Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pseudoephedrine hydrochloride; Triprolidine hydrochloride
McNeil Products Ltd
R01BA52
Pseudoephedrine hydrochloride; Triprolidine hydrochloride
60mg ; 2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03100000; GTIN: 5010123708528
left margin 14 mm right margin 12 mm 6 mm 6 mm spot = 12 x 2 centered in the margin of 14 mm Distance between cutted line/middel of the spot = 83.6 MM left margin 12 mm right margin 14 mm 6 mm 6 mm Barcodes placed at 14 mm Hight for bars : 10 mm reading way 14 SIZE: Main body text (PIL’s only) 145 x 210 mm Job Bag No. Version Product Description Country Date Manufacturer Software A print out of this image should not be used for exact colour matching but to check if the layout, spelling, text and colour references are correct. Please check thoroughly. COLOURS: 7.5 pts 12-0058 1 Actifed MA Tablets Pil UK 25/04/12 Illustrator CS5 Val De Reuil BLACK PROFILE PMS PROCESS BLUE MULTI-ACTION ACTIFED TABLETS ® _pseudoephedrine, triprolidine_ ■ This medicine is used to relieve the symptoms of colds, flu and allergies including runny nose, watery eyes, nasal congestion and blocked sinuses. ■ This medicine is for use by adults and children aged 12 years and over. ■ DO NOT USE THIS MEDICINE: ■ There are some people who should not use this medicine. _To find out if you are one of them See _ _ _ _ _ _Section 2_ c ■ If you have ever had a BAD REACTION to any of the ingredients. _For the list of ingredients See Section 6_ c ■ SPEAK TO YOUR DOCTOR: ■ If you suffer from any of the conditions mentioned in Section 2. _See Section 2_ c ■ If you are taking any OTHER MEDICINES. _See _ _ _ _ _ _Section 2_ c ■ FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. _See _ _ _ _ _ _Section 3_ c NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. Keep the leaflet: you might need it again. 1 WHAT THE MEDICINE IS FOR Multi-Action Actifed Tablets is a medicine which is used to relieve the symptoms of colds, flu and allergies including sneezing, runny nose, watery eyes, nasal congestion and blocked sinuses. The tablets contain 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 water Izlasiet visu dokumentu
OBJECT 1 MULTI-ACTION ACTIFED TABLETS Summary of Product Characteristics Updated 04-Nov-2009 | McNeil Products Ltd 1. Name of the medicinal product Multi-Action ACTIFED Tablets 2. Qualitative and quantitative composition Each tablet contains:- Triprolidine hydrochloride 2.5 mg Pseudoephedrine hydrochloride 60.0 mg 3. Pharmaceutical form Tablets for oral administration. 4. Clinical particulars 4.1 Therapeutic indications For the symptomatic relief of upper respiratory tract disorders which are benefited by a combination of a nasal decongestant and histamine H 1 -receptor antagonist, for example: Allergic Rhinitis Vasomotor Rhinitis The Common Cold and Influenza 4.2 Posology and method of administration ADULTS AND CHILDREN OVER 12 YEARS One tablet every 4-6 hours up to 4 times a day USE IN THE ELDERLY No specific studies have been carried out in the elderly, but triprolidine and pseudoephedrine have been widely used in older people. HEPATIC DYSFUNCTION Caution should be exercised when administering Multi-Action ACTIFED Tablets to patients with severe hepatic impairment. RENAL DYSFUNCTION Caution should be exercised when administering Multi-Action ACTIFED Tablets to patients with moderate to severe renal impairment. 4.3 Contraindications Multi-Action ACTIFED is contraindicated in individuals who have previously exhibited intolerance to it or to pseudoephedrine or triprolidine. Multi-Action ACTIFED is contraindicated in patients who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks. The concomitant use of pseudoephedrine and this type of product may occasionally cause a rise in blood pressure. Multi-Action ACTIFED is contraindicated in patients with severe hypertension or severe coronary artery disease. The antibacterial agent furazolidone, is known to cause a dose-related inhibition of monoamine oxidase. Although there are no reports of hypertensive crises caused by the concurrent administration of Multi- Action ACTIFED Tablets and furazolidone they should not be taken together. 4. Izlasiet visu dokumentu