What you need to know before you take Surenal

Do not take Surenal

• If you are allergic to sunitinib or any of the other ingredients of Surenal (listed in section 6).

Warnings and precautions

Talk to your doctor before taking Surenal:

• If you have high blood pressure. Surenal can raise blood pressure. Your doctor may check your blood pressure during treatment with Surenal, and you may be treated with medicines to reduce the blood pressure, if
• If you have or have had blood disease, bleeding problems, or bruising. Treatment with Surenal may lead to a higher risk of bleeding and/or gastrointestinal bleeding, respiratory bleeding, urinary tract bleeding, cell death and bleeding in the brain; and may lead to changes in the number of certain cells in the blood which may lead to anaemia or decrease neutrophil and platelet count, 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 Surenal.
• If you have heart problems. Surenal can cause heart problems. Tell your doctor if you have shortness of breath, or have swollen feet and ankles. It may lead to a disease of the heart muscle that makes it difficult to pump blood (cardiomyopathy).
• If you have abnormal heart rhythm changes. Surenal can cause abnormality of your heart rhythm and QT prolongation on ECG. Your doctor may obtain electrocardiograms to evaluate for these problems during your treatment with Surenal. Tell your doctor if you feel dizzy, faint, or have abnormal heartbeats while taking Surenal.
• 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 one side of your body, trouble talking, headache or dizziness while on treatment with
• If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel
• If you have or have had damage to the smallest blood vessels known as thrombotic microangiopathy (TMA).
• If you have thyroid glands problems. Surenal can cause thyroid gland problems. Tell your doctor if you get tired more easily, generally feel colder than other people, or your voice deepens, you gain or loss weight, increase appetite, sweating whilst taking Surenal. Your thyroid function should be checked before you take Surenal 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 disorders. Tell your doctor if you develop any of the following signs and symptoms: pain in the area of the stomach (upper abdomen) or back, nausea, vomiting and fever. These may be caused by inflammation of the pancreas or
• If you have or have had liver problems. Tell your doctor if you develop any of the following signs and symptoms during Surenal treatment: itching, yellow eyes or skin, dark urine, pale stool and pain or discomfort in the right upper stomach area, fever, nausea. Your doctor should do blood tests to check your liver function before and during treatment with Surenal, and as clinically indicated.
• If you have or have had kidney problems. Your doctor will monitor your kidney Baseline urinalysis is recommended, and patients should be monitored for the development or worsening of proteinuria.
• If you are going to have surgery or if you had an operation recently. Surenal may affect the way your wounds heal. You will usually be taken off Surenal if you are having an operation. Your doctor will decide when to start Surenal

 

You may be advised to have a dental check-up before you start treatment with Surenal.

 

• If you have or have had osteonecrosis of jaw, 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 Surenal 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
• If you have or have had skin and subcutaneous tissue disorders. While you are on this medicine “pyoderma gangrenosum” (painful skin ulceration) or “necrotizing 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 Surenal discontinuation. Severe skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, and 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 Patients should be advised that depigmentation of the hair or skin may occur during treatment with Surenal. Other possible dermatological effects may include dryness, thickness or cracking of the skin, blisters, or rash on the palms of the hands and soles of the feet.
• 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, decreased alertness, altered mental functioning.
• 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 minimize 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).
• If you have had Tumor lysis syndrome (TLS). A condition that occurs when a large number of cancer cells die within a short period, releasing their contents in to the blood; your doctor may consider stopping the medication.
• If you have had serious infections, inform your doctor.
• If fistula formation (when inflammation causes sores, or ulcers, to form on the inside wall of the intestine or nearby organs) occurs, Surenal treatment should be interrupted.
• If undesirable reactions (hypersensitivity) lead to rapid swelling, of the area beneath the skin or mucosa (angioedema – swelling of the face and throat), notify your doctor at the earliest.
• If you are pregnant or plan to become pregnant. Surenal can harm your unborn baby.

Females who are able to become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment with Surenal.
• You should use effective birth control (contraception) during treatment and for at least 4 weeks after your last dose of Surenal.
• Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Surenal.

Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 7 weeks after your last dose of Surenal.

Surenal may cause fertility problems in males and females. Tell your doctor if this is a concern for you.

• If you are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with Surenal and for at least 4 weeks (1 month) after the last dose.

 

Children and adolescents

Surenal is not recommended for people aged under 18.

 

Other medicines and Surenal

 

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 Surenal in your body. You should inform your doctor if you are taking medicines containing the following active substances:

• ketoconazole, itraconazole: used to treat fungal
• erythromycin, clarithromycin, rifampicin: used to treat
• Ritonavir: used to treat
• 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

 

Surenal with food and drink

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

 

Pregnancy and breast-feeding

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 Surenal.

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

 

Fertility

Male and female fertility may be compromised by treatment with Sunitinib.

 

Driving and using machines

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

 

Surenal contains sodium

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