Donnatal 16.2 mg-0.1037 mg/5 mL (5 mL) oral elixir

Generic name:
Belladonna alkaloids/phenobarbital - oral

Pronunciation
(bell-a-DON-a al-KA-loyd/FEE-noe-BAR-bi-tal)

This product contains several medications: belladonna alkaloids (made up of the drugs hyoscyamine, atropine, and scopolamine) and phenobarbital. Belladonna alkaloids help to reduce the symptoms of stomach and intestinal cramping. They work by slowing the natural movements of the gut and by relaxing the muscles in the stomach and intestines. Belladonna alkaloids belong to a class of drugs known as anticholinergics/antispasmodics. Phenobarbital helps to reduce anxiety. It acts on the brain to produce a calming effect. Phenobarbital belongs to a class of drugs known as barbiturate sedatives.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to relieve the symptoms of irritable bowel syndrome.

Take this medication by mouth as directed by your doctor. If you are taking the immediate-release tablets or liquid form of this medication, take it as directed by your doctor, usually 3 to 4 times a day.

If you are using the liquid, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

If you are taking the extended-release tablets, take them as directed by your doctor, usually every 12 hours. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Swallow the whole tablet without crushing or chewing.

Antacids lower the absorption of this medication. If you are taking an antacid, take it at least 2 hours apart from this medication.

The dosage is based on your medical condition and response to treatment. Children's dosage is also based on weight.

Do not increase your dose or take this drug more often without your doctor's approval. Your condition will not improve any faster and the risk of serious side effects may increase.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as anxiety, muscle twitching, shakiness, dizziness, worsening weakness, nausea, vomiting). Withdrawal from the phenobarbital can be severe and include seizures and (rarely) death. To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

When this medication is used for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. Talk with your doctor if this medication stops working well.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if your condition lasts or gets worse.

Dizziness, drowsiness, weakness, blurred vision, dry eyes, dry mouth, nausea, constipation, and abdominal bloating may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. To relieve dry eyes, consult your pharmacist for artificial tears or other eye lubricants.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

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:

• decreased sweating
• dry/hot/flushed skin
• fast/irregular heartbeat
• loss of coordination
• trouble speaking
• fainting
• mental/mood changes (such as confusion, agitation, unusual excitement, depression, rare thoughts of suicide)
• difficulty urinating
• decreased sexual ability
• signs of anemia (such as unusual tiredness, pale skin)
• easy bruising/bleeding

Get medical help right away if you have any very serious side effects, including:

• eye pain/swelling/redness
• vision changes (such as seeing rainbows around lights at night)
• slow/shallow breathing

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:

• fever
• swollen lymph nodes
• 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 this medication, tell your doctor or pharmacist if you are allergic to hyoscyamine, atropine, or scopolamine; or to anti-seizure medications (such as carbamazepine, fosphenytoin, oxcarbazepine, phenytoin, primidone); 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:

• personal or family history of glaucoma (angle-closure type)
• problems with urination (due to enlarged prostate, a blocked urinary tract)
• other stomach/intestinal problems (such as slow gut, blockage, ulcerative colitis, infection, little/no stomach acid, ileostomy/colostomy patients with diarrhea)
• overactive thyroid
• heart problems (such as coronary artery disease, angina, heart failure, fast/irregular heartbeat, heart problems due to severe bleeding)
• high blood pressure
• heartburn problems (such as acid reflux, hiatal hernia, esophagus problems)
• certain nervous system problem (autonomic neuropathy)
• myasthenia gravis
• liver problems
• kidney problems
• a certain blood disorder (porphyria)
• restlessness or excitement during past use of phenobarbital
• breathing/lung problems
• personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
• mental/mood conditions (such as depression, thoughts of suicide, psychosis)

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

The liquid form of this product may contain alcohol or sugar. Caution is advised if you have diabetes, alcohol dependence, liver disease, or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, confusion, unusual excitement, constipation, and urination problems. Drowsiness and confusion can increase the risk of falling.

Children may be more sensitive to the side effects of this drug. This drug can often cause excitement instead of drowsiness in young children.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using belladonna alkaloids/phenobarbital. This medication may harm an unborn baby. Ask about reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) while using this medication. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

See also the How to Use section.

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.

Some products that may interact with this drug include:

• darunavir
• potassium tablets/capsules
• sodium oxybate
• drugs that are affected by slowed gut movement (such as pramlintide)

This medication may affect the absorption of other products such as griseofulvin, certain azole anti-fungal drugs (ketoconazole, itraconazole), slowly dissolving forms of digoxin, among others.

Other medications can affect the removal of phenobarbital from your body, which may affect how this product works. Examples include St. John's wort, among others.

Phenobarbital can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include artemether/lumefantrine, asunaprevir, atazanavir, cobicistat, etravirine, lurasidone, ranolazine, rilpivirine, sofosbuvir, sorafenib, voriconazole, certain calcium channel blockers (such as felodipine/nimodipine), among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products, diet aids) because they may contain ingredients that cause drowsiness or a fast heartbeat. Ask your pharmacist about using those products safely.

Phenobarbital is very similar to primidone. Do not use medications containing primidone while using phenobarbital.

This medication may interfere with certain lab tests (such as gastric secretion tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

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 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: large pupils, hot/dry skin, fever, severe dizziness, severe drowsiness, severe thirst, mental/mood changes (such as confusion, unusual excitement), fast/irregular heartbeat, muscle weakness, inability to move (paralysis), slowed breathing, fainting, inability to wake up, seizures.

Do not share this medication with others.

Management of digestive disorders may include lifestyle changes such as stress reduction programs, exercise, stopping smoking, and dietary changes, in addition to medication. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

If this medication is used for a long time, lab and/or medical tests (such as blood counts, liver function) may 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 near the time of 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. Avoid freezing the liquid. Do not store in the bathroom. 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.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.