Loperamide 2mg Capsules

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Loperamide Hydrochloride 2mg capsules is and what it is used for
2. What you need to know before you take Loperamide Hydrochloride 2mg capsules
3. How to take Loperamide Hydrochloride 2mg capsules
4. Possible side effects
5. How to store Loperamide Hydrochloride 2mg capsules
6. Contents of the pack and other information

This medicine is suitable for most people, but a few people should not use it:

• If you are allergic to loperamide hydrochloride or any of the other ingredients.
• If it is for a child aged under 12 (or under 18 for an IBS patient).
• If you have severe diarrhoea after taking antibiotics.
• If you are having a flare-up of an inflammatory bowel condition like ulcerative colitis.
• If you are constipated, or your stomach appears swollen (especially in children with severe dehydration).
• If you have acute dysentery, the symptoms of which may include blood in your stools and a high temperature.

If any of these applies to you, talk to a doctor or pharmacist and do not take Loperamide Hydrochloride 2mg capsules.

Consult a doctor before use if you have a history of drug abuse; loperamide is an opioid and addiction is observed with opioids as a class.

Talk to your doctor first...

• If you have AIDS and your stomach becomes swollen, stop taking the capsules immediately and contact your doctor.
• If you suffer from liver disease.
• If you have diarrhoea that lasts for more than 48 hours.
• If you have been told by your doctor that you have an intolerance to some sugars.
• If you have severe diarrhoea as your body loses more fluid, sugars and salts than normal.
• If you are taking any other medicines,
  • including: ritonavir (used to treat HIV).
  • quinidine (used to treat abnormal heart rhythm or malaria).
  • oral desmopressin (used to treat excessive urination).
  • itraconazole or ketoconazole (used to treat fungal infection)
  • gemfibrozil (used to treat high cholesterol).

If you are unsure about any of the medicines you are taking, show the bottle or pack to your pharmacist. If any of these applies to you (now or in the past), talk to a doctor or pharmacist.

• If you are pregnant, think you are pregnant or planning to have a baby: Ask your doctor or pharmacist for advice before taking this medicine.
• If you are breast-feeding do not take this medicine. Small amounts may get into the mother’s milk. Talk to your doctor about a suitable treatment.

• This medicine may make you feel dizzy, tired or sleepy. You may feel less alert, feel faint or pass out.
  If you’re affected do not drive, cycle or use machines.

• Your body can lose large amounts of fluids and salts when you have diarrhoea. You need to replace the fluid by drinking more liquid than usual. Ask your pharmacist about rehydration therapy to replace lost salts. This is especially important for children, and frail or older people.
• Do not take this product for anything other than its intended use (see Section 1) and never take more than the recommended amount (see section 3). Serious heart problems (symptoms of which include fast or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active ingredient in Loperamide Hydrochloride 2mg capsules.

• This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.

• This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.

Use only if your doctor has previously diagnosed IBS.

Check the following:

Do not take this medicine

• If you are aged under 18.

Talk to your doctor first...

• If you are aged 40 or over and it is some time since your last IBS attack.
• If you are aged 40 or over and your IBS 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.

If any of these applies to you, talk to your doctor before taking Loperamide Hydrochloride 2mg capsules.

• Swallow the correct number of capsules whole with a drink of water. For oral use only.
• Do not use more than the dose shown in the tables.
• The capsules are not for long-term treatment.

Short-term diarrhoea

Age

Adults and children aged 12 and over

Dose

Take two capsules to start treatment.

Take one capsule after each loose bowel movement.

• Do not take for attacks lasting longer than 48 hours.
• Do not take more than six capsules in a 24-hour period.
• Replace lost fluid by drinking more liquid than usual.
• Not for children aged under 12.

You can use this medicine for up to 48 hours.

If your attack lasts longer than 48 hours, stop taking Loperamide Hydrochloride 2mg capsules and talk to your doctor.

IBS diarrhoea

Age

Adults and young people aged 18 and over

Dose

Take two capsules to start treatment.

Take one capsule after each loose bowel movement (or as advised by your doctor).

• You can use this medicine for up to 2 weeks for repeated attacks, but do not take for any one attack lasting longer than 48 hours.
• Do not take more than six capsules in a 24-hour period.
• Replace lost fluid by drinking more liquid than usual.
• Not for children and young people aged under 18.

• If you have been using this medicine continuously for 48 hours.
• If you develop new IBS symptoms.
• If your IBS symptoms get worse.
• If your IBS symptoms have not improved after 2 weeks.

You can use this medicine for up to 2 weeks for repeated attacks of IBS diarrhoea. But if any one attack lasts for longer than 48 hours stop taking Loperamide Hydrochloride 2mg capsules and talk to your doctor.

If you have taken too many Loperamide Hydrochloride 2mg capsules immediately contact a doctor or hospital for advice.

Symptoms may include: increased heart rate, irregular heartbeat, changes to your heartbeat (these symptoms can have potentially serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.

Children react more strongly to large amounts of Loperamide Hydrochloride 2mg capsules than adults. If a child takes too much or shows any of the above symptoms, call a doctor immediately.

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.

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

• Itchiness or hives.
• Stomach pain or swollen stomach.

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

• Difficulties passing water.
• Severe constipation.
• Miosis (narrowing of the pupils of the eye).

If you notice any of the above, stop using the medicine and talk to a doctor.

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.
• Vomiting, indigestion.
• Dry mouth.

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

• Tiredness.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is loperamide hydrochloride.

Each hard gelatin capsule contains loperamide hydrochloride 2mg.

The other ingredients are: Lactose anhydrous, Maize starch, Polysorbate 80, Talc, Magnesium stearate, Silica colloidal anhydrous.

Capsule cap: Gelatin, Sodium laurilsulfate, Iron oxide yellow, Indigo carmine, Titanium dioxide.

Capsule body: Gelatin, Sodium laurilsulfate, Erythrosine, Iron oxide black, Titanium dioxide.

Imprinting Ink: Shellac, Ethanol anhydrous, Isopropyl alcohol, Butanol, Propylene glycol, Ammonia solution concentrated, Iron oxide black, Potassium hydroxide.

Green/Grey coloured, size '4' hard gelatin capsules imprinted with “C” on the cap and '24' on the body, filled with white to off white powder.

Loperamide Hydrochloride 2mg capsules are supplied in clear PVC/Aluminium blister of 10 and 14 capsules. Pack size: 28, 30, 50, 56, 84 and 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation and Manufacturer