PATIENT INFORMATION LEAFLET

Norimode 2mg Tablets

(Loperamide Hydrochloride 2mg)

What this medicine is and what it is used for

The active ingredient in Norimode is Loperamide which belongs to a group of medicines called 'antidiarrhoeals' which are used to treat diarrhoea.

Norimode is used to treat sudden, short-lived (acute) attacks of diarrhoea in adults and children over 9 years of age. It is also used to treat sudden flare-ups of long-lasting (chronic) diarrhoea in adults.

It reduces diarrhoea by slowing down an overactive bowel. It also helps the body to absorb more water and salts from the bowel.

The name of this medicine is Norimode (Loperamide) and is referred to as Norimode throughout this leaflet.

What you need to know before you take Norimode

Do not take Norimode if:

■    you are allergic (hypersensitive) to Loperamide or any of the other ingredients of this medicine (see see section 6 "Contents of the pack and other information”)

■    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 acute ulcerative colitis (a form of inflammatory bowel disease) which can cause abdominal pain, bloody diarrhoea, fever and weight loss

■    you have constipation, blockage of the bowel or a bloated tummy (in particular, in children with severe dehydration)

■    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 dysentery, which may include blood in your stools and a high temperature

Warnings and precautions

Talk to your doctor before taking Norimode if:

■    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 have liver disease. You should consult your doctor or pharmacist before taking Norimode as it may cause side effects

■    you have inflammatory bowel disease (inflammation of the intestines), which can cause abdominal pain and bloody diarrhoea

■    you are taking Norimode to treat diarrhoea caused by Irritable Bowel Syndrome (IBS). You should consult your doctor if:

-    there is no improvement in your symptoms within 48 hours

-    your symptoms change

-    your episodes of diarrhoea last for more than 2 weeks

■    you have a bloated tummy and you have AIDS. You should stop taking this medicine immediately and contact your doctor

Other medicines and Norimode

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, for abnormal and increased heart rhythm

■    Ritonavir or tipranavir, for HIV infection and AIDS

■    Itraconazole and ketoconazole, for 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).

Pregnancy and breast-feeding

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

It is not known if it is safe to take, especially during the first 3 months of pregnancy. Talk to your doctor about a suitable treatment.

Breast-feeding

If you are breast-feeding, you should not take Norimode, as small amounts of this medicine get into your breast milk. Talk to your doctor about a suitable treatment.

Driving and using machines

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.

Norimode contains Lactose

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

How to take Norimode

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

■    Norimode is to be taken by mouth

■    Swallow whole with some liquid

■    The score line on the tablet is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses

continued....

Acute diarrhoea Adults:

■    2 tablets (4mg) initially, followed by 1 tablet (2mg) after each loose stool for up to 5 days.

■    The usual dosage is 3 to 4 tablets (6 - 8mg) a day

■    The maximum dose for adults is 8 tablets (l6mg) in 24 hours

Children aged 9-17 years:

■    1 tablet (2mg) initially, followed by 1 tablet (2mg) after each loose stool for up to 5 days

■    The usual dosage is 3 to 4 tablets (6 - 8mg) a day

■    The maximum dose for children is related to body weight (3 tablets per 20kg). but should not exceed 8 tablets (16mg) a day

Children under 9 years:

This medicine should not be given to children under 9 years.

Loperamide (active ingredient) must not be given to children under 2 years of age.

Chronic diarrhoea Adults:

■    The initial dose is usually 2 tablets (4mg) a day

■    The 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 for adults with chronic diarrhoea is 8 tablets (16mg) a day

Older people and patients with kidney problems:

Same dose as for adults.

Patients with liver problems:

See 'Warnings and precautions' (section 2)

Use in children

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

Do not take Norimode for longer than 5 days.

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

Replacing fluids and salts

When you have diarrhoea your body loses large amounts of fluid and salts. In addition to your medicine, you should take more liquids which contain sugar and salts, than normal.

■    Drink plenty of clear fluids containing salt and sugar (special oral rehydration powders are available from pharmacists), unsweetened fruits juices or clear soups

■    Avoid excessive plain water

■    Do not drink alcohol or milk

■    Do not eat fruit, green vegetables or fatty foods

■    Two or three days after symptoms have disappeared you may return to your normal diet

If you take more Norimode than you should

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.

Symptoms of an overdose include:

Constipation, difficulty passing urine, feeling bloated, stupor, difficulty co-ordinating movements, pupils of the eyes become smaller, increased muscle tension, difficulty sleeping and breathing problems.

If you forget to take Norimode

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.

Possible side effects

Like all medicines Norimode can cause side effects, although not everybody gets them.

Seek medical advice immediately if you develop the following symptoms:

■    Bloated tummy and you have AIDS

■    Allergic reactions such as swollen face, lips

or eyelids and serious reactions such as passing out,

difficulty breathing and dizziness

■    Blistering of the skin, mouth, eyes and genitals (Stevens Johnson Syndrome or toxic epidermal necrolysis)

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

■    Headache

■    Constipation

■    Feeling sick (nausea)

■    Stomach wind (flatulence)

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

■    Dizziness

■    Drowsiness

■    Stomach pain or discomfort

■    Dry mouth

■    Being sick (vomiting)

■    Indigestion

■    Rash

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

■    Loss of consciousness

■    Reduced ability to respond to stimulation (stupor) or reduced consciousness

■    Abnormal increase in muscle tension

■    Difficulty co-ordinating movement

■    Pupils of the eyes become smaller

■    Blockage of the bowel

■    Enlargement of the large intestine, which may cause constipation, bloating and tenderness of the stomach or fever (megacolon or toxic megacolon)

■    Painful or burning feeling of the tongue

■    Bloated tummy

■    Itchy rash (urticaria) or itching (pruritus)

■    Difficulty in urinating (passing water)

■    Tiredness

Reporting of side effects

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 internet at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

51 How to store Norimode

■    Keep this medicine out of the sight and reach of children.

■    Store below 25°C. Store in the original package in order to protect from light and moisture.

■    Do not use this medicine after the expiry date which is stated on the carton/blister after EXP. The expiry date refers to the last day of that month.

■    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

[7    Contents of the pack and

L⁶    other information

What Norimode contains:

Each tablet contains 2mg of Loperamide Hydrochloride The other ingredients are:

Ludipress (consisting of lactose monohydrate 94% and polyvinypyrrollidone 6%) and magnesium stearate.

What Norimode looks like and contents of the pack

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 tablets are available in packs of 30 tablets.

Marketing Authorisation Holder & Manufacturer

Tillomed Laboratories Ltd,

3 Howard Road, Eaton Socon, St. Neots, Cambridgeshire, PE19 8ET,UK

Product Licence Number

PL 11311/0016

This leaflet was last revised in March 2015

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