Other names: Premarin, Estrace, Equin, Femtrace, Gynodiol

 

Each tablet contains 0.625 mg conjugated estrogen as the active ingredient.

The non-active ingredients are: lactose, starch, talc and magnesium stearate.

 

Equin is indicated for hormone replacement therapy (HRT) in the:

- Treatment of either natural or surgical menopausal symptoms such as hot flahes, night sweats, urogenital system disorders (atrophic vulvovaginitis).

- Prevention of bone thinning (osteoporosis) in postmenopausal women at high risk of future fractures and who are not able to take other medicinal products approved for the prevention of osteoporosis. You should discuss all the available options with your doctor.

Equin should not be used to prevent heart disease, nor to increase intellectual capacity.

Equin is not a contraceptive, nor will it restore fertility.

 

Carefully follow your doctor's instructions. Read the following information before you take Equin.

 

Do not take Equin if:

- You have past or suspected breast cancer or endometrial cancer.

- You know or suspect you are pregnant.

- You have any abnormal vaginal bleeding.

- You have endometrial hyperplasia (abnormal growth of the endometrium).

- You have or have had venous thrombosis or pulmonary embolism.

- You are suffering from a disorder which affects the coagulation of the blood (thrombophilia).

- You have or have had recent arterial thromboembolic disease such as angina pectoris, myocardial infarction, cerebrovascular accident or retinal vascular thrombosis.

- You have or have had any serious liver disease, until the liver function tests return to normal.

- You are allergic to any of the ingredients of Equin.

- You have porphyria (a disease affecting the metabolism of porphyrin pigments).

 

Take special care with Equin (Premarin, Estrace, Ogen, Femtrace, Gynodiol):

You should see your doctor for regular checkups at least once a year. At these checkups you should discuss whether it is necessary to adjust or continue treatment. For the treatment of climacteric symptoms, the HRT should only be initiated if the symptoms affect the quality of life of the woman. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and hormone replacement therapy should only be continued as long as the benefits outweigh the risks. This medication should be prescribed at the lowest effective dose and for the shortest duration. Before you start the hormone replacement therapy (HRT), you should inform your doctor about your own and your family's medical history. A thorough physical and gynecological examination should be carried out by your doctor before initiating the treatment and periodically during the treatment.

 

 

If any of the following conditions have been aggravated or appear during treatment with Equin (Premarin, Estrace, Ogen, Femtrace, Gynodiol) you should consult your doctor immediately:

- Gynecological disorders of any type.

- Changes in your breasts.

- An increase in fatty substances (triglycerides) in the blood or a family history of this condition.

- High blood pressure, in particular if it worsens or does not improve with antihypertensive drug treatment.

- Liver disorders.

- Diabetes.

- Cholelithiasis.

- Severe and frequent migraines.

- An autoimmune disease called systemic lupus erythematosus.

- Epilepsy.

- Asthma.

- Jaundice (yellowing of the skin and whites of the eyes).

- Pregnancy.

Take special care not to exceed the recommended dosage.

Hormone replacement therapy may increase the risk of some serious diseases such as blood clotting (thrombosis) and some types of tumors.

 

Thrombosis (blood clots)

Hormone replacement therapy increases the risk of thrombosis, especially during the first year of taking it.

Blood clots may block main blood vessels. If the blood clot forms in a deep vein in your leg, it may travel and cause blockage of an artery in the lungs (pulmonary embolus). Blood clots are also formed, though less frequently, in arteries in the heart (myocardial infarction, angina pectoris), in arteries in the brain (cerebral thrombosis) or in the eyes (loss of vision or double vision). If you notice any possible sign of a blood clot, inform your doctor immediately. The symptoms include:

- Pain or swelling of a leg

- Sudden cough

- A strong pain in your chest that may spread to your arm

- Breathing difficulties

- Severe and unexplained headaches

- Visual disturbances (loss of vision, double vision)

- Difficulty speaking clearly

- Dizziness

- Convulsions

- Weakness or numbness which affects a part of the body

- Difficulty walking or holding things

The risk of getting a blood clot may be temporarily increased during periods of prolonged immobilization following major surgery or other reasons. Therefore your doctor should be consulted in these cases because it may be convenient to temporarily stop treatment until the woman is completely mobilized. If you are going to have surgery and know you are going to have to be in bed for a long period of time inform your doctor.

 

 

Tumors

HRT increases the risk of breast cancer. An excess risk becomes apparent within the first years of starting treatment and increases with the duration of use of HRT. Your doctor will inform you how to check your breast for any changes and will carry out regular checkups during the treatment. The excess risk disappears in the course of about 5 years after stopping treatment. Long term use (especially more than 10 years) of estrogen has been associated with an increased risk of ovarian cancer.

 

Taking estrogen for a long time can also increase the risk of tumors and abnormalities of the endometrium. If you still have your uterus, your doctor may prescribe another hormone named progestogen which helps to lower the risk of uterine cancer. Bleeding may be experienced at the end of the treatment with progestogen. If you have any heavy or irregular bleeding you should tell your doctor. You and your doctor should carefully consider the possible benefits and risks of HRT and the duration of the treatment. This should be evaluated periodically during the treatment. Equin (Premarin, Estrace, Ogen, Femtrace, Gynodiol) is not a contraceptive and should not be used as such, nor will it restore fertility.

Hormone replacement therapy will not improve your memory nor your intellectual capacity; it may even worsen if you are over 65 years of age.

 

Equin should not be administered to children.

 

Consult your doctor or pharmacist before taking any medication. Equin should not be used during pregnancy or if trying to become pregnant.

 

Consult your doctor or pharmacist before taking any medication. Lactating mothers should not use Equin.

 

There is no evidence to suggest that taking Equin will affect your ability to drive or to operate machinery.

 

Inform your doctor or pharmacist if you are taking or have recently taken any other medications, even those twithout a prescription. It is particularly important that you inform your doctor if you are taking or going to take any of the following medications, as they may interact with Equin (Premarin, Estrace, Ogen, Femtrace, Gynodiol)  and alter its effect: anticonvulsants (e.g. phenobarbital, phenytoin or carbamazepine), an anti-inflammatory (phenylbutazone), antibiotics and other anti-infectives (e.g. rifampicin rifabutin, erythromycin, ketoconazole, nevirapine, efavirenz, ritonavir, nelfinavir), some medications used to treat ulcers (cimetidine) and herbal preparations containing St John's Wort (Hypericum perforatum). The effect of these herbal preparations lasts up to 2 weeks after ceasing therapy.

 

 

Remember to take your medication.

If you think that the action of Equin is too strong or too weak for you, inform your doctor or pharmacist. Equin is administered orally.

 

Unless indicated otherwise by your doctor, follow these instructions:

- The usual dose is one or two Equin tablets per day depending on your doctor's indications. It is recommended that the minimum effective dose be used to treat your symptoms. The dosage should be individualized so as to obtain the optimal response from each patient. For women with an intact uterus, it is recommended that a progestogen be administered concomitantly so as to help prevent endometrial cancer. A 21 day course of treatment with a one week rest period is recommended.

 

The dosing schedule is as follows:

- Climacteric symptoms: one or two tablets per day.

- Prevention of osteoporosis: one tablet per day.

Patients should be re-evaluated periodically (every 3 to 6 months) to determine if treatment for symptoms is still necessary.

 

If you take more Equin (Premarin, Estrace, Ogen, Femtrace, Gynodiol)  than you should:

If you take more Equin than you should, consult your doctor or pharmacist immediately.

In the case of an overdose or accidental ingestion, contact your local poison control centre. Serious side effects have not been reported following acute ingestion of large doses of estrogen. The most common symptoms of overdose are nausea, vomiting and withdrawal bleeding in woman. Gastric flushing, administration of activated charcoal and general supportive measures may be necessary in the treatment of an overdose. 

If you forget to take Equin (Premarin, Estrace, Ogen, Femtrace, Gynodiol) :

Do not take double the usual dose to make up for missed tablets.

 

Like all medications, Equin may cause side effects.

The following adverse reactions have been reported and are listed in the table in frequency categories:

Very Common: >10% of women treated

Common: >1% and <10% of women treated

Uncommon: >0.1% and <1% of women treated

Rare: >0.01% and <0.1% of women treated

Very Rare: <0.01% of women treated

 

- Gastrointestinal Disorders: - Common: Nausea, vomiting, abdominal pain, anorexia. - Rare: Pancreatitis.

- Psychiatric Disorders: - Common: Depression. - Uncommon: Changes in libido and mood disturbances.

- Reproductive System and Breast Disorders: - Common: Breakthrough bleeding/spotting, breast discharge, gynecomastia, breast pain, amenorrhea and dysmenorrhoea. - Uncommon: Change in menstrual flow.

- Hepato-biliary Disorders: - Common: Cholestatic hepatitis and jaundice.

- Nervous System Disorders: - Common: Dizziness and headache. - Uncommon: Vertigo and migraine. - Rare: Cerebrovascular accident / stroke.

- Vascular Disorders: - Uncommon: Venous thromboembolism.

- Neoplasms benign and malignant: - Common: Endometrial hyperplasia. - Uncommon: Breast cancer. - Rare: Ovarian cancer.

- General Disorders and Administration Site Conditions: - Uncommon: Oedema.

- Skin and Subcutaneous Tissue Disorders: - Common: Alopecia. - Rare: Rash, urticaria, chloasma and hirsutism.

- Infections and Infestations: - Uncommon: Vaginitis.

- Immune System Disorders: - Rare: Anaphylactic / anaphylactoid reactions.

- Metabolism and Nutrition Disorders: - Common: Weight increase. - Rare: Glucose intolerance.

- Respiratory, Thoracic and Mediastinal Disorders: - Rare: Exacerbation of asthma.

- Eye Disorders: - Rare: Intolerance to contact lenses.

 

You should tell your doctor or pharmacist if you notice any other unwanted effects not mentioned above whilst you are taking Equin.

 

Always keep Equin (Premarin, Estrace, Ogen, Femtrace, Gynodiol) out of the reach and sight of children.

Store the tablets in their original packaging. Do not store above 25°C.

Expiry: Do not use this medicine after the expiry date stated on the packaging.