Skip to Content

COFSED LINCTUS

Active substance(s): CHLORPHENAMINE MALEATE / EPHEDRINE HYDROCHLORIDE / PHOLCODINE

View full screen / Print PDF » Download PDF ⇩
Transcript
1. What the medicine is for

Cofsed Linctus

FRONT FACE TOP

(pholcodine, chlorphenamine maleate,
ephedrine hydrochloride)
Important information about Cofsed Linctus
• This medicine relieves coughs and
congestion.
• It can be used by adults and children over
12 years.
Do not take….
• If allergic to any of the ingredients. See
section 6.
• With other cough, cold or decongestant
medicines.
• Or give to children under 1­­2 years.
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.

Cofsed Linctus is an oral solution containing
pholcodine which reduces the desire to cough.
It also contains ephedrine hydrochloride, a
decongestant and chlorphenamine maleate
which relieves nasal congestion caused by
allergies. The medicine relieves dry or painful
coughs in adults and children over 12 years of
age and relieves congestion in the nose in colds
and hay fever.

2. Before you use this
medicine
Do not use the medicine if you
have….

• An allergy to any of the ingredients listed in
section 6.
• Taken medicine for depression (monoamine
oxidase inhibitors/MAOIs within the last two
weeks.
• Taken other cough, cold or decongestant
medicines.
• Epilepsy.
• An overactive thyroid gland.
• Glaucoma (raised pressure inside the eyeball).
• Liver disease.
• Severe kidney problems.
• Prostate trouble.
• Trouble passing urine.
• A blockage from the stomach to the small
intestine.
• Heart or circulation problems, including high
blood pressure, or are taking medicines to
lower your blood pressure e.g. beta blockers.
• Breathing problems or shortage of breath
including chronic bronchitis.
• Phaeochromocytoma (a rare tumour of the
adrenal gland).
• Or are under 12 years.

Talk to your doctor if you have….

• Asthma • Kidney problems • Diabetes.
• A cough for a long time or a cough which
produces lots of phlegm.
• Or you are elderly.

T alk to your doctor or pharmacist if
you are taking….
• Diuretics, which help remove fluid from the
body, e.g. furosemide, hydrochlorothiazide.
• Medicines used to treat sleeplessness,
anxiety, depression and schizophrenia.
• Medicines or supplements to reduce your
appetite or make you more alert.
• Alcohol.
• Pain killers, e.g. morphine.
• Lopinavir (used to treat HIV).
• Phenytoin (for epilepsy).
• Muscle relaxing drugs, e.g. atropine, used for
irritable bowel syndrome.
• Histamine (for some types of cancer).
• Betahistine (for vertigo).
• Caffeine.
• Theophylline (for asthma or bronchitis).
• Medicines for irregular heartbeat e.g. digoxin.
• Ergotamine or methysergide for migraine.
• Oxytocin, used to induce labour.
• Dexamethasone, a steroid used e.g. for
arthritis.
• Medicines for Parkinson’s Disease
e.g. rasagiline, selegiline, levodopa,
bromocriptine.
• Furazolidone, an antibiotic.
• Or are having surgery, as muscle relaxants
used may react with this medicine.
• Or are having skin tests for allergies, as this
medicine may interfere with the results.



Ask your doctor for advice before using
this medicine if you are pregnant, might be
pregnant or are breastfeeding. Cofsed Linctus
should not be used in pregnancy unless the
doctor has told you to do so.

Driving and using machines….

Colours Used

Cofsed Linctus

Component

Leaflet

Pack Size

100ml

IG Code

22892111

Dimensions

338 x 148mm flat (29 x 148mm folded)

Proof No.

1

Process Black
Keyline (Does not print)

Date

05.03.2015

PCP Header Box
Operator

Approved by
Date

gill.kennedy

Artwork No 561754
Suf fix

CRN

12028

Reason for
Change

Addition of reporting of side
effects statement

A

Issued by
Date

MHRA/IMB
submission Yes
required

Fonts Used

Helvetica

3. How to use this medicine
Take this medicine by mouth.

Adults and children over 12 years
Two 5ml spoonfuls (10ml) three times a day.
No more than 3 doses should be given in any
24 hours.

This medicine may cause drowsiness or other
side effects which could affect your ability to
drive or use machinery (see section 4 for a full
list of side effects). You should not drive or
operate machinery until the effects have worn off.
 

Children under 12 years

• This medicine contains small amounts of
ethanol (alcohol), less than 100mg per 10ml
dose.
• It also contains sucrose and invert sugar. If
you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicine.
• It contains 7.8g of sucrose and 0.17g invert
sugar per 10ml dose. This should be taken
into account in people with diabetes.
• It contains parahydroxybenzoates which may
cause allergic reactions (possibly delayed),
and exceptionally, bronchospasm.

If you take too much

Important information about some
of the ingredients

Do not give to children under 12 unless your
doctor tells you to.
DO NOT EXCEED THE STATED DOSE.
If symptoms persist you should ask your
doctor for advice.
If you accidentally take too much, see a doctor
straight away. Take the pack with you to show
which medicine you have swallowed.
If you forget a dose
Take the next dose as soon as you remember.
Do not take a double dose. You can then carry
on with the normal dose.

Turn over



22892111

MHRA Header Box
Product
Title

Pregnant or breastfeeding….

Data Matrix: 22892111 VERIFIED

4. Possible side effects

REVERSE FACE TOP

Like all medicines, Cofsed Linctus can have
side effects, although these don’t affect
everyone.
Important side effects:
If you think you have any of the following side
effects or symptoms, stop using this medicine
immediately and see a doctor as soon as
possible.
• Allergic reactions which may cause difficulty
in breathing, fever, swelling of the mouth, lips
or skin, severe rashes, itching or stomach pain.
Other possible side effects are:
• Feeling drowsy or dizzy.
• Feeling sick or being sick.
• Abdominal pain, diarrhoea or constipation.
• Altered taste and smell.
• Headache.
• Blurred vision, dilation of the pupils, raised
pressure inside the eye (glaucoma).
• Ringing in the ears (tinnitus).
• Anorexia.
• Skin rashes.
• Increased sensitivity to sunlight.
• Dry mouth or increased amounts of saliva.
• Thicker phlegm, or difficulty coughing up
phlegm.
• Feeling short of breath.
• Sweating.
• Hairs standing on end (Goose bumps).
• Cold hands and feet.
• Muscle trembling, feeling weak, “pins and
needles” or face twitching.
• Problems controlling movement.
• Fits.
• Feeling anxious, restless, irritable, excited or
confused.
• Feeling fearful, depressed or seeing things.

• Insomnia (unable to sleep) or disturbed sleep.
• Awareness of the heartbeat, irregular or fast
heartbeat.
• High or low blood pressure.
• High blood sugar.
• Blood problems (e.g. anaemia, unexplained
bleeding or bruising).
• Liver problems.
• Problems passing urine.
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.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the following
national reporting systems:
United Kingdom
Yellow Card Scheme www.mhra.gov.uk/yellowcard
Malta
www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide
more information on the safety of this
medicine.

6. Further information
What is in this medicine

The active ingredients per 5ml are:
pholcodine 5mg, ephedrine hydrochloride 8mg,
chlorphenamine maleate 2mg.
The other ingredients are: ethanol,
glycerol (E422), invert sugar, menthol, methyl
parahydroxybenzoate (E218), ethyl
parahydroxybenzoate (E214), propyl
parahydroxybenzoate (E216), aniseed flavour,
quinoline yellow (E104), sucrose and purified
water.

What the medicine looks like

Cofsed Linctus is a clear, yellow liquid which
smells of aniseed.
It is supplied in 100ml bottles.

Marketing authorisation holder and
manufacturer
Thornton and Ross Ltd., Huddersfield,
HD7 5QH, UK.

This leaflet was last revised in March 2015
Cofsed is a trade mark of Thornton & Ross Ltd.

5. Storing this medicine

• Keep it out of the sight and reach of children.
• Protect from light.
• Do not use after the expiry date shown on the
carton. The expiry date refers to the last day
of that month.
• 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.



22892111

MHRA Header Box
Colours Used

Product
Title

Cofsed Linctus

Component

Leaflet

Pack Size

100ml

IG Code

22892111

Dimensions

338 x 148mm flat (29 x 148mm folded)

Proof No.

1

Process Black
Keyline (Does not print)

Date

05.03.2015

PCP Header Box
Operator

Approved by
Date

gill.kennedy

Artwork No 561754
Suf fix

CRN

12028

Reason for
Change

Addition of reporting of side
effects statement

A

Issued by
Date

MHRA/IMB
submission Yes
required

Fonts Used

Helvetica

Data Matrix: 22892111 VERIFIED

Expand view ⇕

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