Zeldox (Ziprasidone)

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
• are taking any medications for heart disease or blood pressure that makes you prone to low blood pressure
• have a history of stroke or “mini-stroke”
• 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 breast-feeding
• are allergic to any medicines
• drink alcohol or use recreational drugs
• abuse drugs
• 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 white blood cell counts
• have low levels of potassium or magnesium in your blood
• are dehydrated
• 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”).

If you are a woman of child bearing potential and receiving ZELDOX you should use a reliable method of birth control.

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.

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
• constipation
• dizziness
• restlessness
• abnormal movements
• diarrhea
• rash
• 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 sleepiness with ZELDOX, you should avoid driving a car or operating machinery until you know how ZELDOX affects you.

Because some medicines can affect how ZELDOX works, and some medicines may increase the risk of heart rhythm problems, 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.

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.

Overdose

If you have taken more ZELDOX capsules than your doctor has recommended, contact your regional Poison Control Centre and talk to your doctor right away or go to your nearest hospital emergency department. Take the medication package with you.

Missed dose:

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.