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Document: leaflet MAH BRAND_PL 11311-0025 change

• leaflet MAH BRAND_PL 11311-0025
• leaflet MAH GENERIC_PL 11311-0025

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PATIENT INFORMATION LEAFLET

Normaloe 2mg Tablets

(Loperamide Hydrochloride 2mg)

What this medicine is and what it is used for

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

Normaloe is used to treat sudden, short-lived (acute) attacks of diarrhoea in adults and children over 12 years of age.

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 Normaloe (Loperamide) and is referred to as Normaloe throughout this leaflet.

What you need to know before you take Normaloe

Do not take Normaloe if:

■    you are allergic (hypersensitive) to Loperamide or any of the other ingredients of this medicine (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 Normaloe if:

■    you have or think you may have lost body fluids and salts through diarrhoea (see 'Replacing fluids and salts', section 3)

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

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

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

If any of the above apply to you, please consult your doctor or pharmacist.

Other medicines and Normaloe

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.

Normaloe should not be taken with the following:

■ Other antidiarrhoea preparations, except for oral

rehydration therapy (see "Replacing fluids and salts" in section 3)

Normaloe 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

Normaloe 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 Normaloe.

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 Normaloe, 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.

Normaloe 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 Normaloe

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

■    Normaloe is for oral use only

■    Swallow the tablets 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....

Adults and children over 12 years:

To treat sudden, short-lived (acute) attacks of diarrhoea

Adults:

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

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

■    The maximum daily dose for adults is 8 tablets (16mg)

Children over 12 years:

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

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

■    The maximum daily dose for children is related to body weight (3 tablets per 20kg) but should not exceed 8 tablets (l6mg)

Children under 12 years:

This medicine should not be given to children under 12 years of age.

Older people and patients with kidney problems:

Same dose as for adults.

Patients with liver problems:

See 'Warnings and precautions' (section 2)

Do not take Normaloe for longer than 5 days. If your symptoms do not improve within 24 hours, please contact your doctor.

Also see your doctor if your episodes of sudden, short lived (acute) attacks of diarrhoea continue for more than 2 weeks or you need continuous treatment for more than 2 weeks.

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 Normaloe than you should

If you accidentally take too many tablets, contact your doctor or go to your 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 Normaloe

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 Normaloe 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 Normaloe

■    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.

□ Contents of the pack and other information

What Normaloe contain:

Each tablet contains 2mg of Loperamide Hydrochloride.

The other ingredients are: Lactose monohydrate, povidone, crospovidone and magnesium stearate

What Normaloe looks like and contents of the pack:

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

Normaloe is available in:

Normaloe tablets are available in packs of 6, 10, 12, 18, 20 or 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder & Manufacturer

Tillomed Laboratories Ltd,

3 Howard Road,

Eaton Socon, St. Neots,

Cambridgeshire,

PE198ET UK

Product Licence Number:

PL 11311/0025

This leaflet was last revised in September 2016

Hard to Read? Phone 0800 970 6115 for help

Till-Ver.6s