Generic Colofac ( Mebeverin hydrochloride )

Buy Generic Colofac (Mebeverin hydrochloride) without prescription in Canada

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Colofac (mebeverine hydrochloride) is a musculotropic antispasmodic medicine that helps relieve the painful cramps, abdominal pain, bloating, and bowel disturbances associated with irritable bowel syndrome and other gastrointestinal conditions. It works by directly relaxing the smooth muscle of the gut wall without affecting the normal, rhythmic motility that moves food through the digestive tract. This targeted action helps ease the spasm and discomfort of a hypersensitive or overactive bowel, restoring comfort and digestive predictability.

Usual adult dose: The standard dose for adults and adolescents over 10 years of age is one 135 mg tablet taken three times daily, approximately 20 minutes before the three main meals of the day. This pre‑meal timing allows the medication to work proactively during the digestive period when symptoms are most likely to be triggered. The dose may be gradually reduced after several weeks once the desired clinical effect has been achieved.

Dosage form: Film‑coated oral tablet containing 135 mg of mebeverine hydrochloride.

Onset of action: Mebeverine is rapidly absorbed and begins to exert its smooth‑muscle‑relaxing effect within approximately one hour of oral dosing, with peak plasma concentrations of its active metabolite achieved around 1 hour after administration. Symptomatic relief of post‑prandial cramping may therefore be noticeable from the first dose.

Duration of action: The clinical effect of a single 135 mg dose is sufficient to cover the digestive period of a main meal, with the three‑times‑daily regimen providing round‑the‑clock coverage. The steady‑state elimination half‑life of the main metabolite is approximately 2.45 hours, and the drug is completely cleared between doses with no accumulation.

Alcohol recommendation: Alcohol does not have a known direct pharmacological interaction with mebeverine; animal studies have specifically demonstrated an absence of interaction between mebeverine hydrochloride and ethanol. However, because alcohol is a common trigger for IBS symptoms and can independently cause gastrointestinal irritation, it is sensible to limit or avoid alcohol consumption to help maximise the benefit of treatment.

Most common side effects: Mebeverine is generally very well tolerated. Adverse effects are rare but may include mild skin reactions such as rash, urticaria (hives), itching, or facial swelling. Very rarely, hypersensitivity (anaphylactic) reactions have been reported.

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General Information about Colofac (Mebeverine)

• INN (International Nonproprietary Name): Mebeverine hydrochloride
• Brand names available in Canada: Colofac (marketed internationally by Abbott Healthcare), Colofac MR, Duspatalin, Aurobeverine. Mebeverine is not currently listed as a marketed product in the Health Canada Drug Product Database; the brand Colofac is recognised internationally and is available to Canadian patients through international pharmacy channels.
• ATC code: A03AA04
• Dosage forms and strengths: 135 mg film‑coated tablet for immediate release. A 200 mg modified‑release capsule formulation is also available in some markets.
• Manufacturers in Canada: Mebeverine is not manufactured in Canada. It is manufactured internationally by Abbott Healthcare (Colofac) and by Mylan Products Ltd. (generic mebeverine) in the United Kingdom. The product is obtained via the international supply chain for personal importation.
• Registration status in Canada: Not marketed in Canada. Mebeverine has not been issued a Notice of Compliance by Health Canada and is not listed in the Canadian Drug Product Database. It is, however, approved and widely available in the United Kingdom, Australia, and numerous other countries worldwide.
• OTC / Rx classification: Prescription only (Rx). A valid prescription from a licensed Canadian healthcare professional is required.

Mechanism of Action and Pharmacology

Mebeverine is a musculotropic antispasmodic with a direct action on the smooth muscle of the gastrointestinal tract, relieving spasm without affecting normal gut motility. The exact mechanism of action is not fully understood, but it is known to involve several complementary effects at the level of the gut wall. Mebeverine decreases the permeability of ion channels in the smooth‑muscle cell membrane, stabilising excitable membranes and preventing the excessive influx of calcium ions that drives sustained contraction. It also blocks the reuptake of noradrenaline by sympathetic nerve endings, exerts a local anaesthetic action, and has weak anti‑muscarinic and phosphodiesterase‑inhibitory properties. Crucially, all of these actions are exerted locally within the gastrointestinal wall; mebeverine does not produce the systemic anticholinergic side effects (such as dry mouth, blurred vision, and constipation) that are typical of classical antispasmodic agents.

After oral administration, mebeverine hydrochloride is rapidly and completely absorbed. It is extensively metabolised by esterases, which first split the ester bonds to yield veratric acid and mebeverine alcohol. The mebeverine alcohol is further oxidised to the corresponding carboxylic acid (MAC) and demethylated carboxylic acid (DMAC). DMAC is the main metabolite found in plasma; its steady‑state elimination half‑life is 2.45 hours. Peak plasma concentrations of DMAC after a 135 mg dose are approximately 1670 ng/mL, achieved at around 1 hour. Mebeverine is not excreted unchanged; the metabolites are eliminated almost completely via the urine. No significant accumulation occurs with multiple dosing.

Indications

• Symptomatic treatment of irritable bowel syndrome (IBS), including the relief of abdominal pain and cramps, persistent diarrhoea (with or without alternating constipation), flatulence, bloating, and the passage of small, hard, pellet‑like stools.
• Conditions usually included in the IBS grouping: chronic irritable colon, spastic constipation, mucous colitis, and spastic colitis.
• Symptomatic treatment of gastrointestinal spasm secondary to organic diseases of the digestive tract.
• Colofac is also used for the relief of bowel spasm and cramping in functional abdominal pain where no organic cause can be identified.

Important Warnings and Precautions

At‑risk groups

• Pregnancy: There are no or only limited data from the use of mebeverine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. As a precautionary measure, Colofac is not recommended during pregnancy unless the expected benefit clearly outweighs any potential risk. The standard caution concerning the administration of any drug during pregnancy should be observed.
• Breastfeeding: It is unknown whether mebeverine or its metabolites are excreted in human breast milk. The excretion of mebeverine in milk has not been studied in animals. Colofac should not be used during breastfeeding.
• Paediatrics: The safety and efficacy of mebeverine have been evaluated primarily in adults. The 135 mg tablet is licensed for use in children over 10 years of age. It is not recommended for children under 10 years. Modified‑release capsules are not licensed for use in children under 18 years. Specialist paediatricians do occasionally prescribe mebeverine for intestinal spasms in younger children based on individual clinical judgment.
• Elderly: No specific dose adjustment is required in the elderly. The standard adult dose applies, though older patients who are frail or have multiple comorbidities should be monitored as for any new medication.
• Hepatic impairment: No dose adjustment is recommended in mild to moderate hepatic impairment. Mebeverine is extensively metabolised by esterases rather than cytochrome P450 enzymes; therefore, hepatic dysfunction has a limited impact on its clearance. Nevertheless, patients with severe liver disease should use the medication with caution due to the absence of specific data in this population.
• Renal impairment: No dose adjustment is required in renal impairment. The metabolites are excreted in the urine, but they are pharmacologically inactive and their accumulation in renal failure has not been associated with toxicity.
• Paralytic ileus and intestinal atony: Mebeverine is contraindicated in patients with paralytic ileus (complete cessation of bowel motility). It should be used with caution in patients with pre‑existing intestinal atony (loss of muscle tone).
• Ulcerative colitis: Use with caution in patients with ulcerative colitis, as the colon may be at increased risk of perforation in the presence of altered motility.
• Porphyria: Mebeverine is considered unsafe in patients with porphyria and is contraindicated in these patients.
• Sucrose intolerance: The coated tablets contain sucrose and should not be used by patients with rare hereditary problems of fructose intolerance, glucose‑galactose malabsorption, or sucrase‑isomaltase insufficiency.
• Allergy: Do not take Colofac if you have a known hypersensitivity to mebeverine hydrochloride or any of the tablet excipients.

Driving and alcohol

Mebeverine has no or negligible influence on the ability to drive and use machines. No studies on the effects on the ability to drive and use machines have been performed; however, the pharmacodynamic and pharmacokinetic profile, as well as extensive post‑marketing experience, do not indicate any harmful effect of mebeverine on the ability to drive or to use machines. Regarding alcohol, no interaction studies have been performed in humans, but in vitro and in vivo animal studies have demonstrated the absence of any interaction between mebeverine hydrochloride and ethanol. Nonetheless, patients with IBS are often sensitive to alcohol, which can independently provoke gastrointestinal symptoms; moderation or abstinence is therefore advisable for symptom control, not for a drug‑interaction reason.

Dosage Instructions

• Standard adult dose: One 135 mg tablet taken three times daily, approximately 20 minutes before breakfast, lunch, and the evening meal. The tablet should be swallowed whole with a glass of water and must not be crushed or chewed.
• Children aged 10 years and over: The same dose as for adults: one 135 mg tablet three times daily before meals.
• Children under 10 years: The 135 mg tablet is not recommended.
• Duration of therapy: Colofac is intended for symptomatic relief. After a period of several weeks, when the desired clinical effect has been obtained, the dosage may be gradually reduced. There is no fixed limit on the duration of treatment; some patients benefit from long‑term, regular use, while others use it on an as‑needed basis during symptomatic flare‑ups.
• Missed dose: If a dose is missed, simply take the next scheduled dose at the usual time. Do not take a double dose to make up for the missed tablet.
• Overdose: On theoretical grounds, central nervous system excitability (tremor, convulsions) may occur in cases of significant overdosage. Treatment is supportive and symptomatic. There is no specific antidote.

Side Effects and Contraindications

• Common side effects: Mebeverine is exceptionally well tolerated, and most patients experience no adverse effects at all. When side effects do occur, they are almost always mild and self‑limiting.
• Uncommon side effects: Mild skin reactions, including rash, urticaria (hives), exanthema, and pruritus.
• Rare but serious side effects: Hypersensitivity reactions, including angioedema (swelling of the deeper layers of the skin, often around the face, lips, and tongue), facial oedema, and very rarely anaphylactic reactions. These are estimated to occur in fewer than 1 in 10,000 treated patients. Discontinue the medication immediately and seek medical attention if any signs of a severe allergic reaction develop.
• Other reported events: Dizziness, headache, and mild gastrointestinal upset have been reported in post‑marketing surveillance, although a causal relationship to mebeverine has not been firmly established.
• Contraindications: Known hypersensitivity to mebeverine hydrochloride or any excipient in the tablet. Paralytic ileus. Porphyria. Rare hereditary conditions of fructose intolerance, glucose‑galactose malabsorption, or sucrase‑isomaltase insufficiency (due to the sucrose content of the coating).

Drug Interactions

• Alcohol: No interaction studies have been performed in humans, but animal studies have specifically demonstrated the absence of any pharmacokinetic or pharmacodynamic interaction between mebeverine and ethanol.
• Other IBS remedies: It is generally best not to take mebeverine together with other antispasmodic remedies for irritable bowel syndrome (e.g., alverine citrate, peppermint oil capsules), as these medicines work in the same way and additive effects are unlikely to provide extra benefit while potentially increasing the risk of side effects. Do not take more than one IBS remedy at a time unless advised by a doctor.
• Prescription medicines and painkillers: Mebeverine is safe to take with most prescription medicines and with everyday painkillers such as paracetamol and ibuprofen. No clinically significant interactions with other drugs have been identified.
• Herbal remedies and supplements: There is insufficient information to state definitively that complementary medicines and herbal remedies are safe to take with mebeverine. They are not tested in the same way as conventional medicines. Patients should inform their doctor or pharmacist if they are taking any herbal remedies, vitamins, or other dietary supplements.
• Contraceptives: Mebeverine does not affect any type of hormonal contraception, including the combined oral contraceptive pill, the progestogen‑only pill, or emergency contraception.

Practical Advice

• Administration: Take one tablet with a glass of water approximately 20 minutes before each of your three main meals. Swallow the tablet whole; do not crush or chew it. Taking the medication before eating allows it to be absorbed and to begin working in the gut just as the digestive process is starting, which is when IBS symptoms are most commonly triggered.
• Monitoring: No specific laboratory monitoring is required during treatment with mebeverine. The patient should self‑monitor symptoms and report any new or worsening symptoms, or any lack of improvement after a reasonable period of treatment, to their healthcare provider.
• Storage: Store at room temperature (15‑30 °C) in a dry place, protected from moisture, heat, and light. Keep in the original packaging and out of the reach and sight of children.
• Lifestyle and diet: Medication is most effective when combined with dietary and lifestyle adjustments. A high‑fibre diet may help some patients, though the specific dietary approach depends on the pattern of IBS (diarrhoea‑predominant, constipation‑predominant, or mixed). Keeping a food and symptom diary can help identify trigger foods. Stress management techniques—such as regular relaxation, gentle exercise, and adequate sleep—can also reduce symptom severity.
• When to seek medical review: Consult your doctor if symptoms do not improve after a few weeks of treatment, if you develop new symptoms, or if your existing symptoms become worse. Particularly, report any rectal bleeding, unexplained weight loss, persistent vomiting, or difficulty swallowing.
• Disposal: Return unused or expired medication to a pharmacy for safe disposal. Do not flush down the toilet or discard in household waste.

Alternative Medications

• Other antispasmodics: Alverine citrate (Spasmonal) is an alternative smooth‑muscle relaxant used for IBS. Hyoscine butylbromide (Buscopan) is another widely used antispasmodic that works partly through an anticholinergic mechanism. Peppermint oil capsules (e.g., Colpermin) are a natural, over‑the‑counter alternative with antispasmodic properties.
• Dietary and fibre‑based products: Ispaghula husk (Fybogel) is a bulk‑forming laxative that can help regulate bowel habit in IBS. Fybogel Mebeverine is a combination product containing both ispaghula husk and mebeverine in a single formulation.
• Medications targeting specific IBS subtypes: For diarrhoea‑predominant IBS, loperamide (Imodium) can be used for symptomatic control. For constipation‑predominant IBS, osmotic laxatives such as polyethylene glycol (Lax‑A‑Day) may be helpful. Lubiprostone (Amitiza) is a prescription chloride‑channel activator used for IBS with constipation in women.
• Neuromodulators: Low‑dose tricyclic antidepressants (e.g., amitriptyline) or selective serotonin reuptake inhibitors (e.g., paroxetine) are sometimes prescribed for moderate to severe IBS, particularly when pain is a dominant feature and first‑line antispasmodics have been insufficient.
• Non‑pharmacological approaches: Cognitive behavioural therapy (CBT), gut‑directed hypnotherapy, and mindfulness‑based stress reduction have a strong evidence base for improving IBS symptoms and quality of life. They can be used alone or alongside medication.

Clinical Efficacy

Mebeverine has been in widespread clinical use for the symptomatic management of irritable bowel syndrome since it was first registered in 1965. Its clinical effectiveness in reducing abdominal pain, relieving cramps, and improving overall well‑being in patients with IBS has been confirmed in a number of clinical studies and is supported by decades of real‑world prescribing experience. All formulations of mebeverine have been shown to be generally safe and well tolerated in the recommended dose regimen. The medication is included in international guidelines for the management of functional gastrointestinal disorders, and it is considered a first‑line pharmacotherapy for the relief of global symptoms and abdominal pain in IBS, in most regions where it is licensed.

A recent 2025 randomised controlled trial evaluated mebeverine in a paediatric population (adolescents aged 12–17 years) with IBS or functional abdominal pain not otherwise specified, and while mebeverine was not shown to be superior to placebo in that study—a finding that was in line with outcomes for many other pharmacological agents in this notoriously difficult‑to‑treat patient group—adverse events in the mebeverine arm were mild and infrequent, confirming the drug's benign safety profile. In the adult population, mebeverine's clinical role as a well‑tolerated, locally acting antispasmodic with negligible systemic effects remains firmly established.

Important:

Colofac (mebeverine hydrochloride) is a prescription medication that should be used only under the supervision of a qualified healthcare professional. It is intended for the symptomatic relief of irritable bowel syndrome and related functional gastrointestinal disorders. It is not a cure for the underlying condition, and patients should combine pharmacotherapy with appropriate dietary and lifestyle modifications. If symptoms persist, worsen, or are accompanied by alarm features such as rectal bleeding, unintended weight loss, or nocturnal waking with pain, seek prompt medical review. Do not exceed the recommended dose, and do not use this medication concomitantly with other antispasmodic IBS remedies without medical advice. If you develop signs of a hypersensitivity reaction—including rash, swelling of the face, lips, or throat, or difficulty breathing—discontinue the medication immediately and seek emergency medical attention. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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