Oekolp forte

Leaflet accompanying the packaging: patient information

OEKOLP forte, 0.5 mg, vaginal globules

Estriol

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is OEKOLP forte and what is it used for
• 2. Important information before using OEKOLP forte
• 3. How to use OEKOLP forte
• 4. Possible side effects
• 5. How to store OEKOLP forte
• 6. Contents of the packaging and other information

1. What is OEKOLP forte and what is it used for

OEKOLP forte belongs to a group of medicines called hormone replacement therapy (HRT) for vaginal use. The medicine contains the female sex hormone estriol (estrogen). OEKOLP forte is used in women after menopause, at least 12 months after the last natural menstrual period.
OEKOLP forte is used to alleviate menopausal symptoms in the vagina, such as dryness or irritation. In medical terminology, this phenomenon is referred to as "atrophic vaginitis". It is caused by a decrease in estrogen levels in the body and occurs naturally after menopause.
If the ovaries are surgically removed before menopause (a procedure called oophorectomy), estrogen production decreases very quickly.
Estrogen deficiency can cause dryness and increased sensitivity of the vaginal walls, which can lead to painful intercourse and the occurrence of inflammatory conditions and severe itching of the vagina. Estrogen deficiency can also cause symptoms of urinary incontinence and recurrent urinary tract infections. These symptoms often disappear after using estrogen-containing medications. Noticeable improvement usually occurs after a few days or weeks of treatment.
OEKOLP forte works by replacing estrogen, which is normally produced by the woman's ovaries. The medicine is administered vaginally, so the hormone is released where it is needed.
This can alleviate discomfort in the vagina. Improvement may only be noticeable after a few days or even weeks.
In addition to the above indications, OEKOLP forte may also be used to:

• accelerate the healing of postoperative wounds in women who have undergone vaginal surgery,
• facilitate the accurate assessment of cervical smears in postmenopausal women.

2. Important information before using OEKOLP forte

Medical history and regular check-ups

The use of HRT is associated with a risk that should be considered when deciding to start or continue therapy.
Experience with the treatment of women who have premature menopause (due to ovarian failure or after surgery) is limited. In women with premature menopause, the risk associated with HRT may vary.
Always consult a doctor.
Before starting (or resuming) HRT, the doctor will take a medical history and ask about the patient's health and family medical history. The doctor may also decide to perform a physical examination, including a breast examination and/or gynecological examination through the vagina, if necessary.
After starting OEKOLP forte, regular check-ups with the doctor should be scheduled (at least once a year). During the check-up, the benefits and risks associated with continuing therapy with OEKOLP forte should be discussed with the doctor.
Regular breast examinations should be performed as recommended by the doctor.

When not to use OEKOLP forte

OEKOLP forte should not be used if any of the following situations apply to the patient. If in doubt, consult a doctor before using OEKOLP forte.
When not to use OEKOLP forte:

• If the patient is allergicto estriol or any of the other ingredients of this medicine (listed in section 6).
• If breast canceris present or has been diagnosed in the past, or if there is a suspicion of breast cancer.
• If there is an estrogen-dependent tumor, such as endometrial cancer (cancer of the lining of the uterus), or if there is a suspicion of such a tumor.
• If there is vaginal bleedingof unknown cause.
• If there is untreated endometrial hyperplasia(thickening of the lining of the uterus).
• If blood clots in the blood vessels(venous thrombosis) are present or have occurred in the past, such as deep vein thrombosis or pulmonary embolism.
• If there are blood clotting disorders(such as protein C or protein S deficiency, or antithrombin deficiency).
• If there are currently or recently arterial diseasescaused by blood clots, such as heart attack, stroke, or angina pectoris.
• If there is currently or has been liver diseasein the past, and liver function tests have not returned to normal.
• If there is a rare blood disease called "porphyria", which is inherited through family members.

If any of the above health conditions occur for the first time while using OEKOLP forte, treatment should be stopped immediately and a doctor should be consulted.

Warnings and precautions

Before starting treatment, the doctor should be informed if any of the following conditions are present or have occurred in the past, as they may recur or worsen during treatment with OEKOLP forte. If this happens, more frequent check-ups with the doctor should be scheduled:

• uterine fibroids (leiomyoma)
• growth of endometrial cells outside the uterus (endometriosis) or a history of endometrial hyperplasia
• increased risk of blood clots (see "Blood clots in veins (venous thrombosis)")
• increased risk of estrogen-dependent tumors (e.g., breast cancer in the mother, sister, or grandmother)
• high blood pressure
• liver disorders, such as liver tumors
• diabetes with or without vascular complications
• gallstones
• migraine or severe headaches
• immune system disease affecting multiple organs (systemic lupus erythematosus; chronic connective tissue disease with skin changes throughout the body)
• epilepsy
• asthma
• disease affecting the eardrum and causing hearing loss (otosclerosis)
• fluid retention due to heart or kidney disease
• hereditary and acquired angioedema.

The doctor should be informed if the patient has hepatitis C and is being treated with medications such as ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir. More information can be found in the "OEKOLP forte and other medicines" section.
The doctor should be told if the patient notices any changes in their condition while using OEKOLP forte.

Stop using OEKOLP forte and consult a doctor immediately,

if any of the following conditions occur while using HRT:

• any of the conditions listed in the "When not to use OEKOLP forte" section
• yellowing of the skin and whites of the eyes (jaundice), which may be a sign of liver disease
• swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, with difficulty breathing, suggesting angioedema
• significant increase in blood pressure (which may manifest as headache, fatigue, dizziness)
• migraine-like headaches occurring for the first time
• pregnancy
• symptoms suggesting the formation of blood clots, such as:
• painful swelling and redness of the legs
• sudden chest pain
• breathing difficulties. More information can be found in the "Blood clots in veins (venous thrombosis)" section.

Note:OEKOLP forte is not a contraceptive. If it has been less than 12 months since the last menstrual period or the woman is under 50 years old, contraception should be used to avoid pregnancy. Consult a doctor.

HRT and tumors

Endometrial hyperplasia (thickening of the uterine lining) and endometrial cancer

The use of estrogen-only HRT in the form of tablets for a long time may increase the risk of developing endometrial cancer.
It is not certain whether a similar risk exists with the repeated or long-term (longer than one year) use of OEKOLP forte. However, it has been shown that OEKOLP forte is absorbed into the bloodstream to a very small extent, and therefore, the addition of progestogen is not necessary.
Bleeding or spotting should not usually be a cause for concern, but a doctor should be consulted. This may be a sign of endometrial hyperplasia.
To prevent endometrial stimulation, the maximum dose should not be exceeded, and it should not be taken for longer than a few weeks (up to 4 weeks).
The risks described below are associated with HRT medications that circulate in the blood. OEKOLP forte, on the other hand, is intended for local use in the vagina and is absorbed into the bloodstream to a very small extent. The worsening or recurrence of the following conditions during treatment with OEKOLP forte is less likely, but if there are any concerns, a doctor should be consulted.

Breast cancer

Data indicate that the use of OEKOLP forte does not increase the risk of breast cancer in women who have never had breast cancer before. It is not known whether OEKOLP forte can be safely used in women who have had breast cancer.

Regular breast examinations should be performed and a doctor should be consulted if any changes are noticed, such as:

• indentation or retraction of the skin
• changes in the nipple
• any visible or palpable thickening and/or lumps.

In addition, it is recommended to perform screening mammograms as advised by the doctor.

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. The use of estrogen-only HRT is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, in women between the ages of 50 and 54 who do not use HRT, ovarian cancer will be diagnosed in about 2 out of 2000 women over a 5-year period. In women who use HRT for 5 years, ovarian cancer will be diagnosed in about 3 out of 2000 women (i.e., about 1 additional case).

Effect of HRT on the heart or circulatory system

Blood clots in veins (venous thrombosis)

The risk of developing blood clots in the veins is about 1.3 to 3 times higher in women using HRT than in those not using HRT, especially in the first year of treatment.
Venous thrombosis can have serious consequences. If a clot reaches the lungs, it can cause chest pain, shortness of breath, fainting, or even death.
The likelihood of developing blood clots in the veins increases with age and in the following situations. If any of the following situations apply to the patient, the doctor should be informed:

• prolonged immobilization due to major surgery, injury, or illness (see also section 3 "Need for surgery")
• significant overweight (body mass index over 30 kg/m²)
• blood clotting disorders requiring long-term use of anticoagulant medications
• venous thrombosis in the legs or lungs, or other organs in a close relative
• systemic lupus erythematosus (chronic connective tissue disease with skin changes throughout the body)
• cancer.

Symptoms of venous thrombosis are listed in the "Stop using OEKOLP forte and consult a doctor immediately" section.
Comparison
In the population of women over 50 years old who do not use HRT, venous thrombosis is expected to occur in about 4 to 7 out of 1000 women over a 5-year period.
In the group of women over 50 years old who have used estrogen-only HRT for more than 5 years, the number of cases will be 5 to 8 out of 1000 women (i.e., 1 additional case).

Heart disease (heart attack)

In women using estrogen-only HRT, the risk of developing heart disease is not increased.

Stroke

The risk of stroke is about 1.5 times higher in women using HRT than in those not using HRT. The number of additional stroke cases associated with HRT increases with age.
Comparison
It is estimated that in women over 50 years old who do not use HRT, stroke will occur in about 8 out of 1000 women over a 5-year period, while in women of the same age group using HRT, the rate will be 11 cases per 1000 women over a 5-year period (i.e., 3 additional cases).

Other disorders

HRT will not prevent memory loss. Some evidence suggests a higher risk of memory loss in women who start HRT at an age over 65. Consult a doctor about this.

OEKOLP forte and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription, herbal medicines, or other natural products. Also, inform other healthcare professionals who prescribe or dispense other medicines that you are taking OEKOLP forte.
Some medicines may affect the efficacy of OEKOLP forte, and OEKOLP forte may affect the action of other medicines. This may lead to irregular bleeding. This applies to the following medicines:

• antiepileptic drugs(such as phenobarbital, phenytoin, and carbamazepine)
• medicines used to treat tuberculosis(such as rifampicin, rifabutin)
• medicines used to treat HIV infection(such as nevirapine, efavirenz, ritonavir, and nelfinavir)
• herbal products containing St. John's Wort(Hypericum perforatum).

HRT may affect the action of other medicines:

• medicines for the treatment of viral hepatitis C (such as combination therapy with ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin; glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir) may cause increased liver enzyme activity in blood tests in women using combined hormonal contraceptives containing ethinyl estradiol. OEKOLP forte contains estriol instead of ethinyl estradiol. It is not known whether increased liver enzyme activity may occur when using OEKOLP forte with such combination therapy.

Lab tests

If blood tests are necessary, the doctor or laboratory staff should be informed about the use of OEKOLP forte, as it may affect the results of some tests.

OEKOLP forte with food and drink

Food and drink do not affect the efficacy of OEKOLP forte.

Pregnancy and breastfeeding

OEKOLP forte is intended for use only in postmenopausal women.
Pregnancy
If pregnancy occurs, the use of OEKOLP forte should be stopped, and a doctor should be consulted.
Breastfeeding
Women who are breastfeeding should consult a doctor before using OEKOLP forte.

Driving and using machines

The use of OEKOLP forte should not affect the ability to drive or operate machines. However, individual reactions to the medicine may vary.

OEKOLP forte contains butylhydroxytoluene

The medicine may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to use OEKOLP forte

This medicine should always be used as directed by the doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
In the case of atrophic changes in the lower genital tract, 1 globule is usually used per day for the first weeks (up to 4 weeks), then the dose is gradually reduced to 1 globule twice a week.
To improve wound healing in postmenopausal women who have undergone vaginal surgery, 1 globule is usually used per day for 2 weeks before surgery and 1 globule twice a week for 2 weeks after surgery.
To facilitate the interpretation of cervical smear results in postmenopausal women, 1 globule is usually used every other day in the week preceding the smear.
The globule should be inserted deeply into the vagina, in a half-lying position, before going to bed. The globule should not be used rectally.

To remove the globule from the packaging, the aluminum foil should be torn or cut from the tip along the globule, following the arrow, until the globule can be easily removed.
The doctor will try to prescribe the lowest possible dose, which should be taken for the shortest time necessary to alleviate the symptoms.
If you feel that the effect of OEKOLP forte is too strong or too weak, consult a doctor.

Using more than the recommended dose of OEKOLP forte

If a higher dose than recommended is used, consult a doctor or pharmacist immediately.
If the globules are swallowed, it does not pose a risk to health and life. However, the doctor should be informed. Symptoms of overdose are usually nausea and vomiting; in women, menstrual bleeding may also occur a few days later.

Missing a dose of OEKOLP forte

A double dose should not be used to make up for a missed dose.
If a dose is missed, the medicine should be used as soon as possible, unless the missed dose is noticed on the day of the next dose. If the missed dose is noticed on the day of the next dose, the missed dose should be skipped, and the next doses should be used according to the previously established schedule.

Stopping the use of OEKOLP forte

A doctor should always be consulted if therapy is stopped or terminated prematurely due to side effects.

Need for surgery

Patients who are to undergo surgery should tell the surgeon that they are using OEKOLP forte. It may be necessary to stop using the medicine about 4 to 6 weeks before surgery to reduce the risk of blood clots (see section 2 "Blood clots in veins (venous thrombosis)"). The doctor should be asked when it is possible to start using OEKOLP forte again.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, OEKOLP forte can cause side effects, although not everybody gets them.
The following conditions are reported more frequently in women using HRT medications that circulate in the blood than in those not using HRT. This risk is less likely to apply to vaginally administered medicines like OEKOLP forte:

• ovarian cancer
• presence of blood clots in the veins of the legs or lungs (venous thromboembolism)
• stroke
• possible memory loss if HRT is started at an age over 65. More information about side effects can be found in section 2.

Depending on the doses used and the patient's sensitivity, the following side effects may occur:

• breast swelling and tenderness
• mild vaginal bleeding
• increased vaginal discharge
• nausea
• fluid retention in tissues, usually manifesting as swelling of the ankles or feet
• local irritation or itching
• flu-like symptoms.

Most patients experience relief from these symptoms after a few weeks of treatment.
The following side effects have been reported during the use of other HRT medications:

• cholecystitis
• various skin disorders:
• skin discoloration, especially on the face or neck (chloasma)
• painful red lumps on the skin (erythema nodosum)
• rash with plate-like, red lesions or ulcers (erythema multiforme).

Reporting side effects

If side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed.
Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store OEKOLP forte

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after "Expiry date". The expiry date refers to the last day of the month.
The medicine should be stored at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What OEKOLP forte contains

• The active substance is estriol. 1 vaginal globule contains 0.5 mg of estriol.
• The other ingredients are: butylhydroxytoluene, cetomacrogol 1000, mono- and di-glycerides, hard fat.

What OEKOLP forte looks like and contents of the pack

Uniform, white globules. Aluminum foil blisters in a cardboard box containing 10 or 24 vaginal globules.

Marketing authorization holder and manufacturer

DR. KADE Pharmazeutische Fabrik GmbH
Rigistrasse 2
12277 Berlin
Germany
For more information, contact the representative of the marketing authorization holder:
Kadefarm Sp. z o.o.
Sierosław, ul. Gipsowa 18
62-080 Tarnowo Podgórne, Poland
tel.: +48 61 862 99 43
e-mail: kadefarm@kadefarm.pl

Date of last revision of the leaflet: