- Approval Id
- 6a4c78dc6fd602f2
- Drug Approval Emc Name
- Acidex Advance Aniseed 200 mg/10 ml, 1000 mg/10 ml Oral suspension Aniseed
- Drug Name
- Acidex Advance Aniseed 200 mg/10 ml, 1000 mg/10 ml Oral suspension Aniseed
- Company Name
- Pinewood Healthcare
- Company Address
- Ballymacarby, Clonmel, Co. Tipperary, Co. Tipperary, Ireland
- Company Website
- http://www.pinewood.ie
- Company Telephone
- 00 353 52 6186000
- Company Fax
- +353 52 6136311
- Company Medical Info Direct Line
- +353 52 6186000
- Company Medical Info Email
- [email protected]
- Company Medical Info Fax
- +353 52 6136311
- Atc Code
- A02BX13
- Legal Category
- General Sales List
- Authorisation Holder
- 7. Marketing authorisation holder Pinewood Laboratories Limited Ballmacarbry Clonmel Co Tipperary Ireland
- Authorisation Number
- 8. Marketing authorisation number(s) PL 04917/0151
- Authorisation Date
- 9. Date of first authorisation/renewal of the authorisation 31/03/2021
- Instruction Authorisation Holder
- 7. Marketing authorisation holder Pinewood Laboratories Limited Ballmacarbry Clonmel Co Tipperary Ireland
- Instruction Authorisation Number
- 8. Marketing authorisation number(s) PL 04917/0151
- Instruction Authorisation Date
- 9. Date of first authorisation/renewal of the authorisation 31/03/2021
- Instruction Composition
- 2. Qualitative and quantitative composition Each 10 ml contains: Sodium Alginate Potassium hydrogen carbonate 1000 mg 200 mg Excipient(s) with known effect: Ethyl parahydroxybenzoate (E214) Propyl parahydroxybenzoate (E216) Butyl parahydroxybenzoate Sodium 15.0 mg/10 ml 5.50 mg/10 ml 2.50 mg/10 ml 106 mg/10 ml For a full list of excipients, see section 6.1
- Instruction Dosage Form
- 3. Pharmaceutical form Oral Suspension, Aniseed flavoured white or cream coloured suspension
- Instruction Clinical Particulars
- 4. Clinical particulars 4.1 Therapeutic indications Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. Can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy. 4.2 Posology and method of administration Adults and children 12 years and over: 5 -10ml after meals and at bedtime Children under 12 years: Should be given only on medical advice. Elderly: no dose modification is required in this age group. Hepatic Impairment: No dose modification necessary. Renal insufficiency: caution if highly restricted salt diet is necessary (see section 4.4) 4.3 Contraindications This medicinal product is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients, or any of the excipients listed in section 6.1, including ethyl parahydroxybenzoate (E214) and propyl Parahydroxybenzoate (E216) (see section 4.4). 4.4 Special warnings and precautions for use If symptoms do not improve after seven days, the clinical situation should be reviewed. This medicinal product contains 106 mg (
- Instruction Pharmacology
- 5. Pharmacological properties 5.1 Pharmacodynamic properties ATC Code: A02BX13 Pharmaceutical group: Other drugs for peptic ulcer and gastro-oesophageal reflux On ingestion the suspension reacts with gastric acid to rapidly form a raft of alginic acid gel having a near-neutral pH which floats on the stomach contents effectively impeding gastro-oesophageal reflux for up to 4 hours, and protecting the oesophagus from acid, pepsin and bile. In severe cases the raft itself may be refluxed into the oesophagus in preference to the stomach contents and exert a demulcent effect. In addition in vitro evidence has shown that the raft has a secondary action and is able to entrap bile and pepsin within it structure, further protecting the oesophagus from these gastric components. 5.2 Pharmacokinetic properties The mode of action of the product is physical and does not depend on absorption into the systemic circulation. 5.3 Preclinical safety data There are no preclinical data of relevance to the prescriber in addition to that included in other sections of the SmPC.
- Instruction Pharmaceutical Particulars
- 6. Pharmaceutical particulars 6.1 List of excipients Calcium Carbonate Carbomer Sodium Hydroxide Saccharin Sodium Ethyl Parahydroxybenzoate (E214) Propyl Parahydroxybenzoate (E216) Butyl Parahydroxybenzoate Isopropyl Alcohol Star Anise Oil Purified Water 6.2 Incompatibilities None known. 6.3 Shelf life 24 months Use within 3 months of opening 6.4 Special precautions for storage Do not store above 25◦C. Do not refrigerate or freeze. 6.5 Nature and contents of container Pharmaceutical Grade Type III amber glass bottles with white polypropylene caps that have a Low density Polyethylene (LDPE) liner Pack sizes: 150ml, 200ml, 250ml, and 300ml. Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling Not applicable.
- Instruction Content
- ## Composition
2. Qualitative and quantitative composition Each 10 ml contains: Sodium Alginate Potassium hydrogen carbonate 1000 mg 200 mg Excipient(s) with known effect: Ethyl parahydroxybenzoate (E214) Propyl parahydroxybenzoate (E216) Butyl parahydroxybenzoate Sodium 15.0 mg/10 ml 5.50 mg/10 ml 2.50 mg/10 ml 106 mg/10 ml For a full list of excipients, see section 6.1
## Pharmaceutical Form
3. Pharmaceutical form Oral Suspension, Aniseed flavoured white or cream coloured suspension
## Clinical Particulars
4. Clinical particulars 4.1 Therapeutic indications Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. Can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy. 4.2 Posology and method of administration Adults and children 12 years and over: 5 -10ml after meals and at bedtime Children under 12 years: Should be given only on medical advice. Elderly: no dose modification is required in this age group. Hepatic Impairment: No dose modification necessary. Renal insufficiency: caution if highly restricted salt diet is necessary (see section 4.4) 4.3 Contraindications This medicinal product is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients, or any of the excipients listed in section 6.1, including ethyl parahydroxybenzoate (E214) and propyl Parahydroxybenzoate (E216) (see section 4.4). 4.4 Special warnings and precautions for use If symptoms do not improve after seven days, the clinical situation should be reviewed. This medicinal product contains 106 mg (
## Pharmacological Properties
5. Pharmacological properties 5.1 Pharmacodynamic properties ATC Code: A02BX13 Pharmaceutical group: Other drugs for peptic ulcer and gastro-oesophageal reflux On ingestion the suspension reacts with gastric acid to rapidly form a raft of alginic acid gel having a near-neutral pH which floats on the stomach contents effectively impeding gastro-oesophageal reflux for up to 4 hours, and protecting the oesophagus from acid, pepsin and bile. In severe cases the raft itself may be refluxed into the oesophagus in preference to the stomach contents and exert a demulcent effect. In addition in vitro evidence has shown that the raft has a secondary action and is able to entrap bile and pepsin within it structure, further protecting the oesophagus from these gastric components. 5.2 Pharmacokinetic properties The mode of action of the product is physical and does not depend on absorption into the systemic circulation. 5.3 Preclinical safety data There are no preclinical data of relevance to the prescriber in addition to that included in other sections of the SmPC.
## Pharmaceutical Particulars
6. Pharmaceutical particulars 6.1 List of excipients Calcium Carbonate Carbomer Sodium Hydroxide Saccharin Sodium Ethyl Parahydroxybenzoate (E214) Propyl Parahydroxybenzoate (E216) Butyl Parahydroxybenzoate Isopropyl Alcohol Star Anise Oil Purified Water 6.2 Incompatibilities None known. 6.3 Shelf life 24 months Use within 3 months of opening 6.4 Special precautions for storage Do not store above 25◦C. Do not refrigerate or freeze. 6.5 Nature and contents of container Pharmaceutical Grade Type III amber glass bottles with white polypropylene caps that have a Low density Polyethylene (LDPE) liner Pack sizes: 150ml, 200ml, 250ml, and 300ml. Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling Not applicable.
