1 g 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:
1. What Imacillin is and what it is used for
2. What you need to know before you use Imacillin
3. How to take Imacillin
4. Possible side effects
5. How to store Imacillin 6. Contents of the pack
and other ingredients information
1. What Imacillin is and what it is used for
What Imacillin is
Imacillin is an antibiotic. The active substance is amoxicillin, which belongs to the group of drugs “penicillins with extended-spectrum”, which means that it has an effect against several different types of bacteria. Imacillin prevents the bacterium from building a normal cell wall. Without a functioning cell wall, the bacterium dies quickly.
What Imacillin is used for
Imacillin is used to treat infections caused by bacteria in different parts of the body.
Imacillin can also be used in combination with other medicines to treat stomach ulcers.
2. What you need to know before you use Imacillin
Do not take Imacillin
- 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 Imacillin if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Imacillin.
Warnings and cautions
Talk to your doctor or pharmacist before taking Imacillin 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 Imacillin.
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 Imacillin. Imacillin may affect test results.
Other medicines and Imacillin
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 Imacillin, the risk of having an allergic skin reaction may increase.
- If you are taking probenecid (for gout ), your doctor may adjust Imacillin- dose one.
- 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 ) Imacillin may be less effective.
- If you are taking methotrexate (used to treat cancer and in severe psoriasis ), Imacillin may increase the side effects .
Imacillin with food and drink
Imacillin can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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
Imacillin 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.
Imacillin contains aspartame
This medicine contains 20 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
How to take Imacillin
Always take this medicine exactly as your doctor or pharmacist has told you. Dose one is determined by the doctor who adjusts it individually for you. Ask your doctor or pharmacist if you are unsure.
As Imacillin is only available as a tablet with a strength of 1 g, not all dosages are possible. This form of medicine is also not suitable for younger children. If other strengths or pharmaceuticals are needed, other amoxicillin products should be used.
Distribute the doses evenly throughout the day at least 4 hours apart.
The tablet can be swallowed whole or dissolved in a glass of water.
The usual dose is:
Adults, elderly patients, and children weighing 40 kg or more:
The usual dose 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 per day.
The highest recommended dose is 6 grams per day.
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 Imacillin to give your child.
The usual dose is 40-90 mg per kg body weight in one day, divided into two to three doses.
The highest recommended dose is 100 mg per kg body weight per day.
Kidney problems :
If you have kidney problems, you may be given a lower dose.
How long should you take Imacillin?
• Keep taking Imacillin 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 come back.
• If you still do not feel well when the treatment is over, see a doctor again.
If you take more Imacillin than you should
If you have taken too much Imacillin, you may have an upset stomach (nausea, vomiting, or diarrhea) or crystals in your urine, which may turn out to be cloudy urine or difficulty urinating. If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Imacillin
- 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 .
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 Imacillin for a long time. If you get cod, tell your doctor.
If you are taking Imacillin for a long time, your doctor may want to take extra samples to check that your kidneys, liver, and blood are functioning normally.
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 Imacillin and contact 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 in 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 Imacillin. 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.
- Influenza-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 bruising easily. This may be a sign that the blood cells are affected.
- Jarisch-Herxheimer reaction may occur where Lyme disease is treated with Imacillin, 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 afterwards.
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. Imacillin treatment must be stopped.
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 discolour 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 .
- Low number of the type of blood cells 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.
Has been reported (occurs in an unknown number of users)
- Inflammation of the meninges ( aseptic meningitis ).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Imacillin
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. The expiration date is the last day of the specified month.
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
1 tablet contains:
The active substance is: amoxicillin trihydrate corresponding to amoxicillin 1 g.
The other ingredients are polyvidone, flavoring (peppermint), sweetener (aspartame), magnesium stearate.
What the medicine looks like and contents of the pack
Marketing Authorisation Holder:
Meda AB, Box 906, 170 09 Solna
Phone: 08-630 19 00