VINORELBINE ACCORD 80 mg SOFT CAPSULE

Introduction

Package Leaflet: Information for the Patient

Vinorelbina Accord 80 mg Soft Capsule EFG

Read all of this leaflet carefully before you start 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 experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

This medicine contains the active substance vinorelbine, and belongs to a family of medicines called vinca alkaloids, used to treat cancer.

Vinorelbina Accord is used to treat certain types of lung and breast cancer in patients over 18 years of age.

2. What you need to know before you take Vinorelbina Accord

Do not take Vinorelbina Accord

• If you are allergic to vinorelbine or other cancer medicines of the vinca alkaloid family, or to any of the other ingredients of this medicine (listed in section 6).
• If you are breast-feeding.
• If you have had an operation on your stomach or small intestine, or if you have an intestinal disorder that affects the way you absorb food. This may affect the way your body absorbs vinorelbine.
• If you have a low white blood cell count (neutrophils, leucocytes) or a severe current or recent infection of less than two weeks.
• If you have a low platelet count (thrombocytopenia).
• If you plan to receive a yellow fever vaccine or have recently received one.
• If you need long-term oxygen therapy.

Warnings and precautions

Tell your doctor or pharmacist before taking vinorelbine if:

• You have a history of heart attack or severe chest pain.
• Your ability to perform daily activities is severely reduced.
• You have liver problems or have received radiation therapy in the treatment area that includes the liver.
• You have symptoms of infection (such as fever, chills, joint pain, cough).
• You plan to be vaccinated. Many vaccines (live attenuated vaccines) are not recommended during treatment.
• You have a severe liver disorder unrelated to cancer.
• You are pregnant.

Before and during your treatment with vinorelbine, blood cell counts are performed to check that it is safe for you to receive the treatment. If the results of this test are not satisfactory, your treatment may be delayed and more reviews will be performed until these values return to normal.

Children and adolescents

This medicine is not recommended for use in children under 18 years of age.

Other medicines and Vinorelbina Accord

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor should pay special attention if you are taking the following medicines:

• medicines used to dissolve blood clots (anticoagulants),
• an antiepileptic medicine called phenytoin,
• antifungal medicines, such as itraconazole and ketoconazole,
• cancer medicines called mitomycin C or lapatinib,
• medicines that damage the immune system, such as cyclosporine and tacrolimus
• an anti-tuberculosis medicine called rifampicin

The combination of vinorelbine with other medicines with known bone marrow toxicity (which affects white and red blood cells and platelets) may also worsen some side effects.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine, as there are potential risks to the baby. You should not take this medicine if you are pregnant. You should not breast-feed if you are taking vinorelbine.

Women of childbearing age must use effective contraceptive methods (birth control) during treatment and up to 7 months after treatment.

Men treated with vinorelbine are advised not to father a child during and up to 3 months after the last capsule. You should discuss sperm banking with your doctor before starting treatment with vinorelbine, as male fertility may be altered.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. However, as with all cases, you should not drive if you feel unwell or if your doctor has advised you not to drive.

Vinorelbina Accord contains sorbitol, ethanol and sodium

Vinorelbina Accord 80 mg contains 24.09 mg of sorbitol (as partially dehydrated liquid sorbitol) per soft capsule.

This medicine contains 11.56 mg of alcohol in each soft capsule. The amount 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 does not produce any noticeable effect.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; i.e., it is essentially "sodium-free".

3. How to take Vinorelbina Accord

Before and during your treatment with vinorelbine, your doctor will check your blood cell count to determine when you will receive your treatment and what dose is suitable for you. Your doctor will tell you the number and dose of capsules you should take. This will depend on your body surface area, which your doctor will calculate from your weight and height. The usual weekly dose, taken in a single dose, is 60 mg/m2 of body surface area for the first three doses. After the third dose, your doctor will decide if the dose should be increased to 80 mg/m2 of body surface area. In any case, your doctor may adjust the dose of vinorelbine.

If you are receiving the capsules with another medicine to treat your cancer/disease, your doctor will decide what dose is suitable for you.

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

Before opening the blisters that contain vinorelbine, make sure that there are no damaged capsules because the liquid inside is irritating and can be harmful if it comes into contact with your skin, eyes or mucous membranes. If this happens, wash the affected area immediatelyand thoroughly with water.

Taking the soft capsules of vinorelbine:

• Swallow the capsule whole with water, preferably with a light meal. Do not take it with a hot drink, as it will dissolve the capsule too quickly.
• Do notchew or suck the capsules.
• If you chew or suck a capsule by mistake, rinse your mouth well with water and inform your doctor immediately.
• If you vomit in the hours following the intake of the medicine, contact your doctor; do not repeat the dose.

If you take anti-nausea and vomiting medicines

This medicine may cause vomiting, (see section "4. Possible side effects"). If your doctor has prescribed an anti-nausea medicine, always take it exactly as indicated.

Take vinorelbine during a light meal; this will help reduce the feeling of nausea.

If you take more Vinorelbina Accord than you should

If you have taken more capsules than prescribed by your doctor, consult your doctor immediately.

Your body may sometimes react with intense symptoms. Some of these symptoms may appear as signs of an infection (such as fever, chills, cough, joint pain). You may also suffer from intense constipation. You should contact your doctor immediately if you experience any of these severe symptoms.

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

If you forget to take Vinorelbina Accord

Do not take a double dose to make up for forgotten doses. Contact your doctor, who will indicate if you should modify the dose you have to take.

If you interrupt your treatment with Vinorelbina Accord

Your doctor will decide when you should interrupt your treatment. However, if you wish to interrupt your treatment beforehand, you should consult your doctor so that they can assess other treatment options.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 (anemia), which can make the skin pale and cause weakness or shortness of breath;
• Decrease in platelets, which can increase the risk of bleeding or bruising;
• Decrease in white blood cells, which makes you more vulnerable to infections;
• Loss of some reflexes, occasionally difference in touch perception;
• Hair loss, usually mild;
• Fatigue;
• Fever;
• Discomfort;
• Weight loss, loss of appetite.

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

• Difficulty coordinating muscle movements;
• Differences in vision;
• Shortness of breath, cough;
• Difficulty urinating; other genitourinary symptoms;
• Difficulty sleeping;
• Headache; dizziness; difference in taste;
• Inflammation of the throat, difficulty swallowing food or liquids;
• Skin reactions;
• Chills;
• Weight gain;
• Pain in the joints, jaw, muscles;
• Pain in different parts of the body and pain at the tumor site;
• High blood pressure;
• Liver disorders (abnormal liver tests)

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

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

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

• Blood infections (sepsis) with symptoms such as high fever and deterioration of general health;
• Heart attack (myocardial infarction);
• Gastrointestinal bleeding;
• Low sodium level in the blood that causes weakness, muscle spasms, fatigue, confusion and loss of consciousness. This low sodium level may be attributed in some cases to an overproduction of a hormone that causes fluid retention and (Syndrome of Inappropriate Antidiuretic Hormone Secretion - SIADH).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system: Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vinorelbina 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 blister and carton after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C).

Medicines should not be disposed of via wastewater or household waste. For safety reasons, return any unused medicine to your doctor or pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vinorelbina Accord

The active substance is vinorelbine. Each soft capsule contains 80 mg of vinorelbine (as tartrate).

The other ingredients are:

The solution contains: macrogol, glycerol, anhydrous ethanol and purified water.

The capsule shell contains: gelatin, glycerol, partially dehydrated liquid sorbitol (E 420), titanium dioxide (E 171) and yellow iron oxide (E 172).

Printing ink: shellac (E 904), black iron oxide (E 172), ammonium hydroxide (E 527) and propylene glycol (E 1520).

Appearance of Vinorelbina Accord and contents of the pack

Soft gelatin capsules, oblong in shape (20.5 mm x 8 mm), opaque and light yellow in color, free of surface defects, with "JJ3" printed in black, containing a clear and colorless liquid.

Vinorelbina Accord is available in blisters of 1, 2, 3 or 4 soft capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n, Edifici Est, 6ª planta,

08039, Barcelona. Spain.

Manufacturer

Accord Healthcare Polska Sp. z o.o.

Ul. Lutomierska 50, 95-200,

Pabianice, Poland

or

Accord Healthcare B.V.

Winthontlaan 200, 3526 KV

Utrecht, Netherlands

or

Laboratori Fundació Dau

C/ C, 12-14 Pol.

Ind. Zona Franca,

Barcelona, 08040, Spain

or

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

Paola, Malta

or

Accord Healthcare single member S.A.

64th Km National Road Athens,

Lamia, Schimatari,

32009, Greece

Date of last revision of this leaflet:December 2024.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es//