INNOHEP 8,000 IU Anti-Xa / 0.4 mL PRE-FILLED SYRINGE SOLUTION FOR INJECTION

Introduction

Package Leaflet: Information for the User

innohep 8,000 IU anti-Xa/0.4 ml solution for injection in pre-filled syringes

(20,000 IU anti-Xa/ml)

tinzaparin sodium

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

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
• In this leaflet, the term "innohep" will be used to refer to "innohep 8,000 IU anti-Xa/0.4 ml solution for injection in pre-filled syringes".

Contents of the pack

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

1. What is innohep and what it is used for

innohep is a medicine 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 it gets worse or does not improve.

2. What you need to know before you use innohep

Do not use innohep

• if you are allergic to tinzaparin sodium or any of the other ingredients of this medicine (listed in section 6).
• if you have or have had heparin-induced thrombocytopenia.
• if you have a severe bleeding disorder (e.g., in the brain, spinal cord, eyes, or stomach).
• if you have a severe infection of the heart (septic endocarditis).
• if you are scheduled for spinal or epidural anesthesia or a 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 medicines by intramuscular route.
• 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.

Using innohep with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Some medicines may interact with the effect of innohep.

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

• Medicines for the treatment of inflammation and pain, especially non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid
• Medicines used to dissolve blood clots (thrombolytic agents)
• Medicines 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

innohep in pre-filled syringes may be used during all trimesters of pregnancy.

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

Tell your doctor or nurse if you have a prosthetic heart valve

Driving and using machines

innohep does not affect the ability to drive or use machines.

innohep contains sodium metabisulfite

• As innohep contains sodium metabisulfite as an excipient, it may rarely cause severe allergic reactions and bronchospasm.
• This medicine contains 40 mg of sodium (main component of table/cooking salt) per ml. This is equivalent to 2% of the maximum recommended daily intake of sodium for an adult.

3. How to use innohep

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

During treatment, your doctor may ask you to have routine blood tests to assess the effect of innohep.

innohep must be injected under the skin (subcutaneous injection). Administration by intramuscular injection of other medicines should be avoided during treatment with innohep, due to the risk of hematoma formation.

The recommended dose is:

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

Your doctor will indicate the suitable dose for you.

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 medicine. Clean the skin around the injection site with an alcohol swab and let it dry without rubbing.

1. Open the syringe container by lifting the colored cap all the way back and remove the syringe.

Inspect the contents of the syringe before use. If you notice turbidity or a precipitate in the medicine, do not use it and take another syringe. The medicine may have a yellowish color during storage, but it can be used as long as the solution is clear and the expiration date has not been exceeded. Each syringe can only be used once.

1. Fold the safety device downwards, separating it from the needle protector cap.

1. Remove the cap that protects the needle without twisting it. Adjust the syringe contents to the dose prescribed by your doctor. Eliminate the excess volume by pressing the plunger in a vertical position. Do not pull the plunger back or eliminate 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 place.

1. 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, i.e., at a right angle to the skin.

1. Slowly inject the necessary dose into the fatty tissue, for example, the skin of the abdominal area, the front of the thighs, the lower back, or the back of the arms. Wait a few seconds to allow the solution to distribute before removing the needle and releasing the skin fold.

1. Clean the area with a swab if you have bled. Choose a different injection site for the next time (e.g., alternating between the left and right side of the abdomen).

1. Fold the safety device back to its original position so that it is parallel to the needle. Then, with the safety device flat on a rigid surface, press down until the needle is locked into the device.

1. The used syringe, with the needle facing down, can be inserted into the same syringe container or into a container for sharp waste. In this way, the syringe is safe, and the container with the syringe or the container for sharp waste can be delivered to a hospital or 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 high a dose of innohep.

If you forget to use innohep

Do not inject a double dose to make up for a forgotten dose. If you have forgotten to administer more than one dose, consult your doctor as soon as possible.

If you stop using innohep

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

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

4. Possible side effects

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

Serious side effects:

Rarely, serious side effects have been observed that require immediate medical attention during treatment with innohep. 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 appearance of a severe skin rash, swelling of the throat, face, lips, or mouth, difficulty breathing.
• Severe bleeding. Symptoms include urine that is red or brown, stools that look like tar, unusual hematomas (very painful, extensive, or dark) and any bleeding that does not stop.

The following side effects have been observed with the administration of innohep:

Common: may affect up to 1 in 10 people

• Bleeding: May lead to complications such as anemia (low number of red blood cells) or hematomas (bruises)

• Reactions at the injection site (including bruising, bleeding, pain, itching, redness, inflammation, and hardening of the injection site)

Uncommon: may affect up to 1 in 100 people

• Thrombocytopenia (decrease in the number of platelets in the blood)
• Hypersensitivity (allergic reaction)
• Bruising and skin discoloration
• Elevated levels of liver enzymes
• Dermatitis (skin inflammation)
• Rash and itching

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

• Heparin-induced thrombocytopenia (decrease in the number of platelets in the blood due to heparin treatment)
• Thrombocytosis (increase in the number of platelets in the blood)
• Angioedema (swelling of the face, lips, and tongue)
• Anaphylactic reaction (see above "Severe allergic reaction")
• Hyperkalemia (elevated levels of potassium in the blood)
• Toxic skin rash
• Necrosis of the skin (death of skin tissue)
• Habones
• Osteoporosis, observed in long-term treatments
• Priapism (prolonged, often painful, erection without previous sexual stimulation)

Pediatric population

Limited information is available from a clinical trial and post-marketing data, indicating that the profile of adverse reactions in children and adolescents is comparable to that observed in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of innohep

• Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the pack. The expiry date is the last day of the month stated.

• No special storage conditions are required.
• Do not use this medicine if you notice turbidity or a precipitate in the syringe.
• The solution may have 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 via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of innohep

• The active substance is tinzaparin sodium. Each ml of the solution for injection contains 20,000 IU anti-Xa of tinzaparin sodium.
• The other ingredients are sodium metabisulfite (E 223), sodium hydroxide, and water for injections.

Appearance and packaging

Solution for injection.

Transparent glass syringes containing a clear or pale yellow solution, free from turbidity and deposit when the syringe is left to stand.

Package sizes:

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

LEO Pharma A/S

Industriparken 55,

DK-2750 Ballerup

Denmark

Manufacturer:

Laboratoires LEO S.A.

39 Route de Chartres,

FR-28500 Vernouillet Cedex

France

Date of last revision of this leaflet:December 2019.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.