Imipramine 10mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Imipramine hydrochloride

Inapatikana kutoka:

Accord-UK Ltd

ATC kanuni:

N06AA02

INN (Jina la Kimataifa):

Imipramine hydrochloride

Kipimo:

10mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 04030100; GTIN: 5012617010162

Taarifa za kipeperushi

296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Imipramine , Tablets, 10, 25mg,
28 Pack, UK
296x210 (Reel Fed)
51010479
Leaflet for Blisters
1125
R.Paul
26/01/2022
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IMIPRAMINE 10MG, 25MG , TABLET, PIL, UK
Black
Profile
BBBB3923
M.Ellott
16/02/2022
296x210
8
Accord Barnstaple
n/a
n/a
1
Version 7
12.02.2020
German GTIN 14
(incorporating PZN):
Cartons and label leaflets only
(labels only when specified)
page 4
page 1
51010479
BBBB3923
_Continued over page_
_Continued top of next column_
_Continued top of next column_
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 or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
WHAT IMIPRAMINE TABLETS ARE AND
WHAT THEY ARE USED FOR
2
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE IMIPRAMINE TABLETS
3
HOW TO TAKE IMIPRAMINE TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE IMIPRAMINE TABLETS
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT IMIPRAMINE TABLETS ARE AND
WHAT THEY ARE USED FOR
Imipramine belongs to a group of medicines
called tricyclic antidepressant

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
IMIPRAMINE TABLETS BP 10mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg Imipramine Hydrochloride PhEur.
_Excipients with known effect _
Each tablet contains 20.00mg lactose and 0.0025mg sodium benzoate
(E211).
Also contains sucrose, sunset yellow (E110) and amaranth (E123).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Sugar-coated tablet.
Red, circular, biconvex, sugar-coated tablets, nominal diameter 5.9mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1) Treatment of symptoms of depressive illness.
2) Relief of nocturnal enuresis in children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Posology _
_Adults: _1 x 25mg up to three times daily, increasing stepwise to
150-200mg.
This should be reached by the end of the first week and maintained
until
definite improvement has occurred. The subsequent maintenance dose
should
be individually determined by gradually reducing the dosage, usually
to about
50-100mg daily.
In patients in hospital, i.e. severe cases, the dose may be increased
to 100mg
three times daily until a distinct improvement is seen. Again the
subsequent
maintenance dose should be determined individually by reducing the
dosage,
usually to about 100mg daily.
_Elderly: _Patients over 60 years may respond to lower doses of
imipramine
than those recommended above. Treatment should be initiated with 10mg
daily, gradually increasing to 30-50mg daily. The optimum dose should
be
reached after about 10 days and then continued until the end of
treatment.
_Children (for nocturnal enuresis only): _The tablets should be
administered
just before bedtime.
_Over 11 years (weight 35-54kg or 77-119lbs): _50-75mg daily.
_8-11 years (weight 25-35kg or 55-77lbs): _25-50mg daily.
_6-7 years (weight 20-25kg or 44-55lbs): _25mg daily.
_Under 6 years: _Not to be given to children under 6 years of age.
The dose should not exceed 75mg daily. The maximum period of treatment
should not exceed three months, a