Ovestinon 1 mg/g vaginal cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ovestinon 1 mg/g vaginal cream

Estriol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ovestinon 1 mg/g vaginal cream is and what it is used for
2. What you need to know before using Ovestinon 1 mg/g vaginal cream
3. How to use Ovestinon 1 mg/g vaginal cream
4. Possible side effects
5. How to store Ovestinon 1 mg/g vaginal cream
6. Contents of the pack and other information

1. What Ovestinon 1 mg/g vaginal cream is and what it is used for

Ovestinon belongs to a group of medicines called hormone replacement therapy (HRT). It contains the female hormone estriol (an oestrogen). Ovestinon is used in postmenopausal women who have naturally had their last menstrual period at least 12 months ago.

It is used to relieve menopausal symptoms in the vagina, such as dryness or irritation. Medically, this is known as "vaginal atrophy". This condition is caused by a decline in oestrogen levels in the body, which occurs naturally after menopause.

If the ovaries are surgically removed (oophorectomy) before menopause, the drop in oestrogen production occurs very abruptly.

Oestrogen deficiency during menopause can cause the vaginal wall to become thin and dry (vaginal dryness). As a result, sexual intercourse may become painful, and irritation and vaginal infections may occur. Oestrogen deficiency may also lead to symptoms such as urinary incontinence and recurrent cystitis.

Ovestinon works by replacing the oestrogen that is normally produced by the ovaries. It is inserted into the vagina, so the hormone is released exactly where it is needed. This can help relieve vaginal discomfort.

It may take several days or even weeks before you notice an improvement.

In addition to the uses mentioned above, Ovestinon may also be used to:

• help heal wounds in postmenopausal women who have undergone vaginal surgery.

• assist in the evaluation of cervical smears (Papanicolaou test) in postmenopausal women.

2. What you need to know before using Ovestinon 1 mg/g vaginal cream

Medical history and medical check-ups

Hormone replacement therapy (HRT) involves risks that must be considered when deciding whether to start treatment or continue taking it.

Experience with HRT in women with premature menopause (due to ovarian failure or surgical intervention) is limited. If you have premature menopause, consult your doctor, as the risks of using HRT may differ.

Before starting (or restarting) hormone replacement therapy, your doctor will ask about your personal and family medical history. Your doctor may decide to perform a physical examination, which may include a breast examination and/or an internal examination, if necessary.

Once you have started taking Ovestinon, you should visit your doctor for regular check-ups (at least once a year). During these visits, discuss with your doctor the benefits and risks of continuing Ovestinon.

Have mammograms regularly, as recommended by your doctor.

Do not use Ovestinon

If any of the following conditions apply to you or if you have any doubts about them, consult your doctor before using Ovestinon.

Do not use Ovestinon:

• If you are allergic to estriol or to any of the other components of this medicine (listed in section 6).
• If you have or have had breast cancer or suspect you may have it.
• If you have a cancer sensitive to estrogens, such as cancer of the tissue lining the inside of the uterus (endometrium), or if you suspect you may have it.
• If you have any unexplained vaginal bleeding.
• If you have excessive growth of the tissue lining the inside of the uterus (endometrial hyperplasia) that is not being treated.
• If you have or have had a blood clot in a vein (thrombosis), in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
• If you have a blood clotting disorder (such as protein C deficiency, protein S deficiency, or antithrombin deficiency).
• If you have or have recently had a disease caused by blood clots in the arteries, such as myocardial infarction, stroke, or angina pectoris.
• If you have a liver disease and your liver function tests have not returned to normal.
• If you have a rare inherited blood disorder called "porphyria" that runs in families (hereditary).

If any of the above conditions develop for the first time while you are taking Ovestinon, stop taking it immediately and consult your doctor without delay.

Warnings and precautions

Consult your doctor before starting to use Ovestinon if you have had any of the following conditions, as they may reappear or worsen during treatment with Ovestinon. If so, you should visit your doctor more frequently for medical check-ups:

• uterine fibroids
• growth of the tissue lining the inside of the uterus outside the uterus (endometriosis) or history of excessive growth of the tissue lining the uterus (endometrial hyperplasia)
• increased risk of developing blood clots (see “blood clots in a vein (thrombosis)”)
• increased risk of developing an estrogen-sensitive cancer (e.g., if your mother, sister, or grandmother had breast cancer)
• high blood pressure
• a liver disorder, such as a benign liver tumor
• diabetes
• gallstones
• migraine or severe headaches
• an immune system disorder affecting multiple organs (systemic lupus erythematosus, SLE)
• epilepsy
• asthma
• a condition affecting the eardrum and hearing (otosclerosis)
• fluid retention due to heart or kidney problems
• hereditary or acquired angioedema

Inform your doctor if you have hepatitis C and are taking the combination medication regimen of ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. Combining these medications with other medicines containing estrogens may cause increases in blood test results for liver function (elevations in liver enzymes (ALT)). The risk of this occurring with Ovestinon is currently unknown.

Stop using Ovestinon and contact your doctor immediately

If you experience any of the following while taking hormone replacement therapy:

• any of the conditions listed in the section “Do not use Ovestinon”,
• yellowing of the skin or whites of the eyes (jaundice), which may be a sign of liver disease,
• swelling of the face, tongue, or throat and difficulty swallowing or hives accompanied by breathing difficulties, suggesting angioedema,
• a significant increase in blood pressure (symptoms may include headache, fatigue, dizziness),
• new-onset migraine-type headaches,
• if you become pregnant,
• if you experience signs of a blood clot, such as:
• painful swelling and redness in the legs,
• sudden chest pain,
• difficulty breathing.

For more information, see “blood clots in a vein (thrombosis)”.

Hormone replacement therapy and cancer

Excessive thickening of the tissue lining the inside of the uterus (endometrial hyperplasia) and cancer of the tissue lining the inside of the uterus

Taking oral HRT containing only estrogens for a prolonged period may increase the risk of developing cancer of the uterine lining (endometrium).

It is unclear whether there is a similar risk with Ovestinon when used repeatedly or long-term (more than one year). However, absorption of Ovestinon into the bloodstream has been shown to be very low; therefore, adding a progestogen is not necessary.

If you experience bleeding or spotting, it is usually not a cause for concern, but you should schedule an appointment with your doctor. It could be a sign that the endometrium has become thicker.

To avoid endometrial stimulation, do not exceed the maximum daily dose, and do not use this maximum dose for longer than a few weeks (maximum 4 weeks).

The following risks apply to systemic hormone replacement therapy (HRT) that circulates in the blood. However, Ovestinon is intended for local vaginal treatment, and its absorption into the bloodstream is very low. It is less likely that the conditions mentioned below will worsen or reappear during treatment with Ovestinon, but you should consult your doctor if you are concerned.

Breast cancer

Available data indicate that using Ovestinon does not increase the risk of breast cancer in women who have not previously had breast cancer. It is not known whether Ovestinon can be safely used in women who have previously had breast cancer.

Examine your breasts regularly. Contact your doctor if you notice any changes such as:

• skin dimpling,
• changes in the nipple,
• any lump you can see or feel.

In addition, you are advised to participate in mammography screening programs when offered.

Ovarian cancer

Ovarian cancer is rare—much rarer than breast cancer. The use of estrogen-only HRT has been associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, among women aged 50 to 54 who do not take HRT, approximately 2 out of every 2,000 women will be diagnosed with ovarian cancer over a 5-year period. Among women who have taken HRT for 5 years, there will be about 3 cases per 2,000 users (i.e., about 1 additional case).

Effect of Hormone Replacement Therapy on the heart and circulation

Blood clots in a vein

The risk of blood clots in veins is approximately 1.3 to 3 times higher in women using hormone replacement therapy than in those who do not, especially during the first year of treatment.

Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, shortness of breath, fainting, or even death.

The likelihood of developing a venous blood clot increases with age and if you have any of the following conditions. Inform your doctor if any of these apply to you:

• inability to walk for a prolonged period due to major surgery, injury, or illness (see also section 3 “If you need to undergo surgery”),
• significant overweight (BMI > 30 kg/m²),
• a blood clotting disorder requiring long-term treatment with a blood-thinning medication,
• if a close relative has had a blood clot in the leg, lung, or another organ,
• systemic lupus erythematosus (SLE),
• cancer.

For signs of a blood clot, see the section “Stop using Ovestinon and contact your doctor immediately”.

Comparison

On average, 4 to 7 out of every 1,000 women in their 50s who are not on HRT may develop a blood clot in a vein over a 5-year period. Among women in their 50s who have used estrogen-only HRT for more than 5 years, there will be 5 to 8 cases per 1,000 users (i.e., 1 additional case).

Heart disease (myocardial infarction)

Women taking only estrogens do not have an increased risk of developing heart disease.

Stroke

The risk of stroke is about 1.5 times higher in women using hormone replacement therapy than in those who do not. The number of additional stroke cases due to HRT use increases with age.

Comparison

On average, 8 out of every 1,000 women in their 50s who are not on HRT may have a stroke over a 5-year period. Among women of the same age on HRT for more than 5 years, there will be 11 cases per 1,000 users (i.e., 3 additional cases).

Other warnings

Hormone replacement therapy does not prevent memory loss. There is some evidence of an increased risk of memory loss in women who start using hormone replacement therapy after age 65. Seek advice from your doctor.

Note: Ovestinon is not a contraceptive and should not be used as such. If your last menstrual period was less than 12 months ago or if you are under 50 years old, you may still need to use a contraceptive method to avoid pregnancy. Consult your doctor.

Other medicines and Ovestinon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, herbal medicines, or other natural products.

Some medicines may interfere with the effect of Ovestinon, or Ovestinon may interfere with the effect of other medicines. This could cause irregular bleeding. This occurs with the following medicines:

• Medicines for epilepsy (such as phenobarbital, phenytoin, and carbamazepine).
• Medicines for tuberculosis (such as rifampicin, rifabutin).
• Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir, and nelfinavir).
• Herbal medicines containing St. John’s wort (Hypericum perforatum).

Inform your doctor if you have hepatitis C and are taking the combination regimen of ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. The combination of these medicines with other medicines containing estrogens may cause increases in blood test results for liver function (elevations in liver enzymes (ALT)). The risk of this occurring with Ovestinon is currently unknown.

Use of Ovestinon with food and drink

You may eat and drink normally during treatment with Ovestinon.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Ovestinon is intended only for postmenopausal women. If you become pregnant, stop using Ovestinon and contact your doctor.

If you are breastfeeding, consult your doctor before using Ovestinon, as it is excreted in breast milk.

Driving and using machines

Ovestinon is not expected to affect your ability to drive or operate machinery. However, individual responses to the medicine may vary.

Laboratory tests

If you need to have a blood test, inform your doctor or laboratory staff that you are using Ovestinon, as this medicine may alter the results of certain tests.

Important information about some of the components of Ovestinon

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearyl alcohol.

3. How to use Ovestinon 1 mg/g vaginal cream

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Never exceed the dose prescribed by your doctor.

The recommended dose for vaginal discomfort is one application daily during the first weeks (maximum 4 weeks), after which the dose should be gradually reduced, for example, to one application twice a week.

To improve wound healing in postmenopausal women undergoing vaginal surgery, the usual dose is one application daily for 2 weeks before surgery and then one application twice a week for the 2 weeks following surgery.

To assist in evaluating vaginal smears in postmenopausal women, the usual dose is one daily application every day of the week before the test.

Your doctor may interrupt treatment every 2–3 months for a period of 4 weeks to assess whether continued treatment is necessary.

A different dose may be prescribed for other conditions.

Instructions for correct administration of the preparation

Use the applicator to apply the cream into the vagina. It is advisable to do this before going to bed.

One application (applicator filled up to the mark) contains 0.5 g of Ovestinon cream, which contains 0.5 mg of estriol.

1. Unscrew the cap, turn the cap over, and use the sharp tip to pierce the seal of the tube.

2. Screw the applicator onto the tube. Make sure the plunger is fully inserted into the cylinder.

3. Squeeze the tube slowly so that enough cream enters the applicator to fill it up to the mark (red mark; see arrows in the illustration below).

4. Unscrew the applicator and recap the tube.

5. To apply the cream, lie down and insert the end of the applicator deeply into the vagina.

6. Slowly push the plunger until the applicator is empty.

7. After use, remove the plunger from the cylinder by passing the resistance point, and wash both the plunger and the applicator with lukewarm soapy water, then rinse thoroughly. Do not use detergents. Rinse well afterwards.

DO NOT PLACE THE APPLICATOR IN HOT OR BOILING WATER.

8. The applicator can be reassembled by fully inserting the plunger into the cylinder, passing the resistance point.

Discard the applicator once the tube is empty.

The maximum dose (one application daily) should not be used for longer than 2–3 weeks.

Your doctor will aim to prescribe the lowest effective dose for the shortest duration necessary to treat your symptoms. If you feel that the effect of Ovestinon is too strong or too weak, inform your doctor.

If you use more Ovestinon than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If someone accidentally ingests some of the cream, consult a doctor. Symptoms that may occur include nausea and vomiting; in women and girls, vaginal bleeding may also occur after a few days.

If you forget to use Ovestinon

Do not use a double dose to make up for a missed dose.

If you forget to apply a dose, do so as soon as you remember, unless you only realize when it is time for the next dose. In that case, do not apply the missed dose and simply apply the next dose as usual.

If you need to undergo surgery

If you are scheduled for surgery, inform the surgeon that you are using Ovestinon. You may need to stop using Ovestinon 4 to 6 weeks before the operation to reduce the risk of blood clots (see section 2, Blood clots in a vein). Ask your doctor when you can resume using Ovestinon.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Compared to women who do not use hormone replacement therapy, the following conditions have been reported more frequently in women using systemic hormone replacement therapy that circulates in the blood. These risks are less relevant for treatments administered vaginally, such as Ovestinon:

• ovarian cancer,
• blood clots in the veins of the legs or lungs (venous thromboembolism),
• stroke,
• possible memory loss if hormone replacement therapy is initiated after the age of 65.

See section 2 for more information about these adverse effects.

Depending on the dose and patient sensitivity, Ovestinon may uncommonly cause adverse effects such as:

• breast swelling and increased breast tenderness,
• slight vaginal bleeding,
• increased vaginal discharge,
• local irritation or pruritus.

Frequency not known (cannot be estimated from available data):

• flu-like symptoms,
• nausea,
• fluid retention in tissues, usually noticeable as swollen ankles or feet,
• discomfort when urinating (dysuria),
• burning sensation in or around the genital area.

In most patients, these adverse effects disappear after the first few weeks of treatment.

The following adverse effects have been reported with other hormone replacement therapies:

• gallbladder diseases,

• various skin disorders:

• skin pigmentation, especially on the face or neck, known as "pregnancy mask" (chloasma),

• painful red nodules on the skin (erythema nodosum),

  • skin rash with lesions or reddish papules in target-like shapes (erythema multiforme).

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ovestinon 1 mg/g vaginal cream

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Store in the original packaging.

Do not store above 25°C.

Do not freeze.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ovestinon

• The active substance is estriol. Each gram of cream contains 1 mg (milligram) of estriol.
• The other components are octyldodecanol, cetomacrogol emulsifying wax, glycerol (E-422), cetyl alcohol, stearyl alcohol, polysorbate 60, sorbitan stearate, lactic acid, chlorhexidine dihydrochloride, sodium hydroxide and purified water.

Appearance of the medicine and contents of the pack

Homogeneous, soft, white to almost white cream. Ovestinon cream is supplied in a carton containing a tube with 15 g of cream and an applicator.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

ASPEN PHARMA TRADING LTD
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland
Tel: 0034 952010137

Manufacturer

Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
D-23843 Bad Oldesloe
Germany

Local representative

Aspen Pharmacare España S.L.
Avenida Diagonal, 512
Planta Interior 1, Oficina 4
08006 Barcelona, Spain

Date of the most recent review of this leaflet: February 2026.

Detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/