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
Estriolum
Oekolp forte OeKolp forte Ovula 0.5 mgare different trade names for the same drug.

You should carefully read the contents of the leaflet before using the medicine, 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 medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 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 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 the use of 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 for:

• accelerating the healing of postoperative wounds in women undergoing vaginal surgery,
• accurate assessment of cervical smears in women during the postmenopausal period.

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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 vary. You should always consult a doctor.
Before starting (or resuming) HRT, the doctor will take a medical history and examine the patient's health and family medical history. They 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, 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 examinations 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 medicine (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 (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 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 blood clotting disorders(such as protein C deficiency, 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 tests 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 medical conditions occur for the first time while using Oekolp forte, treatment should be stopped immediately and a doctor consulted.
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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 benign liver tumors
• diabetes with or without vascular complications
• gallstones
• migraine or severe headaches
• systemic lupus erythematosus (SLE; a chronic disease of the connective tissue with skin lesions all over the body)
• epilepsy
• asthma
• otosclerosis (a disease affecting the eardrum and causing hearing loss)
• fluid retention due to heart or kidney disease
• hereditary and acquired angioedema.

You should inform your doctor if you have hepatitis C and are being treated with drugs such as ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin. Taking these drugs with some estrogen-containing medications may cause elevated liver function tests (increased ALT enzyme activity); the risk of this occurring with Oekolp forte is currently unknown.
You should tell your doctor if you notice any changes in your condition while using Oekolp forte.
You should stop using Oekolp forte and consult a doctor immediatelyif 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 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, which suggest angioedema
• significant increase in blood pressure (which may manifest as headache, fatigue, dizziness)
• migraine-like headaches that occur 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 is provided 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. You should consult a doctor.

HRT and tumors

Endometrial hyperplasia (thickening of the lining of the uterus) and endometrial cancer (cancer of the lining of the uterus).

The use of estrogen-only HRT in tablet form 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 normally be a cause for concern, but you should consult a doctor. This may be a sign of endometrial hyperplasia.
To prevent endometrial stimulation, you should not exceed the maximum dose or take it 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 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 breast cancer before. It is not known whether Oekolp forte can be safely used in women who have had breast cancer.

You should regularly examine your breasts and consult a doctor if you notice any changes, such as:

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

In addition, it is recommended to perform screening mammograms as advised by your 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 veinsis 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 be severe. 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 you, you should inform your 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/m²)
• blood clotting disorders that require long-term use of anticoagulant medications
• venous thrombosis in the legs, lungs, or other organs in a close relative
• systemic lupus erythematosus (SLE; a chronic disease of the connective tissue with skin lesions all over 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, 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 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. You should consult a doctor about this.

Oekolp forte and other medicines

You should 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.
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).

Laboratory tests

If blood tests are necessary, you should inform your doctor or laboratory staff that you are using Oekolp forte, as it may affect the results of some tests.
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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 only in women after menopause.
Pregnancy
If you become pregnant, you should stop using Oekolp forte and consult a doctor.
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 your 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 your doctor or pharmacist. If you are unsure, consult your 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 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.
Your doctor will try to prescribe the lowest possible dose that should be taken for the shortest necessary period 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 is used than recommended, you should consult a doctor or pharmacist immediately.

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In the event of swallowing a globule, it does not pose a risk to health and life. Nevertheless, you should inform your doctor. 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

You should not take a double dose to make up for a missed dose.
If a dose is missed, the medicine should be taken 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 taken according to the previously established schedule.

Stopping the use of Oekolp forte

You should always consult a doctor if therapy has been stopped or terminated prematurely due to side effects.

Need for surgery

Patients who are to undergo surgery should inform their surgeon that they are using Oekolp forte. It may be necessary to stop using Oekolp forte about 4 to 6 weeks before surgery to reduce the risk of blood clots (see section 2 "Blood clots in veins (venous thrombosis)"). You should ask your doctor when you can start using Oekolp forte again.
If you have any further doubts about the use of this medicine, you should 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 women not using HRT. This risk is less likely to apply to medicines administered vaginally, such as Oekolp forte:

• ovarian cancer
• 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 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 the first few weeks of treatment.
The following side effects have been reported during the use of other HRT medications:

• cholecystitis

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• various skin disorders:
• changes in skin pigmentation, 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
By reporting side effects, you can help provide more information on the safety of this 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. The expiry date refers to the last day of the month.
Do not store above 25°C.

Translation of some abbreviations on the immediate packaging:

Ch.-B./Verwendbar bis: see embossing - Batch number/Expiry date: see embossing.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Oekolp forte contains

• The active substance is estriol. 1 globule contains 0.5 mg of estriol.
• The other ingredients of the medicine are: hard fat, macrogol ester of cetostearyl alcohol, glycerol monoricinoleate (contains butylhydroxytoluene).

What Oekolp forte looks like and contents of the pack

Uniform, white globules. Blister packs of aluminum foil in a carton containing 10 globules.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

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
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Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. Elizy Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warszawa
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź
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:518/12
Date of leaflet approval: 25.08.2022
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