WARNING

Osphena is a medication prescribed for the treatment of painful sexual intercourse due to menopause. While Osphena can provide relief for some women, it is important to be aware of the potential risks associated with its use. Here are some of the risks of taking Osphena:

• Increased risk of blood clots: Osphena has been associated with an increased risk of blood clots, including deep vein thrombosis (DVT) and pulmonary embolism. Women with a history of blood clots or at a high risk of developing them should exercise caution when considering Osphena.
• Stroke: There have been reports of an increased risk of stroke in women taking Osphena, particularly in those who have a history of cardiovascular disease or other risk factors for stroke.
• Endometrial cancer: Osphena has been linked to an increased risk of endometrial cancer, a type of cancer that affects the lining of the uterus. Women who have not had a hysterectomy should be regularly monitored for any signs or symptoms of endometrial cancer while taking Osphena.
• Hot flashes and other menopausal symptoms: Some women may experience an increase in hot flashes and other menopausal symptoms when starting Osphena treatment. These symptoms may gradually improve over time, but it’s essential to discuss any concerns with a healthcare provider.
• Vaginal bleeding: Osphena may cause vaginal bleeding or spotting, especially during the first few months of treatment. It’s important to report any abnormal bleeding to a healthcare provider for further evaluation.
• Allergic reactions: In rare cases, Osphena can cause allergic reactions, including rash, itching, swelling, severe dizziness, or difficulty breathing. If any of these symptoms occur, immediate medical attention should be sought.

It’s crucial to note that the above risks are not exhaustive, and there may be additional considerations or precautions specific to an individual’s medical history and condition. If you are considering taking Osphena, it is recommended to consult with a healthcare professional who can evaluate your specific circumstances and provide personalized advice.

Why is this medication prescribed?

Osphena (ospemifene) is prescribed for the treatment of a specific symptom called dyspareunia, which refers to pain during sexual intercourse. This symptom is commonly experienced by postmenopausal women and can significantly affect their quality of life and sexual well-being.

Osphena is specifically indicated for postmenopausal women who experience moderate to severe dyspareunia due to changes in the vaginal tissues caused by menopause. These changes, including thinning and drying of the vaginal walls, can result in discomfort, pain, and irritation during sexual activity.

Osphena works by acting as a selective estrogen receptor modulator (SERM). It selectively activates estrogen receptors in the vaginal tissues, leading to the restoration of vaginal moisture, elasticity, and thickness. By improving vaginal health, Osphena helps to alleviate the pain and discomfort associated with dyspareunia, ultimately enhancing sexual satisfaction and restoring a woman’s sexual function.

How should this medicine be used?

Osphena (ospemifene) is a prescription medication used to treat painful sexual intercourse in postmenopausal women. Here are some general guidelines on how Osphena should be used:

• Prescription and dosing: Osphena is available as a tablet and should be taken exactly as prescribed by a healthcare professional. Follow the instructions provided by your doctor regarding dosage and duration of treatment.
• Timing: Osphena can be taken with or without food. It is typically taken once daily, preferably at the same time each day. It’s important to adhere to the recommended dosing schedule for optimal effectiveness.
• Swallowing: Swallow the tablet whole with a glass of water. Do not crush, chew, or break the tablet before swallowing.
• Duration of treatment: The duration of Osphena treatment will depend on the individual and the severity of symptoms. Your healthcare provider will determine the appropriate length of treatment for your specific situation.
• Regular check-ups: While using Osphena, it’s important to have regular check-ups with your healthcare provider to monitor your response to the medication and evaluate any potential side effects.
• Additional therapies: Osphena is often used as part of a comprehensive treatment plan for menopausal symptoms. Your healthcare provider may recommend additional therapies, such as lubricants, vaginal moisturizers, or hormone replacement therapy, to help manage your symptoms effectively.

It’s crucial to note that the above instructions are general guidelines. Always follow the specific instructions provided by your healthcare provider and read the medication guide or patient information leaflet that accompanies your prescription for detailed information about Osphena’s use. If you have any questions or concerns about using Osphena, consult with your doctor or pharmacist for clarification.

Other uses for this medicine

Osphena (ospemifene) is primarily prescribed for the treatment of dyspareunia (painful sexual intercourse) in postmenopausal women. However, it is important to note that Osphena is not approved or indicated for any other uses besides this specific condition. It is not intended for the treatment of other menopausal symptoms such as hot flashes, night sweats, or hormonal imbalance.

What special precautions should I follow?

As for special precautions associated with Osphena, here are some important considerations:

• Estrogen-dependent conditions: Osphena has estrogen-like effects in the body, so it should be used with caution in individuals with a history or risk factors for estrogen-dependent conditions such as breast cancer, ovarian cancer, endometrial cancer, or uterine abnormalities.
• Cardiovascular health: Osphena has been associated with an increased risk of blood clots and stroke. Women with a history of blood clots, heart disease, stroke, or other cardiovascular conditions should discuss the potential risks and benefits of Osphena with their healthcare provider before starting the medication.
• Liver function: Osphena is metabolized in the liver, so individuals with impaired liver function may require dosage adjustments or closer monitoring while using the medication.
• Hormone-sensitive conditions: Osphena may have an effect on hormone levels in the body. Therefore, it should be used with caution in individuals with a history or risk factors for hormone-sensitive conditions such as endometriosis, uterine fibroids, or abnormal vaginal bleeding.
• Pregnancy and breastfeeding: Osphena is not intended for use in pregnant or breastfeeding women. It can cause harm to the fetus or pass into breast milk, potentially affecting the nursing infant. If pregnancy occurs during Osphena treatment, it should be discontinued immediately.
• Other medications: Osphena may interact with certain medications, including hormonal therapies, blood thinners, and medications that affect liver enzymes. Inform your healthcare provider about all the medications, supplements, and herbal products you are taking to avoid potential drug interactions.

It’s essential to discuss your medical history, current medications, and any specific concerns with your healthcare provider before starting Osphena. They can provide personalized advice and guidance based on your individual circumstances to ensure the safe and effective use of the medication.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with taking Osphena (ospemifene). You can generally take the medication with or without food, according to your preference.

What should I do if I forget a dose?

If you forget to take a dose of Osphena, follow these general guidelines:

• Timing: Take the missed dose as soon as you remember. If it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule.
• Double dosing: Do not take a double dose to make up for the missed one. Taking more than the prescribed dose can increase the risk of side effects without providing additional benefits.

What side effects can this medication cause?

Osphena (ospemifene) may cause various side effects, although not everyone experiences them. Some common side effects that have been reported with Osphena use include:

• Hot flashes: This is the most commonly reported side effect of Osphena. Hot flashes are characterized by a sudden feeling of warmth, often accompanied by sweating, flushing of the face, and a rapid heartbeat.
• Vaginal discharge: Some women may experience changes in vaginal discharge, including an increase in discharge or changes in consistency.
• Muscle spasms: Muscle spasms, particularly in the legs, have been reported by some individuals taking Osphena.
• Flulike symptoms: Some people may experience symptoms similar to the flu, such as headache, body aches, fatigue, and general malaise.
• Sweating: Excessive sweating or night sweats may occur as a side effect of Osphena.
• Gastrointestinal symptoms: Digestive disturbances, including abdominal pain, nausea, bloating, and diarrhea, have been reported by a small number of individuals.
• Breast pain: Some women may experience breast pain or tenderness while taking Osphena.
• Vaginal bleeding: Spotting or vaginal bleeding, including breakthrough bleeding, may occur in some women using Osphena.

It’s important to note that these side effects are not exhaustive, and individual experiences may vary. If you experience any persistent or bothersome side effects while taking Osphena, it is recommended to consult with your healthcare provider for further evaluation and guidance.

What should I know about storage and disposal of this medication?

• Storage: Keep Osphena in its original container at room temperature, away from excessive heat, moisture, and direct sunlight. Follow any specific storage instructions provided by the manufacturer or your healthcare provider.
• Disposal: When it comes to disposing of Osphena, it is recommended to follow local guidelines and regulations for medication disposal. Do not flush Osphena down the toilet or drain unless instructed to do so. Contact your local pharmacy or waste disposal facility for guidance on proper medication disposal methods.

In case of emergency/overdose

In case of an emergency or suspected overdose, call your local emergency services or seek immediate medical attention. It is helpful to provide healthcare professionals with as much information as possible, including the medication name (Osphena), dosage, and the amount ingested.

What other information should I know?

• Take Osphena exactly as prescribed by your healthcare provider. Do not exceed the recommended dosage or change the treatment duration without consulting your doctor.
• Inform your doctor about any medical conditions you have or medications you are taking, as they may interact with Osphena.
• Osphena may increase the risk of stroke, blood clots, and endometrial cancer. Discuss these risks with your healthcare provider before starting treatment.
• Report any unusual symptoms, side effects, or allergic reactions to your doctor promptly.
• Attend regular check-ups with your healthcare provider to monitor the effectiveness and safety of Osphena.

Remember, this information is meant as a general guide. Always follow the specific instructions provided by your healthcare provider and read the medication’s packaging for any additional guidance or precautions.