Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PSEUDOEPHEDRINE HYDROCHLORIDE; Tripolidine Hydrochloride
DCH AURIGA (MALAYSIA) SDN. BHD.
PSEUDOEPHEDRINE HYDROCHLORIDE; Tripolidine Hydrochloride
10x10x10 Tablets
PT Actavis Indonesia
_Consumer Medication Information Leaflet (RiMUP) _ FEDAC TABLET _ _ Triprolidine HCl, Pseudoephedrine HCl (2.5mg, 60mg) 1 ‘’WHAT IS IN THIS LEAFLET 1. What Fedac is used for 2. How Fedac work 3. Before you use Fedac 4. How to take Fedac 5. While you are using Fedac 6. Side effects 7. Storage and disposal of Fedac 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT FEDAC IS USED FOR Fedac is used to relieve the symptoms of colds, flu and allergies including runny nose, watery eyes, nasal congestion and blocked sinuses. HOW FEDAC WORK Fedac contains pseudoephedrine hydrochloride, which is a decongestant that relieves nasal and sinus congestion and triprolidine hydrochloride which is an antihistamine that helps stop sneezing, runny nose and watery eyes. BEFORE YOU USE FEDAC _-When you must not use it _ Do not take Fedac if: • You are allergic (hypersensitive) to pseudoephedrine hydrochloride, triprolidine hydrochloride or any of the other ingredients • you have very high blood pressure or severe heart disease. • you are taking drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs) within the last two weeks. • you have overactive thyroid (thyroid producing too much thyroid hormone) • You are pregnant, likely to get pregnant, or are breast-feeding • You are consuming alcohol _-Before you start to take it _ You should check with your doctor or pharmacist before taking Fedac if: • you are pregnant or breastfeeding If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Fedac. Children • Not to be used in children less than 2 years of age. • To be used with caution and on doctor’s or pharmacist’s advice in children 2 to 6 years of age. _-Taking other medicines_ Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, including the following: •Sedatives (drugs used to treat anxiety and tension). • Baca dokumen lengkap
AAAN8686 - Fedac All strengths -, PIL, Malaysia 03 28.01.2022 DD 09.06.2022 DD 120 x 208 mm Actavis Jakarta 6 pt Profile Black FEDAC PRODUCT DESCRIPTION: Tablets : Light pink, round and flat tablets, 8 mm diameter with score line and “DHA” logo. Syrup : Clear mixture, yellow in colour, sweet taste with orange flavour. COMPOSITION: 1) Tablets : Triprolidine HCI BP 2.5mg/tablet Pseudoephedrine HCI BP 60mg/tablet 2) Syrup : Triprolidine HCI BP 1.25mg/5ml Pseudoephedrine HCI BP 30mg/5ml Preservatives: Methyl hydroxybenzoate 0.15% w/v Propyl hydroxybenzoate 0.015% w/v PHARMACOLOGY: Triprolidine is an antihistamine which competes with histamine for H1-receptor sites on effector cells. It prevents but does not reverse responses mediated by histamine alone. Its anti-cholinergic actions provide a drying effect on the nasal mucosa. Pseudoephedrine acts on alpha-adrenergic receptors in the mucosa of the respiratory tract, producing vasoconstriction. It shrinks swollen nasal mucous membrane, reduces tissue hyperemia, oedema and nasal congestion, and increases nasal airway patency. Also drainage of sinus secretions may be increased and obstructed eustachian ostia may be opened. INDICATIONS: Symptomatic treatment of nasal and respiratory congestion, common cold, acute sinusitis, allergic rhinitis. RECOMMENDED DOSAGE: Tablet : Adults : 1 tablet 3 times a day Syrup : Adults and children over 12 years: 2 teaspoonfuls 3 times a day. Children : 6 - 12 years: 1 teaspoonful, 2 - 5 years: ½ teaspoon. Doses to be taken 3 times a day. Note: 1 teaspoonful is equal to 5ml. Route of administration : Oral WARNING: When Fedac Syrup is used for treatment of cough and cold: Not to be used in children less than 2 years of age. To be used with caution and on doctor’s or pharmacist’s advice in children 2 to 6 years of age. ADVERSE EFFECTS: Drowsiness, dryness of mouth, nervousness, restlessness, trouble in sleeping. PRECAUTIONS: Patients sensitive to one antihistamine or sympathomimetic may be sensitive to others. Triprolidine may cause Baca dokumen lengkap