Zispin SolTab 30mg orodispersible tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mirtazapine

Available from:

DE Pharmaceuticals

ATC code:

N06AX11

INN (International Name):

Mirtazapine

Dosage:

30mg

Pharmaceutical form:

Orodispersible tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030400

Patient Information leaflet

PATIENT INFORMATION LEAFLET
ZISPIN
® SOLTAB
® 30 MG ORODISPERSIBLE TABLETS
MIRTAZAPINE 30 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.
This medicine is available using any of the above names but will be
referred to as Zispin SolTab throughout this leaflet.
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 DOCTO

Summary of Product characteristics

OBJECT 1
ZISPIN SOLTAB 30MG ORODISPERSIBLE
TABLETS
Summary of Product Characteristics Updated 23-Oct-2019 | Merck Sharp &
Dohme 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