• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

Talk to your doctor before taking Sunitinib:

• If you have high blood pressure. Sunitinib can raise blood pressure. Your doctor may check your blood pressure during treatment with Sunitinib, and you may be treated with medicines to reduce the blood pressure, if needed.
• If you have or have had blood disease, bleeding problems, or bruising. Treatment with Sunitinib may lead to a higher risk of bleeding or lead to changes in the number of certain cells in the blood which may lead to anaemia or affect the ability of your blood to clot. If you are taking warfarin or acenocoumarole, medicines which thin the blood to prevent blood clots, there may be a greater risk of bleeding. Tell your doctor if you have any bleeding while on treatment with Sunitinib.
• If you have heart problems. Sunitinib can cause heart problems. Tell your doctor if you feel very tired, are short of breath, or have swollen feet and ankles.
• If you have abnormal heart rhythm changes. Sunitinib can cause abnormality of your heart rhythm. Your doctor may obtain electrocardiograms to evaluate for these problems during your treatment with Sunitinib. Tell your doctor if you feel dizzy, faint, or have abnormal heartbeats while taking Sunitinib.
• If you have had a recent problem with blood clots in your veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis. Call your doctor immediately if you get symptoms such as chest pain or pressure, pain in your arms, back, neck or jaw, shortness of breath, numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness while on treatment with Sunitinib.
• If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
• If you have or have had damage to the smallest blood vessels known as thrombotic microangiopathy (TMA). Tell your doctor if you develop fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, vision loss, and seizures.
• If you have thyroid glands problems. Sunitinib can cause thyroid gland problems. Tell your doctor if you get tired more easily, generally feel colder than other people, or your voice deepens whilst taking Sunitinib. Your thyroid function should be checked before you take Sunitinib and regularly while you are taking it. If your thyroid gland is not producing enough thyroid hormone, you may be treated with thyroid hormone replacement.
• If you have or have had pancreatic or gallbladder disorders. Tell your doctor if you develop any of the following signs and symptoms: pain in the area of the stomach (upper abdomen), nausea, vomiting, and fever. These may be caused by inflammation of the pancreas or gallbladder.
• If you have or have had liver problems. Tell your doctor if you develop any of the following signs and symptoms of liver problems during Sunitinib treatment: itching, yellow eyes or skin, dark urine, and pain or discomfort in the right upper stomach area. Your doctor should do blood tests to check your liver function before and during treatment with Sunitinib, and as clinically indicated.
• If you have or have had kidney problems. Your doctor will monitor your kidney function.
• If you are going to have surgery or if you had an operation recently. Sunitinib may affect the way your wounds heal. You will usually be taken off Sunitinib if you are having an operation. Your doctor will decide when to start Sunitinib again.
• You may be advised to have a dental check-up before you start treatment with Sunitinib.
  • If you have or have had pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth, tell your doctor and dentist immediately.
  • If you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with Sunitinib in particular when you are also receiving or have received intravenous bisphosphonates. Bisphosphonates are medicines used to prevent bone complications that may have been given for another medical condition.
• If you have or have had skin and subcutaneous tissue disorders. While you are on this medicine "pyoderma gangrenosum" (painful skin ulceration) or “necrotising fasciitis” (rapidly spreading infection of the skin/soft tissue that may be life-threatening) may occur. Contact your doctor immediately if symptoms of infection occur around a skin injury, including fever, pain, redness, swelling, or drainage of pus or blood. This event is generally reversible after sunitinib discontinuation. Severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) have been reported with the use of sunitinib, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. The rash may progress to widespread blistering or peeling of the skin and may be life-threatening. If you develop a rash or these skin symptoms, seek immediate advice from a doctor.
• If you have or have had seizures. Notify your doctor as soon as possible if you have high blood pressure, headache, or loss of sight.
• If you have diabetes. Blood sugar levels in diabetic patients should be checked regularly in order to assess if antidiabetic medicine’s dosage needs to be adjusted to minimise the risk of low blood sugar. Notify your doctor as soon as possible if you experience any signs and symptoms of low blood sugar (fatigue, palpitations, sweating, hunger and loss of consciousness).

Sunitinib is not recommended for people aged under 18.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and even those not prescribed.

Some medicines can affect the levels of Sunitinib in your body. You should inform your doctor if you are taking medicines containing the following active substances:

• ketoconazole, itraconazole – used to treat fungal infections
• erythromycin, clarithromycin, rifampicin –used to treat infections
• ritonavir –used to treat HIV
• dexamethasone – a corticosteroid used for various conditions (such as allergic/breathing disorders or skin diseases)
• phenytoin, carbamazepine, phenobarbital – used to treat epilepsy and other neurological conditions
• herbal preparations containing St. John’s Wort (Hypericum perforatum) – used to treat depression and anxiety

You should avoid drinking grapefruit juice while on treatment with Sunitinib.

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

If you might get pregnant, you should use a reliable method of contraception during treatment with Sunitinib.

If you are breast-feeding, tell your doctor. You should not breast-feed during treatment with Sunitinib.

If you experience dizziness or you feel unusually tired, take special care when driving or using machines.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

If you have accidentally taken too many capsules, talk to your doctor straight away. You may require medical attention.

Do not take a double dose to make up for a forgotten dose.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is sunitinib. Each capsule contains sunitinib malate equivalent to 12.5 mg, 25 mg, 37.5 mg or 50 mg sunitinib. The other ingredients are:

• Capsule content: mannitol (E421), croscarmellose sodium, starch, pregelatinized and magnesium stearate.
• Capsule shell: gelatin, purified water, titanium dioxide (E171), red iron oxide (E172) [only for 12.5 mg; 25 mg and 50 mg], black iron oxide (E172) [only for 25 mg and 50 mg], yellow iron oxide (E172) [only for 25 mg, 37.5 mg and 50 mg].
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), titanium dioxide (E171) [only for 12.5 mg; 25 mg and 50 mg], black iron oxide (E172) [only for 37.5 mg].

Sunitinib 12.5 mg is supplied as hard gelatin capsules (approximately 15 mm) with orange opaque body imprinted with "6" and orange opaque cap imprinted with "MS" in white ink.

Sunitinib 25 mg is supplied as hard gelatin capsules (approximately 16 mm) with orange opaque body imprinted with "7" and caramel opaque cap imprinted with "MS" in white ink.

Sunitinib 37.5 mg is supplied as hard gelatin capsules (approximately 16 mm) with yellow opaque body imprinted with "8" and yellow opaque cap imprinted with "MS" in black ink.

Sunitinib 50 mg is supplied as hard gelatin capsules (approximately 18 mm) with caramel opaque body imprinted with "9" and caramel opaque cap imprinted with "MS" in white ink.

It is available in plastic bottles with desiccant of 28 or 30 capsules and in perforated unit dose blisters containing 14x1, 28x1 or 30x1 capsules.

Not all pack sizes may be marketed.