Prospect: information for the user

innohep 3.500 UI anti-Xa/0.35 ml injectable solution in pre-filled syringes

(10,000 UI anti-Xa/ml)

tinzaparin sodium

1. What innohep is and for what it is used

2. What you need to know before starting to use innohep

3. How to use innohep

4. Possible adverse effects

5. Storage of innohep

6. Contents of the package and additional information.

innohep is a medication that makes blood flow more easily by reducing the natural ability of blood to form clots.

innohep is used for

• to prevent blood clots from forming in the blood of adults before and after surgery.

• to prevent blood clots from forming in the blood of adults with a higher risk of blood clots, for example, due to an acute illness with limited mobility.

to prevent blood clots from forming in the blood of dialysis patients undergoing hemodialysis or hemofiltration. In hemodialysis, waste and fluids from the blood are removed by the machine and dialysis filter that acts as an artificial kidney.

No use innohep:

- If you are allergic to tinzaparin sodium or any of the other components of this medication (listed in section 6).

- If you have or have had heparin-induced thrombocytopenia.

- If you have a severe bleeding (for example, in the brain, spinal cord, eyes, or stomach).

- If you have a severe heart infection (septic endocarditis).

Warnings and precautions

Consult your doctor or nurse before starting to use innohep:

- If you are to undergo spinal or epidural anesthesia or a lumbar puncture.

- If you know you have a tendency to bleed.

- If you are being treated with other medications administered intramuscularly.

- If you have a low platelet count in your blood.

- If you have high levels of potassium in your blood (hyperkalemia).

- If you have a prosthetic heart valve.

- If you have kidney problems.

Children and adolescents

Innohep is not indicated for use in children and adolescents.

Use of innohep with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. Some medications may interact with the effect of innohep.

Inform your doctor if you are using any of the following medications as you may bleed more easily:

- Medications for the treatment of inflammation and pain, especially nonsteroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid.

- Medications used to dissolve blood clots in the blood (thrombolytic agents)

- Medications that block the action of vitamin K (vitamin K antagonists)

- Activated protein C

- Direct inhibitors of factor Xa and IIa.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Innohep in pre-filled syringes can be used during all trimesters of pregnancy.

If epidural anesthesia is required, inform your doctor that you are using innohep.

Inform your doctor or nurse if you have a prosthetic heart valve.

Driving and operating machinery

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

Innohep contains sodium

This medication contains less than 23 mg of sodium (1mmol) per ml; this is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or nurse.If in doubt, consult your doctor or nurse again.

Your doctor may request that you undergo routine blood tests to assess the effect of innohep.

To prevent the formation of blood clots in your veins

Innohep must be injected under the skin (subcutaneous injection). The dose and duration of treatment will depend on the type of surgery or disease you have. Your doctor will inform you of the appropriate dose for you and the duration of your treatment.

To prevent the formation of blood clots during hemodialysis or hemofiltration

Innohep will be introduced into the hemodialysis machine circuit or administered intravenously. The dose will depend on the duration of dialysis.

Instructions for injecting innohep:

1. Wash your hands thoroughly before injecting this medication. Clean the skin around the injection site with an alcohol swab and let it dry without rubbing it.

1. Open the syringe container by lifting the color-coded cap completely back and remove the syringe.

Inspect the syringe contents before use. If you observe turbidity or a precipitate in the medication, do not use it and take another syringe. The medication may exhibit a yellowish color during storage, but it can be used as long as the solution is transparent and does not exceed the expiration date. Each syringe can be used only once.

1. Push the safety device downwards, separating it from the protective cap of the needle.

1. Remove the protective cap from the needle without twisting it. Do not pull the plunger back or remove the air bubble contained in the syringe. If the air bubble is not correctly positioned next to the plunger, gently tap the syringe until the air bubble is in its correct position, next to the plunger.

5.Take a skin fold, without pressing, between the thumb and index finger of one hand and with the other handinsert the needle vertically into the skin fold, that is, at a right angle to the skin.

6.Inject the necessary dose slowly into the fatty tissue, for example, the abdominal skin, the anterior thigh skin, the lower back skin, or the posterior arm skin. Wait a few seconds to allow the solution to distribute before removing the needle and releasing the skin fold.

7.Clean the area with a gauze if blood has leaked out. Choose a different injection site for the next time (for example, alternating between the left and right abdominal areas).

8.Push the safety device back to its original position so that it is in line with the needle. Then, with the safety device flat on a rigid surface, press down until the needle is locked in the device.

9.The used syringe, with the needle pointing downwards, can be inserted into the same syringe container or into a sharps disposal container. In this way, the syringe is safe, and the syringe container or the sharps disposal container can be handed over to a hospital or a pharmacist for destruction.

If you use more innohep than you should

If you are treated with more innohep than you need, bleeding may occur. Consult your doctor or nurse immediately if you do not feel well or think you have been given too much innohep.

In case of overdose or accidental ingestion, you can also contact the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to use innohep

Do not administer a double dose to compensate for the missed doses. If you have forgotten to administer more than one dose, consult your doctor as soon as possible.

If you interrupt the innohep treatment

If you stop administering innohep, the effect of making the blood more fluid will cease. Do not suspend innohep treatment without consulting your doctor or nurse.

If you have any other questions about the use of this medication, ask your doctor or nurse.

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

Severe side effects:

Severe side effects that require immediate medical attention are rare during innohep treatment. If you experience any of the following symptoms, consult your doctor immediately or go to the nearest hospital for emergency treatment.

• Severe allergic reaction. Symptoms include sudden onset of severe skin rash, throat, face, lips, or mouth inflammation, difficulty breathing.
• Severe bleeding. Symptoms include red or brown urine, stool resembling tar, rare hematomas (very painful, extensive, or dark) and any bleeding that does not stop.

The following side effects have been observed with innohep administration:

Frequent: may affect up to 1 in 10 people

• Bleeding. It may lead to complications, such as anemia (low red blood cell count) or hematomas (bruises)
• Reactions at the injection site (including bruises, bleeding, pain, itching, redness, inflammation, and hardening of the injection site)

Rare: may affect up to 1 in 100 people

• Thrombocytopenia (decrease in platelet count in blood)
• Hypersensitivity (allergic reaction)
• Bruises and skin discoloration
• Elevation of liver enzyme levels
• Dermatitis (skin inflammation)
• Rash and itching

Rare: may affect up to 1 in 1,000 people

• Thrombocytopenia induced by heparin (decrease in platelet count in blood due to heparin treatment)
• Thrombocytosis (increase in platelet count in blood)
• Angioedema (swelling of the face, lips, and tongue)
• Anaphylactic reaction (see previously “Severe allergic reaction”)
• Hyperkalemia (elevated potassium levels in blood)
• Toxic skin rash
• Cutaneous necrosis (death of skin tissue)
• Gas
• Osteoporosis, observed in long-term treatments
• Priapism (prolonged, often painful erection, without prior sexual stimulation)

Pediatric population

There is limited information, derived from a clinical trial and post-marketing data, indicating that the adverse reaction profile in children and adolescents is comparable to that observed in adults.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

-Keep this medication out of the sight and reach of children.

-Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

-No special storage conditions are required.

• Do not use this medication if you observe turbidity or a precipitate in the syringe.
• The solution may present a yellowish color during storage, but this does not affect the quality of the product, which is still safe for use.
• Dispose of medications and packaging through the SIGRE point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. This will help protect the environment.

Composition of innohep

-The active ingredient is tinzaparina sodium. Each ml of injectable solution contains 10,000 UI anti-Xa of tinzaparina sodium.

• The other components are sodium acetate, sodium hydroxide, and water for injectables.

Appearance of the product and contents of the packaging

Injectable solution.

Glass transparent syringes containing an colourless or light yellow solution, which does not present turbidity or material that deposits when the syringe is left at rest.

Packaging sizes:

- 0.35 ml (3,500 UI anti-Xa), packaging with 2.10 and 50 syringes.

Some packaging sizes may only be commercially marketed

Marketing authorization holder

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Responsible for manufacturing

Laboratoires LEO S.A.

39 Route de Chartres

FR-28500 Vernouillet Cedex

France

Last review date of this leaflet: December 2019

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.