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

• For adults and children aged 12 and over.
• To treat attacks that last up to 48 hours.
• If your attack lasts longer than 48 hours, talk to your doctor.

• For adults and young people aged 18 and over who have been diagnosed with IBS (Irritable Bowel Syndrome).
• To treat attacks that last up to 48 hours.
• You can use this medicine for up to 2 weeks for repeated attacks, but if any one attack lasts continuously for longer than 48 hours, talk to your doctor.

This medicine contains loperamide hydrochloride, a substance that helps reduce diarrhoea by slowing down an overactive bowel. This allows water and salts that are usually lost in diarrhoea to be absorbed by the body.

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

• if you have ever had a bad reaction to loperamide or to any of the other ingredients in this medicine (listed in section 6).
• 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.

Talk to your doctor or pharmacist before taking Loperamide

• 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 rhythms or malaria).
  • oral desmopressin (used to treat excessive urination).
  • itraconazole or ketoconazole (used to treat fungal infections).
  • 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 may be pregnant or are planning to have a pregnancy, 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 your 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.
• Consult with a doctor if you have a history of drug abuse.
• Loperamide is a type of opioid that acts directly on the gut when used as recommended but can cause other opioid effects when misused at high doses. Addiction is observed with opioids as a class.
• Abuse and misuse of loperamide, the active ingredient in Loperamide hard capsules, have been reported. 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 hard capsules.

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 hard capsules.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

• 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.

Age Dose

Adults and children aged 12 and over 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 hard capsules and talk to your doctor.

IBS diarrhoea

Age Dose

Adults aged 18 and over 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.

Talk to your doctor and stop taking this medicine:

• 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 and talk to your doctor.

If you have taken too many Loperamide, 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 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.

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

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

Not known (frequency cannot be estimated from the available data)

• Upper abdominal pain, abdominal pain that radiates to back, tenderness when touching the abdomen, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).

If you get any of these, stop using the medicine and get medical help at once.

Talk to a doctor as soon as possible

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)
• Hypertonia (muscle tension).
• Coordination abnormality (uncoordinated movements).

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

• Headache
• Feeling sick, constipation or wind

Uncommon: may affect up to 1 in 100 people

• Dizziness or drowsiness
• Vomiting, indigestion
• Dry mouth

Rare: may affect up to 1 in 1000 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 national reporting system listed in Yellow Card Scheme, Website: 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 substances is loperamide hydrochloride.
  Each hard capsule contains 2 mg of loperamide hydrochloride.
• The other ingredients are:
  Capsules content: Lactose monohydrate, maize starch, talc, magnesium stearate.
  Capsules shell: Titanium dioxide (E171), gelatin.
  Printing Ink: Shellac, black iron oxide (E172).

Hard Capsule.

White opaque cap/White opaque body, size ‘4’ hard gelatin capsule shells, imprinted with ‘2’on cap and ‘L’ on body with black ink filled with white to off-white powder.

Loperamide hard capsules are available in clear PVC/Aluminium blisters pack.

Pack sizes:

Blister packs: 6, 8, 10, 12, 15, 18, 20, 30 & 50 hard capsules.

Not all pack sizes may be marketed.

or

or