Ivercare 3 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ivercare 3 mg tablets EFG

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, ask 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ivercare is and what it is used for

This medicine contains the active substance ivermectin. It is a type of 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 nematode called Strongyloides stercoralis.
• A blood infection called microfilaraemia due to lymphatic filariasis. This is a condition caused by a larval stage called 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. This can cause intense itching. This medicine should only be used when your doctor confirms or suspects that you have scabies.

This medicine does not prevent you from getting these infections. It is not effective against adult worms.

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

2. What you need to know before using Ivercare

Do not use Ivercare

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 or peeling skin, blisters, or
mouth sores after taking ivermectin.

In general, if after taking any medicine you experience sudden onset of unusual symptoms such as skin rash, hives, or fever, you may assume you are allergic to that medicine.

Do not use this medicine if any of the above apply to you. If you have any doubts, consult your doctor or pharmacist before starting to use this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

Severe 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.

Before starting treatment with this medicine, inform your doctor about your complete medical history. Tell your doctor:

• If you have a weakened immune system (immune disease).
• If you live or have lived in any area of Africa where human parasitic infestation with the filarial parasite Loa loa, also known as eye worm, occurs.
• If you currently live or have lived in Africa.

Concomitant use of diethylcarbamazine (DEC) for the treatment of a concurrent Onchocerca volvulus infection may increase the risk of experiencing side effects, which may sometimes be serious.

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

This medicine is not indicated for the prevention of tropical parasitic infestations. It is not effective against adult parasitic worms and should only be used following a doctor's recommendation when parasitic infestation is confirmed or strongly suspected.

Children

The safety of this medicine has not been evaluated in children weighing less than 15 kg. For further information, see section 3.

Elderly people

Clinical studies conducted with this medicine have not included sufficient numbers of patients aged 65 years or older to determine whether their response differs from younger patients. Other clinical experience has not identified differences in response between elderly and younger patients. In general, treatment of elderly patients should be cautious, taking into account the higher prevalence of hepatic, renal, or cardiac impairment, as well as concomitant diseases and drug therapies in this age group.

Other medicines and Ivercare

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

In general, you should consult your doctor or pharmacist before taking any medicine.

Pregnancy, breastfeeding and fertility

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.

Pregnancy

Do not take this medicine during pregnancy unless otherwise directed by your doctor.

Breastfeeding

This medicine is excreted in breast milk.

If you are breastfeeding, inform your doctor and do not use this treatment unless instructed otherwise by your doctor.

Consult your doctor or pharmacist before taking any medicine.

Fertility

This medicine has no adverse effect on fertility in rats when administered at a dose 3 times higher than the maximum recommended human dose of 200 μg/kg (on a mg/m2 basis).

Driving and operating machinery

The influence of this medicinal product on the ability to drive and operate machinery has not been studied. In some patients, the possibility of experiencing side effects such as dizziness, somnolence, tremor, or sensation of spinning cannot be excluded, which may affect the ability to drive and operate machinery.

If you experience these symptoms, avoid driving or operating machinery.

3. How to take Ivercare

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

Treatment of gastrointestinal strongyloidiasis (threadworm infection)

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

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

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

15 to 24 kg one

25 to 35 kg two

36 to 50 kg three

51 to 65 kg four

66 to 79 kg five

≥ 80 kg six

Treatment of microfilaraemia caused by Wuchereria bancrofti (lymphatic filariasis)

The recommended dose in mass treatment campaigns for microfilaraemia due to Wuchereria bancrofti (lymphatic filariasis) is approximately 150 to 200 μg of ivermectin per kg of body weight, administered orally as a single dose every 6 months.

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

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

As an alternative, when it is not possible to determine body weight, the ivermectin dose for administration in mass treatment campaigns may be determined based on patient height as follows:

Treatment of human scabies

• Take a dose of 200 μg 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.

Other considerations during scabies treatment

Anyone who has been in contact with you, especially your partner or family members, should see their doctor as soon as possible. The doctor will determine whether these individuals also require treatment. If infected persons with whom you have contact do not receive immediate treatment, there is a risk they may re-infect you.

You should take hygiene measures to prevent re-infection (for example, keep your fingernails short and clean) and strictly follow official recommendations regarding the cleaning of clothing and bed linens.

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

Method of administration

The tablets are administered orally.

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

In children under 6 years of age, the tablets should be split before swallowing.

Treatment consists of a single dose. The prescribed number of tablets should be taken at once, as a single dose. The tablets must 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 drug's absorption in the body is unknown.

If you take more Ivercare than you should

Contact your doctor or pharmacist immediately.

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

If you forget to take Ivercare

Always follow your doctor's instructions. Do not take a double dose to make up for missed doses. If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

These side 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 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 rash or itching) or other severe skin reactions
• Difficulty breathing

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

Other adverse effects

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

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

People with a severe infection by the worm Loa loa may experience the following adverse effects:

• Abnormal brain activity
  • Neck or back pain
  • Eye hemorrhages (or red eyes)
  • Difficulty breathing
  • Loss of sphincter control
  • Difficulty standing or walking
  • Changes in mental status
  • Feeling drowsy or confused
  • Lack of response to others or falling into a coma

People infected with the worm Onchocerca volvulus, which causes onchocerciasis 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 when standing up
  • Increased heart rate
  • Headache or fatigue
  • Vision changes and other vision problems such as infection, redness, or unusual sensations
  • Eye hemorrhages or eyelid swelling
  • Worsening of asthma

People with 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
  • Tremors or shivering
  • Decreased number of white blood cells (leucopenia)
  • Decreased number of red blood cells or hemoglobin (anemia), the red pigment in blood

In cases of strongyloidiasis (threadworm infection), adult worms may also be detected in the stool.

People with microfilaraemia due to lymphatic filariasis caused by Wuchereria bancrofti may experience the following adverse effects:

• Headache
• Sweating or fever
• Unusual weakness
• Muscle pain, joint pain, or generalized body pain
• 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

People with scabies may experience the following adverse effects:

• Possible worsening of itching (pruritus) at the start of treatment, which is usually not prolonged.

Stop taking ivermectin and seek medical help immediately if you notice any of the

following symptoms:

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

Reporting of adverse effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ivercare

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

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and empty containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the container and additional information

Composition of Ivercare

• The active substance is ivermectin.

Each tablet contains 3 mg of ivermectin.

• The other components are:

Microcrystalline cellulose (E460), pregelatinized corn starch, citric acid (E330), butylated hydroxyanisole (E320), and magnesium stearate (E470b).

Appearance of the medicinal product and contents of the container

This medicine is presented as white, round, unmarked tablets, in packs containing 4, 10, or 20 tablets.

The blisters are enclosed in a folding carton box.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Industrial Farmacéutica Cantabria S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

Manufacturer

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

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