Amitriptyline 10mg/5ml oral solution sugar free

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Amitriptyline hydrochloride

Fáanlegur frá:

Wockhardt UK Ltd

ATC númer:

N06AA09

INN (Alþjóðlegt nafn):

Amitriptyline hydrochloride

Skammtar:

2mg/1ml

Lyfjaform:

Oral solution

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04030100; GTIN: 5012727906775

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
Amitriptyline Hydrochloride 10mg/5ml Oral Solution
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE 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, please 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 or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Amitriptyline Oral Solution is and what it is used for
2. What you need to know before you take Amitriptyline Oral Solution
3. How to take Amitriptyline Oral Solution
4. Possible side effects
5. How to store Amitriptyline Oral Solution
6. Contents of the pack and other information
1. What Amitriptyline Oral Solution is and what it is used for
The name of your medicine is Amitriptyline Oral Solution.
Amitriptyline belongs
to a group of medicines known as tricyclic antidepressants. Everybody
has
substances called serotonin and noradrenaline in their brains. It is
thought
that people with depression (and some other conditions) have less of
these
substances compared to those without depression (or other conditions).
Amitriptyline works by increasing the amounts of these substances in
the brain.
Amitriptyline also affects the muscles in the bladder and reduces the
need to
pass urine.
Amitriptyline Oral Solution is used in the treatment of:
•
depression (especially when associated with sleep disturbance)
•
night-time bed-wetting in children aged six years and above.
2. What you need to know before you take Amitriptyline Oral Solution
DO NOT TAKE AMITRIPTYLINE ORAL SOLUTION IF YOU:
•
are allergic to amitriptyline or to any of the other ingredients of
this medicine
(listed in section 6)
•
are taking drugs called Monoamine Oxidase Inhibitors (MAOIs)

Vara einkenni

OBJECT 1
AMITRIPTYLINE HYDROCHLORIDE 10MG/5ML ORAL
SOLUTION
Summary of Product Characteristics Updated 06-Dec-2016 | Wockhardt UK
Ltd
1. Name of the medicinal product
Amitriptyline Hydrochloride 10mg/5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml of solution contains 10mg amitriptyline hydrochloride.
Excipients with known effect
Each 5ml of solution contains:
1mg propyl hydroxybenzoate (E216)
6mg methyl hydroxybenzoate (E218)
3.35g liquid maltitol
Approximately 10.5mg ethanol
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution.
A clear colourless to pale yellow solution with an orange/tangerine
odour.
4. Clinical particulars
4.1 Therapeutic indications
Amitriptyline is indicated for the treatment of:
-Symptoms of depression (especially where sedation is required).
- Nocturnal enuresis in children aged six years and above when organic
pathology has been excluded and
no response has been achieved to all other non-drug and drug
treatments (used only as third line therapy).
Amitriptyline should only be prescribed by a healthcare professional
with expertise in the management of
persistent enuresis.
4.2 Posology and method of administration
Posology
Therapy should be started with a low dosage and increased gradually,
according to the clinical response
and any evidence of intolerance.
Adults - initial dosage: Usually 75mg a day in divided doses (or a
single dose at night). If necessary, this
may be increased to a total of 150mg a day, the additional doses being
given in the late afternoon and/or
at bedtime. The sedative effect is usually rapidly apparent. The
antidepressant activity may be seen within
three or four days or may take up to 30 days to develop adequately.
Adults - maintenance dosage: Usually 50 - 100mg a day. For maintenance
therapy, the total dosage may
be given in a single dose preferably in the evening or at bedtime.
When satisfactory improvement has
been reached, dosage should be reduced to the lowest amount that will
maintain relief of symptoms.
Ma