
What is Paracetamol/Pseudoephedrine Hydrochloride/Diphenhydramine Hydrochloride and what is it used for?
Paracetamol belongs to a class of medications known as pain relievers and fever reducers. Pseudoephedrine hydrochloride belongs to a class of medications known as decongestants and works to reduce nasal congestion that you may experience during colds and flu. Diphenhydramine hydrochloride is an antihistamine (allergy medication) that helps relieve the signs and symptoms of allergies, colds, and flu, such as sneezing, coughing, runny nose, itchy and watery eyes, and itching of the 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 rapid relief of the signs and symptoms associated with colds and flu, such as sore throat, cough, fever, headache, runny nose, muscle aches, and blocked and congested nose.
Do not take paracetamol/pseudoephedrine hydrochloride/diphenhydramine hydrochloride
• If you are allergic to paracetamol, pseudoephedrine hydrochloride, diphenhydramine hydrochloride, or other sympathomimetic drugs (such as appetite suppressants, decongestants, or stimulants) or any of the ingredients in this medicine. Tell your doctor about the allergy and any signs you experience.
• If you are taking other products containing paracetamol, cold and flu medicines, or decongestants, make sure you do not exceed the dose.
• If you are taking or have taken within the last two weeks MAO inhibitors (used to treat depression), such as moclobemide.
Warnings and precautions
• Talk to your doctor or pharmacist if you experience allergic reactions such as shortness of breath, skin rash, swelling of the face or neck, low blood pressure and dizziness.
• Be sure to tell your doctor if you have liver or kidney problems, including alcoholic liver disease, or if you have mild arthritis and need to take pain relievers on a daily basis.
• Talk to your doctor immediately if you have a severe sore throat that lasts more than two days along with a headache, fever, rash, vomiting, or nausea.
• Long-term use of this medicine may be harmful to the liver.
• This medicine should be taken only when necessary.
• Be sure to tell your doctor if you have ever had breathing problems after taking similar pain relievers such as aspirin and ibuprofen.
• Do not use this medicine for other purposes and do not share it with anyone.
• Avoid drinking alcohol with this medicine to avoid liver damage.
• Talk to your doctor before starting treatment if you have trouble urinating due to an enlarged prostate, high blood pressure, liver or kidney problems, heart problems, diabetes (high blood sugar levels), overactive thyroid, breathing problems (such as chronic cough, cough due to smoking, cough with a lot of mucus, asthma, emphysema, chronic bronchitis) or glaucoma (high eye pressure).
• Stop taking the medicine and talk to your doctor if your symptoms are not relieved, get worse, or last for more than 7 days, if you have a persistent cough, rash, swelling, redness, headache, or fever that gets worse or lasts for more than 3 days, or if new symptoms appear, or you experience dizziness, nervousness, or sleeplessness.
Possible side effects
Possible side effects include signs of an allergic reaction, such as rash and itching; signs of breathing problems, such as difficulty breathing (more likely if you have previously experienced them after taking similar pain relievers such as aspirin and ibuprofen); sudden weight loss; nausea; yellowing of the skin and eyes; loss of appetite; unexplained bleeding or bruising; blood in the stool; sudden abdominal pain; sudden severe headache; peeling skin or rash; or mouth sores; difficulty urinating (rare but may occur 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, trouble sleeping, and drowsiness. Other side effects include insomnia, agitation, hallucinations, high blood pressure, feeling extremely happy, confusion, ringing in the ears, blurred vision, headache, loss of coordination, tingling or numbness in the hands or feet, constipation, diarrhea, indigestion or stomach pain, chest discomfort, abnormalities in blood tests for liver function, weakness and fatigue, 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 of the following medicines:
• If you are taking metoclopramide or domperidone (used for vomiting or nausea).
• If you are taking cholestyramine (used to lower blood cholesterol).
• If you take blood-thinning medications (such as warfarin) and need to take a pain reliever every day. Chronic use of pain relievers and blood-thinning medications may increase your risk of bleeding.
• If you are taking other products containing paracetamol, cold and flu medicines, or decongestants.
• If you are taking medication for high blood pressure.
• If you are taking tricyclic antidepressants (used to treat depression), such as amitriptyline and imipramine.
• If you are taking sodium bicarbonate (used to treat indigestion and some kidney diseases).
• If you are taking sedatives.
• If you are taking or have taken within the past two weeks MAO inhibitors (used to treat depression), such as moclobemide.
• If you drink alcohol.
How to take Paracetamol/Pseudoephedrine Hydrochloride/Diphenhydramine Hydrochloride
Adults and children 12 years and older
Take two tablets orally up to four times daily as needed. Do not exceed eight tablets in any 24-hour period.
Children under 12 years old
Do not give Paracetamol/Pseudoephedrine Hydrochloride/Diphenhydramine Hydrochloride tablets to children under 12 years of age.
• Swallow the tablet with or without food.
• Take the 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 dose than recommended.
How to store Paracetamol/Pseudoephedrine Hydrochloride/Diphenhydramine Hydrochloride
• Store the medicine at a temperature below 30°C.
• Keep this medicine out of reach of children and pets.
• Do not use the medicine after the expiry date shown on the carton.
• Keep the medicine in its original package to protect it from moisture and light.
• Do not use damaged grains.
• Do not dispose of medicines in wastewater or household waste.