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VANTAGE ANTI-DIARRHOEA CAPSULES

Active substance(s): LOPERAMIDE HYDROCHLORIDE / LOPERAMIDE HYDROCHLORIDE / LOPERAMIDE HYDROCHLORIDE

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1.3.1 - Patient Information Leaflet – GSL- Asda Anti-Diarrhoea Capsules
Package leaflet: Information for the user

Asda Anti-Diarrhoea Capsules
(Loperamide Hydrochloride)

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel worse after 24 hours.
What is in this leaflet
1.
What this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1. What this medicine is and what it is used for
Asda Anti-Diarrhoea Capsules contain Loperamide Hydrochloride which is an anti-diarrhoeal
medicine which helps to stop diarrhoea by making the stools more solid and less frequent.
This medicine is used for the treatment of sudden short-lived (acute) attacks of diarrhoea.
If your attack lasts longer than 24 hours, talk to your doctor.
Please note that these capsules relieve the symptoms of diarrhoea only and should not
be used as a substitute for rehydration treatment.
2. What you need to know before you take this medicine
Do not take this medicine if:
• you suffer from colitis (inflammation of the colon) or any other inflammatory bowel
disease
• you have bacterial enterocolitis (symptoms may include watery or bloody diarrhoea)
• you have a swollen stomach or tummy, and/or constipation
• you are allergic to any of the ingredients listed in Section 6
• you are suffering from dysentery with blood in your stools and a high temperature
• it is for a child aged under 12.
Talk to your doctor or pharmacist before taking this medicine if:
• you suffer from liver or kidney problems, including difficulty in urinating

• you have severe and persistent diarrhoea and vomiting
• you have diarrhoea that lasts for more than 24 hours
• you suffer from severe diarrhoea as your body loses more fluid, sugar and salts than
normal.
If you have AIDS and your stomach becomes swollen, stop taking the capsules immediately
and contact your doctor.
Warnings and precautions
Do not take this product 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, the active ingredient in this medicine.
Other medicines and this medicine
Tell your doctor or pharmacist if you are taking or have recently taken or might take any
other medicines including medicines obtained without prescription and especially:
• 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 treat high cholesterol).
Pregnancy or breast-feeding
• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
• If you are breast-feeding do not take this medicine. Small amounts may get into your
milk. Talk to your doctor about a suitable treatment.
Driving and using machines
This medicine may make you feel dizzy, tired or sleepy. You may feel less alert, feel faint or
pass out. If you are affected do not drive or use machines.
This medicine contains lactose
The capsules contain lactose; if you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take this medicine
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.
Adults, the elderly and children over 12 years
How to take:
The capsules should be swallowed whole with a drink of water.
Dose and how often to take:
After the first loose stool (bowel motion) take 2 capsules with water.
After each further loose stool, take 1 capsule.
• Rehydration sachets are available separately.








Do not give to children under 12 years of age.
Do not take more than 6 capsules in any 24 hours.
Do not take the capsules for more than 24 hours unless advised by a doctor.
If symptoms persist for more than 24 hours consult your doctor.
Replace lost fluid by drinking more liquid than usual.
DO NOT EXCEED THE STATED DOSE.

If you take more medicine than you should
If you have taken too much of this medicine, immediately contact a doctor or hospital for advice.
Symptoms 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 this medicine than adults. If a child takes too
much or shows any of the above symptoms, call a doctor immediately.
If you forget to take this medicine
You should only take this medicine as you need it, 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.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Rare: (may affect up to 1 in 1,000 people)
Stop taking this medicine and see your doctor immediately if you experience any of
these serious side effects:
• Allergic reactions including unexplained wheezing, shortness of breath, passing out or
swelling of face and throat
• Skin rashes, which may be severe and include blistering or peeling skin
• Loss of consciousness or reduced level of consciousness (passing out, feeling faint or
less alert), uncoordinated movements.
Other side effects
Common: (may affect up to 1 in 10 people)
• Feeling sick, constipation or wind
• Headache.
Uncommon: (may affect up to 1 in 100 people)
• Dizziness or drowsiness
• Abdominal pain or discomfort
• Abdominal pain upper
• Dry mouth
• Vomiting
• Indigestion.

Rare: (may affect up to 1 in 1,000 people)
• Itchiness or hives
• Stomach pain or swollen stomach
• Difficulties in passing water
• Miosis (narrowing of the pupils of the eye)
• Tiredness.
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 this medicine
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original container.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date
refers to the last day of the month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicine you no longer use. These measures will help protect the
environment.

6. Contents of the pack and other information
What this medicine contains:
The active ingredient in the capsules is: Loperamide Hydrochloride 2mg per capsule.
The other ingredients in the capsules are: Lactose, Maize Starch, Talc, Magnesium
Stearate, Gelatin, Quinoline Yellow (E104), Erythrosine (E127), Patent Blue (E131) and
Titanium Dioxide (E171).
What this medicine looks like and contents of the pack
Asda Anti-Diarrhoea Capsules are blue and grey capsules, available in a pack of 6 capsules.

Marketing Authorisation Holder:
Galpharm Healthcare Ltd., Wrafton, Braunton, Devon, EX33 2DL, United Kingdom.
Manufacturer:
Galpharm International Ltd., Elmhirst Park, Middle Field Road, Barnsley, South Yorkshire,
S75 4LS, United Kingdom.
This leaflet was last revised in June 2017.

1.3.1 - Patient Information Leaflet – Pharmacy - Asda Anti-Diarrhoea Capsules
Package leaflet: Information for the user
Asda Anti-Diarrhoea Capsules
(Loperamide Hydrochloride)

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 24 hours.
What is in this leaflet
1.
What this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1. What this medicine is and what it is used for
Asda Anti-Diarrhoea Capsules contain Loperamide Hydrochloride which is an anti-diarrhoeal
medicine which helps to stop diarrhoea by making the stools more solid and less frequent.
This medicine is used for the treatment of sudden short-lived (acute) attacks of diarrhoea.
If your attack lasts longer than 24 hours, talk to your doctor.
Please note that these capsules relieve the symptoms of diarrhoea only and should not
be used as a substitute for rehydration treatment.
2. What you need to know before you take this medicine
Do not take this medicine if:
• you suffer from colitis (inflammation of the colon) or any other inflammatory bowel
disease
• you have bacterial enterocolitis (symptoms may include watery or bloody diarrhoea)
• you have a swollen stomach or tummy, and/or constipation
• you are allergic to any of the ingredients listed in Section 6
• you are suffering from dysentery with blood in your stools and a high temperature
• it is for a child aged under 12.
Talk to your doctor or pharmacist before taking this medicine if:
• you suffer from liver or kidney problems, including difficulty in urinating

• you have severe and persistent diarrhoea and vomiting
• you have diarrhoea that lasts for more than 24 hours
• you suffer from severe diarrhoea as your body loses more fluid, sugar and salts than
normal.
If you have AIDS and your stomach becomes swollen, stop taking the capsules immediately
and contact your doctor.
Warnings and precautions
Do not take this product 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, the active ingredient in this medicine.
Other medicines and this medicine
Tell your doctor or pharmacist if you are taking or have recently taken or might take any
other medicines including medicines obtained without prescription and especially:
• 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 treat high cholesterol)
Pregnancy or breastfeeding
• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
• If you are breastfeeding do not take this medicine. Small amounts may get into your
milk. Talk to your doctor about a suitable treatment.
Driving and using machines
This medicine may make you feel dizzy, tired or sleepy. You may feel less alert, feel faint or
pass out. If you’re affected do not drive or use machines.
This medicine contains lactose
The capsules contain lactose; if you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take this medicine
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.
Adults, the elderly and children over 12 years
How to take:
The capsules should be swallowed whole with a drink of water.
Dose and how often to take:
After the first loose stool (bowel motion) take 2 capsules with water.
After each further loose stool, take 1 capsule.









Rehydration sachets are available separately.
Do not give to children under 12 years of age.
Do not take more than 8 capsules in any 24 hours.
Do not take the capsules for more than 24 hours unless advised by a doctor.
If symptoms persist for more than 24 hours consult your doctor.
Replace lost fluid by drinking more liquid than usual.
DO NOT EXCEED THE STATED DOSE.

If you take more medicine than you should
If you have taken too much of this medicine, immediately contact a doctor or hospital for advice.
Symptoms 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.
If you forget to take this medicine
You should only take this medicine as you need it, 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.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Rare: (may affect up to 1 in 1,000 people)
Stop taking this medicine and see your doctor immediately if you experience any of
these serious side effects:
• Allergic reactions including unexplained wheezing, shortness of breath, passing out or
swelling of face and throat
• Skin rashes, which may be severe and include blistering or peeling skin
• Loss of consciousness or reduced level of consciousness (passing out, feeling faint or
less alert), uncoordinated movements.
Other side effects
Common: (may affect up to 1 in 10 people)
• Feeling sick, constipation or wind
• Headache.
Uncommon: (may affect up to 1 in 100 people)
• Dizziness or drowsiness
• Abdominal pain or discomfort
• Abdominal pain upper
• Dry mouth
• Vomiting
• Indigestion.
Rare: (may affect up to 1 in 1,000 people)







Itchiness or hives
Stomach pain or swollen stomach
Difficulties in passing water
Miosis (narrowing of the pupils of the eye)
Tiredness.

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 this medicine
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original container.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date
refers to the last day of the month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicine you no longer use. These measures will help protect the
environment.

6. Contents of the pack and other information
What this medicine contains:
The active ingredient in the capsules is: Loperamide Hydrochloride 2mg per capsule.
The other ingredients in the capsules are: Lactose, Maize Starch, Talc, Magnesium
Stearate, Gelatin, Quinoline Yellow (E104), Erythrosine (E127), Patent Blue (E131) and
Titanium Dioxide (E171).
What this medicine looks like and contents of the pack
Asda Anti-Diarrhoea Capsules are blue and grey capsules, available in pack of 12 or 30
capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Galpharm Healthcare Ltd., Wrafton, Braunton, Devon, EX33 2DL, United Kingdom.
Manufacturer:
Galpharm International Ltd., Elmhirst Park, Middle Field Road, Barnsley, South Yorkshire,
S75 4LS, United Kingdom.
This leaflet was last revised in June 2017.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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