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Driponin 3 mg tablets

Patient information for Driponin 3 mg tablets

1.What Driponin 3 mg tablets is and what it is used for

1.1 What are the properties of the medicinal product?

Driponin 3 mg tablets contains the active ingredient ivermectin, a drug from the group of so-called anti-parasitic medicines.

Ivermectin requires a prescription and should only be used on medical advice.

1.2 Effective strength and dosage form of Driponin 3 mg tablets

- Tablets containing 3 mg of ivermectin.

Your doctor will determine whether this strength and dosage form are suitable for your treatment.

1.3 Driponin 3 mg tablets is used for treatment

certain parasite infections.

Which includes:

- an intestinal infection called intestinal strongyloidiasis (anguillulosis). This is caused by the nematode "Strongyloides stercoralis".

- an infection in the blood called microfilaraemia caused by "lymphatic filariasis". Lymphatic filariasis is caused by immature stages of the worm "Wuchereria bancrofti".

Driponin 3 mg tablets are not effective against adult worms, only against immature worms.

- an infection caused by skin mites (scabies, scabies). The infection occurs when tiny skin mites dig passages under the surface of the skin. This can cause severe itching.

Driponin 3 mg tablets should only be taken if your doctor has diagnosed you or suspects you may have scabies.

Driponin 3 mg tablets cannot prevent such infections from occurring. It is also not effective against adult worms.

Driponin 3 mg tablets should only be taken if your doctor has diagnosed you or suspects you have a parasite infection.

2. What you need to know before you use Driponin 3 mg tablets

2.1.Driponin 3 mg tablets must not be used

- if you are allergic to ivermectin or any of the other ingredients of this medicine.

In general, if you suddenly develop unusual symptoms after taking a medicine, such as a rash, hives, or fever, it may be an allergic reaction to the medicine.

If these statements apply to you, you must not take Driponin 3 mg tablets. Talk to your doctor or pharmacist before taking Driponin 3 mg tablets if you are not sure.

2.2 Special care is required when using Driponin 3 mg tablets

Talk to your doctor or pharmacist before taking Driponin 3 mg tablets.

Before starting treatment with Driponin 3 mg tablets, tell your doctor about your entire medical history.

Tell your doctor

- if you have a weak immune system (immune disease),

- if you live or have lived in a region of Africa where there have been cases of parasite infections with loa loa (wandering filamentous, also called eye worm) in humans,

- if you live or have lived in Africa.

Concomitant use of diethyl carbamazine citrate (DEC) to treat co-infection with the worm Onchocerca volvulus poses a risk of side effects that may be severe.

Talk to your doctor or pharmacist before taking Driponin 3 mg tablets, if any of the above applies to you (or if you are not sure). Driponin 3 mg tablets is not indicated for the prevention of infections with tropical parasites. It is not effective against adult parasitic worms and should only be used on the order of a doctor if there is a parasitic infection or if there is a strong suspicion of such an infection.

2.2.a) Children

The safety of using Driponin 3 mg tablets in children weighing less than 15 kilograms has not been established.

2.2.b) Elderly patients

There were not enough people aged 65 and over in clinical trials of ivermectin to determine whether elderly patients respond differently to ivermectin than younger patients. Other clinical experience reports show no differences in response between older and younger patients. Elderly patients should generally be treated with caution, as these patients are more likely to have impaired liver, kidney or heart function and to suffer more often from comorbidities or other drug treatments.

2.2.c) Pregnancy

You should only take Driponin 3 mg tablets if your doctor tells you to if you are pregnant.

Fertility: Ivermectin had no effects on the fertility of rats given up to 3 times the maximum recommended human dose of 200 micrograms per kilogram body weight (on a mg / m2 / day basis).

2.2.d) Breastfeeding

The active ingredient in Driponin 3 mg tablets, ivermectin, is excreted in breast milk. If you are breastfeeding, tell your doctor and only take this medicine as directed by your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

2.2.e) Ability to drive and use machines

The effects of Driponin 3 mg tablets on the ability to drive and use machines have not been studied. It cannot be excluded that some patients may experience side effects such as dizziness, sleepiness, tremors and vertigo, which could affect the ability to drive and use machines.

Do not drive or use machines if you experience these symptoms.

2.3 Which interactions with other medicinal products have to be considered?

Tell your doctor or pharmacist if you are taking / using, have recently taken / used or may take / use any other medicines.

Ask your doctor or pharmacist for advice before taking any medicine.

2.4 What should be considered when using Driponin 3 mg tablets together with food, luxury foods and beverages?

Do not eat any food for two hours before and after taking this medicine.

3. How to use Driponin 3 mg tablets

Always use Driponin 3 mg tablets exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.

3.1 Type and duration of application

Oral tablets.

Always follow your doctor’s dosage instructions. Check with your doctor or pharmacist if you are not sure.

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

The treatment consists of a single dose, which means that you take all the tablets that have been prescribed for you at the same time. Take the tablets on an empty stomach with a little water.

Do not eat any food for two hours before and after taking this medicine because it is not known how foods affect the way this medicine is absorbed by the body.

The doctor decides on the duration of the application.

3.2 Unless otherwise prescribed by the doctor, the usual dose is

3.2.a) Treatment of gastrointestinal strongyloidiasis (anguillulosis)

The recommended dose is 200 micrograms ivermectin per kg body weight and is taken as a single dose. The following table serves as a guide for the dosage per kg of body weight:

- Body weight (kg): 15 to 24; Number of 3 mg tablets: 1

- Body weight (kg): 25 to 35; Number of 3 mg tablets: 2

- Body weight (kg): 36 to 50; Number of 3 mg tablets: 3

- Body weight (kg): 51 to 65; Number of 3 mg tablets: 4

- Body weight (kg): 66 to 79; Number of 3 mg tablets: 5

- Body weight (kg): from 80; Number of 3 mg tablets: 6

3.2.b) Treatment of microfilaraemia (lymphatic filariasis) caused by Wuchereria bancrofti

The recommended dosage for the mass treatment of microfilaraemia (lymphatic filariasis) caused by Wuchereria bancrofti is approximately 150 to 200 micrograms ivermectin per kg body weight as a single oral dose every 6 months.

In areas where the disease is persistent in a limited area or population group (endemic areas) and where the medicine can only be given once every 12 months, the recommended dose is 300 to 400 micrograms per kilogram of body weight, around one to achieve adequate suppression of microfilaraemia in the treated patients.

The following table serves as a guide for the dosage per kg of body weight:

In 6-month intervals:

- Body weight (kg): 15 to 25; Number of 3 mg tablets: 1

- Body weight (kg): 26 to 44; Number of 3 mg tablets: 2

- Body weight (kg): 45 to 64; Number of 3 mg tablets: 3

- Body weight (kg): 65 to 84; Number of 3 mg tablets: 4

At 12-month intervals:

- Body weight (kg): 15 to 25; Number of 3 mg tablets: 2

- Body weight (kg): 26 to 44; Number of 3 mg tablets: 4

- Body weight (kg): 45 to 64; Number of 3 mg tablets: 6

- Body weight (kg): 65 to 84; Number of 3 mg tablets: 8

Alternatively, or if no scales are available, the ivermectin dose for mass treatments can also be determined based on the patient's height:

In 6-month intervals:

- height 90 to 119 cm; Number of 3 mg tablets: 1

- body height 120 to 140 cm; Number of 3 mg tablets: 2

- height 141 to 158 cm; Number of 3 mg tablets: 3

- Height over 158 cm: Number of 3 mg tablets: 4

At 12-month intervals:

- height 90 to 119 cm; Number of 3 mg tablets: 2

- body height 120 to 140 cm; Number of 3 mg tablets: 4

- height 141 to 158 cm; Number of 3 mg tablets: 6

- Height over 158 cm: Number of 3 mg tablets: 8

3.2.c) Treatment of scabies in humans

Take a dose of 200 micrograms for every kilogram of body weight.

It takes 4 weeks to tell whether the treatment was successful.

Your doctor may give you a second single dose within 8 to 15 days.

What else should you watch out for if you are being treated for scabies? Anyone who comes in contact with you - especially family members and partners - should see a doctor as soon as possible. The doctor will decide whether these people should also be treated. If infected people with whom you are in contact are not treated immediately, there is a risk that they will re-infect you with scabies.

Please observe hygienic measures to avoid re-infection (i.e. keep fingernails short and clean). Please also follow the official recommendations for cleaning clothes and bed linen.

3.3 If you use more Driponin 3 mg tablets than you should

Contact your doctor or pharmacist immediately.

3.4 If you forget to use Driponin 3 mg tablets

Always take this medicine as directed by your doctor. Do not take a double dose to make up for a forgotten dose.

3.5 Effects if treatment with Driponin 3 mg tablets is stopped

If you want to stop the treatment, please discuss this with your doctor or pharmacist beforehand.

Do not end the drug treatment on your own, as this could jeopardize the success of the therapy.

4. What are the possible side effects?

Like all medicines, Driponin 3 mg tablets can cause side effects, although not everybody gets them.

When evaluating side effects, the following frequencies are used as a basis:

- very common: more than 1 in 10 people

- common: less than 1 in 10, but more than 1 in 100 patients

- uncommon: less than 1 in 100, but more than 1 in 1,000 patients

- rarely: less than 1 in 1,000 but more than 1 in 10,000 people treated

- very rare: less than 1 in 10,000 patients, including isolated cases

- Frequency not known: frequency cannot be calculated from the available data

4.1 Which side effects can occur in detail?

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

The side effects are usually not serious and do not last long. They are more likely to occur in people infected with multiple parasites. This is especially true if you are infected with the "Loa loa" worm. The following side effects may occur after taking this medicine:

- Allergic reaction

Contact a doctor immediately if you experience an allergic reaction. Signs of such a reaction are:

- sudden fever

- Sudden skin reactions (e.g. rash or itching) or other serious skin reactions

- difficulty breathing

Contact a doctor immediately if you experience any of the side effects mentioned.

- Other side effects

- liver disease (acute hepatitis)

- Changes in laboratory values ​​(increased liver enzymes, increased bilirubin (yellow blood pigment) in the blood, increased eosinophil value (subgroup of white blood cells)

- blood in the urine

The following side effects are dependent on the disease being treated with Ivermectin_3 mg and any other infections.

The following side effects may occur in patients with roundworm infection (intestinal strongyloidiasis, anguillulosis):

- feeling unusually weak

- Loss of appetite, stomach pain, constipation or diarrhea

- nausea or vomiting

- drowsiness or dizziness

- trembling

low number of white blood cells (leukopenia)

- low number of red blood cells or a decrease in the blood pigment hemoglobin (anemia)

With intestinal strongyloidiasis (anguillulosis), adult roundworms can also be in the stool.

The following side effects may occur in patients with microfilaraemia due to lymphatic filariasis caused by Wuchereria bancrofti:

- sweating or fever

- A headache

- feeling unusually weak

- Muscle, joint aches and pains all over the body

- Loss of appetite, nausea

- abdominal pain (in the lower or upper abdomen)

- cough or sore throat

- difficulty breathing

- low blood pressure when you stand up - you may feel dizzy or light-headed

- chills

- Dizziness

- testicular pain or discomfort

The following side effects may occur in patients with scabies:

- Itching (pruritus) may get worse at the start of treatment. This usually doesn't last long.

The following side effects may occur in patients with severe infection caused by the Loa loa worm:

- brain dysfunction

- neck or back pain

Bleeding in the whites of the eyes (called red eye)

Shortness of breath

- Loss of bladder or bowel control

- Difficulty standing or walking

- altered state of mind

- drowsiness or confusion

- no reaction to other people or coma

The following side effects may occur in patients infected with the worm Onchocerca volvulus, which causes what is known as river blindness:

- Itching or rash

- joint or muscle pain

- Fever

- nausea or vomiting

- swelling of the lymph nodes

- swelling, especially in your hands, ankles or feet

- diarrhea

- Dizziness

- low blood pressure (hypotension). You may feel dizzy or light-headed when you stand up.

- accelerated heartbeat

- headache or tiredness

- Visual disturbances and other eye problems such as infection, redness or sensory disturbances

- Bleeding in the whites of the eyes or swelling of the eyelid

- Asthma can get worse.

4.2 What countermeasures should be taken if side effects occur?

Let your doctor know if you experience any side effects. He will decide on possible measures.

If you experience a sudden or severe side effect, inform a doctor immediately, as certain drug side effects (e.g. excessive drop in blood pressure, hypersensitivity reactions) can under certain circumstances have serious consequences. In such cases, do not continue to take the medicine without doctor's advice.

Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not listed in the package insert. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept.Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn (website: www.bfarm.de). By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Driponin 3 mg tablets

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

Do not use this medicinal product after the expiry date which is stated on the packaging after "EXP". The expiry date refers to the last day of that month.

Do not store above 25 ° C.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. You help to protect our environment.

6. Source and processing status

Information from the SCHOLZ database based on the data approved by the Federal Office for Drugs and Medical Devices

Copyright by ePrax GmbH, Munich; October 2019 (2)