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

Logo ESTRO-PAUSE* N TABLETS
ESTRO-PAUSE* N FORTE TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ESTRO-PAUSE* N TABLETS
ESTRO-PAUSE* N FORTE TABLETS

COMPOSITION:
ESTRO-PAUSE* N:

16 grey-blue tablets each containing
oestradiol valerate 1 mg followed by 12 white tablets each containing oestradiol valerate 1 mg and norethisterone 1 mg.
ESTRO-PAUSE* N FORTE:
16 blue tablets each containing oestradiol valerate 2 mg followed by 12 pale yellow tablets each containing oestradiol valerate 2 mg and norethisterone 1 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 21.8.2 Progesterones with or without 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.
Norethisterone is absorbed from the gastro-intestinal tract and its effects last for at least twenty four hours. There are large inter-subject variations in elimination, half-life and bioavailability. Norethisterone undergoes a first-pass effect with a resulting loss of one third of the dose.

INDICATIONS:
ESTRO-PAUSE* N
and ESTRO-PAUSE* N FORTE tablets are indicated as hormone replacement therapy for the treatment of menopausal symptoms.

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 markedly impaired liver function, the Dubin-Johnson or Rotor syndromes, cholestatic 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* N / N FORTE should not be administered to pregnant or nursing mothers and to premenopausal women.
ESTRO-PAUSE* N / N FORTE is not an oral contraceptive.

DOSAGE AND DIRECTIONS FOR USE:
Treatment commences with one oestradiol valerate tablet daily for the first sixteen days followed by one combination tablet containing oestradiol valerate and norethisterone, daily for the next twelve days, as directed on the twenty eight day calendar pack.
Therapy may start at any time during the cycle. However, if a patient is menstruating regularly is advised that the patient starts therapy on the first day of bleeding. Menstrual bleeding during initial ESTRO-PAUSE*N / ESTRO-PAUSE* N FORTE therapy may be irregular. Pregnancy should be excluded before starting therapy.
The lowest dose compatible with the control of symptoms should always be used.
ESTRO-PAUSE*N/ ESTRO-PAUSE* N FORTE may be taken continuously by women with an intact uterus as it provides both oestrogen and progestogen to reduce endometrial hyperstimulation.
Use in the elderly:
ESTRO-PAUSE*N/ ESTRO-PAUSE* N FORTE
should only be used in the elderly for the indications listed.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The side-effects include the following : gastro-intestinal disturbances e.g. nausea, and vomiting, melasma or chloasma and other skin or hair changes, headache, water retention, changes in appetite or weight, breast tenderness, and changes in libido. Spotting, breakthrough bleeding, or amenorrhoea can occur during treatment and amenorrhoea may also occur when ESTRO-PAUSE* N/ ESTRO-PAUSE* N FORTE is withdrawn. Some patients may experience depression and other mental changes. Intolerance to contact lenses has been reported.
There is an increased risk of thrombo-embolic and cardiovascular disease and associated mortality related, at least in part, to the oestrogen content. The increased mortality risk from thrombo-embolic disease is greatest with increased age and in cigarette smokers. Other risk factors include obesity, diabetes, hypertension and hyperlipidaemia.
Precautions:
ESTRO-PAUSE* N/ ESTRO-PAUSE* N FORTE
should normally be used only in women more than six months postmenopause and is not intended for oral contraceptive to prevent pregnancy. A thorough gynaecological and physical examination is advised before and periodically during the treatment with ESTRO-PAUSE* N/ ESTRO-PAUSE* N FORTE.
Irregular bleeding during tablet taking may occur during the first few months, but is usually transient. Regular breast examinations should be carried out in women on HRT and breast status should be closely monitored in women with a history of, or known, breast nodules, or fibrocystic disease.
Patients should be carefully observed if they suffer with diseases which may be subject to deterioration during pregnancy or with oestrogen use. These include otosclerosis, migraine, multiple sclerosis, epilepsy, porphyria and uterine fibroids. Patients with endometriosis should be closely monitored.
If migrainous or frequent unusual severe headaches occur for the first time, or any other symptoms that are possible prodromata of vascular occlusion occur, treatment should be suspended pending further investigation.
If jaundice occurs treatment should be stopped immediately. Consider discontinuation of treatment when trauma, illness or impending surgery is considered to entail a risk of thrombosis.
Patients with mild chronic liver disease should have their liver function checked every eight to twelve weeks. Patients with cholelithiasis, Dubin-Johnson syndrome or Rotor syndrome should be closely monitored.
As ESTRO-PAUSE* N/ ESTRO-PAUSE* N FORTE is not an oral contraceptive adequate non-hormonal measures should be taken to exclude pregnancy.

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* N:
16 Grey-blue, biconvex, circular tablets marked E1 on one side, followed by 12 white, biconvex, circular tablets marked N1 on one side.
ESTRO-PAUSE* N FORTE:
16 Blue, biconvex, circular tablets marked E2 on one side, followed by 12 pale yellow, biconvex, circular tablets marked N2 on one side.

PRESENTATION:
Calendar packs of 28 tablets.

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

REGISTRATION NUMBER:
ESTRO-PAUSE* N:
29/21.8.2/0763
ESTRO-PAUSE* N FORTE: 29/21.8.2/0764

NAME AND ADDRESS OF THE APPLICANT:
ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue
Bryanston
2152
Private Bag X69
Bryanston
2021
Under licence from Shire Pharmaceuticals, UK

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
29 JANUARY 1996

*Registered Trade Mark

HOW TO TAKE YOUR ESTRO-PAUSE* N/N FORTE 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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