ZULIMA 3 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Zulima 3mg tablets EFG

Ivermectin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Zulima and what is it used for

This medicine contains the active substance ivermectin. It is a type of medicine 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 Wuchereria bancrofti(lymphatic filariasis). This is a condition caused by a larva called Wuchereria bancrofti. Ivermectin does not act against adult worms, only against the larvae.
• Scabies (skin mites). This occurs when tiny mites are introduced under the skin. This can cause intense itching. This medicine should only be used when your doctor has confirmed or suspects that you have scabies.

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

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

2. What you need to know before you take Zulima

Do not take Zulima

If you are allergic to ivermectin or any of the other ingredients of this medicine (listed in section 6).

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

If you have ever suffered from a severe skin rash or skin peeling, blisters or ulcers in the mouth after taking ivermectin.

Do not use this medicine if you are in any of the above cases. If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult 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 medical attention immediately if you notice any of the symptoms described in section 4 related to these severe skin reactions.

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

• If you have a weakened immune system (immune disease).
• If 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 live in Africa now or have lived in Africa.

Taking diethylcarbamazine (DEC) at the same time to treat a concurrent infection with Onchocerca volvulusmay increase the risk of experiencing 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 medicine.

This medicine 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 the parasitic infestation is confirmed or strongly suspected.

Children

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

Elderly

Clinical studies conducted with this medicine have not included sufficient patients aged 65 and over to determine whether 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 range there is a higher incidence of liver, kidney, or heart failure, as well as concomitant diseases and pharmacological treatments.

Using Zulima with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

If you are pregnant, do not take this medicine unless your doctor tells you to.

Breastfeeding

This medicine 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 medicine.

Fertility

This medicine has no adverse effect on fertility in rats at a dose 3 times higher than the maximum recommended for humans, of 200 μg/kg (with a frequency of mg/m2/d).

Driving and using machines

The influence of this medicine on the ability to drive and use machines 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 feeling of spinning, which may affect the ability to drive and use machines.

If you experience these symptoms, avoid driving or using machines.

3. How to take Zulima

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

Treatment of gastrointestinal strongyloidiasis (anguilulosis)

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

As a guide, the dose based on body weight is:

Treatment of microfilaremia caused by Wuchereria bancrofti(lymphatic filariasis)

The recommended dose in mass treatment campaigns for microfilaremia caused by Wuchereria bancrofti(lymphatic filariasis) is between 150 and 200 μg of ivermectin per kilogram of body weight, approximately, 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 kilogram of body weight to maintain adequate inhibition of microfilaremia in treated patients.

As a guide, the dose based on body weight is:

Alternatively, in case it is not possible to determine the weight, the dose of ivermectin for administration in mass treatment campaigns can be determined based on the patient's 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 have passed since treatment.
• Your doctor may determine if a second dose should be administered 8-15 days later.

Other aspects to consider when receiving treatment for scabies

Anyone who comes into contact with you, especially your partner or family members, should see a doctor as soon as possible. The doctor will determine if these people should also receive treatment. If the people infected with whom you are in 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, keeping your fingernails short and clean) and strictly follow official recommendations for washing clothes and bedding.

If you think 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 indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

In children under 6 years of age, the tablets should 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 2 hours before or after taking the medicine, as it is unknown how food may affect the absorption of the medicine in the body.

If you take more Zulima 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 medicine and the amount ingested.

If you forget to take Zulima

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These side effects are usually not serious or 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 medicine:

Allergic reactions

If you experience an allergic reaction, go to the doctor immediately. The symptoms may include:

• Sudden fever
• Sudden skin reactions (such as rash or itching) or other severe 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 some laboratory test results (increased liver enzymes, increased bilirubin in the blood, increased eosinophils)
• Blood in the urine

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

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

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

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

• Abnormal brain activity
• Pain in the neck or back
• Bleeding in the eyes (or red eyes)
• Difficulty breathing
• Loss of bladder or bowel control
• Difficulty standing or walking
• Changes in mental state
• Feeling of drowsiness or confusion

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

• Lack of response to other people or entry into a coma
• Abnormal brain activity

People infected with the Onchocerca volvulusworm, which causes onchocerciasis, may experience 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

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

• Exceptional weakness
• Lack of appetite, stomach pain, constipation, or diarrhea
• Nausea or vomiting
• Feeling of drowsiness or dizziness
• Tremors or shakiness
• Decreased number of white blood cells (leukopenia)
• Decreased number of red blood cells or hemoglobin (anemia), red pigment in the blood.

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

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

• Headache
• Sweating or fever
• Exceptional weakness
• Muscle, joint, or general body pain
• Lack of appetite, nausea
• Stomach pain (abdominal or epigastric pain)
• Cough or sore throat
• Breathing difficulties
• Low blood pressure when standing up or standing (you may feel dizzy or faint)
• Chills
• Dizziness
• Pain or discomfort in the testicle

People with scabiesmay experience the following side effects:

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

Reporting of side effects

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

5. Storing Zulima

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

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Blister: this medicine does not require special storage conditions. Store in the original packaging to protect it from light.

Bottle: this medicine does not require special storage conditions. Store in the original packaging to protect it from light. It should be used within 83 days of opening.

Medicines should not be thrown away via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Zulima Composition

• The active ingredient is ivermectin. Each tablet contains 3 mg of ivermectin.
• The other components are: Microcrystalline cellulose (E460), pregelatinized corn starch, citric acid (E330), butylhydroxyanisole (E320), and magnesium stearate (E470b).

Appearance of the Product and Packaging Contents

This medication is presented in the form of white, unmarked, round tablets, in packages of 1, 4, 10, and 20 tablets.

HDPE bottle with silica gel desiccant in the tablets

250 tablets in a 35 ml bottle

The blisters are packaged in a foldable cardboard box.

The bottle is packaged in a foldable cardboard box.

Only some package sizes may be marketed.

Marketing Authorization Holder

Exeltis Healthcare S.L

Avda. de Miralcampo 7

Miralcampo Industrial Estate,

19200, Azuqueca de Henares,

Guadalajara, Spain

Manufacturer

Laboratorios Liconsa S.A.

Avda. de Miralcampo 7

Miralcampo Industrial Estate,

19200, Azuqueca de Henares,

Guadalajara, Spain

This leaflet was last revised in:May 2023

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/)