0.03 mg vagitorium 
estriol

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse within 3-4 weeks.

In this leaflet: 
1. What Estrokad is and what it is used for 
2. What you need to know before you use Estrokad 
3. How to use Estrokad 
4. Possible side effects 
5. How to store Estrokad 
6. Contents of the packaging and other information 

1. What Estrokad is and what it is used for

Estrogen belongs to a class of drugs called HRT ( Hormone Replacement Therapy, HRT ) and for local use in the vagina.

Estrogen is used for local treatment of ailments such as dryness or irritation of the vagina in women after the last regular menstruation ( menopause ). The medical term for this is vaginal atrophy. It is caused by declining estrogen levels in the body, which occurs after menopause.

Estrogen works by replacing the estrogen that is normally produced in a woman’s ovaries. Estrogen is inserted into the vagina so that the hormone is released where it is needed. This can relieve the feeling of discomfort in the vagina.

Doctors should always be consulted before using Estrokad for the first time, due to the difficulty of making the correct diagnosis for the first time.

Estriol contained in Estrokad may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Estrokad

Medical history and regular check-ups

The use of HRT involves risks that must be taken into account when deciding to start treatment or continue an ongoing treatment. Consult a physician before starting a treatment or to discuss whether to continue treatment.

Experience is limited for the treatment of women whose menstruation has stopped prematurely (when the ovaries have stopped working or due to surgery). If your period has stopped prematurely, the risks of using HRT may be different. Talk to your doctor.

Before starting treatment (or resuming treatment), your doctor may ask about your own, and your family’s, medical history. Your doctor may do a general medical and gynecological examination, which also includes an examination of your breasts.

Once you have started treatment, you should go for regular medical check-ups, at least once a year. During these check-ups, you should discuss with your doctor the benefits and risks of continued treatment.

Perform regular breast examinations according to your doctor’s recommendations.

Before starting treatment with Estrokad, any infection in your vagina should be treated with appropriate medication.

Do not use Estrokad

if any of the following applies to you. If you are not sure about any of the following, talk to your doctor before using Estrokad.

Do not use Estrokad

  • if you have or have had breast cancer, or if it is suspected that you have it
  • if you have cancer is sensitive to estrogen s, such as cancer of the womb lining ( endometrium ), or if it is suspected that you have it
  • if you have unexplained vaginal bleeding
  • if you have a severe thickening of the uterine lining ( endometrial hyperplasia ) and are not treated for it
  • if you have or have had a blood clot in a vein ( thrombosis ), in the legs (deep vein thrombosis ), or the lungs ( pulmonary embolism )
  • if you have a blood clotting disease (for example protein C, protein S or antithrombin deficiency)
  • if you have or have had a disease caused by blood clots in the arteries are, for example, a heart attack, stroke ( stroke ), or chest pain (angina)
  • if you have or have had liver disease and your liver function tests have not returned to normal
  • if you have a rare blood disorder called “porphyria” which is hereditary in some families
  • if you are allergic to estriol or any of the other ingredients of this medicine (listed in section 6).

If any of the above conditions occur for the first time while you are taking Estrokad, stop using it immediately and contact your doctor.

Warnings and cautions

Talk to your doctor if you have or have had any of the following problems before starting treatment. They may recur or worsen during treatment with Estrokad. Should this occur, have more frequent check-ups with a doctor.

  • muscle nodules ( fibroids ) in the uterus
  • growth of the uterine lining outside the uterus ( endometriosis ) or a previous strong growth of the uterine lining ( endometrial hyperplasia ).
  • increased risk of getting blood clots (see “Blood clots in a vein ( thrombosis )”)
  • increased risk of developing estrogen-sensitive cancer (if, for example, your mother, sister, or grandmother has had breast cancer)
  • high blood pressure
  • liver disease, such as a benign liver tumor
  • diabetes
  • gallstones ar
  • migraine or severe headache
  • a disease of the immune system that affects many organs in the body (systemic lupus erythematosus, SLE )
  • epilepsy
  • asthma
  • a disease that affects the eardrum and hearing (otosclerosis)
  • a very high level of fat in the blood ( triglycerides er)
  • fluid retention in the body due to heart or kidney problems

You should contact your doctor immediately and discontinue treatment with Estrokad

if any of the following occurs:

  • any of the things mentioned in the section “Do not use Estrokad”
  • if skin or whites of the eyes turn yellow (jaundice); it may be a symptom of liver disease
  • if your blood pressure rises sharply (symptoms may be headache, fatigue, or dizziness)
  • if you are experiencing migraine-like headaches for the first time
  • if you become pregnant
  • if you get symptoms of a blood clot, such as:
    • painful swelling and redness of the legs
    • sudden chest pain
    • breathing difficulties more information, see “Blood clots in a vein ( thrombosis )”

Note: Estrokad is not a contraceptive. If it is less than 12 months since your last period, or if you are under 50, you may still need to use contraception to avoid pregnancy. Consult your doctor.

HRT and cancer

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

Use of HRT tablets with estrogen alone for a long time may increase the risk of developing cancer of the uterine lining (endometrium).

It is unclear whether repeated or prolonged (over a year) use of Estrokad involves a corresponding risk. However, it has been shown that the uptake of Estrokad into the blood is very low and therefore an addition of a progestin is not necessary.

If you experience a breakthrough or splash bleeding, there is usually nothing to worry about, but you should contact a doctor. It may be a sign that your uterine lining has become thicker.

The following risks apply to hormone replacement therapy ( HRT ) circulating in the blood. Estrogen, on the other hand, is used topically in the vagina and the uptake into the blood is very low. The conditions described below are unlikely to worsen or recur during treatment with Estrokad, but you should contact your doctor if you are concerned.

Breast cancer

There are indications that the use of Estrokad does not increase the risk of breast cancer in women who have not had breast cancer before. It is unknown whether Estrokad can be used safely in women who have had breast cancer before.

Check your breasts regularly. Contact a doctor if you notice changes such as:

  • indentations or pits
  • changes of the nipple
  • nodules you can see or feel.

It is also recommended that you participate in mammography examinations when called upon to do so.

Ovarian cancer ( ovarian cancer )

Ovarian cancer is rare – much more rare than breast cancer. The use of estrogen-only HRT has been associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. The diagnosis of ovarian cancer will, for example, be made on about 2 women out of 2,000 aged 50 to 54 who do not take HRT for a 5-year period. For women who have taken HRT for 5 years, there will be about 3 cases per 2,000 users (ie about 1 extra case).

How HRT affects the heart and blood circulation

Blood clots in a vein ( thrombosis )

The risk of blood clots in the veins is approximately 1.3–3 times higher for women who take HRT than for those who do not, especially during the first year of treatment.

Blood clots can be serious. If a blood clot ends up in the lungs, it can cause chest pain, shortness of breath, collapse or even lead to death.

You are more likely to get a blood clot in a vein if you are older and if any of the following apply to you. Tell your doctor if any of the following apply to you:

  • you have not been able to walk or stand for a long time due to a major operation, injury or illness (see also section 3, “If you need surgery”)
  • you are severely overweight ( BMI over 30 kg / m 2 )
  • you have a coagulation disorder that requires long-term treatment with drugs that prevent blood clots
  • if a close relative has had a blood clot in the bone, lung, or another organ
  • you have SLE (systemic lupus erythematosus)
  • you have cancer.

The symptoms of a blood clot are described in the section “You should contact a doctor immediately and discontinue treatment with Estrokad”.

Comparison

For women in their 50s who do not take HRT, an average of 4–7 out of 1,000 are expected to have a blood clot in a vein over a 5-year period.

For women in their 50s who have taken HRT with estrogen alone for more than 5 years, 5-8 out of 1,000 users are expected to have a blood clot in a vein (ie 1 extra case).

Heart disease (heart attack)

For women who take estrogen alone, there is no increased risk of developing heart disease.

Stroke (apoplexy)

The risk of stroke is about 1.5 times higher for those who take HRT compared to those who do not. The risk of stroke is age-dependent, therefore the number of cases of stroke increases due to the use of HRT with increasing age.

Comparison

For women in their 50s who do not take HRT, an average of 8 out of 1,000 people is expected to have a stroke over a 5-year period  For women in their 50s who have taken HRT for more than 5 years, 11 out of 1,000 users are expected to have a stroke(ie 3 extra cases).

Other conditions

Using HRT does not prevent memory loss. The risk of memory loss may be slightly higher in women who start using HRT after the age of 65. Consult your doctor.

Other medicines and Estrokad

Tell your doctor or pharmacist if you are taking or using, have recently taken or used, or might take or use any other medicines.

Because Estrokad is used for topical treatment of the vagina, it is unlikely that Estrokad would affect the effectiveness of other medicines. Estrogen may affect the effectiveness of other treatments given in the vagina.

If Estrokad is used at the same time as latex condoms, it can make it less stretchy and therefore reduce the safety of the condom.

Pregnancy and breastfeeding

Estrogen is intended for women whose menstruation has stopped. If you become pregnant, stop taking Estrokad and contact your doctor.

Driving and using machines

Estrogen does not affect the ability to drive and use machines.

Estrogen contains butylhydroxytoluene

Butylhydroxytoluene may cause local skin reactions (eg contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Estrokad

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

During the first 3 weeks of treatment, a vomitorium (equivalent to 0.03 mg estriol) is used daily. Thereafter, a maintenance dose of 1 auditorium twice a week is recommended.

Seek medical attention if symptoms worsen or do not improve within 3-4 weeks.

It is generally recommended to use medicines for menopausal symptoms for the shortest possible time and with the lowest possible dose that helps with the symptoms.

Use

The auditorium should be inserted deep into the vagina, preferably in the evening before bedtime.

Opening information

When using a vomitorium, first pull the foil apart at the top until you can easily remove the auditorium.

If you use more Estrokad then you should

Even if too many victorias were to be used at some point, there is no need to worry. However, you should consult a doctor. You may feel nauseous or vomit and some women may bleed a little from the vagina after a few days.

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Estrokad

  • For daily use within the first 3 weeks of treatment:

If you do not notice until the next day that you have missed a dose, skip the missed dose. Then continue with the usual dosing schedule.

  • When used twice a week:

If you forget to use Estrokad on a scheduled date, make up the missed dose as soon as possible.

If you stop using Estrokad

Talk to your doctor if you have questions about how long the treatment should last or discuss other treatment options.

If you need surgery

If you are going to have surgery, tell your surgeon that you are using Estrokad. You may need to stop using Estrokad for 4 to 6 weeks before the operation to avoid the risk of blood clots (see section 2, “Blood clots in a vein ( thrombosis )”). Ask your doctor when it is appropriate to start using Estrokad again.

If you have any further questions on the use of this product, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following diseases are reported more often in women who use hormone replacement therapy circulating in the blood than in non-users. These risks apply to a lesser extent to vaginally use estrogen treatments:

  • ovarian cancer ( ovarian cancer )
  • blood clots in veins in bones or lungs ( thrombosis )
  • stroke (stroke)
  • probable memory loss if HRT begins after age 65.

See section 2 for more information on these side effects.

Local irritation may occur, especially at the beginning of treatment.

Common (may affect up to 1 in 10 people)

  • burning, itching, and pain in and around the vagina
  • discomfort when urinating ( dysuria ).

Uncommon (may affect up to 1 in 100 people)

  • vaginal discharge
  • discomfort in the anus and rectum.

The following side effects have been reported during treatment with HRT drugs that are taken up in the bloodstream:

  • diseases of the gallbladder
  • various skin diseases:
    • dark skin spots, especially on the face and neck, so-called “pregnancy spots” (chloasma)
    • painful reddish-purple bumps on the skin (erythema nodosum)
    • annular redness or sore rash (erythema multiforme)

5. How to store Estrokad

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and foil after “EXP”. or “EXP”. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is estriol.

1 vagitorium contains 0.03 mg estriol.

The other ingredients are butylhydroxytoluene, glycerol mono/bis [(ZR) -12-hydroxyoctadec-9-enoate], hard fat, and macrogol cetostearyl ether.

What the medicine looks like and the contents of the pack

Estrokad are white vagitorias.

Estrogen is supplied in packs containing 10, 15, 20, 24, and 30 victorias.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

DR. KADE Pharmazeutische Fabrik GmbH

Ringstrasse 2

D – 12277 Berlin

Germany

For further information on Estrokad contact your local representative / Agent:

CampusPharma AB

Karl Gustavsgatan 1A

411 25 Gothenburg

e-mail: info@campuspharma.se

Tel: +46 31 20 50 20

This medicinal product is authorized under the European Economic Area under the names:

Denmark, Finland, Norway: Estrokad

Germany: OeKolp Ovula 0.03 mg

Hungary: Estrokad hüvelykúp

Belgium, Luxembourg: Oekolp 0.03 mg ovule / ovules / vaginal suppositories

Italy: – Atrocom 0.03 mg ovuli

United Kingdom, Ireland: – IMVAGGIS 0.03 mg pessary

Netherlands: – Estriol DR. KADE 0.03 mg ovules

Austria: – Estrokad 0.03 mg vaginal suppositories

Muhammad Nadeem

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