Label: information for the user

innohep 8.000 UI anti-Xa/0.4 ml injectable solution in pre-filled syringes

(20.000 UI anti-Xa/ml)

tinzaparin sodium

Read this label carefully before starting to use this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
  If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label.
• In the text of this label, the term innohep will be used to refer toinnohep 8.000 UI anti-Xa/0.4 ml injectable solution in pre-filled syringes”.

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 side effects

5. Storage of innohep

6. Contents of the package and additional information

innohepis a medication that inhibits the natural ability of blood to form clots (coagulate).

-innohep is used to treat blood clots and prevent the formation of more clots in adults.

You should consult a doctor if you get worse or do not improve.

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).

-If you have a scheduled spinal or epidural anesthesia or lumbar puncture.

Warnings and precautions

Consult your doctor or nurse before starting to use innohep

• If you know you have a tendency to bleed.
• If you are being treated with other intramuscular medications.
• If you have a low platelet count in your blood.
• If you have high potassium levels in your blood (hyperkalemia).
• If you have a heart valve prosthesis.
• 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.

Inform your doctor if you need epidural anesthesia.

Inform your doctor or nurse if you have a heart valve prosthesis

Driving and operating machinery

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

Innohep contains sodium metabisulfite

-As it contains sodium metabisulfite as an excipient, innohep may rarely cause severe allergic reactions and bronchospasm.

-This medication contains 40 mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 2% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions of this medication as indicated by your doctor or nurse. In case of doubt, consult your doctor or nurse again..

During treatment, your doctor may request that you undergo routine blood tests to evaluate the effect of innohep.

Innohep must be injected under the skin (subcutaneous injection). Avoid administering other medications through intramuscular injection during treatment with innohep, due to the risk of hematoma formation.

The recommended dose is:

175 UI anti-Xa per kg of body weight administered once a day.

Your doctor will indicate the suitable dose for you.

The treatment should be administered once a day, for 6 days, and may be extended up to 6 months. The need to extend treatment for more than 6 months should be evaluated by your doctor. Your doctor will indicate the duration of your treatment.

Instructions on how to inject innohep:

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

2.Open the syringe container, lifting the color 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 present 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.

3.Double the safety device downwards, separating it from the protective cap of the needle.

4.Remove the cap that protects the needle without twisting it. Adjust the syringe contents to the prescribed dose by your doctor. Remove the excess volume by pressing the plunger in a vertical position. Do not pull the plunger back, nor 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 place.

5.Take a skin fold, without pressing, between the thumb and index finger of one hand and with the other hand,insert the needle vertically and slowly 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 skin of the abdominal area, the anterior area of the thighs, the lower back, or the posterior area of the arms. 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 come out. Choose a different injection site for the next time (for example, alternating between the left and right abdominal areas).

8.Double the safety device to its original position so that it is in parallel with the needle. Then, with the safety device flat on a rigid surface, press down until the needle is blocked in the device.

9.The used syringe, with the needle downwards, can be introduced into the same syringe container or into a sharp waste container. In this way, the syringe is safe, and the syringe container or the sharp waste container can be delivered to a hospital or to the 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 administered a too-high dose of innohep.

If you forgot to use innohep

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

If you interrupt the treatment with innohep

If you interrupt the administration of innohep, the effect of making blood thinner will cease. Do not interrupt the treatment with innohep without consulting your doctor or nurse.

If you have any other doubts 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:

In rare cases, severe side effects have been observed that require immediate medical attention during innohep treatment. If you experience any of the following symptoms, consult your doctor immediately or visit the nearest hospital for emergency care.

• 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: 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

• Trombocytopenia (decrease in platelet count in the blood)
• Hypersensitivity (allergic reaction)
• Brusing and skin discoloration
• Elevation of liver enzyme levels
• Dermatitis (skin inflammation)
• Skin rash and itching

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

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

Pediatric population

There is limited information, 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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: 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.

No use this medication after the expiration date that appears on the packaging. 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.

- Medicines should not be disposed of through drains or in the trash. Dispose of the containers and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment. .

Composition of innohep

-The active ingredient is tinzaparina sodium. Each ml of injectable solution contains 20,000 UI anti-Xa of tinzaparina sodium.

-The other components are sodium metabisulphite (E 223), sodium hydroxide and water for injections.

Appearance of the product and contents of the packaging

Injectable solution.

Glass syringes with a transparent appearance containing a colourless or pale yellow solution, free from turbidity and sediment when left to stand.

Packaging sizes:

• 0.4 ml (8,000 UI anti-Xa), packs containing 2, 6, 10, 30, 50 and 100 syringes.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

LEO Pharma A/S

Industriparken 55,

DK-2750 Ballerup

Denmark

Responsible manufacturer:

Laboratoires LEO S.A.

39 Route de Chartres,

FR-28500 Vernouillet Cedex

France

Last review date of this leaflet:December 2019.

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.