Ivergalen 3 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Ivergalen 3 mg tablets EFG
Ivermectin
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as 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 other people, even if they have the same symptoms as you, since it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Ivergalen is and what it is used for
- What you need to know before taking Ivergalen
- How to take Ivergalen
- Possible side effects
- How to store Ivergalen
- Contents of the pack and other information
1. What Ivergalen is and what it is used for
Ivergalen contains ivermectin, a medicine used to treat infections caused by certain parasites.
It is used to treat:
- an intestinal infection called strongyloidiasis (also known as threadworm infection). This infection is caused by a roundworm called «Strongyloides stercoralis».
- a blood infection called microfilaria due to «lymphatic filariasis». This is caused by an immature worm called «Wuchereria bancrofti». Ivergalen is not effective against adult worms, only against immature worms.
- skin mites (scabies). This occurs when tiny mites burrow under the skin. It can cause intense itching. Ivergalen should only be taken when your doctor thinks or has confirmed that you have scabies.
Ivergalen will not prevent you from developing any of these infections. It is not effective against adult worms.
Ivergalen should only be taken when your doctor has confirmed or suspects that you have a parasitic infection.
2. What you need to know before taking Ivergalen
Do not take Ivergalen
- If you are allergic to ivermectin or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction to a medicine may include skin rash, difficulty breathing, or fever.
- If you have ever had a severe skin rash, skin peeling, blisters, or mouth sores after taking ivermectin.
In general, if after taking any medicine you experience sudden onset of unusual symptoms such as skin rash, hives, or fever, you may assume you are allergic to that medicine.
Do not take Ivergalen if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking Ivergalen.
Warnings and precautions
Talk to your doctor or pharmacist before starting Ivergalen.
Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with ivermectin treatment. Stop taking ivermectin and seek immediate medical attention if you notice any of the symptoms described in section 4 related to these serious skin reactions.
Before starting treatment with Ivergalen, inform your doctor about all your medical history. Tell your doctor:
- if you have a weakened immune system (immune disorder)
- if you live or have lived in areas of Africa where there are cases of human parasitic infestation with the filarial parasite Loa loa, also known as the eye worm.
- if you currently live or have lived in areas of Africa.
Combining ivermectin with diethylcarbamazine citrate (DEC) to treat a concurrent Onchocerca volvulus infection may increase the risk of experiencing side effects, which may sometimes be severe.
If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before taking Ivergalen.
Ivergalen is not indicated for the prevention of tropical parasitic infestations. It is not effective against adult parasitic worms and should only be used following a doctor's recommendation when parasitic infestation has been confirmed or strongly suspected.
Children
The safety of Ivergalen has not been evaluated in children weighing less than 15 kg.
Elderly patients
Clinical studies with ivermectin did not include a sufficient number of subjects aged 65 years and older to determine whether they respond differently from younger subjects. However, in clinical practice, no differences in response between elderly and younger patients have been identified. In general, caution should be exercised when treating elderly patients, taking into account the higher frequency of impaired hepatic, renal, and cardiac function, as well as concomitant diseases or other medicinal treatments.
Other medicines and Ivergalen
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In general, you should consult your doctor or pharmacist before taking any medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Ivermectin is excreted in breast milk.
Driving and using machines
The effect of Ivergalen on the ability to drive or use machines has not been studied. It cannot be ruled out that some patients may experience side effects such as dizziness, somnolence, vertigo, and tremor, which could affect their ability to drive or use machines. If you experience such symptoms, avoid driving or operating machinery.
3. How to take Ivergalen
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Treatment of intestinal strongyloidiasis (angiostrongylosis)
The recommended dose is 200 micrograms of ivermectin per kg of body weight, taken orally as a single dose.
The guide for determining the dose according to the patient's body weight is as follows:
BODY WEIGHT (kg) | DOSE (number of 3 mg tablets) |
From 15 to 24 | one |
From 25 to 35 | two |
From 36 to 50 | three |
From 51 to 65 | four |
From 66 to 79 | five |
≥ 80 | six |
Treatment of microfilaria caused by Wuchereria bancrofti (lymphatic filariasis)
The recommended dosage for mass treatment of microfilaria caused by Wuchereria bancrofti is 150 to 200 micrograms per kg of body weight as a single dose every 6 months.
In endemic areas where treatment can only be administered once every 12 months, the recommended dosage to maintain adequate suppression of microfilaria is 300 to 400 micrograms per kg of body weight.
The following is the dosing guide based on the patient's body weight:
BODY WEIGHT (kg) | DOSE administered every 6 months (number of 3 mg tablets) | DOSE administered every 12 months (number of 3 mg tablets) |
From 15 to 25 | one | two |
From 26 to 44 | two | four |
From 45 to 64 | three | six |
From 65 to 84 | four | eight |
Alternatively, when it is not possible to determine weight, the ivermectin dose for mass treatment campaigns may be determined based on the patient's height as follows:
HEIGHT (cm) | DOSE administered every 6 months (number of 3 mg tablets) | DOSE administered every 12 months (number of 3 mg tablets) |
90 to 119 | one | two |
120 to 140 | two | four |
141 to 158 | three | six |
>158 | four | eight |
Treatment of scabies in humans
- Take a dose of 200 micrograms per kilogram of body weight.
- It will take 4 weeks before you know whether the treatment has been effective.
- Your doctor may consider a second dose necessary after 8 to 15 days.
What else you should keep in mind when receiving treatment for scabies
All persons who have had contact with you, especially family members and sexual partners, should see a doctor as soon as possible. The doctor will decide whether these individuals also require treatment. If the contacted persons are infected and do not receive immediate treatment, there is a risk that they could re-infect you.
You must follow certain hygiene measures to prevent reinfestation (e.g., keeping fingernails short and clean) and comply with official recommendations regarding the cleaning of clothing and bed linens.
Consult your doctor or pharmacist if you feel that the effect of Ivergalen is too strong or too weak.
Instructions for use
The tablets are for oral use.
Always follow the dosage prescribed by your doctor. In case of doubt, consult your doctor or pharmacist.
In children under 6 years of age, the tablets should be crushed before swallowing.
The treatment consists of a single dose. The prescribed number of tablets must be taken at once. The tablets should be taken with some water and on an empty stomach. Do not eat anything for two hours before or after taking this medicine, as it is unknown whether this could affect its absorption.
If you take more Ivergalen than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Ivergalen
Always follow your doctor's instructions. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The adverse effects of this medicine are usually not serious and do not last long. They are more likely to occur in people infected with multiple parasites, especially the parasite "Loa loa". The following adverse effects may occur with this medicine:
Allergic reactions
If you experience an allergic reaction, seek medical attention immediately. Signs may include:
- sudden fever
- sudden skin reactions (such as rash or itching) or other serious skin reactions
- difficulty breathing
Seek medical advice immediately if you notice any of the adverse effects listed above.
Other adverse effects
- liver disease (acute hepatitis)
- changes in certain laboratory tests (elevated liver enzymes, increased blood bilirubin, increased eosinophils)
- blood in the urine
- decreased level of consciousness, including coma
The following adverse effects depend on the reason for taking Ivergalen, as well as whether you have any other infections.
People with intestinal strongyloidiasis (threadworm infection) may experience the following adverse effects:
- unusual weakness
- loss of appetite, stomach pain, constipation, or diarrhea
- nausea or vomiting
- drowsiness or dizziness
- chills or shivering
- decrease in white blood cell count (leukopenia)
- decrease in red blood cells or in the red pigment of the blood called hemoglobin (anemia)
Additionally, adult roundworms may be found in the stools in intestinal strongyloidiasis (threadworm infection).
People with microfilaremia due to lymphatic filariasis caused by Wuchereria bancrofti may experience the following adverse effects:
- sweating or fever
- headache
- unusual weakness
- muscle, joint, and general body aches
- loss of appetite, nausea
- stomach pain (abdominal and epigastric pain)
- cough and sore throat
- breathing discomfort
- low blood pressure upon standing, which may cause dizziness or lightheadedness
- chills
- dizziness
- pain or discomfort in the testicle
People with scabies may experience the following adverse effect:
- itching (pruritus) may worsen at the beginning of treatment. This usually does not last long.
People infected with the worm "Loa loa" may experience the following adverse effects:
- altered normal brain function
- neck or back pain
- bleeding in the white part of the eye (also known as red eye)
- shortness of breath
- loss of bladder or bowel control
- difficulty standing or walking
- changes in mental state
- drowsiness or confusion
- unresponsiveness to others or coma
People infected with the worm "Onchocerca volvulus" causing onchocerciasis may experience the following adverse effects:
- itching or skin rash
- joint or muscle pain
- fever
- nausea or vomiting
- swelling of the 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 of tiredness
- changes in vision and other eye problems such as infection, redness, or unusual sensations
- bleeding in the white part of the eye or swelling of the eyelids
- asthma may worsen
Stop taking ivermectin and seek immediate medical help if you experience any of the following symptoms:
- flat red spots, or circular or coin-shaped spots on the chest, often with central blisters, skin peeling, mouth ulcers, or ulcers in the throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Reporting of adverse effects
If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ivergalen
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.
Do not store above 25 °C.
Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the
6. Contents of the pack and other information
Composition of Ivergalen
- The active substance is ivermectin. Each tablet contains 3 mg of ivermectin.
- The other components are microcrystalline cellulose (E 460), pregelatinized corn starch, butylhydroxyanisole (E 320), magnesium stearate (E 470b).
Appearance of the product and contents of the pack
This medicine is presented as a round, white or almost white, flat, bevelled tablet.
Pack sizes of 4, 8, 10, 12, 16 and 20 tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Galenicum Derma, S.L.U.
Ctra. N-1, Km 36,
28750 San Agustín del Guadalix (Madrid)
Spain
Manufacturer:
EUROPEENNE DE PHARMACOTECHNIE - EUROPHARTECH
Rue Henri Matisse
63370 Lempdes - France
This medicinal product is authorized in EEA Member States under the following names:
Netherlands | Ivergalen 3 mg tablets |
Spain | Ivergalen 3 mg tablets EFG |
This patient information leaflet was last reviewed in: May 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/