Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cyclizine hydrochloride; Dipipanone hydrochloride
Amdipharm Plc
R06AE53
Cyclizine hydrochloride; Dipipanone hydrochloride
30mg ; 10mg
Oral tablet
Oral
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 5060064170243
28053804 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. The name of your medicine is Dipipanone/Cyclizine 10mg/30mg Tablets. It will be referred to as Dipipanone/Cyclizine Tablets for ease hereafter. WHAT IS IN THIS LEAFLET 1. What Dipipanone/Cyclizine Tablets are and what they are used for 2. What you need to know before you take Dipipanone/Cyclizine Tablets 3. How to take Dipipanone/Cyclizine Tablets 4. Possible side effects 5. How to store Dipipanone/Cyclizine Tablets 6. Contents of the pack and other information 1. WHAT DIPIPANONE/CYCLIZINE TABLETS ARE AND WHAT THEY ARE USED FOR Dipipanone/Cyclizine Tablets contain the active ingredients dipipanone hydrochloride and cyclizine hydrochloride. Dipipanone hydrochloride belongs to a group of medicines called opioid analgesics and is used for pain relief. Cyclizine hydrochloride belongs to a group of medicines called anti-emetics which reduce any nausea and vomiting that may occur. Dipipanone/Cyclizine Tablets are used to relieve moderate to severe pain and nausea in certain medical or surgical situations. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIPIPANONE/CYCLIZINE TABLETS DO NOT TAKE DIPIPANONE/CYCLIZINE TABLETS: • if you are allergic to dipipanone hydrochloride, cyclizine hydrochloride or any of the other ingredients of this medicine (listed in section 6) • if you have allergic reactions which include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing • if Lugege kogu dokumenti
OBJECT 1 DICONAL TABLETS Summary of Product Characteristics Updated 06-Aug-2018 | ADVANZ Pharma • 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 Diconal 10 mg + 30 mg Tablets. Dipipanone/Cyclizine 10 mg/30 mg Tablets. 2. Qualitative and quantitative composition Each tablet contains 10 mg of Dipipanone Hydrochloride and 30 mg of Cyclizine Hydrochloride Excipient with known effect: Lactose: 91.666 mg For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet coloured deep pink, scored and coded 'F3A' The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. Clinical particulars 4.1 Therapeutic indications Diconal Tablets are indicated for the management of moderate to severe pain in medical and surgical conditions in which morphine may be indicated. Cyclizine is effective in preventing nausea and vomiting associated with the administration of narcotic analgesics. 4.2 Posology and method of administration Lugege kogu dokumenti