Sindaxel

Sindaxel Side Effects

paclitaxel

Manufacturer:

Teva

Distributor:

KLN Pharma
Full Prescribing Info
Side Effects
Like all medicines, Paclitaxel can cause side effects, although not everybody gets them. The following side effects may occur after treatment with Paclitaxel infusion.
The most frequent side effects are hair loss and decreased blood cell count. The hair grows back and the blood cell count returns to normal after the patient have finished the paclitaxel treatment.
If any of the following happens, tell the doctor immediately: Any abnormal bruising, bleeding, or signs of infections such as a sore throat and high temperature.
Severe allergic reaction - the patient may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and the patient may feel the patient is going to faint.
Breathlessness and dry cough due to damage to the lung.
Reaction at the injection site, e.g. local swelling, pain, redness.
Very common (affects more than 1 out of 10 people): An effect on the bone marrow, which can cause decreased numbers of some blood cells. This may cause anaemia. It can also lead to infections, mainly urinary tract and upper respiratory tract infections with reported cases of fatal outcome.
Decreased number of blood platelets and bleeding.
Milder allergic (hypersensitivity) reactions, such as flushing and rash.
Nerve problems affecting the hands and/or feet (peripheral neuropathy), which can cause tingling feelings in the skin, numbness and/or pain.
Low blood pressure.
Feeling sick (nausea), being sick (vomiting) and diarrhoea.
Hair loss.
Muscle or joint pain.
Inflammation of areas such as the lining of the mouth.
Common (affects more than 1 out of 100 people): Slow heart beat (pulse).
Mild changes in nail and skin which soon disappear.
Painful swelling and inflammation where the injection is given which may cause tissue hardening (occasionally cellulitis, thickening and scarring of the skin (skin fibrosis), death of skin cells (skin necrosis)).
Changes in blood tests that check how the liver is working.
Uncommon (affects less than 1 out of 100 people): A state of shock resulting from blood poisoning.
Serious allergic (hypersensitivity) reactions with e.g. decreased or increased blood pressure, swelling of the face, difficulty in breathing, skin rash, chills, back pain, chest pain, fast heart beat, abdominal pain, pain in arms and legs, sweating.
Serious heart problems like heart muscle degeneration (cardiomyopathy), serious changes in the heart's rhythm even with fainting. Heart attack.
Increased blood pressure.
Blood clot (thrombosis), inflammation of a vein in connection with blood clots.
Yellowing of the skin (jaundice).
Rare (affects less than 1 out of 1,000 people): Pneumonia.
Reduced number of a type of white blood cell with fever (febrile neutropenia).
Serious allergic (anaphylactic) reaction.
Effects on the nerves, which can cause muscle weakness in the arms and legs.
Difficulty in breathing, fluid on the lungs, inflammation of the lungs and other lung problems (lung fibrosis, pulmonary embolism), markedly impaired pulmonary function (respiratory failure).
Itching, rash and reddened skin.
Weakness, high temperature (fever), dehydration, oedema, feeling ill.
Blood poisoning.
Blockage of the intestines, penetration of the wall of the small intestine or large bowel, inflammation of the lining of the belly (peritoneum), inflammation of the intestine caused by inadequate blood supply, inflammation of the pancreas.
Increased level of the substance creatinine in the blood.
Very rare (occurs with less than 1 out of 10,000 of the users): Acute leukaemia (a type of blood cancer), myelodysplastic syndrome (a diverse collection of blood cell disorders).
Life threatening allergic reaction (anaphylactic shock).
Loss of appetite, shock due to decreased blood pressure, cough.
Effects on the nervous system which can cause paralysis of the intestines (gut) and a decrease in blood pressure when standing up or sitting up from a lying down position, fits (epileptic seizures), cramps, confusion, dizziness, alteration in brain function or structure, headache, loss of the ability to coordinate muscular movement.
Problems with eyesight and visual disturbances, usually in patients given larger doses.
Reduction or loss of hearing, ringing in the ears (tinnitus), vertigo.
Abnormal heart rhythm (atrial fibrillation, supraventricular tachycardia).
A blood clot in the mesenteric artery, pseudomembranous colitis (an infection of the colon caused by specific bacteria), inflammation of the oesophagus, constipation. Collection of fluid in the abdomen (belly).
Severe inflammation of the large bowel presenting with fever, watery or bloody diarrhoea, and crampy abdominal pain (neutropenic colitis).
Death of liver cells (necrosis of the liver), confusion and other effects (hepatic encephalopathy) caused by changes in the way the liver works (both with reported cases of fatal outcome).
Hives (urticaria), scaling and shedding of the skin usually accompanied by redness.
Severe inflammatory eruption of the skin and mucous membranes (severity ranging from erythema multiforme to Stevens-Johnson syndrome to the most serious toxic epidermal necrolysis (TEN)).
Disintegration of nails. Hands and feet should be protected against sunshine during the treatment time.
If any of the side effects gets serious, please tell the doctor or pharmacist.
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