Zispin SolTab 45mg orodispersible tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Mirtazapine

제공처:

Organon Pharma (UK) Ltd

ATC 코드:

N06AX11

INN (International Name):

Mirtazapine

복용량:

45mg

약제 형태:

Orodispersible tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 04030400; GTIN: 5013257001923

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZISPIN SOLTAB® 45 MG ORODISPERSIBLE TABLETS
mirtazapine
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 Zispin SolTab is and what it is used for
2.
What you need to know before you take Zispin SolTab
3.
How to take Zispin SolTab
4.
Possible side effects
5.
How to store Zispin SolTab
6.
Contents of the pack and other information
1.
WHAT ZISPIN SOLTAB IS AND WHAT IT IS USED FOR
Zispin SolTab is one of a group of medicines called
ANTIDEPRESSANTS
.
Zispin SolTab is used to treat depressive illness in adults.
Zispin SolTab will take 1 to 2 weeks before it starts working. After 2
to 4 weeks you may start feeling
better. You must talk to your doctor if you do not feel better or if
you feel worse after 2 to 4 weeks.
More information is in section 3 heading “When can you expect to
start feeling better”.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZISPIN SOLTAB
DO NOT TAKE ZISPIN SOLTAB:
•
if you are allergic to mirtazapine or any of the other ingredients of
this medicine (listed in
section 6). If so, you must talk to your doctor as soon as you can
before taking Zispin SolTab.
•
if you are taking or have recently taken (within the last two weeks)
medicines called
monoamine oxidase inhibitors (MAO-Is).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Zispin SolTab.
TELL YOUR DOCTOR BEFORE TAKING ZISPIN SOLTAB:
If you have ever developed a severe skin rash or skin peeling,
blistering and/or mouth sores after
taking Zispin SolT

제품 특성 요약

OBJECT 1
ZISPIN SOLTAB 45MG ORODISPERSIBLE
TABLETS
Summary of Product Characteristics Updated 04-Oct-2022 | Organon
Pharma (UK) 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
Zispin SolTab® 15 mg orodispersible tablets
Zispin SolTab® 30 mg orodispersible tablets
Zispin SolTab® 45 mg orodispersible tablets
2. Qualitative and quantitative composition
Each Zispin SolTab 15 mg orodispersible tablet contains 15 mg of
mirtazapine.
Each Zispin SolTab 30 mg orodispersible tablet contains 30 mg of
mirtazapine.
Each Zispin SolTab 45 mg orodispersible tablet contains 45 mg of
mirtazapine.
Excipient(s) with known effect
Each Zispin SolTab 15 mg orodispersible tablet contains 4.65 mg
aspartame and 28 mg sucrose.
Each Zispin SolTab 30 mg orodispersible tablet contains 9.30 mg
aspartame and 56 mg sucrose.
Each Zispin SolTab 45 mg orodispersible tablet contains 13.95 mg
aspartame and 84 mg sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Orod