Loperamide 2mg Capsules (PL 29831/0131)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Loperamide 2mg Hard Capsules are and what they are used for
2. What you need to know before you take Loperamide 2mg Hard Capsules
3. How to take Loperamide 2mg Hard Capsules
4. Possible side effects
5. How to store Loperamide 2mg Hard Capsules
6. Contents of the pack and other information

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

Do not take Loperamide 2mg Hard Capsules:

• if you are allergic to loperamide or any of the other ingredients of 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 your doctor or pharmacist and do not take Loperamide 2mg Hard Capsules.

Warnings and Precautions

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 2mg Hard Capsules.

Talk to your doctor or pharmacist before taking Loperamide 2mg Hard Capsules

• 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.

Special warnings about this medicine

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.

Extra warnings for IBS patients

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 2mg Hard Capsules.

Pregnancy and breast-feeding

• If you are pregnant, think you may be pregnant or are 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 your milk. Talk to your doctor about a suitable treatment.

Driving and using machines

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.

Loperamide 2mg Hard Capsules contain lactose

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

Check the tables below to see how much medicine to take.

• 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 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.

How long to take Loperamide 2mg Hard Capsules for short-term diarrhoea

You can use this medicine for up to 48 hours. If your attack lasts longer than 48 hours, stop taking Loperamide 2mg 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.

How long to take Loperamide 2mg Hard Capsules for IBS diarrhoea

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 2mg Hard Capsules and talk to your doctor.

If you take more Loperamide 2mg Hard Capsules than you should

If you have taken too many Loperamide 2mg Hard 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 2mg Hard Capsules than adults. If a child takes too much or shows any of the above symptoms, call a doctor immediately.

If you forget to take Loperamide 2mg Hard Capsules

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 to make up for a forgotten dose.

Get medical help at once

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

• 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.

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).

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

Other effects that may occur

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.

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 in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

What Loperamide 2mg Hard Capsules contain

The active substance is Loperamide hydrochloride. Each hard gelatin capsule contains 2mg Loperamide hydrochloride.

The other ingredients are maize starch, lactose, povidone, sodium starch glycollate and magnesium stearate. The capsule shell contains gelatin, titanium dioxide (E171), iron oxides (E172) and patent blue V (E131). The printing ink contains shellac, simeticone, titanium dioxide (E171) and propylene glycol (E1520) (see section 2).

What Loperamide 2mg Hard Capsules look like and contents of the pack

The medicine is enclosed in a green and dark grey capsule. The pack contains 6 capsules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

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Product Name Reference Number

Loperamide 2mg Hard Capsules 29831/0131