Procysbi

Nausea, vomiting, stomach/abdominal pain, fever, loss of appetite, breath/skin odor, tiredness, drowsiness, dizziness, and diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion, depression, lack of concentration), deep sleep, unusual tiredness, headache, hearing problems (such as buzzing/ringing in the ears), eye/vision problems (such as blurred vision, loss of vision, eye pain), skin problems (such as thinning of the skin, fragile skin, stretch marks, easy bruising), bone problems (such as bone/joint/back pain, leg pain, broken bones, overly flexible joints).

Get medical help right away if you have any very serious side effects, including: seizures, severe/bloody diarrhea, signs of bleeding or ulcers in the stomach/intestines (such as black/bloody stools, severe stomach/abdominal pain, vomit that looks like coffee grounds).

Cysteamine can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking cysteamine, tell your doctor or pharmacist if you are allergic to it; or to penicillamine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your or your child's medical history, especially of: liver disease, stomach/intestine problems (such as bleeding, ulcers), low white blood cell count.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Products that contain bicarbonate or carbonate may decrease the effect of this medication if taken at the same time. If you are also taking a product that contains bicarbonate or carbonate, separate the time that you take a dose by at least one hour before or after the time that you take cysteamine delayed-release.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Lab and/or medical tests (such as cystine or cysteamine levels, complete blood count, kidney/liver function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is less than 4 hours before the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep this medication in its original container and do not remove the desiccant. Keep the bottle tightly closed. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.