500 mg / 125 mg film-coated tablets 
(Amoxicillin / clavulanic acid)

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 (or your child) only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Amoxicillin / Clavulanic acid Aurobindo is and what it is used for 
2. What you need to know before you use Amoxicillin / Clavulanic acid Aurobindo 
3. How to use Amoxicillin / Clavulanic acid Aurobindo 
4. Possible side effects 
5. How to store Amoxicillin / Clavulanic acid Aurobindo 
6. Contents of the pack and other information 

What Amoxicillin / Clavulanic acid Aurobindo is and what it is used for

Amoxicillin / Clavulanic acid Aurobindo is an antibiotic that works by killing bacteria that cause infection. It contains two different drugs 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.

Amoxicillin / Clavulanic acid Aurobindo is used in adults and children to treat the following infections:

  • infection of the middle ear and sinus infections
  • respiratory infections
  • urinary tract infections
  • skin and soft tissue infections including dental infections
  • skeletal and joint infections amoxicillin / clavulanic acid contained in Amoxicillin / Clavulanic acid Aurobindo may also be authorized for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before you use Amoxicillin / Clavulanic acid Aurobindo

Do not take Amoxicillin / Clavulanic acid Aurobindo:

  • 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 rash or swelling of the face or neck.
  • if you have had liver problems or jaundice (yellowish skin) after taking an antibiotic.
  • → Do not take Amoxicillin / Clavulanic acid Aurobindo if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Amoxicillin / Clavulanic acid Aurobindo.

Warnings and cautions

Talk to your doctor or pharmacist before taking Amoxicillin / Clavulanic acid Aurobindo if you:

  • have glandular fever
  • treated for liver or kidney problems
  • 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 Amoxicillin / Clavulanic acid Aurobindo.

In some cases, your doctor may check the type of bacteria that is causing your infection.

Depending on the results, you may receive a different strength of Amoxicillin / Clavulanic acid Aurobindo or other medicine.

Conditions you must be observant of:

Amoxicillin / Clavulanic acid Aurobindo may aggravate certain pre-existing conditions or cause serious side effects. These include allergic reactions, seizures, and inflammation of the colon. You must be aware of certain symptoms when taking Amoxicillin / Clavulanic acid Aurobindo to reduce the risk of any problems. See “ Conditions you must be observant of ” in section 4.

Blood and urine samples

If you are taking blood samples (eg to check for red blood cells or liver function tests) or urine samples (for glucose ), tell your doctor or nurse that you are taking Amoxicillin / Clavulanic acid Aurobindo. This is because Amoxicillin / Clavulanic acid Aurobindo may affect the results of this type of test.

Other medicines and Amoxicillin / Clavulanic acid Aurobindo

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

If you take allopurinol (for gout ) together with Amoxicillin / Clavulanic acid Aurobindo, the risk of an allergic skin reaction may be greater.

If you are taking probenecid (for gout ) your doctor may change the dose of Amoxycillin / Clavulanic acid Aurobindo.

If you are taking blood-thinning medicines to prevent blood clots (eg warfarin ) together with Amoxicillin / Clavulanic acid Aurobindo you may need to submit additional blood samples.

Amoxicillin / Clavulanic acid Aurobindo may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).

Amoxicillin / Clavulanic acid Aurobindo may affect the function of mycophenolate mofetil (a medicine used to prevent the rejection of new organs after a transplant).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Amoxicillin / Clavulanic acid Aurobindo can have side effects and the symptoms may make you unsuitable as a driver.

Do not drive or use machines if you feel unwell.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Amoxicillin / Clavulanic acid Aurobindo

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Adults and children weighing 40 kg or more

The recommended dose is:

  • 1 tablet 3 times daily.

Children weighing less than 40 kg 

Children 6 years of age or younger should preferably be treated with amoxicillin / clavulanic acid oral suspension or sachets.

Ask your doctor or pharmacist for advice when administering Amoxicillin / Clavulanic acid Aurobindo tablets to children weighing less than 40 kg. Children can be treated with amoxicillin / clavulanic acid in tablets, suspensions, or sachets.

Patients with kidney and liver problems

  • Dose one can be changed if you have kidney problems. Your doctor may choose a different strength or different medicine.
  • If you have liver problems, you can have blood tests more often to check how the liver is working.

How to take Amoxicillin / Clavulanic Acid Aurobindo •

  • Swallow the tablets whole with a glass of water at the beginning of a meal or just before.
  • Distribute the doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses for 1 hour.
  • Do not take Amoxicillin / Clavulanic acid Aurobindo for more than 2 weeks. If you still feel unwell, seek medical attention again.

If you have taken too much Amoxicillin / Clavulanic acid Aurobindo, you may experience symptoms such as upset stomach (nausea, vomiting, or diarrhea) or seizures. Contact your doctor as soon as possible. Bring the carton of medicines and show it to the doctor.

If you forget to use Amoxicillin / Clavulanic acid Aurobindo

If you miss a dose, take it as soon as you remember. You should not take the next dose too early, but wait about 4 hours before taking it. Do not take a double dose to make up for a forgotten dose.

If you stop using Amoxicillin / Clavulanic acid Aurobindo

Continue to take Amoxicillin / Clavulanic acid Aurobindo until the end of treatment, even if you feel better. You need each dose to fight infection one. If some bacteria survive, it can lead to a recurrence of infection.

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 you must be observant of:

Allergic reactions •

  • rash
  • inflammation of blood vessels ( vasculitis ) that can be seen as red or purple, raised spots on the skin but can affect other parts of the body
  • fever, joint pain, swollen glands in the neck, armpits, or groin
  • swelling, sometimes of the face or mouth ( angioedema ) leading to difficulty breathing
  • collapse.
  • acute allergic heart syndrome ( Kunis syndrome )→ Contact a doctor immediately if you get any of these symptoms. Stop taking Amoxicillin / Clavulanic acid Aurobindo.

Inflammation of the colon

Inflammation of the colon that causes watering diarrhea, usually with blood and mucus, stomach pain, and/or fever.

→ Contact a doctor as soon as possible for advice if you get these symptoms.

Very common side effects are

These can occur in more than 1 in 10 users

  • diarrhea (in adults).

Common side effects are

  • fungal infection (cod/candida – a fungal infection of the vagina, mouth, or skin folds)
  • nausea, especially at the high dose you if you experience this, take Amoxicillin / Clavulanic acid Aurobindo before a meal
  • vomiting
  • diarrhea (in children)

Uncommon side effects are

These can occur in up to 1 in 100 users

  • rash, itching
  • raised, itchy rash (hives)
  • indigestion
  • dizziness
  • headache

Uncommon side effects that may show up in blood tests:

  • increase in certain substances ( enzymes ) produced in the liver.

Rare side effects are

These can occur in up to 1 in 1,000 users

  • skin rash, which can turn into blisters and look like small targets (a dark dot in the middle surrounded by a paler area, with a dark ring around the edge – erythema multiforme ) Contact a doctor immediately if you notice any of these symptoms.

Rare side effects that may show up in blood tests:

  • the low number of blood cells involved in the coagulation of the blood
  • low white blood cell count

Side effects have been reported

These occur in an unknown number of users

  • Allergic reactions (see above)
  • Inflammation of the colon (see above)
  • Inflammation of the membranes around the brain and spinal cord ( aseptic meningitis )
  • Inflammation of the bile ducts ( cholangitis )
  • allergic acute heart syndrome ( Kunis syndrome )
  • Severe skin reactions:- a widespread rash with blisters and flaking skin, especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome ), and a severe form that causes extensive flaking of the skin (more than 30% of the body surface – toxic epidermal necrolysis )- extensive red rash with small blisters with var ( bullous exfoliative dermatitis )- a red, scaly rash with lumps under the skin and blisters ( exanthematous pustulosis )
  • flu-like symptoms with rash, fever, swollen glands, and abnormal results from blood tests (including increased white blood cell count ( eosinophilia ) and liver enzymes)(Drug reaction with eosinophilia and systemic symptoms (DRESS))

→ Contact a doctor immediately if you get any of these symptoms. 

  • inflammation of the liver ( hepatitis )
  • jaundice caused by increases in bilirubin in the blood (a substance produced in the liver) that can make the skin and whites of the eyes look yellow
  • inflammation of the kidneys
  • it takes longer for the blood to coagulate
  • hyperactivity
  • seizures (in people taking high doses of Amoxicillin / Clavulanic acid Aurobindo or who have kidney problems)
  • a black tongue that looks hairy
  • stains on the teeth (in children), usually go away with toothbrushing.

Side effects that have been reported that may show up in blood or urine tests:

  • Severe decrease in white blood cell count
  • low red blood cell count (hemolytic anemia )
  • crystals in the urine

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly

Läkemedelsverket 
Box 26 
751 03 Uppsala 
www.lakemedelsverket.se

By reporting side effects, you can help increase drug safety information.

5. How to store Amoxicillin / Clavulanic acid Aurobindo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Store in the original package. Sensitive to light. Moisture sensitive.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

This contains Amoxicillin / Clavulanic acid Aurobindo:

• This contains Amoxicillin / Clavulanic acid Aurobindo

  • The active substances are amoxicillin trihydrate and potassium clavulanate. Each film-coated tablet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin with potassium clavulanate equivalent to 125 mg clavulanic acid.
  • Other ingredients are:

Tablet core:

Microcrystalline cellulose (E460), anhydrous colloidal silica, magnesium stearate (E470b), sodium starch glycolate (type A).

Film coating:

Hypromellose (E464), Macrogol 400, Titanium dioxide (E171).

What the medicine looks like and the contents of the pack

Film-coated tablets.

Amoxicillin / Clavulanic acid Aurobindo 500 mg / 125 mg tablets are white, oval, film-coated tablets with an embossed “A” on one side and “64” on the other.

Amoxicillin / Clavulanic acid Aurobindo tablets are available in blister packs (polyamide/aluminum / PVC – aluminum foil) with 4/5/6/7/8/10/12/14/15/16/20/21/24/25/30/35 / 40/50/100/500 film-coated tablets. 

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Aurobindo Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana FRN 1913

Malta

Manufacturer

Milpharm Limited

Ares, Odyssey Business Park

West End Road

South Ruislip HA4 6QD

UK

or

APL Swift Services (Malta) Limited

HF 26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

This medicinal product is authorized under the European Economic Area under the names:

Austria Amoxicillin / Clavulanic acid A-med 500 mg / 125 mg Film tablet

Belgium AmoxiclavApotex® 500 mg / 125 mg film-coated tablets / compressed pellets / film tablets

Bulgaria ALVOCLAV500 mg / 125 mg film tablets

Denmark Amoxicillin / Clavulanic acid Aurobindo 

Germany Amoxi-Clavulan Aurobindo 500 mg / 125 mg Film tablet

Greece ACCORDIA (500 + 125) mg επικαλυμμένο με λεπτό υμένιο δισκία

Latvia Amoxicillin / Clavulanic acid Aurobindo 500 mg / 125 mg apvalkotās tablets

Netherlands Amoxicilline / Clavulaanzuur Aurobindo 500 mg / 125 mg, film-coated tablets

Poland Auglavin

Portugal Amoxicilina + Ácido Clavulânico Aurobindo

Romania Amoxicillin / Acid clavulanic acid Aurobindo 500mg / 125mg, compressed film

Spanien Amoxicilina / Ácido Clavulánico Aurobindo 500 mg / 125 mg & 875 mg / 125 mg compresses obtained with EFG film

Amoxicillin / Clavulanic acid Aurobindo 500 mg / 125 mg film-coated tablets

United Kingdom Co-amoxiclav 500 mg / 125 mg film-coated tablets

Muhammad Nadeem

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