Zeldox Consumer Medicine Information
|Condition:||Autism, Bipolar Disorder, Schizoaffective Disorder, Schizophrenia|
|Class:||Antipsychotics, Atypical antipsychotics|
|Ingredients:||ziprasidone hydrochloride, lactose monohydrate, magnesium stearate, pregelatinized starch, gelatin capsules|
About This Medication
What the Medication is Used For
ZELDOX belongs to a group of medicines called atypical antipsychotic drugs. ZELDOX is used to treat symptoms of schizophrenia and related psychotic disorders, and symptoms of acute manic or mixed episodes associated with bipolar disorder.
Schizophrenia is characterized by symptoms such as:
- hearing voices, seeing things, or sensing things that are not there (hallucinations)
- mistaken beliefs (delusions)
- unusual suspiciousness
- becoming withdrawn
- becoming depressed or anxious.
Bipolar disorder is characterized by symptoms such as:
- feeling invincible or all powerful
- inflated self-esteem,
- racing thoughts, easily lose your of train of thought
- overreaction to what you see or hear
- misinterpretation of events,
- speeded-up activity,
- talking very quickly, too loudly, or more than usual,
- decreased need for sleep
- poor judgment
ZELDOX is not a cure for your condition, but it can help manage your symptoms as you continue your treatment, and reduce the risk of relapse.
Your physician may have prescribed ZELDOX for another reason. Ask your physician if you have any questions about why ZELDOX has been prescribed for you.
What it Does
Antipsychotic medications affect the chemicals that allow communication between nerve cells (neurotransmitters). Illnesses that affect the brain, such as schizophrenia, may be due to certain chemicals in the brain being out of balance. These imbalances may cause some of the symptoms you may be experiencing. Doctors and scientists are not sure what causes these imbalances to occur. Exactly how ZELDOX works is unknown. However it seems to readjust the balance of the chemicals called dopamine and serotonin.
When it Should not Be Used
You should not take ZELDOX if you are allergic to its main ingredient, ziprasidone, or any of the ingredients listed in the "What the important non-medicinal ingredients are" section of this leaflet.
Do not Take Zeldox If
You have the following heart conditions:
- long QT syndrome (a specific heart rhythm problem)
- a recent heart attack
- severe heart failure
- certain irregularities of heart rhythm (discuss the specifics with your doctor).
The reason for this restriction is that one potential side effect of ZELDOX is that it may change the way the electrical current in your heart works, more than some other antipsychotic drugs do. The change is small and it is not known whether this will be harmful, but some other drugs that cause this kind of change have in rare cases caused dangerous heart rhythm abnormalities. This risk can be increased if you already have certain abnormal heart conditions, or if you are taking certain other medicines that may also change the way the electrical current in the heart works.
Do not Take Zeldox If
You are taking medications that should not be taken in combination with ziprasidone, for example:
- heart medication, such as dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics,
- other anti-psychotics such as mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide
- other medications such as sparfloxacin, levomethadyl acetate, dolasetron mesylate, probucol or tacrolimus.
Tell your doctor about any other medicines that you take, including non-prescription medicines and natural/herbal remedies.
The safety and efficacy of ZELDOX in children under the age of 18 years have not been established.
What the Medicinal Ingredient Is
What the Nonmedicinal Ingredients Are
Nonmedicinal ingredients include: lactose monohydrate, magnesium stearate, pregelatinized starch, and gelatin capsules.
What Dosage Forms it Comes In
Capsules containing 20, 40, 60 and 80 mg of ziprasidone.
Warnings and Precautions
Serious Warnings and Precautions
Studies with various medicines of the group to which ZELDOX belongs, when used in the elderly patients with dementia, have been associated with an increased rate of death. ZELDOX is not indicated in elderly patients with dementia.
BEFORE you use ZELDOX talk to your doctor or pharmacist if you:
- are taking or have recently taken any prescription medicines
- are taking any over-the-counter medicines you can buy without a prescription, including natural/herbal remedies
- have had any problems with your heart or any family history of heart disease
- have had any problems with your liver
- have had any problem with fainting or dizziness
- have ever had blackouts or seizures
- have diabetes or a family history of diabetes
- are pregnant, might be pregnant, or plan to get pregnant
- are breastfeeding
- are allergic to any medicines
- drink alcohol
- have ever had an allergic reaction to ziprasidone or any of the other ingredients of ZELDOX capsules
- exercise vigorously or work in hot or sunny places
- suffer from lactose intolerance because ZELDOX capsules contain lactose
- have low levels of potassium or magnesium in your blood.
- have risk factors for developing blood clots such as: a family history of blood clots, age over 65, smoking, obesity, recent major surgery (such as hip or knee replacement), immobility due to air travel or other reason, or take oral contraceptives ("The Pill").
Effects on Newborns
In some cases, babies born to a mother taking ZELDOX during pregnancy have experienced symptoms that are severe and require the newborn to be hospitalized. Sometimes, the symptoms may resolve on their own. Be prepared to seek immediate emergency medical attention for your newborn if they have difficulty breathing, are overly sleepy, have muscle stiffness, or floppy muscles (like a rag doll), are shaking, or are having difficulty feeding.
Interactions With This Medication
Because some medicines can affect how ZELDOX works, and some medicines may increase the risk of heart rhythm problems (as described in the above section "ABOUT THIS MEDICATION", it is important to tell your physician, pharmacist or other healthcare professional that you are taking ZELDOX before you start taking any other drugs, including over-the-counter medications and natural/herbal remedies.
The effects of alcohol could be made worse while taking ZELDOX. It is recommended that you do not drink alcohol while taking ZELDOX.
Proper Use of This Medication
In order for ZELDOX to help you feel better, it is very important to take it every day, exactly as your doctor has prescribed. Your doctor has decided on the best dosage for you based on your individual needs. Your doctor may increase or decrease your dose depending on your response.
- ZELDOX capsules should be swallowed whole, with a glass of water.
- The capsules should be taken with a meal.
- It is best to take ZELDOX at the same time each day.
- Do not change your dose or stop taking your medicine without your physician's approval.
Dosage directions should be followed carefully. Never exceed the prescribed dose.
- Remember to keep taking ZELDOX, even when you feel better, to avoid relapse of symptoms. ZELDOX should be taken for as long as you and your physician believe it is helping you.
- Never give ZELDOX to anyone else as this medicine has been prescribed only for you.
In case of an overdose, call your physician or poison control centre right away or go to the nearest emergency room.
If you miss a dose of ZELDOX by only a few hours, take it as soon as possible. If most of the day has passed since your missed dose, skip that dose and wait until your next scheduled dose. Do not take 2 doses at once.
Side Effects And What to Do About Them
Like any medication, ZELDOX may cause some side effects. The most common side effects of ZELDOX are:
- feeling unusually tired or sleepy
- nausea or upset stomach
- abnormal movements
- increased cough/runny nose.
Tell your doctor immediately if you experience muscle twitching or abnormal movements of the face or tongue.
It is important to tell your doctor or pharmacist if you have diarrhea, vomiting, or any other illness that can cause you to lose fluids. Your doctor may want to check your blood to make sure that you have the right amount of important salts (“electrolytes”) after such illnesses, because an imbalance in electrolytes is a risk factor for heart problems, which may occur more frequently with ZELDOX than with other anti-psychotics. Disordered eating, alcoholism, and water intoxication are also risk factors for imbalance in electrolytes.
Your doctor should check your body weight before starting ZELDOX and continue to monitor it for as long as you are being treated.
Your doctor should take blood tests before starting ZELDOX. They will monitor blood sugar, and the number of infection fighting white blood cells. Your doctor should continue to monitor your blood for as long as you are being treated.
If you have high levels of prolactin (measured with a blood test) and a condition called hypogonadism you may be at increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.
If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting, or seizures, you should seek immediate medical attention.
Since medications of the same drug class as ZELDOX may interfere with the ability of the body to adjust to heat, it is best to avoid becoming overheated or dehydrated (for example with vigorous exercise or exposure to extreme heat) while taking ZELDOX.
Because some people experience somnolence, you should avoid driving a car or operating machinery until you know how ZELDOX affects you.
Serious Side Effects how Often They Happen and What to Do About Them
|Symptom/effect||Talk with your|
|Skin rash on its own||✓|
|Muscle twitching or abnormal|
movement of your face or tongue
|Sudden weakness or numbness of|
the face, arms, or legs and speech
or vision problems
|Feeling faint, or dizzy, or lose|
consciousness, or feel a change in
the way your heart beats
|Blood clots: swelling, pain and|
redness in an arm or leg that can
be warm to touch. You may
develop sudden chest pain,
difficulty breathing and heart
|Seizure (i.e., loss of|
consciousness with uncontrollable
|Allergic reaction (symptoms|
include skin rash, hives, swelling
of throat and tongue, difficulty
|High fever with pronounced|
muscle stiffness, state of
confusion, rapid or irregular
heartbeat, profuse sweating
|Long lasting (greater than 4 hours|
in duration) and painful erection
of the penis.
|Feeling very hot and unable to|
cool down (generally as a result of
several factor together, such as
vigorous exercise, dehydration,
|New or worsening constipation||✓|
|Severe allergic reaction|
(symptoms include skin rash,
fever, chest pain and abdominal
This is not a complete list of side effects. If you have any unexpected effects while taking ZELDOX, contact your doctor or pharmacist.
How to Store It
Keep ZELDOX and all medicines out of the reach of children. Store ZELDOX capsules at controlled room temperature. (15°-30°C). If your physician tells you to stop taking ZELDOX or if your medicine has expired, return any leftover medicine to your pharmacist for proper discarding.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of the side effect, please contact your health care professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full Product Monograph, prepared for health professionals may be obtained by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001, or www.pfizer.ca