Dosulepin 25mg capsules

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Dosulepin hydrochloride

Beszerezhető a:

Strides Pharma UK Ltd

ATC-kód:

N06AA16

INN (nemzetközi neve):

Dosulepin hydrochloride

Adagolás:

25mg

Gyógyszerészeti forma:

Oral capsule

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 04030100; GTIN: 5031676002697

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
DOSULEPIN CAPSULES 25MG AND TABLETS 75MG
Dosulepin hydrochloride
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, pharmacist or
nurse.
•
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.
WHAT IS IN THIS LEAFLET
:
1. What Dosulepin is and what it is used for
2. What you need to know before you take Dosulepin Capsules and
Tablets
3. How to take Dosulepin Capsules and Tablets
4. Possible side effects
5. How to store Dosulepin Capsules and Tablets
6. Contents of the pack and other information
1. WHAT DOSULEPIN IS AND WHAT IT IS USED FOR
Dosulepin hydrochloride belongs to a group of medicines called
antidepressants. Dosulepin Capsules
and Tablets are used to treat depression and can also help reduce
feelings of anxiety. Your doctor has
prescribed dosulepin as other medicines are unsuitable for you. Please
ask you doctor or pharmacist
if you need more information.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOSULEPIN CAPSULES AND
TABLETS
DO NOT TAKE DOSULEPIN CAPSULES AND TABLETS IF:
•
You know that you are allergic (hypersensitive) to dosulepin or any of
the other ingredients
(listed in section 6 of this leaflet)
•
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
or enlarged prostate)
•
You have been diagnosed as having mania (feeling overexcited with
unusual behaviour)
•
You have fits (epilepsy). Not for use in children.
THOUGHTS OF SUICIDE AND WORSENING OF YOUR DEPRESSION OR ANXIETY

Termékjellemzők

OBJECT 1
DOSULEPIN CAPSULES 25MG
Summary of Product Characteristics Updated 09-Jan-2023 | Strides
Pharma UK Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Thaden Capsules 25mg
Dosulepin Capsules 25mg
2. Qualitative and quantitative composition
Each capsule contains 25mg dosulepin hydrochloride
Excipient(s) with known effects
Each capsule contains 130 mg of lactose monohydrate.
Each capsule contains 0.27 mg of ponceau 4R (E124).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule
A white powder encapsulated within an opaque number 3 capsule with a
red body and a red cap. “TH” is
printed on the cap and “25” is printed on the body in white ink.
4. Clinical particulars
4.1 Therapeutic indications
Dosulepin hydrochloride 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
alt