Vinorelbine Accord 20 mg soft capsule EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Vinorelbine Accord 20 mg soft capsule EFG

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Vinorelbina Accord is and what it is used for

This medicine contains the active substance vinorelbine and belongs to a family of medicines called vinca alkaloids, a family used in the treatment of cancer.

Vinorelbina Accord is used to treat certain types of lung and breast cancer in patients over 18 years of age.

2. What you need to know before starting to take Vinorelbina Accord

Do not take Vinorelbina Accord:

• If you are allergic to vinorelbine, or to other anticancer medicines of the vinca alkaloid family, or to any of the other ingredients of this medicine (listed in section 6).
• If you are breastfeeding.
• If you have had surgery on your stomach or small intestine, or if you have an intestinal disorder that affects how you absorb food. This may affect how your body absorbs vinorelbine.
• If you have a low white blood cell count (neutrophils, leukocytes) or a serious current or recent infection within the last two weeks.
• If you have a low platelet count (thrombocytopenia).
• If you plan to receive, or have just received, a yellow fever vaccine.
• If you require long-term oxygen therapy.

Warnings and precautions

Talk to your doctor or pharmacist before taking vinorelbine if:

• You have a history of heart attack or severe chest pain.
• Your ability to perform daily living activities is significantly reduced.
• You have liver problems or have received radiotherapy in an area that includes the liver.
• You have symptoms of infection (such as fever, chills, joint pain, cough).
• You plan to get vaccinated. Many vaccines (live attenuated vaccines) are not recommended during treatment.
• You have severe liver disease not related to cancer.
• You are pregnant.

Before and during your treatment with vinorelbine, blood cell counts are performed to ensure it is safe for you to receive the treatment. If the results of these tests are not satisfactory, your treatment may be delayed and further monitoring will be required until these values return to normal.

Children and adolescents

This medicine is not recommended for use in children under 18 years of age.

Other medicines and Vinorelbina Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Your doctor must pay special attention if you are taking the following medicines:

• Medicines used to dissolve blood clots (anticoagulants),
• An antiepileptic medicine called phenytoin,
• Antifungal medicines such as itraconazole and ketoconazole,
• Anticancer medicines called mitomycin C or lapatinib,
• Medicines that suppress the immune system, such as cyclosporine and tacrolimus,
• A medicine for tuberculosis called rifampicin.

The combination of vinorelbine with other medicines known to have bone marrow toxicity (affecting white and red blood cells and platelets) could also worsen certain side effects.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine, as there are potential risks to the unborn child. You must not take this medicine if you are pregnant. You must not breastfeed while taking vinorelbine.

Women of childbearing age must use effective contraception (birth control) during treatment and for 7 months after treatment ends.

Men treated with vinorelbine are advised not to father a child during and for 3 months after the last capsule. You should discuss sperm banking with your doctor before starting vinorelbine treatment, as male fertility may be affected.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines. However, as in all cases, you should not drive if you feel unwell or if your doctor has advised you not to drive.

Vinorelbina Accord contains sorbitol, ethanol and sodium

Vinorelbina Accord 20 mg contains 8.03 mg of sorbitol (as partially dehydrated liquid sorbitol) in each soft capsule.

This medicine contains 2.89 mg of alcohol in each soft capsule. The amount in each soft capsule is equivalent to less than 1 ml of beer or 1 ml of wine.

The small amount of alcohol contained in this medicine does not produce any noticeable effect.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially “sodium-free”.

3. How to take Vinorelbina Accord

Before and during your treatment with vinorelbine, your doctor will monitor your blood cell counts to determine when you will receive your treatment and what dose is suitable for you. Your doctor will tell you the number and dose of capsules you should take. This will depend on your body surface area, which your doctor will calculate based on your body weight and height. The usual weekly dose, taken as a single dose, is 60 mg/m² of body surface area for the first three doses. After the third dose, your doctor will decide whether the dose should be increased to 80 mg/m² of body surface area. In any case, your doctor may adjust the dose of vinorelbine.

If you are receiving the capsules together with another medicine to treat your cancer/illness, your doctor will decide what dose is appropriate for you.

Follow exactly the instructions for administering this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before opening the blisters containing vinorelbine, ensure that there are no damaged capsules, as the liquid inside is irritating and may be harmful if it comes into contact with your skin, eyes, or mucous membranes. If this occurs, wash the affected area immediately and thoroughly with water.

Taking vinorelbine soft capsules:

• Swallow the capsule whole with water, preferably with a light meal. Do not take it with a hot drink, as this will dissolve the capsule too quickly.
• Do not chew or suck the capsules.
• If you accidentally chew or suck a capsule, rinse your mouth thoroughly with water and inform your doctor immediately.
• If you vomit within a few hours after taking the medicine, contact your doctor; do not repeat the dose.

If you are taking medicines for nausea and vomiting

This medicine may cause vomiting (see section "4. Possible side effects"). If your doctor has prescribed an anti-nausea medicine, always take it exactly as directed.

Take vinorelbine with a light meal; this will help reduce nausea.

If you take more Vinorelbine Accord than you should

If you have taken more capsules than prescribed by your doctor, contact your doctor immediately.

Your body may sometimes react with severe symptoms. Some of these symptoms may appear as signs of an infection (such as fever, chills, cough, joint pain). You may also experience severe constipation. You should contact your doctor immediately if any of these serious symptoms occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to take Vinorelbine Accord

Do not take a double dose to make up for a missed dose. Contact your doctor, who will advise you whether your dose needs to be adjusted.

If you stop your treatment with Vinorelbine Accord

Your doctor will decide when you should stop treatment. However, if you wish to stop treatment earlier, you must discuss this with your doctor so that alternative treatment options can be considered.

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

4. Possible adverse effects

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

Very common side effects (may affect more than 1 in 10 people)

• Infections at various sites
• Gastrointestinal disorders; diarrhea; constipation; abdominal pain; nausea; vomiting
• Inflammation in the mouth
• Decrease in red blood cells (anemia), which may cause the skin to become pale and lead to weakness or shortness of breath
• Decrease in platelets, which may increase the risk of bleeding or bruising
• Decrease in white blood cells, making you more vulnerable to infections
• Loss of certain reflex responses, occasionally altered sensation of touch
• Hair loss, usually mild
• Fatigue
• Fever
• Malaise
• Weight loss, loss of appetite

Common side effects (may affect up to 1 in 10 people)

• Difficulty coordinating muscle movements
• Changes in vision
• Shortness of breath, cough
• Difficulty urinating; other genitourinary symptoms
• Difficulty sleeping
• Headache; dizziness; altered taste
• Throat inflammation, difficulty swallowing food or liquids
• Skin reactions
• Chills
• Weight gain
• Joint, jaw, or muscle pain
• Pain in various parts of the body and pain at the tumor site
• High blood pressure
• Liver disorders (abnormal liver function tests)

Uncommon side effects (may affect up to 1 in 100 people)

• Heart failure, which may cause difficulty breathing, swelling of the ankles, and irregular heartbeat
• Loss of muscle control may be associated with abnormal gait, changes in speech, and eye movement abnormalities (ataxia)

Frequency not known: frequency cannot be estimated from available data

• Blood infections (sepsis) with symptoms such as high fever and deterioration in general health
• Heart attack (myocardial infarction)
• Gastrointestinal bleeding
• Low sodium levels in the blood causing weakness, muscle spasms, fatigue, confusion, and loss of consciousness. This low sodium level may in some cases be due to overproduction of a hormone causing fluid retention (Syndrome of Inappropriate Antidiuretic Hormone Secretion - SIADH)

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Vinorelbine Accord Storage

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

Do not use this medicine after the expiry date stated on the blister and carton after CAD or EXP. The expiry date refers to the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C).

Medicines should not be disposed of via wastewater or household waste. For safety reasons, return any unused medicine to your doctor or pharmacist. This will help protect the environment.

6. Contents of the container and other information

Composition of Vinorelbina Accord

The active substance is vinorelbine. Each soft capsule contains 20 mg of vinorelbine (as tartrate).

The other components are:

The solution contains: macrogol, glycerol, anhydrous ethanol and purified water.

The capsule shell contains: gelatin, glycerol, partially dehydrated liquid sorbitol (E 420), titanium dioxide (E 171) and yellow iron oxide (E 172).

Printing ink: shellac (E 904), black iron oxide (E 172), ammonium hydroxide (E 527) and propylene glycol (E 1520).

Appearance of Vinorelbina Accord and contents of the container

Oval-shaped soft gelatin capsules (9.3 mm x 6.7 mm), opaque light brown in colour, free from surface defects, with "JJ1" printed in black, containing a clear, colourless liquid.

Vinorelbina Accord is available in blisters containing 1, 2, 3 or 4 soft capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n, Edifici Est, 6th floor,

08039, Barcelona, Spain.

Manufacturer

Accord Healthcare Polska Sp. z o.o.

Ul. Lutomierska 50, 95-200,

Pabianice, Poland

or

Accord Healthcare B.V.

Winthontlaan 200, 3526 KV

Utrecht, The Netherlands

or

Laboratori Fundació Dau

C/ C, 12-14 Pol.

Ind. Zona Franca,

Barcelona, 08040, Spain

or

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

Paola, Malta

or

Accord Healthcare single member S.A.

64th Km National Road Athens,

Lamia, Schimatari,

32009, Greece

Date of the most recent review of this leaflet: December 2024.

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