Colofac

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Colofac on Prescriptsy

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Colofac contains mebeverine hydrochloride, an antispasmodic medicine used in the United Kingdom for the symptomatic relief of irritable bowel syndrome (IBS) and other gastrointestinal conditions involving intestinal spasm.

IBS is one of the most common functional gastrointestinal disorders, affecting approximately 10 to 20% of the UK population and accounting for a significant proportion of GP and gastroenterology consultations.

It is characterised by recurrent abdominal pain or discomfort associated with altered bowel habit in the absence of structural or biochemical abnormality.

Mebeverine works by relaxing the smooth muscle of the gut wall, relieving the painful spasms and cramping that are hallmark symptoms of IBS.

Unlike antimuscarinic antispasmodics, mebeverine does not cause the anticholinergic side effects of dry mouth, blurred vision, or urinary retention, and it does not impair normal bowel motility or cause drowsiness.

This page provides a comprehensive clinical overview of how Colofac works, correct dosing, expected benefits, side effects, safety information, and how to obtain it in the UK.

Important information about Colofac

Before reading further, note the following points. Colofac is available as both a prescription-only medicine and (in the 135 mg tablet strength for IBS) as a pharmacy (P) medicine that can be purchased without a prescription from a registered pharmacist.

• Colofac relieves intestinal spasm and cramping pain. It is not a general painkiller and will not treat non-intestinal pain.
• If you have new bowel symptoms, blood in your stool, unexplained weight loss, or a persistent change in bowel habit (especially if you are over 40), see your GP before starting Colofac. These symptoms require investigation to exclude serious conditions.
• If IBS symptoms do not improve after 2 weeks of regular use, consult your GP for reassessment.
• Colofac does not cause drowsiness and is safe to use while driving or operating machinery.

Understanding irritable bowel syndrome (IBS)

IBS is a chronic functional gastrointestinal disorder diagnosed on the basis of symptoms in the absence of organic pathology.

The Rome IV criteria define IBS as recurrent abdominal pain, on average at least one day per week in the last 3 months, associated with two or more of the following: related to defaecation, associated with a change in stool frequency, or associated with a change in stool form (appearance).

IBS is subtyped into diarrhoea-predominant (IBS-D), constipation-predominant (IBS-C), mixed (IBS-M), and unsubtyped (IBS-U).

The exact pathophysiology of IBS is not fully understood, but it involves a complex interplay of altered gut motility, visceral hypersensitivity (increased perception of normal gut activity as painful), disturbances in the gut-brain axis, low-grade mucosal inflammation, changes in the gut microbiome, and psychosocial factors including stress and anxiety.

Intestinal smooth muscle spasm is a well-recognised contributor to the cramping pain experienced by many IBS patients and is the primary target of antispasmodic therapy.

NICE guideline CG61 (Irritable bowel syndrome in adults) recommends that the diagnosis of IBS should be considered if a patient has had abdominal pain or discomfort, bloating, or change in bowel habit for at least 6 months.

Appropriate initial investigations should exclude red flag conditions.

Once IBS is confirmed, management should be stepwise: first-line advice on diet and lifestyle, followed by pharmacotherapy targeted at the predominant symptom (antispasmodics for pain, laxatives for constipation, antimotility agents for diarrhoea), and consideration of psychological therapies for refractory cases.

How Colofac works: mechanism of action

Mebeverine hydrochloride is a musculotropic antispasmodic that acts directly on the smooth muscle cells of the gastrointestinal tract. Its mechanism involves two complementary actions that distinguish it from both antimuscarinic agents and calcium channel blockers.

First, mebeverine blocks voltage-dependent sodium channels in smooth muscle cells. This prevents the influx of sodium ions that triggers depolarisation and initiates rhythmic contractions.

By stabilising the cell membrane, mebeverine reduces the excitability of gut smooth muscle and inhibits spasmodic contractions.

Second, mebeverine interferes with intracellular calcium stores. It reduces the accumulation of calcium within smooth muscle cells, which is necessary for sustained tonic contraction.

This dual action effectively relaxes spasming gut muscle without paralysing it, meaning that normal peristaltic motility (the coordinated wave-like contractions that propel food through the digestive tract) is preserved.

This selectivity is clinically important.

Antimuscarinic antispasmodics such as hyoscine butylbromide block acetylcholine receptors throughout the body, which can cause dry mouth, blurred vision, urinary retention, constipation, and tachycardia.

Mebeverine avoids these systemic effects because it works downstream of the acetylcholine receptor, directly on the smooth muscle contraction machinery.

It also has no central nervous system activity, meaning it does not cause sedation or impair cognitive function.

Clinical evidence for mebeverine in IBS

Mebeverine has been used for the treatment of IBS for over 50 years and has been the subject of numerous clinical trials.

A Cochrane systematic review of antispasmodic agents in IBS found that antispasmodics as a class are significantly more effective than placebo at reducing abdominal pain (NNT approximately 5), with mebeverine among the most commonly studied agents.

Individual randomised controlled trials have demonstrated that mebeverine reduces the frequency and intensity of abdominal pain episodes, decreases bloating, and improves overall symptom scores compared with placebo.

It is effective across IBS subtypes, though its primary benefit is in patients for whom cramping pain is the predominant symptom.

NICE CG61 recommends antispasmodics as first-line pharmacotherapy for IBS-related abdominal pain and cramping.

Mebeverine is one of the most frequently prescribed antispasmodics in UK primary care, alongside hyoscine butylbromide and peppermint oil capsules.

The choice between these agents is guided by tolerability, patient preference, and the side effect profile.

Dosage and administration

Colofac 135 mg tablets

Take one 135 mg tablet three times daily, approximately 20 minutes before the three main meals. Swallow the tablet whole with water. Do not chew.

The pre-meal timing allows mebeverine to reach effective concentrations in the gut wall before food stimulates intestinal motility.

Colofac MR 200 mg capsules

Take one 200 mg modified-release capsule twice daily, 20 minutes before the two main meals. The modified-release formulation provides a sustained release of mebeverine throughout the day with fewer doses. Do not chew or open the capsules.

Duration of treatment

Colofac can be taken for as long as it is needed to control symptoms.

IBS is typically a long-term condition with fluctuating symptoms, and many patients use mebeverine intermittently during symptom flares or continuously during periods of active symptoms.

There is no evidence of tolerance, dependency, or withdrawal effects with long-term use.

If symptoms have not improved after 2 weeks of regular use, consult your GP to reconsider the diagnosis and management plan.

Missed doses

If you miss a dose, take it before the next meal if there is still time.

If it is nearly time for the next scheduled dose, skip the missed one. Do not double up. Occasional missed doses will not significantly affect symptom control.

Side effects of Colofac

General tolerability

Mebeverine is one of the best-tolerated medicines available for IBS. In clinical trials and decades of post-marketing experience, the incidence of adverse effects attributable to mebeverine (as opposed to the underlying IBS symptoms) is very low.

Rare side effects

Rarely reported effects include allergic skin reactions such as urticaria (hives), rash, and angioedema (swelling of the face, lips, tongue, or throat). Very rarely, anaphylaxis has been reported.

Mild gastrointestinal symptoms (heartburn, constipation, or indigestion) may occur but are difficult to differentiate from the symptoms of IBS itself.

Absence of anticholinergic effects

Unlike antimuscarinic antispasmodics, mebeverine does not cause dry mouth, blurred vision, urinary retention, constipation secondary to anticholinergic activity, drowsiness, or cognitive impairment. This is a significant practical advantage, particularly for patients who need to drive, work, or study without impairment.

When to seek medical advice

Stop taking Colofac and seek emergency medical attention (call 999 or attend A&E) if you develop swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing, or widespread hives.

These may indicate a serious allergic reaction. For any other unexpected symptoms, contact your GP, pharmacist, or NHS 111.

Report suspected adverse reactions via the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk .

Warnings and precautions

Exclusion of serious conditions

IBS is a diagnosis of exclusion. Before starting Colofac (whether obtained on prescription or purchased from a pharmacy), ensure that your symptoms have been appropriately assessed.

Red flag symptoms that require GP investigation include blood in the stool, unintentional weight loss, persistent change in bowel habit lasting more than 4 weeks (especially in patients over 40 or with a family history of bowel cancer), symptoms that wake you from sleep, fever, anaemia, and abdominal or rectal masses.

These may indicate inflammatory bowel disease, coeliac disease, bowel cancer, or other conditions requiring specific treatment.

Pregnancy and breastfeeding

There is limited data on the safety of mebeverine in human pregnancy.

Animal studies have not demonstrated teratogenic effects, but as a precaution, mebeverine should be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the developing baby.

No data are available on excretion into breast milk. If you are pregnant, planning a pregnancy, or breastfeeding, discuss the use of Colofac with your GP or midwife.

Drug interactions

No clinically significant drug interactions have been identified with mebeverine.

It can be taken alongside other IBS medications including loperamide, osmotic laxatives (macrogol, lactulose), bulk-forming agents (ispaghula husk, sterculia), and peppermint oil capsules.

It does not interact with warfarin, the oral contraceptive pill, antidepressants commonly used for IBS (such as low-dose amitriptyline or SSRIs), or proton pump inhibitors.

Excipients

Colofac MR capsules contain sucrose. Patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this formulation. Check the patient information leaflet for the full excipient list for each product.

Colofac versus other IBS antispasmodics

The three most commonly used antispasmodics for IBS in the UK are mebeverine, hyoscine butylbromide (Buscopan), and peppermint oil capsules (Colpermin, Mintec).

Mebeverine has the advantage of no anticholinergic side effects and no sedation, making it the preferred choice for patients who are sensitive to dry mouth, urinary symptoms, or drowsiness.

Hyoscine butylbromide has a faster onset of action but is limited by anticholinergic effects at higher doses.

Peppermint oil is a natural alternative with evidence of efficacy but may cause heartburn in some patients.

Your GP or pharmacist can advise on the best option for your symptom profile.

How to get Colofac in the UK

Colofac IBS tablets (mebeverine 135 mg) are available without a prescription from registered pharmacies as a pharmacy (P) medicine.

The pharmacist will ask you some questions to confirm suitability before supplying them.

This is an appropriate route for adults aged 18 and over with a previous diagnosis of IBS who are familiar with their symptoms.

Colofac 135 mg tablets and Colofac MR 200 mg capsules are also available on prescription from your GP or an authorised online prescriber.

Prescription supply is appropriate for patients who require ongoing treatment, whose diagnosis needs confirmation, or who are under 18.

The standard NHS prescription charge in England is currently 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Managing IBS: a holistic approach

Pharmacotherapy with Colofac is most effective as part of a broader IBS management strategy.

NICE CG61 recommends regular meals, adequate fluid intake (at least 8 cups per day), and limitation of caffeine, alcohol, fizzy drinks, and high-fat or spicy foods.

Increasing soluble fibre (oats, linseeds, ispaghula husk) may improve symptoms, while insoluble fibre (bran) can worsen bloating and should be reduced if problematic.

A dietitian-supervised low-FODMAP diet has strong evidence for reducing IBS symptoms in approximately 75% of patients and is recommended by NICE as a second-line dietary intervention.

Your GP can refer you to an NHS dietitian.

Regular physical activity and stress management techniques (including cognitive behavioural therapy, gut-directed hypnotherapy, and mindfulness) also have evidence of benefit for IBS symptom control.

When to seek medical advice

Contact your GP or NHS 111 if your IBS symptoms change significantly, if you develop any red flag symptoms listed above, or if Colofac is not providing adequate relief.

Seek emergency care (call 999 or attend A&E) if you experience severe abdominal pain, vomiting with inability to pass stool or gas (possible bowel obstruction), or signs of a serious allergic reaction.

Report any adverse reactions via the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk .

Sources

• Colofac 135 mg Tablets, Summary of Product Characteristics (EMC)
• Mebeverine hydrochloride, British National Formulary (BNF)
• NICE CG61: Irritable bowel syndrome in adults: diagnosis and management
• Irritable bowel syndrome (IBS), NHS
• MHRA Yellow Card Scheme