Molipaxin 50mg capsules

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:

50mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030100; GTIN: 5013841101558

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE
USER
MOLIPAXIN 50MG AND 100MG
CAPSULES
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 Capsules are and what they
are used for
2. 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 AR
E USED FOR
The name of your medicine is Molipaxin 50mg
or 100mg C
apsules (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. BEFORE YOU TAKE MOLIPAXIN CAPSULES
DO NOT TAKE THIS MEDICINE AND TELL YOUR
DOCTOR IF YOU:
•
are allergic to trazodone hydrochloride or
any of the other ingredients of Molipaxin
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 Molipaxin
Capsules.
TAKE SPECIAL CARE WITH MOLIPAXIN CAPSULES
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Molipaxin 50mg Capsules / Trazodone Hydrochloride 50mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Trazodone hydrochloride 50 mg per capsule.
Excipients with known effect:
Each tablet contains 78.3 mg lactose.
For a full list of 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
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 100mg should be avoided in
these patients.
It is unlikely that 300mg/day will be exceeded.
Children:
There are insufficient data on safety to recommend the use of
Molipaxin/Trazodone
in
children below the age of 18 years.
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 after a
meal.
_Hepatic Impairment: _
Molipaxin/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. Periodic
monitoring of liver
function may be considered.
_Renal Impairment: _