VINORELBINA 20 mg Soft Capsules

Зміст інструкції

1. VINORELBINA DOC 20 mg soft capsules, 30 mg soft capsules, 80 mg soft capsules
   1. What is VINORELBINA DOC and what is it used for
   2. What you need to know before you take 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

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

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is VINORELBINA DOC and what is it used for

VINORELBINA DOC contains the active ingredient vinorelbine (as tartrate) and belongs to the
class of medicines for the treatment of tumors called vinca alkaloids.
VINORELBINA DOC is used to treat some types of lung cancer and some types of breast
cancer in patients over 18 years of age.

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

2. What you need to know before you take VINORELBINA DOC

Do not take VINORELBINA DOC:

• If you are allergic (hypersensitive) to the active ingredient vinorelbine, or to any of the excipients of this medicine (listed in section 6).
• If you are pregnant or think you might be pregnant.
• If you are breastfeeding.
• If you have a severe liver disease.
• If you have undergone stomach or small intestine surgery or if you have an intestinal disease that affects the absorption of food. This may affect the absorption of VINORELBINA DOC by the body.
• If you have a low number of white blood cells (neutrophils, leukocytes) or if you are currently suffering from a severe infection or have had one recently (within the last two weeks).
• If you have a low number of platelets in the blood (thrombocytopenia).
• If you are planning to have the yellow fever vaccination or have just had it.
• If you need long-term oxygen therapy.

If in doubt, ask your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking VINORELBINA DOC:

• 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 liver problems or have been treated with radiotherapy to an area that includes 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, other medicines, including those available without a prescription;
• if you are planning a vaccination or have just had one.

Before and during treatment with VINORELBINA DOC, your blood cell count will be checked to verify that you can safely take the treatment. If the results of these tests are not satisfactory, treatment may be postponed and further checks may be performed until these values return to normal.

Children and adolescents
The use of this medicine is not recommended in children under the age of 18 years.

Other medicines and VINORELBINA DOC
Tell 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 VINORELBINA DOC together with other medicines that affect the bone marrow, some undesirable effects may worsen.
Your doctor will need to 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 drugs such as, for example, 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. Tell your doctor if you need to have a vaccination.

VINORELBINA DOC with food and drink
The VINORELBINA DOC capsules must be swallowed whole with water, without chewing or sucking. It is preferable to take the capsule with a light meal.
Do not take the soft capsules of VINORELBINA DOC with a hot drink as it would dissolve the capsule too quickly.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before using this medicine as there are potential risks to the baby.

Women of childbearing potential
Women of childbearing potential must use effective contraception (birth control) during treatment and for at least three months after treatment.

Pregnancy
Do not useVINORELBINA DOC if you are pregnant or think you might be.
If you are pregnant when you need to start treatment with VINORELBINA DOC, or if you become pregnant during treatment, do not stop taking VINORELBINA DOC.
Consult your doctor immediately about the potential risks to the unborn child.

Breastfeeding
Do not take VINORELBINA DOC while breastfeeding.
If you need to take VINORELBINA DOC, breastfeeding must be stopped.
Ask your doctor or pharmacist for advice before taking any medicine.

Male fertility
Men treated with VINORELBINA DOC should be advised not to father a child during treatment or for at least three months after taking the last capsule.
Before starting treatment with VINORELBINA DOC, discuss with your doctor the possibility of sperm preservation, as male fertility may be altered.

Driving and operating machinery
It is unlikely that VINORELBINA DOC will affect your ability to drive or operate machinery. However, some of the possible side effects of VINORELBINA DOC may affect your ability to drive or perform specialized tasks: see section 4; details of the possible side effects are given below.
Therefore, it is recommended not to drive if you do not feel well or if your doctor has advised you not to drive.

VINORELBINA DOC contains sorbitol
This medicine contains sorbitol. If your doctor has diagnosed you as having an intolerance to some sugars, contact him before taking this medicine

3. How to take VINORELBINA DOC

VINORELBINA DOC must be administered under the supervision of a qualified physician
experienced in the use of anticancer treatments.
VINORELBINA DOC must be taken orally (by mouth).
VINORELBINA DOC is used in patients over the age of 18 years.
It is not recommended for use in children under 18 years of age.

Take VINORELBINA DOC following the doctor's instructions exactly at all times.
If you have any doubts, consult your doctor or pharmacist

Dose
Before and during your treatment with VINORELBINA DOC, the doctor will check your blood cell count to determine when you can start treatment and what the appropriate dose is for you.
The doctor will tell you the number and dosage of capsules you should take. This will depend on the
body surface area that the doctor calculates from your weight and height.
The doctor will calculate the 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, the doctor will decide whether to increase the dose to 80 mg / m² of body surface area.
In any case, the doctor will adjust the dose of VINORELBINA DOC.
If you are taking the capsules together with another medicine to treat cancer/your condition, the
doctor will assess the most suitable dosage for you.

The total dose should never exceed 160 mg per week.
Never take VINORELBINA DOC more than once a week.
Frequency of administration
Generally, treatment with VINORELBINA DOC is planned once a week. The
frequency will be established by the doctor.

Duration of treatment
The duration of treatment is established by the doctor.

If you take a medicine against nausea
Vomiting may occur with VINORELBINA DOC (see section “4. Possible side effects”). If the doctor has prescribed you a medicine against nausea, take it exactly as
the doctor told you to do.
Take VINORELBINA DOC during a light meal; this will help reduce the feeling of nausea.

Method of administration
Before opening the blister pack containing VINORELBINA DOC, make sure there are no capsules
damaged as the liquid contained in them is an irritant and can be harmful if it comes into contact
with the skin, eyes or mucous membranes. If this should happen, wash the affected area immediatelyand
thoroughly with water.

Do not swallow any damaged capsules,but return them to your doctor or pharmacist.
How to take VINORELBINA DOC soft capsules:

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

If you take more VINORELBINA DOC than you should
If you have taken more VINORELBINA DOC than the prescribed dose, contact a
doctor immediately.
Your dosage of VINORELBINA DOC is carefully monitored and controlled by the doctor and the
pharmacist. However, although you have received the correct amount of chemotherapy, the body can sometimes
react and serious symptoms can develop.
Some of these symptoms can develop into signs of an infection (such as fever, chills, cough, joint pains). You may also become severely constipated. You should contact your doctor immediately if any of these serious symptoms occur.

If you forget to take VINORELBINA DOC
Do not take a double dose to make up for a missed dose. Contact your doctor who
will decide on rescheduling the dose.

If you stop taking VINORELBINA DOC
The doctor will decide when you should stop treatment. However, if you would like to stop the
treatment earlier, you should discuss possible alternatives with your doctor.
If you have any doubts about 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.
li manifestino.

Contact your doctor immediately if, during the use of VINORELBINA DOC,you develop
one of the following symptoms:

• signs of a serious infection, such as cough, fever and chills;
• severe constipation with abdominal pain, when the bowel does not empty for several days;
• severe dizziness, mild confusion when getting up, a sign of a serious drop in blood pressure;
• severe chest pain that you normally do not experience, the symptoms may be due to impaired cardiac function as a result of insufficient blood flow, defined as ischemic heart disease;
• difficulty breathing, dizziness, low blood pressure, rash all over the 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 lung vessel (pulmonary embolism).
• headache, altered mental status that can cause confusion and coma, seizures, blurred vision and high blood pressure, which may be a sign of a neurological condition such as reversible posterior encephalopathy syndrome.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at 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 VINORELBINA 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 the box after
Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What VINORELBINA DOC contains

• The active substance is vinorelbine (as tartrate) 20, 30 or 80 mg.
• The other ingredients are: Capsule content: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 contents of the pack
VINORELBINA DOC 20 mg: soft capsules of oval shape with a light brown colour.
VINORELBINA DOC 30 mg: soft capsules of oblong shape with a pink colour.
VINORELBINA DOC 80 mg soft capsules of oblong shape with a pale yellow colour.
The 20 mg, 30 mg and 80 mg soft capsules are available in packs containing 1 or 4 blisters each containing 1
soft capsule.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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