IVERMECTINA 3 mg Tabletka Powlekana
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Treść ulotki
Ivermectina Difa 3 mg tablets
ivermectina
Generic medicine
Readcarefullythisleafletbeforetakingthismedicinebecause
it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any doubts, ask your doctor or pharmacist.
- This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Ivermectina Difa is and what it is used for
- 2. What you need to know before you take Ivermectina Difa
- 3. How to take Ivermectina Difa
- 4. Possible side effects
- 5. How to store Ivermectina Difa
- 6. Contents of the pack and other information
1. What is Ivermectina Difa and what is it used for
Ivermectina Difa 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”. Ivermectina Difa 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. Ivermectina Difa should only be taken when the doctor is certain or suspects that you have scabies.
Ivermectina Difa does not prevent any of these infections.It does not act against adult worms .
Ivermectina Difa should only be taken when the doctor has confirmed or believes that there is
a parasitic infection.
2. What you need to know before taking Ivermectina Difa
Do not take Ivermectina Difa:
- if you are allergic to ivermectin or any of the other ingredients of this medicine (listed in section 6); the signs of an allergic reaction to a medicine can include skin rash, difficulty breathing or fever.
- If you have ever developed a severe skin rash or peeling of the skin, rash with blisters and/or ulcers in the mouth after taking ivermectin.
In general, if unusual symptoms occur suddenly after taking any
medicine, such as skin rashes, hives or fever, you can assume you are allergic to that
medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ivermectina Difa.
Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with treatment with ivermectin. Stop using ivermectin and
consult a doctor immediately if you notice any of the symptoms related to these serious skin reactions
described in section 4.
In particular, 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 loaalso 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 a risk of adverse effects that are sometimes potentially serious.
If you fall into any of these categories (or if you are not sure), talk to your doctor or pharmacist before taking
Ivermectina Difa.
Ivermectina Difa is not indicated for preventing tropical parasite infestations. It is not effective 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 use of Ivermectina Difa in pediatric patients with a body
weight below 15 kg has not been evaluated.
Other medicines and Ivermectina Difa
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Pregnancy and breastfeeding
- Talk to your doctor immediately before taking Ivermectina Difa if you are pregnant or might become pregnant. If you are pregnant, it should only be taken if clearly necessary. Your doctor will decide together with you.
- If you are breastfeeding or intend to breastfeed, tell your doctor. This is because Ivermectina Difa is excreted in breast milk. Your doctor may decide to start treatment one week after the birth of your baby.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
The effect of Ivermectina Difa 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
effects such as dizziness, drowsiness, feeling of tremor or lightheadedness that may affect
the ability to drive and operate machines.
If such symptoms occur, avoid driving or using machines.
3. How to take Ivermectina Difa
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Method of administration
- Take this medicine orally.
- In children under 6 years of age, the tablets must be crushed before being swallowed.
- Take the number of tablets prescribed by your doctor all at once in a single dose with water on an empty stomach. No food should be taken two hours before or two hours after administration, as the influence of food on the absorption of the medicine in the body is unknown.
Dosage
The treatment is a single dose.
- Take the number of tablets prescribed by your doctor all at once.
- The dose depends on the disease and weight or height.
- Your doctor will tell you how many tablets you need to take.
Treatment of gastrointestinal strongyloidiasis (anguillulosis)
- The usual dose is:
Treatment of lymphatic filariasiscaused by Wuchereria bancrofti
- The usual dose is:
| BODY WEIGHT (kg) | DOSE (number of 3 mg tablets) |
| 1 |
| a 2 |
| n 3 |
| 4 |
a
| 5 |
| ≥ 80 | 6 |
| BODY WEIGHT (kg) | t I DOSE when taken once every 6 months (number of 3 mg tablets) | DOSE when taken once every 12 months (number of 3 mg tablets) |
| 1 | 2 |
a
| 2 | 4 |
i
| 3 | 6 |
| 4 | 8 |
- This is repeated every 6 months or every 12 months.
- Alternatively, and if the weight is not available, the dosage can be determined by the patient's height, as follows:
| g HEIGHT (cm) | DOSE when taken once every 6 months (number of 3 mg tablets) | DOSE when taken once every 12 months (number of 3 mg tablets) |
A
| 1 | 2 |
| 2 | 4 |
| 3 | 6 |
| > 158 | 4 | 8 |
Treatment of human scabies
- Take a dose of 200 micrograms per kilogram of body weight. Your doctor will tell you how many tablets you need to take.
- You will not know if the treatment has been successful before 4 weeks
- Your doctor may decide to prescribe you a second single dose within 8-15 days
If you feel that the effect of Ivermectina Difa is too strong or too weak, consult your
doctor or pharmacist.
If you take more Ivermectina Difa than you should
It is important to take the dose prescribed by your doctor. Cases of decreased level of consciousness and coma have been reported due to overdose with ivermectin.
If you take more Ivermectina Difa than you should, consult your doctor immediately.
If you have any doubts about using this medicine, consult your doctor or pharmacist.
If you forget to take Ivermectina Difa
Always follow your doctor's prescription. Do not take a double dose to make up
for the missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets 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 happens 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 a 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 a doctor immediately.
Stop using ivermectin and consult a doctor immediately if you notice any of the following
symptoms:
- reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
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
- decreased state of alertness, including coma
The side effects listed below depend on the reason why you are taking Ivermectina
Difa. 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). Also, 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, joint and generalized body pain
- loss of appetite, nausea
- stomach pain (abdominal and epigastric pain)
- cough or sore throat
- difficulty breathing
- low blood pressure when getting up or standing - you 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
- changes in 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
- fast 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 Ivermectina Difa
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, the bottle and the carton.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store in the original package 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. Package contents and other information
- The active ingredient is ivermectin. One tablet contains 3 mg of ivermectin.
- The other ingredients are: Microcrystalline cellulose (E460), pregelatinized corn starch, citric acid (E-330), butylated hydroxyanisole, magnesium stearate (E470b)
Description of the appearance of Ivermectina Difa and package contents
This medicine is presented in the form of round, white tablets without scoring.
It is supplied in blisters packaged in cartons containing 1, 4, 8, 10, 12 or 20 tablets.
It is supplied in an HDPE bottle with silica gel desiccant containing 250 tablets.
The blisters are packaged in a foldable cardboard box.
The bottle is packaged in a foldable cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Difa Cooper SpA
Via Milano 160,
21042 Caronno Pertusella. (Va), Italy
Manufacturer
Laboratorios Liconsa, S.A.
Polígono Industrial Miralcampo, Avda. Miralcampo, 7
19200 Azuqueca de Henares – Guadalajara
Spain
Medical Valley Invest AB
Bradgardsvagen 28 2 Tr,
Hollviken, 236 32,
Sweden
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
| Netherlands | Ivermectine Xiromed 3 mg, tabletten |
| Austria | m Ivergelan 3 mg- Tabletten |
| Czech Republic | Ivermectin Exeltis 3 mg tablety |
| Denmark | r Ivermectin “Medical Valley”, tabletter |
| Finland | Ivermectin Medical Valley 3 mg tabletit |
| France | a Ivermectine Liconsa 3 mg comprimé |
| Germany | Iveraxiro 3 mg Tabletten |
| Iceland | F Ivermectin Medical Valley 3 mg töflur |
| Norway | Ivermectin Medical Valley |
| Poland | Ivermectin Medical Valley |
| Slovakia | l Ivermectin Exeltis 3 mg tablety |
| Sweden | Ivermectin Medical Valley 3 mg tabletter |
| Italy | e Ivermectina Difa |
| Portugal | Ivermectina Cantabria 3 mg comprimidos |
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- Kraj rejestracji
- Postać farmaceutycznaCoated tablet, 3 MG
- Kod ATCP02CF01
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki IVERMEKTINA DIFAPostać farmaceutyczna: Coated tablet, 3 MGSubstancja czynna: ivermectinProducent: SUBSTIPHARMWymaga receptyPostać farmaceutyczna: Tablet, 3 MGSubstancja czynna: ivermectinProducent: S.F. GROUP S.R.L.Wymaga receptyPostać farmaceutyczna: Coated tablet, 100 MGSubstancja czynna: mebendazoleProducent: JANSSEN CILAG S.P.A.Wymaga recepty
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IVERMEKTINA DIFA wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w IVERMEKTINA DIFA jest ivermectin. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
IVERMEKTINA DIFA jest produkowany przez DIFA COOPER S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie IVERMEKTINA DIFA jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić IVERMEKTINA DIFA w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (ivermectin) to m.in. IVERSKAB, SKAVER, VERMOX. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
