Trazodone 100mg capsules

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Trazodone hydrochloride

Հասանելի է:

Zentiva Pharma UK Ltd

ATC կոդը:

N06AX05

INN (Միջազգային անվանումը):

Trazodone hydrochloride

Դոզան:

100mg

Դեղագործական ձեւ:

Oral capsule

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 04030100; GTIN: 5000283608356

Տեղեկատվական թերթիկ

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAZODONE HYDROCHLORIDE
50MG AND 100MG CAPSULES
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 any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What trazodone is and what it is used for
2. Before you take trazodone
3. How to take trazodone
4. Possible side effects
5. How to store trazodone
6. Further information
1. WHAT TRAZODONE IS AND WHAT IT IS
USED FOR
The name of your medicine is Trazodone
Hydrochloride 50mg or 100mg Capsules
(called trazodone in this leaflet). This
belongs to a group of medicines called
antidepressants.
Trazodone can be used to treat anxiety and
depression.
2. BEFORE YOU TAKE TRAZODONE
Do not take this medicine and tell your doctor
if you:
• are allergic to trazodone or any of the other
ingredients of these capsules (listed in
section 6).
Signs of an allergic reaction can include:
a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue.
• have recently had a heart attack.
• are a heavy drinker or are taking sleeping
tablets.
• are under 18 years of age.
Do not take this medicine if any of the above
applies to you. If you are not sure, talk to your
doctor or pharmacist before taking trazodone.
TAKE SPECIAL CARE WITH TRAZODONE
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,
since these medicines all take time to work,
usually about two weeks but sometimes
longer.
You may be more likely to think like this if you:
•

Ապրանքի հատկությունները

OBJECT 1
TRAZODONE 100MG CAPSULES
Summary of Product Characteristics Updated 14-Jan-2021 | Zentiva
•
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 Fertility, 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
Molipaxin 100 mg Capsules/Trazodone hydrochloride 100 mg Capsules
2. Qualitative and quantitative composition
Trazodone hydrochloride 100mg per capsule.
For excipients see 6.1
3. Pharmaceutical form
Capsules.
4. Clinical particulars
4.1 Therapeutic indications
Anxiety, depression, mixed anxiety and depression.
4.2 Posology and method of administration
Route of administration: Oral.
DEPRESSION:
_Adults:_
Initially 150mg/day in divided doses after food or as a single dose on
retiring.
This may be increased up to 300mg/day in a single or divided doses.
The major portion of a divided dose to
be taken on retiring. The dose may be further increased to 600mg/day
in divided doses in hospitalised
patients.
_Elderly:_
For very elderly or frail patients, the recommended initial starting
dose is reduced to 100 mg/day given in
divided dose