Mintreleq XL 50mg tablets

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Quetiapine fumarate

Pieejams no:

Aristo Pharma Ltd

ATĶ kods:

N05AH04

SNN (starptautisko nepatentēto nosaukumu):

Quetiapine fumarate

Deva:

50mg

Zāļu forma:

Modified-release tablet

Ievadīšanas:

Oral

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 04020100; GTIN: 5060430040002

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
MINTRELEQ XL 50 MG, 150 MG, 200 MG, 300 MG, 400 MG PROLONGED-RELEASE
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 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. See section 4.
WHAT IS IN THIS LEAFLET
1. What Mintreleq XL is and what it is used for
2. What you need to know before you take Mintreleq XL
3. How to take Mintreleq XL
4. Possible side effects
5. How to store Mintreleq XL
6. Contents of the pack and other information
1.
WHAT MINTRELEQ XL IS AND WHAT IT IS USED FOR
Mintreleq XL contains a substance called quetiapine. This belongs to a
group of medicines
called antipsychotics. Mintreleq XL can be used to treat several
illnesses, such as:
Bipolar depression and major depressive episodes in major depressive
disorder: 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.
When Mintreleq XL is being taken to treat major depressive episodes in
major depressive
disorder, it will be taken in addition to another medicine being used
to treat this illness.
Your doctor may continue to prescribe Mintreleq XL even when you feel
better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MINTRELEQ XL
DO NOT TAKE MINTRELEQ XL
If you are allergic to quetiapine or

Produkta apraksts

OBJECT 1
MINTRELEQ XL 50 MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 09-May-2017 | Aristo Pharma
Limited
1. Name of the medicinal product
Mintreleq XL 50 mg prolonged-release tablets
Mintreleq XL 150 mg prolonged-release tablets
Mintreleq XL 200 mg prolonged-release tablets
Mintreleq XL 300 mg prolonged-release tablets
Mintreleq XL 400 mg prolonged-release tablets
2. Qualitative and quantitative composition
Mintreleq XL 50 mg contains 50 mg quetiapine (as quetiapine fumarate)
Excipient with known effect: 14 mg lactose (anhydrous) per tablet
Mintreleq XL 150 mg contains 150 mg quetiapine (as quetiapine
fumarate)
Excipient with known effect: 42 mg lactose (anhydrous) per tablet
Mintreleq XL 200 mg contains 200 mg quetiapine (as quetiapine
fumarate)
Excipient with known effect: 56 mg lactose (anhydrous) per tablet
Mintreleq XL 300 mg contains 300 mg quetiapine (as quetiapine
fumarate)
Excipient with known effect: 85 mg lactose (anhydrous) per tablet
Mintreleq XL 400 mg contains 400 mg quetiapine (as quetiapine
fumarate)
Excipient with known effect: 113 mg lactose (anhydrous) per tablet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet
Mintreleq XL 50 mg: a white to off white, round biconvex tablet, 7.1
mm in diameter and 3.2 mm in
thickness, engraved with “50” on one side.
Mintreleq XL 150 mg: a white to off white, oblong biconvex tablet,
13.6 mm in length, 6.6 mm in width
and 4.2 mm in thickness, engraved with “150” on one side.
Mintreleq XL 200 mg: a white to off white, oblong biconvex tablet,
15.2 mm in length, 7.7 mm in width
and 4.8 mm in thickness, engraved with “200” on one side.
Mintreleq XL 300 mg: a white to off white, oblong biconvex tablet,
18.2 mm in length, 8.2 mm in width
and 5.4 mm in thickness, engraved with “300” on one side.
Mintreleq XL 400 mg: a white to off white, oval biconvex tablet, 20.7
mm in length, 10.2 mm in width
and 6.3 mm in thickness, engraved with “400” on one side.
4. Clinical particular