Ancool Suspension

Aluminium Hydroxide, Magnesium Hydroxide, Simethicone & Oxetacaine Suspension

Each 5 ml contains:

Dried Aluminium Hydroxide Gel IP 300 mg

(added as Aluminium Hydroxide Paste)

Magnesium Hydroxide IP 150 mg

(added as Magnesium Hydroxide Paste USP)

Simethicone IP 125 mg

Oxetacaine IP 10 mg

Excipients q.s.

In a flavoured syrup base

Oral Suspension

200 ml bottle

4.1 Therapeutic Indications

Ancool® is indicated for the treatment of symptoms of functional gastrointestinal disorders like irritable bowel syndrome, functional dyspepsia, peptic ulcer, gasteroesophagal reflux disease which include smooth muscle spasms, flatulence, abdominal distension, hyperacidity, gastric distress, bloating etc.

4.2 Posology and method of administration

For oral administration:

Adults

5-10 ml taken 20 minutes to 1 hour after meals and at bedtime or as required.

Children (>5yrs): As an appropriate proportion of the adult dose.

Children under 5 years: Maximum of 5ml three times a day.

Elderly: The normal adult dose is appropriate.

It is preferable to take it undiluted. However, a sip of water may be taken if desired.

4.3 Contraindications

Should not be used in patients who are hypersensitive to any of the active substances or excipients.

Patients 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 both aluminium and magnesium increase. In these patients, a long-term exposure to high doses of aluminium and magnesium salts may lead to encephalopathy, dementia, microcytic anemia or worsen dialysis-induced osteomalacia.

Aluminium hydroxide may be unsafe in patients with porphyria undergoing hemodialysis. The prolonged use of antacids in patients with renal failure should be avoided.

Pediatric population: In young children the use of magnesium hydroxide can produce a hypermagnesemia, especially if they present renal impairment or dehydration.

If held in the mouth for a long time, Ancool® owing to its oxetacaine content may anesthetize the tongue and impair taste sensation.

4.5 Drug Interactions

Ancool® should not be taken simultaneously with other medicines as they may interfere with their absorption if taken within 1 hour.

Aluminium-containing antacids may prevent the proper absorption of drugs such as tetracyclines, vitamins, ciprofloxacin, ketoconazole, hydroxychloroquine, chloroquine, chlorpromazine, rifampicin, cefdinir, cefpodoxime, levothyroxine, rosuvastatin, H2 antagonists, atenolol, cyclines, diflunisal, digoxin, bisphosphonates, ethambutol, fluoroquinolones, sodium fluoride, glucocorticoids, indomethacin, isoniazid, lincosamides, metoprolol, phenothiazine neuroleptics, penicillamine,propranolol and iron salts.

Levothyroxine may also bind to simeticone which may delay or reduce the absorption of levothyroxine.

Polystyrene sulphonate

Caution is advised when used concomitantly with polystyrene sulphonate due to the potential risks of reduced effectiveness of the resin in binding potassium, of metabolic alkalosis in patients with renal failure (reported with aluminium hydroxide and magnesium hydroxide), and of intestinal obstruction (reported with aluminium hydroxide).

Quinidine:

Concomitant use of aluminium products with quinidines may increase the serum levels of quinidine and lead to quinidine overdosage.

Tetracycline:

Because of the aluminium content, Maalox Plus should not be concomitantly administered with tetracycline-containing antibiotics or any tetracycline salts.

Citrates:

Aluminium hydroxide and citrates may result in increased aluminium levels, especially in patients with renal impairment.

Urine alkalinisation secondary to administration of magnesium hydroxide may modify excretion of some drugs; thus, increased excretion of salicylates has been seen.

4.6 Use in Special Populations

The safety of Ancool® Suspension in pregnancy has not been established.

Pregnancy:

There are no available data on Ancool® use in pregnant women. No conclusions can be drawn regarding whether or not Maalox Plus is safe for use during pregnancy. Ancool® should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus.

Lactation:

Because of the limited maternal absorption, when used as recommended, minimal amounts, if any, of aluminium hydroxide and magnesium salt combinations are expected to be excreted into breast milk.

Simeticone is not absorbed from the gastrointestinal tract.

No effect on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to aluminium hydroxide, magnesium hydroxide and simeticone is negligible.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

The following CIOMS frequency rating is used, when applicable:

Very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from available data).

Immune system disorders

Frequency not known: hypersensitivity reactions, such as pruritus, urticaria, angioedema and anaphylactic reactions

Gastrointestinal disorders

Gastrointestinal side-effects are uncommon. Uncommon: diarrhoea or constipation Frequency not known: Abdominal pain

Injury, poisoning and procedural complications:

Frequency not known: Hyperaluminemia (related to Aluminium component).

Metabolism and nutrition disorders

Very rare: Hypermagnesemia, including observations after prolonged administration of magnesium hydroxide to patients with renal impairment

Frequency not known:

Hyperaluminemia

Hypophosphatemia, in prolonged use or at high doses or even normal doses of the product in patients with low-phosphorus diets which may result in increased bone resorption hypercalciuria, osteomalacia.

Oxetacaine

Glossitis of the hypersensitivity type, dizziness, faintness and drowsiness have occasionally occurred, especially when the recommended dose is exceeded.

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 email to: medico@zuventus.com
• Website: https://www.zuventus.com/drug-safety-reporting

By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

Serious symptoms are unlikely following overdosage.

Reported symptoms of acute overdose with aluminium hydroxide and magnesium salts combination include diarrhoea, abdominal pain, vomiting.

Large doses of this product may trigger or aggravate intestinal obstruction and ileus in patients at risk.

Aluminium and magnesium are eliminated through urinary route; treatment of acute overdose consists of administration of IV Calcium Gluconate, rehydration and forced diuresis. In case of renal function deficiency, haemodialysis or peritoneal dialysis is necessary.

5.1 Mechanism of Action

Dried aluminium hydroxide gel - antacid Magnesium Hydroxide - antacid Simeticone - antifoaming agent/anti-flatulent Oxetacaine: potent gastric mucosal anaesthetic agent The antacids that act by neutralizing the acid in the stomach and by inhibiting pepsin,

which is a proteolytic enzyme.

5.2 Pharmacodynamic properties

Ancool® is a balanced mixture of two antacids, an anti-flatulent/antifoaming agent simeticone and a potent gastric mucosal anaesthetic agent oxetacaine. The two antacids are magnesium hydroxide which is fast acting and aluminium hydroxide which is a slow acting antacid. The combination produces a fast onset of action and an increase in total buffering time. Aluminium hydroxide on its own is an astringent and may cause constipation. This effect is balanced by the effect of the magnesium hydroxide which is in common with other magnesium salts may cause diarrhoea.

Oxetacaine is a potent local anaesthetic agent and provides prompt relief to the pain in acutely inflamed gastric mucosa.

Simethicone is a surfactant that may decrease foaming and hence esophageal reflux. It is included in many antacid preparations for the management of flatulence. Simethicone acts by decreasing the surface tension of gas bubbles, thus facilitating their coalescence and expulsion as flatus or belching. Simethicone facilitates the passage of gas through bowel lumen and allows patients to excrete a greater volume of gas at one time, thereby reducing the number of flatus events. Thus, less residual gas is present to cause uncomfortable or painful pressure in the stomach and intestines.

5.3 Pharmacokinetic Properties

Aluminium hydroxide, when given by mouth most of it remains in the gastrointestinal tract forming insoluble, poorly absorbable aluminium salts such as hydroxide, carbonates and phosphates which are excreted in the feces.

Magnesium hydroxide is a quick acting antacid and its action is for prolonged duration. In the stomach, magnesium hydroxide combines with gastric acid to form magnesium chloride. In the small intestine, magnesium hydroxide is regenerated and excreted in feces. In contrast to almost all other local anaesthetic, oxetacaine ionizes only to a very small extent at a low pH, such as that of gastric acid. Since the anesthetic effect is due to the non-ionized molecules, which are lipid soluble and can penetrate nerve membranes,

oxetacaine maintains its activity even at low pH. Normally oxetacaine when administered alone is absorbed into blood, metabolized in the liver and excreted in the urine. But when given with aluminium and magnesium hydroxide, its absorption is retarded and hence it remains in contact with gastric mucosa for longer time.

In course of time, it mixes with the food and passes into intestine. However, the concentration obtained there is probably so low that no effect is produced on intestinal mucosa.

6.1 Animal toxicology or Pharmacology

Not available

Pharmacotherapeutic group: Drugs for acid related disorders; Antacids with antiflatulent.   Ancool is a combination of Oxetacaine, Aluminium Hydroxide, Magnesium Hydroxide and Simethicone. Oxetacaine is a local anaesthetic agent. Aluminium hydroxide and Magnesium hydroxide are antacids. Simethicone is liquid dimethicone activated with finely divided silicon dioxide to enhance the defoaming properties of the silicone.

8.1 List of excipients

Carboxymethylcellulose Sodium, Saccharin Sodium, Bronopol, Menthol, Liquid Sorbitol (Non Crystallising), Sodium Citrate, Propylene Glycol, Sorbitan Stearate, Citric Acid Monohydrate, Flavour Coolmints , Glycerol, Polysorbate 20.

8.2 Incompatibilities

Not available

8.3 Shelf life

24 Months

8.4 Packaging information

Bottle PET Transparent [200 ml] with silver cap & measuring cup 10 ml.

8.5 Storage and handling instructions

Store below 30°C, Protected from light. Keep out of reach of children. Shake Well Before Use. Store in tightly closed container and avoid freezing.

If held in the mouth for a long time, Ancool® owing to its oxetacaine content may anesthetize the tongue and impair taste sensation.

Do not take Ancool® Suspension at least 2 hours before or after taking other medicines as it may interact with other medications.

Avoid eating late at night or before bedtime.

Avoid taking Tea, Coffee, Spicy food, and Chocolate.

Avoid alcohol and smoking.

Ancool® Suspension may cause constipation. Drink plenty of water and eat more high-fiber foods. Inform your doctor if it becomes severe or does not go away.

It may take 4-6 weeks or more for the ulcers to heal completely. Do not stop taking the medicine without talking to your doctor first. 

It may take 4-6 weeks or more for the ulcers to heal completely. Do not stop taking the medicine without talking to your doctor first.