Norimode (Loperamide) 2mg Tablets

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

• you are allergic to Loperamide or any of the other ingredients of this medicine (listed in section 6)
• you need to keep the bowel movements normal to avoid complications such as blockage of the bowel and abnormal or rapid widening of the colon
• you have a flare-up of ulcerative colitis (a form of inflammatory bowel disease) which can cause abdominal pain, bloody diarrhoea, fever and weight loss
• you have severe diarrhoea after taking antibiotics (symptoms may include watery or bloody diarrhoea)
• you have constipation, blockage of the bowel or a bloated tummy
• you have a bacterial infection of the small intestine and colon (caused by bacteria such as salmonella, shigella and campylobacter)
• you have inflammation of the colon after taking antibiotics (symptoms may include watery or bloody diarrhoea)
• you have acute (short-lived) dysentery, the symptoms of which may include blood in your stools and a high temperature

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 Norimode.

Talk to your doctor before taking Norimode if:

• there is no improvement in your symptoms within 48 hours
• you have or think you may have lost body fluids and salts through diarrhoea. Particularly important for children and frail or elderly patients with severe diarrhoea (see ‘Replacing fluids and salts’, section 3)
• you suffer from liver problems. You should consult your doctor or pharmacist before taking Norimode as it may cause side effects
• you have a bloated tummy and you have AIDS. You should stop taking this medicine immediately and contact your doctor

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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Norimode should not be taken with the following:

• Other antidiarrhoea preparations, except for oral rehydration therapy (see "Replacing fluids and salts" in section 3)

Norimode may cause serious side effects if taken with the following:

• Quinidine, used to treat abnormal heart rhythms or malaria
• Ritonavir, used to treat HIV infection and AIDS
• Itraconazole and ketoconazole, used to treat fungal infections
• Gemfibrozil, used to lower levels of cholesterol and other lipids (fats) in the blood

Norimode increases the blood levels of the following:

• Oral desmopressin, for reducing urine production (antidiuretic)

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking Norimode.

Pregnancy

If you are pregnant or planning to become pregnant, you are advised not to take Norimode. It is not known if it safe to take, especially during the first 3 months of pregnancy.

Breast-feeding

If you are breast−feeding, you should not take Norimode, as small amounts of this medicine get into your breast milk.

This medicine may make you feel tired, dizzy or drowsy. You may feel less alert, feel faint or pass out. If affected, you are advised not to drive or operate machinery.

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

Adults and adolescents over 17 years:

• 2 tablets (4mg) initially, followed by 1 tablet (2mg) after each loose stool (bowel movement) for up to 5 days.
• The maximum dose is 6 tablets (12mg) in 24 hours.

Use in children (aged 9-17 years):

• 1 tablet (2mg) initially, followed by 1 tablet (2mg) after each loose stool (bowel movement) for up to 5 days.
• The maximum dose is 6 tablets (12mg) in 24 hours.

Adults only:

• The recommended starting dose is 2 tablets (4mg) daily
• This initial dose should be adjusted until 1-2 solid stools a day are obtained. This is usually achieved with a maintenance dose of 1-6 tablets (2mg – 12mg) daily.
• The maximum dose is 6 tablets (12mg) in 24 hours.

Norimode should not be given to children for the treatment of chronic diarrhoea.

See ‘Warnings and precautions’ (section 2).

Norimode should not be given to children under 9 years of age.

If you have diarrhoea and your symptoms do not improve within 48 hours, you should stop taking Norimode and contact your doctor.

When you have diarrhoea your body loses large amounts of fluid and salts. You should therefore replace this lost fluid by drinking more liquids than normal. Drink plenty of clear fluids containing salt and sugar (special oral rehydration powders are available from pharmacists). This is especially important for children, and frail or elderly people.

If you have taken too many tablets, immediately contact a doctor or hospital for advice. Remember to take this leaflet or any remaining tablets with you.

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

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

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

It is important that you keep taking Norimode for as long as your doctor has told you to.

Seek medical advice immediately if you develop the following symptoms:

• Bloated tummy which may be due to enlargement of the large intestine, which may cause constipation, bloating and tenderness of the stomach or fever (megacolon or toxic megacolon)
• Allergic reaction: swelling of the face, throat or tongue, difficulty breathing (anaphylaxis) or dizziness
• Severe blistering of the skin, mouth, eyes and genitals (Stevens Johnson Syndrome or toxic epidermal necrolysis)
• Fever, general ill feeling, itching, joint aches, multiple skin lesions (erythema multiforme)
• Swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema)
• Loss of consciousness or reduced level of consciousness (passing out, feeling faint or less alert)
• Difficulty co-ordinating movement
• Difficulty in urinating (passing water)
• Severe constipation
• Blockage of the bowel

Common side effects (may affect up to 1 in 10 people)

• Headache
• Dizziness
• Constipation
• Feeling sick (nausea)
• Stomach wind (flatulence)

Uncommon side effects (may affect up to 1 in 100 people)

• Drowsiness (somnolence)
• Stomach pain or discomfort
• Dry mouth
• Being sick (vomiting)
• Indigestion (dyspepsia)
• Rash

Rare side effects (may affect up to 1 in 1000 people)

• Abnormal increase in muscle tension (hypertonia)
• Bloated tummy
• Tiredness (fatigue)
• Pupils of the eyes become smaller (miosis)
• Skin rashes with the formation of wheals (urticaria)
• Severe itching (pruritus)

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.

If you get any side effects, talk to your doctor or pharmacist. 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.

Each tablet contains 2mg of Loperamide Hydrochloride.

The other ingredients are:

Lactose monohydrate, povidone, crospovidone and magnesium stearate.

Norimode are round, white, biconvex tablets of diameter 6.35mm marked "T3" on one side and scored on the other.

Norimode is available in:

Norimode is available in packs of 30 tablets.