500 mg hard capsules 
cefadroxil

Read all of this leaflet carefully before you start using 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: 
1. What Cefadroxil Sandoz is and what it is used for 
2. What you need to know before you use Cefadroxil Sandoz 
3. How to use Cefadroxil Sandoz 
4. Possible side effects 
5. How to store Cefadroxil Sandoz 6. Contents of the pack 
and other information 

What Cefadroxil Sandoz is and what it is used for

Cefadroxil Sandoz is an antibiotic (antibacterial agent) belonging to the group of cephalosporins . Cefadroxil Sandoz prevents the bacteria from forming new cell walls and thus has a bactericidal effect.

Cefadroxil Sandoz is used to treat urinary tract infections , skin and soft tissue infections, sore throats and pneumonia . 

Cefadroxil contained in Cefadroxil Sandoz may also be approved for the treatment of other diseases 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.

What you need to know before using Cefadroxil Sandoz

Do not use Cefadroxil Sandoz

  • if you are allergic to cefadroxil, other cephalosporin antibiotics or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before using Cefadroxil Sandoz.

  • If you are allergic to regular penicillins .

If you are diabetic, you should note that during treatment with cefadroxil, a false positive reaction for glucose in the urine may occur when using Benedict’s or Fehling’s solutions, copper sulphate or Clinitest, but not if using enzyme tests such as Clinistix.

Other medicines and Cefadroxil Sandoz

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

The treatment effect may be affected if this medicine is taken at the same time as certain other medicines such as:

  • certain types of antibiotics ,
  • probenecid (remedy for gout ),
  • blood-thinning drugs (prevents blood clotting),
  • high dose er of certain types of diuretics (loop diuretics). Forced diuresis may lead to reduced levels of cefadroxil blood.

The treating physician therefore needs to be aware of such concomitant medication.

Cefadroxil Sandoz with food and drink

Cefadroxil Sandoz should be taken with food, preferably during or after a meal.

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.

Pregnancy

You can use Cefadroxil Sandoz even if you are pregnant. 

Breast-feeding

Low levels of cefadroxil may pass into breast milk, but the dose one that the baby ingests is lower than the dose one prescribed by the doctor. It is possible to breast-feed during treatment with cefadroxil, but breast-feeding (or treatment) should be stopped if the child develops diarrhea, a fungal infection in the mouth or a rash. 

Driving and using machines

Cefadroxil Sandoz does not affect your ability to drive or use machines.

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.

Cefadroxil Sandoz contains sodium

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

3. How to use Cefadroxil Sandoz

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

Dose one is determined by the doctor who adjusts it individually for you. The size of the dose depends on what infection you have, how severe the infection is, and on your age and body weight.

Adults and children (> 40 kg):

The recommended dose is 2 capsules (1 gram) a day. The full daily dose of Cefadroxil Sandoz can be taken at one time or divided on two occasions at approximately 12-hour intervals.

Children <40 kg:

Follow your doctor’s instructions.

You should take Cefadroxil Sandoz at about the same time each day and with a meal. The capsules should be swallowed whole and rinsed with at least 1/2 glass of water.

Signs of overdose include allergic reaction , nausea, vomiting, diarrhea, seizures, electrolyte disturbances, kidney failure , changes in the blood, decreased level of consciousness or acidosis . Symptoms of acidosis include headache, fatigue, nausea, vomiting and decreased level of consciousness with deep and rapid breathing. Symptoms of an allergic reaction , kidney failure and changes in the blood are described in the section Possible side effects below.

If you forget to take Cefadroxil Sandoz

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

If you stop taking Cefadroxil Sandoz

Do not stop taking Cefadroxil Sandoz without talking to a doctor, even if you feel better after a few days. It is important that you take the entire Cefadroxil Sandoz regimen as prescribed . Otherwise, some bacteria may survive for a while, grow and cause an infection to return.

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.

Stop taking Cefadroxil Sandoz and contact a doctor immediately or go to the nearest emergency room:

  • if you experience symptoms of a severe allergic reaction ( angioedema or anaphylactic shock ), such as swelling of the face, tongue or throat; difficulty swallowing; hives and difficulty breathing, pressure over the chest.
  • If you get an infection with symptoms such as fever with severe general deterioration or fever with local symptoms of infection such as sore throat / throat / mouth or difficulty urinating, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytos ). It is important that you then inform about your medication, as Cefadroxil Sandoz in rare cases can affect the white blood cells so that the defense of infection deteriorates.
  • if you notice blood in the urine or cloudy urine, if you produce little or no urine or if you have pain in the lower back. This can be a symptom of kidney problems.

The above side effects are rare and may affect up to 1 in 1,000 people.

You should also contact a doctor immediately if you notice any of the following symptoms:

  • prolonged or severe diarrhea. This can be a symptom of inflammation in the colon.
  • an extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes, such as the genitals.
  • if you notice that your skin is unusually pale or yellowish and you experience weakness or shortness of breath. This may be a symptom of a decrease in the number of red blood cells in your blood.

The above side effects occur in an unknown number of users.

Other side effects:

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

  • Diarrhea, abdominal pain, nausea, vomiting and acid regurgitation.
  • Inflammation of the tongue.
  • Skin rash, hives and itching .

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

  • Fever, general malaise with or without swollen glands in the neck or muscle aches (serum sickness)
  • Joint pain
  • Fungal infections of the abdomen and mouth.
  • Unexplained bruising or bleeding that may have been caused by a decrease in the number of platelets in the blood, which help the blood to coagulate
  • An increase in certain white blood cells , which can be detected in a blood test

Very rare (may affect up to 1 in 10,000 people) :

  • Headache, dizziness, nervousness, insomnia, fatigue.

Has been reported (occurs in unknown number of users):

  • Increased amount of certain liver enzymes (which show how the liver works and can be detected in blood tests).
  • Skin rash on the face and on the arms and legs

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 Cefadroxil Sandoz

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.

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 substance is cefadroxil (as monohydrate). One capsule contains 500 mg of cefadroxil.
  • The other ingredients are magnesium stearate, sodium lauryl sulphate, microcrystalline cellulose, gelatin, titanium dioxide (dye E 171).

What the medicine looks like and the contents of the pack

Appearance :

White opaque capsule.

Pack sizes:

Blisters: 14, 20, 30, 100 and 100×1 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder and Manufacturer

Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria

Information is provided by

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Muhammad Nadeem

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