Ivertilene 3 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ivertilene 3 mg tablets EFG

ivermectin

Read the 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Ivertilene is and what it is used for

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

It is used to treat:

• An intestinal infection called strongyloidiasis (threadworm infection), caused by a type of roundworm called Strongyloides stercoralis.
• A blood infection called microfilaraemia due to lymphatic filariasis. This is a condition caused by the larval stage of Wuchereria bancrofti. Ivermectin is not effective against adult worms, only against the larvae.
• Scabies (skin mites). This occurs when tiny mites burrow under the skin, which can cause intense itching. This medicine should only be taken when your doctor confirms or suspects that you have scabies.

Ivermectin does not prevent you from getting these infections. It is not effective against adult worms. Ivermectin should only be taken when your doctor confirms or suspects that you have a parasitic infection.

2. What you need to know before taking Ivertilene

Do not take Ivertilene:

• 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 rash, difficulty breathing, or fever.
• If you have ever had a severe skin rash, peeling skin, blisters, or mouth sores after taking ivermectin.

Warnings and precautions

Talk to your doctor before starting ivermectin:

• Serious 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.
• If you have a weakened immune system.
• 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 "eye worm".

Concomitant use of diethylcarbamazine citrate (DEC) with ivermectin for the treatment of a concurrent infection with "Onchocerca volvulus" (causing "river blindness") may increase the risk of experiencing side effects, which can sometimes be serious.

Children

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

Other medicines and Ivertilene

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist 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, somnolence, tremors, or sensation of spinning. If you experience these symptoms, do not drive or operate machinery.

3. How to take Ivertilene

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

Method of administration

• The tablets are taken orally.
• In children under 6 years of age, the tablets should be split before swallowing.
• The tablets should be taken with water and on an empty stomach.
• Do not consume any food during the two 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 consists of a single dose.
• Your doctor will tell you how many tablets you should take.
• The prescribed number of tablets should be taken at the same time.
• The dose will depend on your condition, weight, and height.

For intestinal infection called gastrointestinal strongyloidiasis (threadworm infection)

• The recommended dose based on body weight is:

For blood infection called "microfilaremia" caused by lymphatic filariasis

• The recommended dose based on body weight is:

• Administered every 6 months or every 12 months.
• As an alternative when it is not possible to determine the patient's weight, the ivermectin dose can be determined from the patient's height as follows:

For skin mites (Scabies)

• 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 whether to administer a second dose at 8–15 days.

If you take more Ivertilene than you should

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

Cases of decreased level of consciousness and coma have been reported in patients who took excessive ivermectin.

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 Ivertilene

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

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 can cause adverse effects, although not everyone will experience them.

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

The following adverse effects may occur with this medicine:

Allergic reactions

If you experience an allergic reaction, seek medical attention immediately. Symptoms may include:

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

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

Red, non-elevated spots, or circular or coin-shaped lesions on the chest, often with central blisters, skin peeling, or ulcers in the mouth, throat, nose, genitals, or eyes. 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).
• Changes in the results of certain laboratory tests (increased liver enzymes, increased blood bilirubin, increased eosinophils).
• Blood in the urine.
• Decreased level of consciousness, including coma.

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

Individuals with a gastrointestinal infection called “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.
• Shaking or tremors.
• Adult worms may be detected in the stools.

Individuals with a blood infection called “microfilaraemia” caused by lymphatic filariasis may experience the following adverse effects:

• Sweating or fever.
• Headache.
• Unusual weakness.
• Muscle pain, joint pain, or generalized body aches.
• Loss of appetite, nausea.
• Stomach pain (abdominal or epigastric pain).
• Cough or sore throat.
• Breathing discomfort.
• Low blood pressure upon standing (you may feel dizzy or lightheaded).
• Chills.
• Dizziness.
• Pain or discomfort in the testicle.

Individuals with skin mites (scabies) may experience the following adverse effects:

• Possible worsening of itching (pruritus) at the beginning of treatment, which usually does not last long.

Individuals with a severe infection by the worm “Loa loa” may experience the following adverse effects:

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

Individuals infected with the worm “Onchocerca volvulus” (which causes “river blindness”) may experience the following adverse 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 lightheaded upon standing.
• Increased heart rate.
• Headache or fatigue.
• Changes in vision and other vision problems such as infection, redness, or unusual sensations.
• Bleeding in the eyes or swelling of the eyelids.
• Worsening of asthma.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 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 it from light.

PVC/PVDC blister:

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. 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 components are microcrystalline cellulose (E460), magnesium stearate (E470b), butylated hydroxyanisole (E320), anhydrous citric acid (E330), anhydrous colloidal silica (E551), and pregelatinized corn starch (E1422).

Appearance of the product and contents of the pack

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

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

Only certain 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 14

3566 17 Vysoké Mýto

Czech Republic

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

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

Date of the last revision of this leaflet: September 2024.

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).