Quixidar - patient leaflet, side effects, dosage

What Quixidar is and what it is used for

Before you use Quixidar

How to use Quixidar

Possible side effects

How to store Quixidar

Further information

WHAT QUIXIDAR IS AND WHAT IT IS USED FOR

Do not use Quixidar:

• if you are allergic (hypersensitive) to fondaparinux sodium or to any of the other ingredients of are bleeding excessively

have a bacterial heart infection you have very severe kidney disease.

Tell your doctor if you think any of these applies to you. If they do, you must not use Quixidar.

Take special care with Quixidar:

Your doctor needs to know before you take Quixidar:

• if you have a risk of uncontrolled bleeding (haemorrhage) including:
• stomach ulcer
• bleeding disorders
• recent bleeding into the brain (intracranial bleeding)
• recent surgery on the brain, spine or eye
• if you have severe liver disease
• if you have kidney disease
• if you are 75 years old or older
• if you weigh less than 50 kg.

^ Tell your doctor if any of these applies to you.

Children

Quixidar has not been tested in children and adolescents under the age of 17 years.

Using other medicines

Tell your doctor or pharmacist if you are taking any other medicines , or have recently taken any. This includes medicines you bought without a prescription. Some other medicines may affect the way that Quixidar works or be affected by Quixidar.

Pregnancy and breast feeding

Quixidar should not be prescribed to pregnant women unless clearly necessary. Breast-feeding is not recommended during treatment with Quixidar. If you are pregnant , think you might be, or if you are breast feeding:

^ tell your doctor or pharmacist.

Important information about some of the ingredients of Quixidar

This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially sodium-free.

3. HOW TO USE QUIXIDAR

Always use Quixidar exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is 2.5 mg once a day, injected at about the same time each day.

If you have kidney disease, the dose may be reduced to 1.5 mg once a day.

How is Quixidar given

• Quixidar is given by injection under the skin (subcutaneously) into a skin fold of the lower abdominal area. The syringes are pre-filled with the exact dose you need. There are different syringes for the 2.5 mg and 1.5 mg doses. For step-by-step instructions please see over the page
• Do not inject Quixidar into muscle.

How long should Quixidar be taken for

You should continue Quixidar treatment for as long as your doctor has told you, since Quixidar prevents development of a serious condition.

If you inject too much Quixidar

Contact your doctor or pharmacist for advice as soon as possible because of the increased risk of bleeding.

If you forget to take Quixidar

• Take the dose as soon as you remember. Do not inject a double dose to make up for a forgotten dose.
• If you are not sure what to do, ask your doctor or pharmacist.

Don’t stop using Quixidar without advice

If you stop the treatment before your doctor told you to, you are at risk of developing a blood clot in a vein of your leg or lung. Contact your doctor or pharmacist before stopping.

If you have any further questions about how to use this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTSLike all medicines, Quixidar can cause side effects, although not everybody gets them.

Common side effects

These may affect more than 1 in 100 people treated with Quixidar.

• bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, gums)
• anaemia (a reduction in the number of red blood cells).

Uncommon side effects

These may affect up to 1 in 100 people treated with Quixidar.

• bruising or swelling (oedema)
• feeling sick or being sick (nausea or vomiting)
• chest pain
• breathlessness
• rash or itchy skin
• oozing from operation wound site
• fever
• reduction or increase in the number of platelets (blood cells necessary for blood clotting)
• increase in some chemicals (enzymes) produced by the liver.

Rare side effects

These may affect up to 1 in every 1000 people treated with Quixidar.

• allergic reaction
• internal bleeding in the brain or abdomen
• anxiety or confusion
• headache
• fainting or dizziness, low blood pressure
• drowsiness or tiredness
• flushing
• coughing
• leg pain or stomach pain
• diarrhoea or constipation
• indigestion
• wound infection
• increase in bilirubin (a substance produced by the liver) in the blood
• reduction in potassium in your blood.

If you get side effects

^ Tell your doctor or pharmacist if any of the side effects gets severe or troublesome , or if you notice any side effects not listed in this leaflet.

HOW TO STORE QUIXIDAR

Keep out of the reach and sight of children

Do not freeze

Quixidar does not need to be kept in the fridge.

Do not use Quixidar:

Instructions for use

• 1. Wash your hands thoroughly with soap and water and dry them with a towel.

• 2. Remove the syringe from the carton and check that:

• the expiry date has not passed
• the solution is clear and colourless and doesn’t contain particles
• the syringe has not been opened or damaged

• 3. Sit or lie down in a comfortable position.

Choose a place in the lower abdominal (tummy) area, at least

5 cm below your belly button (picture A ).

Alternate the left and right side of the lower abdominal area at each injection. This will help to reduce the discomfort at the injection site.

If injecting in the lower abdominal area is not possible, ask your nurse or doctor for advice.

• 4. Clean the injection area with an alcohol wipe.

• 5. Hold the body of the syringe firmly in one hand.

Remove the cap that protects the plunger by pulling it off (picture B ).

Discard the plunger cap.

• 6. Remove the needle guard , by first twisting it and then pulling it in a straight line away from the body of the syringe (picture C ).

Discard the needle guard.

Important note

• Do not touch the needle or allow it to touch any surface before the injection.
• It is normal to see a small air bubble in this syringe. Do not try to remove this air bubble before making the injection – you may lose some of the medicine if you do.

• 7. Gently pinch the skin that has been cleaned to make a fold. Hold the fold between the thumb and the forefinger during the entire injection (picture D ).

• 8. Hold the syringe firmly by the finger grip.

Insert the full length of the needle at right angles into the skin fold (picture E ).

• 9. Inject ALL of the contents of the syringe

down on the plunger as far as it goes. This will activate the automatic needle protection system (picture F ).

• 10. Release the plunger and the needle will automatically nd go back into the security sleeve ermanently (picture G ).

  Picture C

  
  

  Picture F

  
  

  Picture G

  
  
  
  

  Do not dispose of the used syringe in the household waste. Dispose of it as your doctor or pharmacist has instructed.