What is Paracetamol /Chlorpheniramine maleate /Pseudoephedrine Hydrochloride /Caffeine anhydrous and what is it used for This product consists of four active ingredients: paracetamol, chlorpheniramine maleate, pseudoephedrine hydrochloride and caffeine. Paracetamol is a medication that belongs to a class of medications known as analgesics (pain relievers) and antipyretics (fever reducers). Chlorpheniramine is an antihistamine that acts by decreasing the effects of histamine in your body and therefore helps in relieving allergy signs and symptoms, like, sneezing, watery eyes, itching, and runny nose. Pseudoephedrine 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. Caffeine is used to increase the absorption of paracetamol and thus enhances its analgesic effect. It is mainly used as a relief of the signs and symptoms of cold and flu including: • Headache • Congestion and sinus pain • Sneezing • Body aches • Itchy and watery eyes • Blocked and runny nose • Fever Do not take Paracetamol /Chlorpheniramine maleate /Pseudoephedrine Hydrochloride /Caffeine anhydrous • If you are allergic to Paracetamol, or Chlorpheniramine, or Pseudoephedrine Hydrochloride, or Caffeine, or other antihistamines 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 antihistamines or cough or cold and flu medications or decongestants. Make sure not to exceed the dose. • If you have high blood pressure or severe liver, kidney or heart problems. • If you have urinary retention. • If you have angle-closure glaucoma (type of elevated pressure in your eye). • If you are taking or have taken during the previous two weeks MAO inhibitors (used to treat depression), like, moclobemide. Do not give this medication to children less than 6 years old. 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. • Long term use of this medication may be harmful to your liver. • Contact your doctor if symptoms are not relieved after 3 days. • Do not drink alcohol when taking this medication. • Concomitant use of this medication with other medications that may cause drowsiness, like hypnotics (used for sleeping problems) and anxiolytics (used to treat anxiety) may cause excessive sedation. Therefore, make sure to avoid taking any of these medications together. • This medication contains pseudoephedrine which has been linked to cases of posterior reversible encephalopathy / reversible cerebral vasoconstriction syndrome (medical conditions affecting the brain). Symptoms of posterior reversible encephalopathy / reversible cerebral vasoconstriction syndrome include nausea, sudden onset of severe headache, visual disturbances, and vomiting. Contact your doctor if you experience any of these signs. • Talk to your doctor before starting this medication if you have an enlarged prostate, blood vessel problems, glutathione depletion (e.g. sepsis), high blood pressure, liver or kidney problems, heart or blood circulation problems, diabetes (high blood glucose levels), overactive thyroid, pheochromocytoma (a tumor on your adrenal glands of your kidneys) or glaucoma (high pressure in your eye). • Talk to your doctor before starting this medication if you are taking high blood pressure medications including beta blockers (used for some heart problems and high blood pressure) or tricyclic antidepressants (used to treat depression), like, amitriptyline and imipramine. • Talk to your doctor if you have a history of convulsions or respiratory problems (e.g. bronchial asthma, bronchitis and bronchiectasis). • This medication contains pseudoephedrine which has been linked to cases of ischemic colitis (decreased blood flow to your colon) that is manifested by signs and symptoms, like, rectal bleeding, abdominal pain, diarrhea, nausea, cramping or tenderness in your abdomen, urgency to pass stools, passing blood without stools and maroon or bright red blood in your stools. Stop taking the medication and contact your doctor or seek immediate medical help If you experience similar signs. • Make sure to avoid excessively taking products that contain caffeine (e.g. tea, coffee, and some canned drinks). Concomitant intake of this medication with caffeine containing products may cause tension and irritation. Possible side effects Possible side effects include signs of an allergic and skin reactions, 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, irregular or fast heartbeat, and signs of liver damage, like, yellowing of the eyes and skin. Other side effects include drowsiness, difficulty sleeping, fatigue, headache, hallucinations, twitching or jerking muscles, blurred vision, difficulty concentrating, dizziness, nausea, indigestion or vomiting, restlessness, dry mouth nose and throat, rapid heart rate, loss of coordination, nervousness and irritability and constipation. Other medicines and Paracetamol /Chlorpheniramine maleate /Pseudoephedrine Hydrochloride /Caffeine anhydrous 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 antihistamines or cough or cold and flu medications or decongestants. • If you are taking medications that may cause drowsiness, like hypnotics (used for sleeping problems) and anxiolytics (used to treat anxiety). • If you are taking appetite suppressants. • If you are taking opioid analgesics (type of painkillers). • If you are taking medications used to treat bladder problems and urinary tract infections. • If you are taking medications used to treat heart problems and high blood pressure including beta blockers (used for some heart problems and high blood pressure). • If you are taking chloramphenicol (antibiotic). • If you are taking alcohol. • If you are taking tricyclic antidepressants (used to treat depression), like, amitriptyline and imipramine. • If you are taking medications used to treat behavioral problems. • If you are taking medicines used to treat epilepsy (convulsions), like, phenytoin. • If you are taking or have taken during the previous two weeks MAO inhibitors (used to treat depression), like, moclobemide. How to take Paracetamol /Chlorpheniramine maleate /Pseudoephedrine Hydrochloride /Caffeine anhydrous Adults and children aged 12 years and over Take 1 tablet orally three times per day (1 tablet every 8 hours) as needed or as recommended by your doctor. Make sure not to exceed the dose. Children under 12 years Do not give Paracetamol /Chlorpheniramine maleate /Pseudoephedrine Hydrochloride /Caffeine anhydrous tablets to children below 12 years of age. • Take tablet with or without food. • Take tablet with a full glass of water. • Do not take a higher than recommended dose and do not take the medication more frequently than recommended. How to store Paracetamol /Chlorpheniramine maleate /Pseudoephedrine Hydrochloride /Caffeine anhydrous • Keep out of the reach of children and pets • Store this medicine in a cool dry place at a temperature below 25°C • 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 A valid prescription should be available upon delivery

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