VINORELBINE MEDAC 20 mg SOFT CAPSULES

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 other anticancer medicines of 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 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 last 2 weeks)
• if you are scheduled to be vaccinated against yellow fever or have been vaccinated recently
• if you require long-term oxygen therapy

Warnings and precautions

Tell your doctor or pharmacist before starting Vinorelbina medac:

• if you have a history of heart attack or severe chest pain
• if your ability to carry out daily activities is severely reduced
• if you have received radiotherapy whose treatment field included the liver
• if you have symptoms of infection (such as fever, chills, cough)
• if you plan to be vaccinated. Live attenuated virus vaccines (e.g. measles, mumps, rubella...) are not recommended with vinorelbine, 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.

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

Children and adolescents

Vinorelbina medac is not recommended for use in children under 18 years of age.

Other medicines and Vinorelbina medac

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor should be particularly careful if you are taking:

• medicines used to thin the blood (anticoagulants)
• anti-epileptic medicines (e.g. phenytoin)
• antifungal medicines (e.g. itraconazol)
• anticancer medicines such as mitomycin C or lapatinib
• medicines that impair the immune system, such as cyclosporin and tacrolimus

The combination of Vinorelbina medac with other medicines with known bone marrow toxicity (affecting red blood cells, white blood cells and platelets) may also worsen certain side effects.

Pregnancy, breastfeeding and fertility

Before starting treatment, you must inform your doctor if you are pregnant, think you may be pregnant or plan to become pregnant, as there are potential risks to the baby. You should not breastfeed while taking Vinorelbina medac.

Women of childbearing age must use effective contraceptive methods during treatment and for at least 7 months after the end 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 to seek advice on sperm preservation before treatment, as Vinorelbina medac may affect male fertility.

Driving and using machines

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

However, as with all cases, you should not drive if you do not feel well or if your doctor has advised you not to do so.

Vinorelbina medac contains sorbitol

Each 20 mg vinorelbine soft capsule contains 10.54 mg of sorbitol.

Each 30 mg vinorelbine soft capsule contains 15.96 mg of sorbitol.

Each 80 mg vinorelbine soft capsule 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 does not produce any noticeable 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 and which dose of capsules to take, how often to take the capsules, and for how long you should be treated, depending on your body surface area, blood test results, and general condition.

The total dose should never exceed 160mg per week.

Never take Vinorelbina medac more than once a week.

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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

To open the "peel-push" type blister:

1. Cut the blister along the black dotted line with scissors.
2. Peel off the soft plastic foil.
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 because the capsule will dissolve too quickly.
• Do not chew or suck the capsules.
• If you accidentally chew or suck a capsule, rinse your mouth thoroughly and inform your doctor immediately.
• If you vomit a few hours after taking this medicine, contact your doctor immediately. Do not repeat the dose.

If you are taking an anti-nausea medicine

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 instructed by your doctor.

Take this medicine during 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 appear, and you may show signs of infection (such as fever, chills, cough). You may also suffer from severe constipation.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service, phone 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 forgotten doses. Contact your doctor, who will decide whether to reschedule your dose.

If you stop taking Vinorelbina medac

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

If you have any further questions on the use of 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.

While 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, fainting when standing up, sign of severely reduced blood pressure
• Severe chest pain, which is abnormal for you; symptoms may be due to altered heart function after insufficient blood flow, called myocardial infarction (sometimes with a fatal outcome)
• Difficulty breathing, dizziness, low blood pressure, rash all over the body, or swelling of the eyelids, face, lips, or throat, which can be signs of an allergic reaction
• Chest pain, difficulty breathing, and fainting that can be symptoms of a blood clot in a blood vessel in the lungs (pulmonary embolism)
• Headaches, changes in mental status that can lead to confusion and coma, seizures, blurred vision, and high blood pressure, which could indicate a neurological disorder such as posterior reversible encephalopathy syndrome

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

• Infections at different sites
• Gastrointestinal disorders; diarrhea; constipation, abdominal pain; nausea, vomiting
• Mouth inflammation
• A decrease in red blood cells that can make the skin pale and cause weakness or shortness of breath
• A decrease in platelets that can increase the risk of bleeding or bruising
• A decrease in white blood cells that can make you more vulnerable to infections
• Loss of certain reflexes; occasionally altered touch perception
• Hair loss, usually mild
• Fatigue
• Fever
• Discomfort
• 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 disorders
• Difficulty sleeping
• Headache, dizziness; altered taste perception
• Esophageal inflammation, difficulty swallowing food or liquids
• Skin reactions
• Chills
• Weight gain
• Joint pain, jaw pain, muscle pain
• Pain in different parts of the body, and at the tumor site
• High blood pressure
• Liver disorders (abnormal liver tests)

Uncommon(may affect up to 1 in 100 people)

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

Frequency not known: cannot be estimated from the available data

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency's online platform: www.notificaRAM.es.

By reporting side 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 which is stated on the blister and carton after “EXP/CAD”. The expiry date is the last day of the month shown.

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

Medicines should not be disposed of via wastewater or household waste. For safety reasons, all unused capsules should be returned to your doctor or pharmacist for destruction. This will help protect the environment.

6. Contents of the pack and further information

Composition of Vinorelbina medac

The active substance is vinorelbine (as tartrate) 20 mg, 30 mg, or 80 mg.

The other ingredients are:

Contents of the capsule:

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 lacquer coating, black iron oxide (E172), propylene glycol)

medium-chain triglycerides

Appearance and packaging

20 mg soft capsule: Oval-shaped soft capsule, light brown in color, 9.0 mm x 7.0 mm in size, with "20" printed in black on the surface

30 mg soft capsule: Oblong soft capsule, pink in color, 15.0 mm x 6.0 mm in size, with "30" printed in black on the surface

80 mg soft capsule: Oblong soft capsule, pale yellow in color, 20.0 mm x 8.0 mm in size, 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 with 1 soft capsule each

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

Pack of 4 blisters with 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

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6

22880 Wedel

Germany

Tel.: +49 4103 8006-0

Fax: +49 4103 8006-100

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Laboratorios Gebro Pharma, S.A.

Avenida Tibidabo n° 29

08022 Barcelona

Spain

Tel. +34 93 205 86 86

Manufacturer

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6

22880 Wedel

Germany

This medicine is authorised in the Member States of the European Economic Area 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/80 mg soft capsules EFG.

France: VINORELBINE MEDAC

Italy: Vinorelbina medac

Portugal: Vinorrelbina medac

Date of last revision of this leaflet: 06/2023

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