Benylin Four Flu Tablets

BENYLIN FOUR FLU TABLETS contains an analgesic (paracetamol), an antihistamine (diphenhydramine) and a decongestant (pseudoephedrine). It belongs to a class of medicines which is used to relieve the symptoms of colds and flu. BENYLIN FOUR FLU TABLETS is used to help relieve cough, congestion, fever and body pains. Paracetamol is an analgesic and an antipyretic which acts to relieve pain and fever (high temperature). Diphenhydramine is an antihistamine which helps to relieve coughing. Pseudoephedrine is a decongestant which helps unblock stuffy noses.

Do not take BENYLIN FOUR FLU TABLETS if you or your child:

• Are hypersensitive (allergic) to diphenhydramine, pseudoephedrine hydrochloride, paracetamol or any of the other ingredients of BENYLIN FOUR FLU TABLETS (listed in section 6).
• Suffer from high blood pressure, heart disease or an over-active thyroid.
• Have phaeochromocytoma (rare tumour which affects your heart rate and blood pressure).
• Suffer from closed angle glaucoma (pressure in the eye).
• Suffer from severe liver problems.
• Are going to have surgery and cyclopropane, halothane, or other halogenated anaesthetic medicines are going to be used.
• Are taking medicines known as monoamine oxidase inhibitors (MAOIs).
• If your child is under the age of 6 years.
• Have difficulty urinating or emptying your bladder (urinary retention) or if you have prostate disease.
• Are taking sympathomimetics (medicines used to treat congestion and asthma), beta-blockers, paracetamol or diphenhydramine-containing medicines.
• Are diabetic (high blood sugar levels).
• Suffer from a severe kidney disease.

Warnings and precautions

Take special care with BENYLIN FOUR FLU TABLETS:

• If you or your child suffer from any respiratory diseases such as emphysema (lungs are enlarged and damaged), persistent inflammation of the bronchi (chronic bronchitis) or acute or persistent bronchial asthma.
• If you are regularly consuming a large amount of alcohol (chronic alcoholism).
• If you or your child take medicines which make you drowsy or give you a dry mouth (sometimes called anti-cholinergics) while you are taking BENYLIN FOUR FLU TABLETS the chances of these side-effects are increased (see Other medicines and BENYLIN FOUR FLU TABLETS).
• If you or your child suffer from fits (seizures).
• If you are elderly.
• If you suffer from a persistent cough such as occurs with asthma or produce a lot of mucus (phlegm).

BENYLIN FOUR FLU TABLETS can make some people feel drowsy or cause difficulty in concentration. Make sure that you or your child are not affected if you are going to do anything where you need to be alert. Be especially careful if you are taking another medicine which may also cause drowsiness. If symptoms persist or get worse, or if new symptoms occur, you should stop using BENYLIN FOUR FLU TABLETS and consult a doctor.

Stop taking BENYLIN FOUR FLU TABLETS if the following happens to you or your child:

• You suddenly develop a skin rash, or small pustules, with or without fever, after starting treatment with BENYLIN FOUR FLU TABLETS.
• You develop any skin adverse reaction, such as toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS) or drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE), treatment with BENYLIN FOUR FLU TABLETS must immediately be discontinued. These reactions can be life-threatening and are characterised by redness, inflamed or swollen skin, blisters, hives, itching and sometimes peeling or pain. Should you or your child experience any of these symptoms, contact your health care provider immediately.
• You suddenly develop symptoms such as pain in your stomach area, blood in your stool, nausea (feeling sick) or vomiting (being sick) (signs of ischaemic colitis).

Do not share medicines with any other person. For adults, the elderly and children 12 years and older: The usual dose is two tablets 4 times a day. Do not exceed 8 tablets in 24 hours. For children aged 6 to less than 12 years: The usual dose is one tablet 4 times a day. Do not exceed 4 tablets in 24 hours. Children under 6 years Not recommended. For oral use only. BENYLIN FOUR FLU TABLETS can be taken with or without food. Always take BENYLIN FOUR FLU TABLETS 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.

If you have the impression that the effect of BENYLIN FOUR FLU TABLETS is too strong or too weak, tell your doctor or pharmacist.

If you take more BENYLIN FOUR FLU TABLETS than you should In the event of an overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take along any medicine that is left and the carton so that the hospital can easily tell what medicine you have taken. Immediate medical advice should be sought in the event of an overdose even if you feel well because of the risk of delayed serious liver damage.

If you forget to take BENYLIN FOUR FLU TABLETS If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for forgotten individual doses.

BENYLIN FOUR FLU TABLETS can have side effects. Not all side effects reported for BENYLIN FOUR FLU TABLETS are included in this leaflet. Should your or your child’s general health worsen or if you experience any untoward effects while taking BENYLIN FOUR FLU TABLETS, please consult your health care provider for advice.

If any of the following happens, stop taking or giving BENYLIN FOUR FLU TABLETS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash, hives or itching;
• fainting.

These are all very serious side effects. If you or your child have them, you may have had a serious allergic reaction to BENYLIN FOUR FLU TABLETS. 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:

• bleeding or bruising more easily than normal;
• frequent infections such as fever, severe chills, sore throat or mouth ulcers;
• fits (seizures);
• stroke (sudden numbness or weakness in the face, arm or leg, especially on one side of your body);
• changes in the way your heart beats (beating faster, slower or irregular);
• chest pain;
• heart failure (shortness of breath, fatigue and weakness, swelling of the legs, ankles and feet, rapid or irregular heartbeat, persistent cough with white or pink phlegm);
• heart attack (pain in your chest, back, jaw and other areas of your upper body that lasts more than a few minutes or that goes away and comes back, shortness of breath);
• difficulty breathing;
• water in your lungs (trouble breathing or feeling like you are suffocating, a bubbly, wheezing or gasping sound when you breathe);
• sudden skin eruptions (pustules) arising within large areas of red swollen skin;
• difficulty urinating, pain when urinating, inability to empty your bladder completely;
• yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems.

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

Tell your doctor if you notice any of the following: Side effect occurring frequently:

• sedation (depressed consciousness);
• difficulty falling or staying asleep (insomnia);
• nervousness;
• headache or dizziness;
• sleepiness (varying from drowsiness to deep sleep), lack of energy, lack of coordination;
• feeling abnormally excited;
• slowing down of physical and emotional reactions, including speech and affect;
• blurred vision;
• upset stomach, nausea (feeling sick), dry mouth;
• thickened mucus;
• abnormal physical weakness or lack of energy.

Side effects occurring less frequently:

• anaemia (fatigue, loss of energy, pale skin, cramps in your legs, difficulty with concentration);
• pain in the upper, middle region of your stomach;
• nausea (feeling sick);
• redness of your skin;
• lack/loss of appetite (anorexia), increased appetite, altered metabolism including changes in your blood sugar levels;
• unrealistic feeling of well-being;
• feeling anxious, confused, irritable, agitated, depressed, restless;
• psychosis (a mental disturbance in which you cannot distinguish between reality and imagination; seeing or hearing things that do not exist;
• tremors (involuntary trembling or shaking of your hands and feet);
• extrapyramidal symptoms (characterised by continuous spasms and muscle contractions;
• abnormal coordination;
• tingling or numbness of your hands and feet (pins and needles);
• ringing in your ears;
• low blood pressure or high blood pressure;
• chest discomfort, chest discomfort, dry throat, nasal dryness;
• vomiting (being sick), diarrhoea, constipation, increased saliva, pain in your stomach, indigestion;
• sweating;
• feeling weak, including muscle weakness;
• increased liver enzymes (transaminase) when blood tests are done.

Side effects occurring with unknown frequency:

• too low levels of potassium when blood tests are done (weakness and fatigue, muscle cramps and pain).

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

Reporting of side effects If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of BENYLIN FOUR FLU TABLETS.

For further information, please contact the Consumer Care Contact Centre on email: [email protected].

• Keep in the original container until required for use.

• Store all medicines out of reach of children.

• Store at or below 25 °C.

• Store in a dry place, protected from light.

• Do not use after the expiry date stated on the label / carton.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).