Senshio

Package leaflet: Information for the patient

Senshio 60 mg film-coated tablets

ospemifene
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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 side 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 who have moderate to severe symptoms in the inner and outer areas of the vagina, such as itching, dryness, burning, and pain during sexual intercourse (dyspareunia). This condition is known as vulvar and vaginal atrophy and is caused by the reduced levels of the female hormone estrogen in the body. In this situation, the vaginal wall may become thinner. This is a natural phenomenon after menopause (postmenopause).
Senshio works in a way similar to some of the beneficial effects of estrogens and helps improve the symptoms and underlying causes of vulvar and vaginal atrophy.

2. What you need to know before taking Senshio

Do not take Senshio

• if you are allergic to ospemifene or to any of the other ingredients of this medicine (listed in section 6).
• if you have or have previously had a blood clot in a vein (thrombosis), for example in the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in the eyes (retinal thrombosis).
• if you have vaginal bleeding of unknown origin.
• if your doctor thinks you may have breast cancer or if you are being treated for breast cancer.
• if your doctor thinks you may have an oestrogen-sensitive cancer or if you are being treated for an oestrogen-sensitive cancer, such as uterine cancer.
• if you have an abnormally thickened uterine lining, for example endometrial hyperplasia.

Warnings and precautions
Once you have started treatment with Senshio, you must visit your doctor for regular check-ups (at least once a year). During these visits, discuss with your doctor the benefits and risks of continuing treatment with Senshio.
Talk to your doctor or pharmacist before taking Senshio if any of the following apply to you:

• A close relative has previously had a blood clot in the legs, lungs, or other organs.
• You are severely overweight (BMI > 30 kg/m²).
• You suffer from an autoimmune disease called systemic lupus erythematosus (SLE).
• You have had a stroke (cerebrovascular accident) or your doctor has told you that you are at high risk of stroke.
• You suffer from any gynaecological condition other than vulvar and vaginal atrophy.
• You have had breast cancer.

While taking Senshio

• If you are unable to walk for a prolonged period or remain seated for long periods due to major surgery, an accident, or a serious illness, this may impair blood circulation and temporarily increase the risk of blood clots. Contact your doctor immediately. Your doctor may advise you to stop treatment at least 4–6 weeks before major surgery or during prolonged bed rest (e.g. due to an accident or illness). Treatment with Senshio may be resumed once you are mobile again and after consulting your doctor.
• If you experience vaginal bleeding while taking Senshio or shortly after stopping treatment, consult your doctor.
• If you develop signs of a blood clot while taking Senshio, such as swelling and redness in the legs accompanied by pain, sudden chest pain, difficulty breathing, or stroke, stop taking Senshio and contact your doctor 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 take any other medicines.

Do not take Senshio with any of the following 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), because it may increase the amount of ospemifene in the blood. Your doctor may consider stopping treatment with Senshio while you are taking fluconazole.
• any of the following medicines, because 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, because their concentration may increase 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 anticancer medicine for advanced (metastatic) colon or rectal cancer.

Pregnancy, breastfeeding and fertility
Senshio is intended exclusively for postmenopausal women. It must not be taken by pregnant women, women who could still become pregnant, or women who are breastfeeding. This is because there are no data on the use of Senshio in pregnant, premenopausal, or breastfeeding women.
Inform your doctor immediately if you become pregnant while taking Senshio; treatment must be stopped immediately.

Driving and using machines
Senshio does not affect or affects only very slightly the ability to drive and use machines.

Senshio contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Senshio contains sodium
Senshio contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Senshio

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet taken orally each day at the same time. Senshio must be taken with food. The tablets must be swallowed whole with food.
Senshio must be taken every day for the duration prescribed by the doctor.

Patients with liver disease
This medicine is not recommended if 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, 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 receive the benefits of Senshio if you stop taking it without consulting your doctor. Your doctor will explain the consequences of stopping treatment and will discuss other possible treatment options with you.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

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

• a genital fungal infection (candidiasis)
• hot flushes (including excessive sweating)
• muscle cramps
• vaginal or genital discharge
• skin rash
• headache
• vaginal bleeding

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

• thickening of the lining of the womb (endometrium) visible on ultrasound (endometrial hypertrophy)
• allergic reaction. Symptoms of an allergic reaction may include skin rash, skin itching, skin hives (urticaria), swelling of the tongue and throat, which may cause difficulty breathing or swallowing.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Senshio contains

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

Description of the appearance of Senshio and contents of the pack
Senshio 60 mg film-coated tablets (tablets) are oval, biconvex, film-coated tablets, white to off-white in colour (approximately 12 mm long and 6.45 mm wide), with “60” printed on one side.
They are packaged in blisters and available in packs of 7, 28 or 84 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Shionogi B.V.
Herengracht 464
1017 CA Amsterdam
The Netherlands

Manufacturer
Shionogi B.V.
Herengracht 464
1017 CA Amsterdam
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

AT, BE, BG, CY, CZ, DK, EE, IE, EL, FI, HR, HU, IE, IS, DE, LT, LU, LV, MT, NL, NO, PL, RO, SE, SI, SK
Shionogi GmbH
Shionogi B.V.
Tel: +49 (0) 30 2062980 66
Tel/Tel./Teл./Tlf./Tél/Puh/Sími/Τηλ: [email protected]
+31 (0)20 703 8327
[email protected]

ES, IT
Shionogi SLU
Shionogi Srl
Tel: +34 911 239 258
Tel: +39 06 94 805 118
[email protected]
[email protected]

PT
Lifewell Pharmaceutical & Healthcare, Lda.
Tel: +351 215810558
[email protected]

FR
Shionogi SAS
Tél: +33 (0) 186655806
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.