Country: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
DE Pharmaceuticals
N02BE01
Paracetamol
500mg
Suppository
Rectal
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100
L I M I T E D L I M I T E D _Colours_ _(Printed)_ _Title:_ _Ref:_ _Date:_ _Size (mm):_ _Modified:_ Paracetamol 500mg Suppositories PIL - Patient Information Leaflet 05/01/16 265(W) x 360(H) 18/04/19 _Colours_ _(Non printed)_ PROCESS BLACK REFERENCE TRIM REFERENCE PERF PACKAGE LEAFLET: INFORMATION FOR THE USER PARACETAMOL 500MG SUPPOSITORIES PARACETAMOL Number of Suppositories 1 1 or 2 Minimum Length of time between doses 4 – 6 hours 4 – 6 hours Maximum number of suppositories in 24 hours 4 8 WHAT IS IN THIS LEAFLET 1. What Paracetamol Suppositories are and what they are used for 2. What you need to know before you use Paracetamol Suppositories 3. How to use Paracetamol Suppositories 4. Possible side effects 5. How to store Paracetamol Suppositories 6. Contents of the pack and other information 1. WHAT PARACETAMOL SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR Paracetamol Suppositories contain a medicine called paracetamol. This belongs to a group of medicines called pain-killers (analgesics). A suppository is a small, torpedo-shaped, medicine which is inserted into the back passage (rectum). Paracetamol Suppositories are used to treat pain and high temperature (fever) in adults and children over 10 years of age. They are used when it is difficult to take paracetamol as tablets or syrup. You must talk to a doctor if you do not feel better or if you feel worse after 3 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PARACETAMOL SUPPOSITORIES DO NOT USE PARACETAMOL SUPPOSITORIES: • if you are allergic to paracetamol, soya, peanuts or any of the other ingredients of this medicine (listed in Section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Paracetamol Suppositories. TAKE SPECIAL CARE WITH THE USE OF PARACETAMOL SUPPOSITORIES AND TALK TO YOUR PHARMACIST OR DOCTOR IF: • you have problems with your liver or kidneys. OTHER MEDICINES AND PARACETAMOL SUPPOSITORIES Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Par Прочитајте комплетан документ
OBJECT 1 PARACETAMOL 500MG SUPPOSITORIES Summary of Product Characteristics Updated 12-Jun-2019 | Typharm 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 Paraserts 500mg Suppositories Paracetamol 500mg Suppositories 2. Qualitative and quantitative composition Each suppository contains Paracetamol 500mg For excipients, see 6.1 3. Pharmaceutical form Suppositories 4. Clinical particulars 4.1 Therapeutic indications For the treatment of mild to moderate pain and fever. Paraserts/Paracetamol Suppositories may be especially useful in patients unable to take oral forms of paracetamol, e.g. post-operatively or with nausea and vomiting. 4.2 Posology and method of administration Method of administration: Rectal Children 10 years – 12 years (30-40kg): 1 suppository every 4 to 6 hours up to a maximum of 4 suppositories in 24 hours. Adults + Children 12 years and over: 1 -2 suppositories every 4 to 6 hours up to a maximum of 8 suppositories in 24 hours. Dosages should be b Прочитајте комплетан документ