Before you begin taking a medication, be sure to inform your doctor of
any medical conditions or Allergies you may have, any medications you are
taking, whether you are pregnant or breast-feeding, and any other significant
facts about your health. These factors may affect how you should take this
medication.
Behavioural and mood changes: Sandoz Entacapone may cause mood and
psychiatric changes, including hallucinations, hypersexuality, pathological gambling,
and increased libido. Tell your doctor as soon as possible if you notice any
unusual changes in your behaviour, have thoughts of harming yourself, or feel
depressed.
If you have depression or a history of depression, discuss with your doctor
how Sandoz Entacapone may affect your medical condition, how your medical
condition may affect the dosing and effectiveness of Sandoz Entacapone, and
whether any special monitoring is needed. If you experience symptoms of
depression such as poor concentration, changes in weight, changes in sleep,
decreased interest in activities, or notice them in a family member who is
taking Sandoz Entacapone contact your doctor as soon as possible.
Diarrhea: Diarrhea is a common side effect of Sandoz Entacapone. It may
appear as early as the first week of starting treatment or many months after
starting treatment. For some people, the diarrhea causes weight loss. If you
notice any weight loss or have excessive diarrhea, contact your doctor.
Dizziness/reduced alertness: Sandoz Entacapone may cause low blood
pressure or dizziness and lightheadedness when rising from a lying or sitting
position. People taking medications that can cause dizziness should rise slowly
from sitting or lying down to reduce the possibility of severe dizziness or fainting.
Do not drive, operate machinery, or perform other hazardous tasks until you
have determined how Sandoz Entacapone affects you.
Fructose intolerance: Sandoz Entacapone contains fructose. If you have
fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase
insufficiency, you should not take Sandoz Entacapone. Talk to your doctor.
Heart disease: Sandoz Entacapone may cause an increase in the risk of
heart attack or heart disease. If you have a history of heart disease, discuss
with your doctor how Sandoz Entacapone may affect your medical condition, how
your medical condition may affect the dosing and effectiveness of this
medication, and whether any special monitoring is needed.
Liver function: Liver disease or reduced liver function may cause
Sandoz Entacapone to build up in the body, causing side effects. Sandoz Entacapone
is not recommended for people with liver problems.
Melanoma: People with Parkinson's disease may be at increased risk of
developing melanoma (a type of Skin Cancer). It is not known if this increased
risk is due to Parkinson's disease or to the medications used to treat
Parkinson's disease. Your doctor will monitor you for skin cancer while you are
taking Sandoz Entacapone. Talk to your doctor if you have any concerns.
Neuroleptic malignant syndrome (NMS): Sandoz Entacapone may cause a
potentially fatal reaction called neuroleptic malignant syndrome (NMS). If you
develop symptoms of NMS, such as muscle stiffness, fever, confusion, sweating,
or irregular heartbeat, stop taking Sandoz Entacapone and seek immediate medical
attention.
Prostate Cancer: A recent study has shown an increase in the number
of cases of prostate cancer among men who have taken levodopa/carbidopa with or
without entacapone for approximately 3 years. Although it is not clear whether
this increased risk of prostate cancer is due to the medication or something
else, it is important to have regular prostate examinations while taking
medications for Parkinson's Disease.
Rhabdomyolysis (muscle breakdown): Occasionally, Sandoz Entacapone may
cause rapid breakdown of muscle tissue. If you notice signs of muscle weakness
or pain, high body temperature, unexpected bruising, confusion, or difficulty
passing urine, contact your doctor immediately.
Stopping Sandoz Entacapone: Stopping Sandoz Entacapone too quickly can
cause potentially life-threatening side effects. Before stopping this
medication, discuss the risks and benefits with your doctor. Do not stop taking
Sandoz Entacapone until you have spoken with your doctor first.
Sudden onset of sleep: There are reports of people who take this
combination medication treatment (entacapone with levodopa - carbidopa) falling
asleep without prior warning or drowsiness. If you have a sleep disorder,
discuss this with your doctor. If you experience drowsiness while taking this
medication, avoid driving or using machinery.
Pregnancy: Sandoz Entacapone should not be used during pregnancy unless
the benefits outweigh the risks. If you become pregnant while taking this
medication, contact your doctor immediately.
Breast feeding: It is not known if entacapone passes into breast
milk. If you are a breast-feeding mother and are using Sandoz Entacapone, it may
affect your baby. Talk to your doctor about whether you should continue
breast-feeding.
Children: The safety and effectiveness of using Sandoz Entacapone have
not been established for children less than 18 years of age.
