Scatol 3 mg Ivermectin Tablets
What Scatole Is And What It Is Used For
Scatole contains the active substance ivermectin. It is a drug used to treat certain parasitic infections.
It is used to treat:
- An infection in the gut called intestinal strongyloidiasis (strongyloid infection). Infection is caused by a roundworm called Strongyloides stercoralis.
- An infection in the blood called microfilaremia due to lymphatic filariasis. Infection is caused by an immature worm called Wuchereria bancrofti. School is not effective against adult worms but only against immature worms.
- Scabies infection. Scabies is a small mite that digs under the skin. This can cause severe itching. Scatole should only be used if your doctor has shown or suspects scabies.
Scatole does not prevent you from getting any of these infections. It is not effective against adult worms.
Ivermectin contained in Scatol may also be approved for treating other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
Before You Use Scatole
Do Not Use Scatole
- If you are allergic to ivermectin or any of the other ingredients of this medicine (listed in section 6).
If you have any sudden and unusual symptoms, such as a rash, hives, or fever, after taking any medicine, it probably means you are allergic to them.
Take Special Care With Scatole.
Talk to your doctor or pharmacist before taking Scatol.
Tell your doctor
- If you have a weakened immune system (a disease of the immune system)
- If you live or have lived in areas of Africa where parasitic infection occurs in people with the filaria worm Loa loa (also called eye worm)
- If you live or have lived in Africa.
Concomitant use of diethylcarbamazine citrate (DEC) for treating Onchocerca volvulus infection may present a risk of adverse reactions, which may sometimes be severe.
If any of the above apply to you (or you feel unsure), talk to your doctor or pharmacist before taking Scatol.
School is not intended to prevent tropical parasites. It is not effective against adult worms and should only be used according to the doctor’s instructions if there is a strong or strong suspicion of a parasitic infection.
Children
It is not known if using Scatol for children weighing less than 15 kg is safe.
Use Of Other Medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 this medicine.
Pregnancy
If you are pregnant, do not take Scatol unless your doctor tells you to.
Breast-feeding
Scatole is excreted in human milk. Tell your doctor if you are breastfeeding. Do not use Scatol while breastfeeding unless your doctor tells you to.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving And Using Machines
The effect of Scatol on the ability to drive and use machines has not been studied. It can not be ruled out that some patients may experience side effects such as
- Dizziness
- Drowsiness
- Tremors, or dizziness, may affect the ability to drive and use machines.
Avoid driving or using machinery if you experience these symptoms.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How To Use Scatole
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dosage
Treatment of intestinal strongyloidiasis (strongyloid infection)
Follow your doctor’s instructions on how many tablets to take.
Treatment of microfilaremia caused by Wuchereria bancrofti ( lymphatic filariasis)
- Follow your doctor’s instructions on how many tablets to take.
- Your doctor may decide to repeat the treatment.
Treatment of scabies
- Take the recommended Scatol dosering according to your doctor’s instructions.
- It takes 4 weeks to know if the treatment has had an effect.
- Your doctor may give you an additional single dose within 8-15 days.
Other things you should be aware of when you are being treated for scabies
All people who come in contact with you, especially family members and your partner, should see a doctor as soon as possible. The doctor is considering whether these people should also be treated. If infected contact persons are not treated without delay, there is a risk that you will again be infected with scabies.
You should apply hygiene routines to prevent re-infection (ie, keep your fingernails short and clean) and follow official recommendations regarding cleaning clothes and bedding.
If you have the impression that the effect of Scatol is too strong or too weak, talk to your doctor or pharmacist.
Method of administration
The tablets should be swallowed.
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The tablets should be crushed before swallowing by children under 6 years of age.
The treatment consists of a single dose. All prescribed tablets should be taken simultaneously as a single dose. The tablets should be taken with water on an empty stomach. Do not eat food within two hours before or after taking medicine, as it is unknown how food affects the absorption of the medicine in the body.
If You Use More Scatol Than You Should
If you have ingested too much medicine or if, e.g., a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If You Forget To Take Scatole
Always follow your doctor’s prescription.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
Possible Scatol Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them. The side effects are usually not serious or long-lasting. Side effects can be more common in people infected with several parasites. This is especially true for people with Loa loa masks. The following side effects may occur when using this medicine:
Allergic reactions
Seek medical attention immediately if you have an allergic reaction. Signs of an allergic reaction may include:
- Sudden fever
- Sudden skin reactions (such as skin rash or itching ) or other serious skin reactions
- Breathing difficulties.
Seek medical attention immediately if you get any of the above side effects.
Other Scatol side effects are
- Liver disease ( acute hepatitis )
- Changes in certain laboratory tests (increase in liver enzymes, increase in bilirubin in the blood, increase in the number of eosinophils )
- Blood in the urine
The side effects listed below are grouped according to the use of the School. The side effects also depend on whether you have any other infection.
People with intestinal strongyloidiasis can develop the following side effects:
- Unusual feeling of weakness
- Loss of appetite, abdominal pain, constipation, or diarrhea
- Nausea or vomiting
- Drowsiness or dizziness
- Shaking or trembling
- Decreased white blood cell count ( leukopenia )
- Decreased number of red blood cells or decreased amount of the red blood dye hemoglobin ( anemia ).
In intestinal strongyloidiasis (strongyloid infection in the intestine), adult roundworms may occur in the stool.
People with microfilaremia due to lymphatic filariasis caused by Wuchereria bancrofti may experience the following side effects:
- Sweating or fever
- Headache
- Unusual feeling of weakness
- Pain in muscles, joints, or in several places in the body
- Loss of appetite
- Nausea
- Stomach pain (pain in the abdomen or abdomen)
- Cough or sore throat
- Discomfort when breathing
- Low blood pressure when standing or getting up – you may feel dizzy or weak.
- Overindulge
- Dizziness
- Pain or discomfort in the testicles.
People with scabies can get the following side effects:
- The itching may get worse at the beginning of the treatment. This is usually not long.
People with severe Loa loa infection can get the following side effects:
- Abnormal brain function
- Pain in the neck or back
- Bleeding in the whites of the eyes (red eyes)
- Shortness of breath
- Urinary or fecal incontinence
- Difficulty standing or walking
- Changes in mental state
- Drowsiness or confusion
- Not to react to other people or to end up in a coma.
People infected with the Onchocerca volvulus worm that causes river blindness can have the following side effects:
- Itching or rash
- Joint or muscle pain
- Fever
- Nausea or vomiting
- Swelling of lymph nodes
- Swelling, especially in the hands, ankles, or feet
- Diarrhea
- Dizziness
- Low blood pressure ( hypotension ). You may feel dizzy or weak as you get up.
- Fast heart rate
- Headache or fatigue
- Vision changes and other eye problems, such as
- Infection
- Redness
- Unusual sensations
- Bleeding in the whites of the eyes or swollen eyelids
- Worsening asthma
Reporting of side effects are
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the safety of medicines.
How To Store Scatol
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton. The expiration date is the last day of the specified month.
- Do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Further Information
Content Declaration
- The active substance is ivermectin. One tablet contains 3 mg of ivermectin.
- The other ingredients are
- Microcrystalline cellulose (E460)
- Pregelatinized maize starch
- Butyl hydroxy anisole (E320)
- Magnesium stearate (E470b)
What The Medicine Looks Like And The Contents Of The Pack
- Round, white, or off-white, flat, beveled tablets.
- Ash with 4, 8, 10, 12, 16, or 20 tablets.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder:
2care4 Generics ApS
Stenhuggervej 12-14
DK-6710 Esbjerg V
Denmark
Manufacturer:
EUROPEAN DE PHARMACOTECHNIE – EUROPHARTECH
Rue Henri Matisse
63370 Lempdes
France
2care4 Generics ApS
Stenhuggervej 12-14
DK-6710 Esbjerg V
Denmark
The Medical Products Agency
Box 26
751 03 Uppsala