Pinewood Heartburn Relief 800mg/10ml Oral Suspension (Peppermint Flavor)
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pinewood Heartburn Relief 800mg/10ml Oral Suspension (Peppermint flavour)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml contains:
Excipients include:
15.0 mg/10ml
5.50 mg/10ml
2.50 mg/10ml
Ethyl parahydroxybenzoate (E214)
Propyl parahydroxybenzoate (E216)
Butyl parahydroxybenzoate
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Suspension,
Peppermint flavoured white or cream coloured suspension
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Alleviation of the symptoms of gastro-oesophageal reflux by suppressing the reflux itself. It is indicated for the treatment of dyspepsia and heartburn due to gastric reflux associated with hiatus hernia, pregnancy and reflux oesophagitis
Posology and method of administration
For oral use
|
Adults and children over 12 years and the Elderly: |
5 - 10 ml |
|
Children under 12 years: |
only under medical supervision |
Doses should be taken after meals and at bedtime.
4.3 Contraindications
Hypersensitivity to any of the ingredients of this medicinal product, including the esters of hydroxybenzoates (Parabens) (see section 6.1).
4.4 Special warnings and precautions for use
1. Treatment of children younger than 12 years of age is not generally recommended, except on medical advice
2. This medicinal product contains about 7.5 mmol of sodium per 10ml dose. To be taken into consideration by patients on a controlled sodium diet e.g. in cases of cardiac failure and renal impairment.
2. Each 10ml contains 200 mg (2.0 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
3. Compound Alginate Oral suspensions should not be taken within 1 to 2 hours of taking other medicines by mouth, or for more than 7 days if symptoms persist.
4. Parahydroxybenzoates (E214, E216) may cause allergic reactions (possibly delayed)
5. If symptoms do not improve after seven days, medical advice should be sought.
6. There is a possibility of reduced efficacy in patients with very low levels of gastric acid.
4.5 Interaction with other medicinal products and other forms of interaction
1. Antacids may interact with other drugs as they alter the gastric pH which may affect dissolution, solubility or ionization of the other drug. Antacids reduce the absorption of certain drugs from the following groups: ACE Inhibitors, Analgesics, Antibacterials, Antiepileptics, Antifungals, Antimalarials, Antipsychotics, Bisphosphonates, Lithium and Penicillamine.
2. Antacids may increase the pH of the urine and affect the rate of drug elimination. Excretion of basic drugs is decreased whereas acidic drugs are eliminated more rapidly.
3. Due to effects at the renal level sodium bicarbonate may reduce plasma lithium levels and increase plasma quinidine levels.
4.6 Fertility, pregnancy and lactation
An open, uncontrolled study in 146 pregnant women did not demonstrate any significant adverse effects of this product on the course of pregnancy or on the health of the fetus/new-born child.
No effects during pregnancy are anticipated, since systemic exposure to this product is negligible. This product can be used during pregnancy. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to this product is negligible.
Based on this and previous experience this product may be used during pregnancy and lactation, however it is recommended to limit the treatment duration as much as possible.
4.7 Effects on ability to drive and use machines
There are no known effects on ability to drive or operate machinery.
4.8 Undesirable effects
Constipation, flatulence, stomach cramps or belching may occasionally occur.
Very rarely, in less than one in ten-thousand cases, patients sensitive to the ingredients develop allergic manifestations such as bronchospasm, urticaria, and anaphylaxis.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
As Compound Alginate Oral suspensions mode of action is physical, overdosage in terms of the alginate content is virtually no hazard. The only consequence is abdominal distension which is best treated conservatively. The relatively low concentrations of sodium and calcium carbonate in this product would also make serious consequences from overdosage very unlikely.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: A02BX13
Pharmaceutical group: Other drugs for peptic ulcer and gastro-oesophageal reflux
When taken after a meal Sodium Alginate forms a raft of alginic acid in the stomach reducing gastric reflux. This raft formed is maintained in the stomach for two hours. Sodium bicarbonate reacts with gastric acid to produce carbon dioxide which is retained in the gel and allows the raft to rise to the surface of the gastric contents. Calcium ions from calcium carbonate link the alginic acid molecules and strengthen the raft.
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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Carbomer
Sodium Hydroxide Saccharin Sodium
Ethyl Parahydroxybenzoate (E214) Propyl Parahydroxybenzoate (E216) Butyl Parahydroxybenzoate Isopropyl Alcohol Peppermint 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 25C.
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: 150 ml, 200 ml, 250 ml and 500 ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Shake bottle well before use
7 MARKETING AUTHORISATION HOLDER
Pinewood Laboratories Ltd.,
Ballymacarbry,
Clonmel,
Co. Tipperary, Ireland.
8 MARKETING AUTHORISATION NUMBER(S)
PL 04917/0093
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
27/01/2014
10 DATE OF REVISION OF THE TEXT
27/01/2014