Dosulepin 25mg capsules

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Dosulepin hydrochloride

Dostupno od:

Teva UK Ltd

ATC koda:

N06AA16

INN (International ime):

Dosulepin hydrochloride

Doziranje:

25mg

Farmaceutski oblik:

Oral capsule

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 04030100; GTIN: 5017007113027

Uputa o lijeku

DOSULEPIN
CAPSULES 25 MG
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.
1. What Dosulepin is and what it is used for
2. What you need to know before you take
Dosulepin
3. How to take Dosulepin
4. Possible side effects
5. How to store Dosulepin
6. Content of the pack and other 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.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE DOSULEPIN
DO NOT TAKE DOSULEPIN CAPSULES AND SPEAK
TO YOUR DOCTOR:
- if you know that you are allergic to
dosulepin or any of the other ingredients of
this medicine (listed in section 6)
- if you have an irregular heart beat or any
other heart problems
- if you have liver problems
- if you have an eye condition known as
glaucoma
- if you are a man that has prostate problems
(difficulty in passing water)
- if you have been diagnosed as having
mania (feeling over-excited with unusual
behaviour)
- if you have fits (epilepsy).
Dosulepin should not be given to children.
WARNINGS AND PRECAUTIONS
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

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dosulepin 25mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25 mg dosulepin hydrochloride.
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules
Brown/pink gelatin capsules containing a white powder, printed BERK
3D2
25, or 3D2 25.
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 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.
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.
_ _
_ _
_ Paediatric _
_ population_
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.
Method of administration
For oral administration.
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