IVERMECTIN TEVA 3 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Ivermectin Teva 3 mg Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, because it contains important information for you.

It is important to note that this medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Ivermectin Teva and what is it used for

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

It is used to treat:

• A intestinal infection called strongyloidiasis (anguilulosis), caused by a type of nematode called Strongyloides stercoralis.
• A blood infection called 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 the larvae.
• Scabies (skin mites). It occurs when tiny mites are introduced under the skin. This can cause intense itching. This medication should only be used when your doctor confirms or suspects that you have scabies.

This medication does not prevent you from contracting these infections. It does not act against adult worms.

This medication should only be used when your doctor confirms or suspects that you have a parasitic infection.

2. What you need to know before taking Ivermectin Teva

Do not take Ivermectin Teva

If you are allergic to ivermectin or any of the other ingredients of this medication (listed in section 6). The signs of an allergic reaction to a medication can include skin rash, difficulty breathing, or fever.

Do not take this medication if you are in any of the above cases. If you have doubts, consult your doctor or pharmacist before starting to take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ivermectin Teva.

In particular, consult your doctor or pharmacist before taking this medication if:

• You have a weakened immune system.
• You live or have lived in an area 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 in or have lived in Africa.
• You live or have spent time in African areas. The use of diethylcarbamazine citrate (DEC) if you are infected with Onchocerca volvulusmay increase the risk of side effects, which can sometimes be serious.

If any of the above applies to your case (or you are not sure), consult your doctor or pharmacist before taking this medication.

Children

The safety of using this medication in children under 15 kg in weight has not been evaluated.

Elderly

Clinical studies conducted with this medication have not included sufficient patients aged 65 or over to determine if their response is different from that of younger patients. Other clinical experimentation has not identified differences when comparing the response of elderly patients to that of younger patients. In general, the treatment of an elderly patient should be cautious and take into account that in this age group there is a higher incidence of liver, kidney, or heart failure, as well as concomitant diseases and pharmacological treatments.

Other medications and Ivermectin Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Pregnancy and breast-feeding

• Consult your doctor immediately before taking ivermectin if you are pregnant or may become pregnant. If you are pregnant, you should only take it if it is clearly necessary. You and your doctor will decide this.
• Talk to your doctor if you are breast-feeding or plan to breast-feed. This is because ivermectin passes into breast milk. Your doctor may decide to start your treatment one week after the birth of your child.

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

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

3. How to take Ivermectin Teva

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

Taking this medication

• Take this medication orally.
• For children under 6 years, crush the tablets before swallowing.
• Take the number of tablets that your doctor has prescribed at the same time with water and on an empty stomach. Do not eat any food within 2 hours before or after taking the tablets. This is because it is not known how food affects the way your body absorbs the medication.

How much to take

Treatment is a single dose.

• Take the number of tablets that your doctor has prescribed at the same time.
• The dose depends on your disease and your weight or height.
• Your doctor will tell you how many tablets to take.

Treatment of gastrointestinal strongyloidiasis (anguilulosis)

The recommended dose is:

Treatment of microfilaremia due to lymphatic filariasis caused by Wuchereria bancrofti

The recommended dose is:

This is repeated every 6 months or every 12 months.

Alternatively, and if scales are not available, the dosage can be determined based on the patient's height, as follows:

Treatment of human scabies

• Take a dose of 200 micrograms per kilogram of body weight.

This corresponds to:

• You will not know if the treatment has been completely successful until 4 weeks later.
• Your doctor may decide to administer a second single dose within 8 to 15 days.

If you think the effect of Ivermectin is too strong or too weak, consult your doctor or pharmacist.

If you take more Ivermectin Teva than you should

Consult your doctor or pharmacist immediately.

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 medication and the amount ingested.

If you forget to take Ivermectin Teva

Try to take Ivermectin following the instructions of your doctor. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone 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 loaworm. The following side effects may occur with this medication:

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 serious skin reactions
• Difficulty breathing

Go to the doctor immediately if you notice any of these side effects.

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

The side effects that appear below will depend on the reason why you are taking this medication, as well as whether you have any other infection.

People with gastrointestinal strongyloidiasis (anguilulosis)may have the following side effects:

• Feeling unusually weak
• Lack of appetite, stomach pain, constipation, or diarrhea
• Nausea or vomiting
• Feeling drowsy or dizzy
• Shakes or tremors
• A decrease in the number of white blood cells (leukopenia)
• A decrease in the number of red blood cells or the hemoglobin pigment of the blood (anemia).

Additionally, in gastrointestinal strongyloidiasis (anguilulosis), adult roundworms may be found in the stool.

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

• Sweating or fever
• Headache
• Feeling unusually weak
• Muscle, joint, and general body aches
• Lack of appetite, nausea
• Stomach pain (abdominal and epigastric pain)
• Cough or sore throat
• Discomfort when breathing
• Low blood pressure when standing up or getting up; you may feel dizzy or faint
• Chills
• Dizziness
• Pain or discomfort in the testicles.

People with scabiesmay have the following side effects:

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

People with a severe infection by the Loa loawormmay have the following side effects:

• Abnormal brain activity
• Neck or back pain
• Bleeding in the eyes (or red eyes)
• Difficulty breathing
• Loss of control of sphincters
• Difficulty standing or walking
• Changes in mental state
• Feeling drowsy or confused
• Lack of response to other people or entering a coma

People infected with the Onchocerca volvulusworm, which causes onchocerciasis, may have 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 vision problems such as infection, redness, or strange sensations
• Bleeding in the eyes or swelling of the eyelids
• Worsening of asthma

Reporting side effects

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

5. Storage of Ivermectin Teva

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 and blister after CAD or EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ivermectin Teva

• 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), anhydrous citric acid (E 330), and magnesium stearate (E 572)

Appearance of the product and contents of the pack

Ivermectin Teva are round, white tablets, marked with “A 300” on one side.

The tablets are available in aluminum strips of 1, 4, 6, 8, 10, 12, or 20 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031 GA Haarlem,

Netherlands

Manufacturer

Coripharma ehf.

Reykjavikurvegur 78

IS-220 Hafnarfjordur

Iceland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108, Madrid (Spain)

Date of the last revision of this package leaflet: November 2022

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