Fludrex syrup 120 ml

Paracetamol / Chlorpheniramine / Pseudoephedrine Hydrochloride

What is Paracetamol 120 mg/Chlorpheniramine 15 mg/Pseudoephedrine Hydrochloride 0.75 mg used for?

This product consists of three active ingredients:

• Paracetamol, Chlorpheniramine, and Pseudoephedrine Hydrochloride.
• Paracetamol is a medicine that belongs to a class of drugs known as analgesics (pain relievers) and antipyretics (fever reducers).
• Chlorpheniramine is an antihistamine that works by reducing the effects of histamine in the body and thus helps relieve allergy signs and symptoms such as sneezing, watery eyes, itching, and runny nose.
• Pseudoephedrine belongs to a class of medications known as decongestants and works to reduce nasal congestion that you may experience during colds and flu.
• It is used for nighttime relief of cold and flu symptoms.

It is used to relieve the following symptoms:

• headache
• Sinus congestion and pain
• sneezing
• body aches
• watery and itchy eyes
• stuffy and runny nose
• fever

Do not take Paracetamol/Chlorpheniramine/Pseudoephedrine Hydrochloride:

• If you are allergic to paracetamol, chlorpheniramine, pseudoephedrine hydrochloride, other antihistamines, or any of the ingredients in this medicine.
• Tell your doctor about allergies and any signs you have.
• If you are taking other products containing paracetamol, other antihistamines, cough, cold and flu medicines, or decongestants.
• Make sure not to exceed the dose.
• If you have high blood pressure or severe kidney or heart problems.
• If you are taking or have taken within the past 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, rash, swelling of the face or neck, low blood pressure, or dizziness.
• Be sure to tell your doctor if you have liver or kidney problems, including alcoholic liver disease, or if you have mild arthritis (arthritis) and need to take painkillers on a daily basis.
• Long-term use of this medication may be harmful to the liver.
• Contact your doctor if symptoms do not relieve.
• Do not drink alcohol when taking this medicine.
• Concomitant use of this medication with other medications that may cause drowsiness, such as hypnotics (used to treat sleep problems) and anxiolytics (used to treat anxiety), may cause excessive sedation. Therefore, be sure to avoid taking any of these medications together.
• This medication contains pseudoephedrine, which has been linked to cases of reversible posterior encephalopathy/reversible cerebral vasoconstriction syndrome (RCVS) (medical conditions affecting the brain). Symptoms of RVES/RCVS 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 (such as sepsis), high blood pressure, liver or kidney problems, heart or circulation problems, diabetes (high blood sugar levels), overactive thyroid, pheochromocytoma (tumor of the adrenal glands in the kidneys), or glaucoma (high pressure in your eye).
• Talk to your doctor before starting this medicine 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), such as amitriptyline and imipramine.
• Talk to your doctor if you have a history of seizures or respiratory problems (such as asthma, bronchitis, and bronchiectasis).
• This medication contains pseudoephedrine, which has been linked to cases of ischemic colitis (reduced blood flow to the colon) manifested by signs and symptoms such as rectal bleeding, abdominal pain, diarrhea, nausea, abdominal cramping or tenderness, urgent need to have a bowel movement, passing blood without a bowel movement, and maroon or bright red blood in your stool. Stop taking the medication and contact your doctor or seek medical help right away if you experience similar signs.

Possible side effects:

• Possible side effects of paracetamol/chlorpheniramine/pseudoephedrine hydrochloride include signs of an allergic reaction, such as rash and itching, signs of breathing problems such as difficulty breathing (more likely to occur if you have previously experienced them after taking similar painkillers such as aspirin and ibuprofen), sudden weight loss, nausea, yellowing of the skin and eyes, loss of appetite, unexplained bleeding or bruising and irregular or rapid heartbeat.

Other side effects include:

• Drowsiness or drowsiness, difficulty sleeping, fatigue, headache, hallucinations, muscle twitching or shaking, nervousness, blurred vision, difficulty concentrating, agitation, dizziness, nausea, indigestion or vomiting
• Dry mouth, nose and throat, rapid heartbeat, loss of coordination, nervousness and irritability.
• Other medicines and paracetamol/chlorpheniramine/pseudoephedrine hydrochloride

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 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, other antihistamines, cough, cold and flu medicines, or decongestants.
• If you are taking medicines that may cause drowsiness, such as hypnotics (used for sleep problems) and anxiolytics (used to treat anxiety).
• If you are taking appetite suppressants.
• If you are taking opioid painkillers (a type of painkiller).
• If you are taking medications to treat bladder problems and urinary tract infections.
• If you are taking medicines 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 (an antibiotic).
• If you drink alcohol.
• If you are taking tricyclic antidepressants (used to treat depression), such as amitriptyline and imipramine.
• If you are taking medication to treat behavioral problems.
• If you are taking medicines to treat epilepsy (seizures), such as phenytoin.
• If you are taking or have taken within the past two weeks MAO inhibitors (used to treat depression), such as moclobemide.

How to use Paracetamol/Chlorpheniramine/Pseudoephedrine Hydrochloride:

Children from 6 to 12 years:

• Two teaspoons (10 ml) 3 times daily (every 8 hours).
• Or as directed by a specialist physician.

How to store paracetamol/chlorpheniramine/pseudoephedrine hydrochloride

• Keep out of reach of children and pets.
• Store this medicine in a cool, dry place at a temperature below 30°C.
• Do not use after the expiry date printed 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.