Dosulepin 25mg capsules

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Dosulepin hydrochloride

Saadav alates:

Phoenix Healthcare Distribution Ltd

ATC kood:

N06AA16

INN (Rahvusvaheline Nimetus):

Dosulepin hydrochloride

Annus:

25mg

Ravimvorm:

Oral capsule

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 04030100

Infovoldik

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,

Toote omadused

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
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 150 mg daily after a few days if required. In certain
circumstances, e.g.
under hospital conditions, dosages up to 225 mg daily have been used.
_ _
_Children _
Not recommended.
_ _
_Elderly: _
50-75 mg daily initially. The initial dose should be increased with
caution under
close supervision.
A satisfactory clinical response may be seen when half the normal
adult dose is
administered.
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 in severe liver disease.
Hypersensitivity to dosulepin or
to any of the excipients LISTED IN SECTION 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Toxicity in overdose
Dosulepin is associated with high mortality in over