VINORELBINA 20 mg Soft Capsules

Зміст інструкції

1. Vinorelbina medac 20 mg soft capsules, 30 mg soft capsules, 80 mg soft capsules
   1. What is Vinorelbina medac and what is it used for
   2. What you need to know before you take Vinorelbina medac
   3. How to take Vinorelbina medac
   4. Possible side effects
   5. How to store Vinorelbina medac soft capsules
   6. Package contents and other information

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

vinorelbine tartrate

Generic medicine

Read 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 others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 is Vinorelbina medac and what is it used for

Vinorelbina medac contains the active ingredient vinorelbine, which belongs to a family of medicines
used for the treatment of cancer known as vinca alkaloids.
Vinorelbina medac is used to treat some types of lung cancer and some types of breast cancer in patients over 18 years of age.

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

Do not take Vinorelbina medac:

• if you are allergic to vinorelbine or to any of the anti-cancer 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 undergone 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 had one recently (within the last 2 weeks)
• if you are planning to have the yellow fever vaccine or if you have just had 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 perform daily activities is severely reduced
• you have been treated with radiotherapy and the irradiation field included the liver
• you have symptoms of an infection (such as fever, chills, cough)
• you are planning to have a vaccination. Live attenuated vaccines (e.g. measles, mumps, rubella vaccine, etc.) are not recommended with vinorelbine as they may increase the risk of vaccine-related illness, which could be life-threatening
• you have a serious liver disease not related to cancer
• you are pregnant. Blood cell counts will be performed before and during treatment with Vinorelbina medac to verify that the treatment is safe for you. If the results of these tests are not satisfactory, treatment may be postponed and further checks 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Your doctor will need to pay particular attention if you are taking any of the following medicines:

• medicines used to thin the blood (anticoagulants)
• anti-epileptic medicines (e.g. phenytoin)
• antifungals (e.g. itraconazole)
• anti-cancer 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 with known toxicity to the bone marrow (with
a negative effect on white blood cells and red blood cells and platelets) may also worsen some side
effects.

Pregnancy, breastfeeding and fertility
Before starting treatment, you must inform your doctor if you are pregnant, or if you suspect or
are planning a pregnancy as there are potential risks to the baby. You must not breastfeed if
you are taking Vinorelbina medac.
Women of childbearing potential must use effective contraceptive measures (contraception) 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 advice on
sperm preservation before treatment because Vinorelbina medac may impair
male fertility.

Driving and using machines
No studies have been conducted on the ability to drive vehicles and operate machinery, but based on
the pharmacodynamic profile, vinorelbine does not impair the ability to drive and operate machinery.
However, as with 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 check your blood cell count.
Your doctor will tell you the number and dosage of capsules you should take, the frequency
of administration and the duration of treatment based on your body surface area, the results
of your blood tests and your general health conditions.

The total dose should never exceed 160 mg per week.
Never take Vinorelbina medac more than once a week.
Take this medicine exactly as your doctor or pharmacist has instructed. If you have
any doubts, consult your doctor or pharmacist.
Before opening the blisters containing Vinorelbina medac, make sure there are no damaged
capsules as the liquid contained inside is irritating and may be harmful if it comes into contact with the skin, eyes
or mucous membranes. If this should happen, wash the affected area immediately and thoroughly.

Do not ingest 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 dashed line.
• 2. Peel off the soft plastic film.
• 3. Press on the aluminum film to push out 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 to avoid it dissolving too quickly.
• Do not chew or suck on the capsules.
• If you accidentally chew or suck on a capsule, rinse your mouth thoroughly with water and inform your doctor immediately.
• If you vomit within a few hours of taking Vinorelbina medac, contact your doctor immediately. Do not take the dose again.

If you are taking medicine against nausea
Vomiting may occur with Vinorelbina medac (see section “4. Possible side effects”). If
your doctor has prescribed you medication against nausea, always take it exactly as directed by
your doctor.
Take Vinorelbina medac during a light meal; this will help reduce nausea.

If you take more Vinorelbina medac than you should
If you have taken more Vinorelbina medac than you should, contact a doctor immediately.
Serious symptoms related to your blood components 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 a missed dose. Contact your doctor who
will decide on rescheduling the dose.

If you stop taking Vinorelbina medac
Your doctor will decide when you should stop treatment. However, if you wish to stop the
treatment early, you should discuss other options with your doctor.
If you have any questions about using 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.

Contact your doctor immediately if you develop any of the following symptoms while taking Vinorelbina medac:

• 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, feeling faint when standing up, a sign of a significant drop in blood pressure
• Severe chest pain that is not normal for you; the symptoms may be due to a change in heart function due to insufficient blood flow, a so-called myocardial infarction (sometimes fatal)
• Difficulty breathing, dizziness, low blood pressure, rash all over the body or swelling of 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 the lungs (pulmonary embolism)
• Headache, altered mental status that can cause confusion and coma, seizures, blurred vision and high blood pressure, which may be a sign of a neurological condition such as reversible posterior encephalopathy syndrome

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

• Infections in various locations
• Stomach problems; diarrhea; constipation, abdominal pain; nausea, vomiting
• Inflammation in the mouth
• Reduction in red blood cells which can make the skin pale and cause weakness or shortness of breath
• Reduction in platelets which can increase the risk of bleeding or bruising
• Reduction in white blood cells which increases vulnerability to infections
• Loss of some reflex reactions, occasionally different perception of 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 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 at the tumor site
• High blood pressure
• Liver disorders (abnormal liver function tests).

Uncommon(may affect up to 1 in 100 people)

• Heart failure which can cause shortness of breath and swelling of the ankles, irregular heartbeat
• Lack of muscle control may be associated with abnormal gait, speech alterations and abnormalities in eye movement (ataxia).

Not known: frequency cannot be estimated from available data

• Blood infections (sepsis) with symptoms such as high fever and deterioration of general health
• Heart attack (myocardial infarction)
• Gastrointestinal bleeding
• Low level of sodium in the blood leading to weakness, muscle cramps, fatigue, confusion and loss of consciousness. This low level of sodium may be attributed in some cases to the overproduction of a hormone that causes fluid retention (syndrome of inappropriate antidiuretic hormone secretion - SIADH).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Vinorelbina medac soft capsules

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

6. Package contents and other information

What Vinorelbina medac contains
The active ingredient is vinorelbine (as tartrate) 20 mg, 30 mg or 80 mg
The other ingredients are:
Capsule content:
anhydrous ethanol
purified water
glycerol
macrogol 400
Capsule shell:
gelatin
glycerol
partially dehydrated sorbitol liquid
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, 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, measuring
9.0 mm x 7.0 mm with “20” printed in black on the surface
30 mg soft capsule: pink, oblong-shaped soft capsule, measuring
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, measuring
20.0 mm x 8.0 mm with “80” printed in black on the surface.
Vinorelbina medac 20 mg soft capsules: Pack of 1 blister with 1 soft capsule.
Pack of 4 blisters containing 1 soft capsule
each
Vinorelbina medac 30 mg soft capsules: Pack of 1 blister with 1 soft capsule.
Pack of 4 blisters containing 1 soft capsule
each
Vinorelbina medac 80 mg soft capsules: Pack of 1 blister with 1 soft capsule.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Denmark, Germany, Norway: Vinorelbin medac
Finland, Malta, Poland, Czech Republic, Slovakia, Sweden: Vinorelbine medac
France: VINORELBINE MEDAC
Italy, Spain: Vinorelbina medac
Portugal: Vinorrelbina medac