Dosulepin 25mg capsules

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Dosulepin hydrochloride

Доступна с:

Viatris UK Healthcare Ltd

код АТС:

N06AA16

ИНН (Международная Имя):

Dosulepin hydrochloride

дозировка:

25mg

Фармацевтическая форма:

Oral capsule

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 04030100; GTIN: 5016695300467

тонкая брошюра

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,

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
DOSULEPIN CAPSULES 25 MG
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dosulepin Hydrochloride BP (Dosulepin) 25 mg
3
PHARMACEUTICAL FORM
Capsules
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
Dosulepin Capsules 25mg are for oral administration.
_ADULTS _
Initially 25 mg three times daily, gradually increasing the dosage to
50mg three times
daily, if necessary, or 75 - 150mg as a single night-time dose. In
certain
circumstances, e.g. in hospital use for severely depressed patients,
dosages up to 225
mg daily have been used.
_ELDERLY _
50 - 75 mg daily initially. Half the normal adult maintenance dose may
be sufficient
to produce a satisfactory clinical response.
4.3
CONTRAINDICATIONS
Recent Myocardial Infarction. Any degree of heart block of other
cardiac
arrhythmias. Mania. Severe Liver Disease.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
TOXICITY IN OVERDOSE
Dosulepin is associated with high mortality in overdose. There is a
low margin
of safety between the (maximum) therapeutic dose and potentially fatal
doses.
Onset of toxicity occurs within 4-6 hours.
-
A limited number of capsules should be prescribed to reduce the risk
from
overdose for all patients and especially for patients at risk of
suicide.
-
A maximum prescription equivalent to two weeks supply of 75mg/day
should be considered in patients with increased risk factors for
suicide at
initiation of treatment, during any dosage adjustment and until
improvement occurs.
-
Avoid concomitant medications which may increase the risk