NUROFEN SINUS RELIEF, NUROFEN COLD AND FLU - patient leaflet, side effects, dosage

Patient leaflet - NUROFEN SINUS RELIEF, NUROFEN COLD AND FLU

Nurofen Sinus Relief

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Nurofen Sinus Relief will be referred to as this medicine throughout this leaflet.

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.
– You must talk to a doctor if you do not feel better or if you start to feel worse.

What is in this leaflet:

1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

1. What this medicine is and what is it used for

This medicine contains two active ingredients (which make the medicine work). These are Ibuprofen and Pseudoephedrine Hydrochloride.

Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by reducing 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.

This medicine can be used in children older than 12 years and works in the following ways:

clears a blocked nose and sinuses
relieves aches, pains, headache and high temperature (fever)
eases the discomfort of a sore throat.

2. what you need to know before you take this medicinedo not take this medicine if you: are allergic to ibuprofen, pseudoephedrine or any of the other ingredients of this medicine (listed in section 6) or to aspirin or other non-steroidal antiinflammatory drugs

have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking aspirin or similar medicines
have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding
have had gastrointestinal bleeding or perforation when previously taking (nonsteroidal anti-inflammatory drugs) (NSAIDs).
are taking other NSAID painkillers or more than 75mg aspirin a day
have severe heart disease or very high blood pressure
have severe heart, kidney or liver problems
are in the last 3 months of pregnancy.
are under 12 years of age
are taking Monoamine Oxidase Inhibitors (for depression and known as MAOIs) or have taken these in the last 14 days.

Check with your pharmacist or doctor before taking this medicine if you:

have asthma
have Systemic Lupus Erythematosus (SLE)- an illness affecting the immune system causing joint pain, skin changes and other problems
have liver or kidney problems, especially in dehydrated children and adolescents, as kidney problems can be made worse
have high cholesterol or have previously had a heart attack or a stroke
have a history of gastrointestinal disease (such as ulcerative colitis, Crohn’s disease)
are a smoker
have an over-active thyroid
are diabetic, have a phaeochromocytoma, glaucoma or prostate problems
reduction of blood flow to your optic nerve may occur with this medicine. if you develop sudden loss of vision, stop taking this medicine and contact your doctor or seek medical attention immediately. See section 4.
have an infection – please see heading „Infections“ below

Infections

This medicine may hide signs of infections such as fever and pain. It is therefore possible that this medicine may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

Skin reactions

Serious skin reactions have been reported in association with this medicine. You should stop taking this medicine and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.

Taking other medicines

This medicine 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) as their affects may be increased
medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta- blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan) and diuretics as this medicine can reduce the effects of these drugs.
Corticosteroids, anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs) as there is an increased risk of gastrointestinal bleeding
Cardiac glycosides used to stimulate the heart.
medicines for depression (lithium, selective serotonin uptake inhibitors) may affect or be affected by treatment with pseudoephedrine.
Methotrexate as this medicine can increase plasma levels of these drugs.
This product should not be taken within 8–12 days of taking Mifepristone (for termination of pregnancy)
Zidovudine (for HIV treatment).
Quinolone antibiotics
When using Monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide) and/or Reversible inhibitors of monoamine oxidase A (RIMAs), or within 14 days of stopping treatment with these medicines.
Other sympathomimetic agents such as decongestants, amphetamine-like psychostimulants and appetite suppressants, as their effect may be increased by the pseudoephedrine contained in this medicine.
Oxytocin as there is a risk of increase in blood pressure.
Anticholinergics as they can affect the way that pseudoephedrine works.

Some other medicines may also affect or be affected by the treatment of this medicine. You should therefore always seek the advice of your doctor or pharmacist before you use this medicine with other medicines.

Other warnings

This medicine belongs to a group of medicines which may impair fertility in women. This is reversible on stopping the medicine. It is unlikely that this medicine, used occasionally, will affect your chances of becoming pregnant. However, tell your doctor before taking this medicine if you have problems becoming pregnant.
Anti-inflammatory/pain-killer medicines such as 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.
Sudden abdominal pain or rectal bleeding may occur with Nurofen Sinus Relief, due to inflammation of the colon (ischemic colitis). If you develop these gastrointestinal

symptoms, stop taking Nurofen Sinus Relief and contact your doctor or seek medical attention immediately. See section 4.

You should discuss your treatment with your doctor or pharmacist before taking this medicine 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 of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).
– have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
If you develop a feverish generalised erythema associated with pustules, stop taking Nurofen Sinus Relief and contact your doctor or seek medical attention immediately. See section 4.
Reduction of blood flow to your optic nerve may occur with this medicine. if you develop sudden loss of vision, stop taking this medicine and contact your doctor or seek medical attention immediately. See section 4.

Important information about the ingredients in Nurofen Sinus Relief:

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‚sodium-free‘.

3. how to take this medicine

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

Do not take it for longer than 10 days unless your doctor tells you to. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

The recommended dose is: Adults, the elderly and children of 12 years and older: Take 1 or 2 tablets with water, up to three times a day as required.

Leave at least 4 hours between doses.

Do not take more than 6 tablets in 24 hours.

Not suitable for children under 12 years.

Whilst taking this medicine:

If symptoms persist or pain or fever worsen, or if any new symptoms occur, consult your doctor or pharmacist.

If you have taken more of this medicine than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.

The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling and breathing problems have been reported.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP TAKING the medicine and seek immediate medical help if you develop:

Signs of intestinal bleeding such as:
– bright red faeces (stools/motions), black tarry stools, vomiting blood or dark particles that look like coffee grounds.
Signs of serious allergic reaction such as:
– Difficulties in breathing
– Dizziness or faster heartbeat
– Severe forms of skin reactions such as itchiness, skin rash with redness, peeling, flaking or blistering (e.g. Steven-Johnson syndrome)
– Swelling of your face, tongue or throat

signs of aseptic meningitis with neck stiffness, headache, feeling sick, being sick, fever or consciousness. Patients with autoimmune disorders (lupus, mixed connective tissue disease) may be more likely to be affected.
a severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
sudden onset of fever, reddening of the skin, or many small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis – AGEP) that may occur within the first 2 days of treatment with Nurofen Sinus Relief. See section 2.
A red, scaly widespread rash with bumps under the skin and blisters mainly localised on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). See also section 2.
inflammation of the colon due to insufficient blood supply (ischaemic colitis) (frequency not known).
– indigestion, heartburn or feeling sick
– pains in your stomach (abdomen) or other abnormal stomach problems
– hallucinations, restlessness or sleep disturbance

TELL YOUR DOCTOR if you have any of the following side effects, they become worse or you notice any effects not listed:

Uncommon may affect up to 1 in 100 people:

– allergic reactions, such as skin rashes (urticaria), itching, peeling
– headaches, tremors

Rare: may affect up to 1 in 1,000 people:

– flatulence (wind), diarrhoea, constipation and vomiting

Very rare: may affect up to 1 in 10,000 people:

– blood disorder resulting in unexplained or unusual bruising or bleeding, fever, sore throat, mouth ulcers, flu-like symptoms and severe exhaustion
– drop in blood pressure or irregular heart beat
– stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation of the lining of the mouth with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis)
– Liver and kidney problems, characterised by yellowing of the skin or eyes; swollen hands, legs, ankles or feet; dark-coloured or bloody urine; pale, bloody or tar like stools; fatigue; shortness of breath; decreased appetite; or tendency to bruise easily.

Not known: frequency cannot be estimated from the available data:

– worsening of asthma or bronchospasm
– swelling (oedema), high blood pressure, heart failure or attack, chest pain
– worsening of colitis and Crohn's disease or dry mouth
– decreased appetite, anxiety
– excessive sweating, muscle weakness, difficulty in urinating, thirst
– reduced blood flow to the optic nerve (Ischaemic optic neuropathy)
– skin becomes sensitive to light

5. how to store this medicine

Keep all medicines out of the sight and reach of children. Do not use after the expiry date shown on the pack.

Store in a dry place.

6. contents of the pack and other information

Each tablet contains the active ingredients ibuprofen 200mg and Pseudoephedrine Hydrochloride 30mg.

Also contains: Calcium Phosphate, Microcrystalline Cellulose, Polyvinyl Pyrrolidone, Sodium Carboxymethyl Cellulose, Magnesium Stearate, Hydroxypropylmethyl Cellulose, Talc, Titanium Dioxide, Quinoline Yellow and Sunset Yellow (contains Aluminium and E110), black printing ink (contains shellac, Iron Oxide Black (E172) and propylene glycol).

Nurofen Sinus Relief is available in packs of 12 and 24 tablets.

Licence Holder: Reckitt Benckiser Healthcare (UK) Ltd, Slough, SL1 4AQ.

Manufacturer: Reckitt Benckiser Healthcare International Ltd, NG90 2DB.

Product Licence No. PL 00063/0375

Date of revision February 2021