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What Neoamoklav is and what it is used for
Neoamoclav 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 stop working (become inactive). The other active substance (clavulanic acid) prevents this from happening.
Neoamoklav is used in adults and children 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 take Neoamoklav
Do not take Neoamoklav:
if you are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (listed in section 6);
if you have had a severe allergic reaction (hypersensitivity reaction) to any other 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 during antibiotic treatment
Do not take Neoamoklav if any of the above applies to you, if
you are sure, consult your doctor or pharmacist before taking Neoamoklav
Warnings and precautions
Talk to your doctor or pharmacist before taking Neoamoklav if you:
you suffer from infectious mononucleosis;
you are being treated for liver or kidney problems;
you do not urinate regularly.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Neoamoklav.
In some cases, your doctor may test the type of bacteria that is causing your infection. Depending on the results, you may be prescribed a different concentration of Neoamoklav or another drug.
Conditions you need to watch for
Neoamoclav may worsen some existing diseases or cause serious side effects. These include allergic reactions, convulsions (seizures) and inflammation of the colon. You should watch for certain symptoms while taking Neoamoklav to reduce the risk of any problems. See "Conditions you need to watch for" in point 4.
Blood and urine tests
If you have blood tests (such as red blood cell tests or liver function tests) or urine tests (for glucose), tell the doctor or nurse that you are taking Neoamoklav. This is necessary because Neoamoklav can affect the results of these types of studies.
Other drugs and Neoamoklav
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you take allopurinol (used to treat gout) with Neoamoklav, you may be more likely to get a skin allergic reaction.
If you are taking probenecid (used to treat gout), your doctor may decide to adjust your dose of Neoamoklav.
If medicines that prevent the formation of blood clots (such as warfarin) are taken together with Neoamoklav, it may be necessary to carry out additional blood tests.
Neoamoklav may affect the way methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
Neoamoclav may affect the way mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs) works.
Fertility, pregnancy and breastfeeding
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.
Driving and using machines
Neoamoklav may cause side effects and the symptoms may make you unable to drive.
Do not drive or operate machinery unless you feel well.
3. How to take Neoamoklav
Always take Neoamoklav exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Adults and children with a body weight of 40 kg and more
usual dose - 1 tablet twice a day
higher dose - 1 tablet three times a day
Children weighing less than 40 kg
It is recommended that children 6 years of age or younger be treated with amoxicillin/clavulanic acid oral suspension.
Ask your doctor or pharmacist for advice when giving Neoamoklav tablets to children weighing less than 40 kg. Tablets are not suitable for children weighing less than 25 kg.
Patients with kidney and liver problems
If you have kidney problems, the dose may be changed. Your doctor may choose a different concentration of Neoamoklav or another medicine,
If you have liver problems, you may have more frequent blood tests to check how your liver is working.
How to accept
If you have stopped taking Neoamoklav
Continue to take Neoamoklav until the treatment is complete, even if you feel better. You need every dose to 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions you need to watch for
inflammation of the blood vessels (vasculitis), which may appear as a red or purple raised rash on the skin, but may 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
→See a doctor immediately if you experience any of these symptoms. Stop taking Neoamoklav.
Inflammation of the colon
Inflammation of the colon that causes watery diarrhea, usually with blood and mucus, stomach pain and/or fever.
→See your doctor for advice as soon as possible if you get these symptoms.
Very common side effects
These may affect more than 1 in 10 patients
diarrhea (in adults).
Common side effects
These may affect up to 1 in 10 patients
candidiasis (caused by Candida - a fungal infection of the vagina, mouth or skin folds);
nausea, especially when taking high doses;
→if you have such problems, take Neoamoklav before meals
diarrhea (in children).
Uncommon side effects
These may affect up to 1 in 100 patients
skin rash, itching;
raised itchy rash (urticaria);
Uncommon side effects that may show up in your blood tests:
increase in the levels of certain substances (enzymes) produced by the liver.
Rare side effects
These may affect up to 1 in 1,000 patients
a skin rash that may be blister-like and look like small targets (central dark spots surrounded by a lighter area with a dark outline on the periphery - erythema multiforme)
If you notice any of these symptoms, see a doctor immediately.
Rare side effects that may show up in your blood tests:
decrease in the number of cells involved in blood clotting;
decrease in the number of white blood cells.
With an unknown frequency
Frequency cannot be determined from the available data.
Allergic reactions (see above);
Inflammation of the colon (see above);
Inflammation of the protective covering of the brain (aseptic meningitis);
Severe skin reactions:
a generalized rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing extensive peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis);
a widespread red skin rash with small bubbles containing pus (bullous exfoliative dermatitis);
a red, scaly rash with subcutaneous lumps and blisters (exanthematous pustulosis).
→See a doctor immediately if you experience any of these symptoms.
inflammation of the liver (hepatitis);
jaundice caused by an increase in bilirubin (a substance produced in the liver) in the blood. As a result, your skin and the whites of your eyes may appear yellow;
inflammation of the tubules of the kidneys;
slowing of blood clotting;
seizures (in people taking high doses of Neoamoklav or in people with kidney problems);
a black tongue that looks "hairy".
Adverse reactions that can be observed in blood or urine tests:
a serious decrease in the number of white blood cells;
reduced number of red blood cells (hemolytic anemia);
crystals in the urine.
5. How to store Neoamoklav
Keep this medicine out of the reach of children. To be stored in the original packaging.
Do not use this medicine after the expiry date which is stated on the carton. 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 packaging and additional information
What Neoamoklav contains
The active substances are amoxicillin and clavulanic acid. Each tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicycline and potassium clavulanate equivalent to 125 mg of clavulanic acid.
The other ingredients (excipients) are:
Tablet core; magnesium stearate, sodium starch glycolate type A, colloidal anhydrous silica.
Film coating - titanium dioxide (E171), hypromellose (E464), macrogol (400).
What Neoamoklav looks like and what it contains
Neoamoklav 875 tc! 125 mg film-coated tablets. White, oblong film-coated tablets with an embossed image "A" on one side and a score line between "6" and "5" on the other side.
Neoamoclav 875 mg/125 mg film-coated tablets is available in Alu-Alu blister packs of 14 tablets.
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