Navelbine 20 mg soft capsules

Spain
Brand name Navelbine 20 mg soft capsules
Form capsules, soft gelatin
Active substance / Dosage
VINORELBINE TARTRATE · 27,70 mg
Prescription type Hospital Use Only
ATC code
L01C L01CA L01CA04
Registration number 65978
Manufacturer Pierre Fabre Iberica S.A.
Navelbine 20 mg soft capsules capsules, soft gelatin

Table of Contents

Patient Information Leaflet

Introduction

Patient Information Leaflet

Navelbine 20 mg soft capsules

vinorelbine

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, because 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 the leaflet

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

1. What Navelbine is and what it is used for

This medicine contains the active substance vinorelbine (as tartrate) and belongs to a family of medicines called vinca alkaloids, which are used in the treatment of cancer.

Navelbine 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 taking Navelbine

Do not take Navelbine

  • if you are allergic to the active substance (vinorelbine) or to other cancer medicines known as vinca alkaloids, or to any of the other ingredients of this medicine (listed in section 6);

    • if you are breastfeeding;
    • if you have recently undergone surgery on the stomach or small intestine, or if you have intestinal disorders;
    • if you have a significant decrease in white blood cells and/or platelets, or a serious current or recent infection (within the past 2 weeks);
    • if you are scheduled to receive or have recently received the yellow fever vaccine;

  • if you are undergoing continuous oxygen therapy.

Warnings and precautions

Talk to your doctor before starting this medicine, especially if:

  • You have a history of heart attack or severe chest pain;
  • Your ability to perform daily activities is considerably reduced;
  • You are receiving radiotherapy, and the treated area includes the liver;
  • You experience symptoms of infection (such as fever, chills, cough);
  • You are scheduled for vaccination. Use of this medicine with live attenuated vaccines (e.g., measles, mumps, rubella...) is not recommended, as it may increase the risk of fatal vaccine-related disease;
  • You have severe liver disease not related to cancer.
  • You are pregnant.

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

Children and adolescents

Not recommended for use in children and adolescents under 18 years of age.

Taking Navelbine with other medicines

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

Your doctor should pay special attention if you are taking any of the following medicines:

  • blood-thinning medicines (anticoagulants),
  • antiepileptic medicines such as phenytoin,
  • antibiotics (e.g., rifampicin),
  • antifungal medicines (e.g., itraconazole, ketoconazole),
  • anticancer medicines such as mitomycin C,
  • medicines that may impair the immune system such as cyclosporine and tacrolimus.

Combining this medicine with other medicines known to have bone marrow toxicity (affecting white blood cells, red blood cells, and platelets) may worsen certain adverse effects.

The yellow fever vaccine is contraindicated; see section “Do not take Navelbine”.

Taking Navelbine with food and drinks

The soft capsule must be swallowed whole with water, without chewing or sucking it.

It is recommended to take this medicine with a light meal. This medicine should not be taken with a hot drink, as it could dissolve the capsule rapidly.

Pregnancy, breastfeeding, and fertility

If you are pregnant, 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 breastfeed while taking Navelbine (see section 2 “Do not take Navelbine”).

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 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 impair fertility. You should use an effective method of contraception during treatment and for 4 months after stopping treatment.

Driving and using machines

No studies have been conducted on the effects on the ability to drive or operate machinery.

However, as in all cases, you should not drive if you feel unwell or if your doctor has advised you not to drive.

Navelbine contains sorbitol, alcohol, sodium

This medicine contains 5.36 mg of sorbitol in each capsule.

This medicine contains 5 mg of alcohol (ethanol) in each capsule. The amount in each capsule of this medicine 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 Navelbine

This medicine will be administered under the supervision of a physician specialized in cancer treatment.

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

Recommended dose:

Before and during treatment with this medicine, your doctor will monitor your blood cell counts to determine when you should receive treatment and the appropriate dose. Your doctor will advise you of the dose and the number of capsules to take per week.

The total dose must never exceed 160 mg per week.

You must never take this medicine more than once a week.

Frequency of administration

This medicine is usually administered once a week. The frequency will be determined by your doctor.

Duration of treatment

The duration of your treatment will be decided by your doctor.

Use in children and adolescents

Not recommended for use in children or adolescents (under 18 years of age). This medicine is used in adult patients.

Method of administration:

This medicine is taken orally.

How to take the capsules:

  • Swallow the capsule whole with water, preferably with a light meal. Do not take the soft capsule with a hot drink, as this could rapidly dissolve the capsule.
  • Do not chew or suck the capsules.
  • If you accidentally chew or suck the capsule, rinse your mouth thoroughly and inform your doctor immediately.
  • If you vomit within a few hours after taking Navelbine, inform your doctor immediately. Do not repeat the dose.

Before opening the blister pack containing the capsules

Ensure the capsule is not damaged, as the liquid inside is irritating and may cause injury if it comes into contact with skin, mucous membranes, or eyes. If this occurs, immediately wash the affected area thoroughly. Damaged capsules must not be swallowed; they should be returned to the pharmacy or physician.

To open the safety packaging:

  1. Cut the blister along the black dotted line with scissors.
  2. Remove the soft plastic film.
  3. Push the capsule through the aluminum foil.

If you take more Navelbine than you should

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

Severe symptoms related to blood components may occur, and you may develop signs of infection (such as fever, chills, cough). You may experience severe constipation. If this happens, contact your doctor immediately.

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 medicine and the amount ingested.

If you forget to take Navelbine

Do not take a double dose to make up for the missed dose.

Contact your doctor, who will advise you whether to adjust your dose.

If you stop taking Navelbine

Your doctor will decide when you should discontinue treatment. In any case, 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 produce adverse effects, although not everyone will experience them.

Inform your doctor immediately if you experience any of the following symptoms while taking Navelbine:

  • chest pain, difficulty breathing, and fainting, which may be symptoms of a blood clot in a blood vessel in the lungs (pulmonary embolism);
  • headaches, changes in mental status that may lead to confusion and coma, seizures, blurred vision, and high blood pressure, which could indicate a neurological disorder such as reversible posterior encephalopathy syndrome;
  • cough, fever, and chills, which may be signs of an infection;
  • severe constipation with abdominal pain after several days without bowel movements;
  • severe dizziness, lightheadedness upon standing, which may be signs of a severe drop in blood pressure;
    • severe chest pain not typical for you; symptoms may be due to a disturbance in heart function, followed by insufficient blood flow such as myocardial infarction (sometimes fatal);
  • difficulty breathing, dizziness, low blood pressure, rash affecting the entire body, or swelling of the eyelids, lips, face, or throat, which may be signs of an allergic reaction.

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

  • infections at various sites;
  • gastric disorders, diarrhea, constipation, abdominal pain, nausea, vomiting;
  • inflammation in the mouth;
  • decrease in red blood cells which may cause paleness of the skin and lead to weakness or difficulty breathing;
  • decrease in platelet count which may increase the risk of bleeding or bruising;
  • decrease in white blood cells making you more vulnerable to infections;
  • loss of certain reflexes, occasionally disturbances in touch sensation;
  • hair loss, usually mild;
  • fatigue;
  • fever;
  • malaise;
  • weight gain, loss of appetite.

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

  • difficulty coordinating muscle movements;
  • visual disturbances;
  • breathing difficulties, cough;
  • urinary difficulties, other genitourinary symptoms;
  • difficulty sleeping;
  • headache, dizziness, altered taste perception;
  • throat inflammation, difficulty swallowing food or liquids;
  • skin reactions;
  • chills;
  • weight gain;
  • joint pain; jaw pain, muscle pain;
  • pain in various parts of the body and pain at the tumor site;
  • high blood pressure;
  • liver abnormalities (abnormal liver function tests).

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

  • heart failure which may cause difficulty breathing and swelling of the ankles, irregular heartbeats;
  • lack of muscular control which may be associated with abnormal gait, changes in speech, and eye movement abnormalities (ataxia).

Frequency not known (cannot be estimated from available data)

  • blood infections (sepsis) with symptoms such as high fever and general deterioration in health;

  • heart attack (myocardial infarction);

  • gastrointestinal bleeding;

  • low sodium levels in the blood causing weakness, muscle twitching, fatigue, confusion, or 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 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Navelbine

Keep this medicine out of sight and reach of children.

Store in a refrigerator (between 2°C and 8°C). Keep the blister pack tightly closed.

Do not use this medicine after the expiry date stated on the carton and the blister pack, following CAD.

The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Navelbine

The active substance is vinorelbine. Each soft capsule contains 20 mg of vinorelbine (equivalent to 27.7 mg of vinorelbine tartrate).

The solution contains: anhydrous ethanol, purified water, glycerol, macrogol 400.

Capsule shell contains: gelatin, glycerol 85%, Anidrisorb 85/70 (containing: sorbitol (E420); 1,4-sorbitan; mannitol (E421); higher polyols), colouring agents (yellow iron oxide (E-172), titanium dioxide (E-171)), medium-chain triglycerides, PHOSAL 53 MCT (containing: phosphatidylcholine, glycerides).

The edible printing ink contains: carmine acid (E-120), sodium hydroxide, aluminium hexahydrate chloride, hypromellose, propylene glycol (E1520).

Appearance of Navelbine and contents of the pack

Soft capsule, light brown in colour, marked with "N20".

Each pack contains one blister with 1 soft capsule.

Marketing Authorisation Holder

PIERRE FABRE IBÉRICA, S.A.
C/ Ramón Trias Fargas, 7-11
08005 – BARCELONA (Spain)

Manufacturer

FAREVA PAU 1
Avenue du Béarn
64320 IDRON
France

Date of the most recent revision of this leaflet: January 2024

Detailed and up-to-date 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