"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
Noctec Consumer (continued)
Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these rare but very serious side effects occur: slow/shallow breathing, mental/mood changes (such as confusion, thinking that others wish to harm you), sleep-walking, staggering walk/loss of balance, severe dizziness, fainting.
Long-term use may cause serious stomach problems (gastritis) or kidney problems. Tell your doctor immediately if any of these rare but very serious side effects occur: vomit that looks like coffee grounds, difficult/painful swallowing, black/tarry stools, severe stomach/abdominal pain, change in the amount of urine.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Noctec (chloral hydrate) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking chloral hydrate, tell your doctor or pharmacist if you are allergic to it; 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 medical history, especially of: alcohol/drug abuse, heart problems, kidney problems, liver problems, mental/mood conditions (such as depression, thoughts of suicide), irritation of the swallowing tube (esophagus), stomach problems (such as ulcer, gastritis), a certain blood/liver disease (porphyria), breathing problems (such as sleep apnea).
This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Very severe side effects from use with alcohol may include inability to wake up and slowed breathing. Drinking alcohol may also result in severe stomach upset/cramps, nausea, vomiting, headache, or flushing.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially drowsiness and confusion. These side effects can increase the risk of falling.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Additional Noctec Information
- Noctec Drug Interactions Center: chloral hydrate oral
- Noctec Side Effects Center
- Noctec Overview including Precautions
- Noctec FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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