Package Insert: Information for the Patient

Ivermectin Teva 3 mg Tablets EFG

Read this package insert carefully before starting to take this medication, because

it contains important information for you.

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

- This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

It is used to treat:

• Intestinal infection called strongyloidiasis (angiostrongyliasis), caused by a type of nematode called “Strongyloides stercoralis”.
• Blood infection called microfilaremia due to a “lymphatic filariasis”. It is an illness 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 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.

Do not takeIvermectina Teva

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

Do not take this medication if you are in any of the above situations. 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 Ivermectina Teva.

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

• You have a weakened immune system.
• You live or have lived in any area in Africa where there are cases of human parasitic infestation with the Loa loa parasite, also known as eye worm.
• You live in Africa currently or have lived in Africa.
• You live or have lived in African areas. The use of diethylcarbamazine citrate (DEC) if you are infected with “Onchocerca volvulus” may increase the risk of side effects, which can sometimes be severe.

If any of the above applies to your case (or you are unsure), consult your doctor or pharmacist before taking this medication.

Children

The safety of this medication has not been evaluated in children weighing less than 15 kg.

Older adults

Studies conducted with this medication have not included sufficient patients aged 65 years or older to determine if their response is different from that of younger patients. Other clinical trials have not identified differences when comparing the response of older adults and younger patients. Generally, treatment of an older adult should be cautious and take into account that in this age range there is a higher incidence of liver, kidney, or heart insufficiencies, as well as diseases and concomitant pharmacological treatments.

Other medications and Ivermectina Teva

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

Pregnancy andbreastfeeding

• 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 breastfeeding or intend to breastfeed. This is because ivermectin passes into breast milk. Your doctor may decide to start your treatment a week after your child's birth.

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

Driving and operating machinery

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

Taking this medication

• Take this medication orally.
• For children under 6 years, crush the tablets before swallowing.
• Take the number of tablets prescribed by your doctor at the same time with water and an empty stomach. Do not ingest any food within the two 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 often to take

The treatment is a single dose.

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

Gastrointestinal strongyloidiasis (angiostrongyliasis) treatment

The recommended dose is:

Microfilaria treatment 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 no scales are available, the dosage can be determined based on the patients' height, as follows:

Human scabies treatment

• 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.
• 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ivermectin Teva

Try to take Ivermectin as indicated by your doctor. Do not take a double dose to compensate for the missed doses.

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

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

These side effects are usually not serious or long-lasting. They may be more likely to occur in people infected with several parasites. Especially in the case of the wormLoa loa. The following side 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 hives or itching) or other severe skin reactions
• Difficulty breathing

Seek medical attention immediately if you notice any of these side effects.

Other side effects

• Liver disease (acute hepatitis)
• Changes in the results of some laboratory tests (elevated liver enzymes, elevated bilirubin in the blood, elevated eosinophils)
• Blood in the urine

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

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

• Feeling unusually weak
• Loss of appetite, stomach pain, constipation, or diarrhea
• Nausea or vomiting
• Feeling drowsy or dizzy
• Shakiness or tremors
• Decreased white blood cell count (leucopenia)
• Decreased red blood cell count or hemoglobin (anemia)

Additionally, in gastrointestinal strongyloidiasis (angiostrongyliasis), roundworm adults may be found in the stool.

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

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

People with scabiesmay experience 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 wormLoa loamay present the following adverse effects:

• Abnormal brain activity
• Neck or back pain
• Bleeding in the eyes (red eyes)
• Difficulty breathing
• Loss of bladder control
• Difficulty standing or walking
• Changes in mental state
• Sensation of drowsiness or confusion
• Lack of response to others or entering a coma

People infected with the wormOnchocerca volvulus, which causes onchocerciasismay present the following adverse effects:

• Itching or hives
• Muscle or joint pain
• Fever
• Nausea or vomiting
• Lymph node inflammation
• Swelling, especially in the hands, ankles, or feet
• Diarrhea
• Dizziness
• Low blood pressure (hypotension). May feel dizzy or disoriented when 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 type of adverse effect, consult your doctororpharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting adverse 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 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.

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

Composition of Ivermectina Teva

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

Appearance of the product and contents of the packaging

Ivermectina Teva are round, white tablets, marked with “A 300” on one face.

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

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva B.V.

Swensweg 5,

2031 GA Haarlem,

Netherlands

Responsible for manufacturing

Coripharma ehf.

Reykjavikurvegur 78

IS-220 Hafnarfjordur

Iceland

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

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid (Spain)

Last review date of this leaflet: November 2022

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