Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 6 months since last menses.
Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. (See also section 4.4).
The experience of treating women older than 65 years is limited.
One tablet to be taken orally.
Zumenon is an oestrogen only continuous HRT for women with or without a uterus.
In women with a uterus, a progestogen should be added to Zumenon for 12-14 days each month to reduce the risk to the endometrium. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestogen in hysterectomised women.
For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.
In general, treatment should start with Zumenon 1mg. Depending on the clinical response, the dosage can afterwards be adjusted to individual need. If the complaints linked to oestrogen deficiency are not ameliorated the dosage can be increased by using Zumenon 2mg.
In women who are not taking hormone replacement therapy and who are amenorrhoeic, are hysterectomised, or women who switch from a continuous combined hormone replacement therapy, treatment may be started on any convenient day. In women transferring from a cyclic or continuous sequential HRT regimen, treatment should begin the day following completion of the prior regimen. If the patient has regular menstruation periods, treatment is started on day one of bleeding
The dosage is one tablet per day. Zumenon should be taken continuously without a break between packs. Zumenon can be taken with or without food.
If a dose has been forgotten, it should be taken as soon as possible. When more than 12 hours have elapsed, it is recommended to continue with the next dose without taking the forgotten tablet. In the case of a missed or delayed dose the likelihood of breakthrough bleeding or spotting may be increased.
There is no relevant indication for the use of Zumenon in the paediatric population.
Nausea, vomiting, sleepiness, dizziness and withdrawal bleeding may occur in some women. There is no specific antidote and treatment should be symptomatic.
Aforementioned information is also applicable for overdosing in children.
3 years.
This medicinal product does not require any special storage conditions.
The tablets are packed in blister strips of 28. The blister strips are made of PVC film with covering Aluminium foil. Each carton contains 84 tablets.
Medicines no longer required should not be disposed of via wastewater or household waste. Any unused product or waste material should be disposed of in accordance with local requirements.
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