4th SIDE EFFECTS? (Copaxone syringe; leaflet Jan 2010)
.
Like all medicines, Copaxone 20 mg / ml cause side effects, although not everybody gets them.
allergic reactions (hypersensitivity)
rarely can cause serious allergic reactions.
interrupt in the event one of the following responses to treatment with Copaxone 20 mglml immediately and
notify your doctor immediately or find a hospital close to you:
- skin rash (red spots or hives);
- swelling of the eyelids, lips or face,
- sudden shortness of breath,
- convulsive (seizure),
- impotence.
Other reactions immediately following the injection
Within minutes after an injection of Copaxone 20 mg / ml reactions occur with at least one of the following
complaints. Most of these reactions do not cause problems and go back within a half hour
. However, should any of the following symptoms last longer than 30 minutes,
notify your doctor immediately or seek a hospital in your area on
- Flushing (reddening of the skin with a hot sensation in the chest or face),
- tightness in the chest area,
- shortness of breath,
-. Palpitations and increased heart rate
The following adverse events occurred during treatment with Copaxone side effects
in four. occurred landmark clinical trials by more than 2% more often in the Copaxone group than in the placebo group
are highlighted:
Very common (more than 1 in 10)
- Skin reactions at the injection site, including:. erythema , pain, hives, itching, tissue swelling
(Edema), inflammation and hypersensitivity at the injection site. These reactions are not uncommon and
usually go back in time.
Other very common side effects:
- Gastrointestinal disorders: nausea.
- General disorders: weakness, chest pain, nonspecific pain.
- Infectious diseases: infections, flu-like symptoms.
- Diseases of Musculoskeletal: joint pain, back pain.
- Diseases of the Nervous System: Headache.
- Psychiatric disorders: anxiety, depression.
- Skin: Rash.
Common (less than 1 in 10 patients, but more than 1 in 100)
- Blood: swollen lymph nodes.
- Heart disease: increased heart rate, palpitations.
- Ear: Functional disorders of the ears.
- eye disorders: dysfunction of the eyes, double vision.
- Gastrointestinal disorders: disorders of the anus and rectum, constipation, dental caries
, dyspepsia, dysphagia, bowel incontinence, vomiting.
- general disorders: chills, local Reactions, water retention, swollen ankles, swollen face
., Fever, loss of tissue at the injection site.
- Immune system disorders: hypersensitivity reactions.
- infectious diseases: respiratory infections, stomach, ear, colds, cold sores,
tooth abscess, fungal infection of the vagina.
- Hepatobiliary disorders: abnormal liver function test.
continuation of "Common (less than 1 in 10 patients, but more than 1 in 100)"
- Metabolic disorders: Weight gain, loss of appetite.
- diseases of skeletal muscle: Neck pain.
- benign neoplasms and malignant diseases: formation of new skin tissue, formation of new tissue.
- diseases of the nervous system: taste disturbances, increased blood vessel or muscle tone, migraine,
speech disorder, fainting, trembling.
- Psychiatric disorders: nervousness.
- Renal and urinary disorders: urinary retention, urinary urgency, frequent urination.
Uncommon (less than 1 in 100, but more than 1 in 1,000)
- Blood: Changes in the number or type of white blood cells, lower
Platelet counts, spleen enlargement.
- heart disease: cardiac arrhythmias (extra heart beats, slow or rapid pulse). - Endocrine disorders
: enlargement of the thyroid gland, hyperthyroidism.
-eye disease: lens opacity (cataracts), damage to the cornea, dry eye, eye hemorrhage,
drooping eyelid, dilated pupils, blurred vision or visual field loss.
- Gastrointestinal disorders: inflammation of the small or large intestine, colon polyps, eructation, esophageal ulcer
, gingivitis (gum disease), Bleeding of the rectum,
enlargement of the salivary gland.
- general disorders: cysts, hangover feeling of general hypothermia (hypothermia), non-specific inflammation,
tissue destruction (necrosis) at the injection site, mucosal disorders. - Infections: abscess, boils,
inflammation of the skin or kidney, shingles.
- injury and poisoning: post-vaccination syndrome.
- Hepatobiliary disorders: biliary stones, enlargement of the liver.
- Metabolism and nutrition disorders: alcohol intolerance, gout, increased fat in the blood,
changes in the blood (increased sodium, decreased ferritin).
- diseases of skeletal muscle: swollen joints (arthritis or osteoarthritis),
reduction in muscle mass.
- benign neoplasms or malignant diseases: skin cancer.
- Nervous system: numbness and pain sensation in the hand, cognitive impairment, convulsions,
writing disorder, dyslexia, muscle spasm, altered muscle tone, nerve irritation, muscle weakness,
paralysis, nystagmus, foot drop, mental and physical paralysis (stupor),
visual field defects.
- pregnancy, childbirth and perinatal disorders: miscarriage.
- Psychiatric disorders: abnormal dreams, confusion, elevated mood, manic reactions,
hallucinations, hostility, personality disorder, suicide attempt.
- Renal and urinary disorders: bloody urine and other Harnwegsleiden, kidney stones.
- Sex organs: swelling of the breasts, priapism, erectile dysfunction, pelvic prolapse,
disorders of the vagina, prostate or testicular, vaginal bleeding, abnormal cervical smear
.
- Respiratory diseases: disorders of the lung, throat tightness, respiratory arrest, excessive
accelerated or depressed breathing (hyperventilation), nose bleeding.
- diseases of the skin: swelling of the skin and / or mucous membranes (angioedema), contact dermatitis
the skin, skin nodules, nodules Rose (erythema nodosum).
- Vascular: varicose veins.
Rare (1 to 10 of 10,000) and very rare (less than 1 in 10,000)
- severe allergic reactions.
please inform your doctor or pharmacist if any of the side effects get serious
impaired or if you notice any side effects not listed in this leaflet
.
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