Package Leaflet: Information for the User

Granisetrón Aurovitas Spain 1 mg Film-Coated Tablets

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, as 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experienceany side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this package leaflet.See section 4.4.

6. Contents of the pack and additional information

Granisetrón Aurovitas Spain contains a medication called granisetrón. This belongs to a group of medications called 5-HT3 receptor antagonists, or “antiemetics”, which prevent or avoid nausea and vomiting. These tablets are only indicated for adults.

Granisetrón Aurovitas Spain is indicated for the prevention and treatment of nausea and vomiting (feeling of discomfort) caused by certain treatments, such as chemotherapy or radiation therapy in cancer therapy.

Do not take Granisetrón Aurovitas Spain

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

If you are unsure, consult your doctor, nurse or pharmacist before taking these tablets.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Granisetrón Aurovitas Spain, especially:

• If you have intestinal obstruction problems
• If you have heart problems, are receiving cancer medications that may be harmful to your heart and/or suffer from electrolyte imbalances such as potassium, sodium or calcium (electrolyte disturbances)
• If you are taking another medication from the group of "5-HT3 receptor antagonists". Within this group are dolasetron and ondansetron, used, like Granisetrón Aurovitas Spain, for the treatment and prevention of nausea and vomiting.

Serotonin syndrome is a rare but potentially fatal reaction that can occur with granisetron (see section 4). It can cause severe changes in how your brain, muscles, and digestive system function. The reaction can occur if you take granisetron alone but is more likely to occur if you take granisetron with other medications (particularly fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine). Make sure to inform your doctor, nurse or pharmacist of all the medications you are taking.

Children

Children should not take these tablets.

Other medications and Granisetrón Aurovitas Spain

Inform your doctor, nurse or pharmacist if you are using, have used recently or may need to use any other medication, including those purchased without a prescription. This is because Granisetrón Aurovitas Spain may interact with some medications. Some medications may also interact with these tablets.

Inform your doctor or nurse if you are taking or may have taken any of the following medications:

• SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety. For example: fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
• SNRIs (selective serotonin and noradrenaline reuptake inhibitors) used to treat depression and/or anxiety. For example: venlafaxine, duloxetine
• Medications used to treat irregular heartbeats, other "5-HT3 receptor antagonists" such as dolasetron or ondansetron (see "Warnings and precautions")
• Phenobarbital, medication used to treat epilepsy
• Ketoconazole, medication used to treat fungal infections
• Erythromycin, antibiotic used to treat bacterial infections.

Taking Granisetrón Aurovitas Spain with food and drinks

You can take Granisetrón Aurovitas Spain with or without food. Each tablet should be swallowed with a little water.

Pregnancy, breastfeeding and fertility

Do not take these tablets if you are pregnant, trying to become pregnant or breastfeeding, unless your doctor has told you to.

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor, nurse or pharmacist before using this medication.

Driving and operating machines

The influence of Granisetrón Aurovitas Spain on the ability to drive and operate machines is negligible or insignificant.

Granisetrón Aurovitas Spain contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Granisetrón Aurovitas Spain contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Each tablet must be swallowed whole with water.

The recommended dose of Granisetrón Aurovitas Spain varies from one patient to another. This depends on age, weight, and whether you are taking other medications to prevent or treat nausea and vomiting. Your doctor will decide how much you should take.

Prevention of Nausea or Vomiting (Unpleasant Feeling)

The first dose of Granisetrón Aurovitas Spain should be administered one hour before starting radiation or chemotherapy treatment. The dose will be onetablet of 1 mg twice a dayor two tablets of 1mgonce a dayor one tablet of 2mg once a day with a duration of up to one week after radiation or chemotherapy treatment.

Treatment of Nausea or Vomiting (Unpleasant Feeling)

The dose is usually onetablet of 1 mg twice a dayor two tablets of 1mgonce a dayor one tablet of 2mg once a day.

If You Take More Granisetrón Aurovitas Spain Than You Should

If you think you have taken more tablets than you should, inform your doctor or nurse. Symptoms of overdose include a mild headache (cephalea). You will be treated according to your symptoms.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount administered.

If You Forget to Take Granisetrón Aurovitas Spain

If you think you have forgotten to take your medication, ask your doctor or nurse.

Do not take a double dose to compensate for missed doses.

If You Interrupt Treatment withGranisetrón Aurovitas Spain

Do not stop taking your medication before completing treatment. If you interrupt treatment, your symptoms may return.

If you have any other questions about using this product, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not everyone will experience them. If you observe any of the following adverse effects, you must seek immediate medical attention:

• allergic reactions (anaphylaxis). The signs may include throat inflammation, swelling of the face, lips, and mouth, and difficulty breathing or swallowing.

Other adverse effects that may occur while taking this medication are:

Very frequent:may affect more than 1 in 10 people

• headache,
• constipation. Your doctor will monitor your condition.

Frequent:may affect up to 1 in 10 people

• difficulty falling asleep (insomnia),
• through blood tests, changes in liver function are shown,
• diarrhea.

Rare:may affect up to 1 in 100 people

• Serotonin Syndrome. The signs may include diarrhea, nausea, vomiting, fever, and high blood pressure, excessive sweating, and rapid heart rate, agitation, confusion, hallucinations, chills, muscle spasms, tremors, or stiffness, loss of coordination, and restlessness,

• skin eruptions or an allergic reaction or urticaria. The signs may include red itchy patches,
• changes in heart rhythm (rate) and changes in the ECG (electrocardiogram),
• abnormal involuntary movements, such as tremors, muscle stiffness, and muscle contractions.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Composition of Granisetrón Aurovitas Spain

• The active ingredient is granisetron (as hydrochloride of granisetron), 1mg.
• The other components are:
• • Core of the tablet: lactose, microcrystalline cellulose, sodium glycinate (type A) from potato, hypromellose, magnesium stearate.
  • Coating of the tablet: Opadry II85F18378 white (polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc).

Appearance of the product and content of the container

Appearance:

Triangular, biconvex, film-coated tablet, white in color, and with the mark “G1” on one of the faces.

Container size:

Blister packs of 5, 10, and 100 (10x10) film-coated tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Responsible for manufacturing

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Last review date of this leaflet: April 2022

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)