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SUDAFED CONGESTION & HEADACHE RELIEF DUAL ACTION 200MG/6.1MG TABLETS

Active substance(s): IBUPROFEN / PHENYLEPHRINE HYDROCHLORIDE

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Galpharm Pain Relief
& Decongestant
200mg/6.1mg Tablets

Ibuprofen & Phenylephrine Hydrochloride
PATIENT INFORMATION LEAFLET
Read this leaflet carefully because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information
or advice.
• You must contact a doctor or pharmacist if your
symptoms worsen or do not improve.
IN THIS LEAFLET:
4. Possible side effects
1. What this medicine is for
2. Before you take the medicine 5. How to store this medicine
6. Further information
3. How to take the medicine

WHAT THIS MEDICINE IS FOR
This medicine contains ibuprofen and phenylephrine
hydrochloride. Ibuprofen belongs to a group of
medicines called Non-Steroidal Anti-Inflammatory
Drugs (NSAIDs) which work by changing how the
body responds to pain, swelling and high temperature.
Phenylephrine hydrochloride is a decongestant
which shrinks the blood vessels in the nose and
sinuses which opens the airways helping you to
breathe more easily. This medicine is used to relieve
the symptoms of cold and 'flu with associated
congestion, including aches and pains, headache,
fever, sore throat, blocked nose and sinuses.
BEFORE YOU TAKE THE MEDICINE
Do not take this medicine if you:
• are allergic to ibuprofen, phenylephrine hydrochloride,
to any of the ingredients (listed in section 6), or
to aspirin or other painkillers (an allergic reaction
may be recognised as shortness of breath, runny
nose, skin rash or itching)
• have or have had a stomach ulcer, perforation or
bleeding
• have kidney or heart failure or severe liver failure
• have heart problems or high blood pressure
(particularly due to a tumour near the kidney)
• have diabetes
• have prostate problems
• have glaucoma (increased pressure in the eye)
• have an overactive thyroid gland
• are taking more than 75mg of aspirin a day
• are taking Monoamine Oxidase inhibitor
medicines (used for depression) or have taken
them within the last 14 days
• are pregnant or breast feeding.
Talk to your doctor or pharmacist before
taking this medicine if you:
• are elderly because you may be at more risk of having
serious side effects, particularly stomach problems
• have or have suffered from asthma, diabetes,
high cholesterol or have allergies
• have liver or kidney problems
• have stomach or bowel disorders including Crohn’s
disease or a condition known as ulcerative colitis
• have Systemic Lupus Erythematosus (SLE) – an

illness which affects your immune system. It
causes joint pains, skin changes and problems
with other parts of your body.
• have problems with your blood circulation
(including Raynaud’s Phenomenon, which
might appear as paleness or a blue tinge to the
skin and/or pain of the fingers, toes, ears and
nose in response to cold)
• have, have previously had, or are at risk of heart
problems or stroke. Medicines containing ibuprofen
may be associated with a small increased risk of
heart attack (myocardial infarction) or stroke. Any
risk is more likely with high doses and prolonged
treatment. Do not exceed the recommended dose
or duration of treatment (10 days). If you have
previously had a stroke or think that you might
be at risk of heart problems or stroke (for
example if you have high cholesterol or are a
smoker) you should discuss your treatment
with your doctor or pharmacist
If you are taking other medicines
You must not take these tablets if you are taking
certain other medicines - see section 2 ‘Do not
take this medicine if’. Talk to your pharmacist or
doctor before you take the tablets if you are
taking any regular medication, especially:
• low-dose aspirin (up to 75mg daily)
• other medicines for thinning the blood (anticoagulants (against clotting) and anti-platelet
agents such as warfarin and ticlopidin)
• medicines for high blood pressure (ACE-inhibitors
such as captopril, beta-blockers and angiotensin
II antagonists) and water tablets (diuretics)
• corticosteroids
• methotrexate (a medicine for cancer)
• cardiac glycosides (medicines used to treat
heart failure)
• cyclosporin and tacrolimus (immunosuppressant
medicines often used following organ transplants)
• mifepristone (a medicine used to terminate
pregnancy – NSAIDs should not be used for 12
days after mifepristone)
• lithium (for depression or mental problems)
• zidovudine (a medicine to treat viruses)
• quinolone antibiotics (medicines used to treat
bacterial infections)
• tricyclic antidepressants (e.g. amitriptyline)
• some antibiotics and epilepsy treatments
• other nasal decongestants (e.g. pseudoephedrine).
Pregnancy and Breast feeding
Do not take this medicine if you are pregnant or breast
feeding. Ibuprofen belongs to a group of medicines
which may affect fertility in women. Fertility goes back
to normal when you stop taking the medicine. It is
unlikely that if you only take this medicine occasionally
it will affect your chances of becoming pregnant. If you
have problems becoming pregnant talk to your doctor
before taking this medicine.
Important information about some of the
ingredients of this medicine.
This product contains 31.66mg sucrose per
tablet. If you have been told by your doctor that
you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
This product contains tartrazine (E102) which
may cause allergic reactions.
Further information overleaf ➥

HOW TO TAKE THE MEDICINE
Age
Adults, the
elderly and
children over
12 years

Dose and how often to take
Take 2 tablets every 8 hours, as
required. Swallow tablets with a
glass of water preferably with or
after food. Leave at least 4 hours
between doses and do not exceed
six tablets in any 24 hour period.

• This medicine is for short-term use only.
• Take the lowest dose for the shortest time
necessary.
• Do not take this medicine for longer than 10 days.
If you do not get better, or get worse, talk to your
doctor. They will tell you if it is safe to carry on
taking this medicine .
Do not give to children under 12 years.
If you take more of this medicine than you
should: Talk to a doctor straight away, or go to
your nearest hospital casualty department. Take
the carton and this leaflet with you.
POSSIBLE SIDE EFFECTS
Most people take this medicine without any problems,
but it can have side effects, like all medicines.
To reduce the chance of side effects, especially if
you are elderly, use the lowest effective dose for the
shortest possible time.
If you get any of the following at any time
during your treatment STOP TAKING, and get
medical help straight away:
Allergic reactions:
The following reactions may mean you are
having an allergic reaction to this medicine:
• asthma, worsening of asthma, unexplained
wheezing or shortness of breath
• swelling of the face, lips, tongue and throat
(causing difficulty in swallowing or breathing)
• rapid heart rate, low blood pressure, collapse.
• also, there may be skin reaction (including hives,
rash and itching) – very rarely these can be
severe with blistering and peeling skin
Stomach and bowel problems including:
• indigestion or heartburn
• pains in your stomach (abdomen) or other
abnormal stomach problems
• pass blood in your stools or motions
• pass black tarry stools or motions
• vomit any blood or dark particles that look like
coffee grounds
• worsening of bowel problems (ulcerative colitis or
Crohn’s disease)
Blood disorders which can cause:
• unexplained or unusual bruising or bleeding
• sore throat or mouth ulcers
• fever (high temperature)
• extreme paleness or weakness and exhaustion
Heart and circulation effects:
Ibuprofen may be associated with a small
increased risk of heart attack (myocardial
infarction), high blood pressure, heart failure,
swelling due to fluid build-up (oedema) or stroke.

Other side effects that may occur include:
Other stomach and intestine effects including:
• diarrhoea, flatulence, constipation and vomiting.
Other heart and circulation effects including:
• fast heart rate, changes in heart rhythm,
palpitations, high blood pressure.
Liver problems that might be indicated by
yellowing of the skin and eyes (jaundice) and/or
pale coloured stools and dark urine.
Kidney problems that might be indicated by
passing less or more urine than normal, cloudy
urine, blood in the urine, pain in the back and/or
swelling (particularly of the legs) – very rarely
kidney failure.
Nervous system problems including headache
and aseptic meningitis (which can have symptoms
such as severe headache, stiff neck, disorientation,
fever and eye sensitivity to light in those with
existing auto-immune disorders such as lupus).
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 Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.
HOW TO STORE THIS MEDICINE
Do not use after the expiry date (EXP) shown on
the pack. Do not store above 25°C. Store in the
original container.
Keep out of the sight and reach of children.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
FURTHER INFORMATION
What this medicine contains:
The active ingredients are: Ibuprofen 200mg
and Phenylephrine Hydrochloride 6.1mg per
coated tablet.
The other ingredients are: Calcium Hydrogen
Phosphate Dihydrate, Croscarmellose Sodium,
Cellulose Powdered, Talc, Simeticone, Silica
Colloidal Anhydrous. The sugar coating contains:
Talc, Sucrose, Povidone K90, Calcium Carbonate,
Macrogol 6000, Macrogol 4000, Green Spruce Food
Colourant 83270-DO (Containing Sodium Sulphate
(E514), Tartrazine (E102) and Brilliant Blue (E133)),
Titanium Dioxide, Shellac and Theobroma Oil.
What this medicine looks like and contents
of the pack. The tablets are circular, green sugar
coated tablets. This pack contains 16 tablets.
Marketing Authorisation Holder:
Galpharm Healthcare Ltd., Wrafton, Braunton,
Devon, EX33 2DL, United Kingdom.
Manufacturer: Galpharm International Ltd.,
Elmhirst Park, Middle Field Road, Barnsley,
South Yorkshire, S75 4LS, United Kingdom.

Text revised: June 2015.

4005319

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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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