let your doctor know that you are using Ovesse at your next routine appointment.
Go for regular breast and cervical screening, as recommended by your doctor.
Do not use Ovesse if any of the following applies to you. If you are not sure about any of the points below, talk to your pharmacist before using Ovesse.

Do not use Ovesse if you:

• are allergic (hypersensitive) to estriol or any of the other ingredients of Ovesse
• have or have ever had womb or ovarian cancer, or you have symptoms such as vaginal bleeding, or pain, bloating or swelling in your lower abdomen or pelvis that you have not told your doctor about
• have had any vaginal or genital bleeding since your periods stopped due to the menopause
• have recent or suspected endometrial hyperplasia (or e.g., if you have been referred for an ultrasound of your womb and are awaiting the results)
• have any change in the look/feel of the vulval area such as thickening or a lump, or
  if you have noticed any shrinking or scarring in this area
• have previously been treated with systemic oestrogen only HRT (without progestogen) and you have not had your womb removed (hysterectomy)
• have a condition called “vulval dermatoses” or you have any genital skin disorders such as severe vaginal itching or itchy patches or rash. Your pharmacist will ask questions to confirm if the level of itching is a sign of something other than genitourinary syndrome of menopause
• have a current vaginal infection before starting treatment
• have or have ever had breast cancer, or if you are suspected of having it
• 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)
• 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 ever have had a liver disease and your liver function tests have not returned to normal
• have a rare blood problem called “porphyria” which is passed down in families (inherited)

Certain conditions may be made worse during oestrogen treatment, see section 2 of the package leaflet for more information.

You may need to speak to your doctor before using Ovesse. Ask your pharmacist for advice if you:

• Are receiving a type of HRT (including tablets or patches) that circulates in the blood
• Have a history of endometriosis
• Have a history of excessive thickening of the womb lining
• Are switching from another vaginal oestrogen

Stop using Ovesse and see a doctor immediately if you notice any of the following during treatment:

• Any of the conditions mentioned in the 'DO NOT use Ovesse' section
• Any new vaginal bleeding, spotting or itching
• If you have endometriosis and your symptoms come back.

Seek prompt advice from your doctor if you:

• Have yellowing of your skin or the whites of your eyes (jaundice)
• Have a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness) Get migraine-like headaches which happen for the first time Become pregnant

You should inform your doctor at your next appointment that you are using Ovesse.

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How to use

1. Initial dose: 1 applicator filled up to the red ring mark (0.5 mg estriol in 0.5 g of cream) a day for 2 weeks.
2. Maintenance dose: 1 applicator filled up to the red ring mark twice a week (3 or 4 days between each dose).
3. Restarting treatment after a break: You can restart using Ovesse at any time provided it is still suitable and your overall health is unchanged. If you are still experiencing symptom relief after a break from treatment with Ovesse, it is recommended that treatment is restarted at the maintenance dose. If you are experiencing bothersome symptoms again after a break from treatment with Ovesse, it is recommended to restart treatment at the initial daily dose regimen for 2 weeks, followed by the twice weekly maintenance dose.

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Ingredients

The active substance is estriol. Each gram of cream contains 1 milligram of estriol.
The other ingredients are chlorhexidine dihydrochloride, octyldodecanol, cetyl palmitate,
glycerin, cetyl alcohol, stearyl alcohol, polysorbate 60, sorbitan stearate, lactic acid, sodium
hydroxide and purified water.

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