Innohep 12,000 IU anti-Xa/0.6 mL solution for injection in pre-filled syringes

Patient Information Leaflet

Introduction

innohep 12,000 IU anti-Xa/0.6 ml solution for injection in pre-filled syringes

(20,000 IU anti-Xa/ml)

tinzaparine sodium

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult 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 these adverse reactions are not listed in this leaflet.
• In the text of this leaflet, the term innohep will be used to refer to innohep 12,000 IU anti-Xa/0.6 ml solution for injection in pre-filled syringes.

Leaflet Contents

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 tinzaparin sodium 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 (e.g., in the brain, spinal cord, eyes, or stomach).
• if you have a severe infection of the heart (infective 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 administered by intramuscular injection.
• if you have low platelet levels 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.

Use of 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.

Inform your doctor if you are taking any of the following medicines, as they may increase your risk of bleeding:

• Medicines for 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 can 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 metabisulphite

• As it contains sodium metabisulphite 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 recommended sodium intake 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 must 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 hematoma formation.

The recommended dose is:

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.

1. 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 may only be used once.

1. Fold the safety device downward, separating it from the needle protective cap.

1. Remove the needle protective cap without twisting it. Adjust the syringe content to the dose prescribed by your doctor. Expel any excess volume by pressing the plunger while the syringe is held vertically. Do not pull the plunger backward, and do not 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 moves into place.

1. Gently grasp 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. Inject the required dose slowly into the fatty tissue, for example, into 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.

2. Clean the area with gauze if bleeding occurs. For the next injection, choose a different injection site (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 lies parallel to the needle. Then, with the safety device placed flat on a hard surface, press down until the needle is locked inside the device.

1. The used syringe, with the needle pointing downward, can be placed back into its original container or into a sharps disposal container. This makes the syringe safe, and the container with the syringe or the sharps container can then be returned to a hospital or pharmacist for 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 taking innohep, the blood-thinning effect will cease. Do not stop 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:

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

Frequent: may affect up to 1 in 10 people

• Bleeding: May lead to complications such as anaemia (low number of red blood cells in the 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 (reduction in the number of platelets in the 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 (reduction 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”)
• Hyperkalaemia (increased levels of potassium in the blood)
• Toxic skin rash
• Skin necrosis (death of skin tissue)
• Hives
• Osteoporosis, observed with long-term treatment
• Priapism (prolonged, often painful erection 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 type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 to use.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. 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.

Appearance of the product and contents of the pack

Injectable solution.

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

Pack sizes:

• 0.6 ml (12,000 IU anti-Xa), packs containing 2, 6, 10, 30, 50 and 100 syringes.

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