Vinorelbine Accord Healthcare
Italy
Table of Contents
Package leaflet: Information for the user
Vinorelbine Accord Healthcare 20 mg soft capsules, 30 mg soft capsules, 80 mg soft capsules
Equivalent medicinal product
Please read this leaflet carefully before using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
- If you experience any side effects, including any not listed in this leaflet, talk to your doctor, nurse or pharmacist. See section 4.
Contents of this leaflet:
- What Vinorelbine Accord Healthcare is and what it is used for
- What you need to know before taking Vinorelbine Accord Healthcare
- How to take Vinorelbine Accord Healthcare
- Possible side effects
- How to store Vinorelbine Accord Healthcare
- Contents of the pack and other information
1. What Vinorelbina Accord Healthcare is and what it is used for
Vinorelbina Accord Healthcare contains the active substance vinorelbine and belongs to a family of
medicines called vinca alkaloids, used to treat cancers.
Vinorelbina Accord Healthcare 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 taking Vinorelbina Accord Healthcare
Do not take Vinorelbina Accord Healthcare
- if you are allergic to vinorelbine or to any other medicine belonging to the family of anticancer drugs called vinca alkaloids, or to any of the other ingredients of this medicine (listed in section 6);
- if you are breastfeeding;
- if you have had surgery on your stomach or small intestine, or if you suffer from an intestinal disorder that affects how you absorb food. These conditions may affect how your body absorbs Vinorelbina Accord Healthcare;
- if you have a low white blood cell count (neutrophils, leucocytes) or if you currently have or have recently had a severe infection within the last two weeks;
- if your platelet count in the blood is low (thrombocytopenia);
- if you are planning to receive or have recently received a yellow fever vaccination;
- if you require long-term oxygen therapy.
Warnings and precautions
Talk to your doctor or pharmacist before taking Vinorelbina Accord Healthcare if:
you have a history of heart attack or severe chest pain;
your ability to perform daily activities is significantly reduced;
you have liver problems or have received radiotherapy where the treatment field included the liver;
you have signs or symptoms of infection (such as fever, chills, joint pain, cough);
you need to receive a vaccination. Many vaccines (live attenuated vaccines) are not recommended during treatment;
you have severe liver disease unrelated to cancer;
you are pregnant.
Before and during treatment with Vinorelbina Accord Healthcare, your blood cell counts will be monitored to ensure that you can receive the treatment. If the results of these tests are not satisfactory, treatment may be delayed and further monitoring may be required until these values return to normal.
Children and adolescents
The use of this medicine is not recommended in children under 18 years of age.
Other medicines and Vinorelbina Accord Healthcare
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Your doctor must pay special attention if you are taking the following medicines:
medicines used to thin the blood (anticoagulants);
an antiepileptic drug called phenytoin;
antifungal medicines such as itraconazole and ketoconazole;
anticancer drugs such as mitomycin C or lapatinib;
medicines that suppress the immune system, such as cyclosporine and tacrolimus;
an antituberculosis drug called rifampicin.
The combination of Vinorelbina Accord Healthcare with other medicines known to have bone marrow toxicity (affecting white and red blood cells and platelets) may also worsen certain side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, or are planning a pregnancy, consult your doctor before using this medicine, as there are potential risks to the unborn child. You must not take Vinorelbina Accord Healthcare if you are pregnant. You must not breastfeed while taking Vinorelbina Accord Healthcare.
Women who are potentially fertile must use an effective method of contraception (birth control) during treatment and for at least 7 months after treatment ends.
Men treated with Vinorelbina Accord Healthcare are advised not to father a child during treatment and for at least 4 months after taking the last capsule. You should discuss sperm preservation with your doctor before starting treatment with Vinorelbina Accord Healthcare, as male fertility may be affected.
Driving and using machines
No studies have been conducted on the ability to drive and use machines. However, as in all cases, you should not drive if you do not feel well or if your doctor has advised you not to drive.
Vinorelbina Accord Healthcare contains sorbitol, ethanol and sodium
Vinorelbina Accord Healthcare 20 mg contains 8.03 mg of sorbitol (as partially dehydrated liquid sorbitol) in each soft capsule.
Vinorelbina Accord Healthcare 30 mg contains 13.65 mg of sorbitol (as partially dehydrated liquid sorbitol) in each soft capsule.
Vinorelbina Accord Healthcare 80 mg contains 24.09 mg of sorbitol (as partially dehydrated liquid sorbitol) in each soft capsule.
Vinorelbina Accord Healthcare 20 mg contains 2.89 mg of alcohol in each soft capsule.
Vinorelbina Accord Healthcare 30 mg contains 4.35 mg of alcohol in each soft capsule.
Vinorelbina Accord Healthcare 80 mg contains 11.56 mg of alcohol in each soft capsule.
The amount of alcohol in each 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 produce significant effects.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.
3. How to take Vinorelbina Accord Healthcare
Before and during treatment with Vinorelbina Accord Healthcare, your doctor will perform blood cell counts to determine when to administer the treatment and which dose is suitable for you. Your doctor will tell you how many capsules to take and the appropriate dosage. This will depend on your body surface area, which your doctor will calculate based on your weight and height.
The usual weekly dose, taken as a single dose, is 60 mg/m² of body surface area for the first 3 doses. After the third dose, your doctor will decide whether to increase the dose to 80 mg/m² of body surface area. In any case, your doctor may adjust the dose of Vinorelbina Accord Healthcare.
If you are taking the capsules together with another medicine to treat your cancer/condition, your doctor will determine the appropriate dose for you.
The total dose must never exceed 160 mg per week.
Never take Vinorelbina Accord Healthcare more than once a week.
Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Before opening the blister pack containing Vinorelbina Accord Healthcare, ensure that there are no damaged capsules, as the liquid inside is an irritant and may be harmful if it comes into contact with the skin, eyes, or mucous membranes. If this occurs, wash the affected area immediately and thoroughly with water.
Do not ingest damaged capsules, but return them to your doctor or pharmacist.
Administration of Vinorelbina Accord Healthcare:
- Take Vinorelbina Accord Healthcare with some water, preferably with a light meal. It should not be taken with a hot drink, as this would dissolve the capsule too quickly.
- Do not chew or suck the capsules.
- If you accidentally chew or suck the capsule, rinse your mouth carefully with water and inform your doctor immediately.
- If you vomit within a few hours after taking Vinorelbina Accord Healthcare, contact your doctor immediately. Do not repeat the dose.
If you are taking an anti-nausea medicine
Nausea and vomiting may occur with Vinorelbina Accord Healthcare (see section “4. Possible side effects”). If your doctor has prescribed an anti-nausea medicine, take it exactly as directed.
Take Vinorelbina Accord Healthcare during a light meal; this will help reduce nausea.
If you take more Vinorelbina Accord Healthcare than you should
If you have taken more Vinorelbina Accord Healthcare than prescribed, contact your doctor immediately. Sometimes the body may react with severe symptoms. Some of these symptoms may present as signs of infection (such as fever, chills, cough, joint pain). You may also become severely constipated. If any of these serious symptoms occur, contact your doctor immediately.
If you forget to take Vinorelbina Accord Healthcare
Do not take a double dose to make up for the missed dose. Contact your doctor, who will decide on rescheduling the dose.
If you stop taking Vinorelbina Accord Healthcare
Your doctor will decide when you should stop treatment. However, if you wish to stop treatment earlier, you must discuss possible alternatives with your doctor.
If you have any questions about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if, while using Vinorelbina Accord Healthcare, you develop any of the following symptoms:
- signs of infection such as cough, fever, and chills;
- severe constipation with abdominal pain, when your bowel has not moved for several days;
- severe dizziness, feeling of emptiness in the head when standing up, signs of a severe drop in blood pressure;
- severe chest pain that is unusual for you; symptoms may be due to impaired heart function caused by insufficient blood flow, known as myocardial infarction (sometimes fatal);
- difficulty breathing, dizziness, low blood pressure, rash over 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 symptoms of a blood clot in a blood vessel in the lungs (pulmonary embolism);
- headache, altered mental state that may cause confusion and coma, seizures, blurred vision, and high blood pressure, which may indicate a neurological disorder such as reversible posterior encephalopathy syndrome.
Very common side effects (may affect more than 1 in 10 patients):
Infections in different parts of the body;
Gastrointestinal disorders; diarrhoea; constipation; abdominal pain; nausea; vomiting;
Inflammation of the mouth;
A reduction in red blood cells (anaemia), which may make the skin pale and cause weakness or breathlessness;
A reduction in platelets, which may increase the risk of bleeding or bruising;
A reduction in white blood cells, making you more susceptible to infections;
Loss of some reflexes, occasionally altered sensation to touch;
Hair loss, usually mild;
Tiredness;
Fever;
Malaise;
Weight loss, loss of appetite.
Common side effects (may affect up to 1 in 10 patients):
Disorders in coordinating muscle movement;
Visual disturbances;
Shortness of breath, cough;
Difficulty urinating, other genitourinary symptoms;
Difficulty sleeping;
Headache; dizziness; altered taste and flavour perception;
Inflammation of the throat, 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 at the tumour site;
High blood pressure;
Liver disorders (abnormal liver function tests).
Uncommon side effects (may affect up to 1 in 100 patients):
Heart failure, which may cause shortness of breath or swelling of the ankles, irregular heartbeat;
Lack of muscle control, which may be associated with abnormal walking, changes in speech, and eye movement abnormalities (ataxia).
Side effects with unknown frequency (cannot be estimated from the available data):
Blood infection (sepsis) with symptoms such as high fever and general deterioration in health;
Heart attack (myocardial infarction);
Gastrointestinal bleeding;
Low sodium levels in the blood causing weakness, muscle twitching, tiredness, confusion, or loss of consciousness. This decrease may in some cases be due to excessive production of a hormone causing fluid retention (syndrome of inappropriate antidiuretic hormone secretion, SIADH).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, nurse, or pharmacist. You can also report side effects directly via [appropriate national reporting system]. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Vinorelbina Accord Healthcare
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the carton (Exp.).
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Do not dispose of any medicine via wastewater or household waste. For safety reasons, unused capsules must be returned to your doctor or pharmacist for destruction. This will help protect the environment.
6. Contents of the pack and other information
What Vinorelbina Accord Healthcare 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:
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), yellow iron oxide (E 172) [only for 20 mg and 80 mg], red iron oxide (E 172) [only for 30 mg].
The printing edible ink contains: shellac (E 904), black iron oxide (E 172), ammonium hydroxide (E 527), and propylene glycol (E 1520).
Description of the appearance of Vinorelbina Accord Healthcare and contents of the pack
Vinorelbina Accord Healthcare 20 mg are light brown, opaque, oval soft gelatin capsules (9.3 mm x 6.7 mm), free from surface defects, marked with "JJ1" in black, containing a colourless transparent liquid.
Vinorelbina Accord Healthcare 30 mg are pink, opaque, oblong soft gelatin capsules (15 mm x 6.2 mm), free from surface defects, marked with "JJ2" in black, containing a colourless clear liquid.
Vinorelbina Accord Healthcare 80 mg are pale yellow, opaque, oblong soft gelatin capsules (20.5 mm x 8 mm), free from surface defects, marked with "JJ3" in black, containing a colourless clear liquid.
Vinorelbina Accord Healthcare is available in blister packs containing 1, 2, 3, or 4 soft capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
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
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
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,
Lamia, Schimatari,
32009, Greece