Paracetamol 125mg suppositories

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol

Available from:

DE Pharmaceuticals

ATC code:

N02BE01

INN (International Name):

Paracetamol

Dosage:

125mg

Pharmaceutical form:

Suppository

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100

Patient Information leaflet

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_Title:_
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_Date:_
_Size (mm):_
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Paracetamol 125mg Suppositories
PIL - Patient Information Leaflet
05/01/16
265(W) x 360(H)
01/03/16
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_(Non printed)_
PROCESS
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PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 125MG SUPPOSITORIES
PARACETAMOL
Age
1 year (10kg)
Over 1 year to 5 years (20kg)
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
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 children from 1 to 5 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 the patient does not feel better or if
the patient feels worse after 3 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE PARACETAMOL SUPPOSITORIES
DO NOT GIVE PARACETAMOL SUPPOSITORIES TO THE PATIENT:
•
if the patient 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 PHARMACIST OR DOCTOR IF:
•
the patient has problems with their liver or kidneys.
OTHER MEDICINES AND PARACETAMOL SUPPOSITORIES
Tell the patient's doctor or pharmacist if t

Summary of Product characteristics

OBJECT 1
PARACETAMOL 125MG SUPPOSITORIES
Summary of Product Characteristics Updated 05-Sep-2017 | Typharm
Limited
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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
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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
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
•
6.4 Special precautions for storage
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6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
•
11. Dosimetry
•
12. Instructions for preparation of radiopharmaceuticals
1. Name of the medicinal product
Paraserts 125mg Suppositories
Paracetamol 125mg Suppositories
2. Qualitative and quantitative composition
Each suppository contains Paracetamol 125mg
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:
1year – 5 years: 1-2 suppositories every 4 to 6 hours
Dosages should be based on the child's age and weight i.e.
1 year (10kg) – 125mg (1 suppository)
5 years (20kg) – 25