VINORELBINE GLENMARK 20 mg SOFT CAPSULES

2. What you need to know before you take Vinorelbina Glenmark

Do not take Vinorelbina Glenmark:

• If you are allergic to the active substance, vinorelbine, or to any of the other anti-cancer medicines in the vinca alkaloid family.
• If you are allergic to any of the other ingredients of this medicine (listed in section 6).
• If you are breast-feeding.
• If you have had an operation on your stomach or small intestine, or if you have an intestinal disorder that affects the way you absorb food. These can affect the way your body absorbs Vinorelbina.
• If you have a low white blood cell count (neutrophils, leucocytes) or a severe current or recent infection of less than two weeks.
• If you have a low platelet count (thrombocytopenia).
• If you are planning to receive a yellow fever vaccine or have just received one.
• If you need long-term oxygen therapy.

Warnings and precautions

Consult your doctor or pharmacist before taking vinorelbine if:

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

Before and during your treatment with vinorelbine, blood cell counts are performed to check that it is safe for you to receive the treatment. If the results of this test are not satisfactory, your treatment may be delayed and more reviews will be performed 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 Glenmark

Tell your doctor or pharmacist if you are taking, have recently taken or might 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 anti-epileptic medicine called phenytoin,
• antifungal medicines, such as itraconazole and ketoconazole,
• cancer medicines called mitomycin C or lapatinib,

• medicines that damage the immune system, such as cyclosporin and tacrolimus

• antitubercular medicines such as rifampicin

The combination of vinorelbine with other medicines with known bone marrow toxicity (which affects white and red blood cells and platelets) may also worsen some side effects.

Using Vinorelbina Glenmark with food and drinks

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

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

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

Pregnancy, breast-feeding and fertility

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, as there are potential risks to the baby.

You should not breast-feed if you are taking vinorelbine (see section 2 “Do not take Vinorelbina Glenmark”).

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

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 conserving sperm, as this medicine may affect your fertility. You should use an effective method of contraception during treatment and for 4 months after finishing treatment.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. However, as with all cases, you should not drive if you feel unwell 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 some sugars, consult your doctor before taking this medicine.

3. How to take Vinorelbina 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 your body surface area, which your doctor will calculate from your weight and height.

The usual weekly dose, taken in a single dose, is 60 mg/m2 of body surface area for the first 3 doses. After the third dose, your doctor will decide if the dose will 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 with another medicine to treat your cancer/condition, your doctor will decide the suitable dose for you.

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Before opening the blisters that contain vinorelbine, make sure that there are no damaged capsules because the liquid inside is irritating and can be harmful if it comes into contact with your skin, eyes or mucous membranes. If this happens, wash the affected area immediately and thoroughly with water.

Taking Vinorelbina Glenmark soft capsules:

• Swallow the capsule whole with water, preferably with a light meal. It should not be taken with a hot drink, as it will dissolve the capsule too quickly.
• Do notchew or suck the capsules.
• If you chew or suck a capsule by mistake, rinse your mouth well 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 take an anti-nausea medicine

Vomiting may occur with Vinorelbina Glenmark, (see the section "4. Possible side effects"). If your doctor has prescribed an anti-nausea medicine, always take it exactly as indicated.

Take vinorelbine during a light meal; this will help reduce the feeling of nausea.

If you take more Vinorelbina Glenmark than you should

If you may have taken more vinorelbine than the prescribed dose, 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 suffer from severe constipation. You should contact your doctor immediately if you experience any of these severe symptoms.

If you forget to take Vinorelbina Glenmark

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

If you stop taking Vinorelbina Glenmark

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

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

4. Possible side effects

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

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

• Infections in different sites
• Gastrointestinal disorders; diarrhea; constipation, abdominal pain, nausea, vomiting;
• Mouth inflammation;
• Decrease in red blood cells (anemia), which can make your skin pale and cause weakness or shortness of breath;
• Decrease in platelets, which can increase the risk of bleeding or bruising;
• Decrease in white blood cells, which makes you more prone to infections;
• Loss of some reflexes, occasionally difference in touch perception;
• 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; difference in taste;
• Throat inflammation, difficulty swallowing food or liquids;
• Skin reactions;
• Chills;
• Weight gain;
• Pain in the joints, jaw, muscles;
• Pain in different parts of the body and pain at the tumor site;
• High blood pressure;
• Liver disorders (abnormal liver tests)

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

• Heart failure that can cause difficulty breathing and swelling of the ankles, irregular heartbeats;
• Lack of muscle control may be associated with an abnormal gait, changes in speech and abnormalities in eye movement (ataxia).

Frequency not known: frequency cannot be estimated from the available data

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vinorelbina 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 which is stated on the blister and carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to a pharmacy for disposal. Ask your pharmacist how to dispose of containers and any unused medicines. 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) 20 mg.
• The other ingredients are:

Contents of the capsule:polyethylene glycol 400, polysorbate 80 (E433), purified water

Coating of the capsule:gelatin 160, partially dehydrated liquid sorbitol (E420), titanium dioxide (E171), purified water, yellow iron oxide (E172)

Appearance and packaging of the product

Vinorelbina Glenmark 20 mg soft capsules are oval, light brown capsules.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Slovakia Vinorelbine Glenmark 20 mg soft capsules

Spain Vinorelbina Glenmark 20 mg soft capsules EFG

Portugal Vinorelbina Glenmark

Czech Republic Vinorelbine Glenmark

Date of last revision of this leaflet:June 2025.

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/)