AMOKSIKLAV 875mg/125mg x 20 tabl
Leaflet: information for the user
A moxiclav 875 mg / 125 mg film-coated tablets
Amoksiklav 875 mg / 125 mg film - coated tablets
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 personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
What this leaflet contains :
- What Amoxiclav is and what it is used for
- What you need to know before you take 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 destroying 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 ingredient (clavulanic acid) prevents this from happening.
Amoxiclav 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 Amoxiclav
Do not take A moxiclav
- if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of Amoxiclav (listed in section 6);
- if you have had a serious allergic reaction (hypersensitivity) to another antibiotic. This may include a skin rash or swelling of the face or neck.
- if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.
Do not take Amoxiclav if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Amoxiclav.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:
- you have glandular fever
- you are being treated for liver or kidney problems
- you don't urinate regularly
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.
In some cases, your doctor may test the type of bacteria causing your infection. Depending on the results, you may be given Amoxiclav with a different strength of the active substance or a different medicine.
Conditions to watch out for
Amoxiclav may make some existing conditions worse or cause serious side effects. These include allergic reactions, fits (seizures) and inflammation of the colon. You should look out for certain symptoms while taking this medicine to reduce the risk of problems. See “ Conditions to look out for” in section 4.
Blood or urine tests
If you are having blood tests (such as red blood cell counts or liver function tests) or urine tests, tell your doctor or nurse that you are taking Amoxiclav. This is because Amoxiclav may affect the results of these types of tests.
Other drugs and Amoxiclav
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 Amoxiclav, you may be more likely to get an allergic skin reaction.
If you are taking probenecid (used to treat gout), your doctor may decide to adjust the dose of Amoxiclav.
If medicines that prevent blood clots (for example warfarin) are taken with Amoxiclav then additional blood tests may be needed.
Amoxiclav may affect the way methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
If you are taking mycophenolate mofetil (used to suppress the immune system in transplants), close clinical monitoring is necessary during co-administration with the antibiotic and for a short period afterwards.
Amoxiclav with food and drink
To minimize the likelihood of gastrointestinal intolerance, take the tablets immediately before meals.
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.
Amoxiclav should not be used in pregnant or breastfeeding women unless your doctor considers it essential.
The possibility of increased sensitivity should be taken into account.
Consult your doctor or pharmacist before taking any medications.
Driving and using machines
Amoxiclav may cause side effects and the symptoms may make you unable to drive.
You should not drive or operate machinery if you are not feeling well.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
3. How to take Amoxiclav
Always take Amoxiclav exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Adults and children weighing more than 40 kg
- Usual dose – 1 tablet twice a day
- Higher dose (at the discretion of the doctor for some ear infections, sinusitis, lung and urinary tract infections) – 1 tablet three times a day
Children weighing less than 40 kg .
Children aged 6 years or less should preferably be treated with amoxicillin/clavulanic acid oral suspension or sachets.
Ask your doctor or pharmacist for advice when giving Amoxiclav tablets to children weighing less than 40 kg.
Patients with kidney and liver problems
• If you have kidney problems, the dose may be changed. different strength of the active substance or another medicine. Your doctor may choose a different strength of the active substance or a different medicine.
• If you have liver problems, you may have more frequent blood tests to see how your liver is working.
How to take A moxiclav
• Take the tablets at the beginning of a meal or shortly before.
• Space your doses evenly throughout the day, at least every 4 hours. Do not take 2 doses in 1 hour.
• Do not take this medicine for more than 2 weeks. If you still feel unwell, you should see a doctor again.
If you take more A moxiclav than you should
If you take more Amoxiclav than you should, signs may include stomach upset (nausea, vomiting or diarrhoea) or fits. Consult your doctor as soon as possible. Take the medicine pack to show your doctor.
If you forget to take A moxiclav
If you miss a dose, take it as soon as you remember. You should not take the next dose too soon, but wait at least 4 hours before taking the next dose.
If you stop taking Amoxiclav.
Continue to take Amoxiclav until the course of treatment is finished, even if you feel better. You need every dose to help fight the infection. If some bacteria survive, this may cause the infection to come back.
If you have any further questions on 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.
Conditions to watch out for
Allergic reactions
- skin rash
- inflammation of the blood vessels ( vasculitis ), which may appear as raised red or purple spots on the skin, but can 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.
→ Contact a doctor immediately if you experience 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 fever.
→ Contact your doctor as soon as possible for advice if you experience these symptoms.
Other side effects
Very common (affects more than 1 in 10 people)
- diarrhea (in adults).
Common (affects up to 1 in 10 people)
- thrush ( candida - a 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 (in children)
Uncommon (affects up to 1 in 100 people)
- skin rash, itching
- raised itchy rash (hives)
- indigestion
- dizziness
- headache
Uncommon side effects that may show up in your blood tests:
- increased levels of certain substances in the blood ( enzymes ) produced by the liver.
Rare (affects up to 1 in 1,000 people)
- skin rash that may be blister-like 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 your blood tests:
- low number of cells involved in blood clotting
- low white blood cell count (reversible).
Side effects with unknown frequency (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:
- widespread rash with blisters and peeling skin, especially around 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 )
- 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 reference range (including increased levels of white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
→ See a doctor immediately if you experience 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 skin and the whites of your eyes look yellow
- inflammation of the tubes in the kidneys
- blood clots more slowly
- hyperactivity
- seizures (in people taking high doses of Amoxiclav or who have kidney problems)
- meningitis (inflammation of the brain membranes)
- a black tongue that looks hairy
- Tooth staining (in children), usually removed with a brush.
Side effects that may show up in your blood tests
- severe decrease in white blood cell count
- low red blood cell count ( hemolytic anemia )
- crystals in urine
If any of the side effects gets serious or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at the Bulgarian Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia, tel.: + 359 2 890 34 17, website: www.bda.bg. By reporting side effects, you can help to provide more information on the safety of this medicine.
5. How to store Amoxiclav
Store the medicinal product below 25°C.
Store in the original packaging, protected from moisture.
Keep out of the reach of children.
Do not use Amoxiclav after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be thrown away via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.
6. Contents of the pack and other information
What Amoxiclav contains
The active substances are: amoxicillin and clavulanic acid.
Each film-coated tablet of Amoxiclav contains 875 mg of amoxicillin, as amoxicillin trihydrate, and 125 mg of clavulanic acid, as potassium clavulanate. Each tablet contains 25 mg of potassium.
The other ingredients are:
- Core: colloidal anhydrous silica, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose,
- Film coating: hydroxypropylcellulose, ethylcellulose, polysorbate 80, triethyl citrate, titanium dioxide, talc, E171.
What A- moxiclav looks like and contents of the pack
White to off-white, elliptical, film-coated tablets with bevelled edges, scored, debossed with 875/125 on one side and AMC on the other side.
Amoxiclav 875 mg/125 mg is available in boxes with two or four blisters, each containing 5 film-coated tablets (10 or 20 tablets).
Marketing Authorisation Holder
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia
Manufacturers
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia
and
Lek Pharmaceuticals dd, Perzonali 47, 2391 Prevalje, Slovenia
Date of last revision of the leaflet:
10/2020
Advice/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 a course of antibiotics. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being taken. This means that they can survive and even multiply 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 a course of antibiotics, it is intended to treat only your current illness. Paying attention to the following tips will help prevent the development 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 do not understand anything, ask your doctor or pharmacist to explain.
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 was prescribed.
3. You should not take antibiotics that have been prescribed to other people, even if they 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 over when you have finished the course as directed by your doctor, you should take the remainder to the pharmacy to be disposed of appropriately.
Lek Pharmaceuticals d . d . is part of the company
