Sycrest 10mg sublingual tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Asenapine maleate

Disponibil de la:

Lundbeck Ltd

Codul ATC:

N05AH05

INN (nume internaţional):

Asenapine maleate

Dozare:

10mg

Forma farmaceutică:

Sublingual tablet

Calea de administrare:

Sublingual

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 04020300; GTIN: 5702157141586

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SYCREST® 5 MG SUBLINGUAL TABLETS
SYCREST® 10 MG SUBLINGUAL TABLETS
asenapine
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 or
nurse.
-
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 or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sycrest is and what it is used for
2.
What you need to know before you take Sycrest
3.
How to take Sycrest
4.
Possible side effects
5.
How to store Sycrest
6.
Contents of the pack and other information
1.
WHAT SYCREST IS AND WHAT IT IS USED FOR
Sycrest contains the active substance asenapine. This medicine belongs
to a group of medicines called
antipsychotics. Sycrest is used to treat moderate to severe manic
episodes associated with bipolar I
disorder in adults. Antipsychotic medicines affect the chemicals that
allow communication between
nerve cells (neurotransmitters). Illnesses that affect the brain, such
as bipolar I disorder, may be due to
certain chemicals in the brain, such as dopamine and serotonin, being
out of balance and these
imbalances may cause some of the symptoms you may be experiencing.
Exactly how this medicine
works is unknown, however, it is believed to adjust the balance of
these chemicals.
Manic episodes associated with bipolar I disorder is a condition with
symptoms such as feeling “high”,
having excessive amounts of energy, needing much less sleep than
usual, talking very quickly with
racing ideas and sometimes severe irritability.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SYCREST
DO NOT TAKE SYCREST
If you are allergic to asenapine or any of the other ingredients of
this medicine (lis

Caracteristicilor produsului

OBJECT 1
SYCREST 10MG SUBLINGUAL TABLETS
Summary of Product Characteristics Updated 18-Dec-2018 | Lundbeck
Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Sycrest
®
5 mg and 10 mg sublingual tablets
2. Qualitative and quantitative composition
Each sublingual tablet contains 5 mg or 10 mg asenapine (as maleate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Sublingual tablet
5 mg: Round, white to off-white, sublingual tablets debossed with
“5” on one side.
10 mg: Round, white to off-white, sublingual tablets debossed with
“10” on one side.
4. Clinical particulars
4.1 Therapeutic indications
Sycrest is indicated for the treatment of moderate to severe manic
episodes associated with bipolar I
disorder in adults.
4.2 Posology and method of administration
Posology
The recommended starting dose of Sycrest as monotherapy is 5 mg twice
daily. One dose should be taken
in the morning and one dose should be taken in the evening. The dose