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Lomodine 2mg Capsules

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LoModine 2mg Capsules

Loperamide Hydrochloride

Read all of this leaflet carefully 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.

1. What the medicine is for

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


Extra warnings for IBS patients


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


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 this medicine.


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 the active substance Loperamide hydrochloride which helps reduce diarrhoea by slowing down an overactive bowel.

2. Before taking this medicine

Warnings for everyone


This medicine is suitable for most people but a few people should not use it:


Do not take this medicine:


•    If you are allergic to loperamide or any of the ingredients in this medicine

•    If it is for a child under 12 (or under 18 for an IBS patient)

•    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 the above applies to you talk to your doctor

or pharmacist before taking this medicine.


Talk to your doctor first:


If you suffer from liver disease

If you have diarrhoea that lasts more than

48 hours

If you have severe diarrhoea as your body loses more fluid, sugars and salts than normal If you have been told by your doctor that you have an intolerance to some sugars.


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Other medicines and LoModine


Talk to your doctor first if you are taking any other medicines including:

•    Quinidine - used to treat heart conditions or malaria

•    Ritonavir - used to treat HIV

•    Desmopressin - used to treat bed wetting

•    Itraconazole or ketoconazole - used to treat fungal infections

•    Gemfibrozil - used to treat high cholesterol.


Pregnancy or breast feeding


If you are pregnant, think you are pregnant or planning a pregnancy, 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 alternative.


Driving and using machines


This medicine can make you feel dizzy, tired or sleepy. If you think you are affected do not drive or operate machinery.


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 normal.

This is especially important for children and frail or older people. Ask your pharmacist about rehydration therapy to replace lost salts.


Some of the ingredients can cause problems


This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.


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3. How to take this medicine

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. If you take too much medicine contact your doctor or nearest hospital and take this leaflet with you. 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 more than six capsules in a 24-hour period.

•    Do not take for attacks lasting longer than 48 hours.

•    If your attack lasts longer than 48 hours, stop taking LoModine and talk to your doctor.

Reporting of side effects


•    Talk to a doctor as soon as possible if you experience any of the following:

Common (may affect less than 1 in 10 people but more than 1 in 100 people)

•    Headache

•    Feeling sick, constipation, wind Uncommon (may affect less than 1 in 100 people but less than 1 in 1,000 people)

•    Drowsiness

•    Dry mouth

•    Abdominal pain, indigestion or discomfort

•    Skin rash

•    Dizziness

•    Being sick.

Rare (may affect less than 1 in 1,000 but 1 or more in 10,000 people)

•    Miosis (narrowing of the pupils of the eye)

•    Tiredness

•    Itchiness or hives.


IBS diarrhoea

Age

Dose

Adults aged 18 and over

Take two capsules to start treatment.

Take one or two capsules

after each loose bowel movement depending on severity of symptoms.

•    Do not take more than six capsules in a 24-hour period.

•    You can take this medicine for up to 2 weeks for repeated attacks but do not take for any one attack lasting longer than 48 hours.

•    If any attack lasts longer than 48 hours, stop taking LoModine and talk to your doctor.

If you forget to take this medicine


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.    Storing this medicine

Keep the product out of the sight and reach of children.

Do not store above 25°C. Store your medicine in its original container.

Do not use your medicine after the expiry date shown on the packaging.

6.    Further information

You should only take this medicine as you need it, following the dosage instructions 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 LoModine can have side effects although these don’t affect everyone.

If you experience any of the following STOP TAKING this medicine and get medical help at once.

Rare (may affect less than 1 in 1,000 but 1 or more in 10,000 people)

•    Allergic reactions including unexplained wheeziness, shortness of breath, passing out, skin rashes or swelling of the face and throat

•    Skin rashes, which may be severe and include blistering or peeling skin

•    A swollen stomach, severe constipation or difficulty passing water

•    Severe stomach pain or bloating with a fast heart rate, low blood pressure,(dizziness on standing) and high fever

•    Loss of consciousness or reduced level of consciousness (feeling faint or less alert), uncoordinated movements.


What’s in this medicine


The active ingredient in LoModine Capsules is loperamide hydrochloride.

Other ingredients are: lactose monohydrate, maize starch, magnesium stearate, quinolone yellow oxide (E104), indigo carmine (E132), titanium dioxide (E171), gelatin, erythrosine (E127) and black iron oxide (E172).


What the medicine looks like


LoModine are purple and green capsules printed with the name LOMODINE 2.

They are available in packs of 4, 6, 8, 10, 16 and 18 capsules. Not all pack sizes may be sold.

Marketing Authorisation Holder and Manufacturer

Co-pharma Limited Unit 4, Tolpits Lane,

Watford, WD18 9SS, UK.

This leaflet was revised in December 2015.


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