Do not use Fotivda<\/h2>\n\n\n\n- if you are allergic to tivozanib or any of the other ingredients of this medicine (listed in section 6);<\/li>
- if you use St. John’s wort (also called Hypericum perforatum, an herbal medicine used to treat mild depression and mild anxiety).<\/li><\/ul>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor, pharmacist, or nurse before using Fotivda:<\/p>\n\n\n\n
- If you have high blood pressure<\/strong>.
Fotivda can increase your blood pressure. Your doctor will monitor your blood pressure regularly. If it is too high, your doctor will give you medicine that can lower it or reduce your Fotivda- dose. If your blood pressure continues to be too high, your doctor may decide to temporarily or permanently stop your treatment with Fotivda. If you are already taking a medicine for high blood pressure and your doctor is reducing the dose of one of Fotivda or stopping treatment temporarily or permanently, your blood pressure will be checked regularly.
<\/li>- If you have or have had an aneurysm (enlargement and weakening of a vessel wall) or a rupture in a vessel wall
<\/li> - If you have problems with blood clots<\/strong>.
The treatment with Fotivda may increase the risk of developing a blood clot ( thrombosis ) in the blood vessels that could become detached, travel with the bloodstream, and clog another blood vessel.
Tell your doctor if you have ever had any of the following:- Blood clots in the lungs (with cough, chest pain, sudden shortness of breath, or blood cough),<\/li>
- Blood clots in the legs, arms, eyes, or brain (with pain or swelling in the hands and feet, impaired vision, or altered mental state)<\/li>
- Stroke, or signs and symptoms of a “ministroke” (TIA; transient ischemic attack)<\/li>
- Heart attack<\/li>
- High blood pressure<\/li>
- Diabetes<\/li>
- Major surgery<\/li>
- Multiple injuries, e.g. broken bones and damage to internal organs<\/li>
- Could not move for a long time<\/li>
- Heart failure can cause shortness of breath or swollen ankles<\/li>
- Unable to breathe, bluish skin color, fingertips or lips, restlessness, anxiety, confusion, altered state of consciousness, rapid, shallow breathing, a shining heart, or abnormally increased sweating.
<\/li><\/ul><\/li> - If you have or have had any of the following symptoms or are being treated for heart failure<\/strong>.
- Shortness of breath ( dyspnoea ) when you exert yourself or when you lie down<\/li>
- The feeling of weakness and tiredness<\/li>
- Swelling ( edema ) in the legs, ankles, and feet<\/li>
- Decreased ability to exercise physically<\/li>
- Persistent cough or wheezing breathing sound with white or pink blood-colored mucus<\/li><\/ul><\/li><\/ul>\n\n\n\n
Signs and symptoms of heart failure will be monitored as long as you take your medication. If necessary, your doctor may reduce your Fotivda dose, or stop treatment temporarily or permanently.
<\/p>\n\n\n\n
- If you have or are being treated for abnormal heart rate and abnormal heart rhythm<\/strong> ( arrhythmia or heart rhythm disorders). Your doctor will monitor how Fotivda affects your heart by recording your heart’s electrical activity (an electrocardiogram ) or by measuring the levels of calcium , magnesium, and potassium in your blood during treatment.
<\/li>- If you have problems with your liver<\/strong>. Your doctor will regularly monitor how well your liver is working before and during treatment with Fotivda (eg with blood tests) and, if necessary, prescribe you to take Fotivda less often.
<\/li>- If you have thyroid problems<\/strong> or are taking medication to treat the thyroid disease<\/strong>. The treatment with Fotivda can make the thyroid gland function worse than usual. Your doctor will regularly monitor how well your thyroid is functioning before and during treatment with Fotivda (eg with blood tests.
<\/li><\/ul>\n\n\n\nTalk to your doctor, pharmacist, or nurse when using Fotivda:<\/p>\n\n\n\n
- If you get shortness of breath or swollen ankles<\/strong>
Contact a doctor immediately as it may be a symptom of heart failure. Your doctor will monitor this and depending on how serious it is, your doctor may reduce your Fotivda dose or stop treatment temporarily or permanently.
<\/li>- If you have had bleeding problems<\/strong>
Treatment with Fotivda may increase the risk of bleeding. Contact a doctor immediately if you have bleeding problems (painful swollen stomach (abdomen), if you vomit blood, cough up blood, get black stools, blood in the urine, headaches, or if your mental state changes). It may be necessary to temporarily discontinue treatment with Fotivda.
<\/li>- If laboratory tests show that there is a protein in your urine<\/strong>
Your doctor will monitor this at the beginning and during treatment. Depending on the results, your doctor may reduce your Fotivda dose, or discontinue treatment temporarily or permanently.
<\/li>- If you have a disease in the brain called posterior reversible encephalopathy syndrome (PRES)<\/strong>
Contact a doctor immediately if you have symptoms, e.g. headache, seizures, lack of energy, confusion, blindness, or other visual or neurological disorders such as weakness in an arm or a leg. If PRES is diagnosed, your doctor will stop treatment with Fotivda.
<\/li>- If the skin on the hands or soles of the feet<\/strong> becomes dry, cracks, scales or comes off, or if it stings or stings
This may be a symptom of a condition called hand-foot-skin reaction. Your doctor will treat this condition and, depending on how serious it is, the doctor may reduce your Fotivda- dose or interrupt treatment temporarily or permanently.
<\/li>- If you have symptoms of rupture of the intestine or fistula formation<\/strong> (a hole develops in the stomach or intestine or abnormal passages form between different parts of the intestine), e.g. severe abdominal pain, chills, fever, nausea, vomiting or constipation, diarrhea, or rectal bleeding.
Your doctor will regularly monitor these symptoms during treatment with Fotivda.
<\/li>- If you need to have an operation or other form of surgery<\/strong>
Your doctor may recommend that you temporarily stop taking Fotivda if you are going to have surgery or undergo surgery, as this may affect wound healing.
<\/li><\/ul>\n\n\n\nThe printing ink on the capsule with Fotivda 890 micrograms contains tartrazine (E102)<\/strong> which may cause allergic reactions.<\/p>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
Do not<\/strong> give Fotivda to children and adolescents under 18 years of age. This medicine has not been studied in children and adolescents.<\/p>\n\n\n\nOther medicines and Fotivda<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to herbal medicines and other medicines that you take without a prescription.
<\/p>\n\n\n\n
Fotivda may work less well if taken at the same time as some other medicines. Tell your doctor if you are taking any of the following medicines, as your doctor may decide to change your medication:<\/p>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor, pharmacist, or nurse before using Fotivda:<\/p>\n\n\n\n
- If you have high blood pressure<\/strong>.
Fotivda can increase your blood pressure. Your doctor will monitor your blood pressure regularly. If it is too high, your doctor will give you medicine that can lower it or reduce your Fotivda- dose. If your blood pressure continues to be too high, your doctor may decide to temporarily or permanently stop your treatment with Fotivda. If you are already taking a medicine for high blood pressure and your doctor is reducing the dose of one of Fotivda or stopping treatment temporarily or permanently, your blood pressure will be checked regularly.
<\/li>- If you have or have had an aneurysm (enlargement and weakening of a vessel wall) or a rupture in a vessel wall
<\/li>- If you have problems with blood clots<\/strong>.
The treatment with Fotivda may increase the risk of developing a blood clot ( thrombosis ) in the blood vessels that could become detached, travel with the bloodstream, and clog another blood vessel.
Tell your doctor if you have ever had any of the following:- Blood clots in the lungs (with cough, chest pain, sudden shortness of breath, or blood cough),<\/li>
- Blood clots in the legs, arms, eyes, or brain (with pain or swelling in the hands and feet, impaired vision, or altered mental state)<\/li>
- Stroke, or signs and symptoms of a “ministroke” (TIA; transient ischemic attack)<\/li>
- Heart attack<\/li>
- High blood pressure<\/li>
- Diabetes<\/li>
- Major surgery<\/li>
- Multiple injuries, e.g. broken bones and damage to internal organs<\/li>
- Could not move for a long time<\/li>
- Heart failure can cause shortness of breath or swollen ankles<\/li>
- Unable to breathe, bluish skin color, fingertips or lips, restlessness, anxiety, confusion, altered state of consciousness, rapid, shallow breathing, a shining heart, or abnormally increased sweating.
<\/li><\/ul><\/li> - If you have or have had any of the following symptoms or are being treated for heart failure<\/strong>.
- Shortness of breath ( dyspnoea ) when you exert yourself or when you lie down<\/li>
- The feeling of weakness and tiredness<\/li>
- Swelling ( edema ) in the legs, ankles, and feet<\/li>
- Decreased ability to exercise physically<\/li>
- Persistent cough or wheezing breathing sound with white or pink blood-colored mucus<\/li><\/ul><\/li><\/ul>\n\n\n\n
Signs and symptoms of heart failure will be monitored as long as you take your medication. If necessary, your doctor may reduce your Fotivda dose, or stop treatment temporarily or permanently.
<\/p>\n\n\n\n- If you have or are being treated for abnormal heart rate and abnormal heart rhythm<\/strong> ( arrhythmia or heart rhythm disorders). Your doctor will monitor how Fotivda affects your heart by recording your heart’s electrical activity (an electrocardiogram ) or by measuring the levels of calcium , magnesium, and potassium in your blood during treatment.
<\/li>- If you have problems with your liver<\/strong>. Your doctor will regularly monitor how well your liver is working before and during treatment with Fotivda (eg with blood tests) and, if necessary, prescribe you to take Fotivda less often.
<\/li>- If you have thyroid problems<\/strong> or are taking medication to treat the thyroid disease<\/strong>. The treatment with Fotivda can make the thyroid gland function worse than usual. Your doctor will regularly monitor how well your thyroid is functioning before and during treatment with Fotivda (eg with blood tests.
<\/li><\/ul>\n\n\n\nTalk to your doctor, pharmacist, or nurse when using Fotivda:<\/p>\n\n\n\n
- If you get shortness of breath or swollen ankles<\/strong>
Contact a doctor immediately as it may be a symptom of heart failure. Your doctor will monitor this and depending on how serious it is, your doctor may reduce your Fotivda dose or stop treatment temporarily or permanently.
<\/li>- If you have had bleeding problems<\/strong>
Treatment with Fotivda may increase the risk of bleeding. Contact a doctor immediately if you have bleeding problems (painful swollen stomach (abdomen), if you vomit blood, cough up blood, get black stools, blood in the urine, headaches, or if your mental state changes). It may be necessary to temporarily discontinue treatment with Fotivda.
<\/li>- If laboratory tests show that there is a protein in your urine<\/strong>
Your doctor will monitor this at the beginning and during treatment. Depending on the results, your doctor may reduce your Fotivda dose, or discontinue treatment temporarily or permanently.
<\/li>- If you have a disease in the brain called posterior reversible encephalopathy syndrome (PRES)<\/strong>
Contact a doctor immediately if you have symptoms, e.g. headache, seizures, lack of energy, confusion, blindness, or other visual or neurological disorders such as weakness in an arm or a leg. If PRES is diagnosed, your doctor will stop treatment with Fotivda.
<\/li>- If the skin on the hands or soles of the feet<\/strong> becomes dry, cracks, scales or comes off, or if it stings or stings
This may be a symptom of a condition called hand-foot-skin reaction. Your doctor will treat this condition and, depending on how serious it is, the doctor may reduce your Fotivda- dose or interrupt treatment temporarily or permanently.
<\/li>- If you have symptoms of rupture of the intestine or fistula formation<\/strong> (a hole develops in the stomach or intestine or abnormal passages form between different parts of the intestine), e.g. severe abdominal pain, chills, fever, nausea, vomiting or constipation, diarrhea, or rectal bleeding.
Your doctor will regularly monitor these symptoms during treatment with Fotivda.
<\/li>- If you need to have an operation or other form of surgery<\/strong>
Your doctor may recommend that you temporarily stop taking Fotivda if you are going to have surgery or undergo surgery, as this may affect wound healing.
<\/li><\/ul>\n\n\n\nThe printing ink on the capsule with Fotivda 890 micrograms contains tartrazine (E102)<\/strong> which may cause allergic reactions.<\/p>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Do not<\/strong> give Fotivda to children and adolescents under 18 years of age. This medicine has not been studied in children and adolescents.<\/p>\n\n\n\n
Other medicines and Fotivda<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to herbal medicines and other medicines that you take without a prescription.
<\/p>\n\n\n\nFotivda may work less well if taken at the same time as some other medicines. Tell your doctor if you are taking any of the following medicines, as your doctor may decide to change your medication:<\/p>\n\n\n\n
- If you have had bleeding problems<\/strong>
- If you have problems with your liver<\/strong>. Your doctor will regularly monitor how well your liver is working before and during treatment with Fotivda (eg with blood tests) and, if necessary, prescribe you to take Fotivda less often.
- If you have or are being treated for abnormal heart rate and abnormal heart rhythm<\/strong> ( arrhythmia or heart rhythm disorders). Your doctor will monitor how Fotivda affects your heart by recording your heart’s electrical activity (an electrocardiogram ) or by measuring the levels of calcium , magnesium, and potassium in your blood during treatment.
- If you have or have had an aneurysm (enlargement and weakening of a vessel wall) or a rupture in a vessel wall