AMOKSIKLAV 400mg/57mg/5ml 140ml susp
Leaflet: user information
A moxiclav 400 mg /57 mg /5 ml powder for oral suspension
Amoksiklav 400 mg /57 mg /5 ml powder for oral suspension
Amoxicillin/clavulanic acid
( Amoxicillin / clavulanic acid )
Read all of this leaflet carefully before you start 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you/your child. Don't leave it to other people. It can harm them, even if the signs of their illness are the same as yours/your child's.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
What this leaflet contains
- What Amoxiclav is and what it is used for
- What you need to know before taking Amoxiclav
- How to take Amoxiclav
- Possible side effects
- How to store Amoxiclav
- Package contents and additional information
1. What Amoxiclav is and what it is used for
Amoxiclav is an antibiotic and works by killing the bacteria that cause infections.
It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called 'penicillins' which can sometimes be stopped working (become inactive). The other active ingredient (clavulanic acid) prevents this from happening.
Amoxiclav is used in infants and children, less often in adults, to treat the following infections:
- middle ear and sinus infections,
- respiratory tract infections,
- urinary tract infections
- skin and soft tissue infections, including dental infections
- bone and joint infections.
2. What you need to know before taking Amoxiclav
Do not use Amoxiclav in your child:
- if allergic to amoxicillin or clavulanic acid or to any of the other ingredients of this medicine (listed in section 6).
- have ever had a severe allergic reaction (hypersensitivity reaction) to another antibiotic. This may include a skin rash or swelling of the face or neck.
- have ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.
→ Do not use Amoxiclav in your child if any of the above applies to him. If you are not sure, check with his doctor or pharmacist before giving him Amoxiclav.
Warnings and precautions
Talk to your doctor or pharmacist before using Amoxiclav in your child if:
- has glandular fever
- has been treated for liver or kidney problems
- has irregular urination
If you are not sure if any of the above applies to your child, ask a doctor or pharmacist before giving Amoxiclav.
In some cases, the doctor may test for the type of bacteria that is causing your child's infection. Depending on the results, your child may be prescribed Amoxiclav with a different content of the active substance or another drug.
Conditions to watch out for
Amoxiclav may worsen some existing conditions or cause serious side effects. These include allergic reactions, convulsions (seizures) and inflammation of the colon. You should watch out for some symptoms while your child is taking this medicine to reduce the risk of problems. See “ Conditions to watch out for” in section 4.
Blood or urine tests
If your child is having blood tests (such as red blood cell count or liver function tests) or urine tests, tell the doctor or nurse that he is taking Amoxiclav. This is necessary because Amoxiclav can affect the results of these types of studies.
Other drugs and Amoxiclav
Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take any other medicines.
You should consult your doctor if you or your child are taking any of the following medicines:
- allopurinol (used to treat gout) may be more likely to cause an allergic skin reaction
- probenecid (to treat gout) the doctor may decide to adjust the dose of Amoxiclav
- medicines that suppress blood clotting (such as warfarin) may require additional blood tests
- methotrexate (used to treat cancer or rheumatic diseases): Amoxiclav may affect how it works
- mycophenolate mofetil (used to suppress the immune system in transplants): close clinical monitoring is required during co-administration with the antibiotic and for a short period thereafter.
Amoxiclav with food and drink
To minimize the possibility of gastrointestinal intolerance, take or give Amoxiclav to your child immediately before a meal.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine.
The possibility of increased sensitivity should be considered.
This medicinal product contains sodium. The lemon fragrance contains benzyl alcohol.
This medicine contains less than 1 mmol sodium (23 mg) in 5 ml ie. it can be said to be practically sodium-free.
This medicine contains benzyl alcohol.
Benzyl alcohol can cause allergic reactions.
Benzyl alcohol is associated with a risk of severe side effects, including breathing problems (called "choking syndrome") in young children. Do not use in newborns (under 4 weeks of age) unless recommended by your doctor.
Do not use for more than one week in young children (under 3 years of age) unless recommended by your doctor or pharmacist.
Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding, as large amounts of benzyl alcohol can build up in your body and cause an unwanted reaction (called 'metabolic acidosis').
Ask your doctor or pharmacist for advice if you have kidney or liver disease, because large amounts of benzyl alcohol can build up in your body and cause an unwanted reaction (called 'metabolic acidosis').
3. How to use Amoxiclav
Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Adults and children weighing more than 40 kg | This suspension is generally not recommended for adults and children over 40 kg. Ask your doctor or pharmacist for advice. |
Children weighing less than 40 kg | All doses are determined depending on the child's body weight in kilograms. Your doctor will tell you what amount to give your baby or child.
|
Patients with kidney and liver problems
- If you or your child have kidney problems, the dose may be reduced. different content of the active substance or another medicine. Your doctor may choose a different concentration of the active substance or a different medicine.
- If you or your child have liver problems, more frequent blood tests may be needed to monitor how their liver is working.
How to use A moxiclav
• Always shake the bottle well before each dose
• Give the dose at the beginning of the meal or shortly before
• Divide doses evenly throughout the day, at least every 4 hours. Do not take 2 doses in 1 hour.
• Do not take or give your child Amoxiclav for more than 2 weeks. If you or your child still feel unwell, you should take them back to the doctor.
How to prepare this medicine
Before use, check that the cap seal is tight. Shake the bottle to break up the dust. Add the volume of water (as indicated below) in two portions (first to 2/3 and then to the mark), shaking well after each portion. Shake the contents of the bottle well before each intake.
- For 35 ml of Amoxiclav oral suspension 400 mg/57 mg/5 ml add 29.5 ml of water
- For 70 ml of Amoxiclav oral suspension 400 mg/57 mg/5 ml add 59 ml of water
- For 140 ml of Amoxiclav oral suspension 400 mg/57 mg/5 ml add 118 ml of water
If you have taken or given more than the required dose of Amoxiclav to your child
If you take or give your child more than the right dose of Amoxiclav, symptoms may include stomach upset (nausea, vomiting or diarrhoea) or convulsions. Consult your doctor or the child's doctor as soon as possible. Take the medicine bottle to show the doctor.
If you forget to take or give Amoxiclav to your child
If you miss taking or giving your child a dose, do it as soon as you remember. Do not take the next dose too soon, about 4 hours should pass between the two doses.
If you or your child stops taking Amoxiclav
Continue to take or give Amoxiclav to your child until treatment is complete, even if you or he or she feels better. You or your child need each dose to help fight the infection. If some bacteria survive, they can cause the infection to re-emerge.
If you have any further questions related to 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.
Conditions to watch out for
Allergic reactions :
- skin rash
- inflammation of the blood vessels (vasculitis), which can be seen as raised red or purple spots on the skin, but can also affect other parts of the body
- fever, joint pain, swollen lymph nodes in the neck, armpits or groin
- swelling, sometimes of the face or mouth and throat or other parts of the body, which can cause difficulty breathing
- collapse.
→ See a doctor immediately if your child develops any of these symptoms. Stop taking Amoxiclav .
Inflammation of the colon
Inflammation of the colon causing watery diarrhea usually with blood and mucus, abdominal pain and/or high fever.
→ See your doctor as soon as possible for advice if your child develops these symptoms.
Common (affects up to 1 in 10 patients):
- thrush ( candida - fungal infection of the mouth, vagina or skin folds);
- stomach upset (nausea), especially when taking high doses
→ If this happens, Amoxiclav should be taken before meals
- vomiting
- diarrhea
Uncommon (affects up to 1 in 100 patients)
- skin rash, itching
- raised itchy rash (hives)
- indigestion
- dizziness
- headache
Uncommon side effects that may show up in blood tests:
- increase in the levels of certain substances in the blood ( enzymes ) produced by the liver.
Rare (affects up to 1 in 1,000 patients):
- a skin rash that may be like blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge - erythema multiforme ).
→ If you notice any of these symptoms, contact a doctor immediately .
Rare side effects that may show up in blood tests:
- decreased number of cells involved in blood clotting
- decreased white blood cell count (reversible).
Other side effects :
Other side effects have been seen in a very small number of people, but their exact frequency is unknown.
- Growth of microorganisms that are insensitive to the antibiotic.
- Allergic reactions (see above)
- Inflammation of the colon (see above)
- Serious skin reactions:
- a widespread rash with blisters and peeling of the skin, especially in the area of the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), as well as a more severe form causing extensive peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis )
- widespread red skin rash with small blisters containing pus ( bullous exfoliative dermatitis )
- a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis).
- flu-like symptoms with rash, fever, swollen glands, and blood test results that are outside the normal range (including elevated levels of white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
→ See a doctor immediately if your child develops any of these symptoms .
- inflammation of the liver (hepatitis)
- jaundice caused by an increase in bilirubin in the blood (a substance produced by the liver), which can cause the skin and whites of the eyes to turn yellow
- inflammation of the kidney tubules
- prolonged blood clotting time
- hyperactivity
- seizures (in people taking high doses of Amoxiclav or who have kidney problems)
- meningitis (inflammation of the meninges)
- coloring of the tongue in black, with a hairy appearance
- appearance of stains on the teeth (in children), which are usually removed with a brush.
- a significant decrease in the number of white blood cells
- reduced number of red blood cells (hemolytic anemia )
- crystals in the urine (urine may become cloudy and urination may become difficult and painful).
Reporting of suspected adverse drug reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the Executive Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia, phone: +35928903417, website: www.bda.bg. By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Amoxiclav
Keep out of the reach of children.
The powder for oral suspension should be stored below 25 °C in a dry place.
The finished suspension should be stored in a refrigerator (at a temperature of 2 to 8 °C) and used up to 7 days after preparation.
The bottle should be shaken well before each use.
Close the bottle well after use.
Do not use Amoxiclav after the expiration date marked on the package. The expiration date corresponds to the last day of the specified month.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Amoxiclav contains
The active substances are amoxicillin and clavulanic acid. Each 5 ml of the oral suspension (1 measuring device) contains 400 mg of amoxicillin in the form of amoxicillin trihydrate and 57 mg of clavulanic acid in the form of potassium clavulanate.
The other ingredients are:
anhydrous citric acid, sodium citrate, microcrystalline cellulose, carmellose sodium, xanthan gum, anhydrous colloidal silicon dioxide, cherry flavoring, lemon flavoring, saccharin sodium, mannitol.
What A moxiclav looks like and what is in the package
The powder for oral suspension is a white to yellowish white crystalline powder.
Supplied in bottles containing powder for preparation of 35 ml, 70 ml or 140 ml oral suspension. A measuring device is attached - a transparent syringe made of polyethylene (LDPE) with a graduated piston (from polystyrene-PS). One measuring device contains 5 ml.
License holder
Lek Pharmaceuticals dd Verovškova 57, 1526 Ljubljana, Slovenia
Manufacturers
Lek Pharmaceuticals dd Verovškova 57, 1526 Ljubljana, Slovenia
and
Lek Pharmaceuticals dd, Perzonali 47, SI-2391 Prevalje, Slovenia
Date of last revision of leaflet
11/2020
