INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ESTRO-PAUSE* 1 mg
ESTRO-PAUSE* 2 mg

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ESTRO-PAUSE* 1 mg
ESTRO-PAUSE* 2 mg
Tablets

COMPOSITION:
ESTRO-PAUSE* 1 mg Tablets : Each tablet contains
oestradiol valerate 1 mg.
ESTRO-PAUSE* 2 mg Tablets : Each tablet contains oestradiol valerate 2 mg.

PHARMACOLOGICAL CLASSIFICATION:
A.21.8.1 Oestrogens.

PHARMACOLOGICAL ACTION:
Oestradiol valerate is an ester of oestradiol, a naturally occurring female hormone oestrogen. It is absorbed from the gastro-intestinal tract when given orally and is partly bound (about 50%) to plasma proteins. It is rapidly metabolised in the gut wall and liver to the less active oestriol and oestrone; some oestradiol undergoes enterohepatic recycling. It is excreted in the urine as sulphate and glucuronide esters together with a small proportion of unchanged oestradiol. Oestrogens cross the placenta.

INDICATIONS:
ESTRO-PAUSE* Tablets are indicated as hormone replacement therapy for the treatment of menopausal symptoms in hysterectomised women.

CONTRA-INDICATIONS:
Patients with a family or personal history of malignant neoplastic disease of the breast or genital tract (unless indicated for the treatment of the neoplasm) and in those with previous thrombo-embolic disorders, cardiovascular disease, kidney disease, thrombophlebitis, undiagnosed vaginal bleeding, herpes gestationis or endometriosis.
It is also contra-indicated in patients with liver impairment, jaundice, sickle-cell anaemia, persistent itching during a previous pregnancy, otosclerosis that has deteriorated due to pregnancy.
Relative contra-indications include a history of diabetes mellitus, epilepsy, asthma, hypertension, depression, porphyria or states in which fluid retention occur.
ESTRO-PAUSE should not be administered to pregnant or nursing mothers.

DOSAGE AND DIRECTIONS FOR USE:
ESTRO-PAUSE* 1 mg or 2 mg to be taken daily.
Dosage may be adjusted according to severity of symptoms or clinical response. Regular gynaecological check-ups are recommended if used continuously. The lowest dose compatible with the control of symptoms should always be used.
Use in the elderly:
Hormone replacement therapy should not be used except for the control of postmenopausal symptoms.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
There may be sodium and water retention with oedema, weight gain, tenderness and enlargement of the breasts, changes in libido, menstrual disorders and withdrawal bleeding, vaginal discharge, alterations in liver function, jaundice, gall-stones, depression, headache, palpitations, nausea, vomiting, gastro-intestinal disturbances, migraine, dizziness, vertigo, epistaxis, hypertension, a decrease in glucose tolerance and decrease in tolerance of contact lenses. Large doses may cause premature closure of the epiphyses. Skin reactions include chloasma or melasma, rashes and urticaria. Erythema multiforme and erythema nodosum have been reported.
Unopposed oestrogen therapy may cause endometrial proliferation and consequently carcinoma in postmenopausal women who are not hysterectomised. This association may be prevented if oestrogens are administered cyclically with added progestrogens.
Precautions:
If migrainous or frequent unusually severe headaches occur for the first time, or any other symptoms that are possible prodromata of vascular occlusion occur treatment should be stopped.
When impending surgery, trauma or illness is considered to entail a risk of thrombosis treatment should again be stopped. If jaundice or a significant rise in blood-pressure occurs treatment should be stopped immediately.
Patients with mild chronic liver disease should have their liver function checked every eight to twelve weeks. Those patients with cholelithiasis should be closely monitored.
Patients should be carefully observed if they suffer with diseases known to be subject to deterioration during pregnancy (e.g. multiple sclerosis, epilepsy, diabetes, hypertension, porphyria, tetany and otosclerosis).
A thorough gynaecological and physical examination is advised before and periodically during treatment with hormone replacement therapy.
The tablets are best taken at the same time every day. If you forget to take a tablet at the usual time try to take it within twelve hours. If this is not possible leave the forgotten tablet and continue to take the remaining tablets at the usual time.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions. There are no specific antidotes for overdosage and if further treatment is required it should be symptomatic and supportive.

IDENTIFICATION:
ESTRO-PAUSE* 1 mg Tablets: Circular, biconvex, grey-blue, film-coated tablets, coded E1 on one side, plain on obverse.
ESTRO-PAUSE* 2 mg Tablets: Circular, biconvex, blue, film-coated tablets, coded E2 on one side, plain on obverse.

PRESENTATION:
Calendar packs of 28 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
ESTRO-PAUSE* 1 mg: 29/21.8.1/0645
ESTRO-PAUSE* 2 mg: 29/21.8.1/0449

NAME AND ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext. 77
Private Bag x69
Bryanston
2021
Under licence from Shire Pharmaceuticals, UK.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
11 September 1995

* Registered Trademark

HOW TO TAKE YOUR ESTRO-PAUSE* 1 mg/ 2 mg TABLETS
1. You should always take your tablets as directed by your doctor or pharmacist.
2. Take one tablet each day by following the sequence of arrows.
3. You should start your next pack of tablets immediately after you have finished this one (on the same start day as this pack), whether you have any bleeding or not. DO NOT take a break between each pack of tablets unless your doctor tells you to.
4. For further information see the pack "Patient Information Leaflet".

New addition to this site: April 2004
Source: Pharmaceutical Industry

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