BORTEZOMIB 3.5 MG EUROLAB can have side effects.
Not all side effects reported for BORTEZOMIB 3.5 MG EUROLAB are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BORTEZOMIB 3.5 MG EUROLAB, please consult your health care provider for advice.
If any of the following happens, stop taking BORTEZOMIB 3.5 MG EUROLAB and tell your doctor immediately or go to the casualty department at your nearest hospital:
- If you develop sepsis. Symptoms include fever, difficulty breathing, low blood pressure, fast heart rate and mental confusion.
- Headache, fever, neck stiffness, seizures, confusion that can be signs of a brain infection or inflammation (meningitis).
- Fever, bruises or bleeding, swollen legs, decreased urine, confusion, sleepiness or seizures that can be signs of Thrombotic microangiopathy that can be life-threatening.
- Allergic reaction (hypersensitivity), symptoms can include swelling of the hands, feet, ankles, face, lips and mouth or throat which can cause difficulty in swallowing or breathing.
- Feeling lightheaded, difficulty breathing, wheezing, fast heartbeat, confusion, clammy skin. All can be signs of anaphylactic shock.
- Symptoms of nausea, vomiting, diarrhoea, muscle cramps, weakness and tiredness can be a sign of a life-threatening condition called Tumour lysis syndrome.
- Hypovolemia (liquid portion of the blood is too low). Symptoms include weakness, fatigue, fainting and dizziness.
- Numbness or weakness in part of the face, difficulty speaking or difficulty walking, loss of consciousness, double vision, nausea, vomiting, severe headache, trouble speaking, drooping eyelid, neck pain or stiffness, sudden lightheadedness with or without weakness.
- Heart failure, heart attack, chest pain or discomfort, heart palpitations, rapid, reduced or irregular heartbeat, wheezing, shortness of breath, fainting, dizziness, low blood pressure, sweating, pale skin, lightheadedness or fainting, confusion, swollen legs and feet, tiredness and weakness. All can be signs of heart complications.
- Leg pain or swelling, red or discoloured skin on the leg.
- Confusion, unconsciousness, cold, pale and clammy skin, thirst, muscle cramps, decrease in blood pressure (signs of cardiogenic shock).
- Lung embolism or fluid in lungs. Symptoms include shortness of breath, rapid breathing, low oxygen in the body, chest pain, cough, collapsed lung.
- Gastrointestinal perforation – symptoms include chills, fever, nausea and vomiting.
- Liver toxicity or bleeding – symptoms include a rash, stomach pain or swelling, nausea and vomiting, tiredness, dark-coloured urine, yellow skin and eyes, loss of appetite, general sense of feeling unwell, confusion.
- Life threatening skin condition, characterised by a blistering and peeling of the skin (Toxic skin eruption or Toxic epidermal necrolysis).
- Steven-Johnson syndrome - flu-like symptoms appear first, then a painful rash appears that spreads and blisters follow.
- Rhabdomyolysis – a life-threatening condition caused by muscle breakdown and muscle death. Symptoms include dark, reddish urine, a decreased amount of urine, weakness and muscle aches.
- Sudden kidney failure.
These are all very serious side effects listed above. If you have them, you may have had a serious reaction to BORTEZOMIB 3.5 MG EUROLAB. You may need urgent medical attention or hospitalisation.
Treatment with BORTEZOMIB 3.5 MG EUROLAB can very frequently cause a decrease in the numbers of red and white blood cells and platelets in your blood. Therefore, you will have to take regular blood tests before and during your treatment with BORTEZOMIB 3.5 MG EUROLAB, to check your blood cell counts regularly. You may experience a reduction in the number of:
- Platelets, which make you be more prone to bruising, or to bleeding without obvious injury (e.g., bleeding from your bowels, stomach, mouth and gums or bleeding in the brain or bleeding from the liver).
- Red blood cells, which can cause anaemia, with symptoms such as tiredness and paleness.
- White blood cells may make you more prone to infections or flu-like symptoms.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
- Coughing, breathing difficulties or tightness in the chest, shortness of breath, chest pain or discomfort, dizziness, fever or chills, coughing up blood, abnormally rapid breathing or hyperventilation, feeling lightheaded, confusion and dry mouth. These are all symptoms of conditions affecting the lungs.
- Abnormal bumps, unexplained fever, night sweats or unintentional weight loss.
- Bone pain, enlarged liver or spleen.
- Cancerous (malignant) or non-cancerous (benign) growth/cyst.
- A scaly, red rash in areas of the body that usually are not exposed to the sun, sleeplessness.
- Sudden flank or abdominal pain, blood in urine, low blood pressure and shock.
- Cool, numb limbs and muscle pain are symptoms due to a blood clot that blocks blood flow.
- Chronic kidney failure. Symptoms are gradual that includes feeling tired, high blood pressure, loss of appetite, or water-electrolyte imbalance.
These are all serious side effects. You may need urgent medical attention.
Tell your doctor if you notice any of the following:
Frequent side effects:
- Shingles (localised including around the eyes or spread across the body).
- Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, coughing with phlegm, flu-like illness.
- Painful blisters in or around the mouth.
- Skin rash, peeling, small bumps that may be itching or vaginal infection resulting in abnormal discharge, all can be a result of a fungal infection.
- Decreased appetite.
- Dehydration.
- Diabetes mellitus. Symptoms include increased thirst, frequent urination, extreme hunger, unexplained weight loss, tiredness, irritability, blurred vision.
- Mood, and anxiety disorders and disturbances.
- Sleep disorders and disturbances.
- Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage.
- Abnormal sense of touch.
- Stabbing, burning, and often severe pain due to an irritated or damaged nerve.
- Loss of consciousness.
- Dizziness.
- Altered or impaired sense of taste.
- Headache.
- Eye swelling, abnormal or blurred vision.
- Infection of the outermost layer of the eye and the inner surface of the eyelids (conjunctivitis).
- Vertigo (spinning sensation).
- Low blood pressure, sudden fall of blood pressure on standing which may lead to fainting.
- High blood pressure.
- Minor bleeding of the nose.
- Nausea and vomiting, diarrhoea, constipation, indigestion.
- Painful swelling and sores inside the mouth, bloating, throat pain, abdominal pain (including gastrointestinal and splenic pain), oral disorder, flatulence.
- Gastrointestinal bleeding.
- Stomach pain, dark urine, feeling tired, yellowing of your skin or eyes, light-coloured stools, loss of appetite, nausea and vomiting. All can be signs of abnormal liver enzymes.
- Rash, itching, redness of the skin or dry skin.
- Musculoskeletal pain or spasms.
- Limb pain, muscle weakness.
- Fever, feeling tired, weakness or lack of energy.
- Water retention, chills, pain, general discomfort.
- Weight loss.
Less frequent side effects:
- Fever, chills, muscle aches, cough, congestion, runny nose, headaches and tiredness.
- Urinary tract infection, the flu, skin, ear and tooth infections, cellulitis.
- Tiredness, fever, inflamed throat, swollen lymph nodes in the neck, tenderness around spleen and liver area and a rash can be all signs of Epstein-Barr virus.
- Painful, itchy sores on the genital area.
- Tonsillitis – symptoms include a sore throat, difficulty swallowing and tender lymph nodes.
- Ear infection that causes redness, swelling and tenderness around the ear, with possible fever, ear pain and discharge.
- Chronic tiredness, sleep abnormalities, joint and muscle pain.
- Bloody stools, or bleeding from mucosal membranes, e.g., mouth, vagina.
- Small, red, bumps on the face, neck, and upper back.
- Angioedema (fluid retention) – painless swelling underneath the skin, including arms and legs.
- Amyloidosis (a rare disease that occurs when an abnormal protein, called amyloid, builds up in your organs. Symptoms depend on which organs are affected. They may include swelling, fatigue and weakness, shortness of breath, and numbness, tingling or pain in the hands or feet).
- Rash, arthritis, and fever, that can be signs of an immune complex reaction.
- Fatty hump between the shoulders, a rounded face and pink or purple stretch marks.
- Overactive thyroid. Symptoms include unexpected weight loss, rapid or irregular heartbeat, sweating and irritability.
- Nausea and vomiting, headache, confusion, weakness and fatigue due to a condition in which high levels of a hormone causes the body to retain water.
- Underactive thyroid. Symptoms include tiredness, cold sensitivity, constipation, dry skin and unexplained weight gain.
- Failure to thrive.
- Gout - symptoms include severe pain, redness and swelling in joints, often the big toe.
- Increased appetite.
- Alcohol intolerance.
- Mental or psychotic disorder, including suicidal thoughts.
- Hallucination, mental confusion and emotional disruption.
- Restlessness.
- Adjustment disorder.
- Low libido.
- Paralysis, seizures, falling, poor coordination, change in speech, movement disorders, abnormal or change in, or reduced sensation (feeling, hearing, tasting, smelling), difficulty swallowing, using arms, hands, legs or feet, abnormal reflexes.
- Attention disturbance, memory loss, trembling, twitching, seizures, involuntary shaking or muscle movement.
- Visual loss, headaches, limb weakness or numbness.
- Occasional sharp, burning, shooting or burning pain, sensitivity to touch and temperature, itching, numbness and headaches can all be signs of post herpetic neuralgia after a shingles rash has healed.
- Uncontrollable urge to move your legs.
- Migraines.
- Pain radiating from lower back through your hips and buttocks and down each leg.
- Smell disorder.
- Dizziness, fainting upon standing, sensation of fainting, inability to alter heart rate, sweating abnormalities.
- Memory or language problems, decreased mental function, mood changes that can be signs of weakening of muscles.
- Cerebrovascular disorders.
- Pain, numbness, weakness or tingling of an extremity that can be due to spinal cord compression.
- Drooling.
- A red, painful lump near the edge of the eyelid that may look like a boil or pimple.
- Bleeding eye, eye/eyelid infection or inflammation, dry eye, eye irritation or painful eye, eye discharge or excessive watering of eye.
- Eye conditions/disorders that affects vision (lesion on cornea, retinitis, damage to optic nerve of the eye).
- Bulging eye, inflammation of the lacrimal eye gland.
- Different degrees of visual impairment (double vision, blind spot or partial vision loss, eye sensitivity to light, eye floaters or flashes, blindness).
- Ear disorders, including hearing impairment (up to including deafness), ringing in ears, ear discomfort, bleeding in ears.
- Sudden, severe vertigo.
- Low blood pressure, shortness of breath and lightheadedness that can be signs of cardiac tamponade.
- Flushing, increased blood flow causing redness, warmth or burning pain (including in the hands, feet and eyes).
- Inadequate blood circulation, particularly the legs and feet.
- Chest pain that worsens during breathing, hiccups, runny nose.
- Disorder of the voice, wheezing.
- Discomfort or temporary inability to breathe, especially when lying down or during sleeping.
- Widening and rounding of the tips of the fingers or toes.
- Throat tightness, dry throat, increased upper airway secretion, throat irritation.
- Inflammation of the pancreas or intestines, vomiting blood.
- Lip swelling or pain, painful sores in mouth, chapped lips.
- Gastrointestinal obstruction, abdominal discomfort, stomach pain.
- Bleeding or infected gums, coated tongue, swollen tongue, overgrown gums.
- Acid reflux, difficulty or painful swallowing, burping, a feeling of early fullness.
- Irritable bowel syndrome/ spastic colon.
- Dry or bad taste in mouth, mouth lesions, painful jaw and/or compromised movement, making it difficult to chew.
- Pain, tenderness, rigid abdominal muscles, fever, nausea and vomiting. All can be signs of peritonitis (inflammation of the abdominal wall).
- Abdominal swelling, chest pain when eating.
- Unable to control bowel movements, weak anal sphincter.
- Change of bowel habit or abnormal faeces, including hardened, accumulated faeces at the rectum or colon, passage of mucus or other liquid from the anus.
- A small tear in the lining of the anus, painful spasms of the anal sphincter or muscles of the rectum.
- Yellow skin or eyes (jaundice), nausea, vomiting, stomach pain and/or swelling, feeling tired, fever, dark urine and light-coloured bowel movements. These symptoms can all be signs of liver conditions.
- Bleeding in the oesophagus, gallstones.
- Painful, red, scaly or itchy skin mostly on arms, face, neck and scalp.
- Red, itchy or scaly rash, pimple-like eruptions or inflammation of the skin.
- Hair, or nail disorders.
- Tiny round, brown-purple spots due to bleeding under the skin or bruising of the skin.
- Photosensitivity or rare, non-cancerous papular or plaque-like eruptions on the skin (commonly involve sun-exposed areas), hand-foot syndrome (redness, swelling and blistering on the palms of the hands and soles of the feet).
- Excessive sweating, night or cold sweats.
- Bed sores, acne, blisters, small raised tender bumps or open round sores.
- Netlike pattern of reddish-blue skin discoloration and pigmentation disorder.
- Deep thickening of the skin.
- Muscle twitching, joint swelling, arthritis, joint stiffness.
- Muscle weakness, cramps, lack of energy and feeling tired.
- Bone disorder.
- Muscle and connective tissue infection and inflammation.
- Blood in urine, urinary retention or abnormalities when urinating.
- Frequent or non-frequent urination, painful urination, shortness of breath, feeling tired, nausea and vomiting, swelling of face, feet or ankles, muscle cramps, confusion, weakness, excessive drinking of fluids.
- Abnormal vaginal bleeding, genital pain or sores in vaginal area.
- Erectile disfunction, testicle disorder, swelling or inflammation of the prostate gland, testicle pain and tenderness.
- Breast disorder in women.
- Pelvic pain.
- General physical health deterioration.
- Injection site reaction, bleeding, inflammation or pain.
- Chest pain or discomfort, feeling cold.
- Abnormal walking, change in thirst, irritability.
- Catheter related complication, catheter site pain.
- Feeling of change in body temperature, sensation of foreign body.
- Hernia, impaired healing, inflammation, tenderness.
- Ulcers or sores on the lining of your stomach or small intestine.
- Increase in weight or a sensation of heaviness.
- Fall, bruises, fractures, face or joint injury, burns, laceration or skin wound, procedural pain.
If you notice any side-effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get side effects, talk to your doctor. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website or to Eurolab (Pty) Ltd. by email: [email protected]. By reporting side effects, you can help provide more information on the safety of BORTEZOMIB 3.5 MG EUROLAB.
