Product Information for the User

Ivergalen 3 mg TabletsEFG

Ivermectin

Read this entire leaflet carefully before you start taking this medicine, because 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Ivergalen is and what it is used for

2.What you need to know before you start taking Ivergalen

3.How to take Ivergalen

4.Possible side effects

5.Storage of Ivergalen

6.Contents of the pack and additional information

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

It is used to treat:

• an intestinal infection called strongyloidiasis (angiostrongyliasis). This infection is caused by a roundworm called «Strongyloides stercoralis».
• a blood infection called microfilaria by «Wuchereria bancrofti». This is caused by an immature worm. Ivergalen is not effective against adult worms, only against immature worms.
• skin mites (scabies). This occurs when tiny mites penetrate under the skin. It can produce intense itching. Ivergalen should only be taken when the doctor thinksor has confirmed that you have scabies.

Ivergalen will not prevent you from developing any of these infections.It does not work against adult worms.

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

Do not take Ivergalen

• If you are allergic to ivermectin or any of the other components of this medication (listed in section6). The signs of a drug allergy reaction may include skin rash, difficulty breathing, or fever.
• If you have ever experienced a severe skin rash or peeling of the skin, blisters, or mouth sores after taking ivermectin

In general, if after taking any medication you experience unusual symptoms that appear suddenly, such as skin rash, hives, or fever, you can assume that you are allergic to the medication.

Do not take Ivergalen if the above applies to your case. In case of doubt, consult your doctor or pharmacist before taking Ivergalen.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ivergalen.

Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been associated with ivermectin treatment. Stop taking ivermectin and seek medical attention immediately if you observe 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:

• If you have a weakened immune system (immunity disorder)
• If you live or have lived in parts of Africa where there are cases of human parasitic infestation with the Loa loa parasite, also known as eye worm.Loa loa
• If you currently live or have lived in parts of Africa.

The combined use with diethylcarbamazine citrate (DEC) to treat a concomitant infection with Onchocerca volvulus may increase the risk of experiencing side effects that, in some cases, can be severe.

If any of the above applies to your case (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 can only be used after a doctor's recommendation when parasitic infestation is confirmed or strongly suspected.

Children

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

Older adults

Clinical studies with ivermectin did not include a sufficient number of subjects aged 65 years and older to determine if they respond differently to younger subjects. However, in clinical practice, no differences have been identified between the response of older adults and younger patients.In general, extreme caution should be exercised in the treatment of older adults, taking into account the higher frequency of liver, renal, and cardiac function deterioration, as well as concomitant disease or other pharmacological treatments.

Other medications and Ivergalen

Inform your doctor or pharmacist if you are taking/using, have taken/used recently, or may need to take/use any other medication.

In general, you should consult your doctor or pharmacist before taking any medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Ivergalen is excreted in breast milk.

Driving and operating machinery

The effect of Ivergalen on the ability to drive or operate machinery has not been studied. You cannot rule out the possibility that some patients may experience side effects such as dizziness, somnolence, vertigo, and tremors, which may affect your ability to drive or operate machinery. If you experience these symptoms, avoid driving or operating machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Treatment of intestinal strongyloidiasis (angiostrongyliasis)

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

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

Treatment of microfilaria caused byWuchereria bancrofti(lymphatic filariasis)

The recommended dosage for the collective treatment of microfilaria caused by Wuchereria bancrofti is 150 to 200 micrograms per kilogram 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 for maintaining adequate suppression of microfilaria is 300 to 400 micrograms per kilogram of body weight.

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

Alternatively, when it is not possible to determine the patient's 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 at 8 to 15 days.

What else you should consider when receiving treatment for scabies

All people who come into contact with you, especially family members and partners, must visit a doctor as soon as possible. The doctor will decide if these people also need to receive treatment. If the people in contact are infected and do not receive treatment immediately, 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 comply with official recommendations for cleaning clothing and bedding.

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

Administration form

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 old, the tablets must be crushed before swallowing.

The treatment consists of a single dose. The number of tablets prescribed must be taken at once. The tablets must be taken with some water and with an empty stomach. Do not eat anything in the two hours before or after taking this medication, 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 Toxicological Information Service, phone: 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 compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects of this medicine are usually not serious and do not last long. It is 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, seek medical attention immediately. The signs may include:

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

Seek medical attention 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 the blood, increase in eosinophils)
• blood in the urine

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

People with intestinal strongyloidiasis (angiostrongyliasis)may experience the following side effects:

• unusual feeling of 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 (leucopenia)
• decrease in the amount of red blood cells or the red pigment in the blood called hemoglobin (anemia)

Additionally, in intestinal strongyloidosis (angiostrongyliasis), roundworms may be found in the stool.

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

• sweating or fever
• headache
• unusual feeling of weakness
• muscle, joint, and general body pains
• loss of appetite, nausea
• stomach pain (abdominal and epigastric pain)
• cough and sore throat
• difficulty breathing
• low blood pressure when standing up or standing, may feel dizzy or disoriented
• chills
• dizziness
• testicular pain or discomfort

People with scabiesmay experience the following side effects:

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

People infected with the worm «Loa loa»may 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 bladder or bowel control
• difficulty standing or walking
• mental changes
• feeling drowsy or confused
• lack of response to others or coma

People infected with the worm «Onchocerca volvulus» 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). May feel dizzy or disoriented when standing up.
• 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 eyes or swelling of the eyelids
• asthma may worsen

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

• flat, red, non-elevated patches, or circular or coin-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may 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 side effects that do not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store above 25 °C.

Store in the original packaging to protect from light.

Medicines should not be disposed of through drainsor in the trash. Dispose of packaging and medications you no longer need at thepharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ivergalen

•The active ingredient is ivermectin. Each tablet contains 3 mg of ivermectin.

•The other components are microcrystalline cellulose (E 460), pregelatinized cornstarch, butylhydroxyanisole (E 320), magnesium stearate (E 470b).

Appearance of the product and contents of the packaging

This medication is presented as a round, white or almost white, flat and beveled tablet.

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

It may only be marketed in some sizes of packaging.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

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 EEE member states under the following names:

This prospectus has been approved in: December 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/