Before and during your treatment with vinorelbina, 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 that your doctor will calculate from your weight and height.

The usual weekly dose, taken as a single dose, is 60 mg/m2of body surface area for the first 3 doses. After the third dose, your doctor will decide if the dose will increase to 80 mg/m2of body surface area. In any case, your doctor may adjust the dose of vinorelbina.

If you are receiving the capsules with another medication to treat your cancer/condition, your doctor will decide on the suitable dose for you.

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

Before opening the blisters that contain vinorelbina, make sure 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 completely with water.

Taking the soft capsules of vinorelbina:

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

If you are taking an anti-nausea medication

Nausea and vomiting may occur with Vinorelbina Glenmark (see section "4. Possible side effects"). If your doctor has prescribed an anti-nausea medication, take it exactly as indicated.

Take vinorelbina during a light meal; this will help reduce the sensation of nausea.

If you take more Vinorelbina Glenmark than you should

If you may have taken more vinorelbina than the prescribed dose, contact your doctorimmediately.

Your body may react with intense 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 immediately contact your doctor if any of these severe symptoms occur.

If you forget to take Vinorelbina Glenmark

Do not take a double dose to compensate for the missed doses. Contact your doctor, who will decide on reprogramming your dose.

If you interrupt your treatment with Vinorelbina Glenmark

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

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

• Infections at different sites
• Gastrointestinal disorders; diarrhea; constipation, abdominal pain; nausea, vomiting;
• Inflammation in the mouth;
• Decreased red blood cells (anemia), which may cause pale skin and weakness or shortness of breath;
• Decreased platelets, which may increase the risk of bleeding or bruising;
• Decreased white blood cells, making you more vulnerable to infections;
• Loss of some reflexes, occasionally differences in tactile perception;
• Loss of hair, usually mild;
• Fatigue;
• Fever;
• Discomfort;
• Weight loss, loss of appetite.

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

• Difficulty coordinating muscle movements;
• Differences in vision;
• Shortness of breath, cough;
• Difficulty urinating; other genitourinary symptoms;
• Difficulty sleeping;
• Headaches; dizziness; differences in your sense of 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 in 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 may cause difficulty breathing and swelling of the ankles, irregular heartbeats;
• The lack of muscle control may be associated with abnormal gait, changes in speech, and eye movement abnormalities (ataxia).

Unknown: frequency cannot be estimated from available data

• Blood infections (sepsis) with symptoms such as high fever and general deterioration of 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 (SIADH - Syndrome of Inappropriate Antidiuretic Hormone Secretion).
• Darker skin color 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 that does not appear in this prospectus. You can also report them directly through the national notification system: Spanish System of Pharmacovigilance of Medicines for Human Use. Website:www.notificaRAM.es

By reporting adverse 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.

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

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

Unused medications should not be disposed of through drains or in the trash. Return unused medication to your pharmacist. This will help protect the environment..

Vinorelbina Glenmark Composition

• The active ingredient is vinorelbine (as tartrate) 20 mg.
• The other components are:

Caplet content:polyethylene glycol 400, polisorbate 80 (E433), purified water

Caplet coating:gelatin 160, partially dehydrated liquid sorbitol (E420), titanium dioxide (E171), purified water, iron oxide yellow (E172)

Appearance of Vinorelbina Glenmark and packaging contents

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Responsible Manufacturer

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

Paola, Malta

or

Alvogen Malta (Out-Licensing) Ltd

Malta Life Sciences Park,

Building 1, Level 4, Sir

Temi Zammit Buildings, San

Gwann SGN 3000, Malta

For more information about this medication, please contact the local representative of the Marketing Authorization Holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7th Floor

28045 Madrid

Spain

This medication is authorized in the European Economic Area member states with the following names:

SlovakiaVinorelbine Glenmark 20 mg mäkké kapsuly

SpainVinorelbina Glenmark 20 mg soft capsules EFG

PortugalVinorelbina Glenmark

Czech RepublicVinorelbine Glenmark

Last reviewed date of this leaflet:April 2023

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