FONDAPARINUX SODIUM DR REDDYS 7.5 MG / 0.6ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE - patient leaflet, side effects, dosage

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fondaparinux sodium 5 mg/0.4 ml Solution for Injection in Pre-Filled Syringe Fondaparinux sodium 7.5 mg/0.6 ml Solution for Injection in Pre-Filled Syringe Fondaparinux sodium 10 mg/0.8 ml Solution for Injection in Pre-Filled Syringe fondaparinux sodium

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

•  – Keep this leaflet. You may need to -re-ad 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 signs of illness 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:

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Don’t stop using Fondaparinux sodium

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 on the use of this medicine, ask your doctor, pharmacist or nurse.

420 mm

Fondaparinux sodium is a medicine that helps prevent blood clots from forming in the blood vessels (an antithrombotic agent ).

Fondaparinux sodium solution contains a synthetic substance called fondaparinux sodium. This stops a clotting factor Xa (“ten-A”) from working in the blood, and so prevents unwanted blood clots (thromboses) from forming in the blood vessels.

Fondaparinux sodium is used to treat adults with a blood clot in the blood vessels of their legs (deep vein thrombosis ) and/or lungs (pulmonary embolism ).

Do not use Fondaparinux sodium:

• if you are allergic to fondaparinux sodium or to any of the other ingredients of this medicine listed in section 6
• if you are bleeding excessively
• if you have a bacterial heart infection
• if you have very severe kidney disease.

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Fondaparinux sodium:

• if you have previously had complications during treatment with heparin or heparin-like medicines causing a fall in the number of blood platelets (heparin-induced thrombocytopenia)
• 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 apply to you.

Children and adolescents

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

Other medicines and Fondaparinux sodium

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Some other medicines may affect the way that Fondaparinux sodium works or be affected by Fondaparinux sodium.

Pregnancy and breastfeeding

Fondaparinux sodium should not be prescribed to pregnant women unless clearly necessary. Breastfeeding is not recommended during treatment with Fondaparinux sodium. If you are pregnant, or breastfeeding , think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

• Severe allergic reactions (anaphylaxis): These are very rare in people (up to 1 in 10,000) taking Fondaparinux sodium. Signs include: swelling, sometimes of the face or mouth (angioedema), causing difficulty in swallowing or breathing
• collapse

Contact a doctor immediately if you get these symptoms. Stop taking Fondaparinux sodium.

Common side effects

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

• bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, gums)

Uncommon side effects

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

• swelling (oedema)
• headache
• pain
• feeling sick or being sick (nausea or vomiting)
• low number of red blood cells (anaemia)
• low 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 Fondaparinux sodium.

• allergic reaction (including itching, swelling, rash)
• internal bleeding in the brain, liver or abdomen
• rash
• dizziness
• pain and swelling at injection site
• high number of platelets (blood cells necessary for blood clotting)
• increase in the amount of non-protein nitrogen in the blood
• stomach pain
• itching
• indigestion
• diarrhoea or constipation

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 via the Yellow Card Scheme website or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions.

Fondaparinux contains sodium

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

Do not use Fondaparinux sodium :

• after the expiry date which is stated on the label and carton after “EXP”. The expiry date refers to the last day of that month
• if you notice any particles in the solution, or if the solution is discoloured
• if you notice that the syringe is damaged
• if you have opened a syringe and you do not use it straightaway.

Disposal of syringes:

Do not throw away any medicines and syringes via wastewater or household waste. Ask your pharmacist how to throw away medicines ~ you nolongeT use.These measureswlll“hel­pprotectthe^en­vironrmentr

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

You should inject at about the same time each day.

What Fondaparinux sodium contains

• 5 mg fondaparinux sodium in 0.4 ml solution for injection
• 7.5 mg fondaparinux sodium in 0.6 ml solution for injection
• 10 mg fondaparinux sodium in 0.8 ml solution for injection The other ingredients are sodium chloride, water for injections, and hydrochloric acid and/or sodium hydroxide to adjust the pH.

How Fondaparinux sodium is given

• Fondaparinux sodium 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 Fondaparinux sodium into muscle.

How long should Fondaparinux sodium be taken for

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

If you use more Fondaparinux sodium than you should Contact your doctor or pharmacist for advice as soon as possible, because of the increased risk of bleeding.

If you forget to use Fondaparinux sodium

• 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.

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