Vinorelbine Accord

Package Leaflet: Information for the Patient

Vinorelbine Accord, 20 mg, Soft Capsules

Vinorelbine Accord, 30 mg, Soft Capsules

Vinorelbine Accord, 80 mg, Soft Capsules

Vinorelbine

Read all of 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• 4.

Contents of the pack:

• 1. What Vinorelbine Accord is and what it is used for
• 2. What you need to know before you take 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 Vinorelbine Accord is and what it is used for

Vinorelbine Accord contains the active substance vinorelbine and belongs to a group of medicines called vinca alkaloids, which are used in the treatment of cancer.
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. What you need to know before you take Vinorelbine Accord

Do not take Vinorelbine Accord:

• if you are allergic to vinorelbine or other vinca alkaloids used to treat cancer, or 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 that affect food absorption, as they may affect the absorption of Vinorelbine Accord.
• if you have a low white blood cell count (neutrophils, leucocytes), or if you have had a severe infection in the last 2 weeks,
• if you have a low platelet count (thrombocytopenia),
• if you have recently been vaccinated against yellow fever or plan to be vaccinated,
• -if you require long-term oxygen therapy.

Warnings and precautions

Before taking Vinorelbine Accord, tell your doctor or pharmacist if:

• you have had a heart attack or have experienced severe chest pain,
• you have significantly limited ability to perform daily activities,
• you have liver problems or have been treated with radiation therapy, and the treated area included the liver,
• you have symptoms of infection (such as fever, chills, joint pain, cough),
• you are going to be vaccinated. Many vaccines (live attenuated vaccines) are not recommended during treatment with Vinorelbine Accord,
• you have severe liver disease unrelated to cancer,
• you are pregnant.

Before and during treatment with Vinorelbine Accord, blood tests will be performed to check if the treatment is safe for you. 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 should not be used in children under 18 years of age.

Vinorelbine Accord and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Your doctor should pay special attention if you are 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 antituberculosis medicine called rifampicin.

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

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine, as there is a risk to the newborn.
Do not take Vinorelbine Accord if you are pregnant. Do not breast-feed while taking Vinorelbine Accord.
Women of childbearing age must use effective contraception during treatment and for 7 months after treatment ends.
Men taking Vinorelbine Accord and up to 4 months after treatment ends should avoid fathering a child. 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 effects of the medicine on the ability to drive and use machines. Never drive vehicles 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.
The small amount of alcohol in this medicine will not have a noticeable effect.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means it is essentially "sodium-free".

3. How to take Vinorelbine Accord

Before starting and during treatment with Vinorelbine Accord, your doctor will check your blood cell count to determine when you should receive treatment and what dose of the medicine you should take. Your doctor will inform you about the number and strength of the capsules you should take. The dosage will depend on your body surface area, which your doctor will calculate based on your weight and height. The usual weekly dose, taken once, is 60 mg/m2 for the first 3 doses. After the third dose, your doctor will decide whether to increase the dose to 80 mg/m2. In any case, your doctor may adjust the dose of Vinorelbine Accord.
If you are taking capsules with another anticancer medicine, your doctor will decide on the appropriate dose for you.
This medicine should always be taken according to your 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 can be irritating and may be harmful if it comes into contact with the skin, eyes, or mucous membranes. If contact occurs, rinse the affected area thoroughly with water immediately.
How to take Vinorelbine Accord:

• Vinorelbine Accord should be swallowed whole with water, preferably with a light meal. Do not swallow the capsules with hot drinks, as this can speed up 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, return it to your doctor or pharmacist.

• If you vomit within a few hours of taking Vinorelbine Accord, contact your doctor immediately. Do not take a double dose to make up for it.

Use of anti-emetic medicines

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

Taking a higher dose of Vinorelbine Accord than prescribed

If you take more Vinorelbine Accord than you should, contact your doctor immediately.
Severe symptoms may occur. Some of the symptoms may develop as signs of infection (such as fever, chills, cough, joint pain), or severe constipation may occur. If you experience any of these severe symptoms, contact your doctor immediately.

Missing a dose of Vinorelbine Accord

If you miss a dose of Vinorelbine Accord, do not take a double doseto make up for it. Contact your doctor, who will decide on a change in dosage.

Stopping treatment with Vinorelbine Accord

Your doctor will decide when to stop treatment. If you want to stop treatment early, you should discuss it with your doctor.
If you have any further questions about taking this medicine, ask 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 due to lack of bowel movements for several days;
• severe dizziness, feeling of emptiness in the head when standing up, signs of significantly low 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 entire 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 can 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 can cause pale skin and weakness or shortness of breath.
• Decreased platelet count, which can increase the risk of bleeding or bruising.
• Decreased white blood cell count, which can make you more susceptible to infections.
• Weakness of some reflexes, sometimes sensory disturbances.
• Hair loss, usually mild.
• Fatigue.
• Fever.
• General malaise.
• Weight loss, loss of appetite.

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

• Heart failure, which can cause shortness of breath and swelling in the ankles, 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 the available data)

• Blood infection (sepsis) with symptoms such as high fever and worsening overall health.
• Heart attack (myocardial infarction).
• Bleeding from the digestive tract.
• Low sodium levels in the blood, which can lead to weakness, muscle tremors, fatigue, disorientation, and loss of consciousness. Low sodium levels may be associated with 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Monitoring, 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 to gather more information on the safety of this medicine.

5. How to store Vinorelbine Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
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 is vinorelbine. Each soft capsule contains 20 mg, 30 mg, or 80 mg of vinorelbine (as 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: 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: Pale 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