50 mg / ml and 100 mg / ml Powder for oral suspension
Amoxicillin
1. What Imaxi is and what it is used for
What Imaxi is
Imaxi is an antibiotic. The active substance is amoxicillin. Amoxicillin belongs to the group of drugs penicillin er.
What Imaxi is used for
Imaxi is used to treat infections caused by bacteria in different parts of the body. Imaxi can also be used in combination with other medicines to treat stomach ulcers.
Amoxicillin contained in Imaxi may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Imaxi
Do not use Imaxi
- if you are allergic to amoxicillin, other penicillins 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 Imaxi if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Imaxi.
Warnings and cautions
Talk to your doctor or pharmacist before taking Imaxi 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 Imaxi.
Blood and urine samples
If you are leaving:
- urine tests ( glucose ) or blood tests to check liver function
- estriol samples (taken during pregnancy to check that the baby is developing normally).
Tell your doctor or pharmacist that you are taking Imaxi. Imaxi may affect test results.
Other medicines and Imaxi
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 Imaxi, the risk of having an allergic skin reaction may increase.
- If you are taking probenecid (for gout ), your doctor may decide to adjust Imaxi- 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 ), Imaxi may be less effective.
- If you are taking methotrexate (used to treat cancer and in severe psoriasis ), Imaxi may increase the side effects .
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Driving and using machines
Imaxi can have side effects and the symptoms (eg 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 sharpened 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.
Imaxi contains Glucose
This medicine contains maltodextrin ( glucose ). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use Imaxi
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- Shake the bottle well before use.
- Distribute the doses evenly throughout the day (at least 4 hours apart).
The recommended dose is:
Children weighing less than 40 kg
All doses are calculated according to the child’s body weight in kg.
- Your doctor will tell you how much Imaxi to give to your baby or baby.
- The recommended 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 body weight per day.
Adults, the elderly, and children weighing 40 kg or more
Suspension one is not normally prescribed for adults and children weighing more than 40 kg. Consult a doctor or pharmacist.
Kidney problems
If you have kidney problems, you may receive a lower dose than the usual dose.
If you use more Imaxi than you should
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 have taken too much Imaxi, signs of this may include stomach upset (nausea, vomiting, or diarrhea), crystals in the urine (which turns out to be cloudy urine), or difficulty urinating. Talk to a doctor as soon as possible. Take the medicine with you and show it to your doctor.
If you forget to use Imaxi
- If you forget to take a dose , take it as soon as you remember and wait about 4 hours before taking the next dose .
- Do not take a double dose to make up for a forgotten dose .
If you stop using Imaxi
How long should you take Imaxi?
- Keep taking Imaxi 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, infection can return.
- If you still do not feel well when the treatment is over, you should 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 Imaxi for a long time. If you get cod, tell your doctor.
If you are taking Imaxi for a short period of 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 Imaxi 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 that 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 7-12 days after taking Imaxi. 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 severe skin reactions can include changes in skin color, bumps 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 bruising easily. This may be a sign that the blood cells are affected.
- Herxheimer reaction may occur where Lyme disease is treated with iMaxi via and cause fever, chills, headache, muscle aches and rash
- inflammation of the colon with diarrhea (sometimes bloody), pain and fever
- severe 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, redness or bruising on the skin
- darker urine or lighter stools
- yellow skin or yellow whites of the eyes (jaundice). Also read below about anemia that can cause jaundice.
These side effects may occur during treatment or up to several weeks afterward.
If you get any of the above side effects, stop taking the medicine and see a doctor immediately.
Occasionally, less severe skin reactions may occur, for example:
- 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 as treatment with Imaxi must be stopped.
Other possible side effects are:
Common side effects are (may affect up to 1 in 10)
- rash
- nausea
- diarrhea.
Less common side effects are (may affect up to 1 in 100)
- vomiting.
Very rare side effects are (may affect up to 1 in 10 000 users)
- 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 patients taking high doses or having kidney problems.
- dizziness
- hyperactivity
- crystals in the urine (which turns out to be cloudy urine) or difficulty or discomfort when urinating. Be sure to drink plenty of fluids to reduce the risk of developing such symptoms.
- teeth can become discolored but usually return to normal appearance when brushing teeth (this has been reported in children)
- the tongue may discolour and turn yellow, brown or black and have a hairy appearance
- severe degradation of red blood cells that causes 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 ar
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
The Medical Products Agency
Box 26
751 03 Uppsala
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 Imaxi
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. The expiration date is the last day of the specified month.
Before preparation:
Do not store above 25 ° C.
After preparation:
Store in a refrigerator (2 ° C-8 ° C). Once the powder has been mixed with purified water, the suspension should be used within 10 days.
Do not use this medicine if it shows signs of deterioration.
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
Content declaration
The active substance is amoxicillin. 1 ml of oral suspension contains 50 mg or 100 mg of amoxicillin.
50 mg / ml
The other ingredients are crospovidone type A, silica, xanthan gum, colloidal anhydrous silica, acesulfame potassium, saccharin sodium, strawberry flavor (maltodextrin, triethyl citrate [E 1505], flavor components, propylene glycol, and benzyl alcohol).
100 mg / ml
The other ingredients are crospovidone type A, silica, xanthan gum, colloidal anhydrous silicon, acesulfame potassium, saccharin sodium, strawberry flavor (maltodextrin, triethyl citrate [E 1505], flavor components, propylene glycol, and benzyl alcohol).
What the medicine looks like and contents of the pack
Imaxi 50 mg / ml powder for oral suspension:
White to yellowish powder to be mixed with purified water to obtain an oral suspension with strawberry flavor.
The powder is supplied in amber glass bottles containing 60 ml, 75 ml, 80 ml, 100 ml, 120 ml, or 125 ml oral suspension and sealed with a white screw cap.
The bottles are packed in cartons together with a 6 ml plastic syringe for dosing. The syringe is graduated from 0.5 ml to 6 ml.
Imaxi 100 mg / ml powder for oral suspension:
White to yellowish powder to be mixed with purified water to obtain an oral suspension with strawberry flavor.
The powder is supplied in amber glass bottles containing 60 ml, 100 ml, or 125 ml oral suspension and sealed with a white screw cap.
The bottles are packed in cartons together with a 6 ml plastic syringe for dosing. The syringe is graduated from 0.5 ml to 6 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
2care4 Generics ApS
Stenhuggervej 12-14
DK-6710 Esbjerg V
Denmark
Manufacturer:
Pencef Pharma GmbH
Breitenbachstrasse 13-14
13509 Berlin
Germany
Haupt Pharma Latina SRL
Borgo San Michele Strada Statale N. 156
KM 47,600 Latina
04100 Italy
This medicinal product is authorized under the European Economic Area under the names:
| Denmark | Imaxi 50 mg / ml |
| Norway | Imaxi 50 mg / ml and 100 mg / ml |
| Sweden | Imaxi 50 mg / ml and 100 mg / ml |
General advice on the use of antibiotics
Antibiotics are used to treat infections caused by bacteria. They have no effect against infection caused by viruses.
Sometimes an antibiotic regimen does not help with a bacterial infection. One of the most common reasons for this is that the bacterium that causes your infection is resistant (resistant) to the antibiotic used. This means that the bacterium can survive and even multiply despite the antibiotic treatment.
Bacteria can become resistant to antibiotics for many reasons. By being restrained with antibiotics, you can reduce the risk of the bacteria becoming resistant.
When you are prescribed a course of antibiotics by your doctor, it is only there to treat the ongoing disease. Follow the recommendations below and you can help prevent the development of bacterial resistance that can make the antibiotic preparation no longer have any effect.
- It is very important that you take your antibiotic at the right dose , at the right time and for as long as your doctor prescribes it. Read the instructions in the package leaflet and ask your doctor or pharmacist to explain if there is anything you do not understand.
- Do not take antibiotics that have not been prescribed specifically for you. Use it only to treat the infection for which it was prescribed.
- Do not take antibiotics that have been prescribed to other people, even if they have an infection similar to yours.
- Do not give antibiotics prescribed to you to anyone else.
- If you have antibiotics left over after taking a treatment according to your doctor’s instructions, take the leftovers to the pharmacy, which will take care of the waste in an appropriate manner