Quetiapine Fair-Med Starterpack

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Quetiapine; Quetiapine; Quetiapine

Available from:

Fairmed Healthcare GmbH

ATC code:

N05AH; N05AH04

INN (International Name):

Quetiapine; Quetiapine; Quetiapine

Dosage:

25 mg /100 mg/200 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Diazepines, oxazepines, thiazepines and oxepines; quetiapine

Authorization status:

Not marketed

Authorization date:

2012-07-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
QUETIAPINE FAIR-MED 25 MG FILM-COATED TABLETS
QUETIAPINE FAIR-MED 100 MG FILM-COATED TABLETS
QUETIAPINE FAIR-MED 150 MG FILM-COATED TABLETS
QUETIAPINE FAIR-MED 200 MG FILM-COATED TABLETS
QUETIAPINE FAIR-MED 300 MG FILM-COATED TABLETS
QUETIAPINE FAIR-MED STARTERPACK, FILM-COATED TABLETS
Quetiapine
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, 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, pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Quetiapine Fair-Med is and what it is used for
2. What you need to know before you take Quetiapine Fair-Med
3. How to take Quetiapine Fair-Med
4. Possible side effects
5. How to store Quetiapine Fair-Med
6. Contents of the pack and other information
1.
WHAT QUETIAPINE FAIR-MED IS AND WHAT IT IS USED FOR
Quetiapine Fair-Med
contains a substance called quetiapine. This belongs to a group of
medicines
called anti-psychotics. Quetiapine Fair-Med can be used to treat
several illnesses, such as:

Bipolar depression: where you feel sad. You may find that you feel
depressed, feel guilty,
lack energy, lose your appetite or can’t sleep.

Mania: where you may feel very excited, elated, agitated, enthusiastic
or hyperactive or
have poor judgment including being aggressive or disruptive.

Schizophrenia: where you may hear or feel things that are not there,
believe things that
are not true or feel unusually suspicious, anxious, confused, guilty,
tense or depressed.
Your doctor may continue to prescribe Quetiapine Fair-Med even when
you are feeling better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUETIAPINE FAIR-MED
DO NOT

Summary of Product characteristics

Health Products Regulatory Authority
14 October 2021
CRN00CKCF
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Quetiapine Fair-Med Starterpack
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
StarterPack contains 6 tablets of quetiapine (as quetiapine fumarate)
of 25 mg, 3 tablets of 100mg and 1 tablet of 200 mg
Excipient(s) with known affect: Lactose monohydrate and Sunset yellow
(E110)
Each 25 mg film-coated tablet contains 7.00mg of lactose monohydrate
and 0.003 mg of Sunset yellow (E110)
Each 100 mg film-coated tablet contains 28.00mg of lactose monohydrate
Each 200 mg film coated tablet contains 56.00mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Quetiapine Fair-Med 25 mg: Peach, round, biconvex film coated tablets
with a diameter of approximately 5.7mm.
Quetiapine Fair-Med 100 mg: Yellow, round, biconvex film coated
tablets with a score line on one side and a diameter of
approximately 9.1mm.
Quetiapine Fair-Med 200 mg: White, round, biconvex film coated tablets
with a score line on one side and a diameter of
approximately 12.1mm.
The 100 mg and 200 mg tablets can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Quetiapine Fair-Med is indicated for:

treatment of schizophrenia.

treatment of bipolar disorder:
o
For the treatment of moderate to severe manic episodes in bipolar
disorder For the treatment of major
depressive episodes in bipolar disorder For the prevention of
recurrence of manic or depressed episodes in
patients with bipolar disorder who previously responded to quetiapine
treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Different dosing schedules exist for each indication. It must
therefore be ensured that patients receive clear information on the
appropriate dosage for their condition.
Quetiapine Fair-Med can be administered with or without food.
_Adults: _
FOR THE TREATMENT OF SCHIZOPHRENIA
For the treatment of schizophrenia, Quetiapine Fair-Med should be
adm