What is Paracetamol/ Pseudoephedrine hydrochloride/ Diphenhydramine Hydrochloride and what is it used for Paracetamol is a medication that belongs to a class of medications known as analgesics (pain relievers) and antipyretics (fever reducers). Pseudoephedrine hydrochloride is a medication that belongs to a class of medicines known as “decongestants” and acts by decreasing nasal stuffiness that you may experience during cold and flu. Diphenhydramine hydrochloride is an antihistamine (allergy medication) that helps relieve allergy and cold and flu signs and symptoms, like, sneezing, cough, runny nose, itching, watery eyes, itchy nose, eyes and throat. Diphenhydramine also helps you sleep better if you are unable to sleep well due to pain. This combination is used for the fast relief of the cold and flu associated signs and symptoms, like, sore throat, cough, fever, headache, runny nose, muscle aches, stuffy and congested nose. Do not take Paracetamol/ Pseudoephedrine hydrochloride/ Diphenhydramine Hydrochloride • If you are allergic to Paracetamol, or Pseudoephedrine hydrochloride, or Diphenhydramine hydrochloride or other sympathomimetic medications (e.g. appetite suppressants, decongestants or stimulants) or any of the ingredients in this medicine. Tell your doctor about the allergy and what signs you had. • If you are taking other paracetamol containing products or other cold and flu medications or decongestants. Make sure not to exceed the dose. • If you are taking or have taken during the previous two weeks MAO inhibitors (used to treat depression), like, moclobemide. Warnings and precautions • Talk to your doctor or pharmacist if you develop allergic reactions such as shortness of breath, skin rash, swelling of the face or neck, decreased blood pressure and dizziness. • Make sure to tell your doctor if you have liver or kidney problems, including alcoholic liver disease or if you have mild arthritis (joints inflammation) and need to take painkillers on a daily basis. • Talk to your doctor immediately if you experience severe sore throat that persists for more than 2 days with headache, fever, rash, vomiting or nausea. • Long term use of this medication may be harmful to your liver. • This medication should only be taken when necessary. • Make sure to tell your doctor if you have previously experienced breathing problems after taking similar painkiller medications like aspirin and ibuprofen. • Do not use this medication for other purposes and do not share it with anyone. • Avoid drinking alcohol with this medication to avoid liver damage. • Talk to you doctor before starting the medication if you have trouble urinating due to an enlarged prostate, high blood pressure, liver or kidney problems, heart problems, diabetes (high blood glucose levels), overactive thyroid, breathing problems (e.g. chronic cough, cough due to smoking, cough with too much mucus, asthma, emphysema, chronic bronchitis) or glaucoma (high pressure in your eye). • Stop taking the medication and talk to your doctor if your symptoms are not relieved or are getting worse or last more than 7 days, if you experience persistent cough, rash, swelling or redness, headache or fever that is getting worse or lasts more than 3 days, or if new symptoms appear, or you get dizzy, nervous or sleepless. Possible side effects Possible side effects include signs of an allergic reaction, like rash and itching, signs of breathing problems like difficulty breathing (more likely to happen if you have previously experienced them after taking similar painkiller medications like aspirin and ibuprofen), sudden weight loss, nausea, yellowing of the skin and eyes, loss of appetite, unexplained bleeding or bruising, blood in your stools or sudden abdominal pain, sudden severe headache, skin peeling or rash, or mouth ulcers, difficulty urinating (rare but may happen in men with an enlarged prostate gland), irregular or fast heart rate and unusual tiredness. Common side effects include nervousness, vomiting, dry mouth, dizziness, nausea, sleeping problems and drowsiness. Other side effects include irregular or rapid heart rate, restlessness, agitation, hallucinations, high blood pressure, feelings of extreme happiness, confusion, ringing of the ears, blurred vision, headache, tremors, loss of coordination, tingling or numbness in the hands or feet, constipation, diarrhea, indigestion or stomach pain, chest discomfort, abnormalities in your liver function blood tests, weakness and tiredness and changes in blood pressure. Other medicines and Paracetamol/Pseudoephedrine hydrochloride/ Diphenhydramine Hydrochloride Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medications. • If you are taking metoclopramide or domperidone (used for vomiting or nausea). • If you are taking cholestyramine (used to lower blood cholesterol). • If you are taking blood thinning medications (e.g. warfarin) and you need to take a painkiller every day. Concomitant chronic use of painkillers and blood thinning medications may increase the risk of bleeding. • If you are taking other paracetamol containing products or other cold and flu medications or decongestants. • If you are taking medications for high blood pressure. • If you are taking tricyclic antidepressants (used to treat depression), like, amitriptyline and imipramine. • If you are taking sodium bicarbonate (used to treat indigestion and certain kidney conditions). • If you are taking sedatives or tranquilizers. • If you are taking or have taken during the previous two weeks MAO inhibitors (used to treat depression), like, moclobemide. • If you are taking alcohol. How to take Paracetamol/Pseudoephedrine hydrochloride/ Diphenhydramine Hydrochloride Adults and children aged 12 years and above: Take 2 tablets orally up to 4 times daily as needed. Make sure not to exceed 8 tablets in 24 hours. Children under 12 years Do not give Paracetamol/Pseudoephedrine hydrochloride/ Diphenhydramine Hydrochloride tablets to children below 12 years of age. • Swallow tablet with or without food. • Take tablet with a full glass of water. • Take exactly as described in this leaflet or as recommended by your doctor or pharmacist. • Do not take a higher than recommended dose. How to store Paracetamol/ Pseudoephedrine hydrochloride /Diphenhydramine hydrochloride • Store medication below 30°C • Keep out of the reach of children and pets • Do not use beyond the expiry date mentioned on the box • Keep medication in its original pack to protect it from moisture and light • Do not use damaged pills • Do not dispose medication in the wastewater or household waste

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