SmoothX

Natural health product licensed in Canada

Other names

SmoothX 2%, SmoothX 2% Suspension, SmoothX Suspension

Licence holder

Voyageur Pharmaceuticals Ltd.

NPN or DIN-HM

80108081

Status

Active licence

Licence date

10 February 2021

Revision date

7 October 2026

Form

Suspension

Route of administration

Orale

Application type

Non traditionnelle

Composition

Medicinal composition not provided.

Non-medicinal ingredients

Sorbate de potassium, Sacharinate de sodium, Siméthicone, Citrate de sodium, Sorbitol Solution, Gomme de xanthane, Benzoate de sodium, Vanille, Eau purifiée, Acide citrique

Recommended doses in Canada

Uses authorised in Canada

For opacification of the gastrointestinal tract. For computed tomography (CT). For use as a radiological contrast medium for upper and lower gastrointestinal procedures by computed tomography (CT).

A use authorised in Canada is not an authorised health claim in the European Union. See the health claims register.

Warnings in Canada

• Précautions et mises en garde

  For professional use only. Do not use if the inner seal is broken or missing. Diagnostic procedures that involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, or a previous reaction to a contrast agent, warrant special attention. Caution should be excerised with the use of radiopaque media in severly debilitated patients and in those with marked hypertension or advanced cardiac disease. Ingestion of barium is not recommended in patients with a history of food aspiration. If barium swallow studies are required in these patients or in patients in whom integrity of the swallowing mechanism is unknown, proceed with caution. Administer initially small amounts such as a half-teaspoon of low-density barium and carefully observe swallowing under fluoroscopic control. If barium is aspired into the larynx, further administartion of barium should be immediately discontinued. If no aspiration is noted, additional barium may be given with continued fluoroscopic monitoring for aspiration. After any barium study of the G.I. tract, it is important to rehydrate the patient as quickly as possible to prevent impaction of barium. To prevent barium impaction, the colon may also require the use of cathartics following the completion of the examination. Saline cathartics are recommended on a routine basis and especially in patients with a history of constipation unless clinically contraindicated. Usage in Pregnancy: Radiation is known to cause harm to the unborn fetus exposed in utero. Therefore, radiographic procedures should only be used when, in the judgement of the physician, its use is deemed essential to the welfare of the pregnant patient. Safe use of barium sulfate in pregnant is not established.

• Effets indésirables connus

  Rarely, severe allergic reactions of an anaphylactoid nature, have been reported following administration of barium sulfate contrast agents. Nausea, vomiting, diarrhea and abdominal cramping, accompanying the use of barium formulations are infrequent and usually mild. Adverse reaction accompanying the use of barium sulfate formulations are infrequent and usually mild, though severe reactions (approximately 1 in 500,000) and fatalities (approximately 1 in 2,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. EKG changes have been shown to occur following or during barium enemas. It is of the utmost importance to be completely prepared to treat any such occurrence. Allergic reactions: Due to the increased likelyhood of allergic reactions in atopic patients, it is important that a complete history of known and suspected allergies as well as allergic-like symptoms, e.g. rhinitis, bronchial asthma, eczema and uticarial, be obtained prior to any medical procedure utilizing the products. A mild allergic reaction would most likely include generalized pruritus, erythema or urticaria (approximately 1 in 100,000 reactions). Such reaction will generally respond to antihistamine such as 50 mg of diphenhydramine or its equivalent. In the rarer, more serious reactions (approximately 1 in 500,000) laryneal edema, brochospasm or hypotension could develop. Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, or hypotension, reflex tachycardia, dyspnea, agitation, confusion and cyanosis, progressing to unconsciousness. Treatment should be initiated immediately with 0.3 - 0.5 cc of 1:1000 epinephrine subcutaneously. If brochospasm predominates, 0.25 - 0.50 gram of intravenous aminophylline should be given slowly. Appropriate vasopressors might be required. Adrenocorticosteroids, even if given intravenously, exert no significant effect on the acute allergic reaction for a few hours. The administration of thesesteroid agents should not be reagrded as emergency measures for the treatment of allergic reactions. Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following administration of any diagnostic agent. Such reactions are usually non allergenic in nature and best treated by having the patient lie flat for an additional 10 to 30 minutes under observation. In rare occassions following repeated administration, severe stomach cramps and diarrhea may occur. These are transitory in nature and are not considered serious.

• Contre-indications

  Known or suspected fistula, perforation or obstruction in any part of the gastrointestinal tract, recent rectal biopsy or known hypersensitivity to barium sulfate or any of the non medicial ingredients.

Source

Official Health Canada record, licence 80108081

Licensed Natural Health Products Database (LNHPD), Health Canada: licensed products, ingredients, doses, uses and risks, retrieved 27 October 2026.

Contains information licensed under the Open Government Licence – Canada (Health Canada, LNHPD)

Licence du gouvernement ouvert – Canada 2.0 (OGL-Canada 2.0)

The formula sold in Europe under the same name may differ. This information does not replace advice from a doctor or pharmacist.

List in the official revision dated 7 October 2026 (register: Licensed Natural Health Products Database (LNHPD), Health Canada: licensed products, ingredients, doses, uses and risks).

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