VENOFER 20 mg/ml INJECTABLE SOLUTION OR CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Venofer 20 mg/mL

Injectable Solution or Concentrate for Solution for Infusion

Iron-saccharose

Read all of this leaflet carefully before this medicine is administered to you 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 or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Venofer and what is it used for

Venofer is a medicine that contains iron (in the form of iron-saccharose).

Medicines that contain iron are used when there is not enough iron in the body. This condition is called "iron deficiency".

Venofer is used when:

• You cannot take iron orally - for example, if iron tablets do not agree with you.
• You have already taken iron orally and it has not been effective.

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

You must not be given Venofer:

• If you are allergic (hypersensitive) to the product or to any of the other ingredients of this medicine (listed in section 6).
• If you have experienced severe allergic reactions (hypersensitivity) to other iron injectable preparations.

• If you have anaemia that is not due to iron deficiency.

• If you have too much iron in your body or a problem in your body with the use of iron.

Venofer must not be administered to you if any of the above points apply to you. If you are in any doubt, consult your doctor before Venofer is administered to you.

Warnings and precautions

Consult your doctor or nurse before starting to receive Venofer:

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

If you are in any doubt as to whether any of the above points apply to you, consult your doctor or pharmacist before Venofer is administered to you.

Using Venofer with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription and herbal medicines.

This is because Venofer may affect the way other medicines work. Similarly, other medicines may affect the way Venofer works.

In particular, tell your doctor or pharmacist if you are taking:

• Medicines that contain iron and are taken orally. They may not work if taken at the same time as Venofer is administered.

Pregnancy and breast-feeding

Venofer has not been tested in pregnant women in the first three months of pregnancy. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

If you become pregnant during treatment, you should ask your doctor for advice; your doctor will decide whether you should be given the medicine or not.

If you are breast-feeding, ask your doctor for advice before Venofer is administered to you.

If you are pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You are responsible for deciding whether you are fit to drive or perform tasks that require increased attention. 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 7 mg of sodium (the main component of cooking/table salt) per mL. This is equivalent to 0.4% of the maximum recommended daily intake of sodium for an adult.

3. How Venofer is administered

Your doctor will decide how much Venofer to administer to you. Your doctor 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:

• By slow injection into a vein - 1 to 3 times a week.
• By infusion (drip) into a vein - 1 to 3 times a week.
• During dialysis, it will be administered through the venous line of the dialyser.

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

After each administration, you will be kept 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 colour.

Use in children

Venofer is not recommended for use in children.

4. Possible side effects

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

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

• Hypotension (feeling dizzy, faint or passing out).
• Swelling of the face.
• Difficulty breathing.
• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

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

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

Other side effects include:

Common(may affect up to 1 in 10 people)

• Changes in taste, such as metallic taste. This effect usually does not last long.
• Hypotension or hypertension.
• Nausea.
• Reactions around the injection/infusion site, such as pain, irritation, itching, bruising or discolouration of the skin after extravasation of the injection.

Uncommon(may affect up to 1 in 100 people)

• Headache or dizziness.
• Stomach pain or diarrhoea.
• Feeling sick (vomiting).
• Wheezing, difficulty breathing.
• Itching, hives.
• Muscle spasms, cramps or pain.
• Tingling or paresthetic sensation.
• Reduced sense of touch.
• Inflammation of the veins.
• Hot flushes, burning sensation. Constipation.
• Joint pain.
• Pain in the limbs.
• Back pain.
• Chills.
• Weakness, tiredness.
• 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 heartbeat (palpitations).
• Changes in urine colour.
• Chest pain.
• Increased sweating.
• Fever.
• Increased lactate dehydrogenase in the blood.

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

Pseudo-flu-like syndrome may occur a few hours or several days after injection and is usually characterised by symptoms such as elevated temperature and pain in the muscles and joints.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Venofer

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

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date is the last day of the month shown.

Do not store above 25°C. Do not freeze. Store the ampoules or vials in the outer packaging.

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

Normally, it will be the doctor or hospital that stores Venofer.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Venofer

• The active substance is iron (in the form of iron-saccharose). Each millilitre contains 20 mg of iron.
• The other ingredients are water for injections and sodium hydroxide.

Appearance of the product and pack contents

Venofer is a dark brown, non-transparent aqueous solution.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

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, Planta 10

08028 Barcelona

Spain

Date of last revision of this leaflet: 12/2021.

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder.

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

This information is intended only for healthcare professionals:

This information is intended only for healthcare professionals:

Administration

Closely monitor patients for signs and symptoms of hypersensitivity reactions during and after each administration of Venofer.

Venofer should only be administered when immediate availability of personnel and facilities for treatment of anaphylactic reactions is present, in an environment where a complete resuscitation setup is available. The patient should be observed for at least 30 minutes after each administration of Venofer for potential adverse effects.

Method of administration:

Venofer should be administered only by the intravenous route. The procedure can be by infusion, slow injection or directly into the venous line of the dialyser.

Extravasation should be avoided as spillage of Venofer outside the intravenous route can cause pain, inflammation and brown discolouration of the skin at the site of administration.

Intravenous infusion by drip:

Venofer must be diluted only 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:

For stability reasons, dilutions of Venofer to concentrations below this are not permitted.

Intravenous injection:

Administration of Venofer by slow intravenous injection can be performed at a rate of 1 mL of undiluted solution per minute, not exceeding 10 mL Venofer (200 mg of iron) per injection.

Injection into the venous line of the dialyser:

Venofer can be administered during a haemodialysis session directly into the venous line of the dialyser, following the same procedures as for intravenous injection.

Incompatibilities

Venofer must not be mixed with other medicines, 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 medicines. The compatibility of the product with containers other than glass, polyethylene and PVC is unknown.

Shelf life and storage

Do not use this medicine after the expiry date, which is stated on the packaging after EXP. Do not store above 25°C. Do not freeze. Store in the original packaging.

Shelf life after first opening of the packaging

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 medicine should be used immediately after dilution.

Instructions for use and handling

The ampoules or vials should be visually inspected for sediment or damage before use. Only use solutions that have a homogeneous appearance and are free of sediment. The diluted solution should have a brown and transparent appearance.

Disposal of the unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.