Package Insert: Information for the Patient

Senshio 60 mg Film-Coated Tablets

ospemifeno

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may 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 package insert. See section 4.

Senshio contains the active ingredient ospemifeno.

Ospemifeno belongs to a group of medications that do not contain hormones, known as selective estrogen receptor modulators (SERMs).

Senshio is usedto treat women with moderate to severe postmenopausal symptoms inside and outside the vagina, such as itching, dryness, burning, or pain during sex (dyspareunia). This is known as vulvar and vaginal atrophy. It is caused by a reduction in the levels of the female hormone estrogen in the body. When this occurs, the vaginal walls become thinner. This occurs naturally after menopause (postmenopause).

Senshio actsin a similar way to some of the beneficial effects of estrogen, helping to improve these symptoms and the underlying causes of vulvar and vaginal atrophy.

Warnings and precautions

Once you start taking Senshio, you should see your doctor for regular check-ups (at least once a year). During these check-ups, consult with your doctor about the benefits and risks associated with continuing to take Senshio.

Consult your doctor or pharmacist before starting to take Senshioif any of the following situations apply to you:

• If any of your close relatives have ever had a blood clot in the leg, lung or other organ.
• If you have severe obesity (BMI >30 kg/m2).
• If you have a systemic lupus erythematosus (SLE) autoimmune disease.
• If you have had a stroke (cerebrovascular accident) or if your doctor has told you that you are at high risk of having one.
• If you have any gynecological condition other than vulvar and vaginal atrophy.
• If you have had breast cancer.

During Senshio treatment:

• If you are unable to walk for a long time or remain seated for an extended period in the same position due to major surgery, injury or illness, this may prevent good blood circulation and temporarily increase your risk of blood clots. Therefore, you should consult your doctor immediately. Your doctor may recommend that you interrupt treatment for at least 4 to 6 weeks before major surgery or if you need to stay in bed for an extended period of time, either due to injury or illness. Senshio treatment can be resumed as soon as you regain mobility and after consulting your doctor.
• If any vaginal bleeding occurs while taking Senshio or shortly after stopping it,you should consult your doctor.
• If you experience signs of a blood clot, such as swelling and redness of the legs accompanied by pain, sudden chest pain, difficulty breathing or a stroke while taking Senshio,stop taking Senshio and see your doctor immediately.

Children and adolescents

Do not give this medication to children or adolescents. This medication is intended only for postmenopausal women.

Other medications and Senshio

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

Do not take Senshio with any of the following medications:

• Estrogens.
• Any other medication belonging to the group of MSRE, such as tamoxifen, toremifene, bazedoxifene and raloxifene.

Consult your doctor before taking Senshiowith:

• Fluconazole (oral medication used to treat fungal infections), as this may increase the amount of ospemifeno in the blood. Your doctor may consider interrupting Senshio treatment while taking fluconazole.
• Any of the following medications that may result in a reduced effect of Senshio:
• • Rifampicin and rifabutin, used to treat tuberculosis.
  • Carbamazepine and phenytoin, used to treat seizures/epilepsy (anticonvulsants).
  • St. John's Wort, a plant-based medication used sometimes to treat depression.
  • Orlistat, used sometimes to treat obesity.
• Any of the following medications, as their concentrations may increase while taking Senshio:
• • Metformin, used to treat type 2 diabetes.
  • Aciclovir, used to treat herpes labialis and genitalis.
  • Ganciclovir, used to treat infections caused by a virus called cytomegalovirus.
  • Oxaliplatin, a chemotherapy medication for advanced (metastatic) colorectal or rectal cancer.

Pregnancy, breastfeeding and fertility

Senshio is intended for exclusive use in postmenopausal women. Women who are pregnant, may still be able to have a child or are breastfeeding should not take it. This is because there is no data available on the use of Senshio in pregnant women or premenopausal women or those breastfeeding.

If you become pregnant while taking Senshio, inform your doctor immediately;you should stop treatment immediately.

Driving and operating machinery

Senshio has no known influence or its influence on the ability to drive and operate machinery is very small.

Senshio contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Senshio contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is a tablet taken orally at the same time every day. Senshio should be taken with food. The tablets should be swallowed whole with food.

Senshio should be taken every day until your doctor tells you otherwise.

Patients with liver disease

This medication is not recommended if your liver function is severely reduced.

If you take more Senshio than you should

If you take more tablets than you should, inform your doctor or pharmacist.

If you forget to take Senshio

If you forget to take a tablet, you should take the missed tablet (with food) as soon as you remember on the same day. Do not take two tablets on the same day to make up for the missed tablet.

If you interrupt treatment with Senshio

You will not benefit from the effects of Senshio if you interrupt treatment with the medication without consulting your doctor. Your doctor will explain the effects of interrupting treatment and will also discuss other treatment possibilities with you.

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 may experience them.

Frequent Adverse Effects(may affect up to 1 in 10 people):

• Genital infection caused by a fungus (vaginal candidiasis)
• Hot flashes
• Muscle cramps
• Vaginal or genital discharge
• Skin rash
• Headache
• Vaginal bleeding

Less Frequent Adverse Effects(may affect up to 1 in 100 people):

• Thickening of the uterine lining (endometrium) observed by ultrasound (endometrial hypertrophy)
• An allergic reaction. Allergic reaction symptoms may include skin rash, skin irritation, raised skin patches (urticaria), swelling of the tongue and throat that may cause difficulty breathing or swallowing.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about 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 the blister pack after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Senshio

• The active ingredient is ospemifene. Each film-coated tablet contains 60 mg of ospemifene.
• The other components are:

Tablet core:colloidal silicon dioxide (E 551), magnesium stearate (E 578), mannitol (E 421), microcrystalline cellulose (E 460), povidone (E 1201), pregelatinized cornstarch and sodium starch glycolate (type A).

Film coating:hypromellose (E 464), lactose monohydrate, titanium dioxide (E 171), triacetin (E 1518) and polyethylene glycol (E 1521).

Appearance of the product and contents of the package

Senshio tablets are oval, biconvex, white or off-white film-coated tablets (approximately 12 mm in length and 6.45 mm in width), engraved with “60” on one side.

They are packaged in blisters and are available in package sizes of 7, 28 or 84 film-coated tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

Netherlands

Responsible for manufacturing

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

Netherlands

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last date of revision of this leaflet: 01/2023

Other sources of information

Further information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.