Vinorelbine medac

Package Leaflet: Information for the User

Vinorelbine medac, 20 mg, soft capsules

Vinorelbine medac, 30 mg, soft capsules

Vinorelbine medac, 80 mg, soft capsules

Vinorelbine tartrate

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

Contents of the pack and other information

• 1. What is Vinorelbine medac and what is it used for
• 2. Before you take Vinorelbine medac
• 3. How to take Vinorelbine medac
• 4. Possible side effects
• 5. How to store Vinorelbine medac
• 6. Contents of the pack and other information

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

Vinorelbine medac contains the active substance vinorelbine and belongs to a group of medicines called vinca alkaloids used in the treatment of cancer.
Vinorelbine medac is used to treat certain types of lung and breast cancer in patients over 18 years of age.

2. Before you take Vinorelbine medac

When not to take Vinorelbine medac:

• if you are allergic to vinorelbine or any other vinca alkaloid or any of the other ingredients of this medicine (listed in section 6);
• if you are breastfeeding;
• if you have had stomach or small intestine surgery, or have intestinal disorders;
• if you have a low white blood cell count and (or) platelet count or severe infection currently or recently (within the last 2 weeks);
• if you are going to receive or have recently received a yellow fever vaccine;
• if you require long-term oxygen therapy.

Warnings and precautions

Before taking Vinorelbine medac, discuss with your doctor or pharmacist if:

• you have had a heart attack or severe chest pain in the past;
• your ability to perform daily activities is significantly impaired;
• you have been treated with radiation therapy, and the treated area included the liver;
• you have symptoms of infection (such as fever, chills, cough);
• you are going to be vaccinated. During vinorelbine treatment, live attenuated vaccines (e.g. against measles, mumps, and rubella) are not recommended, as they may increase the risk of life-threatening post-vaccination disease;
• you have severe liver disease unrelated to the cancer you are suffering from;
• you are pregnant. Before starting treatment with Vinorelbine medac and during treatment, blood tests are performed to check if the treatment is safe for you. If the test results are unsatisfactory, treatment may be delayed and further tests will be performed until the parameters return to normal values.

Children and adolescents

This medicine should not be used in children under 18 years of age.

Vinorelbine medac and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Your doctor must be particularly careful if you are taking any of the following medicines:

• blood thinners (anticoagulants);
• anti-epileptic medicines (e.g. phenytoin);
• antifungal medicines (e.g. itraconazole);
• anticancer medicines, such as mitomycin C or lapatinib;
• medicines that affect the immune system, such as cyclosporine and tacrolimus.

Taking Vinorelbine medac and other medicines with known toxic effects on the bone marrow (affecting white blood cells, red blood cells, and platelets) may also increase the risk of certain side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or think you may be pregnant, or if you are planning to have a baby, ask your doctor for advice before taking this medicine, as there may be a risk to the baby. If you are taking Vinorelbine medac, you should not breastfeed.
Women of childbearing age must use effective contraception during treatment and for at least 7 months after the end of treatment.
Men should avoid fathering a child during treatment with Vinorelbine medac and for at least 4 months after taking the last capsule. Treatment with Vinorelbine medac may affect fertility in men, so before starting treatment, men should seek advice on sperm storage.

Driving and using machines

No studies have been conducted on the effects of this medicine on the ability to drive and use machines, but based on the pharmacodynamic profile of vinorelbine, it is unlikely to affect the ability to drive and use machines.
However, in all cases, do not drive or operate machinery if you feel unwell or if your doctor advises against it.

Vinorelbine 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.

Vinorelbine medac contains ethanol

This medicine contains 5 mg of alcohol (ethanol) per 20 mg soft capsule, which is equivalent to 2.85%.
The amount of alcohol 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) per 30 mg soft capsule, which is equivalent to 2.85%. The amount of alcohol 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) per 80 mg soft capsule, which is equivalent to 2.85%. The amount of alcohol 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 have a noticeable effect.

3. How to take Vinorelbine medac

Before and during treatment with Vinorelbine medac, your doctor will perform blood tests to check your blood cell count. Your doctor will determine the number and strength of capsules, how often to take them, and how long the treatment should last based on your body surface area, blood test results, and overall health.

The total weekly dose should never exceed 160 mg.

Vinorelbine medac should never be taken more than once a week.

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Before opening the blisters with Vinorelbine medac, check that the capsules are not damaged, as the liquid contents of the capsules are irritating and may cause damage to the skin, eyes, or mucous membranes if they come into contact with them. If this happens, rinse the affected area immediately.
Do not swallow damaged capsules, but return them to your doctor or pharmacist.
Opening the "peel-push" blister:

• 1. Cut the blister with scissors along the black dashed line.
• 2. Tear off the soft plastic foil.
• 3. Push the capsule through the aluminum foil.

Taking Vinorelbine medac:

• The Vinorelbine medac capsule should be swallowed whole with water, preferably with a light meal. The capsule should not be taken with hot drinks, as this will cause the capsule to dissolve too quickly.
• Do not chew or suck the capsules.
• If you accidentally chew or suck a capsule, rinse your mouth thoroughly and tell your doctor immediately.
• If you vomit within a few hours of taking Vinorelbine medac, contact your doctor immediately. Do not take a repeat dose.

Using anti-emetic medicines

During treatment with Vinorelbine medac, nausea and vomiting may occur (see section 4 "Possible side effects"). If your doctor prescribes an anti-emetic medicine, always take it as directed by your doctor.
Vinorelbine medac should be taken with a light meal to help reduce the feeling of nausea.

Taking a higher dose of Vinorelbine medac than prescribed

If you take a higher dose of Vinorelbine medac than prescribed, contact your doctor immediately.
Severe symptoms related to changes in blood morphology and symptoms of infection (such as fever, chills, cough) may occur. Severe constipation may also occur.

Missing a dose of Vinorelbine medac

Do not take a double dose to make up for a missed dose. Contact your doctor, who will decide when to take the next dose.

Stopping treatment with Vinorelbine medac

Your doctor will decide when you should stop treatment. However, if you want to stop treatment early, discuss other options with your doctor.
If you have any further questions about taking 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.

Seek medical attention immediately if you experience any of the following side effects while taking Vinorelbine medac:

• symptoms of infection, such as cough, fever, and chills;
• severe constipation with abdominal pain and no bowel movements for several days;
• severe dizziness, feeling of fainting when standing up, symptoms of significantly decreased blood pressure;
• severe chest pain, which usually does not occur in the patient, which may be a sign of heart problems related to insufficient blood flow, called a heart attack (sometimes leading to death);
• difficulty breathing, dizziness, low blood pressure, rash covering the whole body, or swelling of the eyelids, face, lips, or throat, which may be symptoms 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, which may lead to confusion and coma, seizures, blurred vision, and high blood pressure, which may be symptoms of a neurological disorder, such as posterior reversible encephalopathy syndrome.

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

• infections in various locations;
• stomach disorders; diarrhea; constipation, abdominal pain; nausea, vomiting;
• mouth inflammation;
• decreased red blood cell count, which may cause pale skin and weakness or shortness of breath;
• decreased platelet count, which may increase the risk of bleeding or bruising;
• decreased white blood cell count, which may cause susceptibility to infections;
• weakness of some reflexes, sometimes sensory disturbances;
• hair loss, usually mild;
• fatigue;
• fever;
• malaise;
• weight loss, loss of appetite.

Common(may affect up to 1 in 10 people)

• difficulty with muscle coordination;
• vision disturbances;
• shortness of breath, cough;
• urinary disorders, other symptoms related to the genitourinary system;
• sleep disorders;
• headache; dizziness; altered sense of taste;
• esophagitis, difficulty swallowing solid or liquid foods;
• skin reactions;
• chills;
• weight gain;
• joint pain, jaw pain, muscle pain;
• pain in various parts of the body and pain in the tumor area;
• high blood pressure;
• liver disorders (abnormal liver function test values).

Uncommon(may affect up to 1 in 100 people)

• heart failure, which may cause shortness of breath and swelling in the ankles, irregular heartbeat;
• loss of muscle control may be related to gait disturbances, speech disturbances, and eye movement disturbances (ataxia).

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

• blood infections (sepsis) with symptoms such as high fever and worsening of general health;
• heart attack (myocardial infarction);
• gastrointestinal bleeding;
• low sodium levels in the blood, which may cause weakness, muscle tremors, fatigue, confusion, and loss of consciousness. This low sodium level may in some cases be related to excessive production of the antidiuretic hormone (Syndrome of Inappropriate Antidiuretic Hormone Secretion, SIADH).

Reporting side effects:

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, PL-02-222 Warsaw, phone: +48 22 49-21-301, fax: + 48 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vinorelbine medac

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 carton after:
Expiry date (EXP). The expiry date refers to the last day of the month stated.
Store in a refrigerator (2°C – 8°C) in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. For safety reasons, any unused capsules should be returned to your doctor or pharmacist for destruction. This will help protect the environment.

6. Contents of the pack and other information

What Vinorelbine medac contains

The active substance of Vinorelbine medac is vinorelbine (in the form of vinorelbine tartrate) in a quantity of 20 mg, 30 mg, or 80 mg.
The other ingredients are:
Capsule contents: anhydrous ethanol, purified water, glycerol, macrogol 400
Capsule shell: gelatin, glycerol, liquid sorbitol, partially dehydrated, titanium dioxide (E171),
purified water
Vinorelbine medac 20 mg and 80 mg, soft capsules - yellow iron oxide (E172).
Vinorelbine medac 30 mg, soft capsules - red iron oxide (E172).
Other ingredients: ink for printing (shellac, black iron oxide (E172), propylene glycol), medium-chain triglycerides.

What Vinorelbine medac looks like and contents of the pack

20 mg soft capsule: oval, light brown soft capsule, 9.0 mm x 7.0 mm in size, with black ink printing "20".
30 mg soft capsule: elongated, pink soft capsule, 15.0 mm x 6.0 mm in size, with black ink printing "30".
80 mg soft capsule: elongated, pale yellow soft capsule, 20.0 mm x 8.0 mm in size, with black ink printing "80".
Vinorelbine medac 20 mg soft capsules:
packaging containing 1 blister with 1 soft capsule.
packaging containing 4 blisters with 1 soft capsule each.
Vinorelbine medac 30 mg soft capsules:
packaging containing 1 blister with 1 soft capsule.
packaging containing 4 blisters with 1 soft capsule each.
Vinorelbine medac 80 mg soft capsules:
packaging 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
Phone:
+48 22 43000-30
Fax:
+48 22 43000-31
e-mail: kontakt@medac.pl

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic, Finland, Malta, Poland, Slovakia, Sweden: Vinorelbine medac
Denmark, Norway, Germany: Vinorelbin medac
France: VINORELBINE MEDAC
Spain, Italy: Vinorelbina medac
Portugal: Vinorrelbina medac

Date of last revision of the leaflet: