Vinorelbine Medac

Package leaflet: Information for the user

Vinorelbina medac 20 mg soft capsules, 30 mg soft capsules, 80 mg soft capsules

vinorelbine tartrate
Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Vinorelbina medac contains the active substance vinorelbine, which belongs to a family of medicines
used to treat cancer known as vinca alkaloids.
Vinorelbina medac 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 should know before taking Vinorelbina medac

Do not take Vinorelbina medac:

• if you are allergic to vinorelbine or to any of the antitumor medicines belonging to the vinca alkaloid family, or to any of the other ingredients of this medicine (listed in section 6)
• if you are breastfeeding
• if you have had surgery on the stomach or small intestine, or if you suffer from intestinal disorders
• if you have a low number of white blood cells and/or platelets, or if you currently have a serious infection or have recently had one (within the last 2 weeks)
• if you are planning to receive the yellow fever vaccine or have recently received it
• if you require long-term oxygen therapy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Vinorelbina medac if:

• you have a history of heart attack or severe chest pain
• your ability to carry out daily activities is significantly reduced
• you have undergone radiotherapy and the radiation field included the liver
• you have symptoms of an infection (such as fever, chills, cough)
• you are planning to receive a vaccination. Live attenuated vaccines (e.g. measles, mumps, rubella, etc.) are not recommended with vinorelbine, as they may increase the risk of potentially life-threatening vaccine-related disease
• you have severe liver disease unrelated to cancer
• you are pregnant. Blood cell counts will be performed before and during treatment with Vinorelbina medac to ensure that the treatment is safe for you. If the results of these tests are not satisfactory, treatment may be delayed and further monitoring may be carried out until these values return to normal.

Children and adolescents
Use in children under 18 years of age is not recommended.
Other medicines and Vinorelbina medac
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor should pay particular attention if you are taking any of the following medicines:

• medicines used to thin the blood (anticoagulants)
• antiepileptic medicines (e.g. phenytoin)
• antifungal medicines (e.g. itraconazole)
• anticancer medicines such as mitomycin C or lapatinib
• medicines that suppress the immune system, such as cyclosporine and tacrolimus

The combination of Vinorelbina medac with other medicines known to have bone marrow toxicity (with negative effects on white and red blood cells and platelets) may also worsen certain adverse effects.
Pregnancy, breastfeeding and fertility
Before starting treatment, you must inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, as there are potential risks to the unborn child. You must not breastfeed while taking Vinorelbina medac.
Women of childbearing age must use effective contraceptive measures during treatment and for at least 7 months after treatment.
Men treated with Vinorelbina medac are advised not to father a child during treatment and for at least 4 months after taking the last capsule, and to seek counseling regarding sperm preservation before treatment, as Vinorelbina medac may impair male fertility.
Driving and using machines
No studies have been conducted on the ability to drive vehicles or operate machinery; however, based on its pharmacodynamic profile, vinorelbine does not affect the ability to drive or use machinery.
Nevertheless, 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 medac contains sorbitol
Each soft capsule containing 20 mg of vinorelbine contains 10.54 mg of sorbitol.
Each soft capsule containing 30 mg of vinorelbine contains 15.96 mg of sorbitol.
Each soft capsule containing 80 mg of vinorelbine contains 29.35 mg of sorbitol.
Vinorelbina medac contains ethanol
This medicine contains 5 mg of alcohol (ethanol) in each 20 mg soft capsule, which is equivalent to 2.85%. The amount in 20 mg of this medicine is equivalent to less than 1 mL of beer or 1 mL of wine.
This medicine contains 7.5 mg of alcohol (ethanol) in each 30 mg soft capsule, which is equivalent to 2.85%. The amount in 30 mg of this medicine is equivalent to less than 1 mL of beer or 1 mL of wine.
This medicine contains 20 mg of alcohol (ethanol) in each 80 mg soft capsule, which is equivalent to 2.85%. The amount in 80 mg of this medicine 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.

3. How to take Vinorelbina medac

Before and during your treatment with Vinorelbina medac, your doctor will monitor your blood cell count. Your doctor will instruct you on the number of capsules to take, the dosage, how often to take them, and the duration of treatment based on your body surface area, blood test results, and your overall health condition.
The total dose must never exceed 160 mg per week.
Never take Vinorelbina medac more than once a week.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

Before opening the blister packs containing Vinorelbina medac, make sure that no capsules are damaged, as the liquid inside is irritating and may be harmful if it comes into contact with the skin, eyes, or mucous membranes. If this occurs, immediately and thoroughly wash the affected area.
Do not swallow any damaged capsules; return them to your doctor or pharmacist.

How to open the "peel and press" blister:

1. Using a pair of scissors, cut the blister along the black dotted line.
2. Peel back the soft plastic film.
3. Press on the aluminum foil to release the capsule.

How to take Vinorelbina medac:

• Swallow the Vinorelbina medac capsule whole with water, preferably with a light meal. Do not take the capsule with a hot drink, as this may cause it to dissolve too quickly.
• Do not chew or suck the capsules.
• If you accidentally chew or suck a capsule, rinse your mouth thoroughly with water and inform your doctor immediately.
• If you vomit within a few hours after taking Vinorelbina medac, contact your doctor immediately. Do not take another dose.

If you are taking an anti-nausea medicine
Nausea and vomiting may occur with Vinorelbina medac (see section “4. Possible side effects”). If your doctor has prescribed an anti-nausea medicine, always take it exactly as directed.
Take Vinorelbina medac during a light meal; this may help reduce nausea.

If you take more Vinorelbina medac than you should
If you have taken more Vinorelbina medac than prescribed, contact a doctor immediately.
Severe symptoms related to your blood cells may occur, and you may develop signs of infection (such as fever, chills, cough). You may also develop severe constipation.

If you forget to take Vinorelbina medac
Do not take a double dose to make up for the missed dose. Contact your doctor, who will decide whether and how to reschedule the dose.

If you stop taking Vinorelbina medac
Your doctor will decide when to stop treatment. However, if you wish to discontinue treatment early, you must discuss alternative options with your doctor.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if, while taking Vinorelbina medac,
you develop any of the following symptoms:

• Signs of infection such as cough, fever and chills
• Severe constipation with abdominal pain if you have not had a bowel movement for several days
• Severe dizziness, lightheadedness when standing up, indicating a significant drop in blood pressure
• Severe chest pain that is not usual for you; symptoms may be due to impaired heart function caused by reduced blood flow, a so-called myocardial infarction (sometimes fatal)
• Breathing difficulties, dizziness, low blood pressure, rash over the entire body or swelling of the eyelids, face, 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 status which may cause confusion and coma, seizures, blurred vision and high blood pressure, which may indicate a neurological condition such as reversible posterior encephalopathy syndrome

Very common (may affect more than 1 in 10 people)

• Infections in various sites
• Gastrointestinal disorders; diarrhoea; constipation, abdominal pain; nausea, vomiting
• Inflammation in the mouth
• Reduction in red blood cells which may make the skin pale and cause weakness or shortness of breath
• Reduction in platelets which may increase the risk of bleeding or bruising
• Reduction in white blood cells which increases susceptibility to infections
• Loss of certain reflex responses, occasionally altered sensation to touch
• Hair loss, usually mild
• Fatigue
• Fever
• Malaise
• Weight loss, loss of appetite

Common (may affect up to 1 in 10 people)

• Difficulty coordinating muscle movements
• Changes in vision
• Shortness of breath, cough
• Difficulty urinating, other genitourinary symptoms
• Difficulty sleeping
• Headache; dizziness; changes in taste perception
• Inflammation of the oesophagus, 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 (may affect up to 1 in 100 people)

• Heart failure which may cause shortness of breath and swelling of the ankles, irregular heartbeat
• Loss of muscle control may be associated with abnormal gait, speech disturbances and abnormalities in eye movements (ataxia)

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

• Blood infections (sepsis) with symptoms such as high fever and worsening general health
• Heart attack (myocardial infarction)
• Gastrointestinal bleeding
• Low sodium levels in the blood leading to weakness, muscle cramps, fatigue, confusion and loss of consciousness. This low sodium level 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 or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Vinorelbine medac soft capsule

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 on the carton after
"Exp.". The expiry date refers to the last day of that month.
Store in the refrigerator (2°C – 8°C) in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. For safety reasons, any unused
capsules should be returned to your doctor or pharmacist. This will help protect the environment.

6. Package contents and other information

What Vinorelbina medac contains
The active substance is vinorelbine (as tartrate) 20 mg, 30 mg or 80 mg
The other components are:
Capsule contents:
anhydrous ethanol
purified water
glycerol
macrogol 400
Capsule shell:
gelatin
glycerol
partially dehydrated liquid sorbitol
titanium dioxide (E171)
purified water
Vinorelbina medac 20 mg and 80 mg soft capsules – yellow iron oxide (E172)
Vinorelbina medac 30 mg soft capsules – red iron oxide (E172)
Other ingredients:
printing ink (non-volatile component – shellac glaze, black iron oxide (E172), propylene glycol)
medium-chain triglycerides

Description of the appearance of Vinorelbina medac and package contents
20 mg soft capsule: light brown, oval-shaped soft capsule, size 9.0 mm x 7.0 mm, with "20" printed in black on the surface
30 mg soft capsule: pink, oblong-shaped soft capsule, size 15.0 mm x 6.0 mm, with "30" printed in black on the surface
80 mg soft capsule: pale yellow, oblong-shaped soft capsule, size 20.0 mm x 8.0 mm, with "80" printed in black on the surface

Vinorelbina medac 20 mg soft capsules: Pack containing 1 blister with 1 soft capsule.
Pack containing 4 blisters, each with 1 soft capsule
Vinorelbina medac 30 mg soft capsules: Pack containing 1 blister with 1 soft capsule.
Pack containing 4 blisters, each with 1 soft capsule
Vinorelbina medac 80 mg soft capsules: Pack containing 1 blister with 1 soft capsule.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark, Germany, Norway: Vinorelbin medac
Finland, Malta, Poland, Czech Republic, Slovakia, Sweden: Vinorelbine medac
France: VINORELBINE MEDAC
Italy, Spain: Vinorelbina medac
Portugal: Vinorrelbina medac