IVERTILENE 3 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Ivertilene 3 mg EFG Tablets

ivermectin

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

• Keep this package 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 Package Leaflet

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

1. What is Ivertilene and what is it used for

Ivertilene contains the active substance ivermectin. It is a type of medicine used to treat infections caused by some parasites.

It is used to treat:

• A gastrointestinal infectioncalled strongyloidiasis (anguilulosis), caused by a type of nematode called Strongyloides stercoralis.
• A blood infectioncalled microfilaremia due to lymphatic filariasis. It is a condition caused by a larva called Wuchereria bancrofti. Ivermectin does not act against adult worms, only against larvae.
• Scabies (skin mites). It occurs when tiny mites are introduced under the skin. This can cause intense itching. This medicine should only be taken when your doctor checks or believes you have scabies.

Ivermectin does not prevent you from getting these infections. It does not act against adult worms. Ivermectin should only be taken when your doctor checks or believes you have a parasitic infection.

2. What you need to know before you take Ivertilene

Do not take Ivertilene:

• If you are allergicto 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 a skin rash, difficulty breathing, or fever.
• If you have ever suffered from a severe skin rash, skin peeling, blisters, or ulcers in the mouth after taking ivermectin.

Warnings and precautions

Consult your doctor before starting to take ivermectina:

• Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported 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.
• If you have a weakened immune system.
• If you live or have lived in an area of Africawhere there are cases of human parasitic infestation with the filarial parasite "Loa loa", also known as "eye worm".

The simultaneous use of diethylcarbamazine citrate (DEC) with ivermectin for the treatment of a concomitant infection with "Onchocerca volvulus" (causing "river blindness") may increase the risk of experiencing side effects that can sometimes be serious.

Children

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

Other medicines and Ivertilene

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

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.

If you are pregnant, do not take this medicine unless your doctor tells you to.

Ivermectin is excreted in breast milk. Your doctor may decide to start your treatment one week after the birth of your child.

Driving and using machines

After taking ivermectin, you may experience side effects such as dizziness, drowsiness, tremors, or a feeling of spinning. If you experience these symptoms, do not drive or use machines.

3. How to take Ivertilene

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Method of administration

• The tablets are administered orally.
• In children under 6 years of age, the tablets should be broken before swallowing.
• The tablets should be taken with water and on an empty stomach.
• Do not consume any food during the 2 hours before or after taking the medicine, as the influence of food on the absorption of the medicine in the body is unknown.

How many tablets to take

• The treatment is a single dose.
• Your doctor will indicate how many tablets you should take.
• The number of prescribed tablets should be taken at the same time.
• The dose will depend on your disease, weight, and height.

For a gastrointestinal infection called strongyloidiasis (anguilulosis)

• The recommended dose based on body weight is:

For a blood infection called "microfilaremia" caused by lymphatic filariasis

• The recommended dose based on body weight is:

• Administered every 6 months or every 12 months.
• Alternatively, if it is not possible to determine the weight, the dose of ivermectin can be determined based on the patient's height as follows:

For scabies (skin mites)

• Your doctor will prescribe a dose of 200 micrograms per kilogram of body weight.
• You will not notice improvement until 4 weeks after treatment.
• Your doctor may decide to administer a second dose 8-15 days later.

If you take more Ivertilene than you should

If you take more ivermectin than you should, consult your doctor immediately.

There have been reports of decreased alertness and coma in patients who took more ivermectin than they should.

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

If you forget to take Ivertilene

Take the medication as soon as you remember. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

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

These side effects are usually not serious or long-lasting. They may be more likely in people infected with several parasites, especially in the case of the "Loa loa" worm.

The following side effects may occur with this medicine:

Allergic reactions

If you experience an allergic reaction, go to the doctor immediately. The symptoms can include:

• Sudden fever.
• Sudden skin reactions (such as rash or itching) or other severe skin reactions.
• Difficulty breathing.

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

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

Other side effects:

• Liver disease (acute hepatitis).
• Changes in the results of some laboratory tests (increased liver enzymes, increased bilirubin in the blood, increased eosinophils).
• Blood in the urine.
• Decreased alertness, including coma.

The following side effects will depend on the reason why you are taking this medicine, as well as whether you have any other infection.

People with a gastrointestinal infection called "strongyloidiasis" (anguilulosis)may experience the following side effects:

• Exceptional weakness.
• Lack of appetite, stomach pain, constipation, or diarrhea.
• Nausea or vomiting.
• Drowsiness or dizziness.
• Tremors.
• It is possible to detect adult worms in the stool.

People with a blood infection called "microfilaremia" caused by lymphatic filariasismay experience the following side effects:

• Sweating or fever.
• Headache.
• Exceptional weakness.
• Muscle, joint, or generalized body pain.
• Lack of appetite, nausea.
• Stomach pain (abdominal or epigastric pain).
• Cough or 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 scabies (skin mites)may experience the following side effects:

• Possible worsening of itching (pruritus) when starting treatment, which usually does not last long.

People with a severe infection with the "Loa loa" wormmay experience the following side effects:

• Abnormal brain activity.
• Neck or back pain.
• Bleeding in the eyes (red eyes).
• Breathing difficulties.
• Loss of bladder or bowel control.
• Difficulty standing or walking.
• Changes in mental status.
• Drowsiness or confusion.
• Lack of response to others or entry into a coma.

People infected with the "Onchocerca volvulus" worm (causing "river blindness")may experience the following side effects:

• Itching or rash.
• Muscle or joint 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 faint when standing up.
• Increased heart rate.
• Headache or fatigue.
• Changes in vision and other eye problems such as infection, redness, or unusual sensations.
• Bleeding in the eyes or swelling of the eyelids.
• Worsening of asthma.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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. Storage of Ivertilene

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

Aluminum/Aluminum Blister:

This medicine does not require any special storage temperature. Store in the original packaging to protect from light.

PVC/PVDC Blister:

Do not store above 25 °C. Store in the original packaging to protect from light.

Do not use this medicine after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ivertilene

• The active substance is ivermectin. Each tablet contains 3 mg of ivermectin.
• The other ingredients are microcrystalline cellulose (E460), magnesium stearate (E470b), butylhydroxyanisole (E320), anhydrous citric acid (E330), colloidal anhydrous silica (E551), and pregelatinized corn starch (E1422).

Appearance of the product and packaging contents

Ivertilene 3 mg EFG tablets are white or almost white, round tablets, approximately 5.60 mm in diameter, marked with "Y" on one face and "16" on the other face.

The tablets are available in cardboard boxes with blisters of 1, 4, 2x4, 6, 8, 10, 12, 16, or 20 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 1435

566 17 Vysoké Mýto

Czech Republic

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicine is authorized in the EEA member states under the following names:

Date of last revision of this leaflet:September 2024.

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