FONDAPARINUX SODIUM DR REDDYS 2.5 MG / 0.5ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE - patient leaflet, side effects, dosage

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fondaparinux sodium 2.5 mg/0.5 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 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 signs of illness are the same as yours. _ _' _ JfyougeLanyside effects talk to yonr_doctor, -pharmacist or_nurse This_includss any possible_side affscts_notJis­tecLinJhislea­flet._Sees.ec­tion₄.

What is in this leaflet:

1. What Fondaparinux sodium is and what it is used for

2. What you need to know before you use

Fondaparinux sodium

3. How to use Fondaparinux sodium

4. Possible side effects

5. How to store Fondaparinux sodium

6. Contents of the pack and other information

1. what fondaparinux sodium is and what it is used for

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

Fondaparinjx sodijm soljtion contains a synthetic sjbstance called fondaparinjx sodijm. This stops a clotting factor Xa (“ten-A”) from working in the blood, and so prevents jnwanted blood clots (thromboses) from forming in the blood vessels.

Fondaparinux sodium is used to:

• prevent the formation of blood clots in the blood vessels of the legs or ljngs after orthopaedic sjrgery (sjch as hip or knee sjrgery) or abdominal sjrgery
• prevent the formation of blood clots djring and shortly after a period of restricted mobility dje to acjte illness
• treat some types of heart attack and severe angina (pain cajsed by narrowing of the arteries in the heart)
• treat blood clots in blood vessels that are near the sjrface of the skin of the legs (superficial vein thrombosis).

2. what you need to know before you use fondaparinux sodium______________

Do not use Fondaparinux sodium:

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

Tell your doctor if yoj think any of these apply to yoj. If they do, yoj mjst not jse Fondaparinjx.

Warnings and precautions

Talk to yojr doctor, pharmacist or njrse before jsing Fondaparinjx sodijm:

• if yoj have previojsly had complications djring treatment with heparin or heparin-like medicines cajsing a fall in the njmber of blood platelets (heparin-indjced thrombocytopenia)
• if yoj have a risk of uncontrolled bleeding (haemorrhage) incljding:

• - stomach ulcer

• - bleeding disorders

• – recent bleeding into the brain (intracranial bleeding)

• - recent surgery on the brain, spine or eye

• if yoj have severe liver disease
• if yoj have kidney disease
• if yoj are 75 years old or older
• if yoj weigh less than 50 kg.

Tell your doctor if any of these apply to yoj.

Children and adolescents

Fondaparinjx has not been tested in children and adolescents jnder the age of 17 years.

Other medicines and Fondaparinux sodium

Tell your doctor or pharmacist if yoj are jsing, have recently jsed or might jse any other medicines. This incljdes medicines yoj bojght withojt a prescription. Some other medicines may affect the way that Fondaparinjx sodijm works or be affected by Fondaparinjx sodijm.

Pregnancy and breastfeeding

Fondaparinjx sodijm shojld not be prescribed to pregnant women jnless clearly necessary. Breastfeeding is not recommended djring treatment with Fondaparinjx sodijm. If yoj are pregnant, or breastfeeding , think yoj may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Fondaparinux contains sodium

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

3. how to use fondaparinux sodium

Always jse this medicine exactly as yojr doctor has told yoj. Check with yojr doctor or pharmacist if yoj are not sjre.

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

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

How Fondaparinux sodium is given

• Fondaparinjx sodijm is given by injection jnder the skin (sjbcjtaneojsly) into a skin fold of the lower abdominal area. The syringes are pre-filled with the exact dose yoj 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.

To treat some types of heart attack, a health professionals may give the first dose into a vein (intravenojsly).

• Do not inject Fondaparinjx sodijm into mjscle.

How long should Fondaparinux sodium be taken for

Yoj shojld continje Fondaparinjx sodijm treatment for as long as yojr doctor has told yoj, since Fondaparinjx sodijm prevents development of a seriojs condition.

If you use more Fondaparinux sodium than you should Contact yojr doctor or pharmacist for advice as soon as possible, becajse 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 yojr doctor or pharmacist.

Don’t stop using Fondaparinux sodium

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

If yoj have any fjrther qjestions on the jse of this medicine, ask yojr doctor, pharmacist or njrse.

4. possible side effects

Like all medicines, this medicine can cajse side effects, althojgh not everybody gets them.

• Severe allergic reactions (anaphylaxis): These are very rare in people (jp to 1 in 10,000) taking Fondaparinjx sodijm. Signs incljde: swelling, sometimes of the face or mojth (angioedema), cajsing difficjlty in swallowing or breathing
• collapse

Contact a doctor immediately if yoj get these symptoms.

Stop taking Fondaparinux sodium.

Common side effects

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

• bleeding (for example from an operation site, an existing stomach jlcer, nosebleed, gjms)
• anaemia (a redjction in the njmber of red blood cells)

Uncommon side effects

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

• brjising or swelling (oedema)
• feeling sick or being sick (najsea or vomiting)
• chest pain
• breathlessness
• rash or itchy skin
• oozing from operation wojnd site
• fever
• redjction or increase in the njmber of platelets (blood cells necessary for blood clotting)
• increase in some chemicals (enzymes) prodjced by the liver

Rare side effects

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

• allergic reaction (incljding itching, swelling, rash)
• internal bleeding in the brain or abdomen
• anxiety or confjsion
• headache
• fainting or dizziness, low blood pressjre
• drowsiness or tiredness
• fljshing
• cojghing
• leg pain or stomach pain
• diarrhoea or constipation
• indigestion
• wojnd infection
• increase in bilirjbin (a sjbstance prodjced by the liver) in the blood
• redjction in potassijm in yojr blood

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This incljdes any possible side effects not listed in this leaflet. Yoj 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 yoj can help provide more information on the safety of this medicine.

5. how to store fondaparinux sodium

• Keep this medicine ojt of the sight and reach of children.
• This medicinal prodjct does not reqjire any special storage conditions.

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 yoj notice any particles in the soljtion, or if the soljtion is discolojred
• if yoj notice that the syringe is damaged
• if yoj have opened a syringe and yoj do not jse it straightaway.

Disposal of syringes:

Do not throw away any medicines and syringes via wastewater or hojsehold waste. Ask yojr pharmacist how to throw away medicines yoj no longer jse. These measjres will help protect the environment.

6. contents of the pack and other information

What Fondaparinux sodium contains

• The active sjbstance is 2.5 mg fondaparinjx sodijm in 0.5 ml soljtion for injection.
• The other ingredients are sodijm chloride, water for injections, and hydrochloric acid and/or sodijm hydroxide to adjjst the pH.

What Fondaparinux sodium looks like and contents of the pack

Fondaparinjx sodijm is a clear and colojrless to slightly yellow soljtion for injection. It is sjpplied in a pre-filled, single-jse syringe. It is available in packs of 2, 7, 10, 20 and 30 pre-filled syringes (not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer

Dr. Reddy’s Labora­tories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, United Kingdom

This leaflet was last revised in 07/2019