国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LORATADINE
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
LORATADINE
100 Tablet Tablets; 500 Tablet Tablets
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
_Consumer Medication Information Leaflet (RiMUP) _ 1 CARIN TABLET 10MG Loratadine (10mg) WHAT IS IN THE LEAFLET 1. What Carin is used for 2. How Carin works 3. Before you use Carin 4. How to use Carin 5. While you are using it 6. Side effects 7. Storage and Disposal of Carin 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT CARIN IS USED FOR Carin relieves symptoms associated with allergic rhinitis (hay fever), such as sneezing, runny or itchy nose, and burning or itchy eyes. Carin also be used to relieve symptoms associated with a skin condition called urticaria; these symptoms include itching, redness and lumps on the skin called hives. HOW CARIN WORKS Carin contains an active ingredient loratadine. Loratadine belongs to a class of medicines known as antihistamines. Antihistamines help reduce allergic symptoms by preventing the effects of a substance called histamine, which is produced by the body. Your doctor may have prescribed Carin for another reason. Ask your doctor if you have any questions about why Carin has been prescribed for you. BEFORE YOU USE CARIN _- When you must not use it_ Do not take Carin if you are allergic to loratadine or any of the tablet ingredients listed at the end of this leaflet. If you have an allergic reaction, you may get a skin rash, or experience difficulty in breathing or faintness. Do not use Carin if you are pregnant or breastfeeding unless you and your doctor or pharmacist has discussed the risks and benefits involved. Do not use Carin in children less than 2 years old. Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If you are not sure whether you should start taking Carin, talk to your doctor or pharmacist. - _Before you start to use it_ 1. Tell your doctor or pharmacist if you have allergies to: i. Any other medicines, especially antihistamines. ii. Any other substances, such as foods, preservatives or dyes. 2. Tell your doctor if you have liver dise 完全なドキュメントを読む
DRUG INTERACTIONS When administered concomitantly with alcohol, Loratadine has no potentiating effects as measured by psychomotor performance studies. Co-administration with drugs that inhibit or are metabolized by hepatic cytochromes P450 3A4 and 2D6 may elevate the plasma concentrations of either drug. Increased plasma concentrations of Loratadine has been reported when used concomitantly with ketoconazole, erythromycin and cimetidine. RECOMMENDED DOSAGE Adults and Children ≥ 12 years: 1 tablet (10 mg) once daily. Children 6 - 12 years: 1 tablet (10 mg) once daily. Children 2 - 5 years: half tablet (5 mg) once daily. Not recommended for children under 2 years of age. Patients with severe liver impairment: An initial dose of 5mg once daily or 10 mg every other day is recommended. SYMPTOMS AND TREATMENT FOR OVERDOSAGE AND ANTIDOTE(S) Nausea, vomiting, drowsiness, hypotension, tachycardia and ataxia have been reported in overdosage. Treatment of overdosage should be supportive and symptomatic. This may include induction of emesis, gastric lavage to decrease absorption and the use of saline cathartics to enhance elimination. STORAGE CONDITIONS Store below 30°C in a cool dry place. Protect from excessive moisture. Keep medicines out of reach of children. Jauhi ubat-ubatan daripada kanak-kanak. Route Of administration : Oral SHELF LIFE Please refer to outer package AVAILABILITY Blister packs of 100’s and 500’s PRODUCT REGISTRATION HOLDER: DUOPHARMA MANUFACTURING (BANGI) SDN. BHD. Lot No. 2, 4, 6, 8 & 10, Jalan P/7, Section 13, Bangi Industrial Estate, 43650 Bandar Baru Bangi, Selangor, Malaysia. MANUFACTURER: DUOPHARMA MANUFACTURING (BANGI) SDN. BHD. Lot No. 2 & 4, Jalan P/7, Section 13, Bangi Industrial Estate, 43650 Bandar Baru Bangi, Selangor, Malaysia. PRODUCT DESCRIPTION Carin Tablet 10mg is a white to off-white, oval-shaped tablet, with a break line on one side and plain on the other side. COMPOSITION Each Carin Tablet 10mg contains 10 mg of Loratadine. PHARMACODYNAMICS Loratadine is a non-sedative hista 完全なドキュメントを読む