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

Package leaflet: Information for the user

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 this entire 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet.
• Throughout 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 this leaflet

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

1. What innohep is and what it is used for

innohep is a medicine that inhibits the blood's natural ability to form clots (coagulation).

• innohep is used to treat blood clots and to prevent the formation of further clots in adults.

You should consult a doctor if your condition worsens or does not improve.

2. What you need to know before using innohep

Do not use innohep

• if you are allergic to sodium tinzaparin or to 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 serious bleeding condition (for example, in the brain, spinal cord, eyes, or stomach).
• if you have a severe heart infection (septic endocarditis).
• if you are scheduled to receive spinal or epidural anaesthesia or a lumbar puncture.

Warnings and precautions

Talk to your doctor or nurse before using innohep

• if you know you have a tendency to bleed.
• if you are being treated with other medicines given by intramuscular injection.
• if you have a low platelet count in your blood.
• if you have high levels of potassium in your blood (hyperkalaemia).
• 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 taking, have recently taken, or might need to take any other medicines. Some medicines may interact with the effect of innohep.

Tell your doctor if you are taking 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 factor Xa and IIa inhibitors

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

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

Driving and using machines

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 medicine contains 40 mg of sodium (a main component of table/cooking salt) per ml. This corresponds to 2% of the maximum daily intake of sodium recommended for an adult.

3. How to use innohep

Follow exactly the administration instructions for this medicine given by your doctor or nurse. If in doubt, consult your doctor or nurse again.

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

innohep should be injected under the skin (subcutaneous injection). Administration of other medications by intramuscular injection should be avoided during treatment with innohep, due to the risk of developing a bruise (hematoma).

Recommended dose:

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

Your doctor will determine the appropriate dose for you.

Treatment should be given once daily for 6 days, and may be extended up to 6 months. The need to extend treatment beyond 6 months must be evaluated by your doctor. Your doctor will indicate the duration of your treatment.

Instructions on how to inject innohep:

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

2. Open the syringe container by fully lifting back the colored cap and remove the syringe.

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

3. Fold down the safety device, separating it from the needle protective cap.

4. Remove the cap protecting the needle without twisting it. Adjust the syringe contents to the dose prescribed by your doctor. Remove any excess volume by pressing the plunger while the syringe is held vertically. Do not pull back the plunger, and do not remove the air bubble present in the syringe. If the air bubble is not correctly positioned next to the plunger, tap the syringe very gently until the air bubble is properly positioned.

5. Gently grasp a skin fold, without compressing it, 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.

6. Inject the required dose slowly into the fatty tissue, for example, into 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 disperse before withdrawing the needle and releasing the skin fold.

7. Clean the area with a gauze pad if bleeding occurs. For the next injection, choose a different injection site (for example, alternating between the left and right sides of the abdomen).

8. Fold the safety device back to its original position so that it lies parallel to the needle. Then, with the safety device placed flat against a hard surface, press down until the needle is locked inside the device.

9. The used syringe, with the needle pointing downward, may be placed back into its original container or into a sharps disposal container. In this way, the syringe is rendered safe, and the container with the syringe or the sharps disposal container can be returned to a hospital or pharmacist for proper destruction.

If you use more innohep than you should

If you are treated with more innohep than needed, bleeding may occur. Contact your doctor or nurse immediately if you feel unwell or think you have administered too high a dose of innohep.

If you forget to use innohep

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

If you stop using innohep

If you stop using innohep, the blood-thinning effect will cease. Do not interrupt treatment with innohep without consulting your doctor or nurse.

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

4. Possible adverse effects

Like all medicines, innohep can cause adverse effects, although not everyone experiences them.

Serious adverse effects:

Rarely, serious adverse effects requiring immediate medical attention have been observed during treatment with innohep. If you experience any of the following symptoms, contact your doctor immediately or go to the nearest hospital for emergency treatment.

• Severe allergic reaction. Symptoms include sudden onset of a severe skin rash, swelling of the throat, face, lips or mouth, and difficulty breathing.
• Severe bleeding. Symptoms include red or brown urine, tar-like stools, unusual bruises (very painful, extensive or dark), and any bleeding that does not stop.

The following adverse effects have been observed with administration of innohep:

Common: may affect up to 1 in 10 people

• Bleeding: May lead to complications such as anaemia (low number of red blood cells in blood) or bruising

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

Uncommon: may affect up to 1 in 100 people

• Thrombocytopenia (decrease in the number of platelets in blood)
• Hypersensitivity (allergic reaction)
• Bruising and skin discoloration
• Increased liver enzyme levels
• Dermatitis (inflammation of the skin)
• Skin rash and itching

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

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

Paediatric population

Limited information from a clinical trial and post-marketing data indicates that the adverse reaction profile in children and adolescents is comparable to that observed in adults.

Reporting of adverse effects

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

5. Innohep storage

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

• No special storage conditions are required.
• Do not use this medicine if you notice cloudiness or a precipitate in the syringe.
• The solution may develop a yellowish tint during storage, but this does not affect the quality of the product, which remains safe for use.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. 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 injectable solution contains 20,000 IU anti-Xa of tinzaparin sodium.
• The other components are sodium metabisulfite (E 223), sodium hydroxide, and water for injections.

Nature of the product and contents of the container

Injectable solution.

Clear glass syringes containing a colourless or straw-coloured solution, free from turbidity and from any depositing material when the syringe is left at rest.

Pack sizes:

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 the most recent revision of this leaflet: December 2019.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.