Megace 160mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Megestrol acetate

Available from:

Bausch & Lomb UK Ltd

ATC code:

L02AB01

INN (International Name):

Megestrol acetate

Dosage:

160mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08030200; GTIN: 5012712005636

Patient Information leaflet

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
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4. WHAT
IS IN THIS LEAFLET
1. What Megace tablets are and what they are used for
2. What you need to know before you take Megace tablets
3. How to take Megace tablets
4. Possible side effects
5. How to store Megace tablets
6 . Contents of the pack and other information
1. WHAT MEGACE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Megace tablets. Megace tablets contain
the active ingredient
megestrol acetate. Megestrol acetate belongs to a group of medicines
called progestogens and
is used to treat certain types of cancer known as hormone-dependent
cancer, which include
cancer of the breast. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEGACE
TABLETS DO NOT TAKE
MEGACE TABLETS IF YOU:
-
are allergic to megestrol acetate or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Tell your doctor if you:
-
have severe liver problems
-
currently suffer from, or have a history of suffering from blood clots
(thrombophlebitis)
-
have diabetes, as Megace tablets can increase your blood sugar levels
If you are over 65 years of age your doctor may want to monitor your
kidney function from time to
time, as this can sometimes decrease with age.
OTHER MEDICINES AND MEGACE TABLETS
Tell your d

Summary of Product characteristics

OBJECT 1
MEGACE 160MG TABLETS
Summary of Product Characteristics Updated 26-Oct-2022 | Bausch & Lomb
U.K Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Fertility, pregnancy and lactation
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4.7 Effects on ability to drive and use machines
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4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
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10. Date of revision of the text
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
Tablets
Off-white, oval, biconvex tablets with a break line, 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 effi