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Loperamide Hcl Capsules 2mg

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Package leaflet: Information for the user

DIAQUITTE CAPSULES

(loperamide hydrochloride)

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have 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 or pharmacist. This includes any possible side effects not listed in this leaflet.

-    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 DiaQuitte is and what it is used for

2.    What you need to know before you take DiaQuitte

3.    How to take DiaQuitte

4.    Possible side effects

5.    How to store DiaQuitte

6.    Contents of the pack and other information

1. What DiaQuitte is and what it is used for

DiaQuitte is an anti-diarrhoeal agent. It works by slowing down the speed at which food and stomach contents pass through the bowel. This allows your body more time to take up more water from your stool and so reduce diarrhoea.

DiaQuitte are used to treat sudden, short lived (acute) attacks of diarrhoea in adults and children over 12 years of age

2. What you need to know before you take DiaQuitte Do not take DiaQuitte:

•    If you are allergic to loperamide or any of the other ingredients of this medicine (listed in Section 6)

•    If you are under the age of 12

•    If you have noticed blood in your stools and have high fever

•    If you are constipated (reduced frequency of bowel movements)

•    If you know you suffer from inflamed intestine (diverticular disease) or inflammatory bowel disease (ulcerative colitis, Crohn’s disease)

•    If you know you suffer from bacterial inflammation of the small intestine and the colon

•    If you know you suffer from a blockage in your intestine

•    If you suffer from a bloated tummy (particularly in children with severe dehydration)

•    If you have been told by your doctor that your abdominal pain, inflammation or diarrhoea is caused by bacteria such as Salmonella, Shigella or Campylobacter

   If you have severe diarrhoea after taking antibiotics

Warnings and precautions:

Talk to your doctor or pharmacist before taking DiaQuitte:

•    If you know you suffer from liver problems

•    If you are dehydrated. 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

•    If you are an AIDS sufferer and you develop a bloated tummy, treatment should be stopped

immediately

This medicine is for the relief of the symptoms of diarrhoea and is not a substitute for oral rehydration therapy. It is important to replace body fluids and salts lost during diarrhoea, particularly if you are frail or elderly.

If there is no improvement in your diarrhoea within 24 hours, or you have a fever or your stool contain blood, stop taking DiaQuitte and consult your doctor. Prolonged diarrhoea may be a symptom of a more serious illness and you should not take DiaQuitte for a long period of time unless your doctor has investigated the cause of your diarrhoea and has then prescribed DiaQuitte to be taken for a prolonged period of time

Other medicines and DiaQuitte

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially any of the following:

■    quinidine (used to treat abnormal heart rhythms or malaria)

■    ritonavir (used to treat HIV)

■    itraconazole (used to treat fungal infections) or gemfibrozil (helps reduce cholesterol and triglycerides (fatty acids) in the blood)

■    ketoconazole (used to treat infections caused by a fungus or yeast)

■    desmopressin (used to treat excessive urination)

■    any medicine being taken for any condition affecting your stomach

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

DiaQuitte should not be taken if you are pregnant. Do not breastfeed your baby, as small amounts of loperamide can pass into breast milk.

Driving and using machines

Do not drive or operate machinery or equipment if you feel drowsy, dizzy or tired while taking DiaQuitte. DiaQuitte 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 DiaQuitte

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.

The dose of DiaQuitte that you will need will depend on whether your diarrhoea is a sudden, short-lived attack (acute) or a long-lasting condition (chronic).

Swallow the capsule whole (do not chew) with some liquid. It is important to drink more fluids than you normally would during treatment with DiaQuitte to replace the fluids and salts lost because of the diarrhoea.

The recommended dose is:

Adults (including Elderly) and Children aged 12 years and over

Two capsules initially then one capsule after every loose stool. The recommended dosage is three to four capsules a day. Do not take more than 6 capsules in one day (24 hours).

If there is no improvement within 24 hours of starting treatment, further investigation of the cause of the diarrhoea should be considered.

Children (under age of 12)

DiaQuitte is not recommended

Patients with liver problems

Your doctor will advise you.

If you take more DiaQuitte than you should

Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining capsules with you. Symptoms of overdose include constipation, sleepiness or decreased respiratory rate.

If you forget to take DiaQuitte

Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking DiaQuitte

You should take DiaQuitte for as long as the doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, DiaQuitte can cause side effects, although not everybody gets them.

If any of the following happen, stop taking DiaQuitte and tell your doctor immediately or go to your nearest hospital emergency department:

Rare: (may affect up to 1 in 1,000 people),

•    You have an allergic reaction. Such reactions may appear in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as:

-    rash

-    swelling of the face, lips, mouth, tongue or throat (angioedema)

-    anaphylactic shock (sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing)

•    Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with dark ring around the edge) (erythema multiforme)

•    A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens Johnson Syndrome).

•    A widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis).

•    Loss of consciousness or reduced level of consciousness (feeling faint or less alert), Increased tension of the muscles or arteries and uncoordinated movements.

•    Widening of the large intestine (megacolon), this widening can be rapid and the following symptoms could be noticed; abdominal pain/tenderness, fever and rapid heart rate

These side effects are rare but serious. You may need medical attention.

The following side effects may be seen with Loperamide:

Common (may affect up to 1 in 10 people):

•    Headache, dizziness

•    Constipation, feeling sick, wind

Uncommon (may affect up to 1 in 100 people):

•    Sleepiness

•    Stomach pain, stomach discomfort, upper stomach pain,

•    Vomiting

•    Indigestion

•    Dry mouth

•    Rash

Rare (may affect up to 1 in 1,000 people)

•    Bowel blockage (ileus), a condition where the bowel does not work properly.

•    Burning of the lips, tongue or mouth (glossodynia)

•    Stomach discomfort

•    Difficulty passing water (urine)

•    Tiredness

•    Hives

•    Itching

•    Narrowing of the pupils of the eye (miosis)

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

5. How to store DiaQuitte

Keep out of the sight and reach of children.

Do not store above 250C.

Do not use DiaQuitte after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information What DiaQuitte contains

The active substance is loperamide hydrochloride

Each capsule contains:

Lactose Monohydrate Maize Starch Magnesium Stearate

The capsule cap contains:

Quinoline Yellow Oxide (E104) Indigo Carmine (E132) Titanium Dioxide (E171) Gelatin

The capsule body contains: Erythrosin (E127)

Indigo Carmine (E132)

Black Iron Oxide (E172) Titanium Dioxide (E171) Gelatin

Printing ink contains

Ammonium hydroxide (E527)

Povidone

Shellac

Simeticone

Sodium Hydroxide

Titanium dioxide (E171)

What DiaQuitte looks like and contents of the pack

Your medicine comes as a hard mauve and green capsule marked “LOPERA-MIDE 2”.

DiaQuitte is available in blisters or plastic bottles of 4 or 6 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Generics [UK] Limited Station Close Potters Bar Hertfordshire EN6 1TL

This leaflet was last revised in 07/2014

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