Vinorelbine Doc Generici

Package leaflet: Information for the patient

VINORELBINA DOC 20 mg soft capsules, 30 mg soft capsules, 80 mg soft capsules

Generic medicine
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What VINORELBINA DOC is and what it is used for
2. What you need to know before taking VINORELBINA DOC
3. How to take VINORELBINA DOC
4. Possible side effects
5. How to store VINORELBINA DOC
6. Contents of the pack and other information

1. What VINORELBINA DOC is and what it is used for

VINORELBINA DOC contains the active substance vinorelbine (as tartrate) and belongs to a family of anticancer medicines known as vinca alkaloids.
VINORELBINA DOC is used to treat certain types of non-small cell lung cancer and certain types of advanced or metastatic breast cancer in patients over 18 years of age.

• Non-small cell lung carcinoma
• Locally advanced and metastatic breast carcinoma

2. What you should know before taking VINORELBINE DOC

Do not take VINORELBINE DOC:

• If you are allergic (hypersensitive) to the active substance vinorelbine, or to any of the medicines belonging to the family of anticancer drugs known as vinca alkaloids.
• If you are allergic to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or think you might be pregnant.
• If you are breastfeeding.
• If you have severe liver disease.
• If you have undergone surgery on the stomach or small intestine, or if you have an intestinal disease affecting food absorption. This may affect the absorption of VINORELBINE DOC by the body.
• If you have a low number of white blood cells (neutrophils, leukocytes), or if you currently have or have recently had (within the last two weeks) a serious infection.
• If you have a low platelet count in the blood (thrombocytopenia).
• If you are planning to receive the yellow fever vaccine or have recently received it.
• If you require long-term oxygen therapy.

If in doubt, ask your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking VINORELBINE DOC:

• if you have a history of heart attack or severe chest pain;
• if your ability to perform daily activities is significantly reduced;
• if you have liver problems or have received radiotherapy in an area including the liver;
• if your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine;
• if you have symptoms of infection (such as fever, chills, joint pain, cough);
• if you are taking, or have recently taken, any other medicines, including those without a prescription;
• if you are planning a vaccination or have recently been vaccinated.

Before and during treatment with VINORELBINE DOC, blood cell counts will be performed to ensure that you can safely take the treatment. If the results of these tests are not satisfactory, treatment may be postponed and further monitoring may be carried out until these values return to normal.
Children and adolescents
The use of this medicine is not recommended in children under 18 years of age.
Other medicines and VINORELBINE DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
If you take other medicines together with VINORELBINE DOC that act on the bone marrow, certain side effects may worsen.
Your doctor should pay particular attention if you are taking any of the following medicines:

• medicines used to thin the blood (anticoagulants),
• an antiepileptic drug called phenytoin,
• antifungal medicines such as itraconazole or ketoconazole,
• anticancer drugs such as mitomycin C or lapatinib,
• medicines that suppress the immune system, such as cyclosporine and tacrolimus.

Many vaccines (live attenuated vaccines) are not recommended during treatment. Inform your doctor if you need to be vaccinated.
VINORELBINE DOC with food and drinks
VINORELBINE DOC capsules should be swallowed whole with water, without chewing or sucking them. It is preferable to take the capsule with a light meal.
Do not take the soft capsules of VINORELBINE DOC with a hot drink, as this could dissolve the capsule too quickly.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before using this medicine, as there are potential risks to the unborn child.
Women of childbearing age
Women of childbearing age must use an effective method of contraception (birth control) during treatment and for at least three months after the end of treatment.
Pregnancy
Do not use VINORELBINE DOC if you are pregnant or think you might be pregnant.
If you are pregnant when starting treatment with VINORELBINE DOC, or if you become pregnant during treatment, do not stop taking VINORELBINE DOC.
Contact your doctor immediately to discuss the potential risks to the unborn child.
Breastfeeding
Do not take VINORELBINE DOC while breastfeeding.
If it is necessary to take VINORELBINE DOC, breastfeeding must be discontinued.
Ask your doctor or pharmacist for advice before taking any medicine.
Male fertility
Men treated with VINORELBINE DOC should be advised not to father a child during treatment and for at least three months after taking the last capsule.
Before starting treatment with VINORELBINE DOC, you should discuss with your doctor the possibility of sperm preservation, as male fertility may be impaired.
Driving and using machines
It is unlikely that VINORELBINE DOC will affect your ability to drive or operate machinery. However, some of the possible side effects of VINORELBINE DOC may affect your ability to drive or perform specialized tasks: see section 4; details of possible side effects are listed below.
Therefore, it is recommended not to drive if you do not feel well or if your doctor has advised you not to drive.
VINORELBINE DOC contains sorbitol
This medicine contains sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take VINORELBINE DOC

VINORELBINE DOC must be administered under the supervision of a qualified physician experienced in the use of anticancer therapies.
VINORELBINE DOC is taken by mouth (orally).
VINORELBINE DOC is intended for use in patients over 18 years of age.
It is not recommended for use in children under 18 years of age.
Always take VINORELBINE DOC exactly as your doctor has instructed you.
If you have any doubts, consult your doctor or pharmacist.

Dosage
Before and during your treatment with VINORELBINE DOC, your doctor will monitor your blood cell counts to determine when you can start treatment and which dose is appropriate for you.
Your doctor will tell you the number of capsules and the dosage you should take. This will depend on your body surface area, which your doctor will calculate from your weight and height.
Your doctor will calculate your body surface area in square meters (m²). The usual weekly dose, taken as a single dose, is 60 mg/m² of body surface area for the first 3 doses. After the third dose, your doctor may decide to increase the dose to 80 mg/m² of body surface area.
In any case, your doctor will adjust the dose of VINORELBINE DOC according to your individual needs.
If you are taking the capsules together with another medicine to treat your cancer/condition, your doctor will determine the most appropriate dosage for you.
The total dose must never exceed 160 mg per week.
Never take VINORELBINE DOC more than once a week.

Frequency of administration
Treatment with VINORELBINE DOC is generally scheduled once a week. The exact frequency will be determined by your doctor.

Duration of treatment
The duration of treatment will be determined by your doctor.

If you are taking an anti-nausea medicine
Nausea and vomiting may occur with VINORELBINE DOC (see section “4. Possible side effects”). If your doctor has prescribed an anti-nausea medicine, take it exactly as directed.
Take VINORELBINE DOC with a light meal; this may help reduce nausea.

Method of administration
Before opening the blister pack containing VINORELBINE DOC, check that there are no damaged capsules, as the liquid inside is an irritant and may be harmful if it comes into contact with the skin, eyes, or mucous membranes. If this occurs, wash the affected area immediately and thoroughly with water.
Do not swallow any damaged capsule, but return it to your doctor or pharmacist.

How to take VINORELBINE DOC soft capsules:

• Swallow the VINORELBINE DOC capsule whole with some water, preferably with a light meal. Do not take it with a hot drink, as this may dissolve the capsule too quickly.
• Do not chew or suck the capsules.
• If you accidentally chew or suck a capsule, rinse your mouth carefully with water and inform your doctor immediately.
• If you vomit within a few hours after taking VINORELBINE DOC soft capsules, contact your doctor immediately. Do not take a second dose.

If you take more VINORELBINE DOC than you should
If you have taken more VINORELBINE DOC than prescribed, contact a doctor immediately.
Your dosage of VINORELBINE DOC is carefully monitored and controlled by your doctor and pharmacist. However, even if you have received the correct amount of chemotherapy, your body may sometimes react, and severe symptoms may occur.
Some of these symptoms may progress to signs of infection (such as fever, chills, cough, joint pain). You may also develop severe constipation. You must contact your doctor immediately if any of these serious symptoms occur.

If you forget to take VINORELBINE DOC
Do not take a double dose to make up for a missed dose. Contact your doctor, who will decide how to reschedule your dose.

If you stop taking VINORELBINE DOC
Your doctor will decide when to stop treatment. However, if you wish to stop treatment earlier, you must discuss possible alternatives with your doctor.
If you have any questions about the use of this medicine, consult 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 using VINORELBINA DOC:

• signs of a serious infection, such as cough, fever, and chills;
• severe constipation with abdominal pain, when the bowel has not moved for several days;
• severe dizziness, mild confusion when standing up, which may be a sign of a serious drop in blood pressure;
• severe chest pain that you do not normally experience; symptoms may be due to impaired heart function caused by inadequate blood flow, known as ischemic heart disease;
• difficulty breathing, dizziness, low blood pressure, skin rash over the whole body, or swelling of the 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 a blood vessel in the lungs (pulmonary embolism);
• headache, altered mental status that may lead to confusion and coma, seizures, blurred vision, and high blood pressure, which may be signs of a neurological disorder such as reversible posterior encephalopathy syndrome.

If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, consult your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You may also report side effects directly through the national reporting system at the website 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 VINORELBINE DOC

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (+2°C - +8°C).
Do not use this medicine after the expiry date which is stated on the blister and carton after
Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What VINORELBINA DOC contains

• The active substance is vinorelbine (as tartrate) 20, 30 or 80 mg.
• The other components are: Capsule contents: Polyethylene glycol 400, polysorbate 80 (E433), purified water. Capsule shell: gelatin 160, partially dehydrated sorbitol liquid (E420), titanium dioxide (E171), purified water, yellow iron oxide (E172) (for VINORELBINA DOC 20 mg and 80 mg capsules), red iron oxide (E172) (for VINORELBINA DOC 30 mg capsules).

Description of the appearance of VINORELBINA DOC and package contents
VINORELBINA DOC 20 mg: light brown, oval-shaped soft capsules.
VINORELBINA DOC 30 mg: pink, oblong-shaped soft capsules.
VINORELBINA DOC 80 mg: pale yellow, oblong-shaped soft capsules.
The 20 mg, 30 mg and 80 mg soft capsules are available in cartons containing 1 or 4 blisters, each blister containing 1 soft capsule.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
DOC Generici srl
Via Turati 40,
20121 Milan, Italy

Manufacturers
Pharmadox Healthcare Ltd.
KW20A Kordin
Industrial Park,
Paola PLA 3000, Malta
Adalvo Limited
Malta Life Sciences Park,
Building 1, Level 4,
Sir Temi Zammit Buildings,
San Gwann SGN 3000, Malta