Senshio 60 mg film-coated tablets

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• If you are allergic to ospemifene or any of the other ingredients of this medicine (listed in section 6).
• If you have or have ever had a blood clot in a vein (thrombosis), for example, in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis).
• If you have unexplained vaginal bleeding.
• If your doctor thinks you might have breast cancer or you are being treated for breast cancer.
• If your doctor thinks you might have or you are being treated for cancer which is sensitive to oestrogens, such as cancer of the womb.
• If you have excessive thickening of the womb lining, such as endometrial hyperplasia.

Once you have started on Senshio you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Senshio.

Talk to your doctor or pharmacist before taking Senshio if any of the following apply to you.

• Any of your close relatives has ever had a blood clot in the leg, lung or other organ.
• You are seriously overweight (BMI > 30 kg/m²).
• You have an autoimmune condition called systemic lupus erythematosus (SLE).
• You have had a stroke (a cerebrovascular accident), or if your doctor has told you that you are at high risk of having one.
• You are suffering from any gynaecological illness other than vulvar and vaginal atrophy.
• You have had breast cancer.

• If you are unable to walk for a long time or are sitting for a long time in the same position because of major surgery, injury or illness, it may prevent good blood circulation and may temporarily increase your risk of blood clots. You should therefore speak to your doctor immediately. Your doctor may recommend that you stop treatment at least 4 to 6 weeks prior to major surgery or during a long period of bed rest e.g. injury or illness. Treatment with Senshio can be restarted as soon as you regain your mobility and in consultation with your doctor.
• If any vaginal bleeding occurs while taking Senshio or soon after you have stopped taking it, you should speak to your doctor.
• If you experience signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, difficulty in breathing or a stroke while taking Senshio, stop taking Senshio and see a doctor immediately.

Do not give this medicine to children or adolescents. This medicine is only intended for use in post-menopausal women.

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

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

Talk to your doctor before taking Senshio with:

• 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, which may lead to a reduced effect of Senshio:
  • Rifampicin and rifabutin commonly used to treat tuberculosis.
  • Carbamazepine and phenytoin used to treat convulsions/seizures (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 be increased while taking Senshio:
  • Metformin used to treat Type II diabetes.
  • Aciclovir used to treat cold sores and genital herpes.
  • Ganciclovir used to treat infections caused by a virus called cytomegalovirus.
  • Oxaliplatin, an anti-cancer medicine for advanced (metastatic) cancer of the large bowel (colon) or back passage (rectum).

Senshio is for use only in post-menopausal women. It must not be taken by women who are pregnant, who could still have a baby or are breast-feeding. This is because there are no data on the use of Senshio in pregnant or pre-menopausal women or those who are breast-feeding.

Tell your doctor immediately if you become pregnant while taking Senshio; treatment should be stopped immediately.

Senshio has no or very little influence on the ability to drive and use machines.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

This medicine is not recommended if you have severely reduced liver function.

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

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

You will not benefit from the effects of Senshio if you stop using it without talking to your doctor.

Your doctor will explain the effects of stopping treatment and will also discuss other possibilities for treatment with you.

If you get 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

or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is ospemifene. Each film-coated tablet contains 60 mg ospemifene.
• The other ingredients are:
  • Tablet core: Colloidal silicon dioxide (E 551), magnesium stearate (E 578), mannitol (E 421), microcrystalline cellulose (E 460), povidone (E 1201), pregelatinised starch (maize), sodium starch glycolate (type A) (see section 2 “Senshio contains sodium”).
  • Film coating: Hypromellose (E 464), lactose monohydrate (see section 2 “Senshio contains lactose”), titanium dioxide (E 171), triacetin (E 1518), polyethylene glycol (E 1521).

Senshio 60 mg film-coated tablets (tablets) are oval biconvex, white to off-white, film-coated tablets (approximately 12 mm long by 6.45 mm wide) debossed with “60” on one side.

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

Not all pack sizes may be marketed.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: