Senshio 60 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Senshio 60 mg film-coated tablets

ospemifene

Read the entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Senshio is and what it is used for
2. What you need to know before taking Senshio
3. How to take Senshio
4. Possible adverse effects
5. How to store Senshio
6. Contents of the pack and other information

1. What Senshio is and what it is used for

Senshio contains the active substance ospemifene.

Ospemifene belongs to a group of non-hormonal medicines called selective estrogen receptor modulators (SERMs).

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

Senshio works by mimicking some of the beneficial effects of estrogen, helping to improve these symptoms and the underlying causes of vulvar and vaginal atrophy.

2. What you need to know before starting to take Senshio

Warnings and precautions

Once treatment with Senshio has been started, you must visit your doctor for periodic check-ups (at least once a year). During these check-ups, discuss with your doctor the benefits and risks associated with continuing to take Senshio.

Consult your doctor or pharmacist before starting Senshio if any of the following apply to you:

• If any of your close relatives has ever had a blood clot in the leg, lung, or another organ.
• If you have severe overweight (BMI >30 kg/m²).
• If you have an autoimmune disease called systemic lupus erythematosus (SLE).
• If you have had a stroke (cerebrovascular accident) or if your doctor has informed 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.

While taking Senshio:

• If you are unable to walk for long periods or remain seated for prolonged periods in the same position due to major surgery, injury, or illness, this may impair blood circulation and temporarily increase your risk of blood clots. Therefore, you must consult your doctor immediately. Your doctor may recommend that you stop treatment at least 4 to 6 weeks before major surgery or if you need to remain bedridden for a prolonged period due to injury or illness. Treatment with Senshio may be resumed as soon as you regain mobility and after consulting your doctor.
• If you experience any vaginal bleeding while taking Senshio or shortly after stopping it, you must 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 seek medical attention immediately.

Children and adolescents

Do not give this medicine to children or adolescents. This medicine is intended exclusively for postmenopausal women.

Other medicines and Senshio

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

Do not take Senshio with any of the following medicines:

• Estrogens.
• Any other medicine belonging to the group of SERMs (Selective Estrogen Receptor Modulators), such as tamoxifen, toremifeno, bazedoxifeno, and raloxifeno.

Consult your doctor before taking Senshio with:

• Fluconazole (an oral medicine used to treat fungal infections), as this may increase the amount of ospemifene in the blood. Your doctor may consider interrupting treatment with Senshio while you are taking fluconazole.
• Any of the following medicines, as they may reduce the effect of Senshio:
  • Rifampicin and rifabutin, commonly used to treat tuberculosis.
  • Carbamazepine and phenytoin, used to treat seizures/epileptic fits (anticonvulsants).
  • St. John’s wort, a herbal medicine sometimes used to treat depression.
  • Orlistat, sometimes used to treat obesity.
• Any of the following medicines, as their concentrations may increase while taking Senshio:
  • Metformin, used to treat type 2 diabetes.
  • Aciclovir, used to treat cold sores and genital herpes.
  • Ganciclovir, used to treat infections caused by a virus called cytomegalovirus.
  • Oxaliplatin, an anticancer medicine for advanced (metastatic) cancer of the large intestine (colon) or anal canal (rectum).

Pregnancy, breastfeeding, and fertility

Senshio is intended for use only in postmenopausal women. It must not be taken by women who are pregnant, who could still have children, or who are breastfeeding. This is because there are no data available on the use of Senshio in pregnant, premenopausal, or breastfeeding women.

If you become pregnant while taking Senshio, inform your doctor immediately; treatment must be stopped immediately.

Driving and use of machines

Senshio has no known influence, or its influence on the ability to drive and use machines is negligible.

Senshio contains lactose

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

Senshio contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take Senshio

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

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

Patients with liver disease

This medicine is not recommended if your liver function is severely impaired.

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 stop taking Senshio

You will not benefit from the effects of Senshio if you stop treatment without consulting your doctor. Your doctor will explain to you the consequences of stopping treatment and will also discuss with you other possible treatment options.

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 may cause adverse effects, although not everyone will experience them.

Frequent adverse effects (may affect up to 1 in 10 people):

• Fungal infection of the genital area (vaginal candidiasis)
• Hot flushes
• Muscle cramps
• Vaginal or genital discharge
• Skin rash
• Headache
• Vaginal bleeding

Uncommon adverse effects (may affect up to 1 in 100 people):

• Thickening of the lining of the womb (endometrium) seen on ultrasound (endometrial hypertrophy)
• An allergic reaction. Symptoms of an allergic reaction may include skin rash, skin irritation, raised rash on the skin (urticaria), swelling of the tongue and throat which may cause difficulty breathing or swallowing.

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 via 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 Senshio

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 blister after "EXP". The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Senshio

• The active substance 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 starch (corn), 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 pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

The Netherlands

Manufacturer

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

The Netherlands

For more information about this medicinal product, you may contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: 01/2023

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.