Vinorelbine Medac 30 mg soft capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vinorelbina medac 20 mg soft capsules EFG

Vinorelbina medac 30 mg soft capsules EFG

vinorelbine tartrate

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 others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if the side effects are not listed in this leaflet. 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, and belongs to a family of medicines known as vinca alkaloids, which are used for the treatment of cancer.

Vinorelbine 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 medac

Do not take Vinorelbina medac:

• if you are allergic to vinorelbine, or to any of the anticancer medicines belonging to the family known as vinca alkaloids, or to any of the other ingredients of this medicine (listed in section 6)
• if you are breastfeeding
• if you have undergone stomach or small intestine surgery, or if you have intestinal disorders
• if you have a low white blood cell and/or platelet count, or a severe current or recent infection (within the previous 2 weeks)
• if you are scheduled to receive or have recently received the yellow fever vaccine
• if you require long-term oxygen therapy

Warnings and precautions

Talk to your doctor or pharmacist before starting Vinorelbina medac:

• if you have a history of heart attack or severe chest pain
• if your ability to perform daily activities is severely reduced
• if you have received radiotherapy that included the liver in the treatment field
• if you have symptoms of infection (such as fever, chills, cough)
• if you plan to be vaccinated. Administration of live attenuated virus vaccines (e.g., measles, mumps, rubella...) is not recommended during vinorelbine treatment, as they may increase the risk of potentially fatal vaccine-related disease.
• if you have severe liver disease unrelated to your cancer
• if you are pregnant.

Blood counts are performed before and during treatment with Vinorelbina medac to ensure that treatment is safe for you. If the results of these tests are unsatisfactory, your treatment may be delayed and additional monitoring performed 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 need to take any other medicines.

Your doctor should exercise special caution if you are taking 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 (affecting red blood cells, white blood cells, and platelets) could also worsen certain adverse effects.

Pregnancy, breastfeeding, and fertility

Before starting treatment, you must inform your doctor if you are pregnant, think you might be pregnant, or intend to become pregnant, as there are potential risks to the unborn child. You must not breastfeed while taking Vinorelbina medac.

Women of childbearing potential must use effective contraceptive methods during treatment and for at least 7 months after completion of 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 should seek advice on sperm preservation before treatment, as Vinorelbina medac may impair male fertility.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines; however, based on its pharmacodynamic profile, vinorelbine does not affect the ability to drive or operate 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.

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.

Vinorelbina medac contains ethanol

This medicine contains 5 mg of alcohol (ethanol) in each 20 mg soft capsule, 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, 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.

The small amount of alcohol contained in this medicine does not produce any perceptible effect.

3. How to take Vinorelbina medac

Before and during treatment with vinorelbine, your doctor will monitor your blood cell count. Your doctor will tell you how many capsules to take, the dose, how often to take the capsules, and for how long treatment should continue, based on your body surface area, blood test results, and your overall condition.

The total dose must never exceed 160 mg per week.

You must never take Vinorelbina medac more than once a week.

Always follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Before opening the Vinorelbina medac blister packs, check that no capsule is 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 capsule; return them to your doctor or pharmacist.

To open the "peel-and-press" type blister:

1. Cut the blister along the dotted black line with scissors.
2. Peel back the soft plastic film.
3. Press the capsule through the aluminum foil.

To take Vinorelbina medac:

• Swallow the vinorelbine capsule whole with water, preferably with a light meal. Do not take it with hot drinks, as the capsule would dissolve too quickly.
• Do not chew or suck the capsules.
• If you accidentally chew or suck a capsule, rinse your mouth thoroughly and immediately inform your doctor.
• If you vomit within a few hours of taking this medicine, contact your doctor immediately. Do not repeat the dose.

If you are taking an anti-nausea medicine

Nausea and vomiting may occur with vinorelbine (see section 4, "Possible side effects"). If your doctor has prescribed an anti-nausea medicine, always take it exactly as directed by your doctor.

Take this medicine with a light meal; this will help reduce nausea.

If you take more Vinorelbina medac than you should

If you have taken more medicine than you should, contact your doctor immediately.

Severe symptoms related to blood components may occur, and you may show signs of infection (such as fever, chills, cough). You may also experience severe constipation.

In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service at telephone number 91 562 0420, indicating the medicine and the amount ingested.

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 whether to reschedule your dose.

If you stop taking Vinorelbina medac

Your doctor will decide when to stop treatment. However, if you wish to discontinue treatment earlier, you should discuss alternative options with your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

While you are taking Vinorelbina medac, contact your doctor immediately if you develop any of the following symptoms:

• Signs of infection, such as cough, fever, and chills
• Severe constipation with abdominal pain after several days without bowel movements
• Severe dizziness, lightheadedness upon standing, indicating 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 with fatal outcome)
• Difficulty breathing, dizziness, low blood pressure, rash over the body, or swelling of the eyelids, face, lips, or throat, which may indicate an allergic reaction
• Chest pain, difficulty breathing, and fainting, which may be symptoms of a blood clot in a vessel in the lungs (pulmonary embolism)
• Headaches, changes in mental status that may lead to confusion and coma, seizures, blurred vision, and high blood pressure, which could indicate a neurological disorder such as reversible posterior encephalopathy syndrome

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

• Infections at various sites
• Gastrointestinal disorders; diarrhea; constipation; abdominal pain; nausea, vomiting
• Inflammation of the mouth
• A decrease in red blood cells that may cause paleness, weakness, or shortness of breath
• A decrease in platelets that may increase the risk of bleeding or bruising
• A decrease in white blood cells that may make you more susceptible to infections
• Loss of certain reflexes; 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
• Visual disturbances
• Shortness of breath, cough
• Difficulty urinating; other genitourinary disorders
• Difficulty sleeping
• Headache, dizziness; altered 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 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 may cause shortness of breath and swelling of the ankles; irregular heartbeat
• Loss of muscle control may be associated with abnormal gait, changes in speech, and abnormalities in eye movements (ataxia)

Frequency not known: cannot be estimated from available data

• Blood infections (sepsis), with symptoms such as high fever and deterioration in general health
• Heart attack (myocardial infarction)
• Gastrointestinal bleeding
• Low sodium levels in the blood, causing weakness, muscle spasms, 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 adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vinorelbina 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 “EXP/CAD”. The expiry date refers to the last day of the month indicated.

Store in the refrigerator (between 2 °C and 8 °C) in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. For safety reasons, any 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

Composition of Vinorelbine medac

The active substance is vinorelbine (as tartrate) 20 mg or 30 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

Vinorelbine medac 20 mg soft capsules – yellow iron oxide (E172)
Vinorelbine medac 30 mg soft capsules – red iron oxide (E172)

Other components:

printing ink (non-volatile component – shellac glaze, black iron oxide (E172), propylene glycol)
medium-chain triglycerides

Nature of the product and contents of the container

20 mg soft capsule: Light brown, oval-shaped soft capsule measuring 9.0 mm x 7.0 mm, printed with "20" in black on the surface.

30 mg soft capsule: Pink, oblong soft capsule measuring 15.0 mm x 6.0 mm, printed with "30" in black on the surface.

Vinorelbine medac 20 mg soft capsules: Pack containing 1 blister with 1 soft capsule.
Pack containing 4 blisters, each with 1 soft capsule.

Vinorelbine medac 30 mg soft capsules: Pack containing 1 blister with 1 soft capsule.
Pack containing 4 blisters, each with 1 soft capsule.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Tel.: +49 4103 8006-0
Fax: +49 4103 8006-100

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Laboratorios Gebro Pharma, S.A.
Avenida Tibidabo n° 29
08022 Barcelona
Spain
Tel. +34 93 205 86 86

Manufacturer responsible for batch release

medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany, Denmark, Norway: Vinorelbin medac
Slovakia, Finland, Malta, Poland, Czech Republic, Sweden: Vinorelbine medac
Spain: Vinorelbina medac 20 mg/30 mg soft capsules EFG
France: VINORELBINE MEDAC
Italy: Vinorelbina medac
Portugal: Vinorrelbina medac

Date of the most recent review of this leaflet: 05/2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)