FemmyN 0.03 mg ovules

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Femmyn 0.03 mg vaginal tablets

Oestriol

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Femmyn 0.03 mg vaginal tablets are and what they are used for
2. What you need to know before using Femmyn 0.03 mg vaginal tablets
3. How to use Femmyn 0.03 mg vaginal tablets
4. Possible adverse effects
5. How to store Femmyn 0.03 mg vaginal tablets
6. Contents of the pack and other information

1. What Femmyn 0.03 mg vaginal tablets is and what it is used for

Femmyn belongs to a group of medicines called vaginal Hormone Replacement Therapy (HRT).

It is used to relieve menopausal symptoms in the vagina, such as dryness or irritation. Medically, this is known as “vaginal atrophy”. It is caused by a decrease in estrogen levels in your body. This occurs naturally after menopause.

Femmyn works by replacing the estrogens normally produced by a woman's ovaries. It is inserted into the vagina, allowing the hormone to be released exactly where it is needed. This can help relieve vaginal discomfort.

Femmyn is not a contraceptive and does not restore fertility.

2. What you need to know before using Femmyn 0.03 mg vaginal tablets

Medical history and check-ups

Hormone replacement therapy (HRT) carries risks that must be considered when deciding whether to start or continue treatment.

Experience with treating women with premature menopause (due to ovarian failure or surgical removal of the ovaries) is limited. If you have premature menopause, the risks of using HRT may differ. Please consult your doctor.

Before starting (or restarting) treatment with this medicine, your doctor will ask you a series of questions about your personal and family medical history. Your doctor may also consider it appropriate to perform a physical examination, which could include a breast examination and/or an internal pelvic examination, if necessary.

Once you have started treatment with Femmyn, you should visit your doctor regularly (at least once a year) for check-ups. During these visits, you can discuss with your doctor the benefits and risks of continuing treatment with Femmyn.

Have regular breast examinations as recommended by your doctor.

Do not use Femmyn

If you are in any of the following situations. If you are unsure, consult your doctor before using this medicine:

• If you have or have had breast cancer, or suspect you may have it.
• If you have estrogen-sensitive cancer, such as cancer of the inner lining of the uterus (endometrium), or suspect you may have it.
• If you have abnormal vaginal bleeding.
• If you have excessive thickening of the inner lining of the uterus (endometrial hyperplasia) that is not being treated.
• If you have or have ever had a blood clot in a vein (venous thrombosis), such as in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
• If you have a blood clotting disorder (such as protein C, protein S or antithrombin deficiency).
• If you have or have recently had an arterial blood clot-related disease, such as heart attack, stroke, or angina pectoris.
• If you have or have had a serious liver disorder and liver function tests have not returned to normal.
• If you have a rare inherited blood disorder called "porphyria".
• If you are allergic to estriol or to any of the other ingredients of this medicine (listed in section 6).

If any of the conditions listed above occur for the first time while you are using this medicine, stop taking it immediately and consult your doctor without delay.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Femmyn. Inform your doctor if you have or have had any of the following conditions before starting treatment, as they may recur or worsen during treatment with Femmyn. If this applies to you, you should have more frequent medical check-ups:

• Uterine fibroids.
• Growth of the uterine lining outside the uterus (endometriosis) or history of excessive growth of the uterine lining (endometrial hyperplasia).
• Increased risk of blood clots (see “Blood clots in a vein (thrombosis)”).
• Increased risk of estrogen-sensitive cancers (such as having a mother, sister, or grandmother who had breast cancer).
• High blood pressure.
• Liver disorders, such as benign liver tumors.
• Diabetes.
• Gallstones.
• Migraine or severe headaches.
• Autoimmune disease affecting multiple body systems (systemic lupus erythematosus, SLE).
• Epilepsy.
• Asthma.
• Ear disorder affecting the eardrum (otosclerosis).
• Very high levels of fat in the blood (triglycerides).
• Fluid retention due to heart or kidney problems.
• Hereditary or acquired angioedema.

Vaginal infections should be treated with appropriate medications before starting treatment with this medicine.

Stop using Femmyn and contact your doctor immediately

If you experience any of the following symptoms while taking HRT:

• If any of the conditions listed under “Do not use Femmyn” occur.
• Yellowing of the skin or whites of the eyes (jaundice). These may be signs of liver disease.
• Marked increase in blood pressure (symptoms may include headache, fatigue, dizziness).
• If you experience a first-time migraine or severe headaches.
• Pregnancy.
• If you notice symptoms of thrombosis such as:
  • Pain and swelling in the legs
  • Sudden chest pain
  • Or difficulty breathing

For more information, see “Blood clots in a vein (thrombosis)”.

If any of the above conditions occur, your doctor may need to discontinue your treatment and recommend an alternative.

Note

Femmyn 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 may need to use an additional contraceptive method to prevent pregnancy. Consult your doctor.

HRT and cancer

Excessive growth of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer)

Long-term use of estrogen-only HRT tablets may increase the risk of developing cancer of the uterine lining (endometrium).

It is unclear whether there is a similar risk when Femmyn is used repeatedly or long-term (more than one year). However, Femmyn has shown very low absorption into the bloodstream, so the addition of a progestogen is not necessary.

Bleeding or spotting may occur; this is usually not a cause for concern, but you should consult your doctor. It may be a sign that your endometrium is thickening.

The following risks apply to systemic hormone replacement therapy (HRT) that enters the bloodstream. Femmyn is used for local vaginal treatment and systemic absorption is very low. It is less likely that the conditions described below will worsen or recur during treatment with Femmyn, but you should visit your doctor if you are affected.

Breast cancer

Data suggest that using Femmyn does not increase the risk of breast cancer in women who have not previously had breast cancer. It is not known whether Femmyn can be safely used in women who have previously had breast cancer.

Have regular breast examinations. Visit your doctor if you notice any changes such as:

• Dimpling of the skin.
• Changes in the nipple.
• Any lump you can see or feel.

Additionally, you may have mammograms as recommended.

Ovarian cancer

Ovarian cancer is rare—much rarer 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. For example, among women aged 50 to 54 who are not using HRT, about 2 in 2,000 will be diagnosed with ovarian cancer over a 5-year period. Among women using HRT for 5 years, about 3 in 2,000 women will be diagnosed (i.e., about one additional case).

Effect of HRT on the heart and circulation

Blood clots in a vein (thrombosis)

The risk of developing blood clots in veins is approximately 1.3 to 3 times higher in women using HRT than in those who do not, especially during the first year of use.

Blood clots can be serious; if a clot travels to the lungs, it can cause chest pain, difficulty breathing, fainting (loss of consciousness), and even death.

Your risk of developing a blood clot in a vein increases with age and if you have any of the following conditions. Inform your doctor if any of these apply to you:

• Inability to walk for a prolonged period due to major surgery, injury (damage), or illness (see also section 3, “If you need to undergo surgery”).
• Significant overweight (body mass index > 30 kg/m²).
• A blood clotting disorder requiring long-term treatment with anticoagulant medication.
• A family history of blood clots in the leg, lung, or other organs.
• Systemic lupus erythematosus (SLE).
• Cancer.

For more information on symptoms of blood clot formation, see “Stop using Femmyn and contact your doctor immediately”.

Comparative data

On average, over a 5-year period, among women around the age of 50 who are not taking HRT, 4 to 7 out of 1,000 are expected to develop a blood clot in a vein.

Among women around the age of 50 who have been taking estrogen-only HRT for more than 5 years, there will be 5 to 8 cases per 1,000 users (i.e., one additional case).

Heart disease (myocardial infarction)

There is no increased risk of heart disease in women taking estrogen-only therapy.

Stroke

The risk of stroke is 1.5 times higher in women using HRT than in non-users. The number of additional stroke cases due to HRT use increases with age.

Comparative data

Among women around the age of 50 who are not taking HRT, on average, 8 out of 1,000 would be expected to have a stroke over a 5-year period. Among women around the age of 50 using HRT, there will be 11 cases per 1,000 users over 5 years (i.e., 3 additional cases).

Other warnings

HRT does not prevent memory loss. There is some evidence of an increased risk of memory loss in women who start using HRT after age 65. Seek advice from your doctor.

Use of Femmyn 0.03 mg vaginal tablets with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines, herbal remedies, or other natural products.

This medicine is used for local vaginal treatment and interactions with other medicines are not expected after administration.

This medicine may affect other treatments applied vaginally, but it is unlikely to affect other systemic medicines.

Simultaneous use of this medicine with latex condoms may reduce their strength and affect the safety provided by condoms.

Pregnancy and breastfeeding

Femmyn is indicated for postmenopausal women. If you become pregnant, stop using this medicine and contact your doctor.

Driving and using machines

The effect of this medicine on the ability to drive and use machines is none or negligible.

Femmyn contains butylhydroxytoluene

This medicine may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxytoluene.

3. How to use Femmyn 0.03 mg vaginal tablets

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, please consult your doctor or pharmacist again.

Recommended dose:

The recommended dose is one tablet per day (corresponding to 0.03 mg of estriol daily), administered vaginally, during the first 3 weeks of treatment. Afterwards, a maintenance dose of one tablet twice a week is recommended.

Your doctor will aim to prescribe the lowest effective dose necessary to treat your symptoms and for the shortest duration possible. Please consult your doctor if you think the dose is too strong or not strong enough for you.

Method and duration of administration

The tablet should be inserted deeply into the vagina, preferably at night before going to bed.

To administer the tablet, separate the two foil layers apart sideways until the tablet can be easily removed.

If you need to undergo surgery

If you are scheduled for a surgical procedure, inform your surgeon that you are using Femmyn. It may be necessary to stop using Femmyn approximately 4 to 6 weeks before surgery to reduce the risk of blood clot formation (see section 2, "Blood clots in a vein"). Ask your doctor when you can resume using Femmyn.

If you use more Femmyn than you should

You should not be overly concerned if you occasionally use more tablets than required; however, consult your doctor. Possible symptoms include nausea and vomiting, and vaginal bleeding may also occur after a few days.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 915 620 420, indicating the medication and amount taken.

If you forget to use Femmyn 0.03 mg vaginal tablets

• During the daily treatment in the first three weeks:

If you miss a dose and do not notice until the next day, do not worry about the missed dose and continue your treatment as usual.

• During the twice-weekly maintenance treatment:

If you forget to use Femmyn on the scheduled day, use it as soon as possible and then continue with your regular schedule.

If you stop using Femmyn 0.03 mg vaginal tablets

Even if your symptoms improve significantly, you should continue treatment as directed. If you wish to stop or discontinue treatment, please consult your doctor.

If you have any further questions about the use of this medicine, ask 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 diseases are observed more frequently in women using systemic hormone replacement therapy (HRT) that circulates in the blood, compared to women who do not use HRT. These risks are less associated with treatments administered vaginally, such as Femmyn:

• Ovarian cancer
• Blood clots in the veins of the legs or lungs (venous thromboembolism)
• Stroke
• Possibly memory loss, if HRT is started after the age of 65

For further information on these adverse effects, see Section 2.

Local irritation may occur at the beginning of treatment.

Frequent adverse effects (occurring in 1 to 10 out of every 100 users)

• Vulvovaginal burning, itching, and pain
• Urinary discomfort (dysuria)

Uncommon adverse effects (occurring in 1 to 10 out of every 1,000 users)

• Vaginal discharge
• Anorectal discomfort

The following adverse effects have been reported with other HRTs:

• Gallbladder disease

• Various skin conditions:

• Skin discoloration, especially on the face or neck, known as "pregnancy patches" (chloasma);

• Painful red skin nodules (erythema nodosum);

• Rash with redness or target-shaped sores (erythema multiforme).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Femmyn 0.03 mg vaginal tablets

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

Do not use this medicine after the expiry date stated on the carton and on the strip after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Femmyn 0.03 mg vaginal tablets

• The active substance is estriol. Each tablet contains 0.03 mg of estriol.
• The other components are butylhydroxytoluene, mono/di-(Z,R)-12-hydroxyoctadeca-9-enoate of glycerol, hard fat, macrogol cetyl stearyl ether.

Appearance of the product and contents of the pack

Femmyn are white vaginal tablets.

Femmyn is available in packs of 10, 15, 20 or 30 vaginal tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistraße 2

12277 Berlin

Germany

Date of the most recent review of this leaflet: December 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):

http://www.aemps.gob.es/