Molipaxin 100mg Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Trazodone hydrochloride

Available from:

Neuraxpharm Ireland Limited

ATC code:

N06AX; N06AX05

INN (International Name):

Trazodone hydrochloride

Pharmaceutical form:

Capsule, hard

Therapeutic area:

Other antidepressants; trazodone

Authorization status:

Marketed

Authorization date:

1977-02-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MOLIPAXIN 50MG AND 100MG CAPSULES
Trazodone hydrochloride
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone]
FOR HELP
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.
IN THIS LEAFLET:
1. What Molipaxin Capsules are and what they are used for
2. What you need to know before you take Molipaxin Capsules
3. How to take Molipaxin Capsules
4. Possible side effects
5. How to store Molipaxin Capsules
6. Contents of the pack and other information
1. WHAT MOLIPAXIN CAPSULES ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Molipaxin 50mg or 100mg Capsules (called
Molipaxin Capsules
in this leaflet). Molipaxin Capsules contain a medicine called
trazodone hydrochloride. This
belongs to a group of medicines called antidepressants.
Molipaxin Capsules can be used to treat anxiety and depression.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOLIPAXIN CAPSULES
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
•
You are allergic (hypersensitive) to trazodone hydrochloride or any of
the other
ingredients of Molipaxin Capsules (listed in section 6 Contents of the
pack and other
information).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems,
swelling of your lips, face, throat or tongue.
•
You consume alcohol or are taking sleeping tablets.
•
You have recently had a heart attack.
Do not take this medicine if this applies to you. If you are not sure,
talk to your doctor or
pharmacist before taking Molipaxin Capsules.
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH

Summary of Product characteristics

Health Products Regulatory Authority
29 September 2023
CRN00D8TJ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Molipaxin 100mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg trazodone hydrochloride.
Excipients with known effect:
Each capsule contains 159 mg lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule, hard.
Size No. 2 opaque violet/fawn hard gelatin capsules having the code
‘R365C’ imprinted on one piece, the Roussel logo on the
other piece and containing a white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of symptoms in all types of depression including depression
accompanied by anxiety.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults
According to severity, treatment should be initiated at 75 to 150 mg
per day as a single evening dose and then increased to
200 or 300 mg per day, respectively, at the end of the first week. In
hospitalised patients with exceptionally severe depression,
dosage may be further increased to a maximum of 600 mg per day in
divided doses.
Elderly
For very elderly or frail patients, the recommended initial dose is
reduced to 100 mg a day, administered in divided doses or as
a single night time dose (seesection 4.4). This may be incrementally
increased, as described under Adults, under supervision,
according to tolerance and efficacy. In general, single doses above
100 mg should be avoided in these patients. It is unlikely
that a dose of 300 mg per day will be exceeded.
Paediatric population
The safety and efficacy of Molipaxin in children below the age of 18
years has not yet been established therefore Molipaxin is
not recommended for use in this age group.
Hepatic impairment
Trazodone undergoes extensive hepatic metabolism (see section 5.2) and
has also been associated with hepatotoxicity (see
sections 4.4 and 4.8). Therefore caution should be exercised when
prescribing for patients with hepatic impairment, particularly
in cases of