Molipaxin 150mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Trazodone hydrochloride

Available from:

Zentiva Pharma UK Ltd

ATC code:

N06AX05

INN (International Name):

Trazodone hydrochloride

Dosage:

150mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100; GTIN: 5013841101572

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE
USER
MOLIPAXIN 150MG TABLETS
Trazodone hydrochloride
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
(see section 4).
IN THIS LEAFLET:
1. What Molipaxin Tablets are and what they
are used for
2. 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 AR
E USED FOR
The name of your medicine is Molipaxin
150mg T
ablets (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. BEFORE YOU TAKE MOLIPAXIN TABLETS
DO NOT TAKE THIS MEDICINE AND TELL YOUR
DOCTOR IF YOU:
•
are allergic to trazodone hydrochloride or
any of the other ingredients of Molipaxin
Tablets (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 Molipaxin
Tablets.
TAKE SPECIAL CARE WITH MOLIPAXIN TABLETS
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Molipaxin 150mg Tablets
Trazodone Hydrochloride 150mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablet containing 150 mg of trazodone hydrochloride.
Excipients with known effect:
Each tablet contains 97.65 mg lactose.
For a full list of excipients, see 6.1
3
PHARMACEUTICAL FORM
Tablets.
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
Route of administration: Oral.
DEPRESSION:
a) 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.
b) Elderly:
For very elderly or frail patients the recommended initial starting
dose is reduced to
100mg/day given in divided doses or as a single night-time dose (see
section 4.4).
This may be incrementally increased, under supervision, according to
efficacy and
tolerance. In general, single doses above 100 mg should be avoided in
these patients.
It is unlikely that 300mg/day will be exceeded.
Children:
Molipaxin/Trazodone hydrochloride is not recommended for use in
children below
the age of 18 years due to a lack of data on safety.
DEPRESSION ACCOMPANIED BY ANXIETY:
As for depression.
ANXIETY:
75mg/day increasing to 300mg/day as necessary.
A decrease in side-effects (increase of the resorption and decrease of
the peak plasma
concentration) can be reached by taking Molipaxin/Trazodone
hydrochloride after a
meal..
_Hepatic Impairment: _
Molipaxin/Trazodone hydrochloride 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 hepat