Vinorelbine Glenmark 30 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vinorelbina Glenmark 30 mg soft capsules EFG

Read all of this leaflet carefully before you start taking 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Vinorelbine Glenmark is and what it is used for

This medicine contains the active substance vinorelbine (as tartrate) and belongs to a family of medicines used to treat cancer known as the vinca alkaloids. Vinorelbine Glenmark is used to treat certain types of lung cancer and certain types of breast cancer in patients over 18 years of age.

• Non-small cell lung cancer
• Locally advanced and metastatic breast cancer

2. What you need to know before starting Vinorelbina Glenmark

Do not take Vinorelbina Glenmark:

• If you are allergic to the active substance, vinorelbine, or to any of the anticancer medicines in the vinca alkaloid family.
• If you are allergic to any of the other components 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 affecting how you absorb food. These may affect how your body absorbs Vinorelbina.
• If you have a low white blood cell count (neutrophils, leukocytes) or a severe current or recent infection within the past two weeks.
• If you have a low platelet count (thrombocytopenia).
• If you plan to receive or have recently received the 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 unrelated 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 and adolescents under 18 years of age.

Other medicines and Vinorelbina Glenmark

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

Your doctor should 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,

• Antituberculosis medicines such as rifampicin.

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

Use of Vinorelbina Glenmark with food and drinks

Vinorelbine should be swallowed whole with water, without chewing or sucking the capsule.

It is recommended to take the capsule with a light meal.

Vinorelbine should not be taken with a hot drink, as this will dissolve the capsule too quickly.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine, as there are potential risks to the unborn or breastfed child.

You must not breastfeed while taking vinorelbine (see section 2 “Do not take Vinorelbina Glenmark”).

If you are a woman of childbearing age, you must use an effective method of contraception (birth control) during treatment and for 7 months after treatment ends.

If you are a man being treated with this medicine, you are advised not to father a child during treatment and for 4 months after taking the last capsule. Before starting treatment, you should seek advice on sperm preservation, as this medicine may affect your fertility. You must use an effective method of contraception during treatment and for 4 months after treatment ends.

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 do not feel well or if your doctor has advised you not to drive.

Vinorelbina Glenmark contains sorbitol

This medicine contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Vinorelbine Glenmark

Before and during your treatment with vinorelbine, your doctor will check your blood cell count to determine when you 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 the 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 3 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 vinorelbine dose.

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

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

Before opening the blisters containing vinorelbine, make sure 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, immediately and thoroughly wash the affected area with water.

Taking Vinorelbine Glenmark soft capsules:

• Swallow the capsule whole with water, preferably with a light meal. It should not be taken 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 a few hours after taking the medicine, contact your doctor; do not repeat the dose.

If you are taking an anti-nausea medicine

Vomiting may occur with Vinorelbine Glenmark (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 Glenmark than you should

If you may have taken more vinorelbine than prescribed, contact your doctor immediately.

Your body may sometimes react with serious 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 must contact your doctor immediately if any of these serious symptoms occur.

If you forget to take Vinorelbine Glenmark

Do not take a double dose to make up for missed doses. Contact your doctor, who will decide whether to reschedule your dose.

If you stop your treatment with Vinorelbine Glenmark

Your doctor will decide when you should stop treatment. However, if you wish to stop treatment earlier, you must discuss other options with your doctor.

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

4. Possible adverse reactions

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

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

• Infections at various sites
• Gastrointestinal disorders: diarrhea, constipation, abdominal pain, nausea, vomiting
• Inflammation of 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 susceptible to infections
• Loss of certain reflex responses, occasionally altered sensation to touch
• Hair loss, usually mild
• Fatigue
• Fever
• Malaise
• Weight loss, loss of appetite

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

• Difficulty coordinating muscle movements
• Visual disturbances
• Shortness of breath, cough
• Difficulty urinating; other genitourinary symptoms
• Difficulty sleeping
• Headache; dizziness; altered taste perception
• 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)

Rare adverse 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 the available data

• Blood infections (sepsis) with symptoms such as high fever and deterioration in general health status
• 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 excessive production of a hormone causing fluid retention (Syndrome of Inappropriate Antidiuretic Hormone Secretion - SIADH)
• Darkening of the skin following the path of the veins

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vinorelbine Glenmark

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

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vinorelbina Glenmark

• The active substance is vinorelbine (as tartrate) 30 mg.
• The other components are:

Capsule contents: polyethylene glycol 400, polysorbate 80 (E433), purified water

Capsule shell: gelatin 160, partially dehydrated liquid sorbitol (E420), titanium dioxide (E171), purified water, iron oxide red (E172)

Appearance of the product and contents of the pack

Vinorelbina Glenmark 30 mg soft capsules are pink, oblong soft capsules.

Available in packs of 1 or 4 blisters, each containing 1 soft capsule.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

Paola, Malta

Alvogen Malta (Out-Licensing) Ltd

Malta Life Sciences Park

Building 1, Level 4, Sir

Temi Zammit Buildings, San

Gwann SGN 3000, Malta

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Slovakia Vinorelbine Glenmark 30 mg mäkké kapsuly

Spain Vinorelbina Glenmark 30 mg cápsulas blandas EFG

Portugal Vinorelbina Glenmark

Czech Republic Vinorelbine Glenmark

Date of the most recent revision of this leaflet: June 2025.

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