TESCO HEALTHCARE DIARRHOEA RELIEF 2 MG CAPSULES HARD, LOPERAMIDE 2 MG HARD CAPSULES - patient leaflet, side effects, dosage

2. what you need to know before you take loperamide 2mg hard capsules

This medicine is suitable for most people, but a few people should not use it: Do not take Loperamide 2mg Hard Capsules:

• If you are allergic to loperamide or any of the other ingredients of this medicine (listed in section 6);
• If it is for a child aged under 12 (or under 18 for an IBS patient);
• If you have severe diarrhoea after taking antibiotics;
• If you are having a flare-up of an inflammatory bowel condition like ulcerative colitis;
• If you are constipated, or your stomach appears swollen (especially in children with severe dehydration);
• If you have acute dysentery, the symptoms of which may include blood in your stools and a high temperature;
• If any of these apply to you, talk to your doctor or pharmacist and do not take Loperamide 2mg Hard Capsules.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Loperamide 2mg Hard Capsules:

• If you have AIDS and your stomach becomes swollen, stop taking the capsules immediately and contact your doctor;
• If you suffer from liver disease;
• If you have diarrhoea that lasts for more than 48 hours;
• If you have been told by your doctor that you have an intolerance to some sugars;
• If you have severe diarrhoea as your body loses more fluid, sugars and salts than normal;
• If you have a history of drug abuse. Loperamide is an opioid and addiction is observed with opioids as a class
• If you are taking any other medicines, including:

• – 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).

If you are unsure about any of the medicines you are taking, show the bottle or pack to your pharmacist. If any of these applies to you (now or in the past), talk to a doctor or pharmacist.

Pregnancy and 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’re affected do not drive, cycle or use machines.

Special warnings about this medicine Your body can lose large amounts of fluids and salts when you have diarrhoea. You need to replace the fluid by drinking more liquid than usual. Ask your pharmacist about rehydration therapy to replace lost salts. This is especially important for children, and frail or older people.

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 Loperamide 2 mg Capsules.

Loperamide 2mg Hard Capsules contain 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.

Extra warnings for IBS patients.

Use only if your doctor has previously diagnosed IBS.

Check the following:

Do not take this medicine:

• If you are aged under 18.

Talk to your doctor first:

• If you are aged 40 or over and it is some time since your last IBS attack;
• If you are aged 40 or over and your IBS 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.

If any of these applies to you, talk to your doctor before taking Loperamide 2mg Hard Capsules.

3. how to take loperamide 2mg hard capsules

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

Check with your doctor or pharmacist if you are not sure.

Check the tables on the next page to see how much medicine to take.

• Swallow the correct number of capsules whole with a drink of water;
• For oral use only;
• Do not use more than the dose shown in the tables.

The capsules are not for long-term treatment.

Short term diarrhoea:

Age	Dose
Adults and children aged 12 and over	Take two capsules to start treatment. Take one capsule after each loose bowel movement.
Do not take for attacks lasting longer than 48 hours. Do not take more than six capsules in a 24-hour period.
Replace lost fluid by drinking more liquid than usual. Not for children aged under 12.

How long to take Loperamide 2mg Hard Capsules for short-term diarrhoea

You can use this medicine for up to 48 hours. If your attack lasts longer than 48 hours, stop taking Loperamide 2mg Hard Capsules and talk to your doctor.

IBS diarrhoea

Age	Dose
Adults and children aged 18 and over	Take two capsules to start treatment. Take one capsule (or as advised by your doctor) after each loose bowel movement.
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 capsules in a 24-hour period.
Replace lost fluid by drinking more liquid than usual. Not for children and young people aged under 18.

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.

How long to take Loperamide 2mg Hard Capsules for IBS diarrhoea

You can use this medicine for up to 2 weeks for repeated attacks of IBS diarrhoea. But if any one attack lasts for longer than 48 hours, stop taking Loperamide 2mg Hard Capsules and talk to your doctor.

If you take more Loperamide 2mg Hard Capsules than you should

If you have taken too many Loperamide 2mg Hard Capsules, 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 Loperamide 2mg Hard Capsules than adults. If a child takes too much or shows any of the above symptoms, call a doctor immediately.

If you forget to take Loperamide 2mg Hard Capsules

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. Most are usually mild.

Get medical help at once.

Rare:

(may affect up to 1 in 1,000 people)

• Allergic reactions including unexplained wheezing, shortness of breath, passing

out or swelling of the 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.
• Difficulties passing water.
• Severe constipation.
• Miosis (narrowing of the pupils of the eye).
• Tiredness.

If you get any of these, stop using the medicine and get medical help at once.

Talk to a doctor as soon as possible Uncommon:

(may affect up to 1 in 100 people)

• Dizziness or drowsiness;
• Vomiting, indigestion;
• Dry mouth;
• Itchiness or hives;
• Stomach pain or swollen stomach.

If you notice any of the above, stop using the medicine and talk to a doctor.

Other effects that may occur.

Common:

(may affect up to 1 in 10 people)

• Feeling sick, constipation or wind;
• Headache.

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: 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 loperamide 2mg hard capsules

Keep out of the sight and reach of children. Store in the original package.

Do not use this medicine after the expiry date which is stated on the outside packaging {EXP}.

The expiry date refers to the last day of that month.

Do not throw away any 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 Loperamide 2mg Hard Capsules contain

The active substance is Loperamide hydrochloride. Each hard gelatin capsule contains 2mg Loperamide hydrochloride. The other ingredients are 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, dimeticone, titanium dioxide (E171) and propylene glycol (E1520) (see section 2).

What Loperamide 2mg Hard Capsules look like and contents of the pack.

The medicine is enclosed in a green and dark grey capsule. The pack contains 6 capsules.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited,

Cheshire House, Gorsey Lane, Widnes, WA8 0RP, UK.

| POM |

This leaflet was last revised in August 2021.

PL 20395/0289

RelonGhem

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Tesco Health Diarrhoea Relief 2mg Capsules will be referred to as Diarrhoea Relief 2mg Capsules throughout this leaflet.

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

• 1. What Diarrhoea Relief 2mg Capsules are and what they are used for.

• 2. What you need to know before you take Diarrhoea Relief 2mg Capsules.

• 3. How to take Diarrhoea Relief 2mg Capsules.

• 4. Possible side effects.

• 5. How to store Diarrhoea Relief 2mg Capsules.

• 6. Contents of the pack and other information.

• 1. What Diarrhoea Relief 2mg Capsules are and what they are used for

Diarrhoea Relief 2mg Capsules are 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 capsules 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.

2. what you need to know before you take diarrhoea relief 2mg capsules

This medicine is suitable for most people, but a few people should not use it: Do not take Diarrhoea Relief 2mg Capsules:

• If you are allergic to loperamide or any of the other ingredients of this medicine (listed in section 6);
• If it is for a child aged under 12 (or under 18 for an IBS patient);
• If you have severe diarrhoea after taking antibiotics;
• If you are having a flare-up of an inflammatory bowel condition like ulcerative colitis;
• If you are constipated, or your stomach appears swollen (especially in children with severe dehydration);
• If you have acute dysentery, the symptoms of which may include blood in your stools and a high temperature;
• If any of these apply to you, talk to your doctor or pharmacist and do not take Diarrhoea Relief 2mg Capsules.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Diarrhoea Relief 2mg Capsules:

• If you have AIDS and your stomach becomes swollen, stop taking the capsules immediately and contact your doctor;
• If you suffer from liver disease;
• If you have diarrhoea that lasts for more than 48 hours;
• If you have been told by your doctor that you have an intolerance to some sugars;
• If you have severe diarrhoea as your body loses more fluid, sugars and salts than normal;
• If you have a history of drug abuse. Loperamide is an opioid and addiction is observed with opioids as a class
• If you are taking any other medicines, including:

• – 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).

If you are unsure about any of the medicines you are taking, show the bottle or pack to your pharmacist. If any of these applies to you (now or in the past), talk to a doctor or pharmacist.

Pregnancy and 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’re affected do not drive, cycle or use machines.

Special warnings about this medicine

Your body can lose large amounts of fluids and salts when you have diarrhoea. You need to replace the fluid by drinking more liquid than usual. Ask your pharmacist about rehydration therapy to replace lost salts. This is especially important for children, and frail or older people.

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 Loperamide 2mg Capsules.

Diarrhoea Relief 2mg Capsules contain 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.

Extra warnings for IBS patients.

Use only if your doctor has previously diagnosed IBS.

Check the following:

Do not take this medicine:

• If you are aged under 18.

Talk to your doctor first:

• If you are aged 40 or over and it is some time since your last IBS attack;
• If you are aged 40 or over and your IBS 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.

If any of these applies to you, talk to your doctor before taking Diarrhoea Relief 2mg Capsules.

3. how to take diarrhoea relief 2mg capsules

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

Check with your doctor or pharmacist if you are not sure.

Check the tables below to see how much medicine to take.

• Swallow the correct number of capsules whole with a drink of water;
• For oral use only;
• Do not use more than the dose shown in the tables.

The capsules are not for long-term treatment.

Short term diarrhoea:

Age	Dose
Adults and children aged 12 and over	Take two capsules to start treatment. Take one capsule after each loose bowel movement.
Do not take for attacks lasting longer than 48 hours. Do not take more than six capsules in a 24-hour period.
Replace lost fluid by drinking more liquid than usual. Not for children aged under 12.

How long to take Diarrhoea Relief 2mg Capsules for short-term diarrhoea

You can use this medicine for up to 48 hours. If your attack lasts longer than 48 hours, stop taking Diarrhoea Relief 2mg Capsules and talk to your doctor.

IBS diarrhoea

Age	Dose
Adults and children aged 18 and over	Take two capsules to start treatment. Take one capsule (or as advised by your doctor) after each loose bowel movement.
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 capsules in a 24-hour period.
Replace lost fluid by drinking more liquid than usual. Not for children and young people aged under 18.

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.

How long to take Diarrhoea Relief 2mg Capsules for IBS diarrhoea

You can use this medicine for up to 2 weeks for repeated attacks of IBS diarrhoea. But if any one attack lasts for longer than 48 hours, stop taking Diarrhoea Relief 2mg Capsules and talk to your doctor.

If you take more Diarrhoea Relief 2mg Capsules than you should

If you have taken too many Diarrhoea Relief 2mg Capsules, 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 Diarrhoea Relief 2mg Capsules than adults.

If a child takes too much or shows any of the above symptoms, call a doctor immediately.

If you forget to take Diarrhoea Relief 2mg Capsules

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. Most are usually mild.

Get medical help at once.

Rare:

(may affect up to 1 in 1,000 people)

• Allergic reactions including unexplained wheezing, shortness of breath, passing out or swelling of the 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.
• Difficulties passing water.
• Severe constipation.
• Miosis (narrowing of the pupils of the eye).
• Tiredness.

If you get any of these, stop using the medicine and get medical help at once.

Talk to a doctor as soon as possible Uncommon:

(may affect up to 1 in 100 people)

• Dizziness or drowsiness;
• Vomiting, indigestion;
• Dry mouth;
• Itchiness or hives;
• Stomach pain or swollen stomach.

If you notice any of the above, stop using the medicine and talk to a doctor.

Other effects that may occur.

Common:

(may affect up to 1 in 10 people)

• Feeling sick, constipation or wind;
• Headache.

5. how to store diarrhoea relief 2mg capsules

Keep out of the sight and reach of children.

Store in the original package.

Do not use this medicine after the expiry date which is stated on the outside packaging {EXP}.

The expiry date refers to the last day of that month.

Do not throw away any 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 Diarrhoea Relief 2mg Capsules contain

The active substance is Loperamide hydrochloride. Each hard gelatin capsule contains 2mg Loperamide hydrochloride. The other ingredients are 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, dimeticone, titanium dioxide (E171) and propylene glycol (E1520) (see section 2).

What Diarrhoea Relief 2mg Capsules look like and contents of the pack.

The medicine is enclosed in a green and dark grey capsule. The pack contains 6 capsules.

Marketing Authorisation Holder and Manufacturer:

Relonchem Limited,

Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK.

[POM]

This leaflet was last revised in August 2021.

PL 20395/0289

D27–0485

130 mm

130 mm