ALOXI 250 MCG Roztwór do wstrzykiwań

Treść ulotki

1. Aloxi 250 micrograms injectable solution
   1. What is Aloxi and what is it used for
   2. What you need to know before you receive Aloxi
   3. How Aloxi is administered
   4. Possible side effects
   5. How to store Aloxi
   6. Contents of the pack and other information
2. Aloxi 500 micrograms soft capsules
   1. What is Aloxi and what is it used for
   2. What you need to know before you take Aloxi
   3. How to take Aloxi
   4. Possible side effects
   5. How to store Aloxi
   6. Contents of the pack and other information

Aloxi 250 micrograms injectable solution

Palonosetron

Read this leaflet carefully before you receive 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 nurse.
• This medicine has been prescribed for you only. Do not pass it on to others.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What Aloxi is and what it is used for
• 2. What you need to know before you receive Aloxi
• 3. How Aloxi is administered
• 4. Possible side effects
• 5. How to store Aloxi
• 6. Contents of the pack and other information

1. What is Aloxi and what is it used for

Aloxi contains the active ingredient palonosetron, which belongs to a category of medicines called
“serotonin (5HT) antagonists”.
Aloxi is used in adults, adolescents and children over one month of age to help
inhibit the feeling or state of discomfort (nausea and vomiting) during anticancer treatments
called chemotherapy.
It works by blocking the action of a chemical substance called serotonin, which can cause feelings of
discomfort or vomiting.

2. What you need to know before you receive Aloxi

Do not take Aloxi if:

• you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6). You will not receive Aloxi if you fall into the cases listed above. If you have any doubts, consult your doctor or nurse before receiving this medicine.

Warnings and precautions
Talk to your doctor or nurse before you receive Aloxi if:

• you have a bowel obstruction or have had repeated constipation in the past
• you have had heart problems or your family members have had heart problems, such as changes in your heartbeat (“QT prolongation”)
• you have an imbalance that has not been treated, of certain minerals in the blood, such as potassium and magnesium.

If you fall into any of the cases listed above (or if you have any doubts), talk to your doctor or nurse
before receiving Aloxi.

Other medicines and Aloxi
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicines. In particular, tell them if you are taking the following medicines:

Medicines for depression or anxiety
Tell your doctor or nurse if you are taking medicines for depression or anxiety, such as:

• medicines called SSRIs (“selective serotonin reuptake inhibitors”), such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
• medicines called SNRIs (“serotonin-norepinephrine reuptake inhibitors”), such as venlafaxine, duloxetine (may lead to the development of serotonin syndrome and must be used with caution).

Medicines that can affect your heartbeat
Tell your doctor or nurse if you are taking medicines that affect your heartbeat;
this is because they could cause a heart problem if taken with Aloxi. These
include:

• medicines for heart problems, such as amiodarone, nicardipine, quinidine
• medicines for infections, such as moxifloxacin, erythromycin
• medicines for serious mental health problems, such as haloperidol, chlorpromazine, quetiapine, thioridazine
• a medicine for feeling or being sick (nausea and vomiting) called domperidone. If you fall into any of the cases listed above (or if you have any doubts), talk to your doctor or nurse before taking Aloxi, because these medicines could cause a heart problem if taken together with Aloxi.

Pregnancy
If you are or think you might be pregnant, your doctor will not give you Aloxi unless it is
absolutely necessary. This is because we do not know if Aloxi can harm the baby.
Ask your doctor or nurse for advice before receiving this medicine if you are or think you might
be pregnant.

Breast-feeding
It is not known whether Aloxi passes into breast milk.
Ask your doctor or nurse for advice before receiving this medicine during
breast-feeding.

Driving and using machines
You may feel dizzy or tired after receiving this medicine. If this happens, do not drive
vehicles and do not use tools or machines.

Aloxi containssodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially
‘sodium-free’.

3. How Aloxi is administered

Aloxi is usually administered by a doctor or a nurse.

• You will receive the medicine approximately 30 minutes before the start of chemotherapy.

Adults

• The recommended dose of Aloxi is 250 micrograms.
• This is administered as an injection into a vein.

Children and adolescents (from 1 month to 17 years of age)

• The doctor will calculate the correct dose based on body weight.
• The maximum dose is 1,500 micrograms.
• Aloxi is administered as an infusion (slow infusion into a vein).

The administration of Aloxi is not recommended on the days following chemotherapy, unless
you need to undergo another cycle of chemotherapy.
If you have any doubts about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine:

Serious side effects
Tell your doctor immediately if you notice any of the following serious side effects:

• allergic reaction - signs may include swelling of the lips, face, tongue or throat, difficulty breathing or collapse, rash with swelling and itching (urticaria). This is a very rare effect: it may affect up to 1 in 10,000 people. Tell your doctor immediately if you notice any of the serious side effects listed above.

Other side effects
Tell your doctor if you notice any of the following side effects:

Common: may affect up to 1 in 10 people

• headache, dizziness,
• constipation, diarrhoea.

Uncommon:may affect up to 1 in 100

• change in the colour of the vein and enlargement of the veins
• feeling happier than usual or feeling anxious
• feeling sleepy or difficulty sleeping
• decreased or loss of appetite
• weakness, feeling tired, fever or flu-like symptoms
• sensations of numbness, burning, itching or tingling on the skin
• itchy rash
• altered vision or eye irritation
• motion sickness
• ringing in the ears
• hiccups, flatulence, dry mouth or indigestion
• abdominal (stomach) pain
• difficulty urinating
• joint pain.

Tell your doctor if you notice any of the side effects listed above.

Uncommon side effects detected in tests: may affect up to 1 in 100

• low or high blood pressure
• abnormal heart rate or lack of blood flow to the heart
• exceptionally high or low potassium levels in the blood
• high blood sugar levels or presence of sugar in the urine
• low calcium levels in the blood
• high levels of the pigment bilirubin in the blood
• high levels of certain liver enzymes
• abnormalities in the ECG (electrocardiogram) (“QT prolongation”).

Very rare:may affect up to 1 in 10,000

• burning, pain or redness at the injection site.

Children and adolescents
Common: may affect up to 1 in 10

• headache

Uncommon: may affect up to 1 in 100

• dizziness
• jerky body movements
• irregular heartbeat
• cough or shortness of breath
• nosebleeds
• itchy rash or urticaria
• fever
• pain at the infusion site.

Tell your doctor if you notice any of the side effects listed above.

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 through the national reporting system indicated in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Aloxi

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the vial and the outer packaging after “Exp.”. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• For single use only, any unused solution should be discarded.

6. Contents of the pack and other information

What Aloxi contains

• The active ingredient is palonosetron (as hydrochloride). Each ml of solution contains 50 micrograms of palonosetron. Each vial of 5 ml of solution contains 250 micrograms of palonosetron.
• The other ingredients are mannitol, sodium edetate, sodium citrate, citric acid monohydrate, water for injections, sodium hydroxide and hydrochloric acid.

Description of the appearance of Aloxi and contents of the pack
Aloxi injectable solution is a clear, colourless solution, supplied in a pack of one
Type I glass vial with a siliconised chlorobutyl rubber stopper and an aluminium cap,
containing 5 ml of solution. Each vial contains one dose.
Available in packs of 1 vial containing 5 ml of solution.

Marketing Authorisation Holder and Manufacturer
Helsinn Birex Pharmaceuticals Ltd.
Damastown
Mulhuddart
Dublin 15
Ireland
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Aloxi 500 micrograms soft capsules

Palonosetron

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it may 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 Aloxi is and what it is used for
• 2. What you need to know before you take Aloxi
• 3. How to take Aloxi
• 4. Possible side effects
• 5. How to store Aloxi
• 6. Contents of the pack and other information

1. What is Aloxi and what is it used for

Aloxi contains the active ingredient palonosetron belonging to a category of medicines called
“serotonin (5HT) antagonists”.
Aloxi is used in adults to help inhibit the feeling or state of discomfort (nausea and
vomiting) during cancer treatments called chemotherapy.
It works by blocking the action of a chemical substance called serotonin, which can cause a feeling of
discomfort or vomiting.

2. What you need to know before you take Aloxi

Do not take Aloxi:

• if you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6). Do not take Aloxi if you fall into any of the above cases. If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Aloxi if:

• you have a bowel obstruction or have had repeated constipation in the past
• you have had heart problems or your family members have had heart problems, such as heart rhythm disturbances (“QT prolongation”)
• you have an imbalance that has not been treated, of certain minerals in the blood, such as potassium and magnesium.

Children
Do not give this medicine to children.

Other medicines and Aloxi
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. In particular, tell them if you are taking the following medicines:

Medicines for depression or anxiety
Tell your doctor or pharmacist if you are taking medicines for depression or anxiety, such as:

• medicines called SSRIs (“selective serotonin reuptake inhibitors”), such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
• medicines called SNRIs (“serotonin-noradrenaline reuptake inhibitors”), such as venlafaxine, duloxetine (may lead to the development of serotonin syndrome and should be used with caution).

If you fall into any of the above cases (or if you have any doubts), talk to your doctor or pharmacist
before taking Aloxi.

Medicines that can affect the heartbeat
Tell your doctor or pharmacist if you are taking medicines that affect the heartbeat;
this is because they may cause a heart rhythm problem if taken with Aloxi. These
include:

• medicines for heart problems, such as amiodarone, nicardipine, quinidine
• medicines for infections, such as moxifloxacin, erythromycin
• medicines for serious mental health problems, such as haloperidol, chlorpromazine, quetiapine, thioridazine
• a medicine for feeling or state of discomfort (nausea and vomiting) called domperidone.

If you fall into any of the above cases (or if you have any doubts), talk to your doctor or pharmacist
before taking Aloxi, because these medicines may cause a heart rhythm problem
if taken together with Aloxi.

Pregnancy
If you are or think you may be pregnant, your doctor will not use Aloxi unless in case of
strict necessity. This is because we do not know if Aloxi can cause harm to the baby.
Ask your doctor or pharmacist for advice before taking this medicine if you are or think you may
be pregnant.

Breastfeeding
It is not known whether Aloxi passes into breast milk.
Ask your doctor or pharmacist for advice before using this medicine while breastfeeding.

Driving and using machines
You may feel dizzy or tired after taking this medicine. If this happens, do not drive
vehicles and do not use tools or machinery.

Aloxi contains sorbitol and may contain traces of soy
This medicine contains 7 mg of sorbitol (a type of sugar) per capsule. If your doctor has
told you that you are intolerant to certain sugars, talk to your doctor before taking this medicine.
Aloxi may contain traces of lecithin derived from soy. If you are allergic to peanuts or soy, do not
take this medicine. Consult your doctor immediately if you notice signs of an allergic reaction. These signs may include swelling of the lips, face, tongue or throat, difficulty
breathing or collapse; you may also notice a rash with swelling and itching
(urticaria).

3. How to take Aloxi

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

• The recommended dose is one capsule (500 micrograms)
• Normally you should take the capsule approximately 60 minutes before the start of chemotherapy.
• This medicine can be taken with or without food.

The administration of Aloxi is not recommended on the days following chemotherapy, unless
you need to undergo another cycle of chemotherapy.

If you take more Aloxi than you should
If you think you have taken more medicine than you should, inform your doctor immediately.

If you forget to take Aloxi
It is unlikely that you will forget to take this medicine. However, if you think you have forgotten
a dose, inform your doctor immediately.

If you stop taking Aloxi
Do not stop treatment with this medicine without talking to your doctor. If you decide not to
take Aloxi (or other similar medicines), it is likely that chemotherapy will cause you to feel unwell or
sick (nausea and vomiting).
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.
The following side effects may occur with this medicine:

Serious side effects
Tell your doctor immediately if you notice any of the following serious side effects:

• allergic reaction - signs may include swelling of the lips, face, tongue or throat, difficulty breathing or collapse, rash with swelling and itching (urticaria). This is a very rare effect: it can affect up to 1 in 10,000 people. Tell your doctor immediately if you notice any of the serious side effects listed above.

Other side effects
Tell your doctor if you notice any of the following side effects:

Common: may affect up to 1 in 10 people

• headache.

Uncommon: may affect up to 1 in 100 people

• difficulty sleeping
• shortness of breath
• swelling of the eyes
• abnormal electrical impulses in the heart
• constipation
• nausea
• high levels of the pigment “bilirubin” (a marker of liver problems) in the blood
• muscle pain. Tell your doctor if you notice any of the side effects listed above.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system detailed in Appendix V.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Aloxi

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the blister and the outer packaging after "Exp.”. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.

6. Contents of the pack and other information

What Aloxi contains

• The active ingredient is palonosetron. Each capsule contains 500 micrograms of palonosetron (as hydrochloride).
• The other ingredients are glycerol monocaprylocaprate (Type I), polyglycerol oleate, glycerol, purified water, butylhydroxyanisole, gelatin, sorbitol, titanium dioxide.

Description of Aloxi and contents of the pack
Aloxi 500 micrograms soft capsules are smooth, round to oval, opaque, light beige capsules containing a clear, yellowish solution.
They are supplied in polyamide/aluminium/PVC blisters containing one or five capsules.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Helsinn Birex Pharmaceuticals Ltd.,
Damastown,
Mulhuddart, Dublin 15,
Ireland.
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu.