IVERSCAB 3 mg Coated Tablet
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Інструкція із застосування IVERSKAB
Зміст інструкції
Iverscab 3 mg tablets
Ivermectin
Generic medicine
Read this leaflet carefully before taking this medicine as it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Iverscab is and what it is used for
- 2. What you need to know before you take Iverscab
- 3. How to take Iverscab
- 4. Possible side effects
- 5. How to store Iverscab
- 6. Contents of the pack and other information
1. What is Iverscab and what is it used for
Iverscab contains the active ingredient ivermectin. This is a type of medicine that is used
for infections caused by certain parasites.
It is used to treat:
- an infection in the intestine called intestinal strongyloidiasis (anguillulosis). It is caused by a type of roundworm called " Strongyloides stercoralis"
- a blood infection called microfilaremia caused by "lymphatic filariasis". It is caused by an immature worm called " Wuchereria bancrofti". Iverscab does not act against adult worms but only against immature worms.
- skin mites (scabies). This happens when tiny mites burrow under the skin. It can cause severe itching. Iverscab should only be taken when the doctor is certain or suspects that you have scabies. Iverscab does not prevent any of these infections.It does not act against adult worms. Iverscab should only be taken on the advice of a doctor when the parasitic infection is certain or suspected.
2. What you need to know before taking Iverscab
Do not take Iverscab:
- if you are allergic to ivermectin or any of the other ingredients of this medicine (listed in section 6);
In general, if unusual symptoms occur suddenly after taking any medicine,
such as skin rashes, hives or fever, you may deduce that you are allergic to that medicine.
Do not take Iverscab if you experience what is described above. If you are not sure, ask your doctor or
pharmacist before taking Iverscab.
Warnings and precautions
Talk to your doctor or pharmacist before taking Iverscab.
Before starting treatment with Iverscab, tell your doctor about your medical history.
Talk to your doctor:
- if you have a weakened immune system (immune disorder)
- if you live or have lived in parts of Africa where there are cases of human parasitic infestation with the filarial worm Loa loa, also called the eye worm
- if you currently live or have lived in parts of Africa.
The combined use of diethylcarbamazine citrate (DEC) to treat a co-infection with Onchocerca
volvulusmay lead to the risk of side effects that are sometimes potentially serious.
If you fall into any of these cases (or if you are not sure), talk to your doctor or pharmacist before
taking Iverscab.
Iverscab is not intended to prevent parasitic infestations. It does not act against adult parasitic worms and can only be used on the advice of a doctor when the parasitic infestation
is certain or strongly suspected.
Children
The safety of using Iverscab in pediatric patients with a body weight
less than 15 kg has not been evaluated.
Elderly patients
Clinical studies with ivermectin did not include a sufficient number of subjects aged 65 years or older to determine whether the response of elderly patients is different from that of younger patients. Other clinical experience reported has not identified differences in responses between
elderly and younger patients. In general, treatment of an elderly patient should be
cautious, considering the higher frequency of decreased hepatic, renal or cardiac function and
of concomitant pathology or any other ongoing pharmacological therapy.
Other medicines and Iverscab
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In general, you should consult your doctor or pharmacist before taking any medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant, do not take Iverscab unless your doctor has prescribed it for you.
Breastfeeding
Iverscab is excreted in breast milk.
If you are breastfeeding, tell your doctor and do not follow this treatment unless your doctor has prescribed
it for you.
Ask your doctor or pharmacist for advice before taking any medicine.
Fertility
Ivermectin has not shown adverse effects on the fertility of rats at up to 3 times the maximum
recommended dose for humans of 200 μg/kg (mg/m²/day).
Driving and using machines
The effect of Iverscab on the ability to drive and operate machines has not been studied.
It is not possible to exclude the possibility that some patients may experience adverse reactions
such as dizziness, drowsiness, vertigo and a feeling of tremor that may affect the ability
to drive and operate machines.
If you experience such symptoms, avoid driving or using machines.
3. How to take Iverscab
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Dosage
Treatment of gastrointestinal strongyloidiasis (anguillulosis)
The recommended dose is 200 μg of ivermectin per kg of body weight, taken orally
as a single administration.
As a guide, the dose, in relation to the patient's weight, is as follows:
Treatment of microfilaremia caused by Wuchereria bancrofti(lymphatic filariasis)
The recommended dose for mass treatment campaigns of microfilaremia caused by
Wuchereria bancrofti(lymphatic filariasis) is approximately 150-200 μg of ivermectin / kg of weight
body weight, taken orally as a single administration every 6 months.
In endemic areas where treatment can only be administered once every 12 months, to
maintain adequate suppression of microfilaremia in treated patients, the recommended dose is
300 - 400 μg / kg of body weight.
As a guide, the dose, in relation to the patient's weight, is as follows:
| BODY WEIGHT (kg) | DOSE (number of 3 mg tablets) |
| e 1 |
| 2 |
| d 3 |
| 4 |
| 5 |
| ≥ 80 | a 6 |
| BODY WEIGHT (kg) | DOSE when taken once a every 6 months (number of tablets 3 mg) | DOSE when taken once every 12 months (number of tablets of 3 mg) |
| 1 | 2 |
i
| 2 | 4 |
z
| 3 | 6 |
| 4 | 8 |
Alternatively, and if weight is not available, the dose of ivermectin to be used in mass treatment
campaigns can be determined by the patient's height as follows:
| g HEIGHT (cm) | DOSE when taken once every 6 months (number of tablets of 3 mg) | DOSE when taken once every 12 months (number of tablets of 3 mg) |
A
| 1 | 2 |
| 2 | 4 |
| 3 | 6 |
| > 158 | 4 | 8 |
Treatment of human scabies
- Take a dose of 200 micrograms for each kilogram of body weight
- You will not know if the treatment has been successful before 4 weeks
- The doctor may decide to prescribe a second single administration within 8-15 days
What you must do while being treated for scabies
People who have come into contact with you, especially family members and partners, should see a
doctor as soon as possible. The doctor will decide whether these people also need to follow the
treatment.
If infected people who have come into contact with you are not treated promptly, there is a risk that
they may re-infect you.
Hygiene measures should be followed to prevent re-infection (e.g. keeping nails short
and clean) and appropriate recommendations on cleaning clothes and
bed linen should be followed.
If you feel that the effect of Iverscab is too strong or too weak, consult your doctor or
pharmacist.
How to administer
Tablets for oral use.
Always follow the dosage indicated by your doctor. If in doubt, consult your doctor or pharmacist.
In children under 6 years of age, the tablets must be crushed before being swallowed.
Treatment consists of a single administration. The number of tablets prescribed should
be taken at the same time in a single administration. The tablets should be
taken with water on an empty stomach. No food should be consumed two hours before or two hours
after administration, as the influence of food on the absorption of
the medicine in the body is unknown.
If you take more Iverscab than you should
Consult your doctor or pharmacist immediately.
If you forget to take Iverscab
Always follow your doctor's prescription. Do not take a double dose to make up for the
missed dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects are usually not serious and do not last long. They may be more likely to occur in people infected with various parasites. This occurs especially in cases of infections
caused by the worm " Loa loa".
After taking this medicine, the following side effects may occur:
Allergic reactions
If you experience an allergic reaction, consult your doctor immediately. Signs may include:
- sudden fever
- sudden skin reactions (such as rash or itching) or other serious skin reactions
- difficulty breathing If you notice any of the above side effects, consult your doctor immediately.
Other side effects:
- liver disease (acute hepatitis)
- alteration of some laboratory tests (increased liver enzymes, increased bilirubin in the blood, increased eosinophils)
- blood in the urine
The side effects listed below depend on the reason why you are taking Iverscab. They
also depend on other ongoing infections.
People with intestinal strongyloidiasis (anguillulosis)may experience the following side effects:
- unusual feeling of weakness
- loss of appetite, stomach pain, constipation, or diarrhea
- nausea or vomiting
- drowsiness or dizziness
- agitation or tremors
- decreased number of white blood cells (leukopenia)
- decreased amount of red blood cells or hemoglobin in the blood (anemia)
Furthermore, in the case of intestinal strongyloidiasis (anguillulosis), adult roundworms may be found
in the stool.
People with microfilaremia due to lymphatic filariasis caused byWuchereria bancrofti
may experience the following side effects:
- sweating or fever
- headache
- unusual feeling of weakness
- muscle pain, joint pain, and generalized body pain
- loss of appetite, nausea
- stomach pain (abdominal and epigastric pain)
- cough or sore throat
- discomfort during breathing
- low blood pressure when getting up or standing - may feel dizzy or lightheaded
- chills
- dizziness
- pain or discomfort in the testicles
People with scabiesmay experience the following side effects:
- itching that may worsen at the beginning of treatment. It is usually short-lived.
People with a severe infection with the worm "Loa loa"may experience the following side effects:
- abnormal brain function
- neck or back pain
- bleeding in the white of the eye (also known as red eye)
- shortness of breath
- loss of bladder or bowel control
- difficulty standing or walking
- altered mental status
- feeling sleepy or confused
- unresponsiveness to stimuli or coma
People infected with the worm "Onchocerca volvulus" that causes river blindnessmay have the
following side effects:
- itching or rash
- joint or muscle pain
- fever
- nausea or vomiting
- swollen lymph nodes
- swelling, especially in the hands, ankles, or feet
- diarrhea
- dizziness
- low blood pressure (hypotension). You may feel dizzy or lightheaded when standing
- rapid heart rate
- headache or feeling tired
- changes in vision and other eye problems such as infection, redness, or unusual sensations
- bleeding in the white of the eye or swelling of the eyelids
- worsening of asthma
Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How to store Iverscab
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and on the packaging after
Exp. The expiry date refers to the last day of that month.
Store at a temperature below 25°C
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Iverscab contains
- The active ingredient is ivermectin. One tablet contains 3 mg of ivermectin.
- The other ingredients are: Microcrystalline cellulose (E460), pregelatinized corn starch, butylated hydroxyanisole (E320), magnesium stearate (E470b)
Description of the appearance of Iverscab and contents of the pack
This medicine is presented in the form of round, white or almost white, flat
bevelled tablets.
Pack sizes of 4, 8, 10, 12, 16 and 20 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUBSTIPHARM
24 rue Erlanger
75016 PARIS – France
Manufacturer
EUROPEENNE DE PHARMACOTECHNIE - EUROPHARTECH
Rue Henri Matisse
63370 Lempdes - France
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Netherlands:Iverscab
Italy :Iverscab
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- Країна реєстрації
- Лікарська формаCoated tablet, 3 MG
- Код АТХP02CF01
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до IVERSKABЛікарська форма: Coated tablet, 3 MGДіюча речовина: ИвермектинВиробник: DIFA COOPER S.P.A.Потрібен рецептЛікарська форма: Tablet, 3 MGДіюча речовина: ИвермектинВиробник: S.F. GROUP S.R.L.Потрібен рецептЛікарська форма: Coated tablet, 100 MGДіюча речовина: мебендазолаВиробник: JANSSEN CILAG S.P.A.Потрібен рецепт
Аналоги IVERSKAB в інших країнах
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Аналог IVERSKAB у Іспанія
Аналог IVERSKAB у Польща
Лікарі онлайн щодо IVERSKAB
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Часті запитання
IVERSKAB потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у IVERSKAB — Ивермектин. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
IVERSKAB виробляється компанією SUBSTIPHARM. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування IVERSKAB з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати IVERSKAB у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (Ивермектин) включають IVERMEKTINA DIFA, SKAVER, VERMOX. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
