Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Mirtazapine
Organon Pharma (UK) Ltd
N06AX11
Mirtazapine
15mg
Orodispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400; GTIN: 5013257001961 5013257001947
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZISPIN SOLTAB® 15 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 Read the complete document
OBJECT 1 ZISPIN SOLTAB 15MG 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 Read the complete document