Granisetron Sandoz 2, omhulde tabletten 2 mg

[Nationally approved name] belongs to a group of medicines called antiemetics, in other words medicines to prevent nausea (feeling sick) and vomiting (being sick).

[Nationally approved name] is being prescribed by your doctor to treat nausea and vomiting caused by chemotherapy and/or radiotherapy.

Do not use [Nationally approved name]

• if you are allergic to granisetron or any of the other ingredients of this medicine listed in section 6. If you know that you are allergic to granisetron or one of the excipients, you must tell your doctor.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking [Nationally approved name]

• if you suffer from sudden constipation while you are taking this medicine, as this will have to be carefully monitored. This also applies if your constipation is less sudden and less severe. Your doctor can tell you more about this.
• if you have an irregular heart beat. .

If one of the above warnings applies to you or has applied to you in the past, you must tell your doctor.

Other medicines and [Nationally approved name]

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other

medicines.

In particular, tell your doctor, nurse or pharmacist if you are taking the following medicines:

• medicines used to treat an irregular heartbeat known as beta-blockers (such as atenolol or propranolol)
• other antiemetic medicines such as dolasetron or ondansetron.

[Nationally approved name] with food and drink

The tablets can be taken before, during or after a meal.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

There is not enough information available on the use of granisetron in pregnancy for the possible harmful effects to be evaluated. [Nationally approved name] must only be taken in pregnancy following consultation with your doctor.

It is not known whether granisetron enters breast milk, and therefore, breastfeeding should be discontinued during therapy.

Driving and using machines

There are no known data on effects on driving or the ability to use machines.

[Nationally approved name] contains lactose.

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. If you notice that the effect granisetron is having is too strong or, conversely, not strong enough, talk to your doctor or pharmacist.

[Nationally approved name] tablets must be taken on the day of your chemotherapy or radiotherapy.

Dosage

• [Nationally approved name] 1 mg tablets: the recommended dose is 1 tablet twice a day. You must take the first tablet shortly before (usually less than an hour before) you start your chemotherapy and/or radiotherapy.
• [Nationally approved name] 2 mg tablets: the recommended dose is 1 tablet once a day. You must take the tablet shortly before (usually less than an hour before) you start your chemotherapy and/or radiotherapy.

Use in children

[Nationally approved name] should not be given to children under 12 years of age or children weighing less than 50 kg.

The tablets should be swallowed whole with a glass of water.

If you take more [Nationally approved name] than you should

If you have used or taken too much [Nationally approved name], contact your doctor or pharmacist immediately.

If you forget to take [Nationally approved name]

If you forget to take your tablet(s), take them as soon as you can. Never take a double dose of [Nationally approved name] to make up for the dose you forgot to take. After that, take the next tablets in accordance with the prescribed timetable.

If you stop taking [Nationally approved name]

Do not stop taking your medicine before the treatment is finished. If you do stop taking your medicine, your symptoms may return.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice the following problem you must see a doctor straight away:

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

Other side effects that may be experienced while taking this medicine are:

Very common side effects (may affect more than 1 in 10 people):

• Headache
• Constipation. Your doctor will monitor your condition.

Common side effects (may affect up to 1 in 10 people):

• Difficulty sleeping (insomnia)
• Diarrhoea
• Changes in how your liver is working shown by blood tests

Uncommon side effects (may affect up to 1 in 100 people)

• Skin rash
• changes in the heartbeat (rhythm) and changes seen on ECG readings (electrical recordings of the heart)
• abnormal involuntary movements, such as shaking, muscle rigidity and muscle contractions

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not mentioned in this leaflet. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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

This medicinal product does not require any special storage conditions. Store in the original package. Do not use this medicine after the “do not use after” or “EXP” date stated on the pack.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What [Nationally approved name] tablets contain:

The active substance is granisetron hydrochloride. Each tablet contains either 1 mg or 2 mg granisetron as granisetron hydrochloride.

The other ingredients (excipients) are lactose monohydrate, microcrystalline cellulose (E460), hypromellose (E464), sodium starch glycolate, magnesium stearate (E470b), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433).

What [Nationally approved name] looks like and contents of the pack

[Nationally approved name] 1 mg tablets are round, white or whitish film-coated tablets marked “GS” on one side and with no marking on the other side.

[Nationally approved name] 2 mg tablets are round, white or whitish film-coated tablets marked “GS2” on one side and with no marking on the other side.

The following forms of Granisetron are available:

[Nationally approved name] 1 mg Tablets – a strip of 1, 2, 4, 5, 6, 7, 10, 14, 20, 28, 30, 50, 90, 100, 150, 200, 250, 500 white tablets

[Nationally approved name] 2 mg Tablets – a strip of 1, 2, 4, 5, 6, 7, 10, 14, 20, 28, 30, 50, 90, 100, 150, 200, 250, 500 white tablets

Not all pack sizes may be marketed.

MA number and product name: [To be completed nationally]

MA number and product name: [To be completed nationally]

Marketing Authorisation Holder and Manufacturer:

[To be completed nationally]

This leaflet was last approved in

[To be completed nationally]