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

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

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Package leaflet: Information for the patient
Ibuprofen/Pseudoephedrine hydrochloride 100 mg/15 mg 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 15 years and over: You must talk to a doctor if you do not feel better or if you
feel worse after 3 days.
For adults: 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 is and what it is used for
2.
What you need to know before you take Ibuprofen/Pseudoephedrine hydrochloride
3.
How to take 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 15 and older.

2.

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

Do not take Ibuprofen/Pseudoephedrine hydrochloride:
if you are allergic to ibuprofen, pseudoephedrine hydrochloride or any of the other ingredients
of this medicine (listed in section 6).
if you are less than 15 years old.
if you have or have ever had an allergic reaction or wheezing after taking other antiinflammatory pain killers (NSAIDs).
Ibu/Pseudo/Susp/MAT/PIL

-

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if you take other similar medicines.
if 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.
if you have or have ever had a stomach ulcer or other gastric complaint.
if 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.
if you are pregnant or breastfeeding.
if you have or have ever had bleeding in your brain.
if you have or have ever had unexplained blood clotting problems.
if you have a history of :
• seizures
• stroke
• heart attack
if 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
if 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”).
if you have high blood pressure, diabetes, high cholesterol, have a family history of heart
disease or stroke, or if you are a smoker.
if you are diagnosed with psychosis.
if 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.
if you have had seizures or changes in behaviour when you have used medicines containing the
same active substances before.
if you are older and have urinary disorders.
if you have surgery scheduled.
if you are an athlete, as this pseudoephedrine present in this medicine can lead to positive results
in doping tests.
if you are scheduled to have blood tests.
if you have asthma or have suffered from asthma.
if you have a history of ulcer or bleeding in your stomach.
if 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.
Children and adolescents
Ibuprofen/Pseudoephedrine hydrochloride is contraindicated in children less than 15 years old.
There is a risk of renal impairment in dehydrated adolescents.
Other medicines and Ibuprofen/Pseudoephedrine hydrochloride
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Ibu/Pseudo/Susp/MAT/PIL

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)

-

medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers
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 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 15 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
Ibu/Pseudo/Susp/MAT/PIL

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 an 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 dose, i.e. essentially ‘sodium- free’.

3.

How to take Ibuprofen/Pseudoephedrine hydrochloride

Always take this medicine exactly as described in the leaflet or as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults and adolescents aged 15 years and above: Depending on the severity of the symptoms 10 ml to
20 ml every six hours. Never exceed the maximum daily dose of 60 ml.
-

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 15 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 cup 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.
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.

Ibu/Pseudo/Susp/MAT/PIL

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:
Uncommon: may affect up to 1 in 100 people
Stomach or intestinal ulcers
Worsening of colitis and Crohn's disease.
Rare: may affect up to 1 in 1,000 people
Kidney problems (papillary necrosis) and increased uric acid concentrations in the blood
Very rare: may affect up to 1 in 10,000 people
Worsening of infectious inflammations
If you observe stiff neck, headache, nausea, vomiting, fever or disorientation in patients with
pre-existent autoimmune diseases (SLE, mixed connective tissue disease) (aseptic meningitis);
Decreased number of white blood cells (leucopenia)
Changes in the blood clotting capacity of the blood, increasing risk of bleeding
(thrombocytopenia);
Severe reduction in blood cells which can cause weakness, bruising or make infections more
likely (pancytopenia)
Severe reduction in number of white blood cells which makes infections more likely
(agranulocytosis)
Low number of the most important type of white blood cells in the blood (neutropenia)
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.
Psychotic reactions
Heart attack
Inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis)
Liver failure
Inflammation of the liver (hepatitis)
Severe skin infections and /or blistering, peeling off of the skin (erythema multiforme, Toxic
epidermal necrolysis);
Not known: frequency cannot be estimated from the available data
Stroke
Chest pain
Irregular heart beats
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, stomach ache, loss of appetite
Feeling & being sick
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Diarrhoea, wind or constipation

Uncommon: may affect up to 1 in 100 people
Allergic reactions with signs such as hives, itching, skin rash and asthma attacks (with drop in
blood pressure)
Headache, dizziness, sleeplessness, agitation, irritability or tiredness
Difficulty in seeing
Rare: may affect up to 1 in 1,000 people
Nervousness, anxiety, restlessness, tremor, hallucinations
Ringing in your ears
Worsening of asthma
Very rare: may affect up to 1 in 10,000 people
Disorders of the blood such as anaemia
Depression
Swelling (oedema), high blood pressure, feeling your heartbeat
Inflammation of the throat due to reflux (oesophagitis)
Yellowing of the eye and/or skin, which may be a sign of liver problems
Hair loss
Soft-tissue complications in a chickenpox infection
Not known: frequency cannot be estimated from the available data
Abnormal behaviour
Fits
Rapid heart beats
Dry mouth, thirst, nausea, vomiting
Rash, itching, hives, excessive sweating, skin redness
Difficulties passing urine in men with enlarged prostate gland
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 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 store above 25°C. Store in the original container in order to protect from light.
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.

Ibu/Pseudo/Susp/MAT/PIL

6.

Contents of the pack and other information

What Ibuprofen/Pseudoephedrine hydrochloride contains
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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 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:
Ibuprofen/Pseudoephedrine hydrochloride is available in 100 ml and 180 ml bottles. Not all pack sizes
may be marketed.
A polypropylene 20 ml measuring cup with a 10 ml graduation is included to help measure the dose.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
United Kingdom
Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi.com
Manufacturer
Istituto De Angeli S.r.l.
Loc. Prulli, 103/C
50066 Reggello (Firenze)
Italy
This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany
BoxaGrippal Erkältungssaft 200 mg/10 ml + 30 mg/10 ml Suspension zum
Einnehmen
United Kingdom
Ibuprofen/Pseudoephedrine hydrochloride 100mg/15mg per 5 ml Oral
suspension

This leaflet was last revised in August 2017

Ibu/Pseudo/Susp/MAT/PIL

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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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