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Sterets Unisept

Package leaflet: Information for the patient
Sterets® Unisept 0.05% w/v Cutaneous Solution
Chlorhexidine gluconate
Read all of this leaflet carefully before you are
administered this medicine because it contains
important information for you.

Warnings and precautions

• Keep this leaflet. You may need to read it again.

• Avoid contact with the eyes and ears.

• Ask your doctor or nurse if you need more
information or advice.

• Common bleaches (which contain
hypochlorites) may cause brown stains to
develop in fabrics which have previously been
in contact with Sterets® Unisept solution.

• If you get any side effects talk to your doctor
or nurse. This includes any possible side effects
not listed in this leaflet.
What is in this leaflet
1. What Sterets® Unisept is and what it is
used for
2. What you need to know before Sterets
Unisept is used


3. How Sterets® Unisept will be used
4. Possible side effects
5. How to store Sterets® Unisept
6. Contents of the pack and other information
1. What Sterets® Unisept is and what it is used for
Sterets® Unisept is a sterile, pink, cutaneous
solution containing Chlorhexidine gluconate,
which has antiseptic properties
(that is, it kills germs).
Sterets® Unisept is used to help prevent infection
from occurring during and after childbirth, and
also in wounds and burns.
2. What you need to know before Sterets®
Unisept is used
Do not use Sterets Unisept:

• if you are allergic to Chlorhexidine gluconate or
to any of the other ingredients of this medicine
(listed in section 6). If you are not sure if this
applies to you, talk to your doctor or nurse
before this medicine is used.
• if the product could come into contact with the
brain, meninges (the membranes surrounding
the brain and spinal cord) or the inside of
the ear.
• inside the body’s internal spaces.

Talk to your doctor or nurse before Sterets®
Unisept is used.

• The product’s action may be reduced if used
with soap or detergents.
Other medicines and Sterets® Unisept
Tell your doctor or nurse if you are using, have
recently used or might use any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or nurse for advice before this
medicine is used.
3. How Sterets® Unisept will be used
For external use on the skin only.
Not for injection.
When used in a sterile procedure, the outside
of the sachet should be disinfected with a 70%
isopropyl alcohol solution before opening.
Any surplus product should be immediately
discarded after use.
Adults, the elderly and children:
Undiluted Sterets® Unisept solution will be
applied to the affected area of skin.
If you have any further questions on the use of
this medicine, ask your doctor or nurse.

4. Possible side effects

6. Contents of the pack and other information

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The following side effects may occur; it is not
known how often these happen but available data
suggests these are very rare (probably affect
fewer than 1 in every 10,000 people).

What Sterets® Unisept contains
• The active substance is Chlorhexidine
gluconate 0.05% w/v.
• The other ingredients are Purified water,
Nonoxinol 10, Carmoisine Red (E122) and
Sodium hydroxide.

• Serious allergic reactions which can cause
breathing difficulties, weakness, collapse and
death, and can sometimes be preceded by
swelling (in particular lip/tongue and facial
swelling), or rash.

What Sterets® Unisept looks like and contents
of the pack

At the first sign of any of these reactions, tell
your doctor or nurse and application of Sterets®
Unisept should be stopped immediately.
Other possible side effects, for which it is not
known how often they occur, are: allergic skin
disorders such as dermatitis (inflammation of
the skin), pruritus (itch), erythema (redness of
the skin), eczema, rash, urticaria (hives), skin
irritation and blisters.
If you get any side effects, talk to your doctor or
nurse. This includes any side effects not listed in
this leaflet.
5. How to store Sterets® Unisept

Sterets® Unisept is a clear pink cutaneous
solution presented in plastic laminate sachets
containing either 25ml or 100ml of the liquid.
These sachets are packed together in an outer
plastic pouch.

Marketing Authorisation Holder And Manufacturer
Medlock Medical Ltd.,
Tubiton House, Medlock Street,
Oldham, OL1 3HS, United Kingdom.
Tel: +44 (0)161 621 2100
Fax: +44 (0)161 627 0932

This leaflet was last revised in July 2013

Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is printed on the plastic sachets.
The expiry date refers to the last day of
that month.
Do not store the product above 25°C.
Store the sachets in the outer container
(plastic pouch).
Do not use this medicine if you notice any
damage to, or leakage from, the plastic pouches.
Do not throw away any medicines via wastewater.
Ask your pharmacist how to throw away
medicines you no longer use. These measures
will help protect the environment.

Sterets is a registered trademark of Medlock Medical Ltd.


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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.