Amitriptyline 50mg/5ml oral solution sugar free

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Amitriptyline hydrochloride

Commercializzato da:

Rosemont Pharmaceuticals Ltd

Codice ATC:

N06AA09

INN (Nome Internazionale):

Amitriptyline hydrochloride

Dosaggio:

10mg/1ml

Forma farmaceutica:

Oral solution

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04030100; GTIN: 5016119070891

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JOB INFORMATION
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PREFLIGHT
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JOB SPECIFICATION
MAIN BODY TEXT
Univers Roman
UNIVERS BOLD
50mg/5ml
BLACK
7474
PANTONE
PANTONE
265
KEYLINE
BRAILLE
UKL413
408
150 x 500mm
N/A
150 x 33mm
1
8pt
(horizontally
condensed to 90%)
No
150ml
150ml
N/A
F5ND1RBJ2
F5ND1RBJ1
N/A
1 of 2
Amitriptyline Hydrochloride 50mg/5ml
Oral Solution
20/04/18
-
DH
-
3
-
APPROVALS
THIRD PARTY APPROVAL REQUIRED
Name:
Name:
Signature:
Signature:
Date:
Date:
AUTHORITY APPROVAL SUPPLIED
REGULATORY SIGN-OFF
YES
YES
NO
N/A
TICK APPLICABLE BOX
TICK APPLICABLE BOX
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
n
Keep this leaflet. You may need to read it again.
n
If you have any further questions, ask your doctor or pharmacist.
n
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.
n
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 50mg/5ml Oral Solution is and what it is
used for
2.
What you need to know before you take Amitriptyline 50mg/5ml Oral
Solution
3.
How to take Amitriptyline 50mg/5ml Oral Solution
4.
Possible side effects
5.
How to store Amitriptyline 50mg/5ml Oral Solution
6.
Contents of the pack and other information
1. WHAT AMITRIPTYLINE 50MG/5ML ORAL SOLUTION IS AND WHAT IT IS USED
FOR
Amitriptyline belongs to a group of medicines known as tricyclic
antidepressants.
This medicine is used to treat:
n
Depression in adults (major depressive episodes)
n
Neuropathic pain in adul

Scheda tecnica

OBJECT 1
AMITRIPTYLINE HYDROCHLORIDE 50MG/5ML ORAL
SOLUTION
Summary of Product Characteristics Updated 03-May-2018 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Amitriptyline Hydrochloride 50mg/5ml Oral Solution
2. Qualitative and quantitative composition
Amitriptyline Hydrochloride 50mg/5ml
3. Pharmaceutical form
Oral Solution
4. Clinical particulars
4.1 Therapeutic indications
Amitriptyline is indicated for:
• the treatment of major depressive disorder in adults
• the treatment of neuropathic pain in adults
• the prophylactic treatment of chronic tension type headache (CTTH)
in adults
• the prophylactic treatment of migraine in adults
• the treatment of nocturnal enuresis in children aged 6 years and
above when organic pathology,
including spina bifida and related disorders, have been excluded and
no response has been achieved to all
other non-drug and drug treatments, including antispasmodics and
vasopressin-related products. This
medicinal product should only be prescribed by a healthcare
professional with expertise in the
management of persistent enuresis.
4.2 Posology and method of administration
Posology
Not all dosage schemes can be achieved with all the pharmaceutical
forms/strengths. The appropriate
formulation/strength should be selected for the starting doses and any
subsequent dose increments.
_Major depressive disorder _
Dosage should be initiated at a low level and increased gradually,
noting carefully the clinical response
and any evidence of intolerability.
_Adults_
Initially 25 mg 2 times daily (50 mg daily). If necessary, the dose
can be increased by 25 mg every other
day up to 150 mg daily divided into two doses.
The maintenance dose is the lowest effective dose.
_Elderly patients over 65 years of age and patients with
cardiovascular disease _
Initially 10 mg – 25 mg daily.
The daily dose may be increased up to 100 mg – 150 mg divided into
two doses, depending on individual
patient response and tolerability.
Doses above 100 mg should be used with caution.
Th