AMOKSIKLAV 400mg/57mg/5ml 140ml susp
Leaflet: information for the user
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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours/your child's.
- If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 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 ingredient (clavulanic acid) stops this from happening.
Amoxiclav is used in babies 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 take Amoxiclav
Do not use Amoxiclav on your child:
- if you are allergic to amoxicillin or clavulanic acid or 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) when taking an antibiotic.
→ Do not use Amoxiclav on your child if any of the above apply to them. If you are not sure, talk to your child's doctor or pharmacist before giving them Amoxiclav.
Warnings and precautions
Talk to your doctor or pharmacist before using Amoxiclav on 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, talk to a doctor or pharmacist before giving him Amoxiclav.
In some cases, the doctor may test the type of bacteria causing your child's infection. Depending on the results, your child may be prescribed 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 your child is taking this medicine to reduce the risk of problems. See “ Conditions to look out for” in section 4.
Blood or urine tests
If your child is having blood tests (such as red blood cell counts or liver function tests) or urine tests, tell the doctor or nurse that your child is 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 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 (for the treatment of gout) may be more likely to cause an allergic skin reaction
- probenecid (for the treatment of gout) your doctor may decide to adjust the dose of Amoxiclav
- medicines that suppress blood clotting (such as warfarin) additional blood tests may be necessary
- methotrexate (used to treat cancer or rheumatic diseases): Amoxiclav may affect the way it works
- 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 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, ask your doctor for advice before using this medicine.
The possibility of increased sensitivity should be taken into account.
This medicinal product contains sodium. The lemon flavour contains benzyl alcohol.
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially 'sodium-free'.
This medicine contains benzyl alcohol.
Benzyl alcohol can cause allergic reactions.
Benzyl alcohol is associated with a risk of serious side effects, including breathing problems (called “choking syndrome”) in young children. Do not use in newborns (up to 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 may cause a side effect (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 may cause a side effect (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 not usually 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 how much 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 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 or your child has liver problems, more frequent blood tests may be needed to monitor how their liver is functioning.
How to use A moxiclav
• Always shake the bottle well before each dose
• Give the dose at the beginning of a meal or shortly before it
• Space your 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 to the doctor again.
How to prepare this medicine
Before use, check that the cap seal is tight. Shake the bottle to disperse the powder. Add the volume of water (as indicated below) in two portions (first to 2/3, 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 take or give more Amoxiclav than you should to your child
If you take or give your child more Amoxiclav than you should, signs may include stomach upset (nausea, vomiting or diarrhoea) or fits. Consult your doctor or your 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 a dose, take it as soon as you remember. Do not take the next dose too soon, there should be about 4 hours between doses.
If you or your child stops taking Amoxiclav
Continue to take or give your child Amoxiclav until the treatment is finished, even if you or your child feel better. You or your child needs every dose to help fight the infection. If some bacteria survive, they 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, 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 may appear 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 may cause difficulty breathing
- collapse.
→ Contact a doctor immediately if your child experiences 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.
→ Contact your doctor as soon as possible for advice if your child experiences these symptoms.
Common (affects up to 1 in 10 patients):
- thrush ( candida - a 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):
- 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 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:
- 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)).
→ Contact a doctor immediately if your child experiences 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 yellowing of the skin and the whites of the eyes
- 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 brain membranes)
- black, hairy-looking tongue discoloration
- appearance of stains on the teeth (in children), which are usually removed with a brush.
- significant decrease in white blood cell count
- low red blood cell count (hemolytic anemia )
- crystals in the urine (urine may become cloudy and urination may become difficult and painful).
Reporting suspected adverse drug reactions
If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Bulgarian Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia, tel.: +35928903417, website: www.bda.bg. By reporting side effects, you can help to obtain more information on 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 at a temperature below 25 °C in a dry place.
The prepared 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.
After use, close the bottle tightly.
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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
6. Contents of the pack and other information
What Amoxiclav contains
The active substances are amoxicillin and clavulanic acid. Each 5 ml of oral suspension (1 measuring device) contains 400 mg of amoxicillin as amoxicillin trihydrate and 57 mg of clavulanic acid as potassium clavulanate.
The other ingredients are:
anhydrous citric acid, sodium citrate, microcrystalline cellulose, carmellose sodium, xanthan gum, anhydrous colloidal silicon dioxide, cherry flavor, lemon flavor, saccharin sodium, mannitol.
What A- moxiclav looks like and contents of the pack
The powder for oral suspension is a white to yellowish-white crystalline powder.
It is supplied in bottles containing powder for preparation of 35 ml, 70 ml or 140 ml of oral suspension. A measuring device is provided – a transparent polyethylene (LDPE) syringe with a graduated plunger (polystyrene-PS). One measuring device contains 5 ml.
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, SI-2391 Prevalje, Slovenia
Date the leaflet was last revised
11/2020
