Label: information for the user

Venofer 20 mg/mL

Injectable solution or concentrate for infusion solution

Iron-saccharose

Read this label carefully before this medicine is administered to you, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this label. See section 4.

1. What Venofer is and for what it is used

2. What you need to know before Venofer is administered to you

3. How Venofer is administered

4. Possible adverse effects

5. Storage of Venofer

6. Contents of the package and additional information

Venoferis a medication that contains iron(in the form of iron saccharate).

Iron-containing medications are used when there is not enough iron in the body. Thisconditionis called “iron deficiency”.

Venofer is used when:

• You cannot take iron orally – for example if iron tablets make you feel unwell.
• You have already taken iron orally and it hasnot been effective.

Do not receiveVenofer:

• If you are allergic (hypersensitive) to the product or to any of the other components ofthis medication (listed in section6).
• If you have experienced severe allergic reactions (hypersensitivity) to other injectable iron preparations.

• If you have anemia not attributable to iron deficiency.

• If you have too much iron in your bodyor a problem with your body's use of iron.

Do not receive Venofer if any of the above points apply to you. If you have any doubts, consult your doctor before receivingVenofer.

Warnings and precautions

Consult your doctor or nurse before starting to receive Venofer:

• If you have a history of allergies to medications.
• If you have systemic lupus erythematosus.
• If you have rheumatoid arthritis.
• If you have severe asthma, eczema, or other allergies.
• If you have any infection.
• If you have liver problems.

If you have any doubtsas towhether any of the above points apply to you,consult your doctor or pharmacist before receivingVenofer.

Use of Venofer with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription and herbal medications.

This is because Venofer may affect the functioning of other medications. Similarly, other medications may affect the functioning of Venofer.

Specifically, inform your doctor or pharmacist if you are taking:

• Medications containing iron taken orally. They may not work if taken at the same time as Venofer is administered.

Pregnancy and breastfeeding

Venofer has not been evaluated in women in the first three months of pregnancy. If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

If you become pregnant during treatment, ask your doctor for advice; this way, your doctor can decide whether to administer the medication or not.

If you are breastfeeding, ask your doctor for advice before receiving Venofer.

If you are pregnant or breastfeeding, consult your doctor or pharmacist for advice before using any medication.

Driving and operating machinery

You are responsible for deciding whether you are fit to drive or perform tasks that require a higher state of alertness.After receiving Venofer, you may feel dizzy, confused, or disoriented. If this happens, do not drive or use machines or tools. Consult your doctor if you have any doubts.

Venofer contains sodium

Venofer contains a maximum of 7mg of sodium (main component of table salt/for cooking) per mL. This is equivalent to 0.4% of the maximum daily sodium intake recommended for an adult.

Your doctor will decide how much Venofer to administer to you. They will also decide how often you need it and for how long. Your doctor will perform a blood test to determine the dose you need.

The doctor or nurse will administer Venofer in one of the following ways:

• Through slow injection into a vein –1 to3 times per week.
• Through a venous infusion (drip) –1 to3 times per week.
• During dialysis, it will be administered through the venous line of the dialyzer.

Venofer will be administered in a facility where allergic reactions can be treated promptly and adequately.

After each administration, you will remain under observation for at least 30 minutes under the supervision of the doctor or nurse.

Venofer is a brown liquid, so the injection or infusion will have a brown color.

Use in Children

Venofer is not recommended for use in children.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Allergic reactions(infrequent). If you have an allergic reaction, inform your doctor or nurse immediately. Symptoms may include:

• Hypotension (feeling dizzy, lightheaded, or fainting).
• Swelling of the face.
• Difficulty breathing.
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

In some patients, these allergic reactions (rare) may be severe or potentially life-threatening (known as anaphylactoid/anaphylactic reactions).

Inform your doctor or nurse immediately if you think you are having an allergic reaction.

Other side effects include:

Frequent(may affect up to 1 in 10 people)

• Changes in taste, such as a metallic taste. This effect usually does not last long.
• Hypotension or hypertension.
• Uncomfortable feeling (nausea).
• Reactions around the injection/infusion site, such as pain, irritation, itching, hematoma, or skin discoloration after injection extravasation.

Infrequent(may affect up to 1 in 100 people)

• Headache or dizziness.
• Stomach pain or diarrhea.
• Feeling sick (vomiting).
• Wheezing, difficulty breathing.
• Itching, urticaria.
• Muscle spasms, cramps, or pain.
• Tickling or paresthesia.
• Reduced sense of touch.
• Vein inflammation.
• Hot flashes, burning sensation.Constipation.
• Joint pain.
• Pain in the extremities.
• Back pain.
• Chills.
• Weakness, fatigue.
• Swelling of hands and feet.
• Pain.
• Increased levels of liver enzymes (CGT, ALT, AST,CGT) in the blood.
• Increased levels of serum ferritin.

Rare(may affect up to 1 in 1,000 people)

• Fainting.
• Drowsiness.
• Strong heart rhythm (palpitations).
• Changes in urine color.
• Chest pain.
• Increased sweating.
• Fever.
• Increased lactate dehydrogenase in the blood.

Other side effects of unknown frequency include: decreased alertness, feeling confused; loss of consciousness; anxiety; tremors; swelling of the face, mouth, tongue, or throat that may cause breathing difficulties; low pulse rate; high pulse rate; circulatory collapse;inflammation of the veins that causes clot formation;acute narrowing of the airways; itching, urticaria, hives, or erythema; cold sweat; general feeling of discomfort; pale skin; sudden potentially life-threatening allergic reactions.

The flu-like illness may occur several hours or days after injection and is usually characterized by symptoms such as elevated temperature and muscle and joint pain.

Reporting side effects

If you experienceany type of side effect, consult your doctor or nurse, even if it is apossibleside effect not listed in this prospectus.You can also report them directly through the national notification system included in the Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not store above25°C. Do not freeze.Store the ampoules or vials in the outer packaging.

Once opened, the Venofer ampoules or vials should be used immediately. After dilution with sodium chloride solution, the diluted solution should be used immediately..

Normally, it will be the doctor or the hospital that storesVenofer.

Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition ofVenofer

• The active ingredient isiron (in the form of iron-saccharate). Each milliliter contains 20mg of iron.
• The other components are water for injectable preparations and sodium hydroxide.

Appearance of the productand contents of the container

Venoferis a dark brown, non-transparent aqueous solution.

Venofer is available in the following container sizes:
•5 glass ampoules of 5mL. Each 5 mL ampoule corresponds to 100mg of iron.
•5 glass vials of 5mL. Each 5mL vial corresponds to 100mg of iron.

Only some container sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Vifor France

100-101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex, France

Tel. +33 (0)1 41 06 58 90

Fax +33 (0)1 41 06 58 99

Local representative:

Vifor Pharma España, S.L.

Av. Diagonal 611, 10th floor

08028 Barcelona

Spain

Last review date of this leaflet: 12/2021.

For further information about this medicinal product, please contact the local representative of the marketing authorization holder..

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

This information is intended solely for healthcare professionals:

This information is intended solely for healthcare professionals:

Administration

Monitor patients closely for signs and symptoms of hypersensitivity reactions during and after each administration of Venofer.

Venofer should only be administered when there is immediate availability of trained personnel to evaluate and treat anaphylactic reactions, in an environment where a complete resuscitation device can be guaranteed. The patient should be observed for at least 30 minutes after each administration of Venofer for potential adverse effects.

Administration route:

Venofer should only be administered intravenously. The procedure can be by infusion, slow injection, or directly into the venous dialyzer line.

Extravasation should be avoided, as the leakage of Venoferoutside the intravenous routemay cause pain, inflammation, and brown discoloration of the skinat the administration site.

Intravenous infusion by drip::

Venofer should only be diluted in a sterile sodium chloride solution (NaCl) 0.9% m/V. The dilution should be performed immediately before infusion, and the solution should be administered as follows:

Due to stability reasons, dilutions of Venofer to lower concentrations are not permitted.

Slow intravenous injection:

The administration of Venofer by slow intravenous injection can be performed at a rate of 1mL of undiluted solution per minute, without exceeding 10mL Venofer (200mg of iron) per injection.

Injection into the venous dialyzer line:

Venofer can be administered during a hemodialysis session directly into the venous dialyzer line, following the same procedures described for slow intravenous injection.

Incompatibilities

Venofer should not be mixed with other medications, except for sterile sodium chloride solution 0.9% m/V. There is a potential risk of precipitation and/or interaction if mixed with other solutions or medications.The compatibility of the product with containers other than glass, polyethylene, and PVC is unknown.

Shelf life and storage

Do not use this medicinal product after the expiry date, which is indicated on the container after CAD. Do not store above 25°C. Do not freeze. Store in the original container.

Shelf life after the first opening of the container

From a microbiological point of view, the product should be used immediately.

Shelf life after dilution with sterile sodium chloride solution (NaCl) 0.9% m/V

From a microbiological point of view, the medicinal product should be used immediately after dilution.

Instructions for use and handling

The ampoules or vials should be visually inspected for sediment or possible damage before use. Only use solutions that present a homogeneous and sediment-free appearance. The diluted solution should show a brown and transparent appearance.

The disposal of unused medicinal product and all materials that have been in contact with it, will be carried out in accordance with local regulations.