Demazin Cold and Flu. Ibuprofen 200 mg/30 mg Tablets

DEMAZIN COLD & FLU 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 Demazin Cold and flu:

• if you are hypersensitive (allergic) to ibuprofen, pseudoephedrine hydrochloride or any of the other ingredients of Demazin Cold and Flu (see section 6.)
• if you are hypersensitive (allergic) to any other nonsteroidal anti-inflammatory medicine, aspirin or any other pain or fever relieving medicine
• if 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
• if you have had or are suffering from prostatic hypertrophy (enlargement of the prostate gland), overactive thyroid, diabetes mellitus (sugar diabetes), glaucoma (an eye disease)
• if you are pregnant or breast-feeding (see “Pregnancy and Breastfeeding”)
• 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).

Demazin Cold and Flu must not be given to children under 12 years.

Warnings and precautions

Take special care with Demazin Cold & Flu:

• If you have trouble sleeping, take the last dose for each day several hours before bedtime.
• Do not drink alcoholic beverages while taking Demazin Cold and Flu, as side effects may be more likely to occur.
• 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.
• 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 Demazin Cold and Flu”).

Ask your doctor or pharmacist for advice before taking Demazin Cold and Flu 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, stomach ulcer or other stomach or intestinal problems
• epilepsy, anaemia, systemic lupus erythematosus (SLE) bleeding problems.

Other medicines and Demazin Cold and Flu

Always tell your health care provider if you are taking any other medicines. (This includes all complementary or traditional medicines.) Medicines that may interact with Demazin Cold and Flu tablets include:

• medicines to reduce the clotting of the blood
• medicines to treat diabetes
• medicines to reduce your blood pressure or medicines to stimulate the heart.
• lithium, methotrexate, corticosteroids, diuretics, quinolones, selective serotonin reuptake inhibitors (a class of antidepressant), alcohol, phenytoin, beta blockers, insulin, oral antidiabetic medicines, antiplatelets such as clopidogrel and ticlopidine
• aspirin, any other product that contains ibuprofen or any other pain or fever relieving medicine
• central nervous system stimulation - producing medicines, levodopa, quinidine, tricyclic antidepressants, halogenated anaesthetics, digitalis, thyroid hormones, citrates, nitrates
• monoamine oxidase inhibitors (see “Do not take Demazin Cold and Flu tablets”)
• any other medicine that contains pseudoephedrine hydrochloride or any other decongestant
• mifepristone should not be used for 8 – 12 days after taking Demazin Cold and Flu because it can weaken the effect of mifepristone
• appetite suppressants and medicines called amphetamine-like psycho stimulants may increase the risk of elevating blood pressure
• the effect of medicines called anti-cholinergic medicines for example tricyclic antidepressants may be increased.

Do not share medicines prescribed for you with any other person. Always take Demazin Cold and Flu exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are unsure.

The usual dose for adults and children 12 years and older is 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.

Demazin Cold and Flu 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. For safe and effective use of Demazin Cold and Flu, 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 Demazin Cold and Flu 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 Demazin Cold and Flu

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.

Demazin Cold and Flu can have side effects. Not all side effects reported for Demazin Cold and Flu are included in this leaflet. Should your general health worsen of if you experience any untoward effects while taking Demazin Cold and Flu, please consult your health care provider for advice.

If any of the following happens, stop taking Demazin Cold and flu and tell your doctor immediately or go to the casualty department at your nearest hospital:

• fainting
• facial swelling
• fast or irregular breathing
• shortness of breath
• chest pain
• wheezing or tightness in chest
• fast or irregular heart beat or pulse
• unusual flushing or warmth of the skin
• hive-like swellings on face, eyelids, mouth, lips or tongue

These are all very serious side effects. If you have them, you may have had a serious reaction to Demazin Cold and Flu. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately of go to the nearest hospital if you notice any of the following:

• 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

Tell your doctor if you notice any of the following:

Frequent side effects:

• burning feeling in the throat, chest or stomach
• dizziness
• heartburn, indigestion
• nausea
• trouble sleeping
• nervousness, feeling irritable, drowsiness
• restlessness

Less frequent side effects:

• bladder pain
• bloody or cloudy urine
• any problem with urination
• blurred vision or any change in vision
• ringing or buzzing in ears, change in hearing

Frequency of side effects unknown:

• sensitivity to light (eyes or skin)
• fear, confusion
• appetite decreased, feeling thirsty
• when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood. This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.

If you notice any of the side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

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).