Prospect: Information for the User

Navelbine 20 mg Soft Capsules

vinorelbina

Read this entire prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must 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 do not appear in this prospect. See section 4.

This medication contains the active ingredient vinorelbine (as tartrate), and belongs to a family of medications known as vinca alkaloids, a family used for cancer treatment.

Navelbine is used to treat certain types of lung and breast cancer in patients aged 18 years and older.

Do not take Navelbine

- if you are allergic to the active ingredient (vinorelbine) or other cancer-related medications called vinca alkaloidsor to any of the other components of this medication (listed in section 6);

- if you are receiving continuous oxygen therapy.

Warnings and precautions

Consult your doctor before starting this medication, especially if:

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

Children and adolescents

This medication is not recommended for use in children or adolescents under 18 years old.

Taking Navelbine with other medications

Inform your doctor or pharmacist if you are taking or have recently taken or may need to take any other medication.

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

- blood thinners (anticoagulants),

- antiepileptic medications such as phenytoin,

- antibiotics (e.g. rifampicin),

- antifungal medications (e.g. itraconazole, ketoconazole)

- cancer chemotherapy medications such as mitomycin C,

- immunosuppressive medications such as cyclosporine and tacrolimus.

The combination of this medication with other medications known to have bone marrow toxicity (affecting white blood cells, red blood cells, and platelets) may worsen some adverse effects.

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

Taking Navelbine with food and drinks

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

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

Pregnancy, breastfeeding, and fertility

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

Do 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 contraceptive method (birth control) during treatment and for 7 months after completing treatment.

If you are a man being treated with this medication, you are advised not to father a child during treatment and for 4 months after taking the last capsule, and before starting treatment, you should seek advice to preserve sperm as this medication may affect fertility. You should use an effective contraceptive method during treatment and for 4 months after completing treatment.

Driving and operating machinery

No studies have been conducted on the effects on driving and operating machinery.

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

Navelbine contains sorbitol, alcohol, sodium

This medication contains 5.36 mg of sorbitol in each capsule.

This medication contains 5 mg of alcohol (ethanol) in each capsule. The amount in each capsule of this medication is equivalent to less than 1 ml of beer or 1 ml of wine.

The small amount of alcohol contained in this medication does not produce any noticeable effect.

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.

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

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

The recommended dose is:

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

Administration frequency

This medication will be administered normally once a week. The frequency will be determined by your doctor.

Treatment duration

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

Use in children and adolescents

This medication is not recommended for use in children or adolescents (under 18 years). This medication is used in adult patients.

Administration method:

This medication 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 quickly.

- Do not chew or suck the capsules.

- If you accidentally chew or suck the capsule, thoroughly rinse your mouth 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 containing the capsules

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

To open the safety packaging:

1. Cut the blister along the black dotted 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.

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

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

If you forget to take Navelbine

Do not take a double doseto compensate for the missed dose.

Contact your doctor who will inform you if you should modify the dose you need to take.

If you interrupt treatment with Navelbine

Your doctor will decide when you should stop treatment. In any case, if you want to interrupt treatment beforehand, consult your doctor to evaluate other treatment options.

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

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

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

• infections in different locations;
• gastrointestinal disorders, diarrhea, constipation, abdominal pain, nausea, vomiting;
• inflammation in the mouth;
• decrease in red blood cells that may cause pale skin and cause weakness or difficulty breathing;
• decrease in platelets that may 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 tactile perception;
• moderate hair loss;
• fatigue;
• fever;
• uncomfortable feeling;
• weight gain, loss of appetite.

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

• difficulty coordinating muscle movements;
• vision differences;
• difficulty breathing, cough;
• difficulty urinating, other genitourinary symptoms;
• difficulty sleeping;
• headaches, dizziness, alteration of taste perception;
• inflammation of the throat, 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 changes (altered liver tests).

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

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

Frequency not known (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 produce weakness, muscle contractions, fatigue, confusion, or loss of consciousness. This low sodium level may 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 type of side effect, consult your doctor or pharmacist even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side 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). Keep the blister pack perfectly closed.

Do not use this medication after the expiration date that appears on the box and on the blister pack, after CAD.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at your pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofNavelbine

The active ingredient 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 coating 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 ink contains: carminic acid (E-120), sodium hydroxide, aluminum chloride hexahydrate, hypromellose, propylene glycol (E1520).

AppearanceofNavelbineand content of the container

Soft capsule, light brown in color, with the imprint N20.

Each container contains a blister pack with 1 soft capsule.

Marketing authorization holder

PIERRE FABRE IBÉRICA, S.A.

C/ Ramón Trias Fargas, 7-11

08005 – BARCELONA (Spain)

Responsible for manufacturing

FAREVA PAU 1

Avenue du Béarn

64320 IDRON

France

Last review date of this leaflet:January 2024

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