Apohealth Diarrhoea Relief Plus

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Loperamide hydrochloride and Simethicone
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about APOHEALTH Diarrhoea Relief PLUS Chewable Tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits.
If you have any concerns about using APOHEALTH Diarrhoea Relief PLUS Chewable Tablets ask your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.

What APOHEALTH Diarrhoea Relief PLUS Chewable Tablets are used for

APOHEALTH Diarrhoea Relief PLUS Chewable Tablets are used to treat acute diarrhoea.
APOHEALTH Diarrhoea Relief PLUS Chewable Tablets also relieve the symptoms of too much gas such as abdominal pain, bloating, cramping and flatulence (wind).
APOHEALTH Diarrhoea Relief PLUS Chewable Tablets make 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.
APOHEALTH Diarrhoea Relief PLUS Chewable Tablets also help the body to get rid of excess gas trapped in the stomach and bowel.
Your doctor may have prescribed APOHEALTH Diarrhoea Relief PLUS Chewable Tablets for another reason.
Ask your doctor if you have any questions about why APOHEALTH Diarrhoea Relief PLUS Chewable Tablets has been prescribed for you.

Before you take APOHEALTH Diarrhoea Relief PLUS Chewable Tablets

When you must not take it:

Do not take APOHEALTH Diarrhoea Relief PLUS Chewable Tablets if:
you have an allergy to APOHEALTH Diarrhoea Relief PLUS Chewable Tablets 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
the packaging is torn or show signs of tampering
Do not use APOHEALTH Diarrhoea Relief PLUS Chewable Tablets after the expiry date (month and year) printed on the pack. If you take APOHEALTH Diarrhoea Relief PLUS Chewable Tablets after the expiry date it may not work.
Do not give APOHEALTH Diarrhoea Relief PLUS Chewable Tablets 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 (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 medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.
In particular, 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 action of the stomach and intestines.

Taking APOHEALTH Diarrhoea Relief PLUS Chewable Tablets

How to take:

APOHEALTH Diarrhoea Relief PLUS Chewable Tablets should be chewed, then swallowed. No liquid intake is necessary.

How much to take:

Adults and children aged 12 years and over:
The usual adult dose is two APOHEALTH Diarrhoea Relief PLUS Chewable Tablets initially, followed by one tablet after each loose unformed stool as needed.
Do not take more than four tablets in one day.
Your doctor may prescribe a different dose for you.
APOHEALTH Diarrhoea Relief PLUS Chewable Tablets should be chewed.
Children:
APOHEALTH Diarrhoea Relief PLUS Chewable Tablets should not be given to children under 12 years of age.

If you forget to take it

If you forget to take APOHEALTH Diarrhoea Relief PLUS Chewable Tablets 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 have taken too much (overdose):

Immediately telephone your doctor or the Poisons Information Centre for advice, or go to Accident and Emergency at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Poisons Information Centre telephone numbers:
Australia: 13 11 26
New Zealand: 0800 POISON or 0800 764 766
Keep these telephone numbers handy in case of an emergency.
If you take too much APOHEALTH Diarrhoea Relief PLUS Chewable Tablets you may have any of the following symptoms: sleepiness, nausea and vomiting, constipation, difficulty passing urine, weak breathing, muscle stiffness, stupor, constriction of pupils, abdominal discomfort and distension, and uncoordinated movements.
Children are more sensitive than adults to medicines such as APOHEALTH Diarrhoea Relief PLUS Chewable Tablets. An accidental overdose is especially dangerous. Make sure APOHEALTH Diarrhoea Relief PLUS Chewable Tablets is kept out of reach of children.

While you are using APOHEALTH Diarrhoea Relief PLUS Chewable Tablets

Things you must do:

If you do not improve after taking APOHEALTH Diarrhoea Relief PLUS Chewable Tablets for 48 hours tell your doctor or pharmacist
Drink plenty of fluids, to avoid dehydration
Tell your doctor if diarrhoea persists beyond 48 hours
Tell your doctor if you become pregnant while taking APOHEALTH Diarrhoea Relief PLUS Chewable Tablets
Tell your doctor or pharmacist that you are taking APOHEALTH Diarrhoea Relief PLUS Chewable Tablets if you are about to start taking a new medicine.

Things you must not do:

Do not take more than four tablets in one day
Do not use APOHEALTH Diarrhoea Relief PLUS Chewable Tablets 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 treatment if you get some side effects.
Do not be alarmed by this list of possible 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 experience any of the following and they worry you:
nausea or vomiting
headache, chills, fever
constipation, dry mouth or bad taste
dizziness or drowsiness cough
rash and sweat
itching
difficulty passing urine
tiredness
abdominal pain/discomfort/distension
excessive flatulence indigestion
rapid heart rate
These side effects are usually mild.
The above list does not represent all side effects that have been reported for APOHEALTH Diarrhoea Relief PLUS Chewable Tablets. If you notice side effects not mentioned in this leaflet, please inform your pharmacist or doctor.
STOP taking APOHEALTH Diarrhoea Relief PLUS Chewable Tablets and tell your doctor immediately 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.
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 APOHEALTH Diarrhoea Relief PLUS Chewable Tablets.
Ask your pharmacist or doctor if you do not understand anything in this list.

After using APOHEALTH Diarrhoea Relief PLUS Chewable Tablets

Storage

Keep your APOHEALTH Diarrhoea Relief PLUS Chewable Tablets in the pack until it is time to take them.
Keep your APOHEALTH Diarrhoea Relief PLUS Chewable Tablets in a cool dry place where the temperature stays below 25 degrees C.
Do not store APOHEALTH Diarrhoea Relief PLUS Chewable Tablets, or any other medicine, in the bathroom or near a sink. Do not leave medicines in the car or on windowsills. Heat and dampness can destroy some medicines.
Keep your medicines where children cannot reach them.
A locked cupboard at least one-and-a-half metres (1.5 m) above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking APOHEALTH Diarrhoea Relief PLUS Chewable Tablets or your medicine has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.

Product description

What APOHEALTH Diarrhoea Relief PLUS Chewable Tablets look like:

APOHEALTH Diarrhoea Relief PLUS Chewable Tablets are white to off- white, 15.9 mm diameter round bevel edged, slightly mottled, uncoated, chewable tablets
Each pack contains 2, 4, 6, 12 or 18 tablets.

Ingredients

Each APOHEALTH Diarrhoea Relief PLUS Chewable Tablets contains 2mg of loperamide hydrochloride and 125 mg of simethicone as the active ingredients.
The chewable tablets also contain:
magnesium carbonate hydrate
calcium phosphate
glucose monohydrate
povidone
silicon dioxide
acesulfame potassium
hypromellose
xylitol
stearic acid
peppermint flavour
The chewable tablets do not contain gluten.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2114
This leaflet was prepared in March 2018.
Australian Registration Number:
AUST R 235981