Patient Information Leaflet: Ivercare 3 mg EFG Tablets

Ivercare 3 mg tablets EFG

Read this 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. Do not pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Ivercare is and what it is used for

2. What you need to know before using Ivercare

3. How to use Ivercare

4. Possible side effects

5. Storage of Ivercare

6. Contents of the pack and additional information

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

It is used to treat:

• Intestinal infection known as strongyloidiasis (angiostrongyliasis), caused by a type of nematode calledStrongyloides stercoralis.
• Blood infection known as microfilaremia due to lymphatic filariasis. It is an infection caused by a larva calledWuchereria 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 useIvercare

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.

If you have ever had a severe skin rash or skin peeling, blisters, or sores in your mouth after taking ivermectin.

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

Do not use this medication if you are in any of the above situations. If you are unsure, consult your doctor or pharmacist before starting to use this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

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 your treatment with this medication, inform your doctor about your complete medical history. Inform your doctor:

• If you have a weakened immune system (immunodeficiency).
• If 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 the eye worm.
• If you live in Africa currently or have lived there.

The simultaneous use of diethylcarbamazine (DEC) for the treatment of a concomitant infection with Onchocerca volvulus may increase the risk of experiencing side effects, which may be severe in some cases.

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

This medication 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 this medication has not been evaluated in children weighing less than 15 kg. For more information, see section 3.

Older people

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 patients and younger patients. Generally, treatment of an older patient 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 Ivercare

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication.

Pregnancy

Do not take this medication unless your doctor tells you to.

Breastfeeding

This medication is excreted in breast milk.

If you are breastfeeding, inform your doctor and do not use this treatment unless your doctor tells you to.

Consult your doctor or pharmacist before taking any medication.

Fertility

This medication has no adverse effect on fertility in rats when applying a dose three times higher than the maximum recommended for humans, 200 μg/kg (with a frequency of mg/m2/d).

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery has not been studied. In some patients, it cannot be ruled out that they may experience side effects such as dizziness, drowsiness, tremors, or a sensation of spinning, which may affect the ability to drive and 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 gastrointestinal strongyloidiasis (angiostrongyliasis)

The recommended dose is 200 μg of ivermectin per kg of body weight, administered orally in a single dose.

As a guide, the dose according to body weight is:

BODY WEIGHT (kg) DOSAGE (number of 3 mg tablets)

15 to 24one

25 to 35two

36 to 50three

51 to 65four

66 to 79five

≥ 80six

Treatment of microfilaria caused byWuchereria bancrofti(lymphatic filariasis)

The recommended dose in mass treatment campaigns for microfilaria caused byWuchereria bancrofti(lymphatic filariasis) is between 150 and 200 μg of ivermectin per kg of body weight, administered orally in a single dose every 6 months.

In endemic areas where treatment can only be administered once every 12 months, the recommended dose is between 300 and 400 μg per kg of body weight to maintain adequate inhibition of microfilaria in treated patients.

As a guide, the dose according to body weight is:

Alternatively, in cases where it is not possible to determine the weight, the dose of ivermectin for administration in mass treatment campaigns can be determined from the patient's height as follows:

Treatment of human scabies

Other aspects to consider when receiving scabies treatment

Anyone in contact with you, especially your partner or family members, should see your doctor as soon as possible. The doctor will determine if these people should also receive treatment. If infected people with whom you maintain contact do not receive immediate treatment, there is a risk that they may infect you again.

You should take hygiene measures to prevent a new infection (for example, keep your fingernails short and clean) and follow official recommendations for cleaning clothing and bedding.

If you consider that the effect of this medicationis too strong or too weak, consult your doctor or pharmacist.

Administration form

The tablets are administered orally.

Always follow the dose indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

In children under 6 years, the tablets must be broken before swallowing.

The treatment consists of a single dose. The number of tablets prescribed should be taken at the same time, as a single dose. 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 medication, as the effect of food on the absorption of the medication in the body is unknown.

If you take moreIvercarethan 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 forgot to takeIvercare

Always follow your doctor's instructions. Do not take a double dose to compensate for the missed dose. If you have any other questions about the use of this medication, consult your doctor or pharmacist.

Like all medicines, this medicine can 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.

Reactions to Allergies

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

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

Other Adverse Effects

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 a severe infection caused by the wormLoa loamay experience the following adverse effects:

• Abnormal brain activity
• • Neck or back pain
  • Eye hemorrhages (or red eyes)
  • Difficulty breathing
  • Loss of bladder control
  • Difficulty standing or walking
  • Mental state changes
  • Sensation of drowsiness or confusion
  • Lack of response to others or coma

People infected with the wormOnchocerca volvulus, which causes onchocerciasis, may experience 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). You may feel dizzy or lightheaded when standing up
  • 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 eyelid swelling
  • Worsening of asthma

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

• Exceptional weakness
• • Loss of appetite, stomach pain, constipation, or diarrhea
  • Nausea or vomiting
  • Sensation of drowsiness or dizziness
  • Tremors or shivering
  • Decreased white blood cell count (leukopenia)
  • Decreased red blood cell count or hemoglobin (anemia), red blood pigment.

In the case of strongyloidiasis (angiostrongyliasis), it is also possible to detect adult worms in the stool.

People with lymphatic filariasis caused byWuchereria bancrofti, which may cause microfilaremia, may experience the following adverse effects:

People with scabies may experience the following adverse effects:

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

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, mouth ulcers, throat, nose, genital, or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting Adverse Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this prospectus. You can also report side effects directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: 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 after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofIvercare

Each tablet contains 3mg of ivermectin.

Cellulose, microcrystalline (E460), pregelatinized cornstarch, citric acid (E330), butylhydroxyanisole (E320), and magnesium stearate (E470b).

Appearance of the product and contents of the packaging

This medication is presented in the form of round white tablets without markings, in packaging of 4, 10, or 20 tablets.

The blisters are packaged in a folding cardboard box.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Industrial Farmacéutica Cantabria S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

Responsible for manufacturing

Laboratorios Liconsa S.A.

Avda. Miralcampo, Nº 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

This leaflet was last reviewed in: April 2023

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