Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pseudoephedrine hydrochloride
Thornton & Ross Ltd
R01BA02
Pseudoephedrine hydrochloride
60mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03100000; GTIN: 5011309876512 5011309872514
MHRA HEADER BOX PCP HEADER BOX PRODUCT TITLE COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE COLOURS USED FONTS USED OPERATOR ARTWORK NO. CRN REASON FOR CHANGE SUFFIX MHRA/IMB SUBMISSION REQUIRED APPROVED BY DATE ISSUED BY DATE Leaflet 24's 23630405 210 x 148mm 2 18.07.2016 Galpseud Tablets Custom Yes B gill.kennedy 673457 13085 Replace Customer with T&R as batch release site Helvetica Process Black Keyline (Does not print) MHRA HEADER BOX PCP HEADER BOX PRODUCT TITLE COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE COLOURS USED FONTS USED OPERATOR ARTWORK NO. CRN REASON FOR CHANGE SUFFIX MHRA/IMB SUBMISSION REQUIRED APPROVED BY DATE ISSUED BY DATE Leaflet 24's 23630405 210 x 148mm 2 18.07.2016 Galpseud Tablets Custom Yes B gill.kennedy 673457 13085 Replace Customer with T&R as batch release site Helvetica Process Black Keyline (Does not print) GALPSEUD TABLETS (pseudoephedrine hydrochloride) IMPORTANT INFORMATION ABOUT GALPSEUD TABLETS • This medicine relieves congestion in the nose, sinus and upper chest. • It can be used by adults, the elderly and children over 12 years. DO NOT GIVE.... • To children under 12 years old. • To anyone who is allergic to the ingredients listed. See section 6. • With other nasal decongestants including sprays. NOW READ ALL OF THE LEAFLET BEFORE YOU USE THIS MEDICINE. IT INCLUDES OTHER INFORMATION WHICH MIGHT BE ESPECIALLY IMPORTANT FOR YOU. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need any more information or advice. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 1. WHAT THE MEDICINE IS FOR Galpseud Tablets are for the relief of nose, sinus and upper chest congestion. The tablets contain pseudoephedrine which works to restrict blood vessels, reduces swelling and production of mucous and so relieves congestion. 2. BEFORE YOU USE THIS MEDICINE DO NOT USE THE MEDICINE IF YOU HAVE…. • An ALLERGY to any of the ingredients Lees het volledige document
OBJECT 1 GALPSEUD TABLETS Summary of Product Characteristics Updated 27-Feb-2015 | Thornton & Ross Ltd 1. Name of the medicinal product Galpseud Tablets 2. Qualitative and quantitative composition Active Ingredient: Pseudoephedrine hydrochloride 60.0mg (Per Tablet). For full list of excipients, see section 6.1. 3. Pharmaceutical form Tablets. Round, curved white tablets embossed with 60 on one side. 4. Clinical particulars 4.1 Therapeutic indications Indicated for the relief of nasal, sinus and upper respiratory congestion. 4.2 Posology and method of administration For oral administration. _Adults and children over 12 year_s: One tablet four times daily. _Elderly_: Adult dose is appropriate. 4.3 Contraindications This product should not be used in patients hypersensitive to pseudoephedrine or any of the other ingredients. Patients receiving monoamine oxidase inhibitors or who have received these agents in the last two weeks. Patients using other sympathomimetic decongestants or beta-blockers. (See Section 4.5). Patients with cardiovascular disease including ischaemic heart disease, occlusive vascular disease and hypertension. Children under 12 years of age. Patients with: • Severe renal impairment • Phaeochromocytoma • Diabetes • Hyperthyroidism • Closed angle glaucoma. 4.4 Special warnings and precautions for use Caution should be used when prescribing pseudoephedrine for patients with prostatic enlargement or bladder dysfunction. Also use with caution in patients with severe hepatic impairment, or with mild to moderate renal impairment. If any of the following occur, the product should be stopped • Hallucinations • Restlessness • Sleep disturbances. Patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose- galactose malabsorption should not take this medicine. Do not exceed the stated dose. Keep out of the sight and reach of children. 4.5 Interaction with other medicinal products and other forms of interaction Caution should be exercised with pa Lees het volledige document