Package leaflet: Information for the patient Ibuprofen/Pseudoephedrine hydrochloride 100mg/15mg per 5ml Oral Suspension

Ibuprofen and Pseudoephedrine hydrochloride

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:

-    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 anti

inflammatory 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.

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)

-    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 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 <dose>, i.e. essentially ‘sodium- free’.

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.

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 10,000people)

-    Changes in the blood clotting capacity of the blod, increasing risk of bleeding (thrombocytopenia); (very rare, may affect up to 1 in 10,000people)

-    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 10,000people)

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 100people):

-    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):

-    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 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 StraBe 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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