Loperamide 2mg Capsules

Usage

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

Adults, the elderly and children over 12 years

How to take: The capsules should be swallowed whole with a drink of water.

Dose and how often to take:

After the first loose stool (bowel motion) take 2 capsules with water. After each further loose stool, take 1 capsule.

• Rehydration sachets are available separately.
• Do not give to children under 12 years of age.
• Do not take more than 6 capsules in any 24 hours.
• Do not take the capsules for more than 24 hours unless advised by a doctor/pharmacist
• If symptoms persist for more than 24 hours consult your doctor or get in touch with one of our pharmacists
• Replace lost fluid by drinking more liquid than usual.
• DO NOT EXCEED THE STATED DOSE.

If you take more medicine than you should, contact your doctor/pharmacist or nearest Accident and Emergency department taking this leaflet with you.

If you forget to take this medicine

You should only take this medicine as you need it, following the dosage instructions above carefully. If you forget to take a dose, take a dose after the next loose stool (bowel movement).

Do not take a double dose.

Swallow each capsule with plenty of water.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Rare: (may affect up to 1 in 1,000 people)
Stop taking this medicine and see your doctor immediately if you experience any of these serious
side effects:

• Allergic reactions including unexplained wheezing, shortness of breath, passing out or swelling of face and throat
• Skin rashes, which may be severe and include blistering or peeling skin
• Loss of consciousness or reduced level of consciousness (passing out, feeling faint or less alert), uncoordinated movements.

Other side effects

Common: (may affect up to 1 in 10 people)

• Feeling sick, constipation or wind
• Headache.

Uncommon: (may affect up to 1 in 100 people)

• Dizziness or drowsiness
• Abdominal pain or discomfort
• Abdominal pain upper
• Dry mouth
• Vomiting
• Indigestion

Rare: (may affect up to 1 in 1,000 people)

• Itchiness or hives
• Stomach pain or swollen stomach
• Difficulties in passing water
• Miosis (narrowing of the pupils of the eye)
• Tiredness.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed here You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard

By reporting side affects you can help provide more information on the safety of this product.
Other Information
If you need more advice consult your doctor or pharmacist.

Keep all medicines out of the sight and reach of children.

Treatment of diarrhoea with loperamide HCl is only symptomatic. Whenever an underlying aetiology can be determined, specific treatment should be given when appropriate.

In patients with diarrhoea, especially in children, frail and elderly patients, fluid and electrolyte depletion may occur. In such cases administration of appropriate fluid and electrolyte replacement therapy is the most important measure.

In acute diarrhoea, if clinical improvement is not observed within 24 hours, the administration of loperamide HCl should be discontinued and patients should be advised to consult their physician.

This product should not be used for prolonged periods. Diarrhoea is a common presentation of a number of significant gastrointestinal conditions. This medicine is indicated only for the symptomatic treatment of acute episodes of diarrhoea associated with irritable bowel syndrome. This medicine should not be used for prolonged periods until an underlying cause for persistent diarrhoea has been investigated and diagnosed by a doctor.

Patients with AIDS treated with loperamide HCl for diarrhoea should have therapy stopped at the earliest signs of abdominal distension. There have been isolated reports of obstipation with an increased risk for toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide HCl.

Although no pharmacokinetic data are available in patients with hepatic impairment, loperamide HCl should be used with caution in such patients because of reduced first pass metabolism. This medicine must be used with caution in patients with hepatic impairment as it may result in a relative overdose leading to CNS toxicity.

Cardiac events including QT interval and QRS complex prolongation, torsade de pointes have been reported in association with overdose. Some cases had a fatal outcome (see section 4.9). Overdose can unmask existing Brugada syndrome. Patients should not exceed the recommended dose and/or the recommended duration of treatment.

For acute diarrhoea

If symptoms persist for more than 24 hours, consult your doctor.

For acute episodes of diarrhoea associated with irritable bowel syndrome

Warnings to be included in the leaflet:

Only take loperamide HCl to treat acute episodes of diarrhoea associated with irritable bowel syndrome (IBS) if your doctor has previously diagnosed IBS.

If any of the following now apply, do not use the product without first consulting your doctor, even if you know you have IBS:

• If you are 40 years or over and it is some time since your last attack of IBS or the symptoms are different this time

• If you have recently passed blood from the bowel

• If you suffer from severe constipation

• If you are feeling sick or vomiting

• If you have lost your appetite or lost weight

• If you have difficulty or pain passing urine

• If you have a fever

• If you have recently travelled abroad

Consult your doctor if you develop new symptoms, or if your symptoms worsen, or if your symptoms have not improved over two weeks.

Keep all medicines out of the reach of children.