Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using STROMECTOL?
STROMECTOL contains the active ingredient ivermectin. STROMECTOL is used to treat river blindness (onchocerciasis), threadworm involving the intestines
(intestinal strongyloidiasis) and scabies which is caused by the Sarcoptes scabiei
mite.
2. What should I know before I use STROMECTOL?
Do not use if you have ever had an allergic reaction to Ivermectin or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with STROMECTOL and affect how it works.
4. How do I use STROMECTOL?
Your doctor will tell you how many tablets you need to take. The dose depends on your infection and your weight or height. Take STROMECTOL as
a single dose with a full glass of water.
5. What should I know while using STROMECTOL?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using STROMECTOL.
Visit your doctor if scheduled, to check the progress of your infection. This is to
help make sure that the infection has cleared up completely
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Things you should not do
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Do not give STROMECTOL to anyone else, even if they have the same condition as you.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how STROMECTOL
affects you
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Looking after your medicine
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Keep your tablets in the aluminium foil blister pack until it is time to take them.
Store it in a cool dry place (below 30°C) away from moisture, heat or sunlight
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6. Are there any side effects?
Like all medicines, STROMECTOL can cause side effects, although not everybody gets
them. Your doctor will discuss these with you and will explain the risks and benefits
of using STROMECTOL.
When you take STROMECTOL, you can have some serious side effects.
Active ingredient:
Ivermectin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using STROMECTOL.
You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using STROMECTOL.
Where to find information in this leaflet:
1. Why am I using STROMECTOL?
STROMECTOL contains the active ingredient Ivermectin. Ivermectin is derived from a class of antiparasitic agents called avermectins.
STROMECTOL is used to treat river blindness (onchocerciasis) and threadworm involving the intestines
(intestinal strongyloidiasis). These are caused by worm infections. In onchocerciasis
the worm infection mainly affects the skin, glands (lymph nodes) and eyes. Changes
to the skin may include an itchy rash, pale or dark patches, nodules (small lumps
under the skin), thickening of the skin and/or loss of elasticity. The infection can
cause enlarged glands in the neck, armpits or groin. The infection can also affect
the eye and may cause conjunctivitis, a gritty or painful eye and may lead to blindness.
In the form of strongyloidiasis that is treated with STROMECTOL, the worm infection
mainly affects the intestines and skin. Symptoms which may occur include itchy rash,
vomiting, diarrhoea and stomach pain.
STROMECTOL works by killing the developing worms.
STROMECTOL is also used to treat scabies which is caused by the Sarcoptes scabiei
mite.
Infection with the scabies mite causes discomfort and often intense itching of the
skin, particularly at night, with irritating blisters or lumps on the skin. Classical
sites of infestation are between the fingers, the wrists, underarm areas, female breasts
(particularly the skin of the nipples), stomach area, penis, scrotum, and buttocks.
Infants are usually affected on the face, scalp, palms and soles.
Scabies is usually spread person to person via direct skin contact, including sexual
contact, though transfer via objects such as clothing or furnishings is also possible.
Each person in contact with the infected person should seek treatment immediately.
Note that the blisters or lumps on your skin may not go way immediately.
Bed linen and clothing should be washed in hot water, no bleaching is required. Shoes
and other non washable items should be placed in a tightly sealed plastic bag for
at least 3 days.
There are 2 types of scabies: typical scabies and crusted scabies (more severe).
Your doctor may have prescribed STROMECTOL for another reason. Ask your doctor if
you have any questions about why STROMECTOL has been prescribed for you.
2. What should I know before I use STROMECTOL?
Warnings
Do not use STROMECTOL if:
you are allergic to Ivermectin, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine
you are pregnant, or intend to become pregnant
the expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work.
Check with your doctor if you:
are breastfeeding or plan to breastfeed.
have or have had any medical conditions, especially:
- liver disease
have been treated for river blindness before.
You may be more likely than others to experience serious side effects with STROMECTOL.
have any allergies to any other medicines or any other substances, such as foods,
preservatives or dyes.
If you have not told your doctor about any of the above, tell them before you take
STROMECTOL.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Safety of the use of STROMECTOL in pregnancy has not been established.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor will discuss the possible risks to your baby if you take STROMECTOL while
you are breastfeeding.
Paediatric
For the treatment of river blindness, do not give STROMECTOL to children under 5 years
of age.
For this worm infection, the safety of STROMECTOL in children under 5 years of age
has not been established.
For the treatment of strongyloidiasis, do not give STROMECTOL to children under 12
years of age.
For this worm infection, the effectiveness of STROMECTOL in children under 12 years
of age has not been established.
For the treatment of scabies, do not give STROMECTOL to children under 5 years of
age or weighing less than 15 kg.
The safety of STROMECTOL in children under 5 years of age or less than 15 kg in weight
has not been established.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and STROMECTOL may interfere with each other. These include warfarin,
used to prevent blood clots.
Your doctor or pharmacist has more information on medicines to be careful with or
to avoid while taking STROMECTOL.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect STROMECTOL.
4. How do I use STROMECTOL?
How much to take
Your doctor will tell you how many tablets you need to take.
The dose depends on your infection and your weight or height. The dose usually ranges
from one tablet to five tablets taken as a single dose.
For river blindness, you may need to take another dose in 6 to 12 months' time.
Depending on whether you have typical or crusted scabies, your doctor will decide
the best treatment for you.
The most common course of treatment is two doses, 8-15 days apart. STROMECTOL can
be used alone or in combination with other treatments for scabies.
How to take STROMECTOL
Take STROMECTOL as a single dose with a full glass of water.
Always take STROMECTOL only as prescribed by your doctor.
If you use too much STROMECTOL
If you think that you have used too much STROMECTOL, you may need urgent medical attention.
If you take too many tablets, you may experience some of the following:
- skin rash, hives;
- swelling of the legs, ankles or feet;
- headache, dizziness, feeling sleepy;
- loss of consciousness
- nausea, vomiting, diarrhoea; stomach pain
- dilated pupils of your eyes
- shortness of breath;
- walking unsteadily; decreased activity; shaking (or tremors); unusual weakness;
tingling or numbness of the hands or feet; seizure.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using STROMECTOL?
Things you should do
Visit your doctor if scheduled, to check the progress of your infection.
This is to help make sure that the infection has cleared up completely. For threadworm,
your doctor may do a follow-up examination of your stools.
For scabies, your doctor may take skin scrapings and check whether the number of mites
has decreased. Your doctor may also take blood samples to monitor your liver function.
Remind any doctor, dentist or pharmacist you visit that you are using STROMECTOL.
Things you should not do
Do not give STROMECTOL to anyone else, even if they have the same condition as you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how STROMECTOL
affects you.
Depressed level of consciousness and coma have been reported with the use of STROMECTOL.
STROMECTOL may cause dizziness, light headedness, spinning sensation (vertigo), tremor,
tiredness or sleepiness in some people.
Make sure you know how you react to STROMECTOL before you drive a car, operate machinery
or perform any other tasks that require you to be alert.
Looking after your medicine
Keep your tablets in the aluminium foil blister pack until it is time to take them.
If you take the tablets out of the box or aluminium foil blister pack they may not
keep well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place (below 30°C) away from moisture, heat or sunlight; for
example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
A locked cupboard at least one and half metres above the ground is a good place to
store medicines.
When to discard your medicine and how to get rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking STROMECTOL.
STROMECTOL helps most people with river blindness, threadworm or scabies, but it may
have unwanted side effects in a few people. 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 of the side effects.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects for patients being treated for river blindness
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Less serious side effects
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What to do
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Muscles and joint related
painful joints or muscles
Skin related
skin rash, itching or swelling
Lung related
worsening asthma
Eye related
swelling of the eyelids, conjunctivitis, a gritty or painful eye, redness of the eye,
visual impairment
Heart related
fast heart beat
Other
painful and tender glands in the neck, armpits or groin
fever
light headedness or dizziness, especially when standing up
headache
swelling of the face, legs, ankles or feet
Some of these are symptoms of an allergic reaction which may occur as a result of
the death of the worms after taking STROMECTOL for river blindness. They are usually
not serious side effects.
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Less serious side effects for patients being treated for threadworm
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Less serious side effects
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What to do
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Gastrointestinal related
nausea, vomiting, diarrhoea, constipation
lack or loss of appetite
stomach pain
Skin related
skin rash, itching or hives
Lung related
worsening asthma
Other
unusual tiredness or weakness
sleepiness
dizziness
spinning sensation, also called vertigo
shaking or tremors
light headedness or dizziness, especially when standing up
These are usually not serious side effects.
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Less serious side effects for patients being treated for scabies
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Less serious side effects
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What to do
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Gastrointestinal related
stomach discomfort
Skin related
rash
Other
tiredness
dizziness
The most common side effects reported are due to the death of the mites and include:
headache
joint pain
loss of appetite
worsening of the itching.
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects for patients being treated for river blindness, threadworm or
scabies
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Serious side effects
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What to do
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Allergic reaction related
severe skin reaction which starts with painful red areas, then large blisters and
ends with peeling of layers of skin. This is accompanied by fever and chills, aching
muscles and generally feeling unwell.
skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and
genitals
These are serious side effects. You may need urgent medical attention. These side
effects are rare.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
If the patient has intestinal worms, ivermectin may kill the worms and patients may
notice them being expelled during defaecation.
Do not be alarmed by this list of possible side effects. You may not experience any
of them
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What STROMECTOL contains
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Active ingredient
(main ingredient)
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ivermectin 3 mg per tablet
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
pregelatinised maize starch
magnesium stearate
butylated hydroxyanisole
citric acid
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STROMECTOL does not contain lactose, sucrose, gluten, tartrazine or any other azo
dyes.
Do not take this medicine if you are allergic to any of these ingredients.
What STROMECTOL looks like
STROMECTOL is a white, round tablet with 'MSD' marked on one side and '32' on the
other side (AUST R 181338).
A pack contains 4 tablets.
Who distributes STROMECTOL
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A 26 Talavera Road
Macquarie Park NSW 2113 Australia
This leaflet was prepared in October 2023.
RCN000024542-AU
Copyright © 2023 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights
reserved.