Granem

Package leaflet: Information for the user

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

granisetron
Equivalent medicine
Please read all of 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, nurse or pharmacist.
• 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Granem is and what it is used for

Granem contains the active substance granisetron, which belongs to a group of medicines known as
“5-HT receptor antagonists” or “antiemetics”. These tablets are intended for use in adults only.
Granem is used to prevent or treat nausea and vomiting (feeling sick and discomfort) caused by
treatment with other medicines, such as chemotherapy or radiotherapy for cancer.

2. What you need to know before taking Granem

Do not take Granem

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

If you have any doubts, consult your doctor, nurse or pharmacist before taking these tablets.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Granem:

• if you have problems with intestinal movements due to intestinal obstruction.
• if you have heart problems, if you 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 "5-HT₃ receptor antagonist" medicines, including dolasetron, ondansetron, used like Granem for the treatment and prevention of nausea and vomiting.

Serotonin syndrome is an uncommon but potentially life-threatening reaction that may occur with Granem (see section 4). It may cause serious changes in how the brain, muscles and digestive system function. The reaction may occur when taking Granem alone, but is more likely to occur when taking Granem together with certain other medicines (particularly fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine and duloxetine). Make sure you inform your doctor, nurse or pharmacist about all the medicines you are taking.
Children
Children must not take these tablets.
Other medicines and Granem
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Granem may affect how some medicines work. Also, other medicines may affect how these tablets work. In particular, tell your doctor or nurse if you are taking any of the following medicines:

• medicines used to treat irregular heartbeat other than "5-HT₃ receptor antagonists" such as dolasetron or ondansetron (see "Warnings and precautions" above)
• phenobarbital, a medicine used to treat epilepsy
• ketoconazole, a medicine used to treat fungal infections
• erythromycin, an antibiotic used to treat bacterial infections
• SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
• SNRIs (serotonin and noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.

Pregnancy and breastfeeding
You must not take these tablets if you are pregnant, trying to become pregnant, or breastfeeding, unless prescribed by your doctor.
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Granem does not affect or has a negligible effect on the ability to drive or use tools or machinery.
Granem contains lactose and sodium
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose (2 mg), i.e. it is essentially "sodium-free".

3. How to take Granem

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of Granem varies from patient to patient. It depends on your age, weight, and whether the medicine has been prescribed to prevent or to treat nausea and vomiting. Your doctor will determine the dose you should take.
Prevention of nausea and vomiting
The first dose of Granem is usually given one hour before radiotherapy or chemotherapy. The dose will be one 1 mg tablet twice daily or one 2 mg tablet once daily, up to one week after radiotherapy or chemotherapy.
Treatment of nausea and vomiting
The dose will be one 1 mg tablet twice daily or one 2 mg tablet once daily.
If you take more Granem than you should
If you think you have taken too many tablets, contact your doctor or nurse. Symptoms of overdose include mild headache. Treatment will be based on the symptoms presented.
If you forget to take Granem
If you think you have missed a dose, contact your doctor or nurse.
Do not take a double dose to make up for the missed tablet.
If you stop taking Granem
Do not stop taking the medicine before the treatment is complete. If you stop taking the medicine, symptoms may return.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

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. Your 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 rigidity, loss of coordination, and restlessness.
• skin rashes or allergic skin reactions or hives (urticaria). Signs may include red, raised, itchy bumps or blisters.
• changes in heart rhythm and abnormalities observed on the electrocardiogram (ECG) (electrical recording of the heart).
• abnormal involuntary movements such as tremors, muscle stiffness, and muscle contractions.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazionireazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Granem

Keep this medicine out of the sight and reach of children.
This product does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton or blister 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 Granem contains
The active substance is granisetron (as hydrochloride).
Each film-coated tablet contains 1 mg of granisetron (as granisetron hydrochloride).
Each film-coated tablet contains 2 mg of granisetron (as granisetron hydrochloride).
The other excipients are:

• Tablet core: lactose; microcrystalline cellulose (E460); sodium starch glycolate; hypromellose (E464); magnesium stearate.
• Tablet coating: Opadry II 85F 18378 white (polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b)).

Description of the appearance of Granem and the contents of the pack
1 mg tablet: white, biconvex, film-coated triangular tablet (7x7 mm) with "G1" printed on one side.
2 mg tablet: white, biconvex, film-coated triangular tablet (9x8 mm) with "G2" printed on one side.
Pack sizes:
1 mg: 10 film-coated tablets in blister pack.
2 mg: 5 film-coated tablets in blister pack.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. Group S.r.l.
Via Tiburtina, 1143
00156 Rome, Italy

Manufacturer
Actavis Ltd.
BLB 015-016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Iceland Granem
Italy Granem