Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Paracetamol; Caffeine; Codeine phosphate
Chefaro Ireland DAC
N02AJ; N02AJ06
Paracetamol; Caffeine; Codeine phosphate
500 mg/30 mg/8 milligram(s)
Film-coated tablet
Product not subject to medical prescription
Opioids in combination with non-opioid analgesics; codeine and paracetamol
Not marketed
2002-09-27
PATIENT INFORMATION LEAFLET: Information for the user Veganin Plus Tablets Paracetamol 500 mg; Caffeine 30 mg; Codeine Phosphate 8 mg 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. • Ask your pharmacist if you need more information or advice. • 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 without prescription. However, you still need to use Veganin Plus carefully to get the best results from it. This medicine can only be used for the short-term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. You should only take this product for a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice. This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it. If you take this medicine for headaches for more than three days it can make them worse. What is in this leaflet 1. What Veganin Plus is and what it is used for 2. What you need to know before you take Veganin Plus 3. How to take Veganin Plus 4. Possible side effects 5. How to store Veganin Plus 6. Contents of the pack and other information 1. What Veganin Plus is and what it is used for Veganin Plus can be used in patients over 12 years of age for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol, or ibuprofen alone. It is suitable for the treatment of migraine, headache, rheumatic pain, period pain, toothache and neuralgia. Veganin Plus is a tablet containing paracetamol, caffeine and codeine phosphate. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. Paracetamo Läs hela dokumentet
Health Products Regulatory Authority 10 October 2022 CRN00CFDF Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Veganin Plus Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Paracetamol 500 mg, Codeine Phosphate hemihydrate 8 mg and Caffeine 30 mg. For excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, capsule-shaped tablet with dimensions of 17.55 mm x 7.5 mm and debossed on one face to read PCC. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Codeine-containing products are indicated in patients older than 12 years of age for the short-term treatment of acute moderate pain which is not relieved by other analgesics such as paracetamol or ibuprofen alone. Suitable for migraine, headache, rheumatic pain, period pain, toothache and neuralgia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ADULTS:_ 2 tablets taken with water every 4-6 hours. No more than 8 tablets in 24 hours. _ _ _ADOLESCENTS AGED 16 - 18 YEARS OF AGE: _ 1-2 tablets taken with water every 6 hours when necessary. Not more than 8 tablets in 24 hours. _Paediatric population:_ _CHILDREN AGED 12 - 15 YEARS:_ 1 tablet taken with water every 6 hours when necessary. Not more than 4 tablets in 24 hours. _CHILDREN AGED LESS THAN 12 YEARS:_ Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see sections 4.3 and 4.4). _ _ Do not exceed the stated dose. The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician. _ _ _Elderly patients _ Experience has indicated that normal adult dose of paracetamol is usually appropriate. However in frail, immobile, elderly subjects or in elderly patients with renal or hepatic impairment, a reduction in the amount or frequency of dosing may be appropriate. The maximum daily dose of paracetamol should not excee Läs hela dokumentet