Page 4 Page 1

- Not known (frequency cannot be estimated from the available data):

•    Bleeding inside or around your brain, symptoms may include sudden severe headache

•    Bleeding behind your abdomen (stomach), symptoms may include a feeling of tenderness and swelling around your stomach

•    Bruising of the spine which may lead to back pain, tingling, numbness or weakness in your legs, bowel or bladder problems

If you have an artificial heart valve, treatment with Fragmin might not be sufficient to prevent a blood clot, and you might develop a clot in the heart valve.

The adverse reactions in children are expected to be the same as in adults, however there is only a little information about the possible side effects of long term use in children.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

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 at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Fragmin

•    Keep out of the sight and reach of children.

•    Do not store above 25°C.

•    Fragmin should not be used after the expiry date mentioned on the pack. The expiry date refers to the last day of that month.

•    Your doctor or nurse will store Fragmin in a safe place under the above conditions.

•    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 pack and other information

What Fragmin contains

•    The active ingredient in Fragmin is dalteparin sodium.

•    Each pre-filled syringe provides a single dose of 7,500 iU (International units) of dalteparin sodium.

•    The other ingredients are water for

injections and either sodium hydroxide or hydrochloric acid for pH adjustment.

What Fragmin looks like and contents of the pack

•    Fragmin is available as a clear, colourless or straw coloured solution in a pre-filled single dose syringe with a grey rubber stopper.

•    Each pack contains 10 pre-filled syringes.

Manufacturer and Product Licence Holder

This product is manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium. It is procured from within the EU by the Product Licence Holder: Swinghope Ltd, Brandon House, Marlowe Way, Croydon CR0 4XS and repackaged by Interport Limited, Brandon House, Marlowe Way, Croydon CR0 4XS.

POM    PL No: 10380/1496

Fragmin® 7,500 IU/0.3 ml Solution for Injection

Leaflet revision date: 17/07/2014

Fragmin^® is a registered trademark of Pfizer Health AB, 112 87, Stockholm, Sweden.

T05028

Fragmin® 7,500 IU/0.3 ml Solution for Injection

(dalteparin sodium)

Patient Information Leaflet

Medicines that can reduce the effect of Fragmin, include:

•    Those for allergy and hay fever (e.g. antihistamines).

•    Those used for heart or circulation problems (e.g. digoxin or digitoxin).

•    Antibiotics known as tetracyclines which are used to treat bacterial infections.

•    Vitamin C (e.g. some vitamin supplements).

Other medicines that may interfere with Fragmin include:

•    Those used to treat angina (intravenous nitroglycerine)

•    Antibiotics such as high dose penicillin which are used to treat bacterial infections.

•    Anti-malarials (e.g. quinine)

•    Tobacco smoking

Please note that if you are being treated with Fragmin for unstable coronary artery disease your doctor may adjust your dose of aspirin accordingly.

Please tell your doctor or pharmacist if you are taking or have recently taken any other low molecular weight heparins or anti-thrombotics.

Pregnancy and breast-feeding

Fragmin has not been found to cause harmful effects during pregnancy. The possibility of harm to the baby appears remote. Tell your doctor if you are pregnant and they will advise you.

Fragmin is not recommended for the prevention of blood clots on artificial heart valves during pregnancy.

If you are receiving Fragmin to treat blood clots, you should not have a local, spinal or epidural anaesthetic.

Ask your doctor or pharmacist for advice before being given or using this medicine whilst breast-feeding.

Driving and using machines

Fragmin does not affect the ability to drive and operate machinery.

3. How Fragmin is given to you

Your medicine will usually be administered by a doctor or nurse or you may be shown how to give the injection yourself at home (See Section on How to Inject Fragmin). The amount of Fragmin you receive will depend on your body weight.

Fragmin is given as a single, once daily, subcutaneous injection, which means it is injected beneath the skin. It is usually injected into a skin fold in your abdomen (stomach), or the outer aspects of your thigh. It should not be injected into your muscles.

Use in adults and the elderly

To treat blood clots (venous thromboembolism)

•    Deep Vein Thrombosis

The usual dose of Fragmin used to treat deep vein thrombosis is 200 IU (units) for every kilogram you weigh, given once a day. Your doctor will select the dose which is appropriate for you based on your bodyweight.

The usual dose used to treat venous thromboembolism in cancer is 200 IU (international units) for every kilogram you weigh (see previous table) once daily during the first month after a thromboembolic event (blood clot), followed by 150 IU for every kilogram you weigh (during months 2-6).

Dose of Fragmin during months 2-6

The following table shows the dose you will receive depending on your body weight:

Abbreviations: IU = International Unit

The maximum daily dose is 18,000 IU.

Fragmin can be used together with other blood thinning medicines known as Vitamin K antagonists. Should this be desired, a minimum of five days would be required.

To treat blood clots (venous thromboembolism) in certain types of cancer and prevent recurrence

This treatment course is not recommended for patients weighing less than 40 kg.

The maximum daily dose is 18,000 IU. The recommended duration of treatment is 6 months. If you are suffering from severe kidney disease or a decreased platelet count (clotting cells) caused by chemotherapy or another condition with an elevated bleeding risk, your doctor will adjust this dose accordingly.

In some cases of decreased platelet count (clotting cells), your doctor may interrupt your treatment with Fragmin for a short period.

Medical staff may take blood samples during your treatment to monitor the effects of Fragmin.

•    Unstable Coronary Artery Disease

The usual dose used to treat unstable coronary artery disease is 120 IU (units) for every kilogram you weigh, given every 12 hours.

The maximum dose in a 12 hour period is

10.000    IU (units).

Doses are usually given for between 5 and 8 days.

If you have an artificial heart valve, the normal dose for prevention of blood clots is not sufficient. Your doctor will discuss this with you.

•    Extended use Adults and the Elderly

If your doctor has recommended a special procedure to restore the blood supply to your heart (angiography or coronary artery surgery), it may be necessary to continue to administer Fragmin for up to 45 days. In this case, the typical dose for adults, including elderly patients should be either 5,000 IU (units) (women less than 80 kg and men less than 70 kg) or 7,500 IU (women 80 kg and above and men 70 kg and over) every 12 hours.

The maximum dose in a 12 hour period is

10.000    IU.

Medical staff may take blood samples during your treatment to monitor the effects of Fragmin.

How to Inject Fragmin

This section of the leaflet explains how you

should go about injecting Fragmin yourself,

but you should only do so if you have been

given permission by your doctor. It is a

simple process and one that you can do at

home.

Fragmin is given by a small injection under the skin. You should inject (or give) the dose of Fragmin at the time recommended by your doctor. Please follow the steps explained below.

•    Gather the single dose Fragmin syringe and the yellow sharps bin.

•    Wash and dry your hands. The injection site should be cleaned.

Please note that if a carer is doing the injecting, it is recommended that they wear gloves to perform the injection.

Step 1:

Get yourself in a comfortable sitting down position where you can see your stomach.

Step 2:

Choose an injection site either on your stomach or outer aspects of your left or right thigh (see shaded areas). Your stomach is usually best as the injection site and it is important that you change the site each time.

Step 3:

Pick up the syringe, grasp the tip of the plastic needle catcher and bend it away from the shield. Remove the grey rubber cover by pulling it straight off. You will notice an air bubble in the syringe. It is supposed to be there and you can just ignore it. It is important not to press the plunger just yet as some of the medicine may be lost.

Step 4:

Hold the syringe in one hand and with the other hand, gently pinch a fold of skin with its fatty tissue (see the shaded areas above) between your thumb and index finger. This will be the injection site.

Step 5:

Hold the syringe above the folded skin keeping it at a right angle (i.e. vertically as in the diagram and not at an angle). Insert the needle into the skin until the needle is fully inserted.

Step 6:

Now press the plunger and inject the Fragmin slowly until all of the medicine has been injected. Keep pinching the fold of skin while you are injecting and then release the fold of skin and pull the needle out.

If there is any oozing of blood at the injection site, apply gentle pressure. Do not rub the injection site as this may encourage bruising.

Step 7:

Place the plastic catcher against a hard stable surface and with one hand pivot the syringe barrel upwards against the needle forcing the needle into the catcher where it locks in place. Continue bending the needle until the syringe exceeds a 45 degree angle with the flat surface to render it permanently unusable.

Dispose of the syringe in the yellow sharps bin provided. Keep your sharps bin out of reach of other people. When the sharps bin is almost full please speak to your doctor or nurse.

Children and adolescents

The dose will be based on both the child’s age and weight. Younger children may need slightly more Fragmin per kg than adults. Your doctor will work out the right dose for you. Medical staff may take blood samples during your treatment to monitor the effects of Fragmin.

If you are given more Fragmin than you

should

If you feel that you have been given more Fragmin than you should, inform your doctor or nursing staff immediately. Your doctor may initiate measures to decrease the risk of bleeding.

If you forget to use Fragmin

Tell your doctor or pharmacist if you think that a dose has been forgotten.

A double dose should not be given to make up for a forgotten dose.

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

4. Possible side effects

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

Stop using Fragmin and talk to a doctor or nurse at once if you get any signs of a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat or eyes)

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

■    A reversible decrease in the number of clotting cells (platelets) in your blood (Type I thrombocytopenia). This may make you bruise more easily.

■    Bleeding at any site

■    Certain substances produced by your liver may increase

■    Pain and reactions at the site of injection

■    Haematoma - collection of blood under the skin

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

■    Increased levels of potassium in your blood (symptoms may include temporary muscle weakness, loss of feeling and changes in your heartbeat)

■    Red skin rash and itchiness

■    Itching

■    Allergic reactions

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

■    An immune system problem resulting in a severe decrease in the number of clotting cells (platelets) in your blood (Type II thrombocytopenia)

■    Alopecia (hair loss)

■    Painful skin lesions

T05028