Amoxicillin mip pharma

Package leaflet: Information for the user

Amoxicillin MIP Pharma, 500 mg, tablets
Amoxicillin MIP Pharma, 1000 mg, tablets
Amoxicillin
Please read all of this leaflet carefully before 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) personally. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Amoxicillin MIP Pharma is and what it is used for
2. What you need to know 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 pack and other information

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

What Amoxicillin MIP Pharma is
Amoxicillin MIP Pharma is an antibiotic. The active substance is amoxicillin. Amoxicillin belongs to a group of medicines called "penicillins".
Why Amoxicillin MIP Pharma is used
Amoxicillin MIP Pharma is used to treat bacterial infections affecting various parts of the body.
Amoxicillin MIP Pharma may also be used, together with other medicines, in the treatment of peptic ulcer disease.

2. Important information before taking Amoxicillin MIP Pharma

When not to use Amoxicillin MIP Pharma

• if the patient is allergic to amoxicillin, penicillin, or any of the other ingredients of this medicine (listed in section 6).
• if the patient has ever had an allergic reaction to any other antibiotic. This may include skin rash or swelling of the face or throat.

If any of the above situations apply, the patient should not take Amoxicillin MIP Pharma.
In case of doubt, consult the treating physician or pharmacist before starting treatment with
Amoxicillin MIP Pharma.
Warnings and precautions
Before starting treatment with Amoxicillin MIP Pharma, discuss with the doctor or pharmacist if the patient:

• has infectious mononucleosis (fever, sore throat, swollen lymph nodes, and extreme fatigue)
• has kidney disease
• urinates irregularly.

If in doubt whether any of the above conditions apply, consult the treating physician or pharmacist before starting to take Amoxicillin MIP Pharma.
Blood and urine tests
If the patient is undergoing:

• urine tests (for glucose) or blood tests to assess liver function,
• tests measuring estriol levels (performed during pregnancy to check whether the baby is developing normally), inform the doctor or pharmacist that the patient is taking Amoxicillin MIP Pharma. Amoxicillin MIP Pharma may affect the results of these tests.

Amoxicillin MIP Pharma and other medicines
Tell the doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

• If the patient is taking allopurinol (used to treat gout) together with Amoxicillin MIP Pharma, skin allergic reactions may be more likely.
• If the patient is taking probenecid (used to treat gout). Concurrent use of probenecid may reduce amoxicillin excretion and is not recommended.
• If the patient is taking anticoagulant medicines (such as warfarin), additional blood tests may be required.
• If the patient is taking other antibiotics (such as tetracyclines), Amoxicillin MIP Pharma may be less effective.
• If the patient is taking methotrexate (used in cancer treatment and severe psoriasis). Penicillins may reduce methotrexate excretion, increasing the risk of adverse effects.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Amoxicillin MIP Pharma may cause adverse effects and symptoms (such as allergic reactions, dizziness, and seizures) that may impair the ability to drive.
Do not drive or operate machinery unless the patient feels well.
3. How to take Amoxicillin MIP Pharma
This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, consult the doctor or pharmacist.

• Tablets should be taken either as a suspension prepared with drinking water or swallowed whole with an adequate amount of water (e.g., one glass). Tablets may be split to adjust to the required dose or to facilitate swallowing.
• Maintain regular intervals of at least 4 hours between doses taken during the day.

Typical dosage:
Children weighing less than 40 kg
All doses are determined based on the child's body weight in kilograms.

• The treating physician will advise 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, divided into two or three doses.
• The maximum recommended dose is 100 mg per kilogram of body weight per day.

Adults, elderly patients, and children weighing 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 - tick-borne infection): erythema migrans (early stage - pinkish-red rash): 4 g per day. Systemic symptoms (late stage - more severe symptoms or multi-organ involvement): up to 6 g per day.
• Peptic ulcer disease: 750 mg or 1 g twice daily for 7 days in combination with other antibiotics and medicines used to treat gastric ulcers.
• Prevention of endocarditis during surgical procedures: the dose may vary depending on the type of surgical procedure. Other medicines may be administered simultaneously. For more detailed information, consult the 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 more than the recommended dose of Amoxicillin MIP Pharma
If the patient takes more Amoxicillin MIP Pharma than recommended, symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhea) or crystals in the urine (which may appear as cloudy urine or difficulty urinating) may occur. Contact the treating physician as soon as possible. Bring the medicine along to show the doctor.
Missing a dose of Amoxicillin MIP Pharma

• If the patient forgets to take a dose, take it as soon as remembered.
• Do not take the next dose too early; wait approximately 4 hours before taking the next dose.
• Do not take a double dose to make up for a missed dose.

How long to take Amoxicillin MIP Pharma

• Continue taking Amoxicillin MIP Pharma for as long as directed by the doctor, even if the patient feels better. All doses are necessary to eliminate the infection. If some bacteria survive, they may cause the infection to recur.
• If the patient still does not feel better after completing treatment with Amoxicillin MIP Pharma, consult the doctor.

Prolonged use of Amoxicillin MIP Pharma may lead to fungal infections
(candidiasis – yeast infections of mucous membranes causing local pain, itching, and white discharge). In such cases, consult the doctor.
If the patient takes Amoxicillin MIP Pharma for a prolonged period, the doctor may order additional tests to monitor kidney and liver function and blood parameters.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient experiences any of the following severe adverse effects, treatment with Amoxicillin MIP Pharma must be stopped immediately and the doctor should be contacted – the patient may require immediate medical attention:
Very rare adverse effects (may occur in no more 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, may be fatal.
• Rash or small, flat, red, round spots beneath the skin surface, or skin bruising, which may indicate vasculitis (inflammation of blood vessels) due to an allergic reaction. This may be associated with joint pain (arthritis) and kidney disease.
• Delayed-type allergic reactions, usually occurring 7 to 12 days after taking Amoxicillin MIP Pharma. Some observed symptoms include: rashes, fever, joint pain, and enlarged lymph nodes, especially under the arms.
• A skin reaction known as erythema multiforme, characterized by itchy red-purple skin lesions, especially on the palms or soles of the feet, skin swelling (resembling hives), irritation around the mouth, eyes, or genital organs. Fever and fatigue may also occur.
• Other severe skin reactions include: skin discoloration, subcutaneous nodules, blisters, pustules, skin peeling, redness, pain, itching, and skin desquamation. These may be associated with fever, headache, and body aches.
• Fever, chills, sore throat, and other signs of infection or tendency to bruise easily. These may indicate blood cell disorders.
• Jarisch-Herxheimer reaction. During treatment with Amoxicillin MIP Pharma for Lyme disease (borreliosis), fever, chills, muscle and headache, and skin rash may occur.
• Inflammation of the large intestine causing diarrhea (sometimes with blood), abdominal pain, and fever.
• Severe adverse effects affecting the liver may occur. These usually occur in patients undergoing prolonged treatment, males, and elderly individuals. The doctor should be informed immediately if the patient experiences: severe diarrhea with bleeding, blisters, skin redness or bruising, dark urine or pale stools, or yellowing of the skin and whites of the eyes (jaundice). Please also read the information below regarding anemia that may cause jaundice. These symptoms may occur during or up to several weeks after discontinuation of the medicine.

The severe adverse effects described below have occurred in a small number of individuals, but their exact frequency is unknown:

• Chest pain associated with an allergic reaction, which may indicate an allergy leading to myocardial infarction (Kounis syndrome)
• Drug-induced enterocolitis (DIES). Drug-induced enterocolitis has occurred mainly in children receiving amoxicillin. It is a type of allergic reaction characterized primarily by recurrent vomiting (1-4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

If the patient experiences any of these symptoms, treatment must be stopped immediately and the doctor should be contacted.
Less severe skin reactions may sometimes occur, such as:

• Moderately itchy rash (round, red-pink lesions), resembling hives, and swelling on the forearms, legs, hands, or feet. This occurs uncommonly (may occur in no more than 1 in 100 patients).

If the patient experiences any of these symptoms, contact the doctor and discontinue treatment with Amoxicillin MIP Pharma.
Other adverse effects:
Common adverse effects (may occur in no more than 1 in 10 patients)

• Skin rash
• Nausea
• Diarrhea.

Uncommon adverse effects (may occur in no more than 1 in 100 patients)

• Vomiting.

Very rare adverse effects (may occur in no more than 1 in 10,000 patients)

• Fungal infections (vaginal, oral, or skin fold candidiasis); a doctor or pharmacist can advise on treatment
• Kidney problems
• Seizures, especially in patients receiving high doses or with kidney problems
• Dizziness
• Hyperactivity
• Crystals in the urine (leading to acute kidney injury), visible as cloudy urine or difficulty or discomfort during urination. To avoid these symptoms, 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, leading to hemolytic anemia. Symptoms include fatigue, headache, shortness of breath, dizziness, pallor, and yellowing of the skin and whites of the eyes.
• Decreased number of white blood cells
• Decreased number of platelets (cells involved in blood clotting)
• Blood may take longer than usual to clot. This may be observed as nosebleeds or prolonged bleeding from cuts.

Unknown (frequency cannot be determined from available data)

• Blistering rash arranged in a ring-like pattern with scabs in the center or resembling a string of pearls (linear IgA dermatosis)

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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. Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Amoxicillin MIP Pharma

Keep the medicine 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 stated month.
Do not store above 30°C.
Keep in the original packaging to protect from light.
Do not use this medicine if you notice any signs of damage.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Amoxicillin MIP Pharma contains
The active substance is 500 mg or 1000 mg of amoxicillin in each tablet.
The other ingredients are:
Microcrystalline cellulose
Low-substituted hydroxypropylcellulose
Saccharin
Apricot flavour (flavours, corn maltodextrin, triacetin, triethyl citrate)
Magnesium stearate
Anhydrous colloidal silicon dioxide
Vanillin

What Amoxicillin MIP Pharma looks like and contents of the pack
Amoxicillin MIP Pharma 500 mg tablets are white to off-white, oblong-shaped (approx. 19.0 x 7.6 mm) with a score line on one side.
The tablets can be divided into equal halves. They are packed in blisters in a cardboard box. The pack contains 8 or 24 tablets.

Amoxicillin MIP Pharma 1000 mg tablets are white to off-white, oblong-shaped (approx. 24.0 x 12.0 mm) with a score line on one side.
The tablets can be divided into equal halves. They are packed in blisters in a cardboard box. The pack contains 8 or 16 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
MIP Pharma GmbH
Kirkeler Straße 41
66440 Blieskastel
Germany

This medicinal product is authorised in the European Economic Area countries
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

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 administered. This means that bacteria can survive or multiply despite the use of the antibiotic.

Bacteria may become resistant to antibiotics for various reasons. Careful use of antibiotics may help reduce the risk of bacterial resistance development.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness. Observing the following advice will help prevent the development of resistant bacteria that could hinder the effectiveness of antibiotics.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the prescribed number of days. Please read the instructions in this leaflet carefully and, if any of them are unclear, ask your doctor or pharmacist for clarification.
2. The patient should not take an antibiotic unless it has been specifically prescribed for them. It should be taken only to treat the infection for which it was prescribed.
3. The patient should not take an antibiotic prescribed for another person, even if that person had a similar infection.
4. Do not give antibiotics prescribed for you to other people.
5. If any unused antibiotic remains after completing the treatment as recommended by your doctor, return it to a pharmacy for proper disposal.