Loperamide 2mg Hard Capsules
Package leaflet: Information for the user
Loperamide 2mg Hard Capsules
Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
• This medicine is available without prescription. However, you still need to take Loperamide Capsules carefully to get the best results from them
• Keep this leaflet. You may need to read it again
• Ask your doctor or pharmacist if you need more information or advice
• 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.
What is in this leaflet:
1. What Loperamide Capsules are and what they are used for
2. What you need to know before you take Loperamide Capsules
3. How to take Loperamide Capsules
4. Possible side effects
5. How to store Loperamide Capsules
6. Contents of the pack and other information
1. WHAT LOPERAMIDE
CAPSULES ARE AND WHAT THEY ARE USED FOR
Loperamide Capsules contain the active ingredient loperamide hydrochloride. Loperamide belongs to a group of medicines called 'antidiarrhoeals' which are used to treat diarrhoea. It reduces diarrhoea by slowing down an overactive bowel. It also helps the body to absorb more water and salts from the bowel.
Loperamide Capsules are used to treat sudden acute cases of diarrhoea in adults and children over 12 years of age.
They can also be used by adults of 18 years and over who have irritable bowel syndrome (IBS), which has been previously diagnosed by a doctor, to relieve short term diarrhoea associated with it.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOPERAMIDE CAPSULES
Do not take Loperamide Capsules if:
• you are allergic to loperamide or any of the other ingredients (see section 2 'Important information about some of the ingredients' and section 6 'Further 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 constipation, blockage of the bowel or a bloated tummy
• you have inflammation or irritation of the bowel e.g. diverticulosis, colitis or bacterial enterocolitis caused by Salmonella, Shigella or Campylobacter (symptoms may include watery or bloody diarrhoea)
• you have symptoms of dysentery, which may include blood in your stools and a high temperature
• you have severe diarrhoea after taking antibiotics.
These capsules should not be given to children under 12 years of age(or under 18 for an IBS patient).
Warnings and Precautions Talk to your doctor or pharmacist before taking Loperamide Capsules 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 have inflammatory bowel disease
• you have AIDS. You must stop taking loperamide if your stomach becomes swollen.
Since persistent diarrhoea can be an indicator of potentially more serious conditions, loperamide should not be used for prolonged periods of time.
You should consult your doctor or pharmacist before taking
Loperamide Capsules as they may cause side effects.
Extra warnings for IBS patients
Only take Loperamide Capsules to treat acute episodes of diarrhoea associated with irritable bowel syndrome if your doctor has previously diagnosed IBS.
If any of the following now apply, do not use the product without first consulting your doctor, even if you know you have IBS:
• If you are 40 years or over and it is some time since your last attack of IBS or the symptoms are different this time
• If you have recently passed blood from the bowel
• If you suffer from severe constipation
• If you are feeling sick or vomiting
• If you have lost your appetite or lost weight
• If you have difficulty or pain passing urine
• If you have a fever
• If you have recently travelled abroad.
Consult your doctor if you develop new symptoms, or if your symptoms worsen, or if your symptoms have not improved over two weeks.
If any of the above apply to you, please consult your doctor or pharmacist.
Other medicines and Loperamide Capsules
Loperamide may interact with other medicines. If you are taking other medicines, including medicines obtained without a prescription and you are unsure about taking Loperamide Capsules, you should contact your doctor or pharmacist.
In particular you should tell your doctor or pharmacist if you are taking any of the following:
• co-trimoxazole, an antibiotic, used in the treatment of bacterial infections such as chronic bronchitis
• quinidine, used in the treatment of an abnormal heart beat
• ritonavir, used in the treatment of HIV infection and AIDS
• oral desmopressin, used in the treatment of diabetes and bedwetting
• itraconazole or ketoconazole (used to treat fungal infections)
• gemfibrozil (used to treat high cholesterol).
Pregnancy and breast-feeding
If you are pregnant or planning to become pregnant, do not take Loperamide Capsules. It is not known if they safe to take.
If you are breast-feeding, you should consult your doctor or pharmacist before taking, as small amounts of this medicine may get into your breast milk.
Driving and using machines
This medicine may make you feel tired, dizzy or drowsy. If affected, do not drive or operate machinery or take part in activities where such effects could put yourself or others at risk.
Loperamide Capsules contains lactose
This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE LOPERAMIDE CAPSULES
Follow the instructions below or ask your pharmacist for help if you are not sure how to take this medicine.
• For oral administration
• Swallow whole with a drink.
For acute diarrhoea Adults:
Two capsules initially followed by one capsule after each period of diarrhoea, for up to 24 hours.
Do not take more than eight capsules in any 24-hour period.
Children aged 12-17 years:
One capsule initially followed by one capsule after each period of diarrhoea, for up to 24 hours.
Do not take more than 3 capsules per 20kg of the child's bodyweight, up to a maximum of eight capsules in any 24-hour period.
You can take this medicine for up to 48 hours. If your attack lasts longer than 48 hours, stop taking Loperamide Capsules and talk to your doctor.
Children under 12 years:
This medicine should not be given to children under 12 years of age.
For acute episodes of diarrhoea associated with irritable bowel syndrome
Adults aged 18 years and over:
Two capsules initially followed by one capsule after each period of diarrhoea, for up to 24 hours.
Do not take more than eight capsules in any 24-hour period.
Talk to your doctor and stop taking this medicine:
• If you have been using this medicine continuously for 48 hours
• If you develop new IBS symptoms
• If your IBS symptoms get worse
• If your IBS symptoms have not improved after 2 weeks.
Replacing fluids and salts
When you have diarrhoea you lose large amounts of fluid and salts and can become dehydrated so, in addition to this medicine you need to take in more liquids than usual. You are more likely to become dehydrated if you are also vomiting.
• Take small frequent sips of water or diluted fruit juice
• If there are signs of dehydration (drowsiness, passing little urine, dry mouth/tongue, unresponsiveness or glazed eyes), particularly in a child, or in frail or elderly people contact your doctor or pharmacist immediately
• If you are worried about becoming dehydrated, the doctor/pharmacist may advise rehydration drinks. These can be obtained from the pharmacy/chemist and provide the correct balance of water, salt and sugar
• Avoid drinking very large amounts of plain water
• Do not drink alcohol or milk
• As soon as you feel like it eat. The best foods to start with are those high in carbohydrates (such as plain bread, pasta, rice or potatoes) and soup. Avoid fatty foods, and fruit and vegetables at first
• Within a couple of days of the symptoms resolving, you should be back on your normal diet.
If you take more Loperamide Capsules than you should
Contact your doctor or go to your nearest casualty department immediately. Take the container and this leaflet with you so that people will know what you have taken.
If you forget to take Loperamide Capsules
Take it as soon as you remember. Never double up a dose to make up for the dose you have missed.
4. POSSIBLE SIDE EFFECTS
Like all medicines Loperamide Capsules can cause side effects, although not everybody gets them.
Stop taking your medicine and contact your doctor immediately or nearest hospital if you experience the following:
• Allergic reactions which can produce swelling of the face, eyes, tongue and/or lips, difficulty breathing and/or swallowing or itching
• Stevens Johnson Syndrome and Toxic Epidermal necrolysis, symptoms of which include a fever, sore throat and generally not feeling very well. Accompanied by an intense skin rash and lesions which may occur on the face, upper body, arms, legs and soles of feet. Ulcers can occur in mucous membranes such as inside the mouth, nostrils and eyelids (a severe form of conjunctivitis) but also in genital and anal regions. Large blisters can progress to extensive peeling of layers of the skin
• necrotising enterocolitis (serious inflammation of the bowel)
• megacolon, including toxic megacolon (abnormal enlargement of the intestines)
Common side effects (may affect up to 1 in 10 people):
• headache
• dizziness
• feeling sick (nausea)
• constipation
• flatulence (passing wind)
Uncommon side effects (may affect up to 1 in 100 people):
• dry mouth
• stomach pain or discomfort
• being sick (vomiting)
• indigestion
• rash
Rare side effects (may affect up to 1 in 1,000 people):
• swollen stomach
Not known (frequency cannot be estimated from the available data)
• drowsiness or tiredness
• loss or decreased levels of consciousness, lack of response to stimulation
• lack of coordination, increased muscle tension
• miosis (narrowing of the pupils of the eye)
• stomach cramps
• obstruction of the bowel, paralysis (non movement) of the bowel muscles which may stop bowel movements
• painful or burning feeling of the tongue
• itching
• skin lesions
• urinary retention (unable to pass urine).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE LOPERAMIDE CAPSULES
Keep out of the sight and reach of children.
Store in the original container in order to protect from moisture.
Do not use these capsules after the expiry date shown on the outside packaging. Return all unused medicines to your pharmacist for safe disposal.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Loperamide Capsules contain:
Active ingredient: Loperamide hydrochloride 2mg
Other ingredients: Maize starch, lactose, povidone, sodium starch glycollate and magnesium stearate. The capsule shell contains gelatin, titanium dioxide (E171), iron oxides (E172) and patent blue V (E131).
The printing ink contains shellac, simeticone, titanium dioxide (E171) and propylene glycol (E1520).
(see section 2 'Important information about some of the ingredients').
What Loperamide Capsules look like and the contents of the pack
The medicine is enclosed in a green and dark grey capsule. The pack contains 6, 8, 10 or 12 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
|
Product Name |
Reference Number |
|
Loperamide 2mg Hard Capsules |
29831/0381 |
This leaflet was last revised in 06/2015
103202/7 PiWOCKHARDT
Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information for you.
• This medicine is available without prescription. However, you still need to take Loperamide Capsules carefully to get the best results from them
• Keep this leaflet. You may need to read it again
• Ask your doctor or pharmacist if you need more information or advice
• 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.
What is in this leaflet:
1. What Loperamide Capsules are and what they are used for
2. What you need to know before you take Loperamide Capsules
3. How to take Loperamide Capsules
4. Possible side effects
5. How to store Loperamide Capsules
6. Contents of the pack and other information
1. WHAT LOPERAMIDE
CAPSULES ARE AND WHAT THEY ARE USED FOR
Loperamide Capsules contain the active ingredient loperamide hydrochloride. Loperamide belongs to a group of medicines called 'antidiarrhoeals' which are used to treat diarrhoea. It reduces diarrhoea by slowing down an overactive bowel. It also helps the body to absorb more water and salts from the bowel.
Loperamide Capsules are used to treat sudden acute cases of diarrhoea in adults and children over 12 years of age.
They can also be used by adults of 18 years and over who have irritable bowel syndrome (IBS), which has been previously diagnosed by a doctor, to relieve short term diarrhoea associated with it.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOPERAMIDE CAPSULES
Do not take Loperamide Capsules if:
• you are allergic to loperamide or any of the other ingredients (see section 2 'Important information about some of the ingredients' and section 6 'Further 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 constipation, blockage of the bowel or a bloated tummy
• you have inflammation or irritation of the bowel e.g. diverticulosis, colitis or bacterial enterocolitis caused by Salmonella, Shigella or Campylobacter (symptoms may include watery or bloody diarrhoea)
• you have symptoms of dysentery, which may include blood in your stools and a high temperature
• you have severe diarrhoea after taking antibiotics.
These capsules should not be given to children under 12 years of age(or under 18 for an IBs patient).
Warnings and Precautions Talk to your doctor or pharmacist before taking Loperamide Capsules 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 have inflammatory bowel disease
• you have AIDS. You must stop taking loperamide if your stomach becomes swollen.
Since persistent diarrhoea can be an indicator of potentially more serious conditions, loperamide should not be used for prolonged periods of time.
You should consult your doctor or pharmacist before taking Loperamide Capsules as they may cause side effects.
Extra warnings for IBS patients
Only take Loperamide Capsules to treat acute episodes of diarrhoea associated with irritable bowel syndrome if your doctor has previously diagnosed IBS.
If any of the following now apply, do not use the product without first consulting your doctor, even if you know you have IBS:
• If you are 40 years or over and it is some time since your last attack of IBS or the symptoms are different this time
• If you have recently passed blood from the bowel
• If you suffer from severe constipation
• If you are feeling sick or vomiting
• If you have lost your appetite or lost weight
• If you have difficulty or pain passing urine
• If you have a fever
• If you have recently travelled abroad.
Consult your doctor if you develop new symptoms, or if your symptoms worsen, or if your symptoms have not improved over two weeks.
If any of the above apply to you, please consult your doctor or pharmacist.
Other medicines and Loperamide Capsules
Loperamide may interact with other medicines. If you are taking other medicines, including medicines obtained without a prescription and you are unsure about taking Loperamide Capsules, you should contact your doctor or pharmacist.
In particular you should tell your doctor or pharmacist if you are taking any of the following:
• co-trimoxazole, an antibiotic, used in the treatment of bacterial infections such as chronic bronchitis
• quinidine, used in the treatment of an abnormal heart beat
• ritonavir, used in the treatment of HIV infection and AIDS
• oral desmopressin, used in the treatment of diabetes and bedwetting
• itraconazole or ketoconazole (used to treat fungal infections)
• gemfibrozil (used to treat high cholesterol).
Pregnancy and breast-feeding
If you are pregnant or planning to become pregnant, do not take Loperamide Capsules. It is not known if they safe to take.
If you are breast-feeding, you should consult your doctor or pharmacist before taking, as small amounts of this medicine may get into your breast milk.
Driving and using machines
This medicine may make you feel tired, dizzy or drowsy. If affected, do not drive or operate machinery or take part in activities where such effects could put yourself or others at risk.
Loperamide Capsules contains lactose
This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE LOPERAMIDE CAPSULES
Follow the instructions below or ask your pharmacist for help if you are not sure how to take this medicine.
• For oral administration
• Swallow whole with a drink.
For acute diarrhoea Adults:
Two capsules initially followed by one capsule after each period of diarrhoea, for up to 24 hours.
Do not take more than eight capsules in any 24-hour period.
Please be ready to give the following information:
|
Product Name |
Reference Number |
|
Loperamide 2mg Hard Capsules |
29831/0381 |
This leaflet was last revised in 06/2015
Children aged 12-17 years:
One capsule initially followed by one capsule after each period of diarrhoea, for up to 24 hours.
Do not take more than 3 capsules per 20kg of the child's bodyweight, up to a maximum of eight capsules in any 24-hour period.
You can take this medicine for up to 48 hours. If your attack lasts longer than 48 hours, stop taking Loperamide Capsules and talk to your doctor.
Children under 12 years:
This medicine should not be given to children under 12 years of age.
For acute episodes of diarrhoea associated with irritable bowel syndrome
Adults aged 18 years and over:
Two capsules initially followed by one capsule after each period of diarrhoea, for up to 24 hours.
Do not take more than eight capsules in any 24-hour period.
Talk to your doctor and stop taking this medicine:
• If you have been using this medicine continuously for 48 hours
• If you develop new IBS symptoms
• If your IBS symptoms get worse
• If your IBS symptoms have not improved after 2 weeks.
Replacing fluids and salts
When you have diarrhoea you lose large amounts of fluid and salts and can become dehydrated so, in addition to this medicine you need to take in more liquids than usual. You are more likely to become dehydrated if you are also vomiting.
• Take small frequent sips of water or diluted fruit juice
• If there are signs of dehydration (drowsiness, passing little urine, dry mouth/tongue, unresponsiveness or glazed eyes), particularly in a child, or in frail or elderly people contact your doctor or pharmacist immediately
• If you are worried about becoming dehydrated, the doctor/pharmacist may advise rehydration drinks. These can be obtained from the pharmacy/chemist and provide the correct balance of water, salt and sugar
• Avoid drinking very large amounts of plain water
• Do not drink alcohol or milk
• As soon as you feel like it eat. The best foods to start with are those high in carbohydrates (such as plain bread, pasta, rice or potatoes) and soup. Avoid fatty foods, and fruit and vegetables at first
• Within a couple of days of the symptoms resolving, you should be back on your normal diet.
If you take more Loperamide Capsules than you should
Contact your doctor or go to your nearest casualty department immediately. Take the container and this leaflet with you so that people will know what you have taken.
If you forget to take Loperamide Capsules
Take it as soon as you remember. Never double up a dose to make up for the dose you have missed.
4. POSSIBLE SIDE EFFECTS
Like all medicines Loperamide Capsules can cause side effects, although not everybody gets them.
Stop taking your medicine and contact your doctor immediately or nearest hospital if you experience the following:
• Allergic reactions which can produce swelling of the face, eyes, tongue and/or lips, difficulty breathing and/or swallowing or itching
• Stevens Johnson Syndrome and Toxic Epidermal necrolysis, symptoms of which include a fever, sore throat and generally not feeling very well. Accompanied by an intense skin rash and lesions which may occur on the face, upper body, arms, legs and soles of feet. Ulcers can occur in mucous membranes such as inside the mouth, nostrils and eyelids (a severe form of conjunctivitis) but also in genital and anal regions. Large blisters can progress to extensive peeling of layers of the skin
• necrotising enterocolitis (serious inflammation of the bowel)
• megacolon, including toxic megacolon (abnormal enlargement of the intestines)
Common side effects (may affect up to 1 in 10 people):
• headache
• dizziness
• feeling sick (nausea)
• constipation
• flatulence (passing wind)
Uncommon side effects (may affect up to 1 in 100 people):
• dry mouth
• stomach pain or discomfort
• being sick (vomiting)
• indigestion
• rash
Rare side effects (may affect up to 1 in 1,000 people):
• swollen stomach
Not known (frequency cannot be estimated from the available data)
• drowsiness or tiredness
• loss or decreased levels of consciousness, lack of response to stimulation
• lack of coordination, increased muscle tension
• miosis (narrowing of the pupils of the eye)
• stomach cramps
• obstruction of the bowel, paralysis (non movement) of the bowel muscles which may stop bowel movements
• painful or burning feeling of the tongue
• itching
• skin lesions
• urinary retention (unable to pass urine).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE LOPERAMIDE CAPSULES
Keep out of the sight and reach of children.
Store in the original container in order to protect from moisture.
Do not use these capsules after the expiry date shown on the outside packaging. Return all unused medicines to your pharmacist for safe disposal.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Loperamide Capsules contain: Active ingredient: Loperamide hydrochloride 2mg
Other ingredients: Maize starch, lactose, povidone, sodium starch glycollate and magnesium stearate. The capsule shell contains gelatin, titanium dioxide (E171), iron oxides (E172) and patent blue V (E131).
The printing ink contains shellac, simeticone, titanium dioxide (E171) and propylene glycol (E1520).
(see section 2 'Important information about some of the ingredients').
What Loperamide Capsules look like and the contents of the pack
The medicine is enclosed in a green and dark grey capsule. The pack contains 6, 8, 10 or 12 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)