Sodium alginate, sodium bicarbonate, calcium carbonate.
Pepticon is an opaque, off-white creamish color, peppermint odour, viscous suspension.
Each 10 mL of suspension contains 500 mg sodium alginate, 213 mg sodium bicarbonate and 325 mg calcium carbonate.
Pharmacology: Pharmacodynamics: Pepticon Double Action Suspension is a combination of two antacids (calcium carbonate and sodium bicarbonate) and an alginate. It works in two ways: Neutralising excess stomach acid to relieve the pain and discomfort.
Forming a protective barrier over the stomach contents to soothe the burning pain in the chest.
Pharmacokinetics: Absorption: The mechanism of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
Distribution: No data available.
Biotransformation: No data available.
Elimination: No data available.
Linear/Non-linear situation: No data available.
Treatment of symptoms resulting from the reflux of acid into the oesophagus such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy, and for symptoms of excess stomach acid (hyperacidity).
For oral use.
Shake well before use.
Adults and children over 12 years: Take 10-20 mL (Two to four 5 mL spoonfuls) after meal and at bedtime, up to four times a day.
Children under 12 years: Not be given unless recommended by the doctor.
In the event of overdose, symptomatic treatment should be given. The patient may notice abdominal distension.
PEPTICON should not be used in patients with known or suspected hypersensitivity to any of the active ingredients or other excipients (parabens) contained in the suspension.
Each 10 mL dose has a sodium content of 124.33 mg. This should be taken into account when a highly restricted salt diet is recommended, e.g. in some cases of congestive cardiac failure and renal impairment.
Each 10 mL contains 130.12 mg calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium renal calculi.
This medicinal product contains methyl paraben (E 218) and propyl paraben (E 216), which may cause allergic reactions (possibly delayed).
If symptoms do not improve after seven days, the clinical situation of patient should be reviewed by a doctor. Patients should avoid using more than they need.
Like as other antacids, antacid-alginate combinations can mask more serious underlying situations.
Do not use PEPTICON in following situations: Patients with severe/partial renal function/failure; Hypophosphatemic patients.
It is possible for this medicine to reduction in activity for the patient who has very low gastric acid levels.
Children with renal failure or gastroenteritis are under a serious hypernatremia risk.
Except medical advice, it is generally not recommended in the treatment of children under 12 years.
Effects on ability to drive and use machine: It has no effect on ability to drive and use machines.
General advice: Pregnancy category is B.
Women of childbearing potential/birth control (contraception): No data is available that proposes additional contraceptive method while PEPTICON treatment.
There is no evidence that the effects on contraception methods.
Pregnancy: Open, controlled study conducted on 281 pregnant women showed that no significant adverse effect of sodium alginate, sodium bicarbonate and calcium carbonate combination on pregnancy or on the foetus/new-born child's health.
Based on such as studies, PEPTICON can be used the pregnancy period.
Breast feeding: Open, controlled study showed no significant adverse effect of sodium alginate, sodium bicarbonate and calcium carbonate combination on new-born child's health.
It can be used during breast feeding.
Fertility: The effect of PEPTICON on reproductive ability/fertility is unknown.
Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10), common (<1/10 and ≥1/100), uncommon (<1/100 and ≥1/1,000), rare (<1/1000 and ≥1/10,000), very rare(<1/10,000) and not known (cannot be estimated from the available data).
Immune System Disorders: Very rare: Allergic symptoms such as urticaria, anaphylactic or anaphylactoid reactions may develop very rarely in patients sensitive to the ingredients of the product.
Metabolism and Nutrition Disorders: Not known: Excess amount of calcium carbonate consumption can cause alkalosis, hypercalcemia, acid rebound, milk alkali syndrome or constipation.
Generally, these side effects can occur when taken more than normal dose.
Respiratory, Thoracic and Mediastinal Disorders: Very rare: Respiratory effects such as bronchospasm.
Gastrointestinal Disorders: Not Known: Constipation.
It is recommended to wait 2 hours before using other medicinal products (especially H2 antihistamines, tetracyclines, digoxin, fluoroquinolone, iron salts, ketoconazole, neuroleptics, penicillamine, beta blockers (atenolol, metoprolol, propranolol), glucocorticoid, chloroquine, bisphosphonates and estramustine (for prostate gland cancer)) since the calcium carbonate in the product has antacid properties.
Since the absorption of medicine containing levothyroxine is impaired when taken together with PEPTICON, it is recommended to wait minimum 2 hours between taking these products.
Additional information on special populations: No interaction studies have been conducted.
Paediatric population: No interaction studies have been conducted.
Store at room temperature below 30°C. Keep in original package, avoid from moisture. Do not keep in refrigerate or do not freeze.
A02A - ANTACIDS ; Used in the treatment of acid-related disorders.
Pepticon Double Action oral susp
(peppermint flavour) 200 mL x 1's; (peppermint flavour) 100 mL x 1's