Consumer medicine information

STOP-IT

Loperamide hydrochloride

BRAND INFORMATION

Brand name

Stop-It

Active ingredient

Loperamide hydrochloride

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using STOP-IT.

What is in this leaflet

This leaflet answers some common questions about STOP-IT.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking STOP-IT against the benefits expected to have for you.

If you have any concerns about using STOP-IT ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What STOP-IT is used for

STOP-IT is used to treat sudden (acute) diarrhoea or long-lasting (chronic) diarrhoea.

STOP-IT makes the stools more solid and less frequent. It does this by normalising the muscle contractions of the intestine. This allows the bowel time to absorb water and produce a more solid stool.

Your doctor may have prescribed STOP-IT for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Before you take STOP-IT

When you must not take it

Do not take STOP-IT if:

  • you have an allergy to STOP-IT or any of the ingredients listed at the end of this leaflet (see Product Description)
  • you are constipated, or have to avoid becoming constipated
  • you have severe diarrhoea with blood in the stools or fever
  • you have inflammation of the lower bowels (for example, ulcerative colitis or pseudomembranous colitis as a result of using antibiotics)
  • you are breast-feeding

Do not use STOP-IT after the expiry (month and year) printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Do not give STOP-IT to children under the age of 12 years.

Before you start to take it

You must tell your doctor or pharmacist if you:

  • are pregnant or planning to become pregnant
  • are breastfeeding
  • have or have ever had liver disease
  • have kidney disease
  • have AIDS (Acquired Immune Deficiency Syndrome)
  • have glaucoma (high pressure in the eye)
  • have bladder problems
  • regularly drink a lot of alcohol.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from a pharmacy, supermarket or health food shop.

Tell your doctor or pharmacist if you are taking any of the following:

  • sleeping tablets or medicines to treat anxiety and nervousness
  • medicines to treat depression
  • medicines that slow down the action of the stomach and intestines

How to take STOP-IT

How to take

STOP-IT capsule should be swallowed with the aid of liquid.

How much to take

Adults:
The usual adult dose is two STOP-IT capsules initially, followed by one capsule after each loose unformed stool as needed.

Do not take more than eight capsules in one day. Your doctor may prescribe a different dose for you.

STOP-IT will usually stop the symptoms of diarrhoea within 48 hours. If it does not, stop taking the medicine and see your doctor.

Children:
STOP-IT should not be given to children under 12 years of age.

If you forget to take it

If you forget to take STOP-IT after an unformed stool, take it when you remember or after your next unformed stool.

Do not take a double dose to make up for the dose you missed. If you are not sure what to do, check with your doctor or pharmacist

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much STOP-IT.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much STOP-IT you may have any of the following symptoms:

  • sleepiness
  • nausea and vomiting
  • constipation
  • difficulty passing urine
  • weak breathing
  • muscle stiffness and uncoordinated movements.

Children are more sensitive than adults to medicines such as STOP-IT. An accidental overdose is especially dangerous.

While you are taking STOP-IT

Things you must do

If you do not improve after taking STOP-IT after 48 hours tell your doctor or pharmacist

Drink plenty of fluids, to avoid dehydration

Tell your doctor if you become pregnant while taking STOP-IT

Tell your doctor or pharmacist that you are taking STOP-IT if you are about to start taking a new medicine.

Things you must not do

Do not take more than 8 capsules in one day

Do not use STOP-IT to treat any other complaint unless your doctor says to

Do not give this medicine to anyone else, even if they have the same symptoms as you.

Things to be careful of

Effects on driving and operating machinery Tiredness, dizziness or drowsiness can be seen with diarrhoea. Therefore, it is advisable to use caution when driving or operating machinery.

Side effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not.

You may need medical attention if you get some of the side effects.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • Nausea or vomiting
  • Constipation
  • Dry mouth or bad taste
  • Headache
  • Stomach pain
  • Flatulence (wind)
  • Difficulty passing urine
  • Tiredness
  • Dizziness or drowsiness

These side effects are usually mild. The above list does not represent all side effects that have been reported for STOP-IT.

If you notice any side effects not mentioned in this leaflet, please inform your pharmacist or doctor.

Tell your doctor immediately and do not take your next dose of STOP-IT if you experience:

  • Asthma, wheezing or shortness of breath
  • Swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
  • Sudden or severe blisters, itching, skin rash, hives
  • Flaking or peeling of skin
  • Loss of or depressed level of consciousness.

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

Other side effects not listed above may also occur in some people.

Tell your doctor if you notice anything making you feel unwell when you are taking, or soon after you have finished taking STOP-IT.

Ask your pharmacist or doctor if you do not understand anything in this list.

After using STOP-IT

Storage

Keep your STOP-IT capsules in a cool dry place where the temperature stays below 25°C.

Do not store STOP-IT, or any other medicine, in the bathroom or near a sink. Do not leave medicines in the car or on the window sills. Heat and dampness can destroy some medicines.

Keep your medicines where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking STOP-IT or they have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

STOP-IT capsules are grey cap/green body capsules.

Each pack contains 10 or 20 capsules.

Ingredients

Each STOP-IT Capsule contains 2 mg of loperamide hydrochloride as the active ingredient.

The capsule also contains:

  • lactose
  • Empty Hard Gelatin Capsule Shell Cap - Grey Body - Green Size 4 (ARTG No. 12417)

Supplier

STOP-IT is supplied in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.alphapharm.com.au

Australian Register Number:
STOP-IT loperamide hydrochloride 2 mg capsule blister pack - AUST R 199731

This leaflet was prepared on 20 March 2013.

Published by MIMS June 2013

BRAND INFORMATION

Brand name

Stop-It

Active ingredient

Loperamide hydrochloride

Schedule

S2