Pandiolo

Patient Information Leaflet: Information for the User

Pandiol 1 mg film-coated tablets, 2 mg film-coated tablets

Granisetron
Generic medicine
Please read all of this leaflet carefully before you take 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Pandiol is and what it is used for

Pandiol contains a medicine called granisetron, which belongs to a group of medicines known as "5-HT3 receptor antagonists" or "antiemetics". These tablets are intended for use in adults only.
Pandiol is used to prevent or treat nausea and vomiting (feeling of sickness and discomfort) caused by treatment with other medicines, such as chemotherapy or radiotherapy for cancer.

2. What you need to know before taking Pandiol

Do not take Pandiol

• if you are allergic to granisetron or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Pandiol.

• If you have problems with intestinal movements due to intestinal blockage.
• If you have heart problems, are being treated for cancer with a medicine known to damage the heart, or if you have problems with levels of salts such as potassium, sodium, or calcium in your body (electrolyte imbalance).
• If you are taking other medicines known as “5-HT₃ receptor antagonists”, which include dolasetron and ondansetron, used like Pandiol for the treatment and prevention of nausea and vomiting.

Serotonin syndrome is an uncommon but potentially life-threatening reaction
that may occur with granisetron (see section 4). The reaction may occur when
granisetron is taken alone, but is more likely to occur when granisetron is taken together with certain other
medicines (particularly fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram,
venlafaxine, duloxetine).
Children
Children must not take these tablets.
Other medicines and Pandiol
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Pandiol may affect how some medicines work. Other medicines may also affect how Pandiol tablets work.
In particular, inform your doctor, nurse, or pharmacist if you are taking the following medicines:

• SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety. Examples are fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.
• SNRIs (serotonin-norepinephrine reuptake inhibitors) used to treat depression and/or anxiety. Examples are venlafaxine, duloxetine.
• Medicines used to treat irregular heartbeat, other "5-HT₃ receptor antagonists" such as dolasetron or ondansetron (see "Warnings and precautions" above).
• Phenobarbital, a medicine used to treat epilepsy.
• A medicine called ketoconazole used to treat fungal infections.
• The antibiotic erythromycin used to treat bacterial infections.

Pandiol with food and drink
You may take Pandiol with or without food.
Swallow the tablets with a glass of water.
Pregnancy and breastfeeding
Do not take these tablets if you are pregnant, planning to become pregnant, or breastfeeding, unless your doctor has told you to do so.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Pandiol has no effect or negligible effect on the ability to drive or operate tools or machinery.
Pandiol contains lactose
Pandiol contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Pandiol

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor, nurse, or pharmacist.
Each tablet must be swallowed whole with water.
The recommended dose of Pandiol varies from patient to patient depending on age, weight, and whether
the medicine has been prescribed to prevent or treat nausea and vomiting. Your doctor will determine the
appropriate dose for you.
Prevention of nausea or vomiting
The first dose of Pandiol is usually administered one hour before radiotherapy or chemotherapy. The
dose will be one or two 1 mg tablets or one 2 mg tablet once daily, up to one week after radiotherapy or
chemotherapy.
Treatment of nausea or vomiting
The usual dose is one or two 1 mg tablets or one 2 mg tablet once daily.
If you take more Pandiol than you should
If you think you have taken too many tablets, contact your doctor or nurse. Symptoms of overdose may
include mild headache. You will be treated according to your symptoms.
If you forget to take Pandiol
If you think you have missed a dose, consult your doctor or nurse. Do not take a double dose to make up
for the missed tablet.
If you stop taking Pandiol
Do not stop taking Pandiol before the treatment is completed. If you stop taking Pandiol, symptoms may
return.
If you have any questions about the use of this medicine, consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. If you notice the following problem, contact your doctor immediately:

• allergic reactions (anaphylaxis) (may affect up to 1 in 100 people). Signs may include swelling of the throat, face, lips, and mouth, difficulty breathing or swallowing.

Other side effects that may occur during treatment with this medicine are:

Very common: may affect more than 1 in 10 people

• headache
• constipation

The doctor will monitor your health status.

Common: may affect up to 1 in 10 people

• difficulty sleeping (insomnia)
• changes in liver function as indicated by blood tests
• diarrhoea

Uncommon: may affect up to 1 in 100 people

• Serotonin syndrome. Signs may include diarrhoea, nausea, vomiting, elevated body temperature and blood pressure, excessive sweating, rapid heartbeat, agitation, confusion, hallucinations, shivering, muscle twitching, muscle contractions or stiffness, loss of coordination, and restlessness.
• skin rashes or allergic skin reactions or hives (urticaria). Signs may include red, raised, itchy bumps.
• changes in heart rate (rhythm) and abnormalities observed on ECG (electrical recording of the heart).
• abnormal involuntary movements such as tremor, muscle rigidity, and muscle contractions.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following address:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pandiol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pandiol contains

• The active substance is granisetron (as hydrochloride) 1 mg.
• The active substance is granisetron (as hydrochloride) 2 mg. The other excipients are:
• Core of the tablet: lactose, microcrystalline cellulose, sodium carboxymethylstarch (type A), hypromellose, magnesium stearate.
• Tablet coating: Opadry II 85F 18378 white (polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc).

Description of the appearance of Pandiol and package contents
Appearance:
1 mg tablet: triangular, white, biconvex, film-coated, 7.4 mm by 7.1 mm, marked with "G1" on one side.
2 mg tablet: triangular, white, biconvex, film-coated, 8.7 mm by 8.4 mm, marked with "G2" on one side.
Pack sizes:
1 mg:
10 film-coated tablets in blister packs.
2 mg:
5 film-coated tablets in blister packs.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Elleva Pharma S.r.l.
Via San Francesco n. 5
80034 Marigliano (NA), Italy

Manufacturer
Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun, ZTN 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Community under the following names:
Italy: Pandiol