Oekolp forte

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Oekolp forte (OeKolp forte Ovula 0.5 mg)
0.5 mg, globules
Estriolum
Oekolp forte and OeKolp forte Ovula 0.5 mg are different trade names for the same medicine.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other individuals, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Oekolp forte is and what it is 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 pack and other information

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

Oekolp forte belongs to a group of medicines called local estrogen replacement therapy (ERT) for vaginal use. The medicine contains the female sex hormone estriol (an estrogen). Oekolp forte is used in postmenopausal women, at least 12 months after the natural cessation of menstruation.

Oekolp forte is used to relieve menopausal symptoms affecting the vagina, such as dryness or irritation. This condition is medically known as "atrophic vaginitis." It is caused by decreased 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 rapidly.

Estrogen deficiency may lead to vaginal dryness and increased sensitivity of the vaginal walls, resulting in painful sexual intercourse, inflammation, and intensified vaginal itching. Estrogen deficiency may also cause urinary incontinence and recurrent urinary bladder infections. These symptoms often improve with estrogen-containing medicines. Noticeable improvement usually occurs within a few days or weeks after starting treatment.

Oekolp forte works by replacing the estrogen normally produced by a woman's ovaries. The medicine is administered vaginally, so the hormone is released exactly where it is needed. This may help relieve vaginal discomfort. Improvement may become noticeable after several days or even weeks.

In addition to the indications described above, Oekolp forte may also be used:

• to accelerate healing after gynecological surgery,
• to facilitate accurate assessment of cervical smears in postmenopausal women.

2. Important information before using Oekolp forte

Medical history and regular check-ups
Hormone replacement therapy (HRT) is associated with risks that should be considered when deciding whether to start or continue treatment.
Experience with treating women who have premature menopause (due to ovarian failure or surgical removal of ovaries) is limited. In women with premature menopause, the risks associated with HRT may differ.
Always consult your doctor.
Before starting (or resuming) HRT, your doctor will take a detailed medical history, including family medical conditions. Your doctor may also decide to perform a physical examination, including, if necessary, a breast examination and/or a gynecological examination via the vagina.
After starting treatment with Oekolp forte, you should have regular check-ups with your doctor (at least once a year). During these visits, discuss with your doctor the benefits and risks of continuing treatment with Oekolp forte.
You should have regular breast examinations performed as recommended by your doctor.

When not to use Oekolp forte
Do not use Oekolp forte if any of the following apply to you. If you are unsure, consult your doctor before using Oekolp forte.

Do not use Oekolp forte:

• If you are allergic to estriol or any of the other ingredients of this medicine (listed in section 6).
• If you currently have or have ever had breast cancer, or if breast cancer is suspected.
• If you have an estrogen-dependent tumor, such as endometrial cancer (cancer of the lining of the womb), or if such a tumor is suspected.
• If you have vaginal bleeding of unknown cause.
• If you have untreated excessive thickening of the lining of the womb (endometrial hyperplasia).
• If you currently have or have ever had blood clots in blood vessels (venous thromboembolism), for example in the deep veins of the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
• If you have blood clotting disorders (such as protein C deficiency, protein S deficiency, or antithrombin deficiency).
• If you currently have or have recently had arterial diseases caused by blood clots, such as heart attack, stroke, or angina pectoris.
• If you currently have or have ever had liver disease, and liver function test results have not returned to normal.
• If you have a rare inherited blood disorder called "porphyria".

If any of the above medical conditions occur for the first time during treatment with Oekolp forte, stop treatment immediately and contact your doctor without delay.

Warnings and precautions
Before starting treatment, inform your doctor if you currently have or have ever had any of the following conditions, as they may recur or worsen during treatment with Oekolp forte. If this occurs, you should have more frequent check-ups:

• Uterine fibroids (leiomyoma)
• Endometriosis (growth of endometrial cells outside the uterus) or previous excessive growth of the endometrium (endometrial hyperplasia)
• Increased risk of venous blood clots (see section "Venous thromboembolism (venous thrombosis)")
• Increased risk of developing estrogen-dependent tumors (e.g. breast cancer in mother, sister, or grandmother)
• Hypertension
• Liver disorders, such as benign liver tumors
• Diabetes mellitus with or without vascular complications
• Gallstones
• Migraine or severe headaches
• An autoimmune disease affecting multiple internal organs (systemic lupus erythematosus - SLE; chronic connective tissue disease with skin changes throughout the body)
• Epilepsy
• Asthma
• Otosclerosis (a disease affecting the ear ossicles and causing hearing loss)
• Fluid retention associated with heart or kidney disease
• Hereditary or acquired angioedema.

Inform your doctor if you have hepatitis C and are being treated with medications such as ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin. Concurrent use of these drugs with certain estrogen-containing medicines may increase liver function test results (elevated liver enzyme ALT); the risk of this occurring with Oekolp forte is currently unknown.
Tell your doctor if you notice any changes in your condition while using Oekolp forte.

Stop using Oekolp forte and contact your doctor immediately if any of the following occur during HRT:

• Any of the conditions listed under "When not to use Oekolp forte"
• Yellowing of the skin or whites of the eyes (jaundice), which may indicate liver disease
• Swelling of the face, tongue, and/or throat and/or difficulty swallowing, or hives with breathing difficulties, suggesting angioedema
• Significant increase in blood pressure (which may manifest as headache, fatigue, dizziness)
• First occurrence of migraine-type headaches
• Pregnancy
• Symptoms indicating blood clot formation, such as:
  • Painful swelling and redness in the legs
  • Sudden chest pain
  • Breathing difficulties. More information is provided in the section "Venous thromboembolism (venous thrombosis)".

Note: Oekolp forte is not a contraceptive. If less than 12 months have passed since your last menstrual period or if you are under 50 years of age, you should use contraception to prevent pregnancy. Consult your doctor.

HRT and tumors

Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Long-term use of oral estrogen-only HRT may increase the risk of developing cancer of the endometrium (womb lining).
It is not certain whether a similar risk exists with 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 adding a progestogen is not necessary.
Bleeding or spotting is usually not a cause for concern, but you should contact your doctor, as it may be a sign of endometrial thickening.
To prevent endometrial stimulation, do not exceed the maximum dose or use it for longer than a few weeks (maximum 4 weeks).

The risks described below apply to systemic HRT medicines that circulate in the blood. Oekolp forte is intended for local vaginal use and is absorbed into the bloodstream to a very small extent. Worsening or recurrence of the disorders mentioned below during treatment with Oekolp forte is less likely, but if you have any concerns, contact your doctor.

Breast cancer
Data indicate that using 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.

You should have regular breast examinations and contact your doctor if you notice any changes, such as:

• Dimpling or pulling of the skin
• Changes in the nipple
• Any visible or palpable lumps or thickening.

Additionally, screening mammography is recommended as advised by your doctor.

Ovarian cancer
Ovarian cancer is rare—much rarer than breast cancer. Estrogen-only HRT is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, among women aged 50 to 54 who do not use HRT, ovarian cancer will be diagnosed in about 2 out of 2000 women over a 5-year period. Among 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

Venous thromboembolism (venous thrombosis)
The risk of venous blood clots is approximately 1.3 to 3 times higher in women using HRT than in those not using it, especially during the first year of treatment.
Venous thromboembolism can be serious. If a clot travels to the lungs, it may cause chest pain, shortness of breath, fainting, or even death.
The likelihood of venous blood clots increases with age and in the following situations. If any of the following apply to you, inform your doctor:

• Prolonged immobility due to major surgery, injury, or illness (see also section 3 "Need for surgery")
• Significant overweight (body mass index above 30 kg/m²)
• Blood clotting disorders requiring long-term anticoagulant therapy
• History of venous thrombosis in the legs, lungs, or another organ in a close relative
• Systemic lupus erythematosus (SLE; chronic connective tissue disease with skin changes throughout the body)
• Cancer.

Symptoms of thrombosis are listed in the section "Stop using Oekolp forte and contact your doctor immediately".

Comparison
In women over 50 years of age not using HRT, about 4 to 7 out of 1000 women can be expected to develop venous thrombosis over a 5-year period.
Among women over 50 using estrogen-only HRT for more than 5 years, the number of cases will be 5 to 8 per 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 it. The number of additional stroke cases associated with HRT increases with age.

Comparison
It is estimated that among women over 50 not using HRT, stroke will occur in about 8 out of 1000 women over a 5-year period, compared to 11 cases per 1000 women in those of the same age using HRT over 5 years (i.e., 3 additional cases).

Other disorders
HRT does not prevent memory loss. Some evidence suggests a higher risk of memory loss in women who start HRT after age 65. Consult your doctor about this.

Oekolp forte and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, herbal remedies, or other natural products.
Some medicines may affect the effectiveness 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 in HIV infection (such as nevirapine, efavirenz, ritonavir, and nelfinavir)
• Herbal products containing St. John's wort (Hypericum perforatum).

Laboratory tests
If you need to have blood laboratory tests, inform your doctor or laboratory staff that you are using Oekolp forte, as it may affect the results of certain tests.

Oekolp forte with food and drink
Food and fluids do not affect the effectiveness of Oekolp forte treatment.

Pregnancy and breastfeeding

Pregnancy
Oekolp forte is intended for use only in postmenopausal women.
If you become pregnant, stop using Oekolp forte and contact your doctor.

Breastfeeding
Women who are breastfeeding should consult their doctor before using Oekolp forte.

Driving and using machines
Using Oekolp forte should not affect your ability to drive or operate machinery. However, individual reactions to the medicine may vary.

Oekolp forte contains butylated hydroxytoluene
This medicine may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Oekolp forte

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
For atrophic changes in the lower part of the urogenital tract, 1 globule is usually used daily for the
first weeks (up to 4 weeks maximum), then the dose is gradually reduced to 1 globule twice a week.
To improve wound healing in postmenopausal women who have undergone vaginal procedures,
1 globule daily is usually used for 2 weeks before the procedure and 1 globule twice a week for
2 weeks after the procedure.
To facilitate interpretation of cervical smear results in postmenopausal women, 1 globule is usually
used every other day during the week preceding the smear collection.
The globule should be inserted deeply into the vagina while lying in a semi-reclining position, before
going to bed for the night. The globules must not be used rectally.

To remove the globule from its packaging, tear or cut the aluminium foil from the tip along the length of the globule, following the arrow, until the globule can be easily removed.
The prescribing doctor will aim to prescribe the lowest possible dose, which should be used for the shortest duration necessary to relieve symptoms.
If you feel that the effect of Oekolp forte is too strong or too weak, consult your doctor.
Use of more Oekolp forte than recommended
If you use more than the recommended dose of this medicine, contact your doctor or pharmacist immediately.
Accidental swallowing of the globules does not pose a health or life hazard. However, you should inform your doctor. Symptoms of overdose most commonly include nausea and vomiting; in women, vaginal bleeding may also occur after a few days.
Missing a dose of Oekolp forte
Do not use a double dose to make up for a forgotten dose.
If you miss a dose, take it as soon as possible, unless you notice the missed dose on the day the next dose is due. If the missed dose is noticed on the day of the next scheduled dose, skip the missed dose and continue with the next dose according to the previously established schedule.
Stopping Oekolp forte treatment
Always consult your doctor if treatment has been interrupted or prematurely discontinued due to the occurrence of adverse effects.
Need for surgery
Patients scheduled for surgery should inform the surgeon that they are using Oekolp forte. It may be necessary to stop using the medicine approximately 4 to 6 weeks before surgery to reduce the risk of blood clots (see section 2, “Venous thromboembolism (venous thrombosis)”). Ask your doctor when you can resume using Oekolp forte.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following conditions are reported more frequently in women using systemic hormone replacement therapy (HRT) medicines that circulate in the bloodstream than in women who do not use HRT. This risk is lower with medicines administered vaginally, such as Oekolp forte:

• ovarian cancer
• presence of blood clots in the veins of the legs or lungs (venous thromboembolic disease)
• stroke
• possible memory loss if HRT is initiated after the age of 65. For more information on adverse effects, see section 2.

Depending on the dosage used and individual patient sensitivity, the following adverse effects may occur:

• swelling and increased tenderness of the breasts
• slight vaginal bleeding
• increased vaginal discharge
• nausea
• fluid retention in tissues, usually manifesting as swelling of the ankles or feet
• local irritation or itching
• influenza-like symptoms. In most patients, these symptoms resolve after the first few weeks of treatment.

The following adverse effects have been reported during the use of other medicines in hormone replacement therapy:

• inflammation of the gallbladder
• various skin disorders:
• skin pigmentation changes, especially on the face or neck (chloasma)
• painful red nodules on the skin (nodular erythema)
• rash with target-shaped red lesions or erosions (erythema multiforme)

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorization holder or parallel importer.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Oekolp forte

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month. Translation of information from the immediate packaging:
Ch.-B./Verwendbar bis: see imprint – Batch number/Expiry date: see imprint
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Oekolp forte contains

• The active substance is estriol. One globule contains 0.5 mg of estriol.
• Other ingredients: glycerol monoricinoleate (contains butylhydroxytoluene), cetostearyl alcohol polyether, hard fat.

What Oekolp forte looks like and contents of the pack
Homogeneous, white globules.
Aluminum foil blisters in a cardboard box containing 10 globules.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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 Warszawa
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
spółka komandytowa ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warszawa
Marketing authorisation number in Germany, the country of export: 22684.00.00
Parallel import licence number: 391/24