Paracetamol 250mg suppositories

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Paracetamol

Διαθέσιμο από:

Typharm Ltd

Φαρμακολογική κατηγορία (ATC):

N02BE01

INN (Διεθνής Όνομα):

Paracetamol

Δοσολογία:

250mg

Φαρμακοτεχνική μορφή:

Suppository

Οδός χορήγησης:

Rectal

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04070100; GTIN: 5060010284291

Φύλλο οδηγιών χρήσης

L I M I T E D
L I M I T E D
_Colours_
_(Printed)_
_Title:_
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_Date:_
_Size (mm):_
_Modified:_
Paracetamol 250mg Suppositories
PIL - Patient Information Leaflet
05/01/16
160(W) x 265(H)
06/04/22
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_(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

Αρχείο Π.Χ.Π.

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
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5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
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6. Pharmaceutical particulars
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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