Vinorelbine Lotus 30 mg soft capsules – patient leaflet, side effects, dosage

1. What Vinorelbine Lotus is and what it is used for

Vinorelbine Lotus contains the active substance vinorelbine (as tartrate), and belongs to a family of medicines used to treat cancer called the vinca-alkaloid family.

Vinorelbine Lotus is used to treat some types of lung cancer and some types of breast cancer in patients over 18 years old.

2. What you need to know before you take Vinorelbine Lotus

Do not take Vinorelbine Lotus if you are

• allergic to vinorelbine, to any of the related family of cancer

  drugs called the vinca alkaloids, or any of the other ingredients of this medicine (listed in section 6).

• breast-feeding.

• have had an operation on your stomach or small bowel, or if you

  have gut disorder, which affects how you absorb food. These may affect how your body absorbs Vinorelbine Lotus.

• have a low white blood cell and/or blood platelets count or a

  severe infection current or recent (within two weeks).

• If you have a low blood platelet cell count (thrombocytopenia)
• plan to have a yellow fever vaccination or have just had one.
• require long-term oxygen therapy.

Warnings and precautions

Talk to your doctor or pharmacist before taking Vinorelbine Lotus if

• you have a history of heart attack or severe chest pain.

• your ability to carry out activities of daily living is strongly

  reduced.

• you have problems with your liver or you have received

  radiotherapy where the treatment field included the liver.

• you have symptoms of infection (such as fever, chills, cough).

• you plan to have a vaccination. Many vaccines (live attenuated

  vaccines) are not recommended during treatment with Vinorelbine Lotus as they can increase the risk of fatal disease following vaccination.

• you have a severe liver disease unrelated to your cancer.
• you are pregnant.

Before starting and during your treatment with Vinorelbine Lotus, 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 under 18 years old.

Other medicines and Vinorelbine Lotus

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).

  • An anti-tuberculosis medicine (e.g. rifampicin)
  • 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.

The combination of Vinorelbine Lotus with other medicines with known bone marrow toxicity (affecting your white and red blood cells and your platelet) could also worsen some side effects.

Pregnancy, breast-feeding and fertility

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.

You should not breast-feed if you are taking Vinorelbine Lotus.

If you are a woman of childbearing potential, you must use effective contraception during treatment and for 7 months after treatment ends.

If you are a man being treated with Vinorelbine Lotus you are advised not to father a child during and up to 4 months after the last capsule. You should discuss sperm banking with your doctor before starting treatment because Vinorelbine Lotus may alter male fertility. You must use effective contraception during treatment and for 4 months after treatment ends.

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 Lotus contains sorbitol

This medicine contains sorbitol.

Vinorelbine Lotus 20 mg capsule contains 38.4 mg sorbitol. Vinorelbine Lotus 30 capsule contains 59.9 mg sorbitol. Vinorelbine Lotus 80 mg capsule contains 99.9 mg sorbitol.

3. How to take Vinorelbine Lotus

Before and during your treatment with Vinorelbine Lotus your doctor will check your blood cell count. 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 weight and height, results of the blood tests and your general health.

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 80 mg/m² of body surface area. In any case, your doctor may adjust the dose. 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 Lotus 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 Lotus, 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 it 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 Lotus soft capsule:

• Swallow Vinorelbine Lotus 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.

• 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

  Lotus, contact your doctor; do not repeat the dose.

  If you take an anti-sickness medicine

  Vomiting can occur with Vinorelbine Lotus, (refer to section “

  1. 4. Possible side effects”). If your doctor has prescribed nausea medication, always take it exactly as the doctor has told you. Take Vinorelbine Lotus during a light meal; this will help to reduce nausea.

If you take more Vinorelbine Lotus than you should

If you have taken more Vinorelbine than the prescribed dose, contact your doctor, the hospital or pharmacist immediately. Your body may sometimes react giving sever symptoms. Some of these symptoms may develop signs of an infection (such as fever, chills, cough, joint pain). You may also become severely constipated.

If you forget to take Vinorelbine Lotus

Do not take a double dose to make up for a forgotten dose. Contact your doctor who will take the

decision about rescheduling your dose.

If you stop taking Vinorelbine Lotus

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 Lotus, if you develop any of the following symptoms:

• Signs of a major or general infection (septicemia) such as cough, fever and chills.
• Severe constipation with abdominal pain when your bowels have not been open for several days.
• Severe dizziness, feeling faint 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 myocardial infarction (sometimes with fatal outcome).
• Difficulty in breathing, dizziness, decreased blood pressure, rash affecting your whole body, or swelling of the eyelids, face, lips or throat which may be signs of an allergic reaction.
• A chest pain, breathlessness and fainting, which can be a symptom 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 sign of a neurological disorder such as posterior reversible encephalopathy syndrome.

Other side effects

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

• Infections at different sites.
• Gastric disorders, diarrhoea, constipation, abdominal pain, nausea, vomiting.
• Inflammation of the mouth.
• A fall in red blood cells which can make the skin pale and cause weakness or shortness of breath.
• A fall in platelets which can increase the risk of bleeding or bruising.
• Decrease in white blood cells, which increases the risk of infections.
• 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 (may affect up to 1 in 10 people):

• Difficulties to coordinate muscle movements.
• Differences in your eyesight.
• Shortness of breath, cough.
• Difficulties to urinate, other genitourinary symptoms.
• Difficulty in sleeping.
• Headache, dizziness, changes in taste.
• Inflammation of the gullet, difficulty swallowing food or liquids.
• Skin reactions.

ART025227P

Package leaflet: Information for the patient

Vinorelbine Lotus 20 mg soft capsules

Vinorelbine Lotus 30 mg soft capsules

Vinorelbine Lotus 80 mg soft capsules

VINORELBINE (AS TARTRATE)

Vinorelbine Lotus 20 mg soft capsule Vinorelbine Lotus 30 mg soft capsule Vinorelbine Lotus 80 mg soft capsule

Vinorelbine Lotus 20 mg soft capsule

Vinorelbine Lotus 30 mg soft capsule

Vinorelbine Lotus 80 mg soft capsule

VINORELBINE (AS TARTRATE)

VINORELBINE (AS TARTRATE)

ART025227P

• Chills.
• Weight gain.
• Joint pain, jaw pain, muscle pain.
• Pain at different sites in your body and pain where your tumour is.
• High blood pressure.
• Liver disorders (abnormal liver test).

Uncommon (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, which may be associated with abnormal

  gait, speech changes and abnormalities in eye movement (ataxia).

Not known (frequency cannot be estimated from the available data):

• Blood infection (sepsis) with symptoms such as high fever and

  deterioration of general health.

• Heart attack (myocardial infarction).
• Gastrointestinal bleeding.

• Low sodium levels 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).

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 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 Lotus

Keep this medicine out of the sight and reach of children. Store in a refrigerator (2 – 8°C).

Do not use 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. Do not throw away any medicines via wastewater or household waste. For safety reasons any unused capsules must be returned to your doctor or pharmacist for destruction. These measures will help protect the environment.

6. Contents of the pack and other information

What Vinorelbine Lotus contains

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

• The other ingredients are: Capsule content: Macrogol 400,

  polysorbate 80 (E433), purified water.

  Capsule shell: Gelatin, sorbitol liquid partially dehydrated (E420),

  titanium dioxide (E171), purified water Vinorelbine Lotus 20 mg and 80 mg soft capsules: iron oxide yellow (E172), Vinorelbine Lotus 30 mg soft capsules: iron oxide red (E172).

What Vinorelbine Lotus looks like and contents of the pack

Vinorelbine Lotus 20 mg soft capsules are oval-shaped light brown coloured with a size of 11×7 mm filled with a transparent, colourless to slightly yellow liquid.

Vinorelbine Lotus 30 mg soft capsules are oblong-shaped pink coloured with a size of 18×6 mm filled with a transparent, colourless to slightly yellow liquid.

Vinorelbine Lotus 80 mg soft capsules are oblong-shaped pale yellow coloured with a size of 21×8 mm filled with a transparent, colourless to slightly yellow liquid.

Soft capsules of 20, 30 and 80 mg are available as packs of 1 or 4 blisters of 1 soft capsule each.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorization Holder

Lotus Pharma Bulgaria EOOD

Cherni Vrah No 102d, Floor 4,

Triaditsa District

1407, Sofia, Bulgaria

Manufacturers

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

Eirgen Pharma Limited

Westside Business Park,

Old Kilmeaden Road,

Waterford, X91 YV67,

Ireland

This leaflet was last revised in 07/2026.