Boots Wind Relief Tablets

For relief from discomfort of painful wind, indigestion, heartburn and excess acidity.

For oral administration.

Adults and children over 12 years: One or two tablets to be sucked or chewed after meals, at bedtime or whenever discomfort is felt.

Children 5 to 12 years: One tablet to be sucked or chewed after meals, at bedtime or whenever discomfort is felt.

Children under 5 years: Not recommended.

Elderly: There is no need for dosage reduction in the elderly.

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1

Patients that are severely debilitated or suffering from kidney failure or hypophosphataemia.

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.

This product should be used with caution in patients with impaired renal function.

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 anaemia, or worsen dialysis-induced osteomalacia.

If symptoms persist for more than 5 days, consult your doctor.

Keep all medicines out of the reach of children.

This medicine contains 571 mg of sucrose (as icing sugar) in each tablet. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. May be harmful to the teeth.

This medicine contains 402 mg of sorbitol in each tablet. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

This product may interfere with the absorption of tetracyclines, chloroquine, penicillamine, phenothiazines and quinolone antibacterials, when these are given concomitantly.

This product should not be taken simultaneously with other medicines and vitamins as they may interfere with their absorption if taken within 1 hour.

With the integrase inhibitors (dolutegravir, raltegravir, bictegravir) the combination should be avoided (please refer to their SmPC for dose recommendations).

As a precaution, staggering the administration times of any orally administered drug and the antacid by at least 2 hours (4 hours for the fluoroquinolones).

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).

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 mdify excretion of some drugs; thus, increased excretion of salicylates has been seen.

There are no adequate human data from the use of aluminium hydroxide and magnesium hydroxide in pregnant women. Studies in animals have not been done. No data are available to suggest any harmful effects in pregnant women, associated with simethicone. Caution should therefore be exercised when taken by pregnant women.

Although some aluminium and magnesium may be secreted in breast milk, the concentration is too small to be harmful. Secretion of simethicone in the breast milk of nursing mothers has not been established but would be most unlikely

No adverse effects known.

Gastrointestinal disorders

Uncommon (≥ 1/1,000 to < 1/100):
 • Diarrhoea or constipation.

Injury, poisoning and procedural complications

Frequency not known (frequency cannot be estimated from the available data):
 • Hyperaluminemia (related to Aluminium component).

Metabolism and nutrition disorders

Very rare (< 1/10,000):
 • Hypermagnesemia, including observations after prolonged administration of magnesium hydroxide to patients with renal impairment.

Frequency not known (frequency cannot be estimated from the available data):
 • 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 (see section 4.4).

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Symptoms of overdosage include nausea, vomiting, gastrointestinal irritation, diarrhoea/constipation. Treatment should be symptomatic and supportive.

Large doses of this product may trigger or aggravate intestinal obstruction and ileus in patients at risk (see section 4.4)

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.

Aluminium hydroxide and magnesium hydroxide have antacid properties and are used to neutralise gastric acid. Activated methylpolysiloxane (simethicone) has anti-foaming/deflatulent activity by virtue of its ability to change the surface tension of gas bubbles, thereby causing them to coalesce.

Magnesium hydroxide reacts with hydrochloric acid in the stomach to produce magnesium chloride. Small amounts of magnesium salts may be absorbed and excreted in the urine, otherwise excretion if via the faeces.

Aluminium hydroxide reacts with hydrochloric acid in the stomach to form aluminium chloride, some of which is absorbed. Absorbed aluminium is eliminated in the urine. The majority of aluminium remains in the gastrointestinal tract and forms insoluble poorly absorbed aluminium salts including hydroxide, phosphate, carbonate and fatty acid derivatives, which are excreted in the faeces.

There is no data availability on the pharmacokinetics of activated methylpolysiloxane.

There are no preclinical data of relevance to the prescriber which are additional to that already included.

Sorbitol pdr

Maize starch pdr

Povidone

Isopropyl alcohol

Icing sugar

Magnesium stearate

Peppermint oil Black leaf

Microcrystalline cellulose

Purified water

Not applicable

36 months

Store below 25°C

PVC/PVDC blister heat sealed to aluminium foil.

Pack sizes: 12, 24, 36, 48

Not applicable