Loperamide hydrochloride 2 mg Orodispersible tablet

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 2 days.

1. What Loperamide hydrochloride 2 mg Orodispersible Tablets are and what they are used for
2. What you need to know before you take Loperamide hydrochloride 2 mg Orodispersible Tablets
3. How to take Loperamide hydrochloride 2 mg Orodispersible Tablets
4. Possible side effects
5. How to store Loperamide hydrochloride 2 mg Orodispersible Tablets
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.

The tablets contain 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 any of the 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.

Talk to your doctor before taking Loperamide hydrochloride 2 mg Orodispersible Tablets:

• If you have AIDS and your stomach becomes swollen, stop taking the tablets 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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 are pregnant or planning 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 hydrochloride 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 hydrochloride 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 hydrochloride.

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

This medicine contains 5 mg aspartame in each orodispersible tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

This medicine contains saccharose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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.

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

Short-term diarrhoea

Age

Adults and children aged 12 and over

Dose

Take two tablets to start treatment. Take one tablet after each loose bowel movement.

• Do not take for attacks lasting longer than 48 hours.
• Do not take more than six tablets 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 this medicine and talk to your doctor.

IBS diarrhoea

Age

Adults aged 18 and over

Dose

Take two tablets to start treatment. Take one tablet 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 tablets 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 this medicine and talk to your doctor.

If you have taken too many tablets, 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 this medicine 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 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), muscle stiffness and uncoordinated movements.
• 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.

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)

• 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 orodispersible tablet contains 2 mg loperamide hydrochloride.

The other excipients are croscarmellose sodium, aspartame E951, fruit flavour (contains acacia gum E414, sugar (saccharose), maltodextrin (potato), triacetin, propylene glycol), banana flavour (contains Maize maltodextrin), magnesium stearate, mannitol.

Round white to off white orodispersible tablets with a diameter of approximately 7 mm

Loperamide hydrochloride 2 mg Orodispersible Tablets are available in packs of 6 and 12 orodispersible tablets.

Not all pack sizes may be marketed.