Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Duloxetine hydrochloride
DE Pharmaceuticals
N06AX21
Duloxetine hydrochloride
30mg
Gastro-resistant capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400
1. WHAT DULOXETINE IS AND WHAT IT IS USED FOR This medicine contains the active substance duloxetine. Duloxetine increases the levels of serotonin and noradrenaline in the nervous system. Duloxetine is used in adults to treat: • depression • generalised anxiety disorder (chronic feeling of anxiety or nervousness) • diabetic neuropathic pain (often described as burning, stabbing, stinging, shooting or aching or like an electric shock. There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain) Duloxetine starts to work in most people with depression or anxiety within two weeks of starting treatment, but it may take 2-4 weeks before you feel better. Tell your doctor if you do not start to feel better after this time. Your doctor may continue to give you Duloxetine when you are feeling better to prevent your depression or anxiety from returning In people with diabetic neuropathic pain it can take some weeks before you feel better. Talk to your doctor if you do not feel better after 2 months. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DULOXETINE Do not take Duloxetine if you: • are allergic to Duloxetine or any of the other ingredients of this medicine (listed in section 6). 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 Duloxetine is and what it is used for 2. What you need to know before you take Duloxetine 3. How to take Duloxetine 4. Possible side effects 5. How to store Duloxetine 6. Contents of the pack and other informa Leggi il documento completo
OBJECT 1 DULOXETINE 30MG GASTRO-RESISTANT CAPSULES Summary of Product Characteristics Updated 29-Nov-2018 | Consilient Health Ltd • 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 Duloxetine 30 mg gastro-resistant capsules 2. Qualitative and quantitative composition Each hard gastro-resistant capsule contains 30 mg duloxetine (as duloxetine hydrochloride). Excipient with known effect: sucrose. Each 30 mg capsule contains 40.1 mg 43.4 mg sucrose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Gastro-resistant capsule, hard White to almost white pellets in a hard gelatine capsule size 3. The capsule body is white and the cap dark blue. The capsule body is imprinted with 30 in black. 4. Clinical particulars 4.1 Therapeutic indications Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Duloxetine is indicated in adults. For further information see section 5.1. 4.2 Po Leggi il documento completo