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FEDLORA is a medicinal product contains two active substances, Loratadine and Pseudoephedrine. Loratadine is a potent long acting tricyclic antihistamine with selective peripheral H1-receplor antagonistic activity. Pseudoephedrine sulfate, one of the naturally occurring alkaloids of Ephedra and an orally administered vasoconstrictor, produces a gradual but sustained decongestant effect facilitating shrinkage of congested mucosa in upper respiratory areas. The mucous membrane of the respiratory tract is decongested through the action of the sympathetic nerves. FEDLORA relieves symptoms associated with allergic rhinitis (hay fever), such as: Nasal and sinus congestion. Sneezing. Runny nose. Watery, Itchy eyes. FEDLORA contains a combination of two medicines: loratadine (an antihistamine) and pseudoephedrine (a decongestant). Antihistamines help reduce allergic symptoms by preventing the effects of a substance called histamine. Histamine is produced by the body in response to foreign substances which the body is allergic to. Decongestants produce narrowing of blood vessels. This leads to clearing of the stuffy or blocked nose. Your doctor or pharmacist, however, may prescribe FEDLORA for another purpose. Ask your doctor or pharmacist if you have any questions about why FEDLORA has been prescribed for you. How to use Adults and children 6-12 years of age (body weight > 30 Kg): 5 ml syrup (one teaspoonful) twice a day (every 12 hours). Do not give to children below 6 years of age. Consult your doctor if symptoms did not improve within 7 days or if symptoms were associated with fever. Be sure to take FEDLORA exactly as your doctor or pharmacist has told you to. If you do not follow their instructions, you may not get relief from your symptoms. Do not take more FEDLORA than recommended by your doctor or pharmacist. Warnings and precautions Do not take FEDLORA if You have an allergy to FEDLORA, or to any of the other ingredients of this medicine (listed in section 6). Do not take FEDLORA If you have, or have had, any of the following medical conditions: Glaucoma Difficulty passing urine Severe high blood pressure Severe blood vessel disease An overactive thyroid gland Do not take FEDLORA if you are taking or within 14 days of discontinuing monoamine oxidase inhibitors (MAOls), medicines used to treat depression. Do not give FEDLORA syrup to children under 6 years of age. Do not take FEDLORA after the expiry date printed on the pack. Do not take FEDLORA if the packaging is torn or shows signs of tampering. Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following: Eye problems (such as high pressure in the eye or glaucoma) Stomach ulcer Intestinal obstruction Prostate or urinary bladder problems Heart disease Diabetes If you are 60 years of age or older, because older adults may be more sensitive 10 the effects of the medicine. Side Effects Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using FEDLORA. FEDLORA helps most people with allergies, but it may have unwanted effects in a few people. Like other medicines. FEDLORA can cause some side effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention. Ask your doctor or pharmacist to answer any questions you may have. Most unwanted effects seen with FEDLORA have been mild to moderate. These include: Trouble sleeping Dry mouth Headache Sleepiness Nervousness Dizziness Fatigue Other unwanted effects may also occur in some people taking FEDLORA. Storage Information Keep the bottle in a cool dry place. Do not store above 30C. Do not store them or any other medicine in the bath room or near a sink. Do not leave them in the car on hot days or on window sills. This medicine will be expired after 30 days from the first opening. Drug Interactions Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop Some medicines should not be taken with FEDLORA. These include: Heart or blood pressure medicines Monoamine oxidase inhibitors, medicines used to treat Depression Antacids Kaolin Ingredients Active ingredients: Loratadine, 5mg / 5 ml Pseudoephedrine sulphate 60mg / 5 ml Other ingredients: Glycerine, Sorbitol 70% solution, Citric acid anhydrous, Sodium citrate anhydrous, Sucralose, Disodium Edetate, Sodium benzoate, Propylene glycol, Strawberry flavour, Raspberry flavor, purified water
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