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GALPSEUD LINCTUS

Active substance(s): PSEUDOEPHEDRINE HYDROCHLORIDE

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Transcript
2. Before you use this
medicine

Galpseud Linctus
(pseudoephedrine hydrochloride)

Do not use the medicine if you or
your child have….

FRONT FACE TOP

Important information about Galpseud Linctus
• This medicine relieves congestion in the nose,
sinus and upper chest.
• It can be used by adults, the elderly and
children over 6 years.
• Follow the dosage instructions carefully.
Children of different ages need different
amounts. See section 3.

• An allergy to any of the ingredients listed in
section 6.
• Taken medicine for depression (monoamine
oxidase inhibitors/MAOIs) within the last two
weeks.
• Severe kidney problems.
• Heart disease.
• Circulation problems.
• High blood pressure.
• Diabetes.
• An overactive thyroid gland.
• Glaucoma (raised pressure inside the
eyeball).
• Taken other nasal decongestants including
sprays.
• Taken beta-blockers.
• Phaeochromocytoma (a rare tumour of the
adrenal glands).
• Or you are pregnant or breastfeeding.
• Do not give to children under 6 years.

Do not give….
• To children under 6 years.
• To anyone who is allergic to the ingredients.
See section 6.
• With other nasal decongestants including
sprays.
Now read the rest of the leaflet before you
use this medicine. It includes other
information which might be especially
important for you.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need any more
information or advice.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.


 Talk to your doctor if you or your

child have….

• Bladder problems.
• Prostate problems.
• Mild kidney problems.
• Severe liver disease.

1. What the medicine is for
Galpseud Linctus is an oral solution for the
relief of nose, sinus and upper chest
congestion. It contains pseudoephedrine
hydrochloride, a decongestant, which works
to restrict blood vessels, reduces swelling
and production of mucous and so relieves
congestion.


Talk to your doctor or pharmacist if

3. How to use this medicine

• Allergic reactions which may cause difficulty
in breathing, fever, swelling of the mouth, lips
or skin, severe rashes, itching or stomach pain.

you or your child are taking….

• Medicines to reduce your appetite.
• Medicines which stimulate the nervous
system, eg. amphetamines (used to treat
Narcolepsy and Attention Deficit Hyperactivity
Disorder).

Take this medicine by mouth.
The normal dose is given below but your doctor
may prescribe a different amount for you.
Always follow the instructions given by the
doctor or pharmacist.

Other possible side effects are:
• Hallucinations.
• Restlessness.
• Unable to sleep or disturbed sleep.
• Feeling sick or being sick.
• Headache.
• Skin rashes, lumps and red skin patches.
• Feeling anxious, irritable or excited.
• Glaucoma (raised pressure in the eyeball).
• Difficulty passing urine.
• Abnormal or rapid heartbeat.
• Palpitations.
• High blood pressure.
• Poor circulation e.g. cold feet or hands.
• Trembling.
• Dry mouth.
• Rarely, mental disorders.


Adults, the elderly and children
over 12 years

Two 5ml spoonfuls three times a day.

REVERSE FACE TOP

Children from 6 – 12 years

One 5ml spoonful three or four times a day.
No more than 4 doses should be given in any
24 hours.

Children under 6 years

Do not give to children under 6 years.
DO NOT EXCEED THE STATED DOSE.

If you take too much

If you accidentallyMHRA
take too
much,
see a doctor
Header
Box
straight away. Take the pack with you to show
which medicine you
have swallowed.
Galpseud Linctus
Product

4. PossibleTitle
side effects
Leaflet
Like all medicines, Component
Galpseud Linctus
can have
side effects, although
these
don’t
affect
Pack Size
2Lt
everyone.
22880806

IG Code

If you notice these or any other side effect not
included above, stop use and tell your doctor or
pharmacist. They will tell you what to do.

• Medicines which lower your blood pressure.
• Medicines for mental illness.
• Antidepressants including moclobemide.
• Beta-blockers for a heart condition.
• Cardiac glycosides (eg. digoxin, digitoxin).
• Rasagiline or Selegiline for Parkinson’s
disease.
• Ergotamine or methysergide for migraine
relief.
• Aproclonidine for glaucoma.
• Quinidine for irregular heartbeat.
• Kaolin and aluminium hydroxide (antacids).
• The antibiotic Furazolidone.
• If you go into hospital, tell the doctor you are
using Galpseud Linctus as it may affect some
hospital medicines and anaesthetics.

Pregnant or breastfeeding….
Galpseud Linctus should not be used in
pregnancy or when breastfeeding. Ask your
doctor or pharmacist for further advice.


Important information about some
of the ingredients
• This medicine contains 1.9 vol% ethanol
(alcohol), i.e up to 154mg per dose,
equivalent to 4ml beer or 2ml of wine per
dose. Harmful for those suffering from
alcoholism. To be taken into account in
pregnant or breastfeeding women, children
and high-risk groups such as people with liver
disease and epilepsy.
• It contains parahydroxybenzoates, sunset
yellow dye and amaranth dye which may
cause allergic reactions (possibly delayed).

Turn over
22880806

• Do not use after the expiry date shown on the
pharmacist’s label.
• Medicine should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of any unused
medicine. These measures will help to protect
the environment.

6. Further information
What is in this medicine

The active ingredient per 5ml is:
pseudoephedrine hydrochloride 30mg.
The other ingredients are: citric acid
monohydrate, sodium methyl
parahydroxybenzoate (E219), sodium ethyl
parahydroxybenzoate (E215), sodium propyl
parahydroxybenzoate, ethanol, amaranth dye
(E123), sunset yellow dye (E110), carmellose
sodium, saccharin sodium, menthol, condensed
milk flavour, orange flavour, glycerol (E422),
purified water.

What the medicine looks like

Galpseud Linctus is a thick deep orange
coloured liquid.It is dispensed for you by the
pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor,
olours
Used any possible Fonts
Used
Marketing
authorisation holder and
pharmacist or nurse. CThis
includes
manufacturer
side effects not listed in Process
this leaflet.
Helvetica
Black You can
Thornton and Ross Ltd., Huddersfield,
also report side effects directly via the Yellow
Keyline (Does not print)
HD7 5QH, UK.
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
This leaflet was revised in October 2013
more information on the safety of this medicine.
Galpseud is a trade mark of Thornton & Ross
Ltd.
5. Storing this medicine

Important side effects:
If you think you have
any of the following
side
210 x 148mm
Dimensions
• Keep it out of the sight and reach of children.
effects or symptoms, stop using this medicine
Proof
No. as soon
Date • D03.10.2013
3
o not store above 25°C.
immediately and see
a doctor
as
• Protect from light.
possible.

22880806

Data Matrix: 22880806 VERIFIED
PCP Header Box
Operator

Approved by
Date

gill.kennedy

Artwork No 452524 - 463399
Suf fix

CRN

9884

Reason for
Change

Type II safety updates

10338

Issued by
Date

MHRA/IMB
submission Yes
required

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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.

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