- Do not share your HYCODAN with other people.
- Keep HYCODAN in a safe place away from children.
- increased sleepiness
- confusion
- difficulty breathing
- shallow breathing
- limpness
- Overdose and death due to medicine dosing errors. Overdose and death can happen if you measure the wrong dose of HYCODAN. Always use an accurate milliliter (mL) measuring device to measure the correct amount of HYCODAN. Do not use a household teaspoon to measure your medicine. You may accidentally take too much. You can ask your pharmacist for the measuring device you should use and how to measure the correct dose.
- Breathing problems (respiratory depression) that can lead to death and opioid withdrawal can happen if you start taking or stop taking other medicines while taking HYCODAN, including:
- certain antibiotics
- certain medicines to treat a fungal infection
- certain medicines to treat Human Immunodeficiency Virus (HIV)-1 infection, Acquired Immune Deficiency Syndrome (AIDS), or Hepatitis C
- rifampin
- carbamazepine
- phenytoin
- Do not take benzodiazepines or any medicine that can cause drowsiness or sleepiness during treatment with HYCODAN.
- Do not drink alcohol or take prescription or over-the-counter medicines that contain alcohol during treatment with HYCODAN.
- HYCODAN is a prescription medicine used in adults 18 years of age and older to treat a cough. HYCODAN contains hydrocodone, an opioid (narcotic) cough suppressant.
- HYCODAN is a federal controlled substance (C-II) because it contains hydrocodone that can be abused or lead to dependence. Keep HYCODAN in a safe place to prevent misuse and abuse. Selling or giving away HYCODAN may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
- have severe breathing problems (respiratory depression) or breathing problems caused by asthma. See "What is the most important information I should know about HYCODAN?"
- have a blockage (obstruction) in your bowel such as a paralytic ileus.
- are allergic to hydrocodone, homatropine, or any of the ingredients in HYCODAN. See the end of this Medication Guide for a complete list of ingredients in HYCODAN.
- have a drug addiction
- have lung or breathing problems
- have a fever and are coughing up mucus
- have had a recent head injury
- have had a brain tumor or other brain problems
- have or have had seizures
- have pain in your stomach-area (abdomen)
- have constipation or other bowel problems
- have bile duct or pancreas problems
- have glaucoma (increased pressure in eyes)
- have prostate problems
- have problems with your urinary tract or difficulty urinating
- have kidney or liver problems
- have adrenal gland problems
- have low blood pressure
- plan to have surgery
- are pregnant or plan to become pregnant. HYCODAN can harm your unborn baby. See "What is the most important information I should know about HYCODAN?"
- are breastfeeding or plan to breastfeed. Hydrocodone passes into your breast milk and can cause serious side effects in your baby including increased sleepiness, breathing problems (respiratory depression), and death. You and your healthcare provider should decide if you will take HYCODAN or breastfeed. You should not do both. See "What should I avoid while taking HYCODAN?"
- plan to have children. HYCODAN may affect the ability to have a child in females and males (fertility problems). It is not known if these fertility problems will be reversible, even after you stop taking HYCODAN. Talk to your healthcare provider if this is a concern for you.
- take pain medicines such as opioids (narcotics).
- take cold or allergy medicines that contain antihistamines or cough suppressants.
- drink alcohol.
- take muscle relaxants.
- take certain medicines used to treat mood, anxiety, psychotic or thought disorders, or depression, including monoamine oxidase inhibitors (MAOIs), tricyclics, selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), or antipsychotics.
- take medicines to lower your blood pressure.
- take water pills (diuretics).
- take medicines called "anticholinergics" used to treat certain health problems including asthma, chronic obstructive pulmonary disease (COPD), or stomach problems.
- See "What is the most important information I should know about HYCODAN?"
- Take HYCODAN exactly as your healthcare provider tells you to take it. Do not change your dose without talking to your healthcare provider.
- Take HYCODAN by mouth only.
- Take HYCODAN using an accurate milliliter (mL) measuring device. If you do not have one, ask your pharmacist to give you a measuring device to help you measure the correct amount of HYCODAN. Do not use a household teaspoon to measure your medicine. You may accidently take too much.
- Do not overfill the measuring device.
- Rinse the measuring device with water after each use.
- If you take too much HYCODAN, call your healthcare provider or go to the nearest hospital emergency room right away.
- Tell your healthcare provider if your cough does not get better within 5 days of treatment with HYCODAN.
- Avoid driving a car or operating machinery during treatment with HYCODAN. HYCODAN can cause you to be drowsy, slow your thinking and motor skills, and affect your vision.
- Do not drink alcohol during treatment with HYCODAN. Drinking alcohol can increase your chances of having serious side effects.
- are pregnant. Use of HYCODAN during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Tell your healthcare provider right away if you are pregnant or think you may be pregnant.
- are breastfeeding. Use of HYCODAN while breastfeeding can cause severe breathing problems (respiratory depression) in your breastfed infant that could be life-threatening.
- take a medicine called a monoamine oxidase inhibitor (MAOI). Avoid taking an MAOI within 14 days after you stop taking HYCODAN. Avoid starting HYCODAN if you stopped taking an MAOI in the last 14 days.
- See "What is the most important information I should know about HYCODAN?"
- Bowel problems including severe constipation or stomach pain. See "Who should not take HYCODAN?"
- Increased pressure in your head (intracranial). Avoid the use of HYCODAN if you have a head injury or have been told that you have changes in the tissue of your brain (brain lesions) or increased pressure in your head.
- Increased risk of seizures in people with seizure disorders. If you have a seizure disorder, HYCODAN may increase how often you have a seizure.
- Low blood pressure. A sudden drop in blood pressure can happen in some people during treatment with HYCODAN and this may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). Your risk of having this problem may be increased if you take HYCODAN with certain other medicines that lower blood pressure. If you have any of these symptoms while taking HYCODAN, sit or lie down. Do not change your body position too fast. Get up slowly from sitting or lying down.
- Adrenal gland problems. HYCODAN can cause serious and life-threatening adrenal gland problems. Your healthcare provider may do blood tests to check for adrenal gland problems. Call your healthcare provider right away if you have any of these symptoms:
- nausea
- vomiting
- not wanting to eat (anorexia)
- fatigue
- weakness
- dizziness
- low blood pressure
- sleepiness
- confusion
- coordination problems
- decrease in mental and physical performance
- lack of energy
- lightheadedness
- dizziness
- headache
- dry mouth
- nausea
- vomiting
- constipation
- Store HYCODAN at room temperature between 68°F to 77°F (20°C to 25°C).
- Store HYCODAN tablets in a tightly closed container, in a dry, cool place away from heat or direct sunlight.
- Keep HYCODAN and all medicines out of the reach of children.
Revised: 12/2021
Document Id: c1633e0f-dae2-4bd4-ac4d-de8498ee9398
Set id: 901d4115-f71a-4681-bd0e-c9b691151b78
