Generic Colofac ( Mebeverin hydrochloride )

Buy cheap Generic Colofac (Mebeverin hydrochloride) without dr prescription at Canadian Pharmacy

Colofac (Mebeverine Hydrochloride 135 mg): Comprehensive Patient Information for Canada

Basic Product Information

Mechanism of Action

In simple terms: Colofac is an antispasmodic medicine that works directly on the muscles of the gut. It relaxes the muscles in the walls of the intestines, which helps relieve the cramping, pain, and bloating associated with irritable bowel syndrome (IBS). Unlike some other antispasmodics, it does not interfere with normal digestive movement and does not cause typical anticholinergic side effects such as dry mouth or constipation. It works best when taken about 20 minutes before meals.

For specialists: Mebeverine hydrochloride is a musculotropic antispasmodic with a direct non-specific relaxant effect on vascular, cardiac, and other smooth muscle. Studies indicate that its spasmolytic activity involves at least three mechanisms: a direct musculotropic action involving calcium ion exchange and stabilisation of excitable membranes; a competitive antimuscarinic activity of about 0.05–0.1 times that of atropine; and a local anaesthetic activity with potentiation of sympathetic inhibitory influences due to blockade of noradrenaline uptake into sympathetic nerve endings. In vitro studies have shown a papaverine-like spasmolytic effect on smooth muscle of the ileum, uterus, and gallbladder. When tested in vivo, mebeverine hydrochloride was found to be three to five times more powerful than papaverine in blocking smooth muscle spasm and twenty times more active than papaverine in relieving carbachol-induced spasm of the sphincter of Oddi in rabbits. In vivo studies also demonstrate that mebeverine has only minor effects on normal intestinal peristalsis but possesses spasmolytic activity when hypermotility is induced. The spasmolytic activity is found in all parts of the gastrointestinal tract and in some experiments has been found to be more active on colonic smooth muscle. Mebeverine is free of central anticholinergic effects and practically free of peripheral effects, with an activity of less than 0.001 times that of atropine. It does not show central depressant or analgesic effects, and no ganglion blocking or interference with neuromuscular transmission occurs.

Pharmacokinetics

• Absorption: Mebeverine is rapidly and completely absorbed after oral administration. Peak plasma concentrations of metabolites occur approximately 1 to 3 hours after dosing. Mebeverine is 75% bound to albumin in plasma.
• Metabolism: Mebeverine is not excreted as such but is completely metabolised. The primary metabolic step is hydrolysis of the ester function by esterases, yielding veratric acid and mebeverine alcohol. The plasma half-life of these metabolites is approximately 2 hours. Mebeverine alcohol is further metabolised to mebeverinic acid.
• Elimination: Veratric acid is excreted into the urine. Mebeverine alcohol is also excreted into the urine, partly as the corresponding carboxylic acid and partly as the demethylated carboxylic acid.
• Onset of Action: Symptomatic relief of abdominal pain and cramps typically begins within the first few days of consistent use.
• Duration of Action: Effects are maintained with continued three-times-daily dosing. The duration of use is not limited, but after several weeks when the desired effect has been obtained, the dosage may be gradually reduced.

Uses in Daily Life and Best Practice Advice

Mebeverine is used in jurisdictions where it is approved for the management of irritable bowel syndrome (IBS), particularly gastrointestinal spasm. In Canada, mebeverine is not approved for sale by Health Canada and is not commercially available through standard Canadian pharmacies. Your physician will determine whether mebeverine is appropriate for your condition.

• Typical Uses: Management of irritable bowel syndrome (also referred to as irritable colon, spastic colon, functional bowel disorders, spastic constipation, or nervous diarrhoea). It is used to treat the symptoms of this condition, including abdominal pain and cramps, persistent non-specific diarrhoea (with or without alternating constipation), and flatulence.
• Administration: Tablets should be swallowed whole with at least 100 mL of water. They should not be chewed because of the unpleasant taste.
• Monitoring: If symptoms do not improve within a reasonable period, or if they worsen, consult your physician. Prior to treating patients with mebeverine, care should be taken to exclude organic disease of the bowel, particularly malignancy.
• Local Policy: In Canada, mebeverine is not available as a Health Canada-approved prescription drug. It may be obtained through international pharmacy channels for personal use under specific circumstances. The drug is approved in many countries including the United Kingdom, Ireland, Australia, New Zealand, and across Europe.

Morning vs. Evening Dosing

Mebeverine is typically taken three times daily, preferably 20 minutes before meals. This timing is important because the medication works best when it is present in the gut before food enters and triggers spasms. There is no specific clinical recommendation for morning versus evening dosing beyond the meal-related timing.

• Three Times Daily: The standard adult dose is one 135 mg tablet three times a day, preferably 20 minutes before each main meal.
• Consistency: Take mebeverine at the same times each day relative to your meals to ensure maximum effectiveness.
• Missed Dose: If you miss a dose, continue with the next dose as prescribed. Do not take the missed dose in addition to the regular dose.
• Dosage Reduction: After a period of several weeks when the desired effect has been obtained, the dosage may be gradually reduced.

Administration With or Without Food

Mebeverine should be taken approximately 20 minutes before meals. This timing allows the medication to be absorbed and reach the intestinal smooth muscle before food stimulates bowel activity, maximising its antispasmodic effect. Taking it with food or after meals may reduce its effectiveness.

• Take one tablet with at least 100 mL (a full glass) of water.
• Swallow the tablet whole. Do not chew it because of the unpleasant taste.
• Take the tablet approximately 20 minutes before breakfast, lunch, and dinner.
• Avoid taking mebeverine at the same time as food, as this may reduce its effectiveness.
• If you have difficulty swallowing tablets, consult your pharmacist about alternative formulations, but note that 135 mg tablets are not suitable for children under 10 years of age.

Interaction Warnings

Indications for Mebeverine

"Off-label" means use outside the official approved indication, usually based on current medical guidelines and scientific evidence. Mebeverine is not approved for human use in Canada.

Dosing According to Clinical Indication

Doses should always be adjusted according to the advice of your physician and depending on your health condition. No dosage adjustment is deemed necessary in elderly, renal, or hepatic impaired patients based on available post-marketing data, but caution is advised.

Side Effects and Safety Profile

Guidelines for Correct Use

• Take mebeverine exactly as prescribed by your physician. The standard adult dose is one 135 mg tablet three times daily.
• Take the tablet approximately 20 minutes before each main meal with at least 100 mL of water.
• Swallow the tablet whole. Do not chew it because of the unpleasant taste.
• Do not exceed the stated dose.
• If you miss a dose, continue with the next dose as prescribed. Do not take the missed dose in addition to the regular dose.
• After several weeks, when the desired effect has been obtained, the dosage may be gradually reduced. Do not stop abruptly without consulting your physician.
• Prior to treatment, your physician should exclude organic disease of the bowel, particularly malignancy.
• Inform your physician if you have a history of cardiac dysrhythmia, liver disease, kidney disease, or if you are pregnant or breastfeeding.
• Keep out of reach of children. Store at room temperature in a dry place.

Alternative Treatment Options

• Alverine citrate: Another antispasmodic used for IBS. Starting dosage is 60–180 mg/day, with a maximum of 360 mg/day. Only combination with simethicone has been shown to reduce abdominal pain and discomfort compared with placebo.
• Otilonium bromide: An antispasmodic with starting dosage of 60 mg/day and maximum of 120 mg/day. Has been shown to reduce abdominal pain frequency and bloating and improve stool frequency and patient global assessment compared with placebo.
• Pinaverium bromide: An antispasmodic with starting dosage of 150 mg/day and maximum of 300 mg/day. Superior in improving global symptoms compared with placebo.
• Peppermint oil: A natural antispasmodic with a dosage of 0.6 mL/day. Superior in controlling abdominal pain. May cause heartburn.
• Hyoscine (anticholinergic): Starting dosage of 30 mg/day, maximum of 60 mg/day. Superior in controlling abdominal pain but associated with typical anticholinergic side effects such as dry mouth, tachycardia, and impaired vision.
• Trimebutine: A miscellaneous antispasmodic with starting dosage of 300 mg/day and maximum of 600 mg/day. Superior in controlling abdominal pain. May cause dry mouth, constipation, or diarrhoea.
• Phloroglucinol: A miscellaneous antispasmodic with a dosage of 160 mg/day. Significantly improved subjects' global assessment and decreased stool frequency. May cause dry mouth, dizziness, and blurred vision.

Comparison: Mebeverine is distinguished from other antispasmodics by its direct musculotropic action on intestinal smooth muscle without systemic anticholinergic side effects such as dry mouth, constipation, or visual disturbances. It is recommended as a first-line pharmacological treatment for IBS pain, with direct inhibitory effects on intestinal smooth muscle and fewer systemic side effects. Clinical studies have shown it to be superior in controlling abdominal pain compared with placebo. The maximum daily dose is 405 mg. Your physician will determine the best option for your specific condition.

Legal Status, Registration, and Coverage in Canada

• Registration: Mebeverine hydrochloride is not approved by Health Canada for sale in Canada. It is approved and marketed in many countries including the United Kingdom (Colofac), Ireland, Australia, New Zealand, and across the European Union. Mebeverine is not approved by the US FDA.
• Prescription Status: Prescription only in jurisdictions where approved. Not available as a Health Canada-approved prescription drug. May be accessible through international pharmacy channels or importation for personal use under specific circumstances.
• Coverage: Not covered by provincial or territorial drug plans in Canada. Private insurance plans may provide partial coverage for international prescriptions in some circumstances. Check with your insurance provider.
• Pharmacovigilance: Adverse reactions to mebeverine should be reported to the relevant national pharmacovigilance authority in the country where the product was obtained.

Recent Research and Clinical Guidelines (2022–2026)

• The 2025 Journal of Neurogastroenterology and Motility review confirms that mebeverine is a first-line antispasmodic for IBS, with a starting dosage of 300 mg/day and a maximum of 405 mg/day. It is superior in controlling abdominal pain compared with placebo. Representative adverse effects include urticaria, angioedema, and anaphylaxis.
• The 2025 National Institute for Health and Care Excellence (NICE) guidance continues to recommend antispasmodics, such as mebeverine, as the initial drug choice for IBS pain, with mebeverine having direct inhibitory effects on intestinal smooth muscle and causing fewer systemic side effects.
• A 2025 clinical review recommends antispasmodics like mebeverine as appropriate first-line agents for abdominal pain in IBS, with benefit mainly for abdominal pain and distension (18% and 14% over placebo) but minimal effect on bowel alterations.
• The European Society for Neurogastroenterology and Motility recommends that antispasmodics, such as mebeverine, may be used as first-line treatment for meal-related abdominal pain.
• The 2025 pediatric IBS and functional abdominal pain guidelines suggest that mebeverine is NOT suggested for use in pediatric patients due to lower certainty of evidence.
• Regular exercise is strongly recommended for all IBS patients when using mebeverine as part of a comprehensive IBS management approach.

Availability and Supply in Canada

Prices and availability may vary significantly by country and pharmacy. Because mebeverine is not approved for sale in Canada, it is not available through standard Canadian pharmacies. Any use in Canada would require a prescription from a physician and importation through international pharmacy channels or Health Canada's Special Access Programme. Check with your physician for current information.

Frequently Asked Questions (FAQ)

1. Is Colofac (mebeverine) available in Canada?
   No. Mebeverine hydrochloride is not approved by Health Canada for sale in Canada. It is approved and marketed in many countries including the United Kingdom, Ireland, Australia, New Zealand, and across the European Union. It may be accessible through international pharmacy channels for personal use under specific circumstances.
2. How does mebeverine work for IBS?
   Mebeverine is an antispasmodic that works directly on the smooth muscle of the gastrointestinal tract. It relaxes the muscles in the intestinal wall, which helps relieve the cramping, pain, and bloating associated with IBS. It does not interfere with normal digestive movement and does not cause typical anticholinergic side effects such as dry mouth or constipation.
3. What is the correct dose of Colofac 135 mg?
   The standard adult dose is one 135 mg tablet three times daily, preferably taken 20 minutes before meals. The maximum daily dose is 405 mg. After several weeks, when the desired effect has been obtained, the dosage may be gradually reduced.
4. Can I take mebeverine with food?
   Mebeverine should be taken approximately 20 minutes before meals, not with food. This timing allows the medication to reach the intestinal smooth muscle before food stimulates bowel activity, maximising its antispasmodic effect.
5. What should I do if I miss a dose of mebeverine?
   If you miss a dose, continue with the next dose as prescribed. Do not take the missed dose in addition to the regular dose.
6. Can I stop taking mebeverine if I feel better?
   After a period of several weeks when the desired effect has been obtained, the dosage may be gradually reduced. Do not stop abruptly without consulting your physician. Your physician will advise you on how to gradually reduce the dose.
7. What are the side effects of mebeverine?
   Reported side effects in clinical studies include indigestion, heartburn, dizziness, insomnia, anorexia, headache, decrease in pulse rate, constipation, and general malaise. In very rare cases, allergic reactions have been reported, including hypersensitivity, urticaria, angioedema, face oedema, and exanthema. Systemic side effects as seen with typical anticholinergic agents are absent at the recommended dosage.
8. Is mebeverine safe during pregnancy?
   Mebeverine is not recommended during pregnancy. There are no or limited amounts of data from the use of mebeverine in pregnant women, and animal studies are insufficient with respect to reproductive toxicity. It should not be used during breastfeeding unless the anticipated benefits outweigh possible risks.
9. Are there alternatives to mebeverine for IBS?
   Yes. Alternatives include other antispasmodics such as alverine citrate, otilonium bromide, pinaverium bromide, peppermint oil, hyoscine, trimebutine, and phloroglucinol. Your physician will determine the best option for your specific condition.

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