Vinorelbine accord

Patient Information Leaflet

Vinorelbine Accord, 20 mg, soft capsules
Vinorelbine Accord, 30 mg, soft capsules
Vinorelbine Accord, 80 mg, soft capsules
Vinorelbinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Vinorelbine Accord is and what it is 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 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 cancer treatment.
Vinorelbine Accord is used in the treatment of certain types of lung cancer and certain types of breast cancer in patients aged over 18 years.

2. Important information before using Vinorelbine Accord

When not to use Vinorelbine Accord:

• if the patient is allergic to vinorelbine or to other drugs containing vinca alkaloids 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 undergone stomach or small intestine surgery, or has intestinal disorders affecting nutrient absorption, as they may affect the absorption of Vinorelbine Accord,
• if the patient has a reduced number of white blood cells (neutrophils, leukocytes), or if they currently have or have recently had (within the last 2 weeks) a severe infection,
• if the patient has a low platelet count (thrombocytopenia),
• if the patient has recently been vaccinated against yellow fever or plans to receive such vaccination,
• if the patient requires long-term oxygen therapy.

Warnings and precautions
Before starting treatment with Vinorelbine Accord, consult a doctor or
pharmacist if:

• the patient has previously had a heart attack or experienced severe chest pain,
• the patient has significantly limited ability to perform daily activities,
• the patient has liver problems or has undergone radiotherapy where the treated area included the liver,
• the patient shows signs of infection (such as fever, chills, joint pain, cough),
• the patient is due 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 cell counts are monitored to
assess whether treatment is safe for the patient. If test results are unsatisfactory,
treatment may be delayed and further tests performed until results return to normal values.
Children and adolescents
Vinorelbine Accord is not recommended for use in children under 18 years of age.
Vinorelbine Accord and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken by the patient.
The doctor should pay particular attention if the patient is taking any of the following
medicines:

• drugs that thin the blood (anticoagulants),
• the antiepileptic drug phenytoin,
• antifungal medicines such as itraconazole and ketoconazole,
• anticancer drugs such as mitomycin C or lapatinib,
• drugs that affect the immune system, such as cyclosporine and tacrolimus,
• the antituberculosis drug rifampicin.

Concurrent use of Vinorelbine Accord and other medicines known to have toxic effects on bone marrow (affecting white and red blood cells and platelets) may intensify certain adverse effects.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child,
she should consult her doctor before using this medicine, as there is a risk to the unborn child.
Do not take Vinorelbine Accord if the patient is pregnant. Do not breastfeed
during treatment with Vinorelbine Accord.
Women of childbearing potential must use effective contraception during treatment and for 7
months after treatment ends.
Men should avoid fathering a child during treatment with Vinorelbine Accord and for 4 months after treatment ends. Before starting treatment with Vinorelbine Accord, patients should
consult their doctor about the possibility of sperm storage due to the risk of impaired fertility in men.
Driving and operating machinery
No studies have been conducted on the effects of the medicine on the ability to drive and operate
machinery. Under no circumstances should patients drive if advised by their doctor or if they feel unwell.
Vinorelbine Accord contains sorbitol, ethanol and sodium
Vinorelbine Accord 20 mg contains 8.03 mg of sorbitol (as partially dehydrated liquid sorbitol) in each capsule.
Vinorelbine Accord 30 mg contains 13.65 mg of sorbitol (as partially dehydrated liquid sorbitol) in each capsule.
Vinorelbine Accord 80 mg contains 24.09 mg of sorbitol (as partially dehydrated liquid sorbitol) in each capsule.
Vinorelbine Accord 20 mg contains 2.89 mg of ethanol in each soft capsule.
Vinorelbine Accord 30 mg contains 4.35 mg of ethanol in each soft capsule.
Vinorelbine Accord 80 mg contains 11.56 mg of ethanol in each 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 cause noticeable effects.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. the medicine is considered "sodium-free".

3. How to use Vinorelbine Accord

Before starting and during treatment with Vinorelbine Accord, your doctor will check your blood cell counts to determine when you should receive treatment and what dose is appropriate for you. Your doctor will inform you of the number and strength of capsules you should take. The dose will depend on your body surface area, which your doctor will calculate based on your body weight and height. The usual weekly dose, administered once weekly, 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 as needed.

If you are taking Vinorelbine Accord capsules together with another anticancer medicine, your doctor will decide the appropriate dose for you.

The total weekly dose must never exceed 160 mg.
Vinorelbine Accord must never be taken more frequently than once a week.

This medicine should always be used exactly as prescribed by your doctor. 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 is irritating and may be harmful if it comes into contact with the skin, eyes, or mucous membranes. If contact occurs, wash the affected area thoroughly with water immediately.

Instructions for taking Vinorelbine Accord:

• Swallow the Vinorelbine Accord capsule whole with water. It is recommended to take it with a light meal. Do not take the capsules with hot drinks, as this may accelerate their dissolution.
• Do not suck or chew the capsules.
• If a capsule is accidentally chewed or sucked, rinse the mouth thoroughly with water immediately and contact your doctor immediately.

Do not swallow a damaged capsule. Return it to your doctor or pharmacist.

• If vomiting occurs within a few hours after taking Vinorelbine Accord, contact your doctor immediately. Do not take a double dose to make up for the missed dose.

Use of antiemetic medicines
Nausea and vomiting may occur during treatment with Vinorelbine Accord (see section 4 "Possible side effects"). If your doctor prescribes antiemetic medicines, always take them exactly as directed.
Taking Vinorelbine Accord with a light meal may help reduce nausea.

Taking more Vinorelbine Accord than prescribed
If you take more Vinorelbine Accord than prescribed, contact your doctor immediately.
Serious symptoms may occur. Some symptoms may appear as signs of infection (such as fever, chills, cough, joint pain), or severe constipation. If any of these severe symptoms occur, contact your doctor immediately.

Missing a dose of Vinorelbine Accord
If you miss a dose of Vinorelbine Accord, do not take a double dose to make up for it. Contact your doctor, who will decide whether to adjust your dosing schedule.

Stopping Vinorelbine Accord treatment
The decision to stop treatment must be made by your doctor. If you wish to discontinue treatment earlier, speak to 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 will experience them.
You should contact your doctor immediately if any of the following symptoms occur while taking Vinorelbine Accord:

• signs of infection such as cough, fever, chills,
• severe constipation associated with abdominal pain due to lack of bowel movement for several days,
• severe dizziness, feeling of emptiness in the head when standing up, signs of significant drop in blood pressure,
• severe chest pain not experienced before, which may indicate impaired heart function due to insufficient blood flow. This is known as myocardial infarction (in some cases leading to death),
• difficulty breathing, dizziness, drop in blood pressure, rash affecting 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 indicate a blood clot in the lung vessels (pulmonary embolism),
• headaches, altered mental state which may lead to confusion and coma, seizures, blurred vision and high arterial blood pressure, which may be clinical signs of a neurological disorder such as posterior reversible encephalopathy syndrome.

Very common adverse reactions (may affect more than 1 in 10 patients)

• Infections at various sites.
• Gastrointestinal disturbances: diarrhoea, constipation, abdominal pain, nausea, vomiting.
• Inflammation of the mucous membrane of the mouth (mucositis).
• Decrease in red blood cell count (anaemia), which may cause paleness of the skin, weakness or shortness of breath.
• Decrease in platelet count, which may lead to increased risk of bleeding or haemorrhagic spots (bruising).
• Decrease in white blood cell count, which may cause susceptibility to infections.
• Weakening of certain reflexes, sometimes sensory disturbances.
• Hair loss, usually mild.
• Fatigue.
• Fever.
• General malaise.
• Weight loss, loss of appetite.

Common adverse reactions (may affect fewer than 1 in 10 patients)

• Difficulty with muscle coordination.
• Visual disturbances.
• Shallow breathing, cough.
• Difficulty urinating and other symptoms related to the genitourinary system.
• Difficulty falling asleep.
• Headache, dizziness, taste disturbances.
• Inflammation of the oesophagus, difficulty swallowing food or fluids.
• Skin reactions.
• Chills.
• Weight gain.
• Joint pain, jaw pain, muscle pain.
• Pain in various parts of the body and pain in the tumour area.
• High blood pressure.
• Liver function disorders (abnormal liver function tests).

Uncommon adverse reactions (may affect fewer than 1 in 100 patients)

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

Adverse reactions with unknown frequency (frequency cannot be determined from available data)

• Blood infection (septicaemia) with symptoms such as high fever and worsening of general health condition.
• Heart attack (myocardial infarction).
• Gastrointestinal bleeding.
• Low sodium concentration in the blood, leading to weakness, muscle twitching, fatigue, disorientation and loss of consciousness. Low sodium levels may 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 adverse reactions not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the 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 stated on the carton and blister after EXP.
The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C - 8°C).
Medicines should not be disposed of via wastewater or household waste. For safety reasons, any unused capsules should be returned to a 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 tartrate).
The other ingredients are:
Contents of the solution: macrogol, glycerol, anhydrous ethanol and purified water.
Capsule shell composition: gelatin, glycerol, liquid sorbitol, 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].
Printing ink composition: 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, free from surface defects, with a black imprint "JJ1", containing a clear, colourless liquid.
Vinorelbine Accord 30 mg: Pink, opaque, elongated (15 mm x 6.2 mm) soft gelatin capsule, free from surface defects, with a black imprint "JJ2", containing a clear, colourless liquid.
Vinorelbine Accord 80 mg: Pale yellow, opaque, elongated (20.5 mm x 8 mm) soft gelatin capsule, free from surface defects, with a black imprint "JJ3", containing a clear, colourless liquid.
Vinorelbine Accord is available in blister packs containing 1, 2, 3 or 4 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer
Accord Healthcare Polska Sp. z o.o.
Lutomierska Street 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
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
32009, Lamia, Schimatari, Greece

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

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