Amoxicillin Mip Pharma

Leaflet accompanying the packaging: patient information

Amoxicillin MIP Pharma, 500 mg, tablets

Amoxicillin MIP Pharma, 1000 mg, tablets

Amoxicillin

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you (or your child). Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Amoxicillin MIP Pharma and what is it used for
• 2. Important information before taking Amoxicillin MIP Pharma
• 3. How to take Amoxicillin MIP Pharma
• 4. Possible side effects
• 5. How to store Amoxicillin MIP Pharma
• 6. Contents of the packaging and other information

1. What is Amoxicillin MIP Pharma and what is it used for

What is Amoxicillin MIP Pharma

Amoxicillin MIP Pharma is an antibiotic. The active substance of the medicine is amoxicillin. Amoxicillin belongs to a group of medicines called "penicillins".

What is Amoxicillin MIP Pharma used for

Amoxicillin MIP Pharma is used to treat bacterial infections of various parts of the body. Amoxicillin MIP Pharma can also be used, in combination with other medicines, to treat stomach ulcer disease.

2. Important information before taking Amoxicillin MIP Pharma

When not to take Amoxicillin MIP Pharma

If any of these conditions apply to the patient, they should not take Amoxicillin MIP Pharma. In case of doubt, consult your doctor or pharmacist before taking Amoxicillin MIP Pharma.

Warnings and precautions

Before taking Amoxicillin MIP Pharma, the patient should discuss it with their doctor or pharmacist if they:

• have infectious mononucleosis (fever, sore throat, swollen lymph nodes, and extreme fatigue)
• have kidney disease
• have irregular urination.

In case of doubt as to whether these conditions apply to the patient, they should consult their doctor or pharmacist before taking Amoxicillin MIP Pharma.

Blood and urine tests

If the patient is to undergo:

• urine tests (for glucose) or blood tests to check liver function,
• estriol tests (performed during pregnancy to check if the baby is developing properly), they should inform their doctor or pharmacist that they are taking Amoxicillin MIP Pharma. Amoxicillin MIP Pharma may affect the results of these tests.

Amoxicillin MIP Pharma and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking, have recently taken, or plan to take.

• If the patient is taking allopurinol (used to treat gout), they may be more likely to experience skin allergic reactions.
• If the patient is taking probenecid (used to treat gout). Taking probenecid at the same time may reduce the excretion of amoxicillin and is not recommended.
• If the patient is taking blood-thinning medicines (such as warfarin), they may need to have additional blood tests.
• If the patient is taking other antibiotics (such as tetracycline), Amoxicillin MIP Pharma may be less effective.
• If the patient is taking methotrexate (used to treat cancer and severe psoriasis). Penicillins may reduce the excretion of methotrexate, leading to increased risk of side effects.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Amoxicillin MIP Pharma may cause side effects and symptoms (such as allergic reactions, dizziness, and seizures) that can affect the ability to drive or operate machinery. The patient should not drive or operate machinery unless they feel well.

3. How to take Amoxicillin MIP Pharma

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

• Tablets should be taken either as a suspension prepared with drinking water or whole, washed down with a sufficient amount of water (e.g., one glass). Tablets can be broken to adjust the dose or facilitate swallowing.
• Equal intervals of at least 4 hours should be maintained between doses administered during the day.

The usual dose is:

Children with a body weight of less than 40 kg

All doses are determined based on the child's body weight in kilograms.

• The doctor will prescribe the dose of Amoxicillin MIP Pharma to be given to the child.
• The usual dose is 40 mg to 90 mg per kilogram of body weight per day, given in two or three divided doses.
• The maximum recommended dose is 100 mg per kilogram of body weight per day.

Adults, elderly, and children with a body weight of 40 kg or more

The usual dose of Amoxicillin MIP Pharma is 250 mg to 500 mg three times a day or 750 mg to 1 g every 12 hours, depending on the severity and type of infection.

• Severe infections:750 mg to 1 g three times a day.
• Urinary tract infections:3 g twice a day for one day.
• Lyme disease (borreliosis - infection transmitted by ticks):single migrating erythema (early stage - pink-red spot): 4 g per day. Systemic symptoms (late stage - more severe symptoms or when the disease affects multiple organs): up to 6 g per day.
• Stomach ulcer disease:750 mg or 1 g twice a day for 7 days in combination with other antibiotics and medicines used to treat stomach ulcers.
• Prevention of endocarditis during surgical procedures:the dose may vary depending on the type of surgical procedure. Other medicines may be administered at the same time. For more detailed information, consult your doctor, pharmacist, or nurse.
• The maximum recommended dose is 6 g per day.

Kidney disease

If the patient has kidney disease, the dose of the medicine may be lower than usual.

Taking a higher dose of Amoxicillin MIP Pharma than recommended

If the patient takes a higher dose of Amoxicillin MIP Pharma than recommended, they may experience symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhea) or crystals in the urine, which may be perceived as cloudy urine or problems urinating. The patient should contact their doctor as soon as possible. They should take the medicine with them to show it to the doctor.

Missing a dose of Amoxicillin MIP Pharma

• If the patient forgets to take a dose, they should take it as soon as they remember.
• The patient should not take the next dose too early; they should wait about 4 hours before taking the next dose.
• The patient should not take a double dose to make up for the missed dose.

How long to take Amoxicillin MIP Pharma

• The patient should continue taking Amoxicillin MIP Pharma for as long as their doctor recommends, even if they feel better. All doses of the medicine are needed to fight the infection. If some bacteria survive, they may cause a relapse of the infection.
• If the patient does not feel better after finishing the treatment with Amoxicillin MIP Pharma, they should consult their doctor.

If the patient takes Amoxicillin MIP Pharma for a longer period, they may experience thrush (candidiasis - fungal infections of the mucous membranes causing local pain, itching, and white discharge). In this case, the patient should consult their doctor. If the patient takes Amoxicillin MIP Pharma for a longer period, their doctor may order additional tests of kidney, liver, and blood function. In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Amoxicillin MIP Pharma can cause side effects, although not everybody gets them.

If the patient experiences any of the following severe side effects, they should stop taking Amoxicillin MIP Pharma and contact their doctor immediately - they may need urgent medical attention:

Very rare side effects (may occur in less than 1 in 10,000 patients)

• allergic reactions, including: itching and skin rash, swelling of the face, lips, tongue, body, or difficulty breathing. These symptoms may be severe and, in rare cases, can be life-threatening.
• rash or flat, pink, red, round spots under the skin surface or bruising of the skin, which may be a sign of allergic vasculitis. This may be associated with joint pain (arthritis) and kidney disease.
• late allergic reactions occurring usually 7 to 12 days after taking Amoxicillin MIP Pharma, some of the observed symptoms include: rashes, fever, joint pain, and swollen lymph nodes, especially in the armpits.
• a skin reaction called erythema multiforme characterized by itchy, red-purple patches on the skin, especially on the hands or soles of the feet, skin swelling (resembling hives), irritation around the mouth, eyes, or genitals. Fever and fatigue may also occur.
• other severe skin reactions include: changes in skin color, lumps under the skin, blisters, pustules, peeling skin, redness, pain, itching, and flaking skin. These may be associated with fever, headache, and body aches.
• fever, chills, sore throat, and other signs of infection or a tendency to bruise. These may be signs of blood cell problems.
• Jarisch-Herxheimer reaction. When taking Amoxicillin MIP Pharma to treat Lyme disease (borreliosis), the patient may experience fever, chills, muscle and headache, and skin rash.
• colitis (inflammation of the colon), which can cause diarrhea (sometimes with blood), abdominal pain, and fever.
• severe liver reactions. These usually occur in patients treated for a longer period, men, and the elderly. The patient should immediately inform their doctor if they experience: severe diarrhea with blood, blisters, redness, or bruising of the skin, dark urine or pale stools, yellowing of the skin and whites of the eyes (jaundice). The patient should also read the information below about anemia, which can cause jaundice. These symptoms may occur during or up to several weeks after stopping the medicine.

The following severe side effects have been reported in a small number of patients, but their exact frequency is unknown:

• chest pain associated with an allergic reaction, which may be a sign of an allergy leading to a heart attack (Kounis syndrome)
• drug-induced colitis (a certain type of allergic reaction, the leading symptom of which is repeated vomiting (1-4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure
• aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord).

If the patient experiences any of these symptoms, they should stop taking the medicine and contact their doctor immediately.

Sometimes, less severe skin reactions may occur, such as:

• mildly itchy rash (round, red-pink patches), resembling hives, swelling of the forearms, legs, hands, feet, or face. This occurs uncommonly (in less than 1 in 100 patients).

If the patient experiences any of these symptoms, they should contact their doctor and stop taking Amoxicillin MIP Pharma.

Other side effects:

Common side effects(may occur in less than 1 in 10 patients)

• skin rash
• nausea
• diarrhea.

Uncommon side effects(may occur in less than 1 in 100 patients)

• vomiting.

Very rare side effects(may occur in less than 1 in 10,000 patients)

• thrush (fungal infections of the vagina, mouth, or skin folds), the doctor or pharmacist will advise on treatment
• kidney problems
• seizures, especially in patients taking high doses or having kidney problems
• dizziness
• excessive activity
• crystals in the urine (leading to acute kidney damage) visible as cloudy urine or difficulties or discomfort while urinating. To avoid these symptoms, the patient should drink plenty of fluids.
• tooth discoloration (in children), which can usually be removed by brushing
• yellow, brown, or black, hairy tongue
• excessive breakdown of red blood cells, which can lead to anemia. Symptoms include: fatigue, headaches, shortness of breath, dizziness, pallor, and yellowing of the skin and whites of the eyes.
• decreased white blood cell count
• decreased platelet count (cells involved in blood clotting)
• blood may take longer to clot than usual. This may be visible in case of nosebleeds or cuts.

Unknown(frequency cannot be estimated from the available data)

• rash with blisters arranged in a ring shape with crusts in the center or like a string of pearls (linear IgA dermatosis)

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Amoxicillin MIP Pharma

The medicine should be stored out of sight and reach of children.

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

Do not store above 30°C.

Store in the original packaging to protect from light.

Do not use this medicine if signs of damage are visible.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Amoxicillin MIP Pharma contains

The active substance of the medicine is 500 mg or 1000 mg of amoxicillin in each tablet.

The other ingredients are:

Microcrystalline cellulose

Low-substituted hydroxypropyl cellulose

Saccharin

Apricot flavor (flavorings, corn maltodextrin, triacetin, triethyl citrate)

Magnesium stearate

Anhydrous colloidal silica

Vanillin

What Amoxicillin MIP Pharma looks like and what the pack contains

Amoxicillin MIP Pharma 500 mg, tablets are white to off-white, elongated (approx. 19.0 x 7.6 mm) with a dividing line on one side.

Tablets can be divided into equal halves. They are packaged in blisters in a cardboard box. The packaging contains 8 or 24 tablets.

Amoxicillin MIP Pharma 1000 mg, tablets are white to off-white, elongated (approx. 24.0 x 12.0 mm) with a dividing line on one side.

Tablets can be divided into equal halves. They are packaged in blisters in a cardboard box. The packaging contains 8 or 16 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

MIP Pharma GmbH

Kirkeler Straße 41

66440 Blieskastel

Germany

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

Austria:

Amoxicillin MIP 500 mg Tabletten

Amoxicillin MIP 1000 mg Tabletten

Bulgaria:

Amoxicillin-MIP 500 mg

Amoxicillin-MIP 1000 mg

Denmark:

Amoxicillin "MIP"

Estonia:

Amoxicillin-MIP 500 mg

Amoxicillin-MIP 1000 mg

Finland:

Amoxicillin MIP Pharma 500 mg

Amoxicillin MIP Pharma 1000 mg

Latvia:

Amoxicillin MIP 500 mg

Amoxicillin MIP 1000 mg

Lithuania:

Amoxicillin MIP 500 mg tabletės

Amoxicillin MIP 1000 mg tabletės

Norway:

Amoxicillin MIP Pharma 500 mg

Amoxicillin MIP Pharma 1000 mg

Poland:

Amoxicillin MIP Pharma

Date of last revision of the leaflet: 16.03.2023

General advice on the use of antibiotics

Antibiotics are used to treat bacterial infections. They are ineffective in treating viral infections.

Sometimes, bacterial infections do not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria are resistant to the antibiotic. This means that the bacteria can survive or multiply despite the use of the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the possibility of bacteria developing resistance.

The antibiotic prescribed by the doctor is intended solely for the treatment of the current illness. Paying attention to the following advice will help prevent the development of resistant bacteria, which could render the antibiotic ineffective.

• 1. It is very important to take the antibiotic in the correct dose, at the right time, and for the right number of days. The patient should read the instructions in the leaflet and, if any of them are unclear, ask their doctor or pharmacist to explain.
• 2. The patient should not take an antibiotic that has not been prescribed specifically for them. They should only take it to treat the infection for which the antibiotic was prescribed.
• 3. The patient should not take an antibiotic prescribed for someone else, even if they had a similar infection.
• 4. The patient should not give their antibiotics to others.
• 5. If there are any leftover antibiotics after completing the treatment as directed by the doctor, the patient should return them to the pharmacy for proper disposal.