Ivermectin Teva 3 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ivermectin Teva 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Ivermectin Teva is and what it is used for
- What you need to know before taking Ivermectin Teva
- How to take Ivermectin Teva
- Possible adverse effects
- How to store Ivermectin Teva
- Contents of the pack and other information
1. What Ivermectin Teva 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:
- A gastrointestinal infection called strongyloidiasis (also known as anguillulosis), 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 larva called Wuchereria bancrofti. Ivermectin does not act 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 does not act 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 taking Ivermectin Teva
Do not take Ivermectin Teva
- 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 developed a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking ivermectin.
Do not take this medicine if any of the above apply to you. If you are unsure,
consult your doctor or pharmacist before starting to take this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ivermectin Teva.
In particular, consult your doctor or pharmacist before taking this medicine if:
- You have a weakened immune system.
- You live or have lived in any 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 currently live or have lived in Africa.
- You live or have spent time in African regions. The use of diethylcarbamazine citrate (DEC) if you are infected with "Onchocerca volvulus" may increase the risk of side effects, which can sometimes be serious.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with ivermectin treatment. Stop using ivermectin and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.
If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before taking this medicine.
Children
The safety of this medicine has not been evaluated in children weighing less than 15 kg.
Other medicines and Ivermectin Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
- Consult your doctor immediately before taking ivermectin if you are pregnant or could become pregnant. If you are pregnant, you should only take it if 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 one week after the birth of your child.
Driving and using machines
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.
3. How to take Ivermectin Teva
Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
How to take this medicine
- Take this medicine by mouth.
- For children under 6 years of age, crush the tablets before swallowing.
- Take the number of tablets prescribed by your doctor at the same time, with water and on an empty stomach. Do not eat any food within two hours before or after taking the tablets. This is because it is not known how food affects the way your body absorbs the medicine.
How much to take
Treatment consists of a single dose.
- Take the number of tablets prescribed by your doctor all at the same time.
- The dose depends on your condition and on your weight or height.
- Your doctor will tell you how many tablets you should take.
Treatment of gastrointestinal strongyloidiasis (threadworm infection)
The recommended dose is:
Body Weight (Kg) | Dosage Number of 3mg tablets |
15 to 24 | one |
25 to 35 | two |
36 to 50 | three |
51 to 65 | four |
66 to 79 | five |
≥ 80 | six |
Treatment of microfilaremia due to lymphatic filariasis caused by Wuchereria bancrofti
The recommended dose is:
Body Weight (kg) | DOSE administered once every 6 months Number of 3 mg tablets | DOSE administered once every 12 months Number of 3 mg tablets |
15 to 25 | one | two |
26 to 44 | two | four |
45 to 64 | three | six |
65 to 84 | four | eight |
This is repeated every 6 months or every 12 months.
Alternatively, if scales are not available, the dosage can be determined based on the patient's height as follows:
Height (cm) | DOSE administered once every 6 months Number of 3 mg tablets | DOSE administered once every 12 months Number of 3 mg tablets |
90 to 119 | one | two |
120 to 140 | two | four |
141 to 158 | three | six |
>158 | four | eight |
Treatment of human scabies
- Take a dose of 200 micrograms per kilogram of body weight.
This corresponds to:
Body Weight (Kg) | Dosage Number of 3 mg tablets |
From 15 to 24 | one |
From 25 to 35 | two |
From 36 to 50 | three |
From 51 to 65 | four |
From 66 to 79 | five |
≥ 80 | six |
- You will not know if the treatment has been completely successful until 4 weeks later.
- Your doctor may decide to administer a second single dose within 8 to 15 days.
If you think that the effect of Ivermectin is too strong or too weak, consult your doctor or pharmacist.
If you take more Ivermectina Teva than you should
It is important to take the dose prescribed by your doctor. Reduced level of consciousness, including coma, has been reported in patients who have overdosed on ivermectin.
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 telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Ivermectina Teva
Try to take Ivermectin as directed by your doctor. Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can 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.
Stop using ivermectin and seek immediate medical help if you experience any of the following symptoms:
- Flat, red, target-shaped or circular rashes, often with central blisters, skin peeling, mouth, 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).
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
- Decreased level of consciousness, including coma
The following side effects depend on the reason you are taking this medicine and whether you have any other infections.
Individuals with gastrointestinal strongyloidiasis (threadworm infection) may experience the following side effects:
- Unusual weakness
- Loss of appetite, stomach pain, constipation, or diarrhea
- Nausea or vomiting
- Drowsiness or dizziness
- Tremors or shaking
- Decreased number of white blood cells (leukopenia)
- Decreased number of red blood cells or hemoglobin, the red pigment in blood (anemia)
Additionally, in gastrointestinal strongyloidiasis (threadworm infection), adult roundworms may be found in the stool.
Individuals with microfilaremia due to lymphatic filariasis caused by Wuchereria bancrofti may experience the following side effects:
- Sweating or fever
- Headache
- Unusual weakness
- Muscle, joint, and general body aches
- Loss of appetite, nausea
- Stomach pain (abdominal and 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 testicles
Individuals with scabies may experience the following side effects:
- Itching (pruritus), which may worsen at the beginning of treatment. This usually does not last long.
Individuals with a severe infection by the Loa loa worm may experience the following adverse effects:
- Abnormal brain activity
- Neck or back pain
- Bleeding in the eyes (or red eyes)
- Difficulty breathing
- Loss of bowel or bladder control
- Difficulty standing or walking
- Changes in mental status
- Drowsiness or confusion
- Lack of response to others or coma
Individuals infected with the Onchocerca volvulus worm, 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 upon standing
- Increased heart rate
- Headache or fatigue
- Vision changes 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 adverse effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ivermectin Teva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after CAD or EXP. The expiry date refers to the last day of the month indicated.
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 their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the package and other information
Composition of Ivermectin Teva
- The active substance is ivermectin. Each tablet contains 3 mg of ivermectin.
- The other components are microcrystalline cellulose (E 460), pregelatinized corn starch, butylated hydroxyanisole (E 320), citric acid (E 330), and magnesium stearate (E 572).
Appearance of the medicine and contents of the pack
Ivermectin Teva tablets are round, white tablets, marked with “A 300” on one side.
The tablets are available in cardboard packs containing blisters with 1, 4, 6, 8, 10 or 20 tablets.
Only certain pack sizes may be commercially available.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva B.V.
Swensweg 5,
2031 GA Haarlem,
The Netherlands
Manufacturer
Coripharma ehf.
Reykjavikurvegur 78
IS-220 Hafnarfjordur
Iceland
For further information about this medicine, contact the local representative of the Marketing Authorization Holder:
Teva Pharma, S.L.U
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,
Alcobendas, 28108, Madrid (Spain)
Date of the most recent revision of this leaflet: May 2023
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/