Molipaxin 150mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Trazodone hydrochloride

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

N06AX; N06AX05

INN (International Name):

Trazodone hydrochloride

Dosage:

150 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antidepressants; trazodone

Authorization status:

Marketed

Authorization date:

1985-12-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MOLIPAXIN 150MG TABLETS
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 Tablets are and what they are used for
2. What you need to know before you take Molipaxin Tablets
3. How to take Molipaxin Tablets
4. Possible side effects
5. How to store Molipaxin Tablets
6. Contents of the pack and other information
1. WHAT MOLIPAXIN TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Molipaxin 150mg Film-coated Tablets
(called Molipaxin Tablets
in this leaflet). Molipaxin Tablets contain a medicine called
trazodone hydrochloride. This
belongs to a group of medicines called antidepressants.
Molipaxin Tablets can be used to treat anxiety and depression.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOLIPAXIN TABLETS
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 Tablets (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 Tablets.
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH MOLIPAXIN TABLETS
THOU

Summary of Product characteristics

Health Products Regulatory Authority
31 March 2022
CRN00CTT6
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Molipaxin 150mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains trazodone hydrochloride 150.0 mg.
Excipients with known effect:
Each tablet contains 97.65 mg lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated Tablets.
Salmon-pink bi-convex tablet, 11mm in diameter. One side has a
breakline and the other is embossed ‘Molipaxin’ and ‘150’.
The tablet can be divided into equal halves.
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
The usual initial daily dose is 75 to 150 mg as a single evening dose
or in divided doses after food during the day, with
subsequent slow increments to the level of optimal control which may
be as high as 600 mg. Doses above 300 mg should only
be administered to hospitalised patients.
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 (see section 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 severe hepatic impairment.