|Medication:||Generic Ivermectin||Generic Ivermectin|
|Dosage:||3 mg, 6 mg, 12 mg||12 mg, 6 mg, 3 mg|
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Name of the medicinal product
Stromectol, Tablet ivermectin
Please read this leaflet carefully before taking Stromectol as it contains important information for you.
* Keep this leaflet. You might need to read it again.
- · If you have any other questions, ask your doctor or pharmacist.
- · Stromectol has been prescribed to you personally. Do not give it to other people. It could be harmful to them, even if the signs of their illness are identical to yours.
- · If you experience any side effects, tell your doctor or pharmacist. This also applies to any adverse reactions that are not mentioned in this leaflet. See section 4.
What does this leaflet contain?
- 1. What is Ivermectin tablet and what is it used for?
- 2. What information do I need to know before taking Ivermectin tablet?
- 3. How to take Ivermectin tablet?
- 4. What are the possible side effects?
- 5. How to store Ivermectin tablet?
- 6. Contents of the package and other information.
1. WHAT IS Ivermectin tablet AND WHAT IS IT USED FOR?
Stromectol, tablet contains a medicine called ivermectin. This type of medicine is used for infestations caused by certain parasites.
It is used in treatment :
- *an infestation of the intestine called intestinal strongyloidosis (anguillulosis). It is caused by a type of roundworm called "Strongyloides stercoralis" ;
- *a blood infestation called microfilaremia due to lymphatic filariasis. It is caused by an immature worm called "Wuchereria bancrofti". Ivermectin tablet does not act on adult worms but only on immature worms ;
- *skin mites (scabies). These tiny mites dig furrows in your skin. This can cause you to experience significant itching. Ivermectin tablet should only be taken when your doctor is sure or thinks that you have scabies.
Ivermectin tablet will not prevent you from having one of these infestations. It has no effectiveness on adult worms. Ivermectin tablet should only be taken with the advice of your doctor when the parasite infestation is certain or is strongly suspected.
2. WHAT INFORMATION SHOULD I KNOW BEFORE TAKING Ivermectin tablet?
Never take Ivermectin tablet :
- if you are allergic to ivermectin or to any of the other ingredients contained in Stromectol, mentioned in section 6. Symptoms of an allergic reaction to a medication may include a skin rash, difficulty breathing, or a fever ;
- if you have ever developed a severe rash or peeling of the skin, blisters and/or sores in your mouth after taking ivermectin.
Do not take Stromectol if you have any of the above symptoms.
If you are in doubt, contact your doctor or pharmacist before taking Stromectol.
Warnings and precautions
Talk to your doctor or pharmacist before taking Stromectol.
Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported as part of ivermectin treatment. Stop taking ivermectin and seek medical attention immediately if you notice any of the symptoms associated with these serious skin reactions described in section 4.
In particular, before taking Stromectol 3 mg, check with your doctor or pharmacist :
- · if you have a deficient immune system ;
- · if you live or have stayed in African regions where some people are infested by a worm called "Loa loa", also called "eye worm" ;
- · if you live or have stayed in African regions. The use of diethylcarbamazine citrate (DEC) to treat an infestation with "Onchocerca volvulus", can increase the risk of occurrence of adverse reactions that can sometimes be serious.
If any of the above applies to you (or if you are in doubt), contact your doctor or pharmacist before taking Stromectol.
The safety of use of Ivermectin tablet in children weighing less than 15 kg has not been evaluated.
Other medicines and Ivermectin, tablet
Tell your doctor or pharmacist if you are taking, have recently taken, or may be taking any other medication.
Ivermectin, tablet with food
Pregnancy and breastfeeding
If you are pregnant or may become pregnant, contact your doctor immediately before taking Ivermectin tablet. In case of pregnancy, only take Ivermectin tablet if absolutely necessary. The decision will be made in agreement with your doctor.
Contact your doctor if you are breast-feeding or intend to breast-feed, as Ivermectin tablet passes into breast milk. Your doctor may decide to start your treatment one week after the birth of your child.
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking Stromectol.
Driving vehicles and using machines
You may have a feeling of dizziness, drowsiness, tremors or dizziness after taking Ivermectin tablet. If you experience such symptoms, avoid driving vehicles or operating machinery.
Ivermectin, tablet contains
3. HOW TO TAKE Ivermectin tablet?
Always take Stromectol exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
Taking the medicine
- · Take Stromectol by mouth.
- · In children under 6 years of age, the tablets should be crushed before swallowing.
- Take the number of tablets prescribed by your doctor at one time, with water and on an empty stomach. Do not take food for the 2 hours before or after taking the tablets, as the influence of diet on the absorption of the drug by your body is not known.
The treatment consists of a single dose.
- * Take the number of tablets prescribed by your doctor at one time.
- * The dose depends on your illness as well as your weight or height.
- · Your doctor will tell you the number of tablets to take.
Treatment of intestinal strongyloidosis (anguillulosis)
The usual dosage is :
|BODY WEIGHT (kg)||DOSE (in the number of 3 mg tablets)|
|15 to 24||one|
|25 to 35||two|
|36 to 50||three|
|51 to 65||four|
|66 to 79||five|
Treatment of human scabies
Take a dose of 200 micrograms of ivermectin per kilogram of body weight.
You will not know, for 4 weeks, if the treatment has been completely effective. Your doctor may prescribe a second single dose within 8 to 15 days.
If you have the impression that the effect of Ivermectin tablet is too strong or too weak, consult your doctor or pharmacist.
If you have taken more Ivermectin tablet than you should
It is important to take the dose prescribed by your doctor. Decreased alertness, including coma, has been reported in patients who have received an ivermectin overdose.
If you have taken more Stromectol than you should, consult your doctor immediately.
If you forget to take Ivermectin tablet
Try to take Ivermectin tablet as prescribed by your doctor. Do not take a double dose to make up for the dose you forgot to take.
If you stop taking Ivermectin tablet
If you have any further questions about the use of Stromectol, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE UNDESIRABLE EFFECTS?
Like all medicines, Stromectol can cause side effects, but not everybody gets them.
The side effects are usually mild and short-lived. They can occur more easily in subjects infested by several parasites. This is especially true in patients who have the worm "Loa loa".
The following side effects may occur with this medication :
Allergic Reactionsstop taking ivermectin and seek medical attention immediately if you experience any of the following symptoms:
- *non-raised reddish spots, in the form of targets or circles, on the trunk, often accompanied by central blisters, peeling of the skin, ulcers of the mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
If you have an allergic reaction, consult a doctor immediately. Symptoms may include :
- *sudden fever
- *sudden skin reactions (such as rashes or itching) or other serious skin reactions
- *difficulty breathing
Consult a doctor immediately if you experience any of the above side effects.
Other adverse reactions :
- *liver disease (acute hepatitis)
- *modification of certain laboratory tests (increase in liver enzymes, increase in the level of bilirubin in the blood, increase in the level of eosinophils ...)
- *presence of blood in the urine
- *decreased alertness, including coma
The side effects below depend on the disease for which you are taking Stromectol. They also depend on the presence or absence of other infections.
Subjects with intestinal strongyloidosis (anguillulosis) may have the following adverse reactions :
- *feeling of unusual weakness
- *loss of appetite, stomach pain, constipation or diarrhea
- *nausea or vomiting
- ·feeling drowsy or dizzy
- ·chills or tremors
In the case of intestinal strongyloidosis (anguillulosis), adult roundworms can also be found in your stool.Subjects with microfilaremia due to lymphatic filariasis, caused by Wuchereria bancrofti may have the following adverse reactions :
- *sweating or fever
- *feeling of unusual weakness
- *muscle, joint and whole body pain
- *loss of appetite, nausea
- *stomach pain (abdominal and epigastric pain)
- *cough or sore throat
- *respiratory discomfort
- *drop in blood pressure when moving to a standing position - you may feel dizzy or have an empty head feeling
- *pain or discomfort in the testicles
Subjects with scabies may have the following adverse reactions :
- *potential worsening of itching (pruritus) at the beginning of treatment with this medication, usually of short duration
Subjects heavily infested with the "Loa loa" worm may have the following adverse effects :
- *disorders of brain function
- *neck pain or back pain
- *bleeding in the area of the white of the eye (also called red eye)
- *shortness of breath
- ·loss of control in the bladder or intestines
- ·difficulty standing or walking
- *mental state disorders
- ·feeling drowsy or confused
- *inability to respond to other people or coma
Subjects infested by the "Onchocerca volvulus" worm responsible for river blindness may have the following adverse effects :
- *itching or skin rashes
- *joint or muscle pain
- *nausea or vomiting
- *swelling of the lymph nodes
- *swelling, especially in the area of the hands, ankles or feet
- *drop in blood pressure (hypotension). You may feel dizzy or have an empty head feeling when moving to a standing position
- *acceleration of the rhythm of the heart
- *headache or feeling tired
- *vision disorders and other eye problems such as infection, redness or unusual sensations
- *bleeding from the whites of the eye or swelling of the eyelids
- *worsening of asthma
Declaration of side effects
If you experience any side effects, tell your doctor or pharmacist. This also applies to any adverse reactions that are not mentioned in this leaflet.
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE Ivermectin tablet?
Keep Stromectol out of the sight and reach of children.
Do not use Stromectol after the expiration date indicated on the carton and the blister after "EXP". The expiration date refers to the last day of this month.
Stromectol does not require special storage precautions.
Do not throw any medicine down the drain or with household waste. Ask your pharmacist to dispose of medicines that you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What Ivermectin tablet contains
The active substance is : ivermectin 3 mg
For one tablet.
·The other components are: microcrystalline cellulose, pregelatinized starch, butylhydroxyanisole, magnesium stearate.
What is Ivermectin, tablet and contents of the pack
Stromectol is available in the form of round, white or almost white, flat and chamfered tablets.
Box of 1, 4, 10 or 20 tablets.
Not all presentations may be marketed.