Reganni 40mg film-coated tablets

1. What Reganni is and what it is used for

Reganni contains the active substance regorafenib. It is a medicine used to treat cancer by slowing down the growth and spread of cancer cells and

cutting off the blood supply that keeps cancer cells growing.

Reganni is used to treat:

- colon or rectal cancer that has spread to other parts of the body in adult patients who have received other treatments or cannot be treated with

other medicines (fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy).

- gastrointestinal stromal tumors (GIST), a type of cancer of the stomach and bowel, that has spread to other parts of the body or is not amenable

to surgery, in adult patients who have been previously treated with other anticancer medicines (imatinib and sunitinib).

If you have any questions about how Reganni works or why this medicine has been prescribed for you, please ask your doctor.

2. How to take Reganni

Always take this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

The recommended daily dose in adults is 4 tablets of Reganni 40 mg (160 mg regorafenib). Your doctor may change your dose. Take the dose of Reganni that your doctor prescribes for you.

Your doctor will usually ask you to take Reganni for 3 weeks and then to stop for 1 week. This is 1 cycle of treatment.

Take Reganni at the same time each day after a light (low-fat) meal. Swallow the tablet whole with water after a light meal that contains less than 30% fat. An example of a light (low-fat) meal would include 1 portion of cereal (about 30 g), 1 glass of skimmed milk, 1 slice of toast with jam, 1 glass of apple juice, and 1 cup of coffee or tea (520 calories, 2 g fat). You should not take Reganni together with grapefruit juice (see also section‘Taking Reganni with food and drink’).

In case of vomiting after regorafenib administration, you should not take additional tablets and you should inform your doctor.

Your doctor may need to reduce your dose or may decide to interrupt or discontinue the treatment permanently if necessary. You will usually takeReganni as long as you are benefiting and not suffering unacceptable side effects.

No dosage adjustment is necessary if you have a mildly impaired liver function. If you have a mildly or moderately impaired liver function while youare being treated with Reganni, your doctor should monitor you closely. If your liver function is severely impaired, you should not be treated with Reganni, as there are no data on the use of Reganni in patients with a severely impaired liver function.

No dosage adjustment is necessary if you have a mildly or moderately impaired kidney function. There are no data available on the use of Reganni in patients with a severely impaired kidney function.

3.Very common side effects (may affect more than 1 in 10 users):

- infection

- reduction in the number of blood platelets, characterised by easy bruising or bleeding (thrombocytopenia)

- reduction in the number of red blood cells (anaemia)

- decreased appetite and food intake

- headache

- high blood pressure (hypertension)

- voice changes or hoarseness (dysphonia)

- frequent or loose bowel movements (diarrhoea)

- painful or dry mouth, painful tongue, mouth sores (stomatitis and/or mucosal inflammation)

- feeling sick (nausea)

- vomiting

- high blood levels of bilirubin, a substance produced by the liver (hyperbilirubinaemia)

- redness, pain, blisters and swelling of the palms of the hands or soles of the feet (hand-foot skin reaction)

- rash

- hair loss (alopecia)

- weakness, lack of strength and energy, excessive tiredness and unusual sleepiness (asthenia/fatigue)

- pain

- fever

- weight loss