Ivermectin Medical Vallei

Package Leaflet: Information for the User

Ivermectin Medical Valley, 3 mg, Tablets

Ivermectin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Ivermectin Medical Valley and what is it used for
• 2. Important information before taking Ivermectin Medical Valley
• 3. How to take Ivermectin Medical Valley
• 4. Possible side effects
• 5. How to store Ivermectin Medical Valley
• 6. Contents of the pack and other information

1. What is Ivermectin Medical Valley and what is it used for

Ivermectin Medical Valley contains the active substance ivermectin. The medicine is used to treat infections caused by certain parasites.

The medicine is used to treat:

• intestinal infection, known as anguillulosis (strongyloidiasis). It is caused by a type of roundworm called Strongyloides stercoralis.
• blood infection with microfilariae in people with lymphatic filariasis. It is caused by an immature form of the worm, called Wuchereria bancrofti. Ivermectin Medical Valley does not work against mature forms, only against immature forms of the worm.
• skin disease caused by small mites (scabies) that multiply under the skin. This can cause intense itching. Ivermectin Medical Valley should only be taken if the doctor has confirmed scabies or suspects that the patient has scabies.

Ivermectin Medical Valley does not prevent the occurrence of these infections. It does not work against mature forms of the worm. Ivermectin Medical Valley should only be taken if the doctor has confirmed or suspects a parasitic infection.

2. Important information before taking Ivermectin Medical Valley

When not to take Ivermectin Medical Valley

• if you are allergic to ivermectin or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction to the medicine may include skin rash, difficulty breathing, or fever.
• If you have ever experienced severe skin rash or peeling after taking ivermectin.

Generally, if unusual symptoms occur suddenly after taking any medicine, such as rash, hives, or fever, it can be suspected that the patient is allergic to the medicine.

Warnings and precautions

Before starting to take Ivermectin Medical Valley, discuss it with your doctor or pharmacist.

Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with ivermectin. You should stop taking ivermectin and seek medical attention immediately if you experience any of the symptoms of severe skin reactions listed in section 4.

In particular, you should tell your doctor if you:

• have a weakened immune system (immunodeficiency),
• live or have lived in areas of Africa where there are cases of human infection with the parasitic worm Loa loa, also known as the eye worm,
• currently live or have lived in some areas of Africa.

Taking the medicine called diethylcarbamazine citrate (DEC) at the same time to treat co-existing Onchocerca volvulus infection may increase the risk of severe side effects.

If any of the above applies to you (or you are not sure), you should consult your doctor or pharmacist before taking Ivermectin Medical Valley.

Ivermectin Medical Valley is not intended to prevent tropical parasitic infections. It is not effective against mature forms of parasites and can only be used on the advice of a doctor when a parasitic infection has been confirmed or suspected.

Children

It is not known whether Ivermectin Medical Valley can be safely used in children with a body weight below 15 kg.

Ivermectin Medical Valley and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.

Pregnancy and breastfeeding

• If you are pregnant or may become pregnant, you should consult your doctor before taking Ivermectin Medical Valley. If you are pregnant, this medicine can only be used if it is absolutely necessary. The decision will be made by you and your doctor together.
• You should talk to your doctor if you are breastfeeding or plan to breastfeed. This is because Ivermectin Medical Valley passes into human milk. Your doctor may decide to start treatment after one week from the birth of your child.

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, you should ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

The effect of Ivermectin Medical Valley on the ability to drive and use machines has not been studied. In some patients, side effects such as dizziness, drowsiness, tremors, or a feeling of spinning may occur, which may affect the ability to drive and use machines.

If you experience such symptoms, you should avoid driving and using machines.

3. How to take Ivermectin Medical Valley

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Taking this medicine:

• This medicine should be taken orally.
• In the case of use in children under 6 years of age, the tablets should be crushed before swallowing.
• The prescribed number of tablets should be taken at the same time as a single dose. The tablets should be taken on an empty stomach, washed down with water. You should not eat any meals for two hours before or after taking this medicine, as it is not known how food affects its absorption.

How many tablets to take

Treatment consists of a single dose.

• The prescribed number of tablets should be taken at the same time as a single dose.
• The dose depends on the type of disease and the patient's body weight or height.
• Your doctor will inform you how many tablets to take.

Intestinal strongyloidiasis (anguillulosis)

• The usual dose is:

Microfilaraemia caused by lymphatic filariasis caused by Wuchereria bancrofti

• The usual dose is:
• This dose is repeated every 6 months or every 12 months.
• Alternatively, if it is not possible to determine the patient's body weight, the dose can be determined based on the patient's height as follows:

Human scabies

• The dose is 200 micrograms per kilogram of body weight. Your doctor will inform you how many tablets to take.
• The effectiveness of the treatment can only be assessed after 4 weeks from the start of treatment.
• Your doctor may decide to administer a second single dose within 8 to 15 days.

If you feel that the effect of Ivermectin Medical Valley is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of Ivermectin Medical Valley than recommended

Take this medicine exactly as your doctor has told you. In some patients, decreased consciousness, including coma, has been reported after overdosing on ivermectin.

If you take more Ivermectin Medical Valley than you should, contact your doctor immediately.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Missing a dose of Ivermectin Medical Valley

Always follow the instructions of your doctor. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Ivermectin Medical Valley can cause side effects, although not everybody gets them.

Side effects are usually not serious and do not last long. They are more likely to occur in people infected with several parasites and especially in people infected with the Loa loa worm.

The following side effects may occur when taking this medicine:

Allergic reactions

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

• sudden fever
• sudden skin reactions (such as rash or itching) or other severe skin reactions
• difficulty breathing

If you experience any of the above side effects, you should seek medical attention immediately.

You should stop taking ivermectin and seek medical attention immediately if you notice any of the following symptoms:

• red, flat, plate-like or round spots on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of such 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 some laboratory tests (increased liver enzyme activity, increased bilirubin levels in the blood, increased eosinophil count)
• blood in the urine
• decreased consciousness, including coma

The following side effects depend on the purpose for which Ivermectin Medical Valley is used and whether the patient has any other infections.

In people with intestinal strongyloidiasis (anguillulosis), the following side effects may occur:

• feeling of unusual weakness
• loss of appetite, abdominal pain, constipation, or diarrhea
• nausea or vomiting
• feeling of drowsiness or dizziness
• chills or tremors
• decreased white blood cell count (leukopenia)
• decreased red blood cell or hemoglobin count, red blood cell pigment (anemia). In the case of intestinal strongyloidiasis (anguillulosis), adult roundworms may be present in the stool.

In people with microfilaraemia due to lymphatic filariasis caused by Wuchereria bancrofti, the following side effects may occur:

• sweating or fever
• headache
• feeling of unusual weakness
• muscle, joint, or body aches
• loss of appetite, nausea
• abdominal pain (abdominal and epigastric pain)
• cough or sore throat
• discomfort while breathing
• low blood pressure when changing position to standing - dizziness or feeling of fainting may occur
• chills
• dizziness
• pain or discomfort in the testicles

In people with scabies, the following side effects may occur:

• intensification of itching (pruritus) at the beginning of treatment. This usually does not last long.

In people with severe Loa loa infection, the following side effects may occur:

• abnormal brain function
• neck or back pain
• bleeding in the whites of the eyes (also known as eye redness)
• shortness of breath
• loss of bladder or bowel control
• difficulty standing or walking
• changes in mental state
• feeling of drowsiness or confusion
• lack of response to other people or coma

In people infected with the Onchocerca volvulus parasite, which causes river blindness, the following side effects may occur:

• itching or rash
• joint or muscle pain
• fever
• nausea or vomiting
• swelling of the lymph nodes
• swelling, especially of the hands, ankles, or feet
• diarrhea
• dizziness
• low blood pressure (hypotension). Dizziness or feeling of fainting may occur when changing position to standing.
• rapid heartbeat
• headache or feeling of fatigue
• changes in vision and other eye problems, such as infection, redness, or unusual sensations
• bleeding in the whites of the eyes or swelling of the eyelids
• worsening of asthma

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ivermectin Medical Valley

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

Do not use this medicine after the expiry date which is stated on the blister and carton after “Expiry Date” (EXP). The expiry date refers to the last day of that month.

There are no special storage instructions for this medicine.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ivermectin Medical Valley contains

• The active substance is ivermectin. One tablet contains 3 mg of ivermectin.
• The other ingredients are: microcrystalline cellulose PH 102, corn starch, citric acid, butylhydroxyanisole, magnesium stearate.

What Ivermectin Medical Valley looks like and contents of the pack

The medicine is in the form of round, white tablets without markings.

The medicine is available in aluminum/aluminum blisters containing 4, 8, 12, or 20 tablets in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

Medical Valley Invest AB, Brädgårdsvägen 28, 236 32 Höllviken, Sweden, email: safety@medicalvalley.se

Manufacturer

Laboratorios Liconsa, S.A., Polígono Industrial Miralcampo, Avda. Miralcampo, 7, 19200 Azuqueca de Henares – Guadalajara, Spain

Medical Valley Invest AB, Brädgårdsvägen 28, 236 32 Höllviken, Sweden

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Ivergelan 3 mg Tablets

Denmark: Ivermectin “Medical Valley”, tablets

Finland: Ivermectin Medical Valley 3 mg tablets

France: Ivermectine Liconsa 3 mg tablet

Netherlands: Ivermectine Xiromed 3 mg, tablets

Iceland: Ivermectin Medical Valley 3 mg tablets

Germany: Iveraxiro 3 mg Tablets

Norway: Ivermectin Medical Valley

Poland: Ivermectin Medical Valley

Portugal: Ivermectina Cantabria 3 mg tablets

Czech Republic: Ivermectin Exeltis 3 mg tablets

Slovakia: Ivermectin Exeltis 3 mg tablets

Sweden: Ivermectin Medical Valley 3 mg tablets

Italy: Ivermectina Difa

Date of last revision of the leaflet:10/2024