Denzapine 50mg/ml oral suspension

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Clozapine

Mevcut itibaren:

Britannia Pharmaceuticals Ltd

ATC kodu:

N05AH02

INN (International Adı):

Clozapine

Doz:

50mg/1ml

Farmasötik formu:

Oral suspension

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 04020100; GTIN: 5055962500087

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
DENZAPINE
® 50 MG/ML ORAL SUSPENSION
Clozapine
The use of Denzapine is restricted to those patients registered with
the Denzapine Monitoring
Service.
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 possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Denzapine is and what it is used for
2.
What you need to know before you take Denzapine
3.
How to take Denzapine
4.
Possible side effects
5.
How to store Denzapine
6.
Contents of the pack and other information
1.
WHAT DENZAPINE IS AND WHAT IT IS USED FOR
Denzapine contains the active substance clozapine, which belongs to a
group of medicines called
atypical antipsychotics. Antipsychotics are mainly used to treat
schizophrenia. Schizophrenia is a
psychiatric disorder that affects the way a person thinks and behaves.
Denzapine is used:
-
to treat schizophrenia when at least two other antipsychotic
medicines, including one of the
newer atypical antipsychotics, have not worked or have caused severe
side effects
-
to treat psychotic disorders occurring in patients with Parkinson’s
disease, when standard
treatment has failed.
Denzapine is available only with a doctor’s prescription. Ask your
doctor if you have any
questions about why this medicine has been prescribed for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DENZAPINE
Denzapine must not be given to anyone who is unconscious or in a coma.
DO NOT TAKE DENZAPINE:
-
if you are allergic to clozapine or to any of the other ingredients of
this medicine (listed in
section 6). It is important to tell your doctor if

Ürün özellikleri

OBJECT 1
DENZAPINE 50MG/ML ORAL SUSPENSION
Summary of Product Characteristics Updated 14-Jun-2019 | Britannia
Pharmaceuticals 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
Denzapine ®50 mg/ml Oral Suspension
As a consequence of a recent European regulatory initiative, the
Denzapine Summary of Product
Characteristics (SmPC) has been harmonised across Europe. The SmPC
states that blood monitoring
should be carried out in accordance with national-specific official
recommendations. These are
reproduced below.
The Denzapine Monitoring Service (DMS) was developed in order to
manage the risk of agranulocytosis
associated with clozapine. It is available 24 hours a day. When a
monitoring service is not used, evidence
suggests a mortality rate from agranulocytosis of 0.3%[1]. This is
compared to a mortality rate when
clozapine is used in conjunction with a Monitoring Service, of
0.01%[2].
The Denzapine Monitoring Service provides centralised monitoring of
leucocyte and