NORMALOE TABLETS, LOPERAMIDE HYDROCHLORIDE 2 MG TABLETS - patient leaflet, side effects, dosage

2. What you need to know before you take Normaloe 2mg Tablets

3. How to take Normaloe 2mg Tablets

4. Possible side effects

5. How to store Normaloe 2mg Tablets

6. Contents of the pack and other information

• 1. WHAT NORMALOE 2MG TABLETS ARE AND WHAT THEY ARE USED FOR

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

Normaloe is used to treat two types of diarrhoea. The two types have different age limits.

Short-term diarrhoea

• 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.

IBS diarrhoea

• 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. The name of this medicine is Normaloe 2mg Tablets and is referred to as Normaloe throughout this leaflet.

2. what you need to know before you take normaloe 2mg tablets

Do not take Normaloe if:

• you are allergic to loperamide hydrochloride 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 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, which may include blood in your stools and a high temperature
• it is for a child aged under 12 (or under 18 for an IBS patient)

Warnings and precautions

Talk to your doctor before taking Normaloe 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 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:

• – 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

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

Do not take this medicine 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, the active ingredient in Normaloe 2mg Tablets. 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.

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, used to treat abnormal heart rhythms and 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

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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you are pregnant or planning to have a baby, you are advised not to take Normaloe.

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 monohydrate

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

3. HOW TO TAKE NORMALOE 2MG TABLETS

• Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. 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 is only there to help you break the tablet if you have difficulty swallowing it whole.

Short-term diarrhoea

Adults and children over 12 years:

• 2 tablets (4mg) initially, followed by 1 tablet (2mg) after each loose stool (bowel movement).
• The maximum daily dose is 6 tablets (12mg).
• Do not take for attacks lasting longer than 48 hours.
• Do not take more than 6 tablets (12mg) in a 24-hour period.

Diarrhoea associated with Irritable Bowel Syndrome Adults aged 18 years and over:

• 2 tablets (4mg) initially, followed by 1 tablet (2mg) after each loose stool, or as previously advised by your doctor.
• The maximum dose is 6 tablets (12mg) a day.
• 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 6 tablets (12mg) in a 24-hour period.

Elderly and patients with kidney problems: Same dose as for adults.

Patients with liver problems:

See ‘Warnings and precautions’ (section 2).

Use in children

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

If you have diarrhoea and your symptoms do not improve within 48 hours, 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
• This is especially important for children, and frail or elderly people
• 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 have taken too many Normaloe 2mg Tablets, immediately contact a doctor or hospital for advice. Remember to take this leaflet and 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, uncoordinated movements, drowsiness, difficulty urinating or weak breathing.

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

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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

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

Serious side effects

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 movements
• Difficulty in urinating (passing water)
• Severe constipation
• Blockage of the bowel

Other side effects

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 1,000 people):

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

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 Yellow Card Scheme at 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.

5. how to store normaloe 2mg tablets

• 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.
• Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Normaloe contains

The active ingredient is loperamide hydrochloride.

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 tablets are available in packs of 6, 10 or 12 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Activase Pharmaceuticals Limited

11 Boumpoulinas, Nicosia 1060, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited

84 Pembroke Road, London, W8 6NX, UK

This leaflet was last revised in 05/2021

A0211/P/PIL-Br/A6