Chlordiazepoxide and Clidinium

Chlordiazepoxide may increase the risk of serious or life-threatening breathing problems, sedation, or coma if used along with certain medications. Tell your doctor if you are taking or plan to take certain opiate medications for cough such as codeine (in Triacin-C, in Tuzistra XR) or hydrocodone (in Anexsia, in Norco, in Zyfrel) or for pain such as codeine (in Fiorinal), fentanyl (Actiq, Duragesic, Subsys, others), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Astramorph, Duramorph PF, Kadian), oxycodone (in Oxycet, in Percocet, in Roxicet, others), and tramadol (Conzip, Ultram, in Ultracet). Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take the combination of chlordiazepoxide and clidinium with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care immediately: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Chlordiazepoxide may be habit forming. Do not take a larger dose, take it more often, or for a longer time than your doctor tells you to. Tell your doctor if you have ever drunk large amounts of alcohol, if you use or have ever used street drugs, or have overused prescription medications. Do not drink alcohol or use street drugs during your treatment. Drinking alcohol or using street drugs during your treatment with chlordiazepoxide also increases the risk that you will experience these serious, life-threatening side effects. Also tell your doctor if you have or have ever had depression or another mental illness.

Chlordiazepoxide may cause a physical dependence (a condition in which unpleasant physical symptoms occur if a medication is suddenly stopped or taken in smaller doses), especially if you take it for several days to several weeks. Do not stop taking this medication or take fewer doses without talking to your doctor. Stopping the combination of chlordiazepoxide and clidinium suddenly can worsen your condition and cause withdrawal symptoms that may last for several weeks to more than 12 months. Your doctor probably will decrease your combination of chlordiazepoxide and clidinium dose gradually. Call your doctor or get emergency medical treatment if you experience any of the following symptoms: unusual movements; ringing in your ears; anxiety; memory problems; difficulty concentrating; sleep problems; seizures; shaking; muscle twitching; changes in mental health; depression; burning or prickling feeling in hands, arms, legs or feet; seeing or hearing things that others do not see or hear; thoughts of harming or killing yourself or others; overexcitement; or losing touch with reality.

The combination of chlordiazepoxide and clidinium is used along with other medications to treat peptic ulcers, irritable bowel syndrome (IBS; a condition that causes stomach pain, bloating, constipation, and diarrhea), and enterocolitis (swelling in the intestines). Chlordiazepoxide is in a class of medications called benzodiazepines. It works by decreasing abnormal electrical activity in the brain. Clidinium is in a class of medications called anticholinergics. It helps to decrease stomach spasms and cramps.

The combination of chlordiazepoxide and clidinium comes as a capsule to be taken by mouth. It usually is taken three or four times a day, before meals and at bedtime. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take chlordiazepoxide and clidinium exactly as directed.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with chlordiazepoxide and clidinium and each time you fill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking chlordiazepoxide and clidinium,

• tell your doctor and pharmacist if you are allergic to chlordiazepoxide, clidinium, any other medications, or any of the ingredients in chlordiazepoxide and clidinium capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking chlordiazepoxide and clidinium. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate).
• tell your doctor if you have glaucoma, prostatic hypertrophy (an enlarged prostate), or bladder neck obstruction (a blockage of your bladder that causes problems with urination). Your doctor will probably tell you not to take chlordiazepoxide and clidinium.
• tell your doctor if you have or have ever had vision problems, urinary problems, or kidney or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking this medication, call your doctor immediately. Clidinium-containing medications may cause fetal harm.
• tell your doctor if you are breastfeeding. Clidinium-containing medications may decrease your breast milk production.
• talk to your doctor about the risks and benefits of taking chlordiazepoxide and clidinium if you are 65 years of age or older. Older adults should not usually take chlordiazepoxide and clidinium because it is not as safe or effective as other medication(s) that can be used to treat the same condition.
• you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how it affects you.

If you take several doses per day and miss a dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Chlordiazepoxide and clidinium may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• weakness or tiredness
• excitement
• anger
• dry mouth
• blurred vision or vision changes
• constipation
• nausea
• difficulty urinating
• changes in sex drive or ability
• irregular menstrual cycles
• coordination problems
• confusion

Some side effects can be serious. If you experience any of the following symptoms or those in the IMPORTANT WARNING section, call your doctor immediately:

• slow or difficult speech
• shuffling walk
• persistent, fine tremor or inability to sit still
• difficulty breathing or swallowing
• rash
• swelling of the arms, hands, feet, ankles, or lower legs
• yellowing of the skin or eyes

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• sleepiness
• confusion
• coma
• slow reflexes
• dry mouth
• blurred vision
• urinary hesitancy
• constipation

Keep all appointments with your doctor. Your doctor will order certain lab tests to check your response to chlordiazepoxide and clidinium.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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