Patient leaflet - Vinorelbine 30 mg soft capsules
1. What Vinorelbine soft capsules are and what they are used for
Vinorelbine belongs to a family of medicines used to treat cancer called the vinca-alkaloid family.
Vinorelbine is used to treat:
- Non-small cell lung cancer
- Advanced breast cancer that has not responded to other medicines.
It is not recommended for use by children under 18 years old.
2. What you need to know before you take Vinorelbine soft capsules
Do not take Vinorelbine soft capsules
- If you are allergic to vinorelbine, to any of the related family of cancer drugs called vinca-alkaloids, or any of the other ingredients of this medicine (listed in section 6).
- If you are breast-feeding.
- If you have had an operation on your stomach or small bowel, or if you have a gut disorder which affects how you absorb food. These may affect how your body absorbs vinorelbine.
- If you have a low white blood cell count (neutrophils, leucocytes) or a severe infection current or recent within two weeks.
- If you have a low blood platelet cell count (thrombocytopenia).
- If you plan to have a yellow fever vaccination or have just had one.
- 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 soft capsules:
- If you have a history of heart attack or severe chest pain.
If your ability to carry out activities of daily living is strongly reduced.
- If you have problems with your liver or you have received radiotherapy where the treatment field included the liver.
- If you have symptoms of infection (such as fever, chills, joint pain and cough).
- If you plan to have a vaccination. Live attenuated vaccines are not recommended during treatment.
- If you have a severe liver disease unrelated to your cancer. Vinorelbine soft capsules are not recommended in this group of patients.
- If you are pregnant.
Before starting and during your treatment with Vinorelbine soft capsules, blood cell counts are performed to check that it is safe for you to receive treatment. If the results of this analysis are not satisfactory, your treatment may be delayed and further checks made until these values return to normal.
Children and adolescents
This medicine is not recommended for use by children or adolescents under 18 years old.
Other medicines and Vinorelbine soft capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription.
Your doctor should take special attention if you are taking the following medicines:
medicines used to thin your blood
(anticoagulants)
- an anti-epileptic medicine (e.g. phenytoin)
- antifungal medicines (such as itraconazole and ketoconazole)
- anti-cancer medicines such as mitomycin C or lapatinib
- medicines that impair your immune system such as ciclosporin and tacrolimus
- anti-tuberculosis medicine called rifampicin.
Many vaccines (live attenuated vaccines) are not recommended during treatment, especially in patients who already have weakened immune systems. Please inform your doctor if you require any vaccinations.
The combination of Vinorelbine soft capsules with other medicines (such as cisplatin) that affect your bone marrow may make some of the side effects worse.
Vinorelbine soft capsules with food and drink
Vinorelbine soft capsules must be swallowed whole with water. It is recommended to take the capsules with some food.
Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine because there are potential risks for the infant.
Breast-feeding
You should not breast-feed if you are taking Vinorelbine soft capsules.
Women of child-bearing potential
Women of child-bearing potential must use an effective contraception (birth control) during treatment and for 7 months after the end of treatment.
Male fertility
Men being treated with Vinorelbine are advised not to father a child during treatment and for 4 months after the last taken capsule.
You should discuss sperm banking with your doctor before starting treatment with Vinorelbine because Vinorelbine may alter your fertility. You must use an effective contraception during treatment and for 4 months after the end of treatment.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
However, as in all cases you should not drive if you feel unwell or if your doctor has advised you not to drive.
Vinorelbine soft capsules contain sorbitol
This medicine contains 9.00 mg sorbitol in each 20 mg soft capsule, 15.30 mg sorbitol in each 30 mg soft capsule and 27.00 mg sorbitol in each 80 mg soft capsule.
Vinorelbine soft capsules contain alcohol (ethanol)
This medicine contains 2.890 mg alcohol (ethanol) in each 20 mg soft capsule. The amount in each 20 mg capsule of this medicine is equivalent to less than 1 ml beer or 1 ml wine.
This medicine contains 4.335 mg alcohol (ethanol) in each 30 mg soft capsule. The amount in each 30 mg capsule of this medicine is equivalent to less than 1 ml beer or 1 ml wine.
This medicine contains 11.560 mg alcohol (ethanol) in each 80 mg soft capsule. The amount in each 80 mg capsule of this medicine is equivalent to less than 1 ml beer or 1 ml wine.
The small amount of alcohol in this medicine will not have any noticeable effects.
3. How to take Vinorelbine soft capsules
Before and during your treatment with Vinorelbine soft capsules, your doctor will check your blood cell count to determine when you receive your treatment and which dose is suitable for you. Your doctor will tell you the number and strength of capsules which you should take, how often you should take the capsules and the duration of your treatment. This will depend on your body surface area, (which your doctor will calculate from your body weight and height), results of the blood tests and your general health.
Your doctor will calculate your body surface area in square meters (m2). The usual weekly dose, taken in a single dose, is 60 mg/m2 of body surface area for the first 3 doses. After the third dose, your doctor will decide if the dose will be increased to 80mg/m2 of body surface area. In any case, your doctor may adjust the dose of Vinorelbine.
If you are receiving the capsules with another medicine to treat your cancer/condition, your doctor will decide on an appropriate dose for you.
The total dose should never exceed 160 mg per week.
You should never take Vinorelbine soft capsules more than once a week
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Before opening the blisters containing Vinorelbine soft capsules, make sure that there are no damaged capsules because the liquid inside is an irritant and may be harmful if it comes into contact with your skin, eyes or mucosa. If this happens, wash the affected area immediately and thoroughly with water.
Do not swallow any damaged capsules;
return them to your doctor or pharmacist
Taking Vinorelbine soft capsules:
- Swallow Vinorelbine soft capsules whole with water, preferably with a light meal. It should not be taken with a hot drink as it will dissolve the capsule too quickly.
70 mm
51 6488 1 732856
Vinorelbine 20 mg,
30 mg, 80 mg
51 6488 1 732856
Vinorelbine 20 mg,
30 mg, 80 mg
Version No.
Date
8.5
3 (Page 1 of 2) (Type IB)
09_11_22 (Vinorelbine Cap(ACC-UK)-PIL)
Do not chew or suck the capsules.- If you chew or suck a capsule by mistake, rinse your mouth thoroughly with water and tell your doctor immediately.
- If you vomit within a few hours after taking your Vinorelbine soft capsules, contact your doctor; do not repeat the dose.
If you take an anti-sickness medicine
Vomiting can occur with Vinorelbine soft capsules, (refer to section 4 “Possible side effects”). If your doctor has prescribed an anti-sickness medication, always take it exactly as the doctor has told you. Take Vinorelbine soft capsules during a light meal; this will help to reduce the feeling of sickness.
If you take more Vinorelbine soft capsules than you should
If you have taken more Vinorelbine than the prescribed dose, contact a doctor immediately. Your body may sometimes react giving severe symptoms. Some of these symptoms may develop as signs of an infection (such as fever, chills, cough, joint pain). You may also become severely constipated. You must immediately contact your doctor if any of these severe symptoms occur.
If you forget to take Vinorelbine soft capsules
Do not take a double dose to make up for a forgotten dose. Contact your doctor who will make the decision about rescheduling your dose.
If you stop taking Vinorelbine soft capsules
Your doctor will decide when you should stop your treatment. However, if you want to stop your treatment earlier, 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.
Serious side effects
Immediately contact your doctor while taking Vinorelbine soft capsules, if you develop any of the following symptoms:
- cough, fever and chills which may be signs of a major infection or a general infection (septicemia) that can be severe
- severe constipation with abdominal pain when your bowels have not been open for several days
- severe dizziness, light-headedness when you stand up. This may be a sign of severe reduced blood pressure
- severe chest pain which is not normal for you, the symptoms may be due to disturbance in the heart function following insufficient blood flow, so-called ischaemic heart disease
- difficulty in breathing, dizziness, decreased blood pressure, rash affecting your whole body, or swelling of the eyelids, face, lips or throat which may be an allergic reaction
- a chest pain, breathlessness and fainting, which can be symptoms of a clot in a blood vessel in the lungs (pulmonary embolism)
- headaches, changed mental state which may lead to confusion and coma, convulsions, blurred vision and high blood pressure, which could be signs of a neurological disorder such as posterior reversible encephalopathy syndrome.
Other side effects:
Very common side effects (may affect more than 1 in 10 people):
- Infection at different sites
- Gastric disorders: diarrhoea, constipation, abdominal pain, nausea, vomiting
- Inflammation or sores in the mouth
- A fall in red blood cells (anaemia) which can make the skin pale and cause weakness or breathlessness
A fall in platelets which can increase the risk of bleeding or bruising
- A decrease in white blood cells which makes you more vulnerable to infection
- Loss of some reflex reactions, occasionally difference in the perception of touch
- Hair loss, usually mild form
- Tiredness
- Fever
- Malaise
- Weight loss, loss of appetite.
Common side effects (may affect up to 1 in 10 people):
- Difficulties coordinating muscle movements
- Differences in your eyesight
- Shortness of breath, cough
- Difficulties urinating, other genitourinary symptoms
- Difficulty sleeping
- Headache, dizziness, a difference in your taste of flavours
- Inflammation of the gullet, difficulty when swallowing food or liquids
- Skin reactions
- Weight gain
- Joint pain (arthralgia), jaw pain, muscle pain (myalgia), pain at different sites in your body and pain where your tumour is
- Chills
- Increased blood pressure
- Liver disorders (abnormal liver test).
Uncommon side effects (may affect up to 1 in 100 people):
- Heart failure which can cause shortness of breath and ankle swelling, irregular heartbeats
- Lack of muscle control may be associated with abnormal gait, speech changes and abnormalities in eyes movement (ataxia).
Not known (frequency cannot be estimated from the available data):
- Blood infections (sepsis) with symptoms such as high fever and deterioration in general health
- Low sodium level in your blood. This low sodium level may be attributed in some cases to an overproduction of a hormone causing fluid retention resulting in weakness, muscle twitching, tiredness, confusion or unconsciousness (Syndrome of Inappropriate Antidiuretic Hormone secretion - SIADH)
- Gastrointestinal bleeding
- Heart attack (myocardial infarction).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Vinorelbine soft capsules
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the blister and carton box after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Vinorelbine soft capsules contain
The active substance is vinorelbine (as tartrate) 20, 30 or 80 mg.
The other ingredients are:
Capsule content: Macrogol 400, glycerol, anhydrous ethanol, purified water
Capsule shell: Gelatin, glycerol 85%, partially dehydrated sorbitol liquid (E420), titanium dioxide (E171), purified water, iron oxide yellow (E172) [Only for 20 mg and 80 mg soft capsules], iron oxide red (E172) [Only for 30 mg soft capsules]
Printing ink: shellac, iron oxide black (E172) and propylene glycol.
What Vinorelbine soft capsules look like and contents of the pack
Vinorelbine 20 mg soft capsules: Light brown colour, opaque, oval shape soft gelatin capsule, free from surface defects, containing clear colourless liquid and imprinted "JJ1" in black ink.
Vinorelbine 30 mg soft capsules: Pink colour, opaque, oblong shape soft gelatin capsule, free from surface defects, containing clear colourless liquid and imprinted "JJ2" in black ink.
Vinorelbine 80 mg soft capsules: Pale yellow colour, opaque, oblong shape soft gelatin capsule, free from surface defects, containing clear colourless liquid and imprinted "JJ3" in black ink.
Clear PVC/PVDC-Aluminium blister containing 1, 2, 3 or 4 soft capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord, Barnstaple, EX32 8NS, UK
Manufacturers
Accord-UK Ltd
Whiddon Valley
Barnstaple
Devon
EX32 8NS
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
Harrow, HA1 4HF,
United Kingdom
This leaflet was last revised in May 2024.
Version No.
Date
8.5
3 (Page 2 of 2) (Type IB)
09_11_22 (Vinorelbine Cap(ACC-UK)-PIL)