ADvil Cold and Sinus Tablets

ADvil Cold and Sinus tablets are used for the relief of symptoms associated with the common cold, sinusitis, or flu, such as blocked nose, headache, fever, body aches and pain. The active substance ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (known as NSAIDs), which reduce fever and relieve pain. The other active substance pseudoephedrine hydrochloride is a decongestant, which relieves nasal congestion.

Do NOT take ADVIL COLD and SINUS if:

• you are allergic to ibuprofen, any other nonsteroidal anti-inflammatory medicine, aspirin or any other pain or fever relieving medicine
• you are allergic to pseudoephedrine hydrochloride
• you are allergic to any other ingredient contained within the tablets (see “What ADVIL COLD and SINUS contains”)
• you have had or are suffering from asthma, recurrent ulcers or bleeding ulcers, any bleeding disorder, heart failure or any heart or blood pressure disorder, a liver disorder or a kidney disorder
• you have had or are suffering from prostatic hypertrophy (enlargement of the prostate gland), overactive thyroid, diabetes mellitus (sugar diabetes), glaucoma (an eye disease)
• you are pregnant or breast-feeding (see “Pregnancy and Breast-feeding”)
• you are taking a prescription monoamine oxidase inhibitor (medicine prescribed for depression, psychiatric or emotional conditions or Parkinson’s disease) or if it has been less than 14 days since you have stopped treatment with a monoamine oxidase inhibitor (MAOI).

ADVIL COLD and SINUS must not be given to children under 12 years.

Take special care with ADVIL COLD and SINUS:

• If you have trouble sleeping, take the last dose for each day several hours before bedtime.
• Do not drink alcoholic beverages while taking ADVIL COLD and SINUS, as stomach problems may be more likely to occur if you drink alcoholic beverages.
• The risk of gastrointestinal bleeding or ulceration is higher with increasing doses, in patients with a history of ulcers and the elderly.
• Serious skin reactions have been reported in association with NSAID therapy. Discontinue treatment at the first appearance of rash or any other sign of hypersensitivity and contact your doctor.

Ask your doctor or pharmacist for advice before taking ADVIL COLD and SINUS tablets if:

• you are older than 65 years.
• you are allergic to any other pain or fever relieving medicines, such as aspirin or other NSAIDs (see “Do not take ADVIL COLD and SINUS if”).

Ask your doctor or pharmacist for advice before taking ADVIL COLD and SINUS tablets if you have suffered or suffer from any other medical problem, or if you are under a doctor’s care for any continuing medical condition, for example:

• asthma, high blood pressure, heart failure or heart disease, fluid retention, hepatitis or other liver disease, kidney disease, diabetes mellitus (sugar diabetes)
• stomach or colon irritation or bleeding, colitis, Crohn’s disease, diverticulitis, stomach ulcer or other stomach or intestinal problems
• epilepsy, anaemia, systemic lupus erythematosus (SLE)
• bleeding problems.

Adults and children 12 years and older:

Take one tablet every 4 to 6 hours. If symptoms do not respond to one tablet, a second tablet may be taken. Do not take more than 6 tablets in any 24-hour period. ADVIL COLD and SINUS should be taken with a glass of water, with food or after meals. Do not take for a cold for more than 7 days or for fever for more than 3 days, unless directed by a doctor. If the cold or fever persists or gets worse, or if new symptoms occur, consult a doctor. Use the lowest effective dose for the shortest possible duration of treatment. Do not share medicines prescribed for you with any other person.

For safe and effective use of ADVIL COLD and SINUS, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your health care professional or as directed on the package label.

If you take more ADVIL COLD and SINUS than you should:

In case of accidental overdose, immediately consult your doctor or pharmacist. If neither is available, immediately contact the nearest hospital or poison control centre.

If you forget to take ADVIL COLD and SINUS:

Do not take double doses to make up for forgotten individual doses. Continue taking the tablets as directed on the label. Contact your healthcare professional for further advice.

ADVIL Cold & Sinus can have side effects. Stop taking ADVIL COLD and SINUS and get medical assistance right away if any of the following side-effects occur: fainting, facial swelling, fast or irregular breathing; shortness of breath, chest pain, wheezing or tightness in chest; fast or irregular heartbeat or pulse; unusual flushing or warmth of the skin; hive-like swellings on face, eyelids, mouth, lips or tongue; puffiness or swelling of eyelids.

Stop taking ADVIL COLD and SINUS and check with your doctor immediately if any of the following side-effects occur: abdominal or stomach pain, cramping or burning; bloody or black stools; chest pain, convulsions (seizures), fever with or without chills; severe or continuing nausea or heartburn or indigestion; sores or ulcers on lips or mouth; unexplained nosebleeds; unusual bleeding or bruising; spitting up blood; vomiting of blood or material that looks like coffee grounds; skin rash; hallucinations.

Also, check with your doctor as soon as possible if any of the following side-effects occur: bladder pain; bloody or cloudy urine; any problem with urination; blurred vision or any change in vision; ringing or buzzing in ears; bleeding from cuts and scratches that lasts longer than usual; severe headache; burning feeling in the throat, chest or stomach; mood or mental changes; unusual tiredness; yellow eyes or skin.

Other side-effects may occur. However, check with your doctor if any of the following side-effects continue or are bothersome: general feeling of discomfort or illness, dizziness, lightheadedness, heartburn, indigestion, nausea, bloated feeling, sensitivity to light (eyes or skin); trouble sleeping, nervousness, restlessness.

Not all side effects reported for ADVIL COLD and SINUS are included in this leaflet. If your general state of health worsens or if you experience any untoward effects while taking ADVIL COLD and SINUS, please consult your doctor, pharmacist or other healthcare professional for advice.

Store at or below 25 °C. Protect from light and exposure to air. Store in the original package. Do not use this medicine after the expiry date shown on the carton. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).