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IBUPROFEN/PSEUDOEPHEDRINE HYDROCHLORIDE 100MG/15MG PER 5 ML ORAL SUSPENSION

Active substance(s): IBUPROFEN / PSEUDOEPHEDRINE HYDROCHLORIDE

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Package leaflet: Information for the patient
Ibuprofen/Pseudoephedrine hydrochloride 100mg/15mg per 5ml Oral Suspension
Ibuprofen and Pseudoephedrine hydrochloride
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
have 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.
• For adolescents 16 years and over: You must talk to a doctor if you do not feel better or
you feel worse after 3 days.
• For adults: You must talk to a doctor if you do not feel better or you feel worse after 5
days.
What is in this leaflet
1.
What is Ibuprofen/Pseudoephedrine hydrochloride and what it is used for
2.
What you need to know before you take Ibuprofen/Pseudoephedrine
hydrochloride
3.
How to use Ibuprofen/Pseudoephedrine hydrochloride
4.
Possible side effects
5.
How to store Ibuprofen/Pseudoephedrine hydrochloride
6.
Contents of the pack and other information

1.

What Ibuprofen/Pseudoephedrine hydrochloride is and what it is used for

Ibuprofen/Pseudoephedrine hydrochloride contains Ibuprofen and Pseudoephedrine
hydrochloride.
Ibuprofen belongs to a group of medicines known as non-steroidal
anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body's response to
pain, swelling and high temperature.
Pseudoephedrine belongs to a group of drugs called vasoconstrictors, which act on the blood
vessels in the nose to relieve nasal congestion.
Ibuprofen/Pseudoephedrine hydrochloride is effective in clearing a blocked nose and sinuses,
relieving aches, pains, headache and feverishness, and easing discomfort of a sore throat.
You should only take this combination product if you have a blocked nose with pain or fever. If
you have only one of these symptoms you should talk to your pharmacist or doctor about using
mono preparations alone.
You must talk to your doctor if you do not feel better or if you feel worse after:
- 5 days if you are an adult
- 3 days when you are an adolescent aged 16 and older.

2.

What you need to know before you use Ibuprofen/Pseudoephedrine
hydrochloride

Do not take Ibuprofen/Pseudoephedrine hydrochloride if:

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you are allergic to any of the active substances or any of the other ingredients of this
medicine (listed in section 6).
you are less than 16 years old.
you have or have ever had an allergic reaction or wheezing after taking other antiinflammatory pain killers (NSAIDs).
you take other similar medicines.
you are using other medicines such as blood thinners, corticosteroids, anti-blood clotting
agents, lithium, antidepressants (or have taken them in the last 14 days) and an anti-cancer
medicine called methotrexate.
you have or have ever had a stomach ulcer or other gastric complaint.
you suffer from heart problems, diabetes, a condition called phaeochromocytoma (a
tumour which causes increased blood pressure, palpitations, increased heart rate and
headaches), glaucoma, prostate enlargement, severe kidney & liver problems.
you are pregnant or breastfeeding.
you have or have ever had bleeding in your brain.
you have or have ever had unexplained blood clotting problems.
you have a history of :
• seizures
• stroke
• heart attack
you have been diagnosed with an automimmune disease (lupus erythematosus).

Warnings and precautions
You should discuss your treatment with your doctor or pharmacist before taking
Ibuprofen/Pseudoephedrine hydrochloride if:
you are taking:
• other NSAID painkillers
• antimigraine medicines
• other medicines such as blood thinners or corticosteroids
you 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”).
you have high blood pressure, diabetes, high cholesterol, have a family history of heart
disease or stroke, or if you are a smoker.
you are diagnosed with psychosis.
you have Systemic Lupus Erythematosus (SLE),a condition to the immune system
affecting connective tissue resulting in joint pains, skin changes and disorder of other
organs.
you have had seizures or changes in behaviour when you have used medicines containing
the same active substances before.
you are older and have urinary disorders.
you have surgery scheduled.
you are an athlete, as this pseudoephedrine present in this medicine can lead to positive
results in doping tests.
you are scheduled to have blood tests.
you have asthma or have suffered from asthma.
you have a history of ulcer or bleeding in your stomach.
you have skin reactions when you have used medicines containing the same active
substances before.
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.

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Other medicines and Ibuprofen/Pseudoephedrine hydrochloride

.
Ibuprofen/Pseudoephedrine hydrochloride 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)

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medicines that reduce high blood pressure (ACE-inhibitors such as captopril, betablockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)

Some other medicines may also affect or be affected by the treatment of Ibuprofen/
Pseudoephedrine hydrochloride. You should therefore always seek the advice of your doctor or
pharmacist before you use Ibuprofen/ Pseudoephedrine hydrochloride with other medicines. This
includes herbal medicines.
In particular, do not give this medicine and tell your doctor or pharmacist if you are taking any of
the following:
Acetylsalicylic acid.
Other NSAIDs.
Medicines used to thin the blood such as Warfarin.
Water tablets (diuretics).
Corticosteroids.
Any medicines for depression such as:
• Selective serotonin reuptake inhibitors (SSRIs) such as paroxetine and fluoxetine.
• Lithium.
• tricyclics such as amitriptyline.
• monoamine oxidase inhibitors (MAOIs) such as phenelzine.
• other indirectly acting agents such as methylphenidate.
-

Digoxin (for heart failure).
Methotrexate (for arthritis, psoriasis or some cancers).
Tacrolimus (for transplant and eczema).
Ciclosporin (for transplant, arthritis or psoriasis).
Antibiotics called Quinolones (such as Ciprofloxacin) and ones used for skin and
pneumonia (such as linezolid).
Zidovudine (used to treat HIV infection).
Decongestants or appetite suppressants.
Digitalis (used for heart arrhythmias).
Phenytoin (used to treat seizures).
Probenecid and sulfinpyrazone (used to treat gout).
Medicines for diabetes.

If you are not sure about the medicines you are taking, show the bottle or pack to your
pharmacist.
Important
Medicines which contain 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

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prolonged treatment. Do not exceed the recommended dose or duration of treatment (see
the next two points). If you have heart problems, previous stroke or think that you might be
at risk of these conditions (for example if you have high blood pressure, diabetes or high
cholesterol or are a smoker) you should discuss your treatment with your doctor or
pharmacist.
If you are an adult you must contact a doctor if your symptoms worsen or do not improve
after 5 days.
If you are giving this medicine to an adolescent aged 16 years and above, you must contact
a doctor if your child’s symptoms worsen or do not improve after 3 days.

Pregnancy and Breast-feeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.
Ibuprofen/Pseudoephedrine hydrochloride is contraindicated during pregnancy and breastfeeding.
Driving and using machines
This medicine is unlikely to affect your ability to drive or to operate machinery. However,
dizziness or hallucinations may appear in exceptional cases, so please take this into account when
driving.
Ibuprofen/Pseudoephedrine hydrochloride contains
Maltitol liquid: If you have been told by your doctor that you or your child have intolerance
to some sugars, contact your doctor before taking this medicinal product.
Sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate: May cause
allergic reactions (possibly delayed).
less than 1 mmol sodium (23 mg) per , i.e. essentially ‘sodium- free’.
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3.

How to use Ibuprofen/Pseudoephedrine hydrochloride

Always take this medicine exactly as described in the leaflet or as your doctor or pharmacist have
told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults and adolescents aged 16 years and above: Depending on the severity of the symptoms
10ml to 20ml every six hours. Never exceed the maximum daily dose of 60mls.
-

Do not take more than the stated dose shown below.
The medicine should be used for shortest time possible and at the lowest dose to relieve
your symptoms.
Do not give to children under 16 years of age
Doses should usually be given every 6 hours as required. Leave at least 4 hours between
doses.

Ibuprofen/Pseudoephedrine hydrochloride should be taken by mouth preferably with or after food.
Before measuring the dose shake the bottle well until the sediment in the bottle is completely
dispersed; a measuring spoon is provided to ensure accuracy.
If you take more Ibuprofen/Pseudoephedrine hydrochloride than you should
If you, your child or someone you know accidentally takes a lot more than the stated dose (an
overdose) of this medicine, either call your doctor straight away, or go to your nearest hospital
casualty department. Always take any remaining medicine, the container and the label with you,
so that the medicine can be identified.
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If you forget to take Ibuprofen/Pseudoephedrine hydrochloride
If you forget to take a dose, take the next dose as soon as you remember unless it is time for the
next one. Do not take a double dose to make up for a forgotten dose.
If you are worried, or not sure of when or how to use this medicine, ask your doctor or pharmacist
for advice.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Whilst taking Ibuprofen/Pseudoephedrine hydrochloride, if you develop any of the following
symptoms you should contact your doctor immediately:
If you observe stiff neck, headache, nausea, vomiting, fever or disorientation (aseptic
meningitis); (very rare, may affect up to 1 in 10,000 people)
Changes in the blood clotting capacity of the blod, increasing risk of bleeding
(thrombocytopenia); (very rare, may affect up to 1 in 10,000 people)
Unexplained wheezing, shortness of breath, skin rash (which may be severe and include
blistering or peeling of the skin), swelling of mouth or tongue, mouth ulcers, itching or
bruising, light headedness, racing heart or fluid retention, e.g. swollen ankles). All these
may be the results of anaphylactic shock and severe allergic reactions. (very rare, may
affect up to 1 in 10,000 people)
Stroke (not known)
Chest pain (not known)
Severe skin infections and /or blistering, peeling off of the skin (erythema multiforme,
Toxic epidermal necrolysis); (very rare, may affect up to 1 in 10,000 people)
These are very serious side effects. You may need immediate medical attention.
Other side effects
If any of the following side effects occur, contact your doctor as soon as possible:
Common (may affect up to 1 in 10 people):
Inflammation of stomach or intestine, sometimes with blood loss leading to anaemia
Indigestion, stomachache, loss of appetite
Feeling & being sick
Diarrhoea, wind or constipation
Uncommon (may affect up to 1 in 100 people):
Hives: swelling of face/lips/mouth/tongue or throat which may cause difficulty in
swallowing or breathing
Skin rashes
Asthma attack
Headache, dizziness, sleeplessness, agitation, irritability or tiredness
Difficulty in seeing
Stomach or intestinal ulcers
Worsening of colitis and Crohn's disease.
Rare (may affect up to 1 in 1,000 people):

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Nervousness, anxiety, restlessness, tremor, hallucinations
Ringing in your ears
Worsening of asthma
Kidney problems

Very rare (may affect up to 1 in 10,000 people):
Worsening of infectious inflammations
Disorders of the blood such as anaemia
Allergic reactions with signs such as face swelling, difficulty in breathing, rapid heart
betas, drop in blood pressure.
Depression
Swelling (oedema), high blood pressure, feeling your heartbeat, heart attack
Inflammation of the throat due to reflux (oesophagitis)
Inflammation of the pancreas, which causes severe pain in the abdomen and back
(pancreatitis)
Yellowing of the eye and/or skin, which may be a sign of liver problems, inflammation of
the liver (hepatitis)
Hair loss, severe condition of the skin-red blotches (erythema multiforme)
Difficulties passing urine
Not known (frequency cannot be estimated from the available data):
Abnormal behaviour
Fits Irregular & rapid heart beats
Dry mouth, thirst, nausea, vomiting
Rash, itching, hives, excessive sweating, skin redness
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.

5.

How to store Ibuprofen/Pseudoephedrine hydrochloride

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original container in order to protect from light.
Do not use this medicine after the expiry date which is stated on the bottle after Exp. The expiry
date refers to the last day of that month. Do not use this medicine after 3 months after first
opening. Shake the bottle well each time before use.
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 protect the environment.

6.

Contents of the pack and other information

What Ibuprofen/Pseudoephedrine hydrochloride contains
-

The active substances are Ibuprofen and Pseudoephedrine hydrochloride.
The other ingredients are glycerol, xanthan gum, maltitol liquid, polysorbate 80, saccharin
sodium, citric acid monohydrate, sodium methyl parahydroxybenzoate (E219), sodium

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propyl parahydroxybenzoate (E217), cherry flavour (consisting of: propylene glycol, water,
flavouring substances + flavouring preparations, trisodium citrate buffer) and purified
water.
What Ibuprofen/Pseudoephedrine hydrochloride looks like and contents of the pack
Ibuprofen/Pseudoephedrine hydrochloride is a sugar free and white in colour oral suspension with
cherry flavouring.
Pack-sizes:
Each bottle contains 100ml of oral suspension. A double-ended 5ml and 2.5ml polypropylene
spoon is also included to help measure the dose.
The Marketing Authorisation holder and manufacturer
Marketing Authorisation Holder:
Boehringer Ingelheim International GmbH
Binger Straße 173,
55216 Ingelheim am Rhein,
Germany
Manufacturer:
Percuro Medica Limited
2 Cunard Road
Park Royal
London NW10 6PN
United Kingdom
This leaflet was last revised in 10/2015.

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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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