Dosulepin 25mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dosulepin hydrochloride

Available from:

Actavis UK Ltd

ATC code:

N06AA16

INN (International Name):

Dosulepin hydrochloride

Dosage:

25mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100; GTIN: 5012617008695

Patient Information leaflet

DOSULEPIN
CAPSULES 25 MG
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 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.
1. WHAT DOSULEPIN IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE DOSULEPIN
3. HOW TO TAKE DOSULEPIN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DOSULEPIN
6. FURTHER INFORMATION
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.
BEFORE YOU TAKE DOSULEPIN
DO NOT TAKE DOSULEPIN 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 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).
Dosulepin should not be given to children.
TAKE SPECIAL CARE WITH DOSULEPIN IF:
- you are going to have general or dental
surgery, tell your surgeon you are taking
Dosulepin. It may affect the anaesthetic
used.
THOUGHTS OF SUICIDE AND WORSENING OF YOUR
DEPRESSION OR ANXIETY DISORDER
If you are depressed and/or have anxiety
disorders you can sometimes have thoughts
of harming or killing yourself. These may be
increased when first starting antidepressants,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dosulepin 25mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains dosulepin hydrochloride 25 mg.
Excipient(s) with known effect
Each capsule contains 153 mg of lactose monohydrate. For the full list
of excipients,
see section 6.1.
3
PHARMACEUTICAL FORM
Size 4 orange/caramel capsules marked ‘MP75’ and ‘25mg’
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
Posology
_Adults _
Initially 75 mg/day in divided doses or as a single dose at night,
increasing to 150
mg/day. In certain circumstances, e.g. in hospital use, dosages up to
225 mg daily
have been used. Suggested regimens: 25 or 50 mg three times daily or,
alternatively,
75 or 150 mg as a single dose at night. Should the regimen of 150 mg
as a single
night-time dose be adopted, it is better to give a smaller dose for
the first few days.
_Use in the elderly: _
50-75 mg daily initially. 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.
It has been found that, in certain cases of depression, the daily dose
of dosulepin given
as a single night-time dose is more effective and even better
tolerated than the
conventional divided day-time dosage. There is evidence that this
single bed-time dose
improves the sleep pattern of the depressed patient.
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 d