Loperamide 2mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Loperamide 2mg Tablets
Loperamide Hydrochloride
Read all of this leaflet carefully because it contains
important information foryou.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 2 (two) days.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Loperamide Tablets are and what they are used for
2. Before you take Loperamide Tablets
3. How to take Loperamide Tablets
4. Possible side effects
5. How to store Loperamide Tablets
6. Further information
1. WHAT LOPERAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Loperamide 2mg Tablets (called Loperamide Tablets in this leaflet). The active ingredient is loperamide hydrochloride. It belongs to a group of medicines which helps reduce diarrhoea by slowing down an overactive bowel. It also helps the body to absorb more water and salts from the bowel.
Loperamide Tablets are used to treat sudden short-lived (acute) attacks of diarrhoea in adults and children over 6 years of age and for the treatment of long-lasting (chronic) diarrhoea in adults.
2. BEFORE YOU TAKE LOPERAMIDE TABLETS
Do not take Loperamide Tablets
• If you have had any allergic reaction to loperamide or to any of the other ingredients in the product.
• If you have severe diarrhoea aftertaking antibiotics
• If you are having a flare up of ulcerative colitis
• If you have acute dysentery, the symptoms of which may include blood in your stools and a high temperature
• If you are constipated or your stomach appears swollen (particularly in children with severe dehydration)
• If you (your child) is less than 6 years old (see section 3 of this leaflet for more information)
Take special care with Loperamide Tablets
Check with your doctor before using Loperamide Tablets if:
• Yousufferfromliverproblems.
• You have AIDS and yourstomach becomes swollen. Stop taking the tablets immediately and contact your doctor.
• You have an intolerance to some sugars
• If you have acute diarrhoea and are not getting better within 2 days of taking your first dose of Loperamide Tablets, stop taking the tablets and go back to your doctor.
You may still be able to use Loperamide Tablets, but you should discuss this with your doctorfirst.
Replacing fluid and salts
Loperamide Tablets only treat the symptoms of diarrhoea. When you have diarrhoea, your body loses large amounts of fluid and salts. You should therefore replace this lost fluid by drinking more than normal. This is especially importantfor children.
Your doctor may also give you a special powder containing sugar and salts (known as oral rehydration therapy) to help your body replace the fluid and salts lost during diarrhoea.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following:
• 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 control cholesterol levels in your blood)
Taking Loperamide Tablets with food and drink
Take Loperamide Tablets with or without food.
Drinking extra fluids is recommended while you have diarrhoea. Check with your doctor if you have questions. Alcohol should be avoided as loperamide may cause drowsiness or dizziness and alcohol may intensify these effects.
Pregnancy and breast-feeding
Tell your doctor before taking Loperamide Tablets if you are pregnant, think you may be pregnant or might become pregnant.
Do not take this medicine if you are breast-feeding as small amounts may get into your milk. Talk to your doctor about a suitable treatment.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
This medicine may make you feel dizzy, tired or sleepy. If affected do not drive oroperate machinery.
Important information about some of the ingredients of Loperamide Tablets
Loperamide Tablets contain lactose. If your doctor has told you that you are intolerant of some sugars, discuss it with them before taking this medicine.
3. HOW TO TAKE LOPERAMIDE TABLETS
Always take Loperamide Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Take this medicine by mouth. Swallow the correct number oftablets with a drink of water. The breakline is to facilitate breaking forease of swallowing.
Short-lived (acute) diarrhoea
Adults and children over 6 years: Take 2 (two) tablets straight away. From then on take 1 (one) tablet after each episode of diarrhoea. You can take this medicine for up to 5 days. Never take more than 8 tablets in any 24 hour period
Children between 2 and 5 years old: Loperamide Tablets are not recommended for children between 2 and 5yearsold. Your doctor may recommend a different formulation, such as an oral solution which is more suitable forchildren.
If you are not getting better within 2 days of taking your first dose of Loperamide Tablets, go back to your doctor. He or she may want to examine you to check on why you have diarrhoea.
Long-lasting (chronic) diarrhoea Adults: Your doctor will tell you how many Loperamide Tablets to take. This will depend on how serious your condition is. You will probably start with a dose of between 2 (two) and 4 (four) tablets spread out over a day. Your doctor will find the dose that suits you best. He or she may then suggest you take the tablets twice a day. Never take more than 8 tablets in any 24 hour period. Children: Loperamide Tablets are not recommended for long-lasting (chronic) diarrhoea.
If you take more Loperamide Tablets than you should
If you take more Loperamide Tablets than you were told to or if someone else has taken any, talk to a doctor or go to the nearest hospital casualty department straight away.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you forget to take Loperamide Tablets
You should only take this medicine as required 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 to make up for a forgotten dose.
If you stop taking Loperamide Tablets
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Loperamide Tablets can cause side effects, although not everybody gets them.
Stop using Loperamide Tablets and tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment.
• Sudden swelling of the face, lipsorthroat.
• Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction
• Blistering of yourskin, mouth, eyes and genitals
• Stomach pain or severe swollen stomach
• Severe constipation
Tell your doctor if you notice any of the following side effects while using Loperamide Tablets:
Common side effects include:
(affects more than 1 in 100 people but less than 1 in 10 people)
• Headache
• Dizziness
• Constipation
• Nausea (feeling sick)
• Flatulence (passing wind)
Uncommon side effects include
(affects more than 1 in 1,000 people but less than 1 in
100 people);
• Feeling sleepy
• Abdominal pain/discomfort
• Dry mouth
• Vomiting
• Indigestion
• Rash
Rare side effects include
(affects more than 1 in 10,000 people but less than 1 in 1,000 people);
• Hypersensitivity reaction
• Serious allergic reaction which causes difficulty in breathing or dizziness
• Loss or decreased level of consciousness
• Abnormal increase in muscle tension
• Coordination abnormality
• Constriction of the pupils of the eyes
• Partial or complete blockage of the small/large intestine
• Rapid widening of the large intestine
• Abdominal swelling,
• Swelling/burning sensation of the tongue/mouth
• Blisters and skin lesions (including Stevens-Johnson syndrome, Toxic epidermal necrolysis and Erythema multiforme)
• Swelling of the deeper layers skin (Angioedema)
• Hives (urticaria)
• Itchy skin (pruritus)
• Lack of ability to urinate (urinary retention)
• Fatigue
If any of the side effects get serious, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOWTO STORE LOPERAMIDE TABLETS
Keep out of the reach and sight of children. This medicine does not require any special storage conditions. If the tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.
Do not use Loperamide Tablets after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. These measures will help protect the environment. Return any leftover Loperamide Tablets to your pharmacist.
6. FURTHER INFORMATION
What Loperamide Tablets contains
The active substance is loperamide, each tablets contains 2 mg loperamide as loperamide hydrochloride.
The other ingredients are lactose monohydrate, maize starch, talc, magnesium stearate, povidone, brilliant blue (E133), quinoline yellow (E104), colloidal anhydrous silica and sodium starch glycolate.
What Loperamide Tablets look like and contents of the pack
Light green coloured capsule shaped, biconvex uncoated tablets, plain on one side and score line on other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Loperamide Tablets are available in blister packs of 30 tablets.
Marketing Authorisation Holder:
Morningside Healthcare Ltd.
115 Narborough Road Leicester, LE30PA.UK
Site responsible for batch release:
Morningside Pharmaceuticals Ltd 5 Pavilion Way,
Loughborough, UK