Skip to Content

RELAXIT MICRO ENEMA 5ML

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Relaxit Micro Enema 5 ml

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Citrate Dihydrate
Sodium Lauryl Sulphate

3

Ph Eur
Ph Eur

450.0 mg
75.0 mg

PHARMACEUTICAL FORM
Rectal Solution

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the removal of impacted faecal material from the sigmoid colon,
particularly when large volume enemas or oral preparations are clinically
undesirable.

4.2

Posology and method of administration
Adults, Elderly and Children over the age of three years:
One tube is usually sufficient, but a second tube may be needed in severe
cases.
The micro enema tip is lubricated with a little of its contents and the nozzle is
fully inserted into the rectum. The contents are squeezed out and the nozzle
withdrawn.
Children below the age of three years:
Administer as for adults, but only half the length of the nozzle is inserted into
the rectum.

4.3

Contraindications
None known

4.4

Special warnings and precautions for use
Insert with care in patients with rectal disease.

4.5

Interaction with other medicinal products and other forms of interaction
None known.

4.6

Pregnancy and lactation
No problems known. Small volume enemas such as Relaxit may be preferable
to systemic aperients.

4.7

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects
Tenesmus (rarely).

4.9

Overdose
Unlikely

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Aided by the surface active properties of sodium lauryl sulphate, the sodium
citrate peptidises the water bound in the hardened faecal mass, resulting in the
liberation and softening of the material that is easily passed. Relaxit passes out
with the motion, thereby avoiding continued bowel stimulation. The faecal
mass is usually softened and passed in fifteen minutes.

5.2

Pharmacokinetic properties
None stated

5.3

Preclinical safety data
None stated

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Glycerol
Sorbic acid
Sorbitol solution 70 %
Purified water

6.2

Incompatibilities
None known

6.3

Shelf life
5 years

6.4

Special precautions for storage
Store below 25 C

6.5

Nature and contents of container
Boxes of 4, 12 or 100 disposable plastic micro-enemas. The micro-enema tube
and cap contains a viscous solution.

6.6

Instruction for Use/Handling
1. Remove the nozzle and cap and squeeze out a drop of fluid to lubricate
the nozzle tip.
2. Insert the nozzle fully into the rectum, unless the patient is under 3
years of age, when only half the length is inserted.
3. Squeeze out the contents fully and then withdraw the nozzle, still
squeezing the tune tightly.

7

MARKETING AUTHORISATION HOLDER
Crawford Healthcare Limited
Cheshire House
164 Main Road
Goostrey
Cheshire
CW4 8JP

8

MARKETING AUTHORISATION NUMBER(S)
PL 20074/0003

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18 October 1995 / 17 April 2001

10

DATE OF REVISION OF THE TEXT
June 2006

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide