Label: Information for the User

Femmyn 0.03 mg Vaginal Tablets

Estriol

Read this entire label carefully before using this medication, as it contains important information for you.

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

1. What Femmyn 0.03 mg Vaginal Tablets are and for what they are used

2. What you need to know before starting to use Femmyn 0.03 mg Vaginal Tablets

3. How to use Femmyn 0.03 mg Vaginal Tablets

4. Possible adverse effects

5. Storage of Femmyn 0.03 mg Vaginal Tablets

6. Contents of the package and additional information

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

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

Femmyn acts by replacing the estrogens that are normally produced in the ovaries of women. It is inserted into the vagina, so that the hormone is released where it is needed. This can relieve vaginal discomfort.

Femmyn is not a contraceptive, nor does it restore fertility.

Medical History and Reviews

The use of THS involves risks that should be taken into account when deciding to start taking them or continue treatment.

The experience in treating women with premature menopause (due to ovarian failure or surgically induced) is limited. If you have premature menopause, the risks of using THS may be different. Consult your doctor.

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

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

Undergo regular breast checks, as recommended by your doctor

Do not use Femmyn

If you are in any of the following situations. If you are unsure,consult your doctorbefore using this medication:

• If you have or have hadbreast cancer, or if you suspect you may have it.
• If you havecancer sensitive to estrogens, such as endometrial cancer, or if you suspect you may have it.
• If you haveabnormal vaginal bleeding.
• If you have anexcessive thickening of the uterine lining(endometrial hyperplasia) that is not being treated.
• If you have or have had ablood clot in a vein(thrombosis) such as in the legs (deep vein thrombosis) or lungs (pulmonary embolism).
• If you have ablood clotting disorder(such as protein C deficiency, protein S deficiency, or antithrombin deficiency).
• If you have or have had a serious disease caused by blood clots in the arteries, such as aheart attack, a strokeor achest pain.
• If you have or have had aserious liver disorderand liver function tests have not returned to normal.
• If you have a rare blood disorder called “porphyria” that is inherited.
• If you areallergictoestriolor to any of the other components of this medication (including those listed in section 6).

If any of the situations mentioned above appear for the first time while using this medication, stop taking it immediately and consult your doctor immediately.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Femmyn. Inform your doctor if you have or have had any of the following diseases before starting treatment, as they may recur or worsen during treatment with Femmyn. If this is the case, you should visit your doctor more frequently for check-ups:

• Fibroids in the uterus.
• Endometriosis or a history of excessive thickening of the uterine lining (endometrial hyperplasia).
• Increased risk of blood clots (see “Blood clots in a vein (thrombosis)”).
• Increased risk of developing cancer sensitive to estrogens (such as having a mother, sister, or grandmother who has had breast cancer).
• High blood pressure.
• Liver disorders, such as a benign tumor in the liver.
• Diabetes.
• Galstones.
• Migraines or severe headaches.
• Systemic lupus erythematosus (LES), a disease that affects many parts of the body.
• Epilepsy.
• Asthma.
• Disease affecting the eardrum and ear (otosclerosis).
• Very high levels of fat in the blood (triglycerides).
• Fluid retention due to heart or kidney problems.
• Hereditary and acquired angioedema.

Before starting treatment with this medication, any vaginal infections should be treated with the appropriate medications.

Stop using Femmynand contact your doctor immediately

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

• If any of the situations indicated in the section “Do not use Femmyn” appear.
• Yellowing of the skin or white part of the eyes (jaundice). These may be signs of liver disease.
• Significant increase in blood pressure (symptoms may include headache, fatigue, dizziness).
• First-time migraines or severe headaches.
• Pregnancy.
• If you notice symptoms of blood clots such as
• • leg pain and swelling
  • sudden chest pain
  • or difficulty breathing

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

If any of the situations mentioned above appear, your doctor may need to ask you to stop treatment and recommend an alternative.

Observation

Femmyn is not a contraceptive. If it has been less than 12 months since your last period or you are under 50 years old, you may need to use an additional contraceptive method to avoid pregnancy. Ask your doctor.

THS and Cancer

Endometrial hyperplasia and endometrial cancer

Taking estrogen-only THS for a long period of time may increase the risk of developing endometrial cancer (cancer of the endometrium).

It is not clear if there is a similar risk if Femmyn is used for repeated or long-term treatments (more than one year). However, Femmyn has shown very low absorption in the blood, so the addition of progestogen is not necessary.

You may experience bleeding or spotting, which is usually not a cause for concern, but consult your doctor. It may be a sign that your endometrium is thickening.

The following risks are applicable to estrogen-only THS that are passed into the bloodstream. Femmyn is used for local treatment in the vagina and has very low absorption into the blood. It is less likely that the situations described below will worsen or recur during treatment with Femmyn, but you should visit your doctor if they affect you.

Breast Cancer

The data suggest that using Femmyn does not increase the risk of breast cancer in women who have not had breast cancer in the past. It is not known if Femmyn can be used safely in women who have had breast cancer in the past.

Regularly check your breasts. Visit your doctor if you notice any changes such as:

• Mothers on the skin.
• Changes in the nipple.
• Any lump that you can see or feel.

Additionally, mammograms may be performed as recommended.

Ovarian Cancer

Ovarian cancer is rare – much rarer than breast cancer. The use of estrogen-only THS has been associated with a slightly higher risk of developing ovarian cancer.

The risk of ovarian cancer varies with age. For example, in women aged 50-54 who are not taking THS, about 2 women out of 2,000 will be diagnosed with ovarian cancer over a 5-year period. In women taking THS for 5 years, about 3 cases per 2,000 women have been observed (i.e., about one additional case).

Effect of THS on the Heart and Circulation

Blood clots in a vein (thrombosis)

The risk of havingblood clots in the veinsis approximately 1.3 to 3 times higher in THS users than in non-users, especially during the first year of use.

Blood clots can be serious, and if one dislodges and travels to the lungs, it can cause chest pain, difficulty breathing, dizziness, and even death.

You are more prone to having a blood clot in the veins as you age and if you have any of the following circumstances. Inform your doctor if you have any of these situations:

• You are unable to walk for a long time due to a major surgical procedure, injury (damage), or disease (see also section 3, If you need to undergo surgery).
• You have significant obesity (body mass index > 30 Kg/m2).
• You have a blood clotting disorder that requires long-term treatment with a medication used to prevent blood clots.
• One of your close relatives has had a blood clot in the leg, lung, or other organ.
• You have systemic lupus erythematosus (LES).
• You have cancer.

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

Comparative data

On average, in a 5-year period, between women aged 50 who are not taking THS, 4 to 7 out of 1,000 will develop a blood clot in the veins.

Between women aged 50 who have been taking estrogen-only THS 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 developing heart disease in women taking estrogen-only THS.

Stroke

The risk of having a stroke is 1.5 times higher in THS users than in non-users. The number of additional stroke cases due to THS use will increase with age.

Comparative data

Between women aged 50 who are not taking THS, on average, 8 out of 1,000 will suffer a stroke over a 5-year period. Between women aged 50 who are taking THS, there will be 11 cases per 1,000 users over a 5-year period (i.e., 3 additional cases).

Other warnings

THS will not prevent memory loss. There are some indications of a higher risk of memory loss in women who start using THS after the age of 65. Ask your doctor.

Use of Femmyn 0.03 mg vaginal tablets with other medications

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

This medication is used for local treatment in the vagina and no interactions with other medications are expected after administration of this medication.

This medication may affect other treatments applied in the vagina, but it is unlikely to affect other medications.

The simultaneous use of this medication with latex condoms may reduce the tension of these and affect the safety provided by the condoms.

Pregnancy and Breastfeeding

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

Driving and Operating Machines

The influence of this medication on the ability to drive and operate machines is negligible or insignificant.

Femmyn contains butylhydroxytoluene

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

Followexactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

The recommended dose is one tablet per day (corresponding to 0.03mg of estriol per day), vaginal, for the first three weeks of treatment. Afterwards, a maintenance dose of one tablet twice a week is recommended.

Your doctor will try to prescribe the lowest dose to treat your symptoms and for the shortest time necessary. Consult your doctor if you think this 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 layers to the sides until it is possible to easily extract the tablet.

If you have to undergo surgery (operation)

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

If you use more Femmyn than you should

You should not worry if you accidentally administer more tablets than necessary on occasion, however, consult your doctor. The symptoms that may appear are nausea and vomiting, and bleeding may also occur after a few days.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service. Phone 915 620 420, indicating the medication and the amount used.

If you forgot to use Femmyn 0.03 mg tablets

• During daily treatment for the first three weeks:

If you forget a dose and do not realize it before the next day, do not worry about the missed dose, and continue with the treatment.

• During maintenance treatment twice a week:

If you forgot to use Femmyn on the scheduled day, administer it as soon as possible and continue with your usual routine.

If you interrupt the treatment with Femmyn 0.03 mg tablets

Although symptoms improve significantly, you should continue with the treatment until the end. If you want to interrupt or end the treatment, consult your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following diseases are observed more frequently in women who use medications with THS that circulate in the blood, compared to women who do not use THS. These risks are less related to vaginal treatments, such as Femmyn:

• Ovarian cancer
• Clots in the veins of the legs or lungs (venous thromboembolism)
• Stroke
• Possibly memory loss, if THS is initiated after the age of 65

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

Local irritation may appear at the beginning of treatment.

Frequent adverse effects (1 to 10 per 100 users)

• Vulvovaginal burning, pruritus, and pain
• Urination discomfort (dysuria)

Rare adverse effects (1 to 10 per 1,000 users)

• Vaginal discharge
• Anorectal discomfort

The following adverse effects have been reported with other THSs:

• Biliary tract disease
• Various skin conditions:

• Decoloration of the skin, especially on the face or neck, known as "pregnancy patches" (melasma);
• Red, painful skin nodules (erythema nodosum);
• Eruption with redness or blisters in the shape of a target (erythema multiforme).

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the label after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Femmyn 0.03 mg tablets

- The active ingredient 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, and cetostearyl ether of macrogol.

Appearance of the product and contents of the packaging

Femmyn are white tablets.

Femmyn are presented in boxes of 10, 15, 20, or 30 tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible manufacturer:

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistraße 2

12277 Berlin

Germany

Last review date of this leaflet: December 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

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