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ROBICOLD COLD & FLU RELIEF 200 MG / 30 MG LIQUID CAPSULES

Active substance(s): IBUPROFEN / PSEUDOEPHEDRINE HYDROCHLORIDE / IBUPROFEN / PSEUDOEPHEDRINE HYDROCHLORIDE / IBUPROFEN / PSEUDOEPHEDRINE HYDROCHLORIDE

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Ibuprofen 200 mg & Pseudoephedrine 30 mg soft capsules
DC - Patient Information Leaflet
UK-H-5670-01-DC Shelf life and storage conditions

Package leaflet: Information for the user

Soft Capsules
Ibuprofen 200 mg / Pseudoephedrine hydrochloride 30 mg
Read all of this leaflet carefully before you start taking – because it contains
important information for you.
is available without prescription. Always take exactly as described in
this leaflet or as your doctor or pharmacist has told you.
 Keep this leaflet. You may need to read it again.
 Ask your pharmacist if you need more information or advice.
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
 You must talk to a doctor if you do not feel better or if you feel worse after 5 days.
What is in this leaflet
1. What is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information

1. What is and what it is used for
What is
contains two active substances, ibuprofen and pseudoephedrine.
 Ibuprofen belongs to a group of medicines called ‘non-steroidal anti-inflammatory drugs’
(NSAIDs). It helps to reduce pain and lower a high temperature (fever).
 Pseudoephedrine belongs to a group of medicines called ‘vasoconstrictors’. It helps to clear the
nasal passages and eases nasal congestion.
What is used for
is used to treat symptoms of the common cold and flu, including headache, high
temperature (fever), sore throat, aches and pains, blocked nose, in adults and young people aged 12
and over.
Only use this medicine if you have a blocked nose together with the symptoms listed above such as
headache and high temperature. Do not use if you only have one of the symptoms listed above.
2. What you need to know before you take
Do not take if:
 you are allergic to ibuprofen or pseudoephedrine, or any of the other ingredients of this medicine
listed in section 6, or you have had an allergic reaction to a similar medicine in the past such as
aspirin or other NSAIDs. Signs of an allergic reaction include skin rash, hives, itching, difficulty
breathing, tightness in the chest, swelling of the mouth, face, lips or tongue
 you have ever had stomach problems after taking , ibuprofen, aspirin or other
NSAIDs in the past, such as stomach ulcers, stomach bleeding or a perforation
 you currently have a stomach ulcer or stomach bleeding, or any other signs of bleeding
 you have severe liver or severe kidney problems
 you are pregnant or breast-feeding
 you are under 12 years of age

Ibuprofen 200 mg & Pseudoephedrine 30 mg soft capsules
DC - Patient Information Leaflet
UK-H-5670-01-DC Shelf life and storage conditions










you have severe problems with your heart including:
- severe heart failure
- very high blood pressure
- severe heart disease
- angina
you have ever had a stroke
you are taking:
- other medicines containing NSAIDs for pain relief such as ibuprofen, or more than 75 mg of
aspirin each day
- other medicines to clear the nasal passages either orally (by mouth) or nasally (through your
nose) such as pseudoephedrine, phenylpropanolamine, phenylephrine or ephedrine
- medicines to treat depression called non-selective monoamine oxidase inhibitors (MAOIs)
such as iproniazid, or if you have taken them in the last 14 days
- other medicines to treat depression called tricyclic anti-depressants such as amitriptyline
you have diabetes, problems with your thyroid gland or a tumour on your adrenal gland (called
phaeochromocytoma)
you have glaucoma (raised pressure in the eye)
you have problems passing urine, due to prostate problems or other causes.

Do not take if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before taking .
Warnings and Precautions
Talk to your doctor or pharmacist before taking if:
 you smoke, have high cholesterol, high blood pressure or diabetes – this is because you may be at
risk of having a heart attack or stroke (see ‘Heart attack and stroke’ below for more information)
 you have asthma – this is because there is a risk of having an asthma attack
 you have liver, kidney or heart problems
 you have problems with your prostate
 you have bleeding problems
 you have ever had stomach problems in the past such as stomach ulcers, stomach bleeding,
ulcerative colitis or Crohn’s disease
 you have systemic lupus erythematosus (SLE) – an illness affecting the immune system causing
joint pain, skin changes and other problems.
If any of the above apply to you, or you are not sure, talk to your doctor or pharmacist before taking
.
Heart attack and stroke
Medicines like may be linked with a small increase in the risk of heart attack or
stroke. The risk is higher if the medicine is taken at a high dose or for a long time.
It is important that you do not take more than the recommended dose or exceed the duration of
treatment of . For more information about the recommended dose of ,
see section 3.
Look out for side effects
can cause some side effects that mean you need to stop taking the medicine straight
away and see a doctor. See ‘Stop taking straight away and tell your doctor or
pharmacist if you notice any of the following side effects’ at the beginning of section 4 for more
information.
Older people
If you are an older person taking , you are more likely to get side effects such as
stomach bleeding or a perforation (signs may include stomach pain and heartburn). This may be life
threatening. See ‘Side effects to look out for at the start of treatment’ in section 4 for more
information.

Ibuprofen 200 mg & Pseudoephedrine 30 mg soft capsules
DC - Patient Information Leaflet
UK-H-5670-01-DC Shelf life and storage conditions

Children and young people
Do not give to children under 12 years of age.
Talk to your doctor or pharmacist before taking if you are 12 to 17 years of age and
you have not been drinking fluids or you are dehydrated due to diarrhoea or being sick. This is
because there is a higher risk of kidney problems with when you are dehydrated.
Operations
Tell your doctor you are taking if you need to have an anaesthetic before an operation
or procedure. Your doctor will ask you to stop taking a few days before your
anaesthetic.
You should also tell your anaesthetist (the doctor giving you the anaesthetic) you have been taking
.
Other medicines and
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This includes medicines obtained without a prescription, and herbal medicines.
Do not take if you are taking any of the following medicines:
 other medicines containing NSAIDs for pain relief such as ibuprofen, or more than 75 mg of
aspirin each day
 other medicines to clear the nasal passages either orally (by mouth) or nasally (through your
nose) such as pseudoephedrine, phenylpropanolamine, phenylephrine or ephedrine
 medicines to treat depression called non-selective monoamine oxidase inhibitors (MAOIs) such
as iproniazid, or if you have taken them in the last 14 days
 other medicines to treat depression called tricyclic anti-depressants such as amitriptyline.
Do not take if any of the above apply to you. If you are not sure talk to your doctor or
pharmacist before taking .
Talk to your doctor or pharmacist before taking if you are taking any of the
following medicines:
 medicines to treat depression called reversible inhibitors of monoamine oxidase A (RIMAs) and
selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine
 linezolid
 bromocriptine, pergolide, lisuride, cabergoline, ergotamine or dihydroergotamine
 oral anticoagulants such as warfarin and other medicines used to thin the blood, such as low dose
aspirin (75 mg each day or less), clopidogrel or ticlopidine – this is because taking Name> as well may lead to stomach bleeding
 heparin when it is being used to treat or prevent a blood clot
 lithium when it is being used to treat severe mood problems
 methotrexate
 medicines used to treat high blood pressure such as ACE inhibitors (ramipril), beta-blockers
(atenolol), angiotensin II receptor antagonists (losartan) or any water tablets (diuretics)
 digoxin or quinidine used to treat heart problems
 ciclosporin or tacrolimus used after a transplant
 potassium sparing diuretics such as amiloride or spironolactone
 phenytoin used to treat epilepsy
 probenecid and sulfinpyrazone used to treat gout
 zidovudine used to treat HIV
 sulphonylureas such as gliclazide or glimepiride used to treat diabetes
 quinolone antibiotics such as ciprofloxacin
 ginkgo biloba
 antacids
 mifepristone used in pregnancy terminations

Ibuprofen 200 mg & Pseudoephedrine 30 mg soft capsules
DC - Patient Information Leaflet
UK-H-5670-01-DC Shelf life and storage conditions

 corticosteroids (a type of anti-inflammatory medicine) such as hydrocortisone
 aminoglycosides such as gentamicin or amikacin
 furazolidone, an anti-bacterial
 guanethidine, reserpine or methyldopa.
If any of the above apply to you, or you are not sure, talk to your doctor or pharmacist before taking
.
with alcohol
Do not drink alcohol while you are taking .
Pregnancy and breast-feeding
 Do not take if you are pregnant or breast-feeding.
 If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
Fertility
Ibuprofen may affect a woman’s ability to become pregnant. This effect is reversed once treatment
with ibuprofen is stopped.
It is unlikely that ibuprofen, if used occasionally, will affect your chances of becoming pregnant. Talk
to your doctor before taking this medicine if you have had problems becoming pregnant in the past.
Sports players
Pseudoephedrine may cause a positive reaction in anti-doping checks. Do not take if
this may affect you.
Driving and using machines
After taking you may feel dizzy, have unusual headaches, or problems with your sight
or hearing, including seeing or hearing things that are not there (hallucinations). If this happens, do
not drive, cycle or use any tools or machines.
contains sorbitol (E 420), soya lecithin and potassium
contains sorbitol (E 420), (a type of sugar). If you have been told by your doctor that
you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
contain soya lecithin. If you are allergic to peanut or soya, do not use this medicinal
product.
contains 0.41 mmol potassium per capsule. To be taken into consideration by patients
with reduced kidney function or patients on a controlled potassium diet.
3. How to take
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
How much to take
 The recommended dose is 1 capsule every 4 to 6 hours.
 If your symptoms are more severe you can take 2 capsules at the same time.
 Do not take more than 6 capsules in 24 hours.
Taking this medicine
Swallow the capsules whole with a large glass of water
How long to take this medicine for
Do not take this medicine for more than 5 days.
 This medicine is for short term use only, take the lowest dose for the shortest time necessary to
treat your symptoms.
 You must talk to a doctor if you do not feel better or if you feel worse or if get any new
symptoms. They will tell you if it is safe to carry on taking this medicine.

Ibuprofen 200 mg & Pseudoephedrine 30 mg soft capsules
DC - Patient Information Leaflet
UK-H-5670-01-DC Shelf life and storage conditions

If you take more than you should
If you take more than you should, talk to a doctor or go to a hospital straight away,
you may need medical help. Take the medicine pack with you.
Do not continue to take if you accidently take more than you should (overdose).
If you forget to take
 Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, can cause side effects, although not everybody gets them. The
chance of getting side effects can be lowered by taking the lowest dose for the shortest time necessary
to treat your symptoms.
The following side effects may happen with this medicine:
Stop taking straight away and tell your doctor or pharmacist if you notice any of
the following side effects:
Common: may affect up to 1 in 10 people
 feeling sick (nausea)
 bleeding from the stomach or bowel, signs include vomiting blood, blood in faeces, or black
coloured faeces.
Uncommon: may affect up to 1 in 100 people
 severe headaches or headaches that are more painful than usual.
Very rare: may affect up to 1 in 10,000 people
 heart attack
 fast heartbeat or palpitations
 allergic reaction to , signs include skin rash, hives, itching, difficulty breathing,
tightness in the chest, swelling of the mouth, face, lips or tongue
 blistering lesions on the skin or mucous membranes such as the inside of your mouth, signs
include burning feeling, with redness, blisters and ulcers.
Not Known: it is not known how often these happen
 stroke
 behavioural problems such as feeling excited, agitated, anxious, restless or nervous.
Stop taking straight away and tell your doctor or pharmacist if you notice any of the
side effects listed above.
Other side effects
Tell your doctor or pharmacist if you get any of the following side effects:
Common: may affect up to 1 in 10 people
 indigestion, stomach ache, being sick (vomiting), diarrhoea, constipation, wind.
Uncommon: may affect up to 1 in 100 people
 stomach ulcer
 not being able to sleep
 feeling drowsy or tired
 feeling dizzy or irritable
 problems with your sight
 headaches that do not go away
 breakouts on the skin such as rash or itching
 inflamed stomach or bowel, worsening of existing inflammatory bowel disease

Ibuprofen 200 mg & Pseudoephedrine 30 mg soft capsules
DC - Patient Information Leaflet
UK-H-5670-01-DC Shelf life and storage conditions

 hypersensitivity such as wheezing and difficulty breathing in patients who have ever had
bronchial asthma or allergic disease.
Rare: may affect up to 1 in 1,000 people
 kidney problems
 ringing in your ears (tinnitus).
Very rare: may affect up to 1 in 10,000 people
 depression
 heart failure
 kidney failure
 high blood pressure
 sore or inflamed mouth
 inflamed pancreas (pancreatitis)
 narrowing of the gut (intestinal stricture)
 aseptic meningitis, worsening of infectious inflammations
 problems with your blood cells – you may be more likely to bruise or get infections
 liver problems including abnormal liver function, hepatitis or jaundice (yellowing of the skin or
eyes).
Not Known: it is not known how often these happen
 chest pain
 dry mouth, feeling thirsty
 abnormal spasm, seizures
 spinning sensation (vertigo)
 haematocrit levels decreased and haemoglobin decreased
 seeing or hearing things that are not there (hallucinations)
 skin rash, red or purple skin discolouration, fluid retention (oedema)
 passing urine less often, blood or protein in your urine (shown in tests).
Tell your doctor or pharmacist if you get any of the side effects listed above.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet.
You can also report side effects directly via the national reporting system listed in Appendix V. By
reporting side effects you can help provide more information on the safety of this medicine.
5. How to store





Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and blister pack after
EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help to protect the
environment.

6. Contents of the pack and other information
What contains
 The active substances are ibuprofen 200 mg and pseudoephedrine hydrochloride 30 mg
 The other ingredients are:
- Liquid fill: potassium hydroxide, macrogol 600, purified water
- Gelatine capsule: sorbitol (E 420), gelatine, black printing ink [Macrogol 400, polyvinyl
acetate phthalate, propylene glycol, iron oxide black (E172)], soya lecithin in triglycerides.

Ibuprofen 200 mg & Pseudoephedrine 30 mg soft capsules
DC - Patient Information Leaflet
UK-H-5670-01-DC Shelf life and storage conditions

What looks like and contents of the pack
is a clear oval shaped, soft capsule. It is imprinted with 200/30 logo in black ink.
is available from your pharmacist in white, opaque, heat sealed Glassine/Aluminium
foil blister strips of 2, 4, 8, 10, 12, 16, 20 or 24 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Company Name
Company Address
Company Telephone
Company Fax
Company Email
< To be completed nationally>
Manufacturer
Pfizer Consumer Manufacturing Italy Srl
Via Nettunense 90
04011 Aprilia
Italy
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: RobiCold Cold & Flu Relief 200mg/30mg Soft Capsules
Ireland: Advil Sinus Relief Soft Capsules
Ibuprofen 200 mg / Pseudoephedrine 30 mg
Romania: Robicold Sinus & Raceala 200 mg/30 mg capsule moi
Slovakia: Robicold Rapid 200mg/30mg mäkké kapsuly
Malta: Advil Sinus Relief Soft Capsules
Ibuprofen 200 mg / Pseudoephedrine 30 mg
This leaflet was last revised in

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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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