Vinorelbine Zentiva

Leaflet attached to the packaging: patient information

Vinorelbine Zentiva, 20 mg, soft capsules

Vinorelbine Zentiva, 30 mg, soft capsules

Vinorelbine Zentiva, 80 mg, soft capsules

Vinorelbine (in the form of vinorelbine tartrate)

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Vinorelbine Zentiva and what is it used for
• 2. Important information before taking Vinorelbine Zentiva
• 3. How to take Vinorelbine Zentiva
• 4. Possible side effects
• 5. How to store Vinorelbine Zentiva
• 6. Contents of the packaging and other information

1. What is Vinorelbine Zentiva and what is it used for

Vinorelbine Zentiva contains the active substance vinorelbine (in the form of vinorelbine tartrate) and belongs to a group of medicines called vinca alkaloids used to treat cancer. Vinorelbine Zentiva is used to treat certain types of lung cancer and certain types of breast cancer in patients over 18 years of age:

• in advanced non-small cell lung cancer as monotherapy or in combination with other chemotherapy
• as adjuvant treatment in non-small cell lung cancer in combination with platinum-based chemotherapy
• in advanced breast cancer as monotherapy or in combination with other factors.

The doctor may prescribe this medicine for other diseases or in different doses than those described in the leaflet. You should always follow the doctor's or pharmacist's recommendations.

2. Important information before taking Vinorelbine Zentiva

When not to take Vinorelbine Zentiva

• if the patient is allergic to vinorelbine or any other anticancer medicine from the vinca alkaloid group,
• if the patient is allergic to any of the other ingredients of Vinorelbine Zentiva (listed in section 6),
• if the patient is breastfeeding,
• if the patient has undergone stomach or small intestine surgery, or has intestinal disorders,
• if the patient has a decreased white blood cell count and/or platelet count or severe infection currently or recently (within the last two weeks),
• if the patient is to receive or has recently received a yellow fever vaccine,
• if the patient requires long-term oxygen therapy.

Warnings and precautions

Before starting treatment with Vinorelbine Zentiva, you should discuss it with your doctor or pharmacist if:

• the patient has had a heart attack or has experienced severe chest pain,
• the patient has significantly limited ability to perform daily activities,
• the patient has been treated with radiation therapy, and the treated area included the liver,
• the patient has symptoms of infection (such as fever, chills, cough),
• the patient is to be vaccinated. During treatment with Vinorelbine Zentiva, live attenuated vaccines (e.g. against measles, mumps, and rubella) are not recommended, as they may increase the risk of fatal systemic disease after vaccination,
• the patient has severe liver disease unrelated to the treated cancer,
• the patient is pregnant.

Before and during treatment with Vinorelbine Zentiva, a blood test will be performed to check if the treatment will be safe for the patient. If the test results are unsatisfactory, the treatment may be postponed and further tests will be performed until the results return to normal.

Children and adolescents

The use of this medicine is not recommended in children under 18 years of age.

Vinorelbine Zentiva and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. The doctor must exercise particular caution if you are taking any of the following medicines:

• medicines that thin the blood (anticoagulants),
• an antiepileptic medicine (e.g. phenytoin),
• antifungal medicines (such as itraconazole),
• anticancer medicines, such as mitomycin C or lapatinib,
• medicines that affect the immune system, such as cyclosporine and tacrolimus.

Concomitant use of Vinorelbine Zentiva and other medicines with known toxic effects on the bone marrow (affecting white and red blood cells and platelets) may also enhance some side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine, due to possible risks to the baby. You should not breastfeed while taking Vinorelbine Zentiva. Women of childbearing age must use effective methods of contraception during treatment and for 7 months after its completion. Men taking Vinorelbine Zentiva should not plan to conceive a child during treatment and for 4 months after its completion, and before starting treatment, they should consult about sperm preservation due to possible irreversible infertility caused by Vinorelbine Zentiva. You should use effective methods of contraception during treatment and for 4 months after its completion.

Driving and using machines

No studies have been conducted on the effect of Vinorelbine Zentiva on the ability to drive and use machines. Therefore, you should not drive vehicles if you feel unwell or if your doctor has advised you to do so.

Vinorelbine Zentiva contains sorbitol

This medicine contains sorbitol. Each Vinorelbine Zentiva 20 mg capsule contains 38.4 mg of sorbitol. Each Vinorelbine Zentiva 30 mg capsule contains 59.9 mg of sorbitol. Each Vinorelbine Zentiva 80 mg capsule contains 99.9 mg of sorbitol.

3. How to take Vinorelbine Zentiva

Before and during treatment, your doctor will order a blood test. The doctor will determine the strength and number of capsules, how often to take them, and the duration of treatment. The dosage will depend on the patient's weight and height, blood test results, and overall health.

The total weekly dose should not exceed 160 mg.

Vinorelbine Zentiva should not be used more frequently than once a week.

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist. Before opening the blisters containing Vinorelbine Zentiva, you should check if the capsules are damaged. The liquid contents of the capsule have irritating properties and can cause damage to the eyes, skin, or mucous membranes if they come into contact with them. If contact occurs, the affected area should be rinsed immediately with water or a physiological saline solution. Do not swallow a damaged capsule, but return it to your doctor or pharmacist. The way to take Vinorelbine Zentiva, soft capsules:

• Vinorelbine Zentiva should be swallowed whole with water, preferably with a light meal. Do not swallow capsules with hot drinks, as this accelerates their dissolution.
• Do not chew or suck the capsules.
• If a capsule is accidentally chewed or sucked, the mouth should be rinsed thoroughly with water or a physiological saline solution and the doctor should be contacted immediately.
• If vomiting occurs within a few hours of taking the medicine, the doctor should be contacted immediately. Do not repeat the dose.

Use of anti-emetic medicines

During treatment with Vinorelbine Zentiva, nausea and vomiting may occur (see section 4 "Possible side effects"). If the doctor recommends anti-emetic medicines, they should always be taken strictly according to the recommendations. Vinorelbine Zentiva should be taken with a light meal to help reduce the feeling of nausea.

Use of a higher dose of Vinorelbine Zentiva than recommended

In the event of taking Vinorelbine Zentiva in a dose higher than described in the leaflet or recommended by the doctor, you should immediately inform the doctor or contact the hospital or pharmacist. Serious changes in blood morphology may occur, which can cause symptoms of infection (such as fever, chills, cough). Severe constipation may also occur.

Missing a dose of Vinorelbine Zentiva

You should not take a double dose to make up for a missed dose. You should contact your doctor, who will decide on changing the dosage.

Stopping treatment with Vinorelbine Zentiva

The doctor will decide when the patient should stop treatment. However, if the patient wants to stop treatment earlier, they should discuss it with their doctor. In case of any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

Severe side effects

You should immediately contact your doctor if you experience the following side effects while taking Vinorelbine Zentiva:

The following side effects:

• Symptoms of severe infection, such as cough, fever, and chills;
• Severe constipation accompanied by abdominal pain caused by not having a bowel movement for several days;
• Severe dizziness, feeling of fainting when standing up, which may be symptoms of significantly decreased blood pressure;
• Severe chest pain that has not occurred before, which may be a symptom of heart problems related to insufficient blood flow, known as a heart attack (which can be fatal in some cases);
• Difficulty breathing, dizziness, low blood pressure, rash covering the entire body, or swelling of the eyelids, lips, or throat, which may be symptoms of an allergic reaction;
• Chest pain, shortness of breath, and fainting, which may be symptoms of a blood clot in a blood vessel in the lungs (pulmonary embolism);
• Headache, altered mental state, which can lead to confusion and coma, seizures, blurred vision, and high blood pressure, which may be symptoms of a neurological disorder, such as posterior reversible encephalopathy syndrome.

Other side effects:

Very common(may occur more frequently than in 1 in 10 patients):

• Infections in various locations,
• Gastrointestinal disorders,
• Diarrhea,
• Constipation, abdominal pain,
• Nausea, vomiting,
• Inflammation of the mucous membrane of the mouth,
• Decreased red blood cell count, which can cause paleness of the skin, weakness, or shortness of breath,
• Decreased platelet count, which can increase the risk of bleeding or bruising (bruises),
• Decreased white blood cell count, which can increase the risk of infection,
• Weakening of some reflexes, sometimes sensory disturbances,
• Hair loss, usually slightly increased,
• Fatigue,
• Fever,
• General malaise,
• Weight loss,
• Lack of appetite.

Common(may occur no more frequently than in 1 in 10 patients):

• Difficulty with muscle coordination,
• Visual disturbances,
• Shortness of breath, cough,
• Difficulty urinating, other symptoms from the urinary and reproductive system,
• Difficulty falling asleep,
• Headache, dizziness, taste disturbances,
• Inflammation of the esophagus, difficulty swallowing solid or liquid foods,
• Skin reactions,
• Chills,
• Weight gain,
• Joint pain, jaw pain, muscle pain, pain in various parts of the body, and pain in the tumor area,
• High blood pressure,
• Liver function disorders (abnormal liver function test results).

Uncommon(may occur no more frequently than in 1 in 100 patients):

• Heart failure, which can cause shortness of breath and swelling in the ankle area,
• Irregular heartbeat,
• Loss of muscle control, which may be accompanied by gait disturbances, speech disturbances, and eye movement disturbances (ataxia).

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

• Blood infection (sepsis) with symptoms such as high fever and worsening of general health,
• Heart attack (myocardial infarction),
• Gastrointestinal bleeding,
• Low sodium levels in the blood (which can lead to symptoms such as fatigue, confusion, muscle tremors, and loss of consciousness). Low sodium levels may, in some cases, be associated with excessive production of the antidiuretic hormone (SIADH).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vinorelbine Zentiva

The medicine should be stored in a place that is out of sight and reach of children. Store in a refrigerator (2-8°C). Do not use this medicine after the expiry date stated on the blister and carton after: EXP. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Vinorelbine Zentiva contains

• The active substance of the medicine is vinorelbine (in the form of vinorelbine tartrate) in a quantity of 20 mg, 30 mg, or 80 mg.
• Other ingredients are:

Capsule contents:macrogol 400, polysorbate 80, purified water.
Capsule shell:gelatin, sorbitol liquid, partially dehydrated (E 420), titanium dioxide (E 171), purified water; Vinorelbine Zentiva 20 mg and 80 mg soft capsules: yellow iron oxide (E 172); Vinorelbine Zentiva 30 mg soft capsules: red iron oxide (E 172).

What Vinorelbine Zentiva looks like and what the pack contains

Vinorelbine Zentiva 20 mg soft capsules are oval in shape, light brown in color, 11 × 7 mm in size, filled with a clear, colorless or slightly yellowish liquid. Vinorelbine Zentiva 30 mg soft capsules are elongated in shape, pink in color, 18 × 6 mm in size, filled with a clear, colorless or slightly yellowish liquid. Vinorelbine Zentiva 80 mg soft capsules are elongated in shape, pale yellow in color, 21 × 8 mm in size, filled with a clear, colorless or slightly yellowish liquid. The 20 mg, 30 mg, and 80 mg soft capsules are available in packs containing 1 or 4 blisters with one soft capsule in each blister. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Zentiva k.s.
U Kabelovny 130
Dolni Měcholupy
102 37 Prague 10
Czech Republic
Manufacturer/Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta

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

Iceland:
Vinorelbine Alvogen 20 mg mjúkt hylki
Vinorelbine Alvogen 30 mg mjúkt hylki
Vinorelbine Alvogen 80 mg mjúkt hylki
Croatia:
Lavib 20 mg meke kapsule
Lavib 30 mg meke kapsule
Lavib 80 mg meke kapsule
Poland:
Vinorelbine Zentiva
Romania:
Vinorelbină Labormed 20 mg capsule moi
Vinorelbină Labormed 30 mg capsule moi
Vinorelbină Labormed 80 mg capsule moi

For more information about this medicine, you should contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o. o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:October 2024