Oekolp forte

Leaflet attached to the packaging: information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Oekolp forte (OeKolp forte Ovula 0.5 mg)

0.5 mg, globules
Estriol
Oekolp forte and OeKolp forte Ovula 0.5 mg are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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. Package contents and other information

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

Oekolp forte belongs to a group of drugs called hormone replacement therapy (HRT) for vaginal use. The drug contains the female sex hormone estriol (estrogen). Oekolp forte is used in postmenopausal women, at least 12 months after the cessation of natural menstruation.
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 is the cause of 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 the use of estrogen-containing drugs. 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 drug is administered vaginally, and 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 for:

• accelerating the healing of postoperative wounds in women undergoing vaginal surgery,
• 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 the use of HRT may be varied.
You should always consult a doctor.
Before starting (or resuming) HRT, the doctor will take a medical history and may decide to perform a physical examination, including a breast examination and/or gynecological examination through the vagina.
After starting Oekolp forte, you should regularly visit your doctor for check-ups (at least once a year). During the check-up, you should discuss the benefits and risks of continuing therapy with Oekolp forte with your doctor.
You should regularly perform breast exams as recommended by your doctor.

When not to use Oekolp forte

Oekolp forte should not be used if any of the following conditions 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 drug (listed in section 6).
• If breast canceris currently present or has occurred in the past, or if there is a suspicion of breast cancer.
• If there is an estrogen-dependent tumor, such as endometrial cancer (the lining of the uterus), or if there is a suspicion of such a tumor.
• If there is vaginal bleeding of unknown cause.
• If there is un-treated endometrial hyperplasia(thickening of the lining of the uterus).
• If blood clots in blood vessels(venous thrombosis) are currently present or have occurred in the past, such as in the blood vessels of the legs (deep vein thrombosis) or lungs (pulmonary embolism).
• If there are bleeding 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 disease, and liver function test results have not returned to normal.
• If there is a rare blood disease called "porphyria", which is inherited by 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 currently present or have occurred in the past, as they may recur or worsen during treatment with Oekolp forte. If this happens, you should visit your doctor more often:

• 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 internal 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 in the body due to heart or kidney disease
• hereditary and acquired angioedema.

If the patient has hepatitis C and is being treated with drugs such as ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, they should inform their doctor. Taking these drugs with some estrogen-containing drugs may cause elevated liver function test results (increased ALT enzyme activity); the risk of this occurring with Oekolp forte is currently unknown.
The doctor should be informed 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 during HRT:

• any of the conditions listed in "When not to use Oekolp forte"
• yellowing of the skin and 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 of blood clots, such as:
• painful swelling and redness of the legs
• sudden chest pain
• breathing difficulties. More information can be found in "Blood clots in veins (venous thrombosis)".

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 lining of the uterus) and endometrial cancer

Long-term use of estrogen-only HRT in tablet form 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 a 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 drugs 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 you have any concerns, you should consult a doctor.

Breast cancer

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

Regular breast exams 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 aged 50-54 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 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 a severe course. If a blood clot enters the lungs, it can cause chest pain, shortness of breath, fainting, or even death.
The likelihood of developing blood clots in veins increases with age and in the following situations. If any of the following situations apply to the patient, they should inform their doctor:

• prolonged immobilization due to major surgery, injury, or illness (see also section 3 "Need for surgery")
• significant obesity (body mass index over 30 kg/m)
• bleeding disorders requiring long-term use of anticoagulant drugs
• venous thrombosis in the legs, 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 "Stop using Oekolp forte and consult a doctor immediately".
Comparison
In the population of women over 50 years old who do not use HRT, on average, 4 to 7 out of 1000 women can expect to develop venous thrombosis over a 5-year period.
In the group of women over 50 years old who 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, on average, 8 out of 1000 women can expect to have a stroke over a 5-year period, while in women of the same age using HRT, the rate is 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 drugs

The doctor or pharmacist should be informed about all drugs currently or recently used by the patient, as well as any drugs planned to be used, including those available without a prescription, herbal remedies, or other natural products.
Some drugs may affect the efficacy of Oekolp forte, and Oekolp forte may affect the action of other drugs. This may lead to irregular bleeding. This applies to the following drugs:

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

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 treatment.

Pregnancy and breastfeeding

Oekolp forte is intended for use in postmenopausal women only.
Pregnancy
If pregnancy occurs, the use of Oekolp forte should be stopped and a doctor 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 drug may vary.

Oekolp forte contains butylhydroxytoluene

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

3. How to use Oekolp forte

This drug should always be used as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
In the case of atrophic changes in the lower urinary and genital tract, 1 globule is usually used per day for the first few 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 deep into the vagina, in a semi-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, according to 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, you should consult a doctor.

Using a higher dose of Oekolp forte than recommended

If a higher dose of Oekolp forte than recommended is used, a doctor or pharmacist should be consulted immediately.
In the event of swallowing globules, it does not pose a risk to health and life. However, a doctor should be informed. Symptoms of overdose are usually nausea and vomiting; in women, bleeding from the genital tract may also occur after a few days.

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 drug 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 adverse reactions.

Need for surgery

Patients who are to undergo surgery should inform the surgeon that they are using Oekolp forte. It may be necessary to stop using the drug about 4 to 6 weeks before surgery to reduce the risk of blood clots (see "Blood clots in veins (venous thrombosis)"). A doctor should be asked when it is possible to restart using Oekolp forte.
If you have any further doubts about the use of this drug, you should consult a doctor or pharmacist.

4. Possible side effects

Like all drugs, this drug can cause side effects, although not everyone will experience them.
The following conditions are reported more frequently in women using HRT drugs that circulate in the blood than in women not using HRT. This risk is less likely to apply to drugs administered vaginally, such as Oekolp forte:

• ovarian cancer
• presence of blood clots in veins of the legs or lungs (venous thromboembolism)
• stroke
• possible memory loss if HRT is started at an age over 65. More information on 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. In most patients, these symptoms will disappear after a few weeks of treatment.

The following side effects have been reported with the use of other HRT drugs:

• 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 any side effects occur, including any side effects not listed in the leaflet, a doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects will help gather more information on the safety of the drug.

5. How to store Oekolp forte

The drug should be stored in a place that is out of sight and reach of children.
The drug should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month. Translation of information from the immediate packaging:
Ch.-B./Verwendbar bis: see imprint – Batch number/Expiration date: see imprint
The drug should not be stored at a temperature above 25°C.
Drugs should not be disposed of in wastewater or household waste. A pharmacist should be asked how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What Oekolp forte contains

• The active substance is estriol. 1 globule contains 0.5 mg of estriol.
• The other ingredients are: glycerol monooleate (contains butylhydroxytoluene), macrogol stearate, solid fat.

What Oekolp forte looks like and what the package contains

Uniform, white globules.
Blister packs of aluminum foil in a cardboard box containing 10 globules.
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in Germany, the country of export:

Besins Healthcare Germany GmbH
Mariendorfer Damm 3
12099 Berlin
Germany

Manufacturer:

Dr. Kade Pharmazeutische Fabrik GmbH
Rigistrasse 2
12277 Berlin
Germany

Parallel importer:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp.
komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Germany, the country of export:22684.00.00

Parallel import authorization number: 391/24

Date of leaflet approval: 12.11.2024

[Information about the trademark]