750 mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.
- Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
- If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4
In this leaflet you will find information about:
1. What Amoxicillin Mylan is and what it is used for
2. What you need to know before using Amoxicillin Mylan
3. How to use Amoxicillin Mylan
4. Possible side effects
5. How to store Amoxicillin Mylan
6. Contents of the pack and other information
What Amoxicillin Mylan is and what it is used for
What Amoxicillin Mylan is
Amoxicillin Mylan is an antibiotic. The active substance is amoxicillin, which belongs to the drug group “penicillins” with extended-spectrum “, which means that it has an effect against several different types of bacteria. Amoxicillin Mylan prevents the bacterium from building a normal cell wall. Without a functioning cell wall, the bacterium dies quickly.
What Amoxicillin Mylan is used for
Amoxicillin Mylan is used to treat infections caused by bacteria in various parts of the body. Amoxicillin Mylan can also be used in combination with other medicines to treat stomach ulcers.
2. What you need to know before you use Amoxicillin Mylan
Do not use Amoxicillin Mylan:
- if you are allergic to amoxicillin, penicillin, or any of the other ingredients of this medicine (listed in section 6).
- if you have previously had an allergic reaction to any antibiotic. For example, there may be a rash or swelling of the face or throat.
Do not take Amoxicillin Mylan if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Amoxicillin Mylan.
Warnings and cautions
Talk to your doctor or pharmacist before taking Amoxicillin Mylan if you:
- have glandular fever (fever, sore throat, swollen lymph nodes, and severe fatigue)
- have kidney problems
- do not urinate periodically.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Amoxicillin Mylan.
Blood and urine samples
If you are leaving:
- urine tests ( glucose ) or blood tests to check liver function
- estradiol samples (taken during pregnancy to check that the baby is developing normally)
you should tell your doctor or pharmacist that you are taking Amoxicillin Mylan. Amoxicillin Mylan may affect test results.
Other medicines and Amoxicillin Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- If you take allopurinol (for gout ) together with Amoxicillin Mylan, the risk of an allergic skin reaction may increase.
- If you are taking probenecid (for gout ), your doctor may change the Amoxicillin Mylandosis.
- If you are taking medicines to prevent blood clots (eg warfarin ), you may need to submit more blood samples.
- If you take other antibiotics (eg tetracycline ), Amoxicillin Mylan may be less effective.
- If you are taking methotrexate (used to treat cancer and severe psoriasis ), Amoxicillin Mylan may increase the side effects.
Amoxicillin Mylan with food and drink
Amoxicillin Mylan can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Amoxicillin Mylan can have side effects and the symptoms (such as allergic reactions, dizziness, and cramps) can make you unsuitable as a driver.
Do not drive or use machines unless you are feeling well.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Amoxicillin Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet / ie is essential ‘sodium-free’.
3. How to use Amoxicillin Mylan
Always take this medicine exactly as your doctor or pharmacist has told you. Doseone is determined by the doctor who adjusts it individually for you.
Ask your doctor or pharmacist if you are unsure.
Distribute the doses evenly throughout the day at least 4 hours apart.
The usual dose is:
As Amoxicillin Mylan is only available in 750 mg film-coated tablets, not all dosages are possible. If other strengths or pharmaceuticals are needed, other amoxicillin products should be used.
Children weighing less than 40 kg
All doses are calculated based on the child’s body weight in kg.
- Your doctor will tell you how much Amoxicillin Mylan to give to your baby.
- The usual dose is 40-90 mg per kg body weight in one day, divided into two or three doses.
- The highest recommended dose is 100 mg per kg of body weight per day.
Adults, elderly patients, and children weighing 40 kg or more
The usual dose of Amoxicillin Mylan is 250–500 mg three times a day, or 750 mg – 1 gram every 12 hours, depending on the severity and type of infection.
- Serious infection: 750 mg – 1 gram three times a day.
- Urinary tract infection: 3 grams twice a day for 24 hours.
- Lyme disease (an infection spread by ticks): Occasional erythema migrans (early stage – a red or pink circular rash): 4 grams per day. For systemic symptoms (late-stage – for more severe symptoms or when the disease spreads in the body): Up to 6 grams per day.
- Gastric ulcer: A dose of 750 mg or 1 gram twice daily for 7 days along with other antibiotics and medicines for gastric ulcer.
- To prevent heart infection during surgery: The dose varies depending on the type of surgery. Other medicines can also be given at the same time. A doctor, pharmacist, or nurse can give you more information.
- The highest recommended dose is 6 grams per day.
If you have kidney problems, you may be given a lower dose.
The tablet can be divided into equal parts and can also be crushed.
If you forget to take Amoxicillin Mylan
- If you forget to take a dose, take it as soon as you remember.
- Do not take the next dose too soon, but wait about 4 hours before taking the next dose.
- Do not take a double dose to make up for a forgotten dose.
How long should you take Amoxicillin Mylan?
- Keep taking Amoxicillin Mylan for as long as your doctor tells you, even if you feel better. All doses are needed to fight infection one. If some bacteria survive, the infection can return.
- If you still do not feel well when the treatment is over, see a doctor again.
Cod (a fungal infection that can occur in moist areas of the body and cause soreness, itching, and a white discharge) can develop if you use Amoxicillin Mylan for a long time. If you get cod, tell your doctor.
If you are taking Amoxicillin Mylan for a long time, your doctor may want to take extra samples to check that your kidneys, liver, and blood have normal functions.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Amoxicillin Mylan and see a doctor immediately if you get any of the following serious side effects – you may need immediate medical attention:
The following side effects are very rare (may affect up to 1 in 10,000 people)
- Allergic reactions, which may manifest as itching or rash, swelling of the face, lips, tongue, or body, or difficulty breathing. These can be serious and deaths have occurred.
- Rash or flat, pin-sized red round dots under the skin surface, or bruises. These are caused by an inflammation of the walls of the blood vessels due to an allergic reaction. Joint pain ( arthritis ) and kidney problems can occur at the same time.
- Delayed allergic reaction, which usually occurs 7 to 12 days after taking Amoxicillin Mylan. Some of the signs of such a reaction are rash, fever, joint pain, and enlarged lymph nodes, especially in the armpits.
- A skin reaction called “erythema multiforme”, when you can get itchy reddish-purple spots on the skin, especially on the palms and soles of the feet, hives-like raised swellings in the skin, sore areas in the oral cavity, eyes, and genitals. You may get a fever and feel very tired.
- Other serious skin reactions may include skin discoloration, lumps under the skin, blisters, blisters, scaling, redness, pain, itching, and flaky skin. Fever, headache, and body aches can occur at the same time.
- Flu-like symptoms with rash, fever, swollen glands, and abnormal results from blood tests (including increased white blood cell count ( eosinophilia ) and liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).
- Fever, chills, sore throat, and other signs of infection, or you can easily get bruises. This may be a sign that the blood cells are affected.
- The Janisch-Herxheimer reaction may occur where Lyme disease is treated with amoxicillin Mylan and cause fever, chills, headache, muscle aches, and rash.
- Inflammation of the colon with diarrhea (sometimes mixed with blood), pain, and fever.
- Serious liver side effects may occur. They mainly affect people who are treated for a long time, men and the elderly. You must tell your doctor immediately if you get:
- severe diarrhea with bleeding
- blisters or redness on the skin, or bruising
- darker urine or lighter stools
- yellowing of the skin or whites of the eyes (jaundice). Also read about anemia below, which can cause jaundice.
These side effects may occur during treatment or for several weeks afterward.
If you get any of the above side effects, stop taking the medicine and see a doctor immediately.
Occasionally, minor skin reactions may occur, such as:
- Slightly itchy rash (round, pinkish spots), hives-like swollen areas on forearms, legs, palms, hands, or feet. This is less common (may affect up to 1 in 100 people).
If you get any of these side effects, talk to your doctor. Treatment with Amoxicillin Mylan must be discontinued.
Other possible side effects are:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Very rare (may affect up to 1 in 10,000 people)
- Cod (a yeast infection in the vagina, mouth, or skin folds). Doctors or pharmacists can give you medicines for cod.
- Kidney problems.
- Cramps. Occurs in people who take high doses or have kidney problems.
- Crystals in the urine, which turn out to be cloudy urine, or difficulty or pain when urinating. Be sure to drink plenty of fluids to reduce the risk of developing such symptoms.
- The tongue may discolor and turn yellow, brown, or black and have a hairy appearance.
- Severe breakdown of red blood cells that cause a certain type of anemia ( anemia). Signs of this are Fatigue, headache, shortness of breath, dizziness, paleness, and yellowish skin and whites of the eyes.
- Low white blood cell count.
- An l number of blood cell types involved in blood coagulation.
- It may take longer than normal for the blood to coagulate. You may notice this if you get nosebleeds or cut yourself.
No known frequency (cannot be calculated from the available data)
- Inflammation of the meninges ( aseptic meningitis ).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Amoxicillin Mylan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP or EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C. Store in the original package in order to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
- The active substance is Amoxicillin trihydrate equivalent to amoxicillin 750 mg.
- Other ingredients are:
Tablet core: Microcrystalline cellulose, sodium starch glycolate, povidone, and magnesium stearate.
Film coating: Talc, titanium dioxide (dye E171), and hypromellose.
What the medicine looks like and the contents of the pack
Pressure pack with 14 and 20 tablets.
Marketing Authorisation Holder
104 35 Stockholm