Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
Typharm Ltd
N02BE01
Paracetamol
250mg
Suppository
Rectal
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5060010284291
L I M I T E D L I M I T E D _Colours_ _(Printed)_ _Title:_ _Ref:_ _Date:_ _Size (mm):_ _Modified:_ Paracetamol 250mg Suppositories PIL - Patient Information Leaflet 05/01/16 160(W) x 265(H) 06/04/22 _Colours_ _(Non printed)_ PROCESS BLACK REFERENCE TRIM 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 children from 6 to 12 years of age. They can be used in children who find it difficult to take paracetamol as tablets or syrup. You must talk to a doctor if your child does not feel better or if your child feels worse after 3 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PARACETAMOL SUPPOSITORIES DO NOT GIVE PARACETAMOL SUPPOSITORIES TO YOUR CHILD: • if your child is allergic to paracetamol, soya, peanuts or any of the other ingredients of this medicine (listed in Section 6). WARNINGS AND PRECAUTIONS Talk to a doctor or pharmacist before using Paracetamol Suppositories. TAKE SPECIAL CARE WITH THE USE OF PARACETAMOL SUPPOSITORIES AND TALK TO YOUR CHILD’S PHARMACIST OR DOCTOR IF: • your child has problems with their liver or kidneys. OTHER MEDICINES AND PARACETAMOL SUPPOSITORIES Tell your child’s doctor or pharmacist if your child is taking, has recently taken or might take any other medicines. This is because Paracetamol Suppositories can have an affect on the way some medicines work and some medicines can have an affect on how Paracetamol Suppositories work. In particular tell yo Прочитайте повний документ
OBJECT 1 PARACETAMOL 250MG SUPPOSITORIES Summary of Product Characteristics Updated 08-Jun-2022 | 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 250 mg Suppositories Paracetamol 250 mg Suppositories 2. Qualitative and quantitative composition Each suppository contains paracetamol 250 mg. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Suppositories. 4. Clinical particulars 4.1 Therapeutic indications For the treatment of mild to moderate pain such as toothache and/or pyrexia. 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: 6 years – 12 years: 1 -2 suppositories every 4 to 6 hours. 10 years – 12 years (30 – 40 kg): 1 -2 suppositories every 4 to 6 hours. Dosages should be based on the child's age and weight. These d Прочитайте повний документ