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CEFADROXIL 500 MG CAPSULES - patient leaflet, side effects, dosage

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Patient leaflet - CEFADROXIL 500 MG CAPSULES

Cefadroxil 500 mg Capsules

Cefadroxil


A SANDOZ

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  • 1. What Cefadroxil Capsules are and what they are used for

  • 2. What you need to know before you take Cefadroxil Capsules

  • 3. How to take Cefadroxil Capsules

  • 4. Possible side effects

  • 5. How to store Cefadroxil Capsules

  • 6. Contents of the pack and other information

What Cefadroxil Capsules are and what they are used for

Cefadroxil is an antibiotic. It belongs to a group of antibiotics that are called cephalosporins. These types of antibiotics are similar to penicillin.

Cefadroxil kills bacteria and it can be used against various sorts of infections.

Like all antibiotics, cefadroxil is only effective against some types of bacteria. So, it is only suitable for treating some types of infection.

Cefadroxil can be used to treat:

  • throat infections
  • chest infections such as bronchitis and some types of pneumonia
  • uncomplicated infections of the bladder and kidneys
  • infections in the skin and the layers just under the skin

What you need to know before you take Cefadroxil capsules

Do not take Cefadroxil

  • You are allergic to cefadroxil or to any of the other ingredients of this medicine (listed in section 6).
  • You are allergic to any other cephalosporin type of antibiotic
  • You have ever had a severe allergic reaction to any sort of penicillin antibiotic

Not all people who are allergic to penicillins are also allergic to cephalosporins. However, you should not take this medicine if you have ever had a severe allergic reaction to any penicillin. This is because you might also be allergic to this medicine (cross-allergy).

If you are not sure about anything, ask your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cefadroxil

  • You have ever had an allergic reaction to any antibiotic or asthma, tell your doctor or pharmacist before you take this medicine.
  • You have ever been told that your kidneys do not work very well. Also, if you are having any sort of treatment (like dialysis) for kidney failure. You may take cefadroxil but you may need a lower dose.
  • If you have ever had inflammation of your bowel, called colitis or any other severe disease affecting your gut.
  • If you are being treated with cefadroxil for a prolonged period. The attending physician must check your blood regularly. Infections due to cefadroxil-resistant micro-organisms (bacteria or germs) may develop.
  • This medicine can alter the results of some blood tests (such as cross-matching blood and the Coombs' test). It is important to tell the doctor that you are taking this medicine if you have to have any of these tests.
  • This medicine can also alter the results of urine tests for sugar (such as Benedict's or Fehling's tests). If you have diabetes and routinely test your urine, tell your doctor. This is because other tests may have to be used to monitor your diabetes while you are having this medicine.

Other medicines and Cefadroxil

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

This medicine can be affected by other medicines that are removed by the kidneys. This is especially if these other medicines also affect how well kidneys work. There are many medicines that can do this, so check with your doctor or pharmacist before taking this medicine.

In particular, tell your doctor or pharmacist if you are taking:

  • Anticoagulants (medicines for blood-thinning)
  • Probenecid (for gout). This can delay the time it takes for cefadroxil to leave your body.
  • Cholestyramine (medicine to lower elevated cholesterol levels)

Do not take Cefadroxil at the same time as:

  • Antibiotics called aminoglycosides (such as gentamycin), polymyxin B and colistin
  • Other antibiotics that inhibit growth of bacteria (such as tetracycline)
  • Water tablets or injections (diuretics) such as furosemide. It might be necessary to check your kidneys often during treatment. This can be done with blood and urine tests.

Leave two or three hours after taking this medicine before taking any of these other medicines.

Taking Cefadroxil with food and drink

Cefadroxil may be taken with or without food.

Pregnancy and breast-feeding

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

You may get headache, dizziness, nervousness, sleeplessness and exhaustion when taking this medicine. This may affect your ability to drive or operate machinery. If this happens, do not drive or use machines.

Cefadroxil contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per hard capsule, that is to say essentially ‘sodium-free’.

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How to take Cefadroxil Capsules

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The dispensing label will tell you how much of this medicine you should take and how often you should take. Please read it carefully. The dose your doctor prescribes depends on the type of infection and how bad the infection is. It also depends on how well the kidneys are working. Your doctor will explain this to you.

Use in children:

  • Children who weigh below 40 kg and need treatment with cefadroxil are usually given liquid oral formulations.
  • In children the dose may be increased up to 100 mg/kg/day
  • For children who weigh below 40 kg and have kidney problems or haemodialysis Cefadroxil must not be taken.

Elderly and patients with kidney problems or on haemodialysis

Adjustment of the dosage is necessary.

Patients with haemodialysis

Patients with haemodialysis are treated with 500 mg to 1000 mg cefadroxil at the end of haemodialysis.

The exact dose will have been worked out by the doctor and shown on the label.

The following table provides a guide to usual doses:

Indications

Adults and young people who weigh more than 40 kg and have normal renal function

Lower respiratory tract infections

1000 mg twice a day

Urinary tract infections

Skin and soft tissue infections

Upper respiratory tract infections (pharyngitis, tonsillitis)

Dosage may be reduced to 1000 mg once a day over at least 10 days

Depending on the severity of the infection, the dose for adults may be increased up to 4 g per day.

Method of administration

The capsules should be swallowed whole with a glass of water.

Duration of treatment

The treatment should be continued for at least 2–3 days after acute symptoms have disappeared.

In the case of streptococcal infections the minimum duration of therapy should be 10 days.

If you take more of Cefadroxil than you should

If you have taken too much of this medicine, contact your doctor or hospital as soon as possible. Symptoms of overdosage may be nausea, hallucinations, increased reflexes, clouding of consciousness or even coma, disorders of kidney function.

If you forget to take Cefadroxil

If you forget to take this medicine, continue treatment following the normal dosage recommended by your doctor. Do not take a double dose to make up for a forgotten dose.

If you stop taking this Cefadroxil

It is important that you take your medicine in accordance with the doctor’s instruc­tions. Do not suddenly stop using this medicine without discussing it first with your doctor. Otherwise symptoms may return.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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Possible side effects

  • changes in kidney function;
  • joint problem;
  • fever, feeling or being sick, weakness and a feeling of generally being unwell.

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

  • anaphylactic reactions (e.g. bronchospasms, purpura and edema of the face and extremities);
  • a type of anaemia that can be severe and is caused by red blood cells breaking up; If you are having a blood test for any reason, tell the person who is taking your blood sample that you are taking this medicine as it may affect your result.
  • headaches, sleeplessness, dizziness, nervousness;
  • inflammation of the gut called pseudomembranous colitis;
  • rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever;
  • abnormal blood tests.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Yellow Card Scheme: or search for MHRA Yellow Card in Google play or Apple App store.. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Cefadroxil Capsules

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 label after EXP. The expiry date refers to the last day of that month.

Store in the original package.

This medicinal product does not require any special temperature storage conditions.

Do not use this medicine if you notice any visible sign of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

If any of the following happens, stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital:

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

Severe allergic reactions (anaphylactic shock) to this medicine. These can include:

  • Sudden wheeziness and tightness of chest
  • Swelling of eyelids, face or lips
  • Severe skin rashes that can blister and may involve the eyes, mouth and throat, and genitals.
  • Loss of consciousness (fainting).

All of these allergic reactions need urgent medical attention.

If you think you are having any of these types of reaction, stop taking this medicine and contact your doctor or your nearest hospital accident and emergency department.

Other possible side effects:

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

  • nausea, vomiting, stomach discomfort, abdominal pain, diarrhoea and swollen, red, sore tongue; If you have severe diarrhoea or if you see blood in your diarrhoea you should stop taking this medicine and talk to your doctor immediately.
  • itching, itchy rash.

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

Having a course of cefadroxil can temporarily increase the chance that you can get infections caused by other sorts of germs. For example, thrush may occur.

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

  • anaemia, drops in the numbers of different cells in the blood (symptoms can include tiredness, new infections, fever and easy bruising or bleeding), increases in some types of white blood cells, decreases in the numbers of small cells that are needed for clotting of the blood;
  • hypersensitivity reactions (These are skin rashes that are less severe allergic reactions than mentioned above, lumpy rash (hives), itching);
  • yellow eyes or skin, changes in blood tests that check how your liver is working;

Contents of the pack and other information

What Cefadroxil Capsules contain

  • – The active substance is cefadroxil. One capsule contains 500 mg cefadroxil (as monohydrate).

  • – The other ingredients are: magnesium stearate, sodium lauryl sulfate, microcrystalline cellulose, titanium dioxide (E171) and gelatine.

What Cefadroxil Capsules looks like and contents of the pack

Capsules, hard, white, opaque capsule containing white to slightly yellowish powder.

Individual packs of 10, 12, 14, 16, 20, 30, 40 and 100 (100×1) capsules

Hospital packs of 100 (10 × 10) and 1000 (100 × 10) capsules in polyvinylchlo­ride/polyviny­lidene (PVC/PV)-Alu-blister strips

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz Limited

Park View, Riverside Way

Watchmoor Park

Camberley, Surrey

GU15 3YL

United Kingdom

Manufacturer:

Sandoz GmbH, A-6250 Kundl, Austria.

This leaflet was last revised in 07/2020.

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