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IBUPROFEN/ PSEUDOEPHEDRINE HYDROCHLORIDE PFIZER 200 MG/ 30 MG CAPSULES

Active substance(s): IBUPROFEN / PSEUDOEPHEDRINE HYDROCHLORIDE

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0389_PIL Text_16 007_v3
UK/H/5671/01/IAIN/003 Patient Information Leaflet
Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/ 30mg Capsules
PL 00165/0389

Package leaflet: Information for the user

Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/ 30mg Capsules
Ibuprofen 200 mg / Pseudoephedrine hydrochloride 30 mg
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine 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 Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules are and what they
are used for
2. What you need to know before you take Ibuprofen/ Pseudoephedrine hydrochloride Pfizer
200mg/30mg Capsules
3. How to take Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules
4. Possible side effects
5. How to store Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules
6. Contents of the pack and other information

1.
What Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules
are and what they are used for
What Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules are
Pfizer 200mg/30mg Capsules contain 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 Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules are used for
Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules are 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 15 and over.
Only use this medicine if you have a blocked nose together with 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 Ibuprofen/ Pseudoephedrine
hydrochloride Pfizer 200mg/30mg Capsules
Do not take Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules 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

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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/ Pseudoephedrine hydrochloride
Pfizer 200mg/30mg Capsules, 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
you have severe liver or severe kidney problems
you are pregnant or breast-feeding
you are under 15 years of age
you have ever had an asthma attack after taking Ibuprofen/ Pseudoephedrine hydrochloride
Pfizer 200mg/30mg Capsules, ibuprofen, aspirin or other NSAIDs in the past
you currently have a brain haemorrhage (bleeding in your brain), or any other signs of bleeding
or a problem with your blood count
you have severe problems with your heart including;
- severe heart failure
- very high blood pressure or high blood pressure that is poorly controlled by treatment
- severe heart disease
- you have ever had a heart attack
you have ever had a stroke
you have ever had a fit (or seizure)
you have systemic lupus erythematosus (SLE) – an illness affecting the immune system causing
joint pain, skin changes and other problems
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
- a medicine used to treat attention deficit hyperactivity disorder (ADHD) called
methylphenidate
- 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
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 Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules if any of the
above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Ibuprofen/
Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Ibuprofen/ Pseudoephedrine hydrochloride Pfizer
200mg/30mg Capsules 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, or a hiatus hernia

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 you have an overactive thyroid gland (hyperthyroidism)
 you have a personality disorder.
If any of the above apply to you, or you are not sure, talk to your doctor or pharmacist before taking
Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules.
You must talk to a doctor if you do not feel better or if you feel worse after 5 days. In particular if:
 you have green or yellow coloured nasal discharge
 you have a high temperature (fever) which will not go down.
Talk to a doctor if any of the above apply to you.
Heart attack and stroke
Medicines like Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules 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 of Ibuprofen/ Pseudoephedrine
hydrochloride Pfizer 200mg/30mg Capsules and that you do not take it for longer than 5 days. For
more information about the recommended dose of Ibuprofen/ Pseudoephedrine hydrochloride Pfizer
200mg/30mg Capsules, see section 3.
Look out for side effects
Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules can cause some side effects
that mean you need to stop taking the medicine straight away and see a doctor. See ‘Stop taking
Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules 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.
Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules may cause side effects
normally seen with anti-inflammatory medicines, which can be severe. This is because at high doses
(more than 6 capsules a day) Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules
works as an anti-inflammatory medicine.
The chance of getting side effects can be lowered by taking the lowest dose for the shortest time
necessary to treat your symptoms.
Older people
If you are an older person taking Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg
Capsules, 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.
Children and young people
Do not give Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules to children
under 15 years of age.
Talk to your doctor or pharmacist before taking Ibuprofen/ Pseudoephedrine hydrochloride Pfizer
200mg/30mg Capsules if you are 15 to 18 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 Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules when you are
dehydrated.
Operations
Tell your doctor you are taking Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg
Capsules if you need to have an anaesthetic before an operation or procedure. Your doctor will ask
you to stop taking Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules a few
days before your anaesthetic.

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You should also tell your anaesthetist (the doctor giving you the anaesthetic) you have been taking
Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules.
Other medicines and Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules
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 Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules 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
 a medicine used to treat attention deficit hyperactivity disorder (ADHD) called methylphenidate
 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.
Do not take Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules if any of the
above apply to you. If you are not sure talk to your doctor or pharmacist before taking Ibuprofen/
Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules.
Talk to your doctor or pharmacist before taking Ibuprofen/ Pseudoephedrine hydrochloride
Pfizer 200mg/30mg Capsules if you are taking any of the following medicines:
Taking Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules with the
following medicines is not recommended:
 medicines to treat depression called reversible inhibitors of monoamine oxidase A (RIMAs)
and selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine
 linezolid
 methylene blue
 bromocriptine, pergolide, lisuride, cabergoline, ergotamine or dihydroergotamine
 oral anticoagulants such as warfarin – this is because taking Ibuprofen/ Pseudoephedrine
hydrochloride Pfizer 200mg/30mg Capsules as well may lead to stomach bleeding
 heparin when it is being used to treat a blood clot
 lithium, when it is being used to treat severe mood problems
 methotrexate at doses above 20 mg each week
 pemetrexed if you have kidney problems


corticosteroids



antiplatelet drugs

Taking Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules with the
following medicines requires caution:
 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)
 methotrexate at doses below 20 mg each week
 pemetrexed if you have normal kidney function
 medicines to treat depression called tricyclic antidepressants such as amitriptyline
 digoxin or quinidine used to treat heart problems
 ciclosporin or tacrolimus used after a transplant.
Taking Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules with the
following medicines should be taken into account:
 blood clotting medicines used to thin the blood, such as low dose aspirin (75 mg each day or
less), clopidogrel or ticlopidine

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potassium sparing diuretics such as amiloride or spironolactone
trimethoprim – an antibiotic
iron chelating substances such as deferasirox
steroids such as prednisolone
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
heparin when it is being used to prevent blood clots.

If any of the above apply to you, or you are not sure, talk to your doctor or pharmacist before taking
Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules.
Pregnancy and breast-feeding
 Do not take Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules 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 Ibuprofen/
Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules if this may affect you.
Driving and using machines
After taking Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules 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.
Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules contain sorbitol (E
420), soya lecithin and Potassium
Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules contain 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.
Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules contain soya lecithin. If you
are allergic to peanut or soya, do not use this medicinal product.
Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules contain 0.41 mmol
potassium per capsule. To be taken into consideration by patients with reduced kidney function or
patients on a controlled potassium diet.

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3.
How to take Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg
Capsules
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 after 5 days. They will tell
you if it is safe to carry on taking this medicine.
If you take more Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules than
you should
If you take more Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules 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.
If you forget to take Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules
 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, Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules 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 Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules 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 Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules,
signs include skin rash, hives, itching, difficulty breathing, tightness in the chest, swelling of
the mouth, face, lips or tongue

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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 Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules straight away
and tell your doctor or pharmacist if you notice any of the side effects listed above.
Side effects to look out for at the start of treatment
Tell your doctor or pharmacist if you get stomach problems such as stomach bleeding or a perforation
(signs may include stomach pain and heartburn) when you start taking Ibuprofen/ Pseudoephedrine
hydrochloride Pfizer 200mg/30mg Capsules. Older people may be more likely to get these side effects
and they may be life threatening.
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
 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
 sweating
 chest pain
 swollen stomach
 dry mouth, feeling thirsty
 abnormal spasm, seizures
 spinning sensation (vertigo)

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transaminases increase (shown in tests)
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)
glaucoma – this is more likely if you are at risk of developing glaucoma.

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 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.

5.
How to store Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg
Capsules





6.

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 after EXP. The expiry
date refers to the last day of that month.
Do not store above 30°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.

Contents of the pack and other information

What Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules contain
 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.
What Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules look like and
contents of the pack
Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules are clear oval shaped, soft
capsules. They are imprinted with 200/30 in black ink.
Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/30mg Capsules are 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
Pfizer Consumer Healthcare Ltd
Ramsgate Road
Sandwich
Kent, CT13 9NJ
United Kingdom
Tel. 0333 555 2526 or email: carelineUK@pfizer.com.
Manufacturer
Pfizer Consumer Manufacturing Italy Srl

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Via Nettunense 90
04011 Aprilia
Italy
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom: Ibuprofen/ Pseudoephedrine hydrochloride Pfizer 200mg/ 30mg Capsules
Poland: Advil Zatoki Sprint, 200 mg/30 mg kapsułki miękkie
Germany: SpaltGrippal Rapid 200 mg / 30 mg Weichkapseln
This leaflet was last revised in February 2016
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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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