Imipramine 10mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
01-08-2018
Shusha Tabia za bidhaa (SPC)
11-09-2018

Viambatanisho vya kazi:

Imipramine hydrochloride

Inapatikana kutoka:

Alliance Healthcare (Distribution) 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

Taarifa za kipeperushi

                                148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Imipramine Tablets
25mg x 28’s (UK)
148x210 (Reel Fed)
50955500
Leaflet for Blisters
9251
T. Hull
07/08/18
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SUPPLIER:
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FMD info
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£
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Details
IMIPRAMINE 10MG & 25MG 28 TABLETS PIL - UK
Black
Profile
BBBA2676
T. Hull
13.08.2018
148x210
7pt
Actavis UK
n/a
n/a
1
Version 2
01.11.2017
IMIPRAMINE 10MG
AND 25MG TABLETS
_Continued over page_
_Continued top of next column_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
•
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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
INDEX
1
WHAT IMIPRAMINE TABLETS ARE AND
WHAT THEY ARE USED FOR
2
BEFORE YOU TAKE
3
HOW TO TAKE
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE
6
FURTHER INFORMATION
1
WHAT IMIPRAMINE TABLETS ARE AND WHAT THEY
ARE USED FOR
Imipramine belongs to a group of medicines called tricyclic
antidepressant drugs. These medicines alter the levels of chemicals in
the brain to relieve the symptoms of depression.
Imipramine is used:
•
to treat the symptoms of depression.
•
for the relief of bed-wetting at night by children.
2
BEFORE YOU TAKE
DO NOT TAKE Imipramine tablets and TELL your doctor if you or
your child (if they are the patient):
•
are ALLERGIC (hypersensitive) to imipramine, other tricyclic
antidepressants or
                                
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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.
For excipients, see 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, and withdrawal should be gradual. If
relapse
should occur, treatment should not be re-instituted until a full
physical
examination has been carried out.
_ _
_Method of Administration _
For oral adm
                                
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