SANCUSO 3,1 MG Plaster transdermalny

Treść ulotki

1. SANCUSO 3.1 mg/24 hours transdermal patch
   1. What is SANCUSO and what is it used for
   2. What you need to know before using SANCUSO
   3. How to use SANCUSO
   4. Possible side effects
   5. How to store SANCUSO
   6. Contents of the pack and other information

SANCUSO 3.1 mg/24 hours transdermal patch

granisetron

Read this leaflet carefully before using 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 nurse.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What is SANCUSO and what is it used for

The active substance contained in SANCUSO is granisetron, which belongs to a group of medicines
called antiemetics and anti-nausea medications.
SANCUSO is a transdermal (cutaneous) patch used to prevent nausea and vomiting in adults
undergoing chemotherapy treatments (medicines for cancer treatment), lasting from 3 to 5
days, and who have difficulty swallowing tablets (for example due to pain, dryness or
inflammation of the mouth or throat).
Contact your doctor if you do not feel better or if you feel worse after the first day of chemotherapy.

2. What you need to know before using SANCUSO

Do not use SANCUSO:

• if you are allergic to granisetron or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to any other anti-nausea medicine whose name ends in "setron", e.g. ondansetron.

Warnings and precautions
Talk to your doctor or nurse before using this treatment if you fall into any of the following cases:

• if you have been told you have a heart disorder or disease
• if you have stomach (abdominal) pain or if your stomach is bloated
• if you have problems with your kidneys or liver.

This medicine may not work optimally and/or may have effects on the skin if exposed to
direct sunlight or to the light of sunlamps or tanning beds. It is important to observe the
following precautions:

• while wearing the transdermal patch, keep it covered with clothing if you are exposed to sunlight or are near a sunlamp, including tanning beds
• keep the area where this medicine has been applied covered for another 10 days after removing the transdermal patch, to protect it from exposure to direct sunlight.

It is not known how activities such as swimming, strenuous exercise or using a sauna or
whirlpool could affect this medicine. Avoid these activities while wearing
this transdermal patch. You can continue to shower and wash normally during
application of the transdermal patch.
Avoid exposing the area of the transdermal patch to external heat sources, e.g. heat
from hot water bottles or heating pads.

Children and adolescents
This medicine should not be used by children or adolescents under 18 years of age.

Other medicines and SANCUSO
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicines. SANCUSO can affect the action of some medicines, and other
medicines can also affect the action of SANCUSO. In particular, tell your doctor or nurse
if you are taking the following medicines:

• Paracetamol, used for the treatment of pain.
• Phenobarbital, used for the treatment of epilepsy.
• Ketoconazole, used for the treatment of fungal infections.
• SSRIs (selective serotonin reuptake inhibitors) for depression and/or anxiety such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.
• SNRIs (serotonin-norepinephrine reuptake inhibitors) for depression and/or anxiety such as venlafaxine, duloxetine.
• Buprenorphine, opioids or other serotonergic medicines.

Pregnancy and breastfeeding
Do not use this medicine if you are pregnant, unless specifically recommended by your doctor.
Stop breastfeeding while wearing the patch.
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor for advice before using this medicine.

Driving and using machines
SANCUSO does not alter or alters negligibly the ability to drive vehicles or use
machinery.

3. How to use SANCUSO

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or nurse.
The recommended dose is a single transdermal patch. The medicine contained in the transdermal
patch gradually passes through the skin to enter the body, and therefore the patch is
applied 1-2 days (24-48 hours) before the start of chemotherapy.
This medicine is for transdermal use. This medicine slowly and
constantly releases the active ingredient through the skin, penetrating into the bloodstream, for the duration of
application of the transdermal patch.
Things to remember when using the transdermal patch

• Do not keep or store the transdermal patch outside the sealed sachet.
• Do not cut the transdermal patch into smaller pieces.
• Use only one transdermal patch at a time.
• When removing the transdermal patch, check the skin and inform the doctor if you notice a severe skin reaction (if the skin is very red, itchy or if you notice any blisters).
• Direct sunlight or exposure to sunlamps can have an effect on the transdermal patch. While wearing the transdermal patch you should keep it covered, e.g. under clothing, if there is a risk of exposure to sunlight or sunlamps. Continue to keep the application site covered for another 10 days after removing the transdermal patch.
• Contact with water while bathing or showering does not alter the action of SANCUSO. However, the transdermal patch may come off partially. Try to avoid wearing the transdermal patch in water for prolonged periods.
• There is no information on the effect of other activities on the transdermal patch, such as intense exercise or the use of saunas or whirlpools; therefore, you should avoid such activities while wearing this transdermal patch.
• You should avoid exposing the area of the transdermal patch to external heat sources (e.g. hot water bottles or heating pads).

When to apply and remove the transdermal patch
Do not remove the transdermal patch from the sachet until you are ready to use it. Apply a patch
transdermically at least 1 day (24 hours) before the scheduled chemotherapy treatment. The patch
transdermically can be applied up to a maximum of 2 days (48 hours) before chemotherapy.
Wear the transdermal patch for the entire duration of the chemotherapy. The transdermal patch may
be worn for a period of up to 7 days, depending on the duration of the chemotherapy treatment.
Remove the transdermal patch after at least 1 day (24 hours) after completion of the
chemotherapy.
Where to apply the transdermal patch
Apply the transdermal patch to a clean, dry and healthy area of skin on the outer
upper arm. If the arms are not suitable for applying the transdermal patch, your doctor
may ask you to apply it to the abdomen. The chosen area should not be oily, recently shaved or
have skin problems, such as lesions (cuts or scrapes) or irritations (redness or rash). Do not apply SANCUSO to areas treated with creams, oils, lotions, powders or other skin products that could prevent the transdermal patch from adhering well to the skin.
How to apply the transdermal patch

• 1. Remove a sachet from the carton and open it following the longitudinal cut provided. Each sachet contains a transdermal patch adhered to a rigid plastic film.
• 2. Remove the transdermal patch from the sachet.

Outer coating of the
patch

• 3. The adhesive side of the transdermal patch is covered by a rigid plastic film divided into two parts. Fold the transdermal patch in half and remove one half of the rigid plastic film. Be careful not to make the transdermal patch stick to itself and avoid touching the adhesive side of the patch.

Holding the other half of the rigid plastic film, apply the transdermal patch to the skin, on the outer upper arm.

• 5. Remove the second half of the rigid plastic film and press the entire transdermal patch firmly into place with your fingers, smoothing it out. Press firmly ensuring good contact with the skin, especially around the edges.
• 6. Wash your hands after applying the transdermal patch.
• 7. Keep the transdermal patch in place for the entire duration of the chemotherapy.
• 8. Do not reuse the transdermal patch after removing it; see below for instructions on removal and disposal (see paragraph 5).

After removing the transdermal patch

• 1. The used transdermal patch still contains some granisetron and must be disposed of immediately, as described in paragraph 5.
• 2. After removing the transdermal patch, you may notice adhesive residue on the skin. Gently wash the area with soap and water to remove it. Alcohol or other solvent liquids, such as nail polish remover, can cause skin irritation and should not be used.
• 3. Wash your hands.
• 4. You may notice slight redness on the skin, at the point where the transdermal patch was removed. This redness should disappear over time. If it does not, inform the doctor.

If the transdermal patch comes off
If the transdermal patch starts to come off, the same patch can be fixed to the same area of the
skin. If necessary, use surgical bandages or surgical tape to hold the transdermal
patch in place. If the transdermal patch is lost or damaged, contact your doctor.

If you use more SANCUSO than you should
If you use more SANCUSO than you should, simply remove the extra patch(es) and contact your
doctor.

If you forget to use SANCUSO
It is important to use this medicine following the doctor's instructions, to prevent nausea or
vomiting after chemotherapy. If you have forgotten to apply the transdermal patch at the right time,
apply it as soon as you remember and inform the doctor as soon as possible before the
chemotherapy treatment.

If you stop using SANCUSO
It is important to use this medicine for the entire duration of the chemotherapy (up to 7 days) to
prevent nausea or vomiting due to chemotherapy. Consult your doctor if you wish to remove the
patch before the end of the chemotherapy cycle (up to 7 days).
If you have any doubts about using 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.
If you are receiving chemotherapy that has a moderate or high ability to cause
nausea and vomiting, you may still experience vomiting despite treatment with an anti-emetic therapy, including this medicine.

Tell your doctor immediatelyif you experience constipation or if you have pain or swelling in the stomach. Constipation is a common side effect and can affect up to 1 in 10 people.

Remove the transdermal patch and tell your doctorif you notice:

• signs and symptoms of a condition called serotonin syndrome, which can be serious and in some cases life-threatening. These may include changes in blood pressure (which may cause dizziness or headache), rapid heartbeat, blurred vision (which may be due to dilated pupils), sweating, increased bowel/intestinal movements or sounds, chills, tremor, muscle contractions or spasms, and overly reactive reflexes. You may also experience a high or very high body temperature (fever), feeling agitated or confused, muscle stiffness and may notice that you are speaking faster. The number of people in whom serotonin syndrome occurs is not known (the number cannot be defined based on available data)
• severe skin reaction (if the skin is very red, itchy or if you notice any blisters). Skin reactions at the application site, such as irritation, itching or redness, are uncommon and can affect up to 1 in 100 people.

Other possible side effects:
Uncommon side effects are:

• headache, feeling dizzy even when resting (vertigo)
• decreased appetite, weight loss
• hot flashes
• nausea, vomiting, dry mouth
• joint pain
• swelling due to fluid retention (edema)
• changes in liver function tests (if you are going to have blood tests, tell your doctor or nurse that you have used SANCUSO).

Rare side effects (may affect up to 1 in 1,000) are:

• abnormal muscle movements (e.g. tremor, muscle stiffness and muscle contractions).

Side effects of unknown frequency (frequency cannot be estimated based on available data):

• Allergic skin reactions with signs such as itchy, red hives

Other possible side effects associated with granisetron-based products (frequency not known)

• Allergic reactions including urticaria (itching, redness and skin rash) and anaphylaxis (a serious allergic reaction that can manifest with sudden signs such as wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching)
• Difficulty sleeping/disturbed sleep
• Excessive drowsiness
• Prolongation of the QT interval on the ECG (changes in the heart tracing (ECG) indicative of a heart rhythm disorder)
• Constipation
• Diarrhea
• Lack of energy/weakness/loss of strength

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. You can also report side effects directly through
the national reporting system listed in Annex V *.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store SANCUSO

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 outer packaging and on the
sachet after “Expiry”. The expiry date refers to the last day of that month.
Store in the original package, to protect the medicine from light.
Used transdermal patches still contain active substances, which may be harmful to others.
Fold the used transdermal patch in half, with the adhesive side inwards, and then dispose of it
safely, out of the reach of children. 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 SANCUSO contains

• The active ingredient is granisetron. Each 52 cm transdermal patch contains 34.3 mg of granisetron, releasing 3.1 mg of granisetron in 24 hours.
• The other ingredients are:
• Transdermal patch adhesive: acrylate-vinyl acetate copolymer
• Outer coating: polyester
• Rigid plastic film: siliconized polyester

Description of the appearance of SANCUSO and contents of the pack
SANCUSO is a rectangular, thin and transparent transdermal patch with rounded edges,
attached to a rigid plastic film. The transdermal patch is contained in a sachet. Each
pack contains one transdermal patch.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Grünenthal GmbH
Zieglerstraße 6
52078 Aachen
Germany

Manufacturer
Pharbil Waltrop GmbH (a subsidiary of NextPharma)
Im Wirrigen 25
45731 Waltrop
Germany
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu