국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Magnesium hydroxide; Aluminium hydroxide gel dried; Simeticone
Sanofi Consumer Healthcare
Magnesium hydroxide; Aluminium hydroxide gel dried; Simeticone
39mg/1ml ; 44mg/1ml ; 5mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 01010100; GTIN: 5012877343635 5000283655855 5000283657682
4831221A V05 - 01-12-2017 _4831220A_ Istruzione - Fronte Maalox Plus - 250 ml UK Origgio Origgio Stesa 157 x 315 mm. 1302 1 - P Reflex Blue C - XXXX - XXXX - XXXX - XXXX - XXXX 10 pt Ocean Sans Pro SAN Light / Light Italic / Bold GDO - GRAPHIC DEPARTMENT ORIGGIO Code: Update: Local code: Current item code: Product/Item type: Country: Artwork by: Plant: Supplier code: Format: Plant barcode: Colours: Fonts: Minimum point size of text: Assembly Card: Layout of Cutting: Technical Card: Technical Constraint: For Sanofi use only Impianti di proprietà Sanofi S.p.A. Vietata la manomissione - Rendere dopo la stampa APPROVAL REJECTED DATE: SIGNATURE: Technical Data _PACKAGING TEAM_ Sanofi READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Maalox Plus careful- ly to get the best results from it. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more informa- tion or advice - You must contact a doctor if your symptoms worsen or do not improve - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Maalox Plus is and what it is used for 2. What you need to know before you take Maa- lox Plus 3. How to take Maalox Plus 4. Possible side effects 5. How to store Maalox Plus 6. Contents of the pack and other information Maalox Plus contains three different medicines: • The first two medicines are called dried aluminium hydroxide gel and magnesium hydroxide. They belong to a group of medicines called antacids • The other medicine is called simeticone. It belongs to a group of medicines called anti-foaming agents Maalox Plus is used for: • The relief of indigestion (dyspepsia) • Heartburn • Wind (flatulence) Maalox Plus works by lowering the amount of acid in your stomach. The anti-foaming agent in Maalox Plus help 전체 문서 읽기
OBJECT 1 MAALOX PLUS SUSPENSION Summary of Product Characteristics Updated 08-Jan-2018 | SANOFI 1. Name of the medicinal product Maalox Plus 2. Qualitative and quantitative composition The active components of Maalox Plus are: Dried Aluminium Hydroxide Gel 230mg/5ml Magnesium Hydroxide 200mg/5ml Simeticone 25mg/5ml Also contains 320mg of sorbitol (E420), per 5ml. For a full list of excipients, see section 6.1 3. Pharmaceutical form Oral suspension White suspension, homogenous after shaking, with the odour and taste of lemon. 4. Clinical particulars 4.1 Therapeutic indications The symptomatic relief of: 1. Dyspepsia. 2. Heartburn. 3. Flatulence. 4.2 Posology and method of administration For oral administration: Adults 5-10ml taken 20 minutes to 1 hour after meals and at bedtime or as required. Children As an appropriate proportion of the adult dose. Children under 5 years Maximum of 5ml t.d.s. Elderly The normal adult dose is appropriate. 4.3 Contraindications Should not be used in patients who are hypersensitive to any of the active substances or excipients, are severely debilitated or suffering from kidney failure, or hypophosphataemia. 4.4 Special warnings and precautions for use Aluminium hydroxide may cause constipation and magnesium salts overdose may cause hypomotility of the bowel; large doses of this product may trigger or aggravate intestinal obstruction and ileus in patients at higher risk such as those with renal impairment, or the elderly. Aluminium hydroxide is not well absorbed from the gastrointestinal tract, and systemic effects are therefore rare in patients with normal renal function. However, excessive doses or long-term use, or even normal doses in patients with low-phosphorous diets, may lead to phosphate depletion (due to aluminium- phosphate binding) accompanied by increased bone resorption and hypercalciuria with the risk of osteomalacia. Medical advice is recommended in case of long-term use or in patients at risk of phosphate depletion. In patients with renal impairment, plasma levels of 전체 문서 읽기