Navelbine 20mg, 30mg and 80mg Soft Capsules

NAVELBINE 20mg soft capsule

NAVELBINE 30mg soft capsule

NAVELBINE 80mg soft capsule

Vinorelbine as tartrate

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have further questions, please ask your doctor or your pharmacist.


• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.


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

In this leaflet:

• 1. What NAVELBINE soft capsule is and what it is used for


• 2. Before you take NAVELBINE soft capsule


• 3. How to take NAVELBINE soft capsule


• 4. Possible side effects


• 5 Storing NAVELBINE soft capsule

What NAVELBINE soft capsule is and what it is used for

Navelbine belongs to a family of medicines used to treat cancer called the vinca-alkaloid family.

Navelbine 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.

Before you take NAVELBINE soft capsule

You should not be given NAVELBINE soft capsule

• If you are allergic (hypersensitive)to the active ingredient, vinorelbine, or any of the related family of cancer drugs called the vinca alkaloids


• If you are allergic to any of the other ingredients in NAVELBINE capsules (refer to section 6 of this leaflet)


• If you are pregnant or think that you might be pregnant


• If you are breast feeding


• If you have a severe liver disease unrelated to your cancer (reduced doses of NAVELBINE may be given in some cases)


• If you 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 Navelbine


• If you have a low white blood cell (neutrophil) count or a severe infection caused by lack of white blood cells (neutropenia).


• If you have a low blood platelet cell (thrombocytopenia)


• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.


• 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.

Take special care with Navelbine soft capsule

Please inform your doctor if:

• You have a history of heart attack or severe chest pain


• 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, joint pain)


• Your ability to carry out activities of daily living is strongly reduced


• You take, or have recently taken, any other medicines including medicines obtained without a prescription


• You plan to have a vaccination or have just had one

Before and during your treatment with Navelbine 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.

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

If you are given Navelbine as well as medicines that affect your bone marrow it may make some of the side effects worse.

Your doctor should take special attention if you are taking the following medicines:

• medicines used to thin your blood (anticoagulants)


• an anti-epileptic medicine called phenytoin


• an antifungal medicine called itraconazole


• an anti-cancer medicine called mitomycin C


• medicines that impair your immune system such as ciclosporin and tacrolimus

Live attenuated vaccines (e.g. Measles vaccine, Mumps vaccine, Rubella vaccine...) and yellow fever vaccines are not recommended with Navelbine as they may increase the risk of life-threatening vaccine disease.

Taking Navelbine soft capsule with food and drink

The soft capsule of Navelbine should be swallowed whole with water without chewing or sucking the capsule.

It is preferable to take Navelbine with a light meal.

Navelbine should not be taken with a hot drink as it will dissolve the capsule too quickly.

Male fertility

Men being treated with Navelbine are advised not to conceive a child during and up to 3 months after the last capsule.

Women of child bearing age

Women of child-bearing age must use effective contraception (birth control) during treatment and up to 3 months after treatment.

Pregnancy

Do not take Navelbine if you are pregnant, or think that you might be pregnant. If you have to start treatment with Navelbine and you are pregnant, or if pregnancy occurs during your treatment with Navelbine, do not stop taking Navelbine. Immediately ask your doctor about the potential risks for the unborn child.

Breast-feeding

Do not take Navelbine if you are breast feeding.

Breast feeding must be discontinued if treatment with Navelbine is necessary.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

It is unlikely that NAVELBINE will affect your ability to drive or operate machinery.

However, some of the possible side effects of Navelbine could affect your ability to drive or perform skilled tasks: see section 4; Possible side effects below for details. Therefore, it is recommended that you should not drive if you feel unwell or if your doctor has advised you not to drive.

Important information about some of the ingredients

This medicine contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per dose, you will not be affected by this small quantity.

How to take NAVELBINE soft capsule

Navelbine should be given under the supervision of a qualified doctor who is experienced in the use of cancer treatments.

Navelbine must be taken by mouth.

Navelbine is used in patients over 18 years old.

It is not recommended for use by children under 18 years old.

Always take NAVELBINE exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure

Dosage

Before and during your treatment with Navelbine 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. This will depend on your body weight and body height.

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 Navelbine.

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 Navelbine more than once a week

Frequency of administration

Normally Navelbine treatment is scheduled once a week. The frequency will be determined by your doctor.

Duration of treatment

The duration of your treatment is decided by your doctor.

If you take an anti-sickness medicine

Vomiting can occur with Navelbine: see section 4. Possible side effects below for details. If your doctor has prescribed an anti-sickness medication, always take it exactly as the doctor has told you.

Take Navelbine during a light meal; this will help to reduce the feeling of sickness.

Method of administration

Before opening the blisters containing Navelbine, 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.

Opening the “peel-push” blister:

• 1. Cut the blister along the black dotted line with a pair of scissors.


• 2. Peel the soft plastic foil off.


• 3. Push the capsule through the aluminium foil.

Taking NAVELBINE soft capsules:

• Swallow Navelbine 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 Navelbine, contact your doctor; do not repeat the dose.

If you take more NAVELBINE soft capsule than you should:

If you may have taken more NAVELBINE than the prescribed dose, contact a doctor or pharmacist immediately.

Your dose of Navelbine is carefully monitored and checked by your doctor and pharmacist. However, although you will have received the correct amount of chemotherapy 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 NAVELBINE soft capsule:

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

If you stop using Navelbine soft capsule

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 product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, NAVELBINE can have side effects although not everybody gets them.

While taking Navelbine, if you develop any of the following symptoms you should contact your doctor immediately:

• signs of a major infection such as cough, fever and chills


• severe constipation with abdominal pain,


• severe dizziness, light-headedness when you stand up


• severe chest pain which is not normal for you


• signs of allergy such as itching, shortness of breath

Very common side effects (can occur in more than 1 in 10 patients treated):

• Feeling sick (nausea)


• Vomiting

Immediately contact your doctor if this becomes uncontrollable. These side effects may be controlled with standard therapy. Do not repeat the dose if you vomit within a few hours after taking your Navelbine.

• A fall in some white blood cells (leucopenia) which can cause bacterial, viral or fungal infections in your body (respiratory, urinary, gastro-intestinal systems and possibly others).

Immediately contact your doctor, especially if your temperature reaches 38°C or higher.

• A fall in red blood cells (anaemia) which can make the skin pale and cause weakness or breathlessness


• A fall in blood platelets (thrombocytopenia) which increases the risk of bleeding or bruising


• Loss of some reflex reactions, occasionally difference in the perception of touch

Immediately contact your doctor for treatment, should these symptoms become severe.

• Inflammation or sores in the mouth or throat (stomatitis)


• Diarrhoea


• Constipation. If you have abdominal pain or if you do not have a bowel movement for several days


• Gastric disorders

Immediately contact your doctor.

• Hair loss (alopecia), normally not severe for long treatment


• Tiredness


• Malaise


• Fever


• Weight loss


• Loss of appetite (anorexia)

Ask your doctor for advice if the symptoms persist.

These are possible symptoms when receiving chemotherapy.

Common side effects (can occur in less than 1 in 10 patients treated):

• Difficulty in sleeping


• Headache


• Dizziness


• A difference in your taste of the flavours


• Inflammation of the throat and gullet (oesophagitis)


• Difficulty when swallowing food or liquids


• Skin reactions


• Joint pain


• Jaw pain


• Muscle pain


• Pain at different sites in your body and pain where your tumour is


• Chills


• Weight gain

Ask your doctor for advice if the symptoms persist.

• A fall in some types of white of blood cells (neutropenia) with a high temperature (fever) which can cause infections which may become serious

Immediately contact your doctor, especially if your temperature reaches 38°C or higher

• Neuromotor disorders


• Differences in your eyesight


• High blood pressure with symptoms such as a headache


• Low blood pressure with symptoms such as dizziness or feeling faint


• Shortness of breath


• Cough


• Abnormal liver test


• Pain, burning and difficulty in passing urine

Immediately contact your doctor for treatment, should any of these symptoms become severe.

Uncommon side effects (can occur in more than 1 in 100 patients treated):

Effects on your blood:

• Low blood sodium (severe hyponatraemia) which can cause symptoms of tiredness, confusion, muscle twitching

Immediately contact your doctor

Effects on your nervous system:

• Seizure similar to an epileptic fit


• Balance disorders (ataxia)

Immediately contact your doctor

Effects on your heart and blood vessels:

• Heart attack


• Tight chest pains across the chest (angina)

Immediately contact your doctor

Effects on your gastrointestinal system:

• Severe constipation with abdominal pain when your bowels have not been open for several days (paralytic ileus)


• Gastrointestinal bleeding

Immediately contact your doctor

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

Storing NAVELBINE

Keep out of the reach and sight of children

Do not use Navelbine after the expiry date which is stated on the blister and box (after Exp). The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C). Do not freeze. Store in the originalpackage in order to protect from light.

Medicines should not be disposed of 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 to protect the environment.

Further Information

What Navelbine soft capsule contains

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

The other ingredients are:

• The solution contains: ethanol anhydrous; purified water; glycerol; macrogol 400


• The capsule shell contains: gelatin; glycerol 85 %; sorbitol/ sorbitan (anidrisorb 85/70); triglycerides, medium chain and PHOSAL 53 MCT (phosphatidylcholine; glycerides; ethanol anhydrous) and colouring agents (E171-titanium dioxide and E172 red and/or yellow iron oxide depending on the strength).


• The edible printing ink contains: cochineal extract (E120), hypromellose, propylene glycol.

What Navelbine soft capsule looks like and contents of the pack

NAVELBINE 20 mg soft capsules are light brown coloured, printed with «N20».

NAVELBINE 30 mg soft capsules are pink coloured, printed with «N30».

NAVELBINE 80 mg soft capsules are pale yellow coloured, printed with «N80».

Soft capsules of 20, 30 and 80 mg are available as packs of 1 blister of 1 soft capsule.

Marketing Authorisation Holder

Pierre Fabre Ltd

Hyde Abbey House

23 Hyde Street

Winchester

Hampshire

S023 7DR

United Kingdom

Manufacturer

Pierre Fabre Médicament Production

Avenue du Béarn

64320 Idron

France

For any information on this product please contact Pierre Fabre Ltd; Phone: 01962 874435

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only). Please be ready to give the following information:

Product Name: Reference Number

Navelbine 20 mg soft capsule: PL 00603/0029

Navelbine 30 mg soft capsule: PL 00603/0030

Navelbine 80 mg soft capsule: PL 00603/0032

This is a service provided by the Royal National Institute of the Blind.

This leaflet was last approved in 04/2010

NAVELBINE : a registered trademark of PIERRE FABRE MEDICAMENT