• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 of side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Riastap is and what it is used for
2. What you need to know before you use Riastap
3. How to use Riastap
4. Possible side effects
5. How to store Riastap
6. Contents of the pack and other information

Riastap contains human fibrinogen which is a protein important for blood clotting (coagulation). Lack of fibrinogen means that the blood does not clot as quickly as it should, which results in an increased tendency of bleeding. The replacement of human fibrinogen with Riastap will correct the coagulation defect.

Riastap is used for treatment of bleeding in patients with a congenital lack of fibrinogen (hypo- or afibrinogenaemia) with bleeding tendency.

• if you are allergic to human fibrinogen or any of the other ingredients of this medicine (listed in section 6).

Please inform your doctor if you are allergic to any medicine or food.

• if you have experienced allergic reactions to Riastap in the past. You should take antihistamines and corticosteroids prophylactically if advised by your doctor.
• when allergic or anaphylactic-type reactions occur (a serious allergic reaction that causes severe difficulty in breathing or dizziness). The administration of Riastap should be stopped immediately (i.e. discontinue injection).
• because of an increased risk of blood clots in a blood vessel (thrombosis), particularly:
  • in case of a high dose or repeated dosing
  • if you have had a heart attack (a history of coronary heart disease or myocardial infarction)
  • if you suffer from liver disease
  • if you have just had surgery (patients postoperatively)
  • if you will be having surgery soon (patients preoperatively)
  • in newborn infants (neonates)
  • if you are more likely to suffer from blood clots than normal (patients at risk of thromboembolic phenomena or disseminated intravascular coagulation)

Your doctor will consider carefully the benefit of treatment with Riastap compared with the risk of these complications.

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include:

• careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and
• the testing of each donation and pools of plasma for signs of virus/infections.

Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV, the AIDS virus), hepatitis B virus and hepatitis C virus (inflammation of the liver), and for the non-enveloped hepatitis A virus (inflammation of the liver).

The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.

Parvovirus B19 infection may be serious:

• for pregnant women (infection of the unborn child) and
• for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).

Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived products.

It is strongly recommended that every time that Riastap is given, your doctor should record the date of administration, the batch number and the injected volume.

• Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
• Riastap must not be mixed with other medicinal products except those mentioned in section “The following information is intended for healthcare professionals only / Reconstitution”.

• 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.
• During pregnancy and breast-feeding Riastap should be given only if it is clearly needed.

Riastap has no or negligible influence on the ability to drive and use machines.

Riastap contains up to 164 mg (7.1 mmol) sodium per vial. This correlates with 11.5 mg (0.5 mmol) sodium per kg body weight of the patient if the recommended initial dose of 70 mg/kg body weight is applied. Please take this into account if you are on a controlled sodium diet.

The amount of human fibrinogen you need and the duration of treatment depend on:

• the severity of your disease,
• the site and intensity of the bleeding,
• your clinical condition.

Your doctor should regularly check your blood clot status during the treatment. In case of overdosage, the risk of development of thromboembolic complications is enhanced.

If you have any further questions on the use of this product, ask your doctor or pharmacist (see section "The following information is intended for medical or healthcare professionals only").

• if any of the side effects occur
• if you notice any side effects not listed in this leaflet.

The following side effect has been observed very commonly (may affect more than 1 in 10 people):

• Increase in body temperature

The following side effect has been observed uncommonly (may affect up to 1 in 100 people):

• A sudden allergic reaction (such as reddening of the skin, skin rash over the whole body, fall in blood pressure, difficulty in breathing).

The following side effect has been observed commonly (may affect up to 1 in 10 people, however incidence was higher in patients receiving no fibrinogen):

• Risk of increased formation of blood clots (see section 2 "What you need to know before you use Riastap").

If you get any side effects, talk to your doctor or healthcare professional. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

UK:

or search for MHRA Yellow Card in the Google Play or Apple App Store

Malta:

Ireland:

The active substance is:

Human fibrinogen (1 g/vial; after reconstitution with 50 ml of water for injections approx. 20 mg/ml).

See section “The following information is intended for healthcare professionals only” for further information.

The other ingredients are:

Human albumin, sodium chloride, L-arginine hydrochloride, sodium citrate, sodium hydroxide (for pH adjustment).

See last paragraph of section 2. "Important information about some of the ingredients of Riastap".

Riastap is presented as a white powder.

After reconstitution with water for injections the product should be clear or slightly opalescent, i.e. it might sparkle when held up to the light but must not contain any obvious particles.

Presentation

Pack with 1 g (Figure 1)

1. One vial containing 1 g human fibrinogen
2. Filter: Pall^® Syringe Filter
3. Dispensing pin: Mini-Spike^® Dispensing Pin