Leaflet: information for the user

Vinorelbina medac 20mg soft capsules EFG

Vinorelbina medac 30mg soft capsules EFG

Vinorelbina medac 80mg soft capsules EFG

vinorelbine tartrate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

1. What isVinorelbina medacand what it is used for

2. What you need to know before starting to takeVinorelbina medac

3. How to takeVinorelbina medac

4. Possible side effects

5. Storage ofVinorelbina medac

6. Contents of the pack and additional information

Vinorelbina medaccontains the active ingredient vinorelbina, and belongs to the family of drugs known as vinca alkaloids, which are used for cancer treatment.

Vinorelbina is used to treat some types of lung cancer and some types of breast cancer in patients over 18 years of age.

Do not take Vinorelbina medac:

• if you are allergic to vinorelbina, or to any of the oncological medications of the family called vinca alkaloids, or to any of the other components of this medication (listed in section6)
• 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 ongoing or recent infection (within the 2weeks prior)
• if you are planning to be vaccinated or have recently been vaccinated against yellow fever
• if you require long-term oxygen treatment

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vinorelbina medac:

• if you have a history of heart attack or intense chest pain
• if your ability to carry out daily activities is severely reduced
• if you have received radiation therapy whose field of treatment included the liver
• if you have symptoms of infection (such as fever, chills, cough)
• if you plan to be vaccinated. The administration of live attenuated virus vaccines (e.g., measles, mumps, rubella...) with vinorelbina is not recommended, as they may increase the risk of potentially fatal vaccine-related disease.
• if you have severe non-cancer-related liver disease
• if you are pregnant.

Before and during treatment with Vinorelbina medac, blood counts are performed to verify that receiving the treatment is safe for you. If the results of these analyses are not satisfactory, your treatment may be delayed and additional checks may be performed until those values return to normal.

Children and adolescents

Use in children under 18years is not recommended.

Other medications and Vinorelbina medac

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Your doctor should exercise special caution if you are taking the following medications:

• blood-thinning medications (anticoagulants)
• antiepileptic medications (e.g., phenytoin)
• antifungal medications (e.g., itraconazole)
• anticancer medications such as mitomycinC or lapatinib
• immunosuppressive medications, such as cyclosporine and tacrolimus

The combination of Vinorelbina medac with other medications known to have bone marrow toxicity (affecting red and white blood cells and platelets) may worsen certain adverse effects.

Pregnancy, breastfeeding, and fertility

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

Women of childbearing age should use effective contraceptive methods during treatment and for at least 7months after completing treatment.

Males treated with Vinorelbina medac are advised not to father a child during treatment and for at least 4months after taking the last capsule, and to seek advice on sperm conservation before treatment, as Vinorelbina medac may affect male fertility.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery, but based on its pharmacodynamic profile, vinorelbina does not affect the ability to drive and operate machinery.

However, as in all cases, do 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 20mg of vinorelbina contains 10.54mg of sorbitol.

Each soft capsule containing 30mg of vinorelbina contains 15.96mg of sorbitol.

Each soft capsule containing 80mg of vinorelbina contains 29.35mg of sorbitol.

Vinorelbina medac contains ethanol

This medication contains 5mg of alcohol (ethanol) in each soft capsule of 20 mg, equivalent to 2.85%. The amount in 20mg of this medication is equivalent to less than 1ml of beer or 1ml of wine.

This medication contains 7.5mg of alcohol (ethanol) in each soft capsule of 30 mg, equivalent to 2.85%. The amount in 30mg of this medication is equivalent to less than 1ml of beer or 1ml of wine.

This medication contains 20mg of alcohol (ethanol) in each soft capsule of 80 mg, equivalent to 2.85%. The amount in 80mg of this medication is equivalent to less than 1ml of beer or 1ml of wine.

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

Before and during vinorelbina treatment, your doctor will monitor your blood cell count.Your doctor will tell you how many capsules to take, how often to take them, and for how long you should be treated, depending on your body surface area, blood test results, and overall health.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before opening the Vinorelbina medac blister pack, check that there are no damaged capsules, as the liquid inside is irritating and can be harmful if it comes into contact with the skin, eyes, or mucous membranes. If this occurs, wash the affected area immediately and thoroughly.

Do not swallow any damaged capsules; return them to your doctor or pharmacist.

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

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

To take Vinorelbina medac:

• Swallow the vinorelbina capsule whole with water, preferably with a light meal. Do not take it with hot beverages, as the capsule may dissolve too quickly.
• Do not chew or suck on the capsules.
• If you accidentally chew or suck on a capsule, rinse your mouth thoroughly and inform your doctor immediately.
• If you vomit a few hours after taking this medication, contact your doctor immediately.Do not repeat the dose.

If you are taking an anti-nausea medication:

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

Take this medication during a light meal; this will help reduce nausea.

If you take more Vinorelbina medac than you should:

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

You may experience severe symptoms related to blood components, 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, consult your doctor or call the Toxicological Information Service, phone 91 562 0420, indicating the medication and the amount ingested.

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 to reschedule your dose.

If you interrupt treatment with Vinorelbina medac:

Your doctor will decide when to stop treatment. However, if you want to stop treatment prematurely, discuss other options with your doctor.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• Infections at different sites
• Gastrointestinal disorders; diarrhea; constipation, abdominal pain; nausea, vomiting
• Inflammation in the mouth
• Decreased red blood cells that may cause pale skin and provoke weakness or lack of air
• Decreased platelets that may increase the risk of bleeding or hematomas
• Decreased white blood cells that may make you more vulnerable to infections
• Loss of certain reflexes; occasionally alteration in tactile perception
• Loss of hair, usually in a mild form
• Fatigue
• Fever
• Malaise
• Weight loss, loss of appetite

Common(may affect up to 1in 10people)

• Difficulty coordinating muscle movements
• Differences in vision
• Lack of air, cough
• Difficulty urinating; other genitourinary disorders
• Difficulty sleeping
• Headache, dizziness; alteration in the perception of flavors
• Inflammation of the esophagus, difficulty swallowing food or liquids
• Skin reactions
• Chills
• Weight gain
• Joint pain, mandibular pain, muscle pain
• Pain in different parts of the body, and in the tumor site
• High blood pressure
• Hepatic disorders (abnormal liver function tests)

Rare(may affect up to 1in 100people)

• Heart failure that may cause shortness of breath and swelling of the ankles; irregular heartbeats
• The lack of muscle controlmay be associated with an 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 general deterioration of health
• Heart attack (myocardial infarction)
• Gastrointestinal bleeding
• Low sodium levels in the blood, which causes weakness, muscle spasms, fatigue, confusion, and loss of consciousness. This low sodium level may be attributed in some cases to an excessive production of a hormone that causes fluid retention (syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.

By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the box after “EXP/CAD”. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. For safety reasons, all unused capsules should be returned to your doctor or pharmacist for destruction. By doing so, you will help protect the environment.

Composition of Vinorelbinamedac

The active ingredient is vinorelbine (in the form of tartrate) 20mg, 30mg or 80mg.

The other components are:

Content of the capsule:

anhydrous ethanol

purified water

glycerol

macrogol 400

Capsule coating:

gelatin

glycerol

partially dehydrated liquid sorbitol

titanium dioxide (E171)

purified water

Vinorelbina medac 20mg and 80mg soft capsules - iron oxide yellow (E172)

Vinorelbina medac 30mg soft capsules - iron oxide red (E172)

Other components:

printing ink (non-volatile lacquer coating, iron oxide black (E172), propylene glycol)

medium-chain triglycerides

Appearance of the product and contents of the package

Soft capsule 20mg:Soft oval capsule of light brown color, 9.0mmx7.0mmin size, with "20" printed in black on the surface

Soft capsule 30mg:Soft oblong capsule of pink color, 15.0mmx6.0mmin size, with "30" printed in black on the surface

Soft capsule 80mg:Soft oblong capsule of pale yellow color, 20.0mmx8.0mmin size, with "80" printed in black on the surface.

Vinorelbina medac 20 mg soft capsules:Package of 1blister with 1soft capsule.

Package of 4blister packs with 1soft capsule each

Vinorelbina medac 30 mg soft capsules:Package of 1blister with 1soft capsule.

Package of 4blister packs with 1soft capsule each

Vinorelbina medac 80 mg soft capsules:Package of 1blister with 1soft capsule.

Only some package sizes may be marketed.

Marketing Authorization Holder

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6

22880 Wedel

Germany

Phone: +49 4103 8006-0

Fax: +49 4103 8006-100

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo n° 29

08022 Barcelona

Spain

Phone: +34 93 205 86 86

Manufacturer

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6

22880 Wedel

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany, Denmark, Norway: Vinorelbin medac

Slovakia, Finland, Malta, Poland, Czech Republic, Sweden: Vinorelbine medac

Spain: Vinorelbina medac 20 mg/30 mg/80 mg soft capsules EFG.

France: VINORELBINE MEDAC

Italy: Vinorelbina medac

Portugal: Vinorrelbina medac

Last review date of this leaflet: 06/2023

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)