SENSHIO 60 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Senshio 60 mg film-coated tablets

ospemifene

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Senshio and what is it 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 usedto treat moderate to severe postmenopausal symptoms in and around the vagina, such as itching, dryness, burning, or pain during sexual intercourse (dyspareunia). This is known as vulvar and vaginal atrophy. It is caused by a decrease in the levels of the female hormone estrogen in your body. When this happens, the vaginal walls become thinner. This occurs naturally after menopause (postmenopause).

Senshio worksin 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.

2. What you need to know before you take Senshio

Warnings and precautions

Once you start treatment with Senshio, you should see your doctor for regular 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 taking Senshioif any of the following apply to you:

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

While taking Senshio:

• If you are unable to walk for a long time or remain seated for a long time in the same position due to major surgery, injury, or illness, this may prevent good blood circulation and may temporarily increase your risk of blood clots. Therefore, you should 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 be bedridden for a prolonged period, either due to injury or illness. Treatment with Senshio can 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 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 medicine to children or adolescents. This medicine is intended only for postmenopausal women.

Other medicines and Senshio

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

Do not take Senshio with any of the following medicines:

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

Consult your doctor before taking Senshiowith:

• Fluconazole (an oral medicine used to treat fungal infections), as this may increase the amount of ospemifene in your blood. Your doctor may consider stopping treatment with Senshio while you are taking fluconazole.
• Any of the following medicines that 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 colon or rectum.

Pregnancy, breastfeeding, and fertility

Senshio is for use in postmenopausal women only. Women who are pregnant, may become pregnant, or are breastfeeding should not take it. This is because there is no data on the use of Senshio in pregnant or premenopausal women or during breastfeeding.

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

Driving and using machines

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

Senshio contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Senshio contains sodium

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

3. How to take Senshio

Follow exactly the instructions for administration of this medicine 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 should be taken with food. The tablets should be swallowed whole with food.

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

Patients with liver disease

This medicine 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 stop taking Senshio

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

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

4. Possible side effects

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

Common side effects(may affect up to 1 in 10 people):

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

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

• Increased thickness of the lining of the uterus (endometrium) observed by ultrasound (endometrial hyperplasia)
• An allergic reaction. The symptoms of an allergic reaction can include rash, skin irritation, hives, swelling of the tongue and throat that can cause difficulty breathing or swallowing.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Senshio

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 blister after “EXP”. The expiry date is the last day of the month stated.

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 no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Senshio

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

Core of the tablet:colloidal silicon dioxide (E 551), magnesium stearate (E 578), mannitol (E 421), microcrystalline cellulose (E 460), povidone (E 1201), pregelatinized starch (from 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 and packaging of the product

Senshio tablets are oval, biconvex, white or almost 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 pack sizes of 7, 28, or 84 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

Netherlands

Manufacturer

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

Netherlands

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet: 01/2023

Other sources of information

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