NAVELBINE 20 mg SOFT CAPSULES

2. What you need to know before you take Navelbine

Do not take Navelbine

• if you are allergic to the active substance (vinorelbine) or other cancer medicines called vinca alkaloids or to any of the other ingredients of this medicine (listed in section 6);
• if you are breast-feeding;
• if you have had stomach or small intestine surgery or have intestinal disorders;
• if you have a significant decrease in the number of white blood cells and/or platelets, or a severe current or recent infection (within 2 weeks);
• if you are scheduled to receive a yellow fever vaccine or have recently received one;

• if you are undergoing continuous oxygen therapy.

Warnings and precautions

Tell your doctor before starting to take this medicine, especially if:

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

Before and during treatment with this medicine, a blood cell count will be performed to check that it is safe for you to receive treatment. If the results of this test are not satisfactory, your treatment may be delayed and other tests may be performed until the results return to normal.

Children and adolescents

It is not recommended for use in children or adolescents under 18 years of age.

Taking Navelbine with other medicines

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

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

• blood-thinning medicines (anticoagulants),
• anti-epileptic medicines such as phenytoin,
• antibiotics (e.g., Rifampicin),
• antifungal medicines (e.g., itraconazole, ketoconazole),
• anticancer medicines such as mitomycin C,
• medicines that can damage the immune system such as cyclosporin and tacrolimus.

Taking this medicine with other medicines that have known bone marrow toxicity may also worsen some side effects.

The yellow fever vaccine is contraindicated, see "Do not take Navelbine" section.

Taking Navelbine with food and drinks

The soft capsule should be swallowed whole with water without chewing or sucking.

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

Pregnancy, breast-feeding, and fertility

If you are pregnant, 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.

Do not breast-feed if you are 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 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, and you should seek advice on sperm preservation before starting treatment, 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 have been performed on the effects on the ability to drive and use machines.

However, as with 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 in this medicine does not produce any noticeable effect.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

3. How to take Navelbine

This medicine will be administered under the supervision of a specialist doctor in cancer treatment.

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

The recommended dose is:

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

The total dose should never exceed 160 mg per week.

Do not take this medicine more than once a week.

Frequency of administration

This medicine will be administered normally 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

It is 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 it may dissolve the capsule too quickly.
• Do not chew or suck the capsules.
• If you chew or suck the capsule by mistake, rinse your mouth thoroughly and inform your doctor immediately.
• If you vomit a few hours after taking Navelbine, inform your doctor immediately. Do not repeat the dose.

Before opening the blister pack that contains the capsules

Make sure the capsule is not damaged as the liquid it contains is irritating and can cause injury if it comes into contact with the skin, mucous membranes, or eyes. If this happens, wash the affected area thoroughly immediately. Damaged capsules should not be swallowed; they should be returned to the pharmacy or doctor.

To open the safety packaging:

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

If you take more Navelbine than you should

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Navelbine

Do not take a double doseto make up for the forgotten dose.

Contact your doctor, who will tell you if you should modify the dose you have to take.

If you stop taking Navelbine

It is your doctor who will decide when you should stop your treatment. In any case, if you want to stop treatment before, you should consult your doctor so that they can assess other treatment options.

If you have any further questions about 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;
• gastric disorders, diarrhea, constipation, abdominal pain, nausea, vomiting;
• inflammation in the mouth;
• decrease in red blood cells that can cause paleness of the skin and cause weakness or difficulty breathing;
• decrease in the number of platelets that can increase the risk of bleeding or bruising;
• decrease in white blood cells that makes you more vulnerable to infections;
• loss of some reflexes, occasionally alterations in touch perception;
• hair loss, usually moderate;
• fatigue;
• fever;
• discomfort;
• weight gain, loss of appetite.

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

• difficulty coordinating muscle movements;
• changes in vision;
• breathing difficulties, cough;
• urination difficulties, other genitourinary symptoms;
• sleeping difficulties;
• headache, dizziness, alteration of taste perception;
• throat inflammation, difficulty swallowing food or liquids;
• skin reactions;
• chills;
• weight gain;
• joint pain; jaw pain, muscle pain;
• pain in different parts of the body and pain where the tumor is located;
• high blood pressure;

• liver disorders (altered liver tests).

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

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

Frequency not known (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 can cause weakness, muscle contractions, fatigue, confusion, or loss of consciousness. This low sodium level can be attributed in some cases to an overproduction of a hormone that causes fluid retention (Syndrome of Inappropriate Antidiuretic Hormone Secretion - SIADH).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Navelbine

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

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

Do not use this medicine after the expiry date that appears on the carton and on the blister pack, after EXP.

The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medicines you no longer need. 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.

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

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

Appearance of Navelbine and contents of the pack

Soft capsule, light brown in color, and printed with N20.

Each pack contains a blister pack 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 last revision of this leaflet:January 2024

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