SUDAFED SINUS PAIN RELIEF 200MG/6.1MG TABLETS
Active substance(s): IBUPROFEN / PHENYLEPHRINE HYDROCHLORIDE / IBUPROFEN / PHENYLEPHRINE HYDROCHLORIDE / IBUPROFEN / PHENYLEPHRINE HYDROCHLORIDE
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
• 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
• 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.
Warnings and precautions
Anti-inflammatory/pain-killer medicines like ibuprofen may
be associated with a small increased risk of heart attack
or stroke, particularly when used at high doses. Do not
exceed the recommended dose or duration of treatment.
You should discuss your treatment with your
doctor or pharmacist before taking Galpharm Pain
Relief & Decongestant 200mg/6.1mg Tablets 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 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 heart problems including heart failure,
angina (chest pain), or if you have had a heart
attack, bypass surgery, peripheral artery
disease (poor circulation in the legs or feet due
to narrow or blocked arteries), or any kind of
stroke (including ‘mini-stroke’ or transient
ischaemic attack “TIA”).
• have high blood pressure, diabetes, high
cholesterol, have a family history of heart
disease or stroke, or if you are a smoker.
Children and adolescents:
There is a risk of renal impairment in dehydrated
children between 12 and 18 years.
Other medicines and Galpharm Pain Relief &
Decongestant 200mg/6.1mg Tablets
You must not take these tablets if you are taking
certain other medicines - see section 2 ‘Do not
take this medicine if’. Galpharm Pain Relief &
Decongestant 200mg/6.1mg Tablets may affect or
be affected by some other medicines. For example:
• medicines that are anti-coagulants (i.e. thin
blood/prevent clotting e.g. aspirin/acetylsalicylic
acid, warfarin, ticlopidine)
• medicines that reduce high blood pressure
(ACE-inhibitors such as captopril, beta-blockers
such as atenolol medicines, angiotensin-II
receptor antagonists such as losartan)
• methotrexate (a medicine for cancer)
• cardiac glycosides (medicines used to treat
• 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
• tricyclic antidepressants (e.g. amitriptyline)
• some antibiotics and epilepsy treatments
• other nasal decongestants (e.g. pseudoephedrine).
Some other medicines may also affect or be
affected by the treatment of Galpharm Pain Relief
& Decongestant 200mg/6.1mg Tablets. You
should therefore always seek the advice of your
doctor or pharmacist before you use Galpharm
Pain Relief & Decongestant 200mg/6.1mg Tablets
with other medicines.
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.
Further information overleaf ➥
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.
HOW TO TAKE THE MEDICINE
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.
Do not give to children under 12 years.
This medicine is for short-term use only
Take the lowest dose for the shortest time necessary
In Adults: Do not take Galpharm Pain Relief &
Decongestant 200mg/6.1mg Tablets for longer
than 10 days unless your doctor tells you to. Talk
to a doctor or pharmacist if you do not get better
or get worse, or if new symptoms occur.
In Children between 12 and 18 years: If in
children between 12 and 18 years this medicinal
product is required for more than 3 days, or if
symptoms worsen a doctor should be consulted.
If you take too many tablets: 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:
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
• worsening of bowel problems (ulcerative colitis or
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,
dizziness, tinnitus 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
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.
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 630004 (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: December 2016.
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.