Vinorelbine Accord

Leaflet accompanying the packaging: patient information

Vinorelbine Accord, 20 mg, soft capsules

Vinorelbine Accord, 30 mg, soft capsules

Vinorelbine Accord, 80 mg, soft capsules

Vinorelbine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. See section
• 4.

Table of contents of the leaflet:

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

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

Vinorelbine Accord contains the active substance vinorelbine and belongs to a group of medicines called vinca alkaloids, used in cancer treatment.
Vinorelbine Accord is used to treat certain types of lung cancer and certain types of breast cancer in patients over 18 years of age.

2. Important information before taking Vinorelbine Accord

When not to take Vinorelbine Accord:

• if the patient is allergic to vinorelbine or other vinca alkaloid medicines used in cancer treatment, or to any of the other ingredients of this medicine (listed in section 6),
• if the patient is breastfeeding,
• if the patient has had stomach or small intestine surgery, or has intestinal disorders that affect food absorption, as they may affect the absorption of Vinorelbine Accord.
• if the patient has a reduced white blood cell count (neutrophils, leukocytes), or has had a severe infection in the last 2 weeks,
• if the patient has a low platelet count (thrombocytopenia),
• if the patient has recently been vaccinated against yellow fever or plans to be vaccinated,
• -if the patient requires long-term oxygen therapy.

Warnings and precautions

Before starting treatment with Vinorelbine Accord, consult 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 liver problems or has been treated with radiation therapy, and the treated area included the liver,
• the patient has symptoms of infection (such as fever, chills, joint pain, cough),
• the patient is to be vaccinated. Many vaccines (live attenuated vaccines) are not recommended during treatment with Vinorelbine Accord,
• the patient has severe liver disease unrelated to cancer,
• the patient is pregnant.

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

Children and adolescents

Vinorelbine Accord is not recommended for use in children under 18 years of age.

Vinorelbine Accord and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken.
The doctor should pay special attention if the patient is taking any of the following medicines:

• blood-thinning medicines (anticoagulants),
• an antiepileptic medicine called phenytoin,
• antifungal medicines such as itraconazole and ketoconazole,
• anticancer medicines such as mitomycin C or lapatinib,
• medicines that affect the immune system, such as cyclosporine and tacrolimus,
• an antitubercular medicine called rifampicin.

Taking Vinorelbine Accord and other medicines with known toxic effects on the bone marrow (affecting white and red blood cells and platelets) may increase some side effects.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, thinks she may be pregnant, or plans to have a child, she should consult her doctor before taking this medicine, as there is a risk to the newborn.
Do not take Vinorelbine Accord if you are pregnant. Do not breastfeed while taking Vinorelbine Accord.
Women of childbearing age must use effective contraception during treatment and for 7 months after its completion.
Men taking Vinorelbine Accord and up to 4 months after treatment completion should avoid fathering children. Before starting treatment with Vinorelbine Accord, consult your doctor about the possibility of storing sperm, due to the risk of fertility disorders in men.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines. In no case should you drive if your doctor advises against it or if you feel unwell.

Vinorelbine Accord contains sorbitol, ethanol, and sodium

Vinorelbine Accord 20 mg contains 8.03 mg of sorbitol (in the form of partially dehydrated liquid sorbitol) per capsule.
Vinorelbine Accord 30 mg contains 13.65 mg of sorbitol (in the form of partially dehydrated liquid sorbitol) per capsule.
Vinorelbine Accord 80 mg contains 24.09 mg of sorbitol (in the form of partially dehydrated liquid sorbitol) per capsule.
Vinorelbine Accord 20 mg contains 2.89 mg of ethanol per soft capsule.
Vinorelbine Accord 30 mg contains 4.35 mg of ethanol per soft capsule.
Vinorelbine Accord 80 mg contains 11.56 mg of ethanol per soft capsule.
The amount of ethanol (alcohol) in each soft capsule is equivalent to less than 1 ml of beer or 1 ml of wine.
A small amount of alcohol in this medicine will not have noticeable effects.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means the medicine is considered "sodium-free".

3. How to take Vinorelbine Accord

Before starting and during treatment with Vinorelbine Accord, the doctor will check the patient's blood cell count to determine when the patient should receive treatment and what dose of the medicine is suitable for them. The doctor will inform the patient about the number and strength of capsules to take. The dosage will depend on the patient's body surface area, which the doctor will calculate based on the patient's weight and height. The usual weekly dose, taken once, is 60 mg/m2 for the first 3 doses. After the third dose, the doctor will decide whether to increase the dose to 80 mg/m2. In any case, the doctor may adjust the dose of Vinorelbine Accord.
If the patient is taking capsules with another anticancer medicine, the doctor will decide on the appropriate dose for the patient.
This medicine should always be taken according to the doctor's instructions. If you have any doubts, consult your doctor or pharmacist.
Before opening the blisters containing Vinorelbine Accord, check that the capsules are not damaged, as the liquid inside has an irritating effect and may be harmful in case of contact with the skin, eyes, or mucous membranes. If contact occurs, rinse the area thoroughly with water immediately.
How to take Vinorelbine Accord:

• Vinorelbine Accord should be swallowed whole with water, and it is recommended to take it with a light meal. Do not swallow capsules with hot drinks, as this accelerates their dissolution.
• Do notsuck or chew the capsules.
• If a capsule is accidentally chewed or sucked, rinse your mouth thoroughly with water and immediatelycontact your doctor.

The total weekly dose should never exceed 160 mg.

Vinorelbine Accord should never be taken more than once a week.

Do not swallow a damaged capsule, but return it to your doctor or pharmacist.

• If vomiting occurs within a few hours of taking Vinorelbine Accord, contact your doctor immediately. Do not take a double dose as a replacement.

Using anti-emetic medicines

During treatment with Vinorelbine Accord, vomiting may occur (see section 4 "Possible side effects"). If your doctor prescribes anti-emetic medicines, always take them exactly as instructed.
Vinorelbine Accord should be taken with a light meal, which will help reduce the feeling of nausea.

Taking a higher dose of Vinorelbine Accord than recommended

In case of taking a higher dose of Vinorelbine Accord than recommended, immediatelycontact your doctor.
Sometimes, serious symptoms may occur. Some of the symptoms may develop as signs of infection (such as fever, chills, cough, joint pain), and severe constipation may also occur.
If any of these severe symptoms occur, contact your doctor immediately.

Missing a dose of Vinorelbine Accord

In case of missing a dose of Vinorelbine Accord, do not take a double doseto make up for it. Contact your doctor, who will decide on changing the dosage.

Stopping treatment with Vinorelbine Accord

The decision to stop treatment will be made by your doctor. If you want to stop treatment earlier, you should discuss it with your doctor.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vinorelbine Accord can cause side effects, although not everybody gets them.
Very common side effects(may affect more than 1 in 10 people)

• Infections in various locations.

Contact your doctor immediately if you experience any of the following symptoms while taking Vinorelbine Accord:

• symptoms of infection, such as cough, fever, chills,
• severe constipation accompanied by abdominal pain caused by not having a bowel movement for several days;
• severe dizziness, feeling of emptiness in the head when standing up, signs of significantly decreased blood pressure,
• severe chest pain that has not occurred before, which may be a sign of heart problems related to insufficient blood flow. This is called a heart attack (which can be fatal in some cases),
• difficulty breathing, dizziness, low blood pressure, rash covering the whole body or swelling of the eyelids, lips, or throat, which may be signs of an allergic reaction,
• chest pain, shortness of breath, and fainting, which may be signs of a blood clot in a blood vessel in the lungs (pulmonary embolism),
• headache, altered mental state, which may lead to confusion and coma, seizures, blurred vision, and high blood pressure, which may be signs of a neurological disorder, such as posterior reversible encephalopathy syndrome.
• Gastrointestinal disorders: diarrhea, constipation, abdominal pain, nausea, vomiting.
• Inflammation of the mucous membrane of the mouth.
• Decreased red blood cell count (anemia), which may cause pale skin and weakness or shortness of breath.
• Decreased platelet count, which may increase the risk of bleeding or bruising.
• Decreased white blood cell count, which may cause susceptibility to infections.
• Weakening of some reflexes, sometimes sensory disturbances.
• Hair loss, usually mild.
• Fatigue.
• Fever.
• General malaise.
• Weight loss, loss of appetite.

Common side effects(may occur less often than in 1 in 10 people)

• Difficulty coordinating muscle movements.
• Visual disturbances.
• Shallow breathing, cough.
• Difficulty urinating and other symptoms related to the urinary and reproductive systems.
• Difficulty sleeping.
• Headache, dizziness, taste disturbances.
• Inflammation of the esophagus, 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 in the tumor area.
• High blood pressure.
• Liver function disorders (abnormal liver function test results).

Uncommon side effects(may occur less often than in 1 in 100 people)

• Heart failure, which may cause shallow breathing and swelling in the ankle area, irregular heartbeat.
• Loss of muscle control, which may be accompanied by gait disturbances, speech disturbances, changes, and disturbances in eye movement (ataxia).

Side effects with unknown frequency(frequency cannot be estimated from available data)

• Blood infection (sepsis) with symptoms such as high fever and worsening overall health.
• Heart attack (myocardial infarction).
• Gastrointestinal bleeding.
• Low sodium levels in the blood, which may lead to weakness, muscle tremors, fatigue, disorientation, and loss of consciousness. Low sodium levels may be related to excessive production of a hormone that causes fluid retention (Syndrome of Inappropriate Antidiuretic Hormone Secretion - SIADH).

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, tell your doctor, 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
Phone: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Vinorelbine Accord

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month stated.
Store in a refrigerator (2°C - 8°C).
Medicines should not be disposed of via wastewater or household waste. For safety reasons, all unused capsules should be returned to your doctor or pharmacist for destruction. This will help protect the environment.

6. Contents of the pack and other information

What Vinorelbine Accord contains

The active substance of Vinorelbine Accord is vinorelbine. Each soft capsule contains 20 mg, 30 mg, or 80 mg of vinorelbine (in the form of vinorelbine tartrate).
The other ingredients are:
Contents of the solution: macrogol, glycerol, anhydrous ethanol, and purified water.
Contents of the capsule shell: gelatin, glycerol, sorbitol liquid, partially dehydrated (E 420), titanium dioxide (E 171), yellow iron oxide (E 172) [Only for 20 mg and 80 mg], red iron oxide (E 172) [Only for 30 mg].

Contents of the ink for printing: shellac (E 904), black iron oxide (E 172), ammonium hydroxide (E 527), and propylene glycol (E 1520).

What Vinorelbine Accord looks like and contents of the pack

Vinorelbine Accord 20 mg: Light brown, opaque, oval (9.3 mm x 6.7 mm) soft gelatin capsule, without surface defects, with black printing "JJ1", containing a clear colorless liquid.
Vinorelbine Accord 30 mg: Pink, opaque, elongated (15 mm x 6.2 mm) soft gelatin capsule, without surface defects, with black printing "JJ2", containing a clear colorless liquid.
Vinorelbine Accord 80 mg: Light yellow, opaque, elongated (20.5 mm x 8 mm) soft gelatin capsule, without surface defects, with black printing "JJ3", containing a clear colorless liquid.
Vinorelbine Accord is available in blisters containing 1, 2, 3, or 4 soft capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp.z o.o.
ul. Lutomierska 50
95-200 Pabianice
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola PLA 3000, Malta
Laboratori Fundació Dau,
C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040, Spain

Importer

Accord Healthcare B.V.
Winthontlaan 200, Utrecht, 3526KV
Netherlands

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

Date of last revision of the leaflet: December 2024