Megace 40 mg/ml Oral Suspension

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Megestrol acetate

Disponibbli minn:

PharmaSwiss Ceska republika s.r.o.

Kodiċi ATC:

L02AB; L02AB01

INN (Isem Internazzjonali):

Megestrol acetate

Dożaġġ:

40 milligram(s)/millilitre

Għamla farmaċewtika:

Oral suspension

Tip ta 'preskrizzjoni:

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

Żona terapewtika:

Progestogens; megestrol

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

1998-12-10

Fuljett ta 'informazzjoni

106223
MX01B012IE01
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING YOUR
MEDICINE.
THIS LEAFLET PROVIDES A SUMMARY OF THE INFORMATION AVAILABLE ON YOUR
MEDICINE. THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU. DO NOT PASS IT ON TO OTHERS. IT MAY HARM
THEM, EVEN IF THEIR SYMPTOMS ARE
THE SAME AS YOURS. IF YOU WANT TO KNOW MORE OR ARE NOT SURE ASK YOUR
DOCTOR OR PHARMACIST.
IN THIS LEAFLET:
1. What Megace Oral Suspension is, and what it is used for
2. What you need to know before you take Megace Oral Suspension
3. How to take Megace Oral Suspension
4. Possible side effects
5. How to store Megace Oral Suspension
6. Further information
- skin rash
- difficulty breathing
As these may be signs of an allergic reaction
Other side effects which may occur with Megace Oral Suspension 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, including increased
facial and body hair
- 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 the following 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)
If any of these side effects con

Karatteristiċi tal-prodott

Health Products Regulatory Authority
27 February 2019
CRN008JY9
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Megace 40 mg/ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of suspension contains 40 mg micronized megestrol acetate.
Excipients with known effect:
Sucrose (50 mg/ml)
Sodium benzoate (2 mg/ml) (E211)
Sodium (<1 mmol/ml)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
White to cream coloured, milky suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Megace Oral Suspension is indicated in male and female patients for
the treatment of anorexia or weight loss secondary to
cancer or AIDS.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_
400-800 mg given as a single daily dose.
At least two months of continuous treatment is considered an adequate
period for determining the efficacy of Megace Oral
Suspension.
_Paediatric population_:
The Safety and efficacy of Megace Oral Suspension in children have not
been established.
This medicine is not recommended for use in children.
_Elderly:_
In general, dose selection for an elderly patient should be cautious,
usually starting at the low end of the dosing range,
reflecting the greater frequency of decreased hepatic, renal, or
cardiac function, and of concomitant disease or other drug
therapy (see section 4.4).
_Renal impairment:_
Megestrol acetate is known to be substantially excreted by the kidney,
and the risk of toxic reactions to this drug may be
greater in patients with impaired renal function.
Method of administration
Health Products Regulatory Authority
27 February 2019
CRN008JY9
Page 2 of 5
For oral use only.
4.3 CONTRAINDICATIONS
Megace is contraindicated in patients who have demonstrated
hypersensitivity to the active substance or to any of the
excipients listed in section 6.1.
Megace is also contraindicated in patients with thromboembolic
disorders.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Megace should be used with caution in patients