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 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 you will find information about: 
1. What Bioclavid is and what it is used for 
2. What you need to know before you take Bioclavid 
3. How to take Bioclavid 
4. Possible side effects 
5. How to store Bioclavid 
6. Contents of the packaging and other information 

1. What Bioclavid is and what it is used for

Bioclavid 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.

Bioclavide 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 Bioclavid may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before you take Bioclavid

Do not take Bioclavid

  • if you are allergic to amoxicillin, clavulanic acid, penicilli, 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 Bioclavid if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Bioclavid.

Warnings and cautions

Talk to your doctor or pharmacist before taking Bioclavid 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 Bioclavid.

In some cases, your doctor may check the type of bacteria that is causing your infection. Depending on the result, you may receive a different strength of Bioclavid or another drug.

Conditions you must be observant of

Bioclavide may aggravate certain existing conditions or cause serious side effects. These include allergic reactions, seizures, and inflammation of the colon. You must be observant of certain symptoms while taking Bioclavid 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 Bioclavid. This is because Bioclavid may affect the results of this type of test.

Other medicines and Bioclavid

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

If you take allopurinol (for gout ) together with Bioclavid, the risk of an allergic skin reaction may be greater.

If you are taking probenecid (for gout ) your doctor may change the dose of Bioclavid.

If you are taking blood-thinning medicines to prevent blood clots (eg warfarin ) with Bioclavid, you may need to submit additional blood samples.

Bioclavide may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).

Bioclavide may affect the function of mycophenolate mofetil (a medicine used to prevent the rejection of new organs after a transplant).

Pregnancy and breastfeeding

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

Bioclavid may 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.

Bioclavide contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to take Bioclavid

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

Use for adults and children weighing 40 kg or more

The usual dose is:

  • 1 tablet 3 times daily

Use for children weighing less than 40 kg

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

Ask your doctor or pharmacist for advice when administering Bioclavid tablets to children weighing less than 40 kg.

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 may need to have blood tests more often to check how your liver is working.

How to take Bioclavid

  • Swallow the tablets whole with a glass of water at the beginning of a meal or just before. The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.
  • Distribute the doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses for 1 hour.
  • Do not take Bioclavid for more than 2 weeks. If you still feel unwell, see a doctor again.

If you forget to take Bioclavid

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 taking Bioclavid

Keep taking Bioclavid 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.

Contact a doctor immediately if you get any of these symptoms. Stop taking Bioclavid.

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 (may affect more than 1 user in 10):

  • diarrhea (in adults).

Common (may affect up to 1 in 10 people):

  • cod ( candidiasis – a yeast infection in the vagina, mouth, or skin fold)
  • nausea, especially if you take high doses → if you suffer from this, take Bioclavid before a meal
  • vomiting
  • diarrhea (in children).

Uncommon (may affect up to 1 in 100 people):

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

Uncommon side effects that may show up in blood tests:

  • increase of some substances ( enzyme- s ) produced in the liver.

Rare (may affect up to 1 in 1,000 people):

  • 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.

Other side effects are

Other side effects have occurred in a very small number of patients but their exact occurrence is unknown.

  • 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 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 Bioclavid or having kidney problems)
  • the black tongue that looks hairy
  • stains on the teeth (in children), usually go away with toothbrushing.
  • severe skin reactions (contact a doctor immediately if you get any of the following symptoms):
    • a widespread rash with blisters and flaking skin, especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome ) and a more severe form that causes extensive flaking of the skin (more than 30% of body surface area – toxic epidermal necrolysis )
    • an 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 )).

Side effects that may appear 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

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Bioclavid

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

Do not store above 25 ° C. Store in the original package. Moisture sensitive

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.

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

Content declaration

  • The active substances are amoxicillin trihydrate corresponding to amoxicillin 500 mg and potassium clavulanate corresponding to clavulanic acid 125 mg.
  • The other ingredients are magnesium stearate, talc, povidone, microcrystalline cellulose, croscarmellose sodium, triethyl citrate, hypromellose, ethylcellulose, and titanium dioxide (E 171).

What the medicine looks like and the contents of the pack

Off-white, oval, biconvex, with a notch

Blister pack of 20, 30, 100, 100×1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sandoz GmbH

Biochemiestrasse 10,

A-6250 Kundl,

Austria

Information provided by:

Sandoz A / S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Muhammad Nadeem

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