Senshio contains the active substance ospemifene. Ospemifene belongs to a group of medicines that do not contain hormones called Selective Estrogen Receptor Modulators (SERMs).1

Senshio is used to treat women with moderate to severe post-menopausal symptoms in and outside the vagina, such as itching, dryness, burning and pain during sex (dyspareunia). This is known as vulvar and vaginal atrophy1

What is atrophic vaginitis or Vulvovaginal Atrophy (VVA)?2

Atrophic vaginitis is very common in postmenopausal women, due to the falling levels of oestrogen. The term genitourinary syndrome of menopause (GSM) is now usually used instead of vulvovaginal atrophy or atrophic vaginitis. It is defined as 'a group of chronic, progressive, hypo-oestrogenic conditions, including vulvovaginal atrophy, atrophic vaginitis, and bladder and urethral dysfunctions'.

During the reproductive years, the vaginal epithelium thickens under the influence of oestrogen and produces glycogen. As they die, the glycogen-rich cells provide food for Döderlein's bacilli, which in turn produce lactic acid, maintaining an acidic vaginal environment. After the menopause, oestrogen levels fall and this produces changes in the vagina:

  • The vaginal mucosa becomes thinner, drier, less elastic and more fragile. It may become inflamed.

  • The vaginal epithelium may become inflamed, contributing to urinary symptoms.

  • Changes in vaginal pH and vaginal flora may predispose to urinary tract infection (UTI) or vaginal infections.

  • Reduced oestrogen levels may affect periurethral tissues and contribute to pelvic laxity and stress incontinence.

Senshio Frequently Asked Questions

Here you can find more information on Senshio but if you are ever in doubt, or have more questions about Senshio or VVA, please don't hesitate to talk to your doctor or pharmacist.

What Senshio is and what it is used for

Senshio contains the active substance ospemifene.1

Ospemifene belongs to a group of medicines that do not contain hormones called Selective Estrogen Receptor Modulators (SERMs). Senshio is used to treat women with moderate to severe post-menopausal symptoms in and outside the vagina, such as itching, dryness, burning and pain during sex (dyspareunia). This is known as vulvar and vaginal atrophy. It is caused by a lowering in the levels of the female hormone oestrogen in your body. When this happens, the vaginal walls can become thinner. This happens naturally after menopause (post-menopause)1

What you need to know before you take Senshio

Do not take Senshio if any of the following apply:1

  • If you are allergic to ospemifene or any of the other ingredients of this medicine (please refer to ' What is in Senshio, are the contents of the pack and other information' below)
  • 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

Warnings and precautions

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.1 

Talk to your doctor or pharmacist before taking Senshio if any of the following apply to you.1

  • 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).
  • If you have had a stroke (a cerebrovascular accident), or if your doctor has told you that you are at high risk of having one.
  • If you are suffering from any gynaecological illness other than vulvar and vaginal atrophy.
  • If you have had breast cancer.

What should I be aware of when taking Senshio?

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.1

If any vaginal bleeding occurs while taking Senshio or soon after you have stopped taking it, you should speak to your doctor.1

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.1

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 these medicines:1

  • 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:1

  • 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).

How do I take Senshio?

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.1

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.1

Senshio must be taken every day for as long as your doctor tells you to.1

  • Patients with liver disease. This medicine is not recommended if you have severely reduced liver function.1
  • If you take more Senshio than you should. If you take more tablets than you should, tell your doctor or pharmacist.1
  • 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 within the same day. Do not take two tablets in one day to make up for a forgotten tablet.1
  • If you stop using Senshio. 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.1

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

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):1

  • An infection of the genitals caused by a fungus (thrush)
  • Hot flushes
  • Muscle cramps
  • Vaginal or genital discharge
  • Rash
  • Headache
  • Vaginal bleeding

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

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

Reporting of side effects1

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard 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.

How to store Senshio

Keep this medicine out of the sight and reach of children.1

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.1

The expiry date refers to the last day of that month. This medicine does not require any special storage conditions.1

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.1

What is in Senshio, are the contents of the pack and other information

What Senshio contains1

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

What Senshio looks like and the contents of the pack1

Senshio 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.

Where can I find more information?

You can download the Senshio patient information leaflet here.

References:

  1. EMC, 2022. Senshio Patient Information Leaflet. Available at: https://www.medicines.org.uk/emc/files/pil.9417.pdf accessed July 2024.
  2. Patient Info 2022, Atrophic Vaginitis. Available at: https://patient.info/doctor/atrophic-vaginitis. Accessed July 2024.
NP-UK-OSP-0072 | July 2024