Flusin S Effervescent 50 mg/4 mg/500 mg/330 mg Tablets

FLUSIN S EFFERVESCENT belongs to a group of medicines called analgesics and antipyretics. FLUSIN S EFFERVESCENT is used to relieve the symptoms of colds and flu in adults and children 12 years or older.

Do not take FLUSIN S EFFERVESCENT:

• If you are hypersensitive (allergic) to chlorphenamine maleate, pseudoephedrine hydrochloride, paracetamol or vitamin C or any of the other ingredients of FLUSIN S EFFERVESCENT (listed in section 6).
• If you have any disease of the heart and blood vessels (angina, ischaemic heart disease, peripheral vascular disease, dysrhythmia or tachycardia).
• If you are pregnant or breastfeeding.
• For a child under the age of 12 years old.
• If you are sensitive to any antihistamines (medicines used to treat symptoms of allergies).
• If you are receiving monoamine oxidase inhibitor antidepressant treatment, or if you stopped this treatment less than 14 days ago.
• If you suffer from severe liver disease, inflammation of the liver or if you are recovering from any form of liver disease.
• If you suffer from severe kidney disease.
• If you are about to have surgery and will need a general anaesthetic; as halothane or other halogenated anaesthetics may bring about an uncoordinated rapid heartbeat (ventricular fibrillation).
• If you suffer from high blood pressure (hypertension), or if you take a certain medicine called beta blockers to lower your blood pressure you should not take FLUSIN S EFFERVESCENT.
• If you have an overactive thyroid (hyperthyroidism).
• If you have a tumour in your adrenal gland (phaeochromocytoma).
• If you suffer from closed angle glaucoma, a condition where your pupil changes and becomes too big (dilated) too quickly and pressure is raised in your eye.
• If you have too much oxalate in your urine (hyperoxaluria).
• If you suffer from diabetes mellitus (a condition where your blood glucose levels are too high).

Warnings and precautions

FLUSIN S EFFERVESCENT contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately.

FLUSIN S EFFERVESCENT may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressants e.g. sedatives and tranquilizers. Caution should be used when driving a motor vehicle or operating machinery or performing potentially dangerous tasks, where loss of concentration may lead to accidents.

Do not share medicines prescribed for you with any other person. Always take FLUSIN S EFFERVESCENT exactly as described in this leaflet or as your doctor, or pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.

The usual dose of FLUSIN S EFFERVESCENT is:

Adults and children over 12 years of age: Take one tablet every 6 hours if necessary. DO NOT EXCEED THE RECOMMENDED DOSE. Place one tablet in a glass of warm water and allow to dissolve. Drink the contents immediately once the whole tablet has dissolved.

If you find that FLUSIN S EFFERVESCENT is too strong or too weak, talk to your doctor or pharmacist. Do not use continuously for more than 7 days without consulting your doctor.

If you take more FLUSIN S EFFERVESCENT than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. FLUSIN S EFFERVESCENT contains paracetamol, which is very harmful when taken in high amounts.

If you forget to take FLUSIN S EFFERVESCENT

Do not take a double dose to make up for forgotten individual doses. If you have missed a dose of FLUSIN S EFFERVESCENT, take the dose that you have missed as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. If you have forgotten to take several doses, contact your doctor without delay.

FLUSIN S EFFERVESCENT can have side effects. Not all side effects reported for FLUSIN S EFFERVESCENT are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FLUSIN S EFFERVESCENT, please consult your healthcare provider for advice.

If any of the following happens, stop taking FLUSIN S EFFERVESCENT and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens - Johnson Syndrome (SJS). Severe Cutaneous Adverse Reactions (SCARS) such as toxic epidermal necrolysis (TEN), Steven - Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), Drug reaction with eosinophilia and systemic symptoms (DRESS)/Drug - induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE). These are all very serious side effects. If you have them, you may have had a serious reaction to FLUSIN S EFFERVESCENT. You may need urgent medical attention or hospitalisation.

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

• Rapid, slow or uneven heartbeats (tachycardia, bradycardia and dysrhythmias),
• pain in the chest with pressure heaviness and tightness (anginal pain, tightness of the chest),
• feeling in the chest that the heart is beating too fast (palpitations),
• sudden loss of heart function, breathing and consciousness (cardiac arrest),
• rise in blood pressure (hypertension),
• inflammation in your liver (hepatitis), including jaundice and liver dysfunction which can present as yellowing of the skin and eyes, dark urine and tiredness,
• blood disorders such as decrease in white blood cells (leucopenia, neutropenia and agranulocytosis), decrease in red blood cells (anaemia and haemolytic anaemia), decrease in most blood cells (pancytopenia) and a decrease in platelets (thrombocytopenia). The first symptoms may include fever, sore throat, surface mouth ulcers, flu - like symptoms, severe tiredness, nasal and skin bleeding or unexplained bruising,
• seeing or hearing things that are not really there (hallucination) and psychotic states,
• difficulty breathing (dyspnoea),
• inflammation of your pancreas, characterised by stomach pain, nausea and vomiting (pancreatitis),
• symptoms such as, but not limited to severe headache, weakness, tingling or numbness in the arms and legs, nausea, difficulty in speaking or understanding speech as this may be due to a bleed in the brain (cerebral haemorrhage),
• excess fluid in the lungs (pulmonary oedema) which causes difficulty breathing, chest pain and tiredness,
• restricted airflow to the lungs (bronchospasm) in those that are allergic to aspirin or other non - steroidal anti - inflammatory drugs (NSAIDS),
• slurred speech and difficulty in movement with muscle spasms and muscle pain,
• painful urination, blood in your urine, cloudy urine, fever as these may be due to a kidney stone is stuck in the urinary tract (renal colic),
• fits (convulsions/seizures).
• symptoms such as, but not limited to, nausea, vomiting, muscle cramps, loss of appetite, swelling of the feet and ankles, dry and itchy skin, shortness of breath as these may be due to a deterioration in kidney function (renal failure),
• if you experience visual disturbances, seizures, headaches and altered mentation this may be a sign of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) a rare condition in which parts of the brain are affected by swelling, you should discontinue the use of FLUSIN S EFFERVESCENT and consult your healthcare professional.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Inability to fall asleep and staying asleep (insomnia), feeling anxious, restlessness,
• fear, confusion, irritability,
• involuntary quivering movement (tremor),
• dizziness,
• feeling weak, sweating,
• tolerance with dependence,
• slight drowsiness to deep sleep (sedation),
• excessive sleepiness, mental weariness, lack of energy (somnolence, lassitude, asthenia),
• inability to use different parts of the body efficiently (incoordination) or clumsy balance and limb movements (ataxia),
• blurred vision,
• nausea, dry mouth.

Less frequent side effects:

• Headache,
• vomiting,
• lesions in the mouth (mucosal lesions),
• itchy, raised, red or skin coloured bumps on the skin (urticaria, erythematous reactions, pruritus),
• loss of appetite, constipation,
• low levels of potassium in the blood (hypokalaemia),
• low blood pressure (hypotension),
• increased saliva in the mouth (hypersalivation),
• difficulty and pain in passing urine (urinary retention, micturition, dysuria),
• changes in blood sugar levels,
• nervousness, excitement and happiness (euphoria),
• nightmares,
• feeling tired (fatigue),
• abnormal sensation, feeling of pins and needles (paraesthesias),
• involuntary movements that you cannot control (extrapyramidal effects),
• ringing in the ears (tinnitus),
• thickening of mucous,
• when stomach acid irritates the food pipe lining (gastric reflux, dyspepsia),
• stomach pain, diarrhoea,
• pain in muscles or a group of muscles (myalgia),
• fever.

Side effects with an unknown frequency:

• Feeling of being threatened in some way (paranoid delusions),
• condition where blood does not flow properly to your eye's optic nerve, eventually causing lasting damage to this nerve (Ischaemic optic neuropathy),
• inflammation and injury of the large intestine (ischaemic colitis),
• an eating disorder where you don’t want to eat (anorexia),
• depression,
• heaviness and weakness of the hands, muscle spasms,
• dryness of the respiratory passages,
• rash due to sun exposure (photosensitivity), skin irritation and rashes (dermatitis),
• increase in body temperature caused by a medicine (drug fever),
• hair loss,
• involuntary (unintended) muscle contractions that cause slow repetitive movements or abnormal postures that can sometimes be painful (dystonia),
• frequent urination,
• increased blood flow to the skin (flushing),
• stomach cramps,
• kidney stones (formation of calcium oxalate calculi, increased urinary oxalate excretion),
• inability to stay still or sit still (psychomotor hyperactivity),
• increased transaminases in your blood which could mean that you have liver damage,
• white blood cells in the urine with no detection of bacteria (sterile pyuria),
• headache, nausea, vomiting, confusion, dizziness, feeling weak or tired, loss of appetite and increased heartbeat due to high acid levels in the body (metabolic acidosis or pyroglutamic aciduria).

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

Store all medicines out of reach of children. Store in a cool place at or below 25 °C. Keep tube tightly closed. Keep in original packaging until required for use.

• Do not store in a bathroom.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).