Dosulepin 75mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dosulepin hydrochloride

Available from:

Dowelhurst Ltd

ATC code:

N06AA16

INN (International Name):

Dosulepin hydrochloride

Dosage:

75mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Dosulepin 75 mg tablets and Dosulepin 25 mg Capsules
Dosulepin hydrochloride
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.
-
If any of the side effects becomes serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.
What Dosulepin is and what it is used for
2.
Before you take Dosulepin tablets or capsules
3.
How to take Dosulepin
4.
Possible side effects
5.
How to store Dosulepin
6.
Further information
1.
WHAT DOSULEPIN IS AND WHAT IT IS USED FOR
Dosulepin belongs to a group of medicines called antidepressants.
Dosulepin is used to treat
depression and can also help reduce feelings of anxiety. This medicine
will only be used when other
medicines have been found to be unsuitable. Please ask your doctor or
pharmacist if you need more
information.
2.
BEFORE YOU TAKE DOSULEPIN TABLETS OR CAPSULES
Do not take Dosulepin tablets or capsules and speak to your doctor if:
-
you know that you are allergic (hypersensitive) to dosulepin or any of
the other ingredients
(listed in section 6 of this leaflet) in Dosulepin tablets or capsules
-
you have an irregular heart beat or any other heart problems
-
you have liver problems
-
you have an eye condition known as glaucoma
-
you are a man that has prostate problems (difficulty in passing water)
-
you have been diagnosed as having mania (feeling over-excited with
unusual behaviour)
-
you have fits (epilepsy)
Take special care with Dosulepin tablets or capsules if:
-
you are going to have general or dental surgery, tell your surgeon or
dentist you are taking
Dosulepin tablets or capsules. It may affect the anaesthetic used.
2
Taking other medicines
You should tell your doctor if you ar

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dosulepin 75mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains dosulepin hydrochloride 75 mg.
Excipient(s) with known effect
Each tablet contains 140 mg of lactose monohydrate and colourants
Sunset Yellow
(E110) and Ponceau 4R Red (E124). For the full list of excipients, see
section 6.1.
3
PHARMACEUTICAL FORM
Red, biconvex, film-coated tablets imprinted with ‘MP76’ on side
and plain on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dosulepin is indicated in the treatment of symptoms of depressive
illness
especially where an anti-anxiety effect is required.
Due to its toxicity in overdose, Dosulepin should only be used in
patients
intolerant of or unresponsive to alternative treatment options (see
sections 4.4
and 4.9).
Initiation of treatment for patients who have not previously received
Dosulepin should be restricted to specialist care prescribers
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Oral
_Adults _
Initially 75 mg/day in divided doses or as a single dose at night. The
dose may be
increased to two 75 mg tablets after a few days if required. In
certain circumstances,
e.g. under hospital conditions, dosages up to 225 mg daily have been
used.
_Children _
The use of dosulepin hydrochloride is
not recommended in children.
_ _
_The elderly: _
50-75
mg
daily
initially
(For
the
50
mg
dose,
the
25
mg
capsule
is
appropriate). As with any antidepressant, the initial dose should be
increased
with caution under close supervision. Half the normal adult dose may
be
sufficient to produce a satisfactory clinical response.
There may be a latent period of up to two to four weeks from the start
of treatment,
before any improvement in the patient’s depression occurs.
4.3
CONTRAINDICATIONS
Dosulepin is contra-indicated in patients who have had a recent
myocardial infarction
or in patients with heart block of any degree or other cardiac
arrhythmias. It is also
contra-indicated in mania and i