500 mg hard capsules

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.

This leaflet contains information about: 
1. What Cefadroxil Mylan is and what it is used for 
2. What you need to know before you use Cefadroxil Mylan 
3. How to use Cefadroxil Mylan 
4. Possible side effects 
5. How to store Cefadroxil Mylan 
6. Package contents and other information

What Cefadroxil Mylan is and what it is used for

What is Cefadroxil Mylan used for?

Your medicine contains the active substance cefadroxil. Cefadroxil is an antibiotic that belongs to a group of medicines called cephalosporins.

Cefadroxil Mylan is used to treat certain bacterial infections of the upper respiratory tract, skin and soft tissues and urinary tract.

Cefadroxil contained in Cefadroxil Mylan may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 Mylan

Do not use Cefadroxil Mylan

if you are allergic or think you may be allergic, to cefadroxil, any other cephalosporin antibiotic, or any of the other ingredients of this medicine (listed in section 6.).

Warnings and cautions

Talk to your doctor or pharmacist before taking Cefadroxil Mylan:

  • if you are allergic to penicillins.
  • if you use chemical tests to check the glucose in your urine. Cefadroxil may cause a false-positive reaction. This does not happen if you use an enzyme test with a stick.
  • if you are going to do a test called the Coombs test, which examines red blood cells in the blood.

Other medicines and Cefadroxil Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines, or if you are taking any other medicines, including medicines obtained without a prescription:

  • antibiotics such as tetracycline, erythromycin, sulfonamides (eg sulfamethoxazole/trimethoprim), chloramphenicol, polymyxin B, vancomycin, colistin, aminoglycoside are eg gentamicin.
  • probenecid (for gout )
  • high doses of diuretics ( diuretics ) such as furosemide.
  • blood-thinning drugs

Taking Cefadroxil Mylan with food and drink

Cefadroxil Mylan 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.

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

Driving and using machines

Cefadroxil should 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 increased 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 Mylan capsules contain sodium

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

3. How to use Cefadroxil Mylan

Dosage instructions

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

Adults and children with bodyweight over 40 kg:

The recommended dose for adults and children weighing more than 40 kg is 500 mg to 1 g twice daily.

Capsules should not be given to children under 6 years of age.

Patients with kidney problems should take 500 mg every 12 to 36 hours depending on the severity of the kidney problem. Follow your doctor’s recommendation carefully.

How to take capsules:

  • Take this medicine during or after a meal.
  • The capsules should be swallowed with plenty of liquid.
  • Swallow the capsules whole.

Remember to take the pack and what is left of the medicine with you. Symptoms of overdose include allergic reaction which causes difficulty breathing or which causes dizziness, drop in blood pressure and increased or decreased heart rate, nausea, vomiting, rash, diarrhea, convulsions, decreased consciousness, muscle contractions, or coma.

If you forget to take Cefadroxil Mylan

Take one dose as soon as you remember, unless it is almost time for the next dose.

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

If you stop using Cefadroxil Mylan

Do not stop taking Cefadroxil Mylan without talking to your doctor, even if you feel better. It is important that you complete the entire cefadroxil treatment prescribed by your doctor. You will need to take Cefadroxil Mylan 2 to 3 days after the symptoms go away or for at least 10 days for certain types 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.

If you experience any of the following, stop taking Cefadroxil Mylan and contact a doctor immediately or go to the nearest emergency room. You may need treatment.

  • Cefadroxil may cause a decrease in the number of white blood cells and your resistance to infection may decrease. If you get an infection with symptoms such as fever and severe general malaise, or fever with local infectious symptoms such as sore throat, pain in the throat or mouth, or difficulty urinating, you should see a doctor immediately. A blood sample will be taken to check if the number of white blood cells has decreased ( agranulocytosis ). It is important that you inform your doctor about your medication.
  • if you experience symptoms of a severe allergic reaction ( angioedema or anaphylaxis ), such as swelling of the face, tongue or throat, difficulty swallowing, hives and/or difficulty breathing, pressure over the chest.
  • 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:

  • severe diarrhea ( colitis ), which may contain blood
  • severe skin reactions, with blisters on the skin, mouth, eyes, and 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 are :

Common (may affect up to 1 in 10 people):
– nausea – severe itching
vomiting – skin rash
– diarrhea – allergic skin reactions
– indigestion – urticaria
– abdominal pain tender, swollen tongue

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

– vaginal fungal infection or fungal infection of the mouth (cod)

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

– unexplained bruising or bleeding, which 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

– fever, general malaise with or without swollen glands in the neck or muscle aches (serum sickness)

joint pain

– changes in the liver enzyme (which shows how the liver works and can be detected in blood tests)

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

fatigue

– headache

– dizziness

– nervousness

insomnia

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

– a red, raised, measles-like rash

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 Mylan

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

Capsules: Store jars and blisters in the outer carton. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the label or 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). Each capsule contains 500 mg of cefadroxil.
  • Other ingredients are Sodium lauryl sulfate, magnesium stearate, microcrystalline cellulose, titanium dioxide (E171), and gelatin.

What the medicine looks like and the contents of the pack

Cefadroxil Mylan 500 mg capsules are hard gelatin capsules that are white and opaque.

Cefadroxil Mylan 500 mg hard capsules are available in pressure packs and in plastic cans of 6, 7, 8, 10, 14, 16, 20, 30, or 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Mylan AB

Box 23033

Tel. 08-555 227 50

Fax 08-555 227 51

Email: inform@mylan.se

Manufacturer:

McDermott Laboratories Ltd to Gerard Laboratories, Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Sandoz GmbH, Biochemiestraße 10, Kundl, 6250, Austria.

Muhammad Nadeem

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