Vinorelbine zentiva

Package leaflet: Information for the patient

Vinorelbine Zentiva, 20 mg, soft capsules
Vinorelbine Zentiva, 30 mg, soft capsules
Vinorelbine Zentiva, 80 mg, soft capsules
Vinorelbine (as vinorelbine tartrate)
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

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

• for 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
• for advanced breast cancer as monotherapy or in combination with other agents.

Your doctor may prescribe this medicine for other conditions or at different doses than those described in this leaflet. Always follow your doctor’s or pharmacist’s instructions.

2. Information before taking Vinorelbine Zentiva

When not to take Vinorelbine Zentiva

• if the patient is allergic to vinorelbine or to any antineoplastic agent belonging to 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 surgery of the stomach or small intestine, or has intestinal disorders,
• if the patient has a low white blood cell count and/or platelet count, or has a severe infection currently or recently (within the last two weeks),
• if the patient is due to receive or has recently received the yellow fever vaccine,
• if the patient requires long-term oxygen therapy.

Warnings and precautions
Before starting treatment with Vinorelbine Zentiva, discuss with your doctor or
pharmacist if:

• the patient has had a myocardial infarction or experienced severe chest pain,
• the patient has significantly limited ability to perform daily activities,
• the patient has been treated with radiotherapy and the treated area included the liver,
• the patient has signs of infection (such as fever, chills, cough),
• the patient is due 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 following vaccination,
• the patient has severe liver disease unrelated to the tumor being treated,
• the patient is pregnant.

Before and during treatment with Vinorelbine Zentiva, blood cell counts will be monitored to ensure the treatment is safe for the patient. If test results are unsatisfactory, treatment may be delayed and further tests performed until results return to normal levels.

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

Vinorelbine Zentiva and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Special caution is required if the patient is taking any of the following medicines:

• medicines that thin the blood (anticoagulants),
• antiepileptic medicines (e.g. phenytoin),
• antifungal medicines (such as itraconazole),
• antineoplastic 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 known to have myelotoxic effects (affecting white and red blood cells and platelets) may also increase certain adverse effects.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine due to potential risks to the fetus.

Breastfeeding must be avoided during treatment with Vinorelbine Zentiva.

Women of childbearing potential must use effective contraception during treatment and for 7 months after treatment ends.

Men taking Vinorelbine Zentiva should not plan to father a child during treatment and for 4 months after its completion. Prior to starting treatment, men should seek advice regarding sperm preservation due to the potential for irreversible infertility caused by Vinorelbine Zentiva. Effective contraception must be used during treatment and for 4 months after its completion.

Driving and operating machinery
No studies on the effects of Vinorelbine Zentiva on the ability to drive and operate machinery have been conducted. Therefore, patients should not drive if they feel unwell or if their doctor advises against it.

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 blood tests. The doctor will determine the strength and number of capsules, how often they should be taken, and the duration of treatment. The dosage will depend on the patient's body weight and height, blood test results, and overall health condition.
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 exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Before opening the blisters containing Vinorelbine Zentiva, check whether the capsules are damaged. The liquid contents of the capsule are irritant and may cause damage upon contact with the eye, skin, or mucous membranes. If contact occurs, immediately rinse the affected area thoroughly with water or saline solution.
Do not swallow a damaged capsule; return it to your doctor or pharmacist instead.
Instructions for taking Vinorelbine Zentiva, soft capsules:

• Swallow the Vinorelbine Zentiva capsule whole with water, preferably with a light meal. Do not take the capsules with hot drinks, as this may accelerate their dissolution.
• Do not chew or suck the capsules.
• If a capsule is accidentally chewed or sucked, thoroughly rinse the mouth with water or saline solution and contact your doctor immediately.
• If vomiting occurs within a few hours after taking the medicine, contact your doctor immediately. Do not repeat the dose.

Use of antiemetic medicines
Vomiting may occur during treatment with Vinorelbine Zentiva (see section 4, "Possible side effects"). If your doctor prescribes antiemetic medicines, always take them exactly as directed.
Taking Vinorelbine Zentiva with a light meal may help reduce nausea.
Taking more than the recommended dose of Vinorelbine Zentiva
If you take more Vinorelbine Zentiva than indicated in the leaflet or prescribed by your doctor, inform your doctor immediately or contact the hospital or pharmacist.
Serious changes in blood counts may occur, leading to symptoms of infection (such as fever, chills, cough). Severe constipation may also occur.
Missing a dose of Vinorelbine Zentiva
Do not take a double dose to make up for a missed dose. Contact your doctor, who will decide whether to adjust the dosage.
Stopping treatment with Vinorelbine Zentiva
Your doctor will decide when you should stop treatment. However, if you wish to discontinue treatment earlier, discuss alternative options with your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Severe adverse reactions
You should contact your doctor immediately if the following adverse reactions occur while taking Vinorelbine Zentiva:

• Signs of severe infection such as cough, fever, and chills;
• Severe constipation associated with abdominal pain due to failure to defecate for several days;
• Severe dizziness, feeling faint when standing up, which may be symptoms of a significant drop in blood pressure;
• Severe chest pain not previously experienced, which may indicate a heart disorder due to insufficient blood flow, so-called myocardial infarction (in some cases leading to death);
• Difficulty breathing, dizziness, low blood pressure, rash affecting the whole 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 the lung vessels (pulmonary embolism);
• Headaches, altered mental status possibly progressing to confusion and coma, seizures, blurred vision, and high blood pressure, which may be clinical signs of a neurological disorder such as posterior reversible encephalopathy syndrome (PRES).

Other adverse reactions:
Very common (may occur in more than 1 in 10 patients):

• Infections at various sites;
• Gastrointestinal disturbances;
• Diarrhea;
• Constipation, abdominal pain;
• Nausea, vomiting;
• Inflammation of the mucous membrane of the mouth (mucositis);
• Decreased number of red blood cells, which may cause pale skin, weakness, or shortness of breath;
• Decreased number of platelets, which may increase the risk of bleeding or bruising (purpura);
• Decreased number of white blood cells, which may increase susceptibility to infections;
• Weakening of certain reflexes, sometimes sensory disturbances;
• Hair loss, usually mild in severity;
• Fatigue;
• Fever;
• General malaise;
• Weight loss;
• Loss of appetite.

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

• Difficulty coordinating muscle movements;
• Visual disturbances;
• Shortness of breath (dyspnea), cough;
• Difficulty urinating, other urinary or genital system symptoms;
• Trouble falling asleep;
• Headache, dizziness, taste disturbances;
• Inflammation of the esophagus, difficulty swallowing solid food or liquids;
• Skin reactions;
• Chills;
• Weight gain;
• Joint pain, jaw pain, muscle pain, pain in various parts of the body, and pain around the tumor site;
• High blood pressure;
• Liver function disorders (abnormal liver function test results).

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

• Heart failure, which may cause shortness of breath and swelling around the ankles;
• Irregular heartbeat;
• Loss of muscle control, possibly accompanied by disturbances in gait, speech, and eye movement (ataxia).

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

• Blood infection (sepsis) with symptoms such as high fever and worsening general health;
• Heart attack (myocardial infarction);
• Gastrointestinal bleeding;
• Low sodium levels in the blood (which may lead to symptoms such as fatigue, confusion, muscle twitching, loss of consciousness). Low sodium levels may, in some cases, be associated with excessive production of a hormone causing fluid retention (Syndrome of Inappropriate Antidiuretic Hormone Secretion - SIADH).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Vinorelbine Zentiva

Keep this medicine out of the 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Vinorelbine Zentiva contains

• The active substance is vinorelbine (as vinorelbine tartrate) in the amount of 20 mg, 30 mg or 80 mg.
• The 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 contents of the pack
Vinorelbine Zentiva 20 mg soft capsules are oval-shaped, light brown in colour,
measuring 11 × 7 mm, filled with a transparent, colourless or slightly yellowish liquid.
Vinorelbine Zentiva 30 mg soft capsules are elongated in shape, pink in colour,
measuring 18 × 6 mm, filled with a transparent, colourless or slightly yellowish liquid.
Vinorelbine Zentiva 80 mg soft capsules are elongated in shape, pale yellow in colour,
measuring 21 × 8 mm, filled with a transparent, colourless or slightly yellowish liquid.
Soft capsules of 20 mg, 30 mg and 80 mg are available in packs containing 1 or 4 blisters,
with one soft capsule in each blister.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised for marketing in 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 further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00