500 mg / 125 mg film-coated tablets, 875 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 may harm them, even if they show symptoms 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.

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

1. What Betaclav is and what it is used for

Betaclav is an antibiotic that works by killing bacteria that cause infection. It contains two different active ingredients 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.

Beta-clef 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 and clavulanic acid contained in Betaclav may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Betaklav

Do not use Betaklav

  • if you are allergic to amoxicillin, clavulanic acid, or any of the other ingredients of this medicine (listed in section 6).
  • if you have ever 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 Betaklav if any of the above apply to you or your child. If you are not sure, talk to your doctor or pharmacist before taking Betaklav.

Warnings and cautions

Talk to your doctor or pharmacist before taking Betaklav 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, contact your doctor or pharmacist before taking Betaklav.

In some cases, your doctor may examine the type of bacteria that is causing your or your baby’s infection. Depending on the result, you or your child may receive a different strength of Betaklav or other medicine.

Conditions you must be observant of:

Betaclavine 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 when you or your child take Betaclav to reduce the risk of any problems. See “ Conditions you must be observant of ” in section 4.

Blood and urine samples

If you or your child take 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 or your child are taking Betaclav. This is because Betaclav can affect the results of this type of test.

Other medicines and Betaclav

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

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

If you are taking probenecid (for gout ), your doctor may need to change the dose of Betaclav.

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

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

Betaclav may affect the function of mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs).

Beta clef with food, drink, and alcohol

Take Betaclav at the beginning of or just before a meal and swallow the tablet whole with a glass of water.

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.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Beta clef can have side effects and the symptoms can 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 Betaklav

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

Adults and children weighing 40 kg or more

500 mg / 125 mg film-coated tablets

The usual dose is:

  • 1 tablet 3 times daily

875 mg / 125 mg film-coated tablets

  • Usual dose – 1 tablet twice daily
  • Higher dose – 1 tablet 3 times daily

Patients with kidney and liver problems

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

How to take Betaklav

  • 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 Betaklav for more than 2 weeks. If you still feel unwell, seek medical attention again.

Use for children and adolescents

Children weighing less than 40 kg

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

Ask your doctor or pharmacist for advice when administering Betaklav tablets to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.

If you use more Betaklav than you should 

If you take more Betaklav than you should 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 Betaclav

Do not take a double dose to make up for a forgotten dose. 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.

If you stop using Betaklav

Continue taking Betaclav until treatment is over, 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
  • shock condition due to a drop in blood pressure (collapse)

Immediately contact MD are if you get any of these symptoms. Stop taking Betaklav.

Inflammation of the colon

Inflammation of the colon that causes watery diarrhea, usually mixed 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: may affect more than 1 user in 10

  • diarrhea (in adults)

Common side effects: may affect up to 1 in 10 people

  • cod ( candida – a yeast infection in the vagina, mouth, or skin fold)
  • nausea, especially when taking high dose s

If you experience the side effects listed below, take Betaklav before a meal

  • vomiting
  • diarrhea (in children)

Uncommon side effects: 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 side effects:  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 (blood clots)
  • low white blood cell count

No known frequency: can not be calculated from the available data

  • allergic reactions (see above)
  • inflammation of the colon (see above)
  • severe skin reactions:
    • 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) ).

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 (excessively active)
  • seizures (in people taking high doses of Betaclav or who have kidney problems)
  • a black tongue that looks hairy

Side effects 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

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 Betaklav

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.

Strip

Do not store above 25 ° C.

Blister

Do not store above 25 ° C.

Store in the original package. 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

Content declaration

The active substances are amoxicillin and clavulanic acid.

Betaclav 500 mg / 125 mg film-coated tablets

Each film-coated tablet contains 500 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium clavulanate ).

Betaclav 875 mg / 125 mg film-coated tablets

Each film-coated tablet contains 875 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium clavulanate ).

The other ingredients are microcrystalline cellulose (E460), sodium starch glycolate (type A), colloidal anhydrous silica (E551), and magnesium stearate (E470b) in the tablet core, titanium dioxide (E171) hypromellose (E464), and macrogol in the film coating.

What the medicine looks like and the contents of the pack

Betaclav 500 mg / 125 mg film-coated tablets

White capsule-shaped film-coated tablet (tablet) with “I 06” imprinted on one side and smooth on the other side, tablet length: 19.40 ± 0.10 mm.

Betaclav 875 mg / 125 mg film-coated tablets

White capsule-shaped film-coated tablet (tablet) with “I 07” imprinted on one side and smooth on the other side, tablet length: 21.70 ± 0.10 mm.

Betaclav is available in cartons with:

  • 10, 12, 14, 16, 20, 21, 24, 30, 100 or 500 film-coated tablets in strips.
  • 10, 12, 14, 16, 20, 21, 24, 30, or 500 film-coated tablets in blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA Sverige AB, Göta Ark 175, 118 72 Stockholm,

Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Muhammad Nadeem

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