Hydrocortisone 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone

Available from:

DE Pharmaceuticals

ATC code:

H02AB09

INN (International Name):

Hydrocortisone

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06030200

Patient Information leaflet

continued....please turn over
1.
What Hydrocortisone Accord Tablets are
and what are they used for
Hydrocortisone Accord Tablets contain a medicine
called hydrocortisone. This belongs to a group of
medicines called ‘steroids’. Their full name is
corticosteroids. These corticosteroids occur naturally
in the body, and help to maintain health and
well-being. Boosting your body with extra corticosteroid
(such as Hydrocortisone Accord Tablets) is an effective
way to treat various illnesses involving inflammation in
the body.
Hydrocortisone Accord Tablets reduce this
inflammation, which could otherwise go on making
your condition worse. You must take this medicine
regularly to get maximum benefit from it.
Hydrocortisone Accord Tablets are used for:
•
adding hydrocortisone usually made naturally in the
body because part of the adrenal gland is not
working properly
•
adding hydrocortisone after injuries, surgery or other
stressful events
• some other types of illness.
Ask your doctor to explain why you have been given
Hydrocortisone Accord Tablets if you are unsure.
2. Before taking Hydrocortisone Accord Tablets
Before you take Hydrocortisone Accord Tablets
Check with your doctor first if
• You have ever had severe depression or manic
depression (bipolar disorder). This includes having
had depression before or while taking steroid
medicines like Hydrocortisone Accord Tablets.
• any of your close family has had these illnesses.
If either of these applies to you, talk to a doctor
before taking Hydrocortisone Accord Tablets.
Do not take Hydrocortisone Accord Tablets if you:
• are allergic (hypersensitive) to hydrocortisone or any
of the other ingredients of Hydrocortisone Accord
Tablets
• have thrush, candida or any other fungal infection.
If you are not sure talk to your doctor or pharmacist
before taking Hydrocortisone Accord Tablets.
Take special care with Hydrocortisone Accord
Tablets
Check with your doctor before taking your medicine if:
• you have recently had a heart attack
•
you have a heart co

Summary of Product characteristics

OBJECT 1
HYDROCORTISONE 10MG TABLETS
Summary of Product Characteristics Updated 05-Aug-2019 | Auden
Mckenzie (Pharma Division) Ltd (a
subsidiary of Actavis PLC)
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Hydrocortisone 10mg Tablets
Hydrocortone 10mg Tablets
Hydrocortisone Accord 10mg Tablets
Hitoden 10mg Tablets
2. Qualitative and quantitative composition
10mg tablet: 10mg hydrocortisone
3. Pharmaceutical form
Tablets
10mg tablets: white, quarter-scored tablets, marked 'HYD 10'. The
tablet can be divided into equal halves or
quarters
4. Clinical particulars
4.1 Therapeutic indications
Corticosteroid
For use as replacement therapy in primary, secondary, or acute
adrenocortical insufficiency.
Pre-operatively, and during serious trauma or illness in patients with
known adrenal insufficiency or doubtful
adrenocortical reserve.
4.2 Posology and method of administration
Posology
Dosage must be individualised according to the response of the
individual patient. The lowest