AMOKSIKLAV 125mg/31.25mg/5ml 100ml susp
Leaflet: user information
A moxiclav 1 2 5 mg /31, 25 mg /5 ml powder for oral suspension
A moxiclav 250 mg /62.5 mg /5 ml powder for oral suspension
Amoksiklav 1 2 5 mg /31, 25 mg /5 ml powder for oral suspension
Amoksiklav 250 mg / 62.5 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 personally for your child. Don't leave it to other people. It can harm them, even if their symptoms are the same as your child's.
- If any of the side effects become serious, or you notice other side effects not described in this leaflet, please tell your doctor or pharmacist. 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 give Amoxiclav
- Possible side effects
- How to store Amoxiclav
- Package contents and additional information
1. What A moxiclav is and what it is used for
Amoxiclav is an antibiotic and works by destroying the bacteria that cause infections. It is effective against a large number of bacteria.
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 powder for oral suspension 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 you give A moxiclav
Do not give Amoxiclav to your child:
- if you are allergic to amoxicillin, clavulanic acid or any of the other ingredients of the product (listed in section 6).
- if there has been a severe allergic reaction (hypersensitivity reaction) to another antibiotic. This may include a skin rash or swelling of the face or neck.
- if you have had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.
Do not give Amoxiclav to your child if any of the above apply to your child. 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 giving your child this medicine if they:
- has glandular fever
- has been treated for liver or kidney problems
- not urinating regularly
If you are not sure if any of the above apply to your child, talk to your child's doctor or pharmacist before giving them 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 given Amoxiclav with a different content of the active substance or another medicine.
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 point 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 studies.
Other drugs and Amoxiclav
Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including over-the-counter and herbal medicines.
In particular, you should consult your doctor if your child is taking any of the following medicines:
- allopurinol (to treat gout) may make it more likely that you will have an allergic skin reaction,
- probenecid (used to treat gout): the doctor may decide to adjust the dose of Amoxiclav,
- medicines that prevent the formation of blood clots (such as warfarin): additional blood tests may be needed,
- methotrexate (used to treat cancer or rheumatic diseases): Amoxiclav can 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.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
The possibility of increased sensitivity should be considered.
This medicinal product contains sodium.
This medicine contains less than 1 mmol sodium (23 mg) in 5 ml ie. it can be said to be practically sodium-free.
The strawberry flavor in Amoxiclav 1 2 5 mg /31.25 mg /5 ml powder for oral suspension contains propylene glycol and benzyl alcohol.
If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving him this medicine, and especially if your baby is being given other medicines that contain propylene glycol or ethanol.
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 give Amoxiclav
Dosage
Always give Amoxiclav exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Adults and children weighing 40 kg or more | This suspension is generally not recommended for adults and children weighing 40 kg or more. Consult your doctor or pharmacist. |
Children weighing less than 40 kg | All doses are determined depending on the child's body weight in kilograms. Your doctor will tell you how much medicine to give your baby or child. • A measuring device is included for dosing and administering the suspension (1 measuring device delivers 5 ml). You must use it to give the correct dose to your baby or child. Usual dose - 20 mg/5 mg to 60 mg/15 mg for each kilogram of body weight per day, divided into three doses. |
Patients with kidney and liver problems
- If your child has kidney problems, the dose may be reduced. different content of the active substance or another medicine. Your doctor may choose a different content of the active substance or a different medicine.
- If your child has liver problems, blood tests may be done more often to see how their liver is working.
How to give 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 give your child Amoxiclav for more than 2 weeks. If your child still feels unwell, you should take him to the doctor again.
If you have given more than the required dose of Amoxiclav to your child
If you have given your child more Amoxiclav than prescribed, symptoms may include gastrointestinal upset (nausea, vomiting and diarrhoea) or convulsions. Consult the child's doctor as soon as possible. Take a medicine bottle to show the doctor.
If you forget to give Amoxiclav
If you forget to give your child a dose, do it as soon as you remember. Do not give your child the next dose too soon, but wait about 4 hours before giving the next dose.
If your child stops taking Amoxiclav
Continue to give Amoxiclav to your child until the treatment is finished, even if he feels better. Your child needs every dose to help fight the infection. If some bacteria survive, they can cause the infection to return.
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, Amoxiclav can cause side effects, although not everybody gets them. The side effects listed below may occur with this medicine.
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 (angioedema), causing 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 has these symptoms.
Common adverse drug reactions:
They may affect up to 1 in 10 people
- thrush (candida - fungal infection of the mouth, vagina or skin folds)
- nausea, especially when taking high doses
→ If this happens, Amoxiclav should be taken before meals
- vomiting
- diarrhea
Uncommon adverse drug reactions
They may affect up to 1 in 100 people
- 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 adverse drug reactions:
They may affect up to 1 in 1,000 people
- a skin rash that may blister 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:
- a small number of cells involved in blood clotting
- low 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 not known.
- 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 in the liver), which can make your child's skin and the whites of the eyes appear yellow
- inflammation of the tubules in the kidneys
- longer blood clotting time
- hyperactivity
- seizures (in people taking high doses of Amoxiclav or who have kidney problems)
- meningitis (inflammation of the meninges)
- black tongue that looks hairy
- tooth staining (in children), usually removed with a brush.
Adverse reactions that may appear in blood or urine tests:
- a serious decrease in the number of white blood cells
- low number of red blood cells (haemolytic anemia)
- crystals in the urine (urine may become cloudy and urination may be difficult and painful).
If any of the side effects become serious, or you notice other side effects not described in this leaflet, please tell your doctor or pharmacist.
Reporting adverse reactions
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the national reporting system to the Executive Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia, phone: + 359 2 890 34 17, 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
To be stored in a place inaccessible to 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 within 7 days after preparation.
The bottle should be shaken well before each use.
Close the bottle well immediately 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.
Medicines should not be disposed of down the drain or in the household waste container. Ask your pharmacist how to dispose of your unwanted medicines. 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 125 mg or 250 mg of amoxicillin, in the form of amoxicillin trihydrate, and 31.25 mg or 62.5 mg of clavulanic acid, in the form of potassium clavulanate.
The other ingredients are:
Amoxiclav 1 2 5 mg /31, 25 mg /5 ml powder for oral suspension
Anhydrous citric acid, sodium citrate, microcrystalline cellulose, carmellose, sodium benzoate, xanthan gum, colloidal anhydrous silica, silica, strawberry flavor, sodium saccharin, mannitol.
Amoxiclav 250 mg /62.5 mg /5 ml powder for oral suspension
Anhydrous citric acid, sodium citrate, microcrystalline cellulose, carmellose, sodium benzoate, xanthan gum, colloidal anhydrous silica, silica, cherry flavor, sodium saccharin, 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.
Pack containing vial of 25 mg powder for preparation of 100 ml oral suspension (measuring device included).
Marketing Authorization Holder:
Lek Pharmaceuticals dd Verovškova 57, Ljubljana, Slovenia
Manufacturers:
Lek Pharmaceuticals dd Verovškova 57, Ljubljana, Slovenia
Lek Pharmaceuticals dd, Perzonali 47, 2391 Prevalje, Slovenia
Date of last revision of leaflet
MM/YYYY
Council/Medical Education
Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.
Sometimes an infection caused by bacteria does not respond to treatment with a given antibiotic. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being taken. This means they can survive and even reproduce despite the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the chance that bacteria will become resistant to them.
When your doctor prescribes an antibiotic treatment, it is intended to treat only your current illness. Consider the following tips to help prevent the emergence of resistant bacteria that can stop the antibiotic from working.
1. It is very important to take the antibiotic in the right dose, at the right time and for the right number of days. Read the instructions on the label, and if you don't understand something, ask your doctor or pharmacist to explain it to you.
2. You should not take an antibiotic unless it is specifically prescribed for you and you should only use it to treat the infection for which it is prescribed.
3. You should not take antibiotics that have been prescribed to other people, even if they have had an infection similar to yours.
4. You should not give antibiotics that have been prescribed for you to other people.
5. If you have any antibiotics left when you have completed the course as directed by your doctor, you must take the remainder to the pharmacy to be disposed of appropriately .
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Instructions for preparing the suspension
The finished suspension is almost white to yellow, homogeneous.
Before use, check the integrity of the cap seal. Shake the bottle to break up the powder. Add water (as indicated below) in two portions (first to 2/3 and then to the mark) and shake well after each addition of water. Shake the contents of the bottle well before each use.
Volume of water to add when preparing the suspension (ml) | |
Amoxiclav suspension 125 mg/31.25 mg/5 ml | 86 |
Amoxiclav suspension 250 mg/62.5 mg/5 ml | 85 |
Lek Pharmaceuticals d . d . is part of the company
