Megace 160 mg tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Megestrol acetate

Disponible desde:

PharmaSwiss Ceska republika s.r.o.

Código ATC:

L02AB; L02AB01

Designación común internacional (DCI):

Megestrol acetate

Dosis:

160 milligram(s)

formulario farmacéutico:

Tablet

tipo de receta:

Product subject to prescription which may not be renewed (A)

Área terapéutica:

Progestogens; megestrol

Estado de Autorización:

Marketed

Fecha de autorización:

1989-02-06

Información para el usuario

Other side effects which may occur with Megace tablets are:
Very Common (affects more than 1 in 10 people)
- increase in appetite and weight gain (not associated with water
retention)
- shortness of breath
- hot flushes, reddening of the face and neck
- high blood pressure
- increased blood sugar levels
- rounded face, sometimes called 'moon' face
- constipation
- swelling of a vein due to a blood clot
- blood clot in the lungs
Signs of a blood clot can include loss of co-ordination, slurred
speech, pains in your groin, pains or numbness in
your arm or leg (especially in calf of leg), shortness of breath,
weakness, headache, and fainting. If you experience
any of these signs tell your doctor immediately.
Common (affects between 1 in 10 to 1 in 100 people)
- temporary increase in the signs and symptoms of your disease.
- changes in mood
- numbness, pain or tingling in fingers or thumb
- heart attack
- hair loss
- diarrhoea
- tiredness
- feeling weak
- impotence
- passing wind
- needing to urinate more often
- feeling sick and being sick
- changes in vaginal bleeding (breakthrough bleeding, spotting)
- build up of fluid which causes swelling (mainly in the ankles)
- pain
- rash, including hives or nettle rash (urticaria)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not
listed in this leaflet. You can also report side effects directly (see
contact details below). By reporting side effects
you can help provide more information on the safety of this medicine.
Ireland:
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1
6764971; Fax: [phone].
Website: www.hpra.ie; E-mail: [e-mail]
United Kingdom:
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store.
5. How to store Megace tablets
Do not store above 25°C. Store in the original package in order to
protect from moisture. They should not get too hot
or damp; so do not leave your tab

Ficha técnica

Health Products Regulatory Authority
27 March 2019
CRN008R59
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Megace 160 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Megestrol Acetate 160 mg.
Excipient with known effect:
Each tablet contains 224.5 mg Lactose Monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Off-white, oval, biconvex tablets with a breakline, engraved ‘160’
on one face.
The break line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Megace is a progestational agent, indicated for the treatment of
certain hormone dependent neoplasms, such as breast cancer.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Breast cancer:
160 mg/day taken once daily.
At least two months of continuous treatment is considered an adequate
period for determining the efficacy of Megace.
Children:
Safety and effectiveness in paediatric patients have not been
established.
Megace is not recommended for use in children.
Elderly:
In general, use in elderly patients should be cautious, reflecting the
greater frequency of decreased hepatic, renal, or cardiac
function, and of concomitant disease or drug therapy. See section 4.4.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Megace should be used with caution in patients with a history of
thrombophlebitis.
This product should be used under the supervision of a specialist and
the patients kept under regular surveillance. This product
can exert adrenocortical effects. This should be borne in mind in
patient surveillance.
Health Products Regulatory Authority
27 March 2019
CRN008R59
Page 2 of 5
This product should be used with caution in patients with impaired
liver function, or with a history of or existent
thromboembolic disorder.
Patients with rare hereditary problems of galactose int