Oekolp forte

Package leaflet: Information for the patient

WARNING: Keep this leaflet. The packaging contains information 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 medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

Oekolp forte belongs to a group of medicines called local oestrogen therapy (hormone replacement therapy, HRT) for vaginal use. The medicine contains the female sex hormone estriol (an oestrogen). 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. In medical terminology, this condition is known as "atrophic vaginitis". It is caused by a decrease in oestrogen levels in the body and occurs naturally after menopause.

If the ovaries have been surgically removed before menopause (a procedure called ovariectomy), oestrogen production decreases rapidly.

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

Oekolp forte works by replacing the oestrogen normally produced by a woman's ovaries. The medicine is administered vaginally, so the hormone is released exactly where it is needed.

This may relieve vaginal discomfort. Improvement may become noticeable only after several days or even weeks.

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

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

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2. Important information before using Oekolp forte

Medical history and regular check-ups
Hormone replacement therapy (HRT) involves 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 vaginal examination.
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 as recommended by your doctor.

When not to use Oekolp forte
Do not use Oekolp forte if any of the following conditions 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 oestrogen-dependent tumour, such as endometrial cancer (cancer of the lining of the womb), or if such a tumour 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 conditions caused by blood clots in arteries, such as myocardial infarction, 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 health conditions occurs for the first time while using Oekolp forte, stop treatment immediately and contact your doctor without delay.
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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 lining of the womb (endometrial hyperplasia)
• Increased risk of blood clots (see section "Blood clots in veins (venous thromboembolism)")
• Increased risk of developing oestrogen-dependent cancer (e.g. breast cancer in mother, sister, or grandmother)
• Hypertension
• Liver disorders, such as benign liver tumour
• Diabetes 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 lesions throughout the body)
• Epilepsy
• Asthma
• Otosclerosis (a disease affecting the ear bones 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 oestrogen-containing medicines may increase liver function test results (elevated liver enzyme ALT activity); 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.
You must stop using Oekolp forte and contact your doctor immediately if any of the following conditions 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 be a sign of 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 present as headache, fatigue, dizziness)
• First occurrence of migraine-type headaches
• Pregnancy
• Symptoms indicating blood clots, such as:
• Painful swelling and redness in the legs,
• Sudden chest pain,
• Breathing difficulties. More information is provided in the section "Blood clots in veins (venous thromboembolism)".

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 avoid pregnancy. Consult your doctor.
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HRT and cancer
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 oestrogen-only HRT may increase the risk of developing cancer of the uterine lining (endometrium).
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 very poorly absorbed into the bloodstream, and therefore the addition of a progestogen is not necessary.
Bleeding or spotting should not usually be 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 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, consult 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 regularly examine your breasts and contact your doctor if you notice any changes, such as:

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

Additionally, screening mammograms are recommended as advised by your doctor.

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer. Oestrogen-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 within 5 years in about 2 out of 2,000 women. Among women who use HRT for 5 years, ovarian cancer will be diagnosed in about 3 out of 2,000 women (i.e. about 1 additional case).

Effect of HRT on the heart or circulatory system
Blood clots in veins (venous thromboembolism)
The risk of blood clots in veins is about 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 developing 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 legs, lungs, or another organ in a close relative
• Systemic lupus erythematosus (SLE; chronic connective tissue disease with skin lesions 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 1,000 women can be expected to develop venous thrombosis within 5 years.
In women over 50 using oestrogen-only HRT for more than 5 years, the number of cases will be 5 to 8 per 1,000 women (i.e. 1 additional case).

Heart disease (myocardial infarction)
In women using oestrogen-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 use increases with age.
Comparison
It is estimated that among women over 50 not using HRT, stroke will occur in about 8 out of 1,000 women within 5 years, whereas in women of the same age using HRT, the rate is 11 cases per 1,000 women within 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 the age of 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 you plan to take, even if they are available without a prescription, herbal remedies, 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 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.
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Oekolp forte with food and drink
Food and drink do not affect the effectiveness of Oekolp forte treatment.

Pregnancy and breastfeeding
Oekolp forte is intended for use in postmenopausal women only.
Pregnancy
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 operating machinery
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 you are
unsure, consult your doctor or pharmacist.
For atrophic changes in the lower urinary and genital tract, usually 1 globule per day is used during
the first weeks (up to a maximum of 4 weeks), after which the dose is gradually reduced to 1
globule twice a week.
To improve wound healing in postmenopausal women who have undergone vaginal procedures,
usually 1 globule per day is used for 2 weeks prior to the procedure, and 1 globule twice a week
for 2 weeks following the procedure.
To facilitate interpretation of cervical smear results in postmenopausal women, usually 1 globule
every other day is used 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 globule must not be used rectally.

To remove the globule from its packaging, tear or cut the aluminum foil along the top, in the
direction of the arrow, alongside the globule, until the globule can be easily removed.
Your doctor will aim to prescribe the lowest possible dose, to be used for the shortest duration
necessary to relieve your symptoms. If you feel that the effect of Oekolp forte is too strong or too
weak, consult your doctor.
Use of a higher than recommended dose of Oekolp forte
If more than the recommended dose has been used, contact your doctor or pharmacist immediately.
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Accidental swallowing of the globule does not pose a health or life hazard. Nevertheless, 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.
Missed dose of Oekolp forte
Do not use a double dose to make up for a missed dose.
If you miss a dose, use it as soon as possible, unless you notice the omission 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 treatment according to the previously established schedule.
Stopping the use of Oekolp forte
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 discontinue the medicine approximately 4 to 6 weeks before surgery to reduce the
risk of blood clots (see section 2, "Blood clots in veins (venous thromboembolism)"). Please consult
your doctor about when you may 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 everybody will experience them.
The following conditions are reported more frequently in women using systemic hormone replacement therapy (HRT) that circulates in the bloodstream, compared to women not using HRT. This risk is lower with transdermal or vaginal preparations 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 started after the age of 65. For more information on adverse effects, see section 2.

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

• breast swelling and tenderness
• 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 will resolve after the first few weeks of treatment.
The following adverse effects have been reported during the use of other hormone replacement therapies:

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Oekolp forte

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

6. Contents of the packaging and other information

Active substance in Oekolp forte

• The active substance is estriol. Each globule contains 0.5 mg of estriol.
• Other ingredients: hard fat, cetostearyl macrogol ether, glycerol monooxyoleate (contains butylhydroxytoluene).

What Oekolp forte looks like and contents of the packaging
Homogeneous white globules. Packaged in aluminum foil blisters in a cardboard box containing 10 globules.

For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Germany, 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., Elizy Orzeszkowej 3/35, 59-820 Leśna

Repackaged in:
Pharma Innovations Sp. z o.o., Jagiellońska 76, 03-301 Warsaw
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., Długosza 49, 51-162 Wrocław
Medezin Sp. z o.o., Zbąszyńska 3, 91-342 Łódź
CANPOLAND SPÓŁKA AKCYJNA, Beskidzka 190, 91-610 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o., Tymiankowa 24/28, 95-054 Ksawerów

Marketing Authorisation Number in Germany, country of export: 22684.00.00
Parallel Import Licence Number: 518/12
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