PATIENT INFORMATION LEAFLET

Arganova 100 mg/ml Concentrate for Solution for Infusion

argatroban monohydrate

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

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

•If you experience any side effects,consult your doctor, pharmacist or nurse, evenif they do not appear in this leaflet. See section 4.

1. What is Arganova and what it is used for

2.What you need to knowbeforestarting touseArganova

3. How to use Arganova

4. Possible side effects

5. Storage of Arganova

6.Contents of the pack and additional information

Arganova is an anticoagulant (a medication that helps prevent the formation of blood clots in your circulatory system). It works by blocking the action of thrombin, a substance present in the blood that is important for its coagulation.

Arganova is used if you suffer from a condition known as heparin-induced thrombocytopenia type II (HIT type II). If you have HIT type II, you are at risk of forming blood clots in your circulation, which can cause heart attacks, strokes, respiratory problems, and problems with blood flow to your extremities.Arganova can prevent these problems or prevent them from getting worse.

No use Arganova

Arganova will not be administered:

• If you have uncontrolled bleeding.

• If you are allergic (hypersensitive) to argatroban or any of the other components of Arganova.

• If you have severe liver failure.

Warnings and precautions

Arganova will be administered with special caution in the following cases:

• If you have an increased risk of bleeding.

• If you have recently received injections or infusions of other anticoagulants, such as heparin.

• If you have any liver disease.

Children and adolescents

It is not recommended to administer this medication to children or adolescents as the effective and safe dose of Arganova has not been clearly established.

Use ofArganova withother medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

The combined use with other anticoagulant medications or medications capable of dissolving blood clots may increase the risk of bleeding.

As Arganova contains ethanol, it may affect the effect of other medications that contain metronidazole (for infections) or disulfiram (for alcoholism).

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving Arganova.

As a precaution, it is preferable to avoid the use of Arganova during pregnancy.

Avoid breastfeeding while using Arganova. See also the section «Arganova contains alcohol».

Driving and operating machines

As Arganova contains alcohol, you should not drive a vehicle or operate machines during treatment. (See also «Arganova contains alcohol»).

Arganova contains alcohol

This product contains 50% ethanol (alcohol), which corresponds to a quantity of 400 mg/ml before dilution, which corresponds to 0.5% in volume after the dilution made according to the instructions. Therefore, the daily dose may contain up to 5 ml (4 g) of alcohol, equivalent to 100 ml of beer or 40 ml of wine.

This medication may be harmful to people with alcoholism.

The alcohol content should be taken into account in the case of pregnant women or breastfeeding women, children, and high-risk groups, such as patients with liver disease, epilepsy, or brain damage. See also «Pregnancy, breastfeeding, and fertility».

If you have a history of alcohol addiction, consult your doctor or pharmacist before taking this medication.

It is unlikely that the amount of alcohol contained in this medication will have any perceptible effect on adults or adolescents. The amount of alcohol contained in this medication may affect the effect of other medications. Consult your doctor or pharmacist if you are taking other medications.

As this medication is usually administered slowly over several hours, the effects of alcohol may be less.

Arganova contains sorbitol

This medication contains 750 mg of sorbitol in each vial (2.5 ml) equivalent to 300 mg/ml.

Sorbitol is a source of fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disease, you should not receive this medication. Patients with HFI cannot break down fructose, which can cause severe adverse effects. Consult your doctor before receiving this medication if you have HFI.

Arganova will always be administered by a healthcare professional. Arganova will be administered intravenously (into a vein) as a continuous infusion. The doctor will determine the dosage and duration of treatment.

Like all medications, Arganova may cause side effects, although not everyone will experience them.

The most common side effect is bleeding.Bleeding of consideration may occur in approximately 5% of patients, and minor bleeding in about 39%.

Inform your doctor immediatelyif you experience any of the following symptoms:

? bleeding or bruises

? blood in the urine or stool
? vomiting or coughing up blood
? black stools

? difficulty breathing

? cold sweat
? dry mouth
? dilated pupils or weak and rapid pulse

These symptoms may indicate that you are experiencing bleeding.

Frequent side effects(may affect up to 1 in 10 users)

? anemia

? blood clots

? bleeding, including small and numerous bleeding in the skin and mucous membranes (purpura)

? nausea

Rare side effects(may affect up to 1 in 100 users)

? infections, such as urinary tract infections

? alteration of hematological values
? blood clots
? loss of appetite

? low blood sugar
? low sodium levels in the blood

? confusion
? dizziness
? fainting

? headache

? stroke
? muscle disorders
? speech disorders

? vision problems
? hearing loss

? heart attacks

? fluid in the pericardium

? abnormal heart rhythm
? tachycardia

? hypotension

? hypertension
? venous inflammation
? shock

? decreased oxygen delivery to tissues

? respiratory difficulty

? fluid around the lungs

? hiccups
? blood when coughing or vomiting or stool

? constipation

? diarrhea
? stomach inflammation

? difficulty swallowing

? tongue disorders
? liver function abnormalities

? jaundice (yellowing of the skin and eyes)

? alterations in liver function blood tests

? rash, including urticaria
? itching

? increased sweating
? hair loss

? muscle weakness

? muscle pain
? kidney insufficiency
? fever
? pain
? fatigue

? reaction at the injection site

? swelling of the legs

? increased suppuration of wounds
? abnormal analytical results

Unknown(frequency cannot be estimated from available data)

?cases of cerebral hemorrhage have been reported

Reporting of side effects

If you experienceany type of side effect, consult your doctor, pharmacist ornurse, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through theSpanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Store the vial in the outer packaging to protect it from light.

Do not refrigerate or freeze.

Reconstituted solutions should not be exposed to direct sunlight.

Solutions should not be used if they are cloudy or contain particles.

Diluted solution: its chemical and physical stability has been demonstrated for use up to 14 days at temperatures of 25 °C and 2 °C to 8 °C in a sodium chloride solution for infusion of 9 mg/ml (0.9%) or glucose of 50 mg/ml (5%) or in an intravenous infusion preparation of sodium lactate.

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user and should normally not exceed 24 hours at a temperature of 2 °C to 8 °C, unless the dilution has been performed in validated and controlled aseptic conditions.

Do not use Arganova after the expiration date appearing on the carton packaging or on the vial after CAD. The expiration date is the last day of the month indicated.

Composition of Arganova

The active principle of Arganova is argatroban monohydrate.

1 vial with 2.5 ml of concentrate for infusion solution contains 250 mg of argatroban monohydrate.

The other components are:

anhydrous ethanol

sorbitol (E-420i)

water for injectable preparations.

Aspect of the product and content of the packaging

This medicine is a clear, colorless or pale yellow concentrate for infusion solution. Each vial contains 2.5 ml of the solution and the vials are packaged in cardboard boxes of 1 or 6 vials.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Ethypharm, 194, Bureaux de la Colline, Building D, 92213 Saint-Cloud cedex, France.

Responsible for manufacturing

Tjoapack Netherlands B.V., Nieuwe Donk 9, Etten-Leur, 4879AC, Netherlands.

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Aguettant Ibérica S.L.

Baldiri Reixac, 4-8, Tower I, 08028 Barcelona

Spain

Phone: +34 93 403 37 80

This medicine is authorized in the Member States of the European Economic Area with the following names:

This information is intended only for doctors or healthcare professionals.

Instructions for use, handling and disposal

Arganova must be diluted in a sodium chloride solution for infusion of 9 mg/ml (0.9%) or glucose solution of 50 mg/ml (5%) or in a prepared intravenous infusion of sodium lactate to a final concentration of 1 mg/ml. The vial must be discarded if the solution is turbid or if it presents any insoluble precipitate.

Each vial of 2.5 ml must be diluted 100 times by mixing it with 250 ml of diluent. Each vial is for single use. 250 mg (2.5 ml) are used per 250 ml of diluent or 500 mg (5 ml) per 500 ml of diluent.

The reconstituted solution is mixed by repeated inversion of the bag or diluent bottle for one minute. The diluted solution must be clear and practically free of visible particles. During reconstitution, the solution may show a slight transient turbidity due to the formation of microprecipitates that dissolve rapidly when mixed. The pH of the intravenous solution reconstituted according to the instructions is 3.2-7.5.

No measures such as protecting the intravenous lines with aluminum foil are necessary to avoid exposure to sunlight. No significant losses of potency have been observed after simulated administration of the solution through intravenous lines.

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.