IVERGALEN 3 mg TABLETS

Introduction

Package Leaflet: Information for the User

Ivergalen 3 mg tabletsEFG

Ivermectin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Ivergalen and what is it used for
2. What you need to know before you take Ivergalen
3. How to take Ivergalen
4. Possible side effects
5. Storing Ivergalen
6. Contents of the pack and other information

1. What is Ivergalen and what is it used for

Ivergalen contains ivermectin, a medicine used to treat infections caused by some parasites.

It is used to treat:

• an infection in the intestine called strongyloidosis (anguilulosis). This infection is caused by a roundworm called Strongyloides stercoralis.
• a blood infection called microfilaremia due to lymphatic filariasis. It is caused by an immature worm called Wuchereria bancrofti. Ivergalen is not effective against adult worms, only against immature worms.
• scabies (skin mites). It 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 does not work against adult parasites.

Ivergalen should only be taken when your doctor has confirmed or thinks you have a parasitic infection.

2. What you need to know before you take Ivergalen

Do not take Ivergalen

In general, if after taking any medicine you experience unusual symptoms of sudden onset such as a skin rash, hives or fever, you may assume that you are allergic to that medicine.

Do not take Ivergalen if any of the above applies to you. If in doubt, consult your doctor or pharmacist before taking Ivergalen.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Ivergalen.

Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with ivermectin treatment. Stop taking ivermectin and seek medical attention immediately if you notice any of the symptoms described in section 4 related to these severe skin reactions.

Before starting treatment with Ivergalen, inform your doctor about all your medical history. Inform your doctor:

Loa loa, also known as the eye worm.

The combined use with diethylcarbamazine citrate (DEC) to treat a concomitant infection with Onchocerca volvulusmay increase the risk of experiencing side effects that can sometimes be serious.

If any of the above applies to you (or you are not sure), 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 can only be used after a doctor's recommendation when parasitic infestation is confirmed or strongly suspected.

Children

The safety of using Ivergalen in children weighing less than 15 kg has not been evaluated.

Elderly patients

Clinical studies with ivermectin did not include a sufficient number of subjects aged 65 and over to determine whether they respond differently to younger subjects. However, in clinical practice, no differences have been identified between the response of elderly patients and younger patients. 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 disease or other pharmacological treatments.

Other medicines and Ivergalen

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Ivergalen 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 excluded that some patients may experience side effects such as dizziness, drowsiness, vertigo, and tremors that may affect their ability to drive or use machines. If you experience these symptoms, avoid driving or using machines.

3. How to take Ivergalen

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Treatment of intestinal strongyloidosis (anguilulosis)

The recommended dose is 200 micrograms of ivermectin per kg of body weight, taken orally in a single dose.

The guide to determine the dose based on the patient's weight would be as follows:

Treatment of microfilaremia caused by Wuchereria bancrofti(lymphatic filariasis)

The recommended dosage in the collective treatment of microfilaremia caused by Wuchereria bancroftiis 150 to 200 micrograms per kg of body weight in 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 microfilaremia is 300 to 400 micrograms per kg of body weight

The guide to determine the dose based on the patient's weight would be as follows:

Alternatively, when it is not possible to determine the weight, the dose of ivermectin for collective treatment campaigns can be determined based on the patient's height as follows:

Treatment of scabies in humans

• Take a dose of 200 micrograms per kilogram of body weight.
• For 4 weeks, you will not know if the treatment has been effective.
• Your doctor may consider a second dose necessary 8 to 15 days later.

What else you should consider when receiving treatment for scabies

All people who come into contact with you, especially family members and partners, should see a doctor as soon as possible. The doctor will decide if these people should also receive treatment. If the people in contact are infected and do not receive immediate treatment, there is a risk that they may re-infect you.

You should follow certain hygiene measures to prevent re-infection (e.g., keep your nails short and clean) and follow official recommendations regarding the cleaning of clothing and bedding.

Consult your doctor or pharmacist if you think the effect of Ivergalen is too strong or too weak.

Method of administration

The tablets are for oral use.

Always follow the dosage indicated 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 number of tablets prescribed should be taken at once. The tablets should be taken with some water and on an empty stomach. Do not eat anything in the 2 hours before or after taking this medicine, as it is not known if this could affect its absorption.

If you take more Ivergalen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ivergalen

Always follow the instructions of your doctor. Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects of this medicine are usually not serious and do not last long. They are more likely to occur in people infected with several parasites, especially the parasite Loa loa. The following side effects may occur with this medicine:

Allergic reactions

If you experience an allergic reaction, see a doctor immediately. The signs may include:

• sudden fever
• sudden skin reactions (such as skin rash or itching) or other severe skin reactions.
• difficulty breathing

Consult a doctor immediately if you notice any of the above side effects.

Other side effects

• liver disease (acute hepatitis)
• alteration of some laboratory tests (increase in liver enzymes, increase in bilirubin in blood, increase in eosinophils)
• blood in the urine
• decreased alertness, including coma.

The following side effects depend on the reason why you are taking Ivergalen. They also depend on whether you have any other infection.

People with intestinal strongyloidosis (anguilulosis)may experience the following side effects:

• unusual weakness
• loss of appetite, stomach pain, constipation or diarrhea
• nausea or vomiting
• drowsiness or dizziness
• chills or tremors
• decrease in the number of white blood cells (leukopenia)
• decrease in the number of red blood cells or the red pigment in the blood called hemoglobin (anemia)

Also, in intestinal strongyloidosis (anguilulosis), adult roundworms may be found in the stool.

People with microfilaremia due to lymphatic filariasis caused by Wuchereria bancroftimay experience the following side effects:

• sweating or fever
• headache
• unusual weakness
• muscle, joint, and general body pain
• loss of appetite, nausea
• stomach pain (abdominal and epigastric pain)
• cough and sore throat
• breathing difficulties
• low blood pressure when standing up or standing, you may feel dizzy or faint
• chills
• dizziness
• pain or discomfort in the testicle

People with scabiesmay experience the following side effects:

• itching (pruritus) may worsen at the start of treatment. It usually does not last long.

People with Loa loaworm infectionmay experience the following side effects:

• alteration of normal brain function
• neck or back pain
• bleeding in the white of the eyes (also known as red eye)

• shortness of breath
• loss of control of the bladder or intestines
• difficulty standing or walking
• changes in mental state
• feeling of drowsiness or confusion
• lack of response to other people or coma

People infected with the Onchocerca volvulusworm that causes onchocerciasismay experience the following side effects:

• itching or skin rash
• joint or muscle pain
• fever
• nausea or vomiting
• swelling of the lymph nodes
• swelling, especially of the hands, ankles, or feet
• diarrhea
• dizziness
• low blood pressure (hypotension). You may feel dizzy or faint when standing up.
• 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 of the eyes or swelling of the eyelids
• asthma may worsen

Stop taking ivermectin and seek medical help immediately if you notice any of the following symptoms:

• red patches, or circular or coin-shaped patches on the chest, often with central blisters, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting of side effects

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Ivergalen

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 carton. The expiry date refers to the last day of the month shown.

Do not store above 25°C.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to your pharmacist. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicine. This will help protect the environment.

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 ingredients 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, and beveled tablet.

Pack of 4, 8, 10, 12, 16, and 20 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Galenicum Derma, S.L.

Ctra. N-1, Km 36,

28750 San Agustín de Guadalix (Madrid)

Spain

Manufacturer:

EUROPEENNE DE PHARMACOTECHNIE - EUROPHARTECH

Rue Henri Matisse

63370 Lempdes - France

This pharmaceutical product is authorized in the EEA Member States under the following names:

This leaflet was last revised in: May 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/