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This document outlines critical safety information and warnings associated with the use of Donnatal. Please read carefully and discuss any concerns with your healthcare provider.

• Risks to Unborn Babies: If you are pregnant or planning to become pregnant, it is crucial to inform your healthcare team. Donnatal should generally be avoided during pregnancy unless the benefits outweigh the risks, as determined by a healthcare professional. The phenobarbital component can cause withdrawal symptoms in newborns, such as weakness and sleep disturbances.

• Risk of Overheating: Donnatal can impair your body's ability to sweat, increasing the risk of overheating, fever, or heatstroke, particularly in hot weather. Ensure you stay well-hydrated by drinking plenty of fluids.

• Dependence and Withdrawal Risk: The phenobarbital in Donnatal can lead to physical dependence. It is essential to follow your prescribed dosage and avoid altering it without consulting your healthcare provider. You may be at higher risk if you have a history of substance use disorders, mental health issues, have used high doses for prolonged periods, or suddenly stop taking the medication.

Contraindications:

Do not use Donnatal if you have any of the following conditions, as it may pose serious health risks. Consult your healthcare provider if any of these apply to you:

• Glaucoma
• Urinary tract blockage
• Stomach or intestinal blockage
• Chronic constipation
• Unstable heart or bleeding disorders
• Severe ulcerative colitis with toxic megacolon
• Myasthenia gravis
• Hiatal hernia with acid reflux
• Acute intermittent porphyria
• Sensitivity to phenobarbital, leading to restlessness or excitement

Please ensure you follow this guidance and consult your healthcare provider for more personalized advice.

When taking this medication, some individuals may experience common side effects such as dizziness, drowsiness, weakness, blurred vision, dry eyes, dry mouth, nausea, constipation, and abdominal bloating. These effects are usually mild, but if they persist or worsen, you should consult a healthcare professional. To alleviate dry mouth, try sucking on sugarless hard candy, ice chips, or chewing gum, and stay hydrated. For dry eyes, artificial tears or eye lubricants may help. Prevent constipation by consuming dietary fiber, drinking adequate water, and exercising regularly; a pharmacist can advise on suitable laxatives if needed.

In some cases, more serious side effects may occur, including decreased sweating, dry or hot skin, fast or irregular heartbeat, difficulty urinating, mental or mood changes, and signs of anemia. If you experience any of these symptoms, contact a healthcare provider promptly. Seek immediate medical attention for very serious side effects like eye pain, vision changes, or slow and shallow breathing.

Although severe allergic reactions are rare, be vigilant for symptoms such as fever, swollen lymph nodes, rash, or trouble breathing. If any of these occur, urgent medical assistance is necessary. Also, be aware of serious skin reactions characterized by severe redness, blisters, or peeling. If you notice any other side effects not mentioned, contact your healthcare provider for further advice.

Phenobarbital can interact with several other drugs and substances. It may interact with medications like Darunavir, potassium supplements, sodium oxybate, and others affected by slowed digestion, such as pramlintide. It can alter the absorption of drugs like griseofulvin and certain antifungals like Ketoconazole and Itraconazole. Additionally, it affects slowly dissolving forms of medications like Digoxin.

Other substances, such as St. John's wort, can influence how phenobarbital is removed from your body, affecting its effectiveness. Conversely, phenobarbital can accelerate the elimination of other medications, potentially reducing their effectiveness. This includes drugs like artemether/lumefantrine, Atazanavir, and cobicistat, among others, as well as some calcium channel blockers like felodipine and Nimodipine.

Phenobarbital can decrease the effectiveness of hormonal contraceptives, such as pills, patches, or rings, potentially leading to unintended pregnancy. Discuss backup contraception options with your healthcare provider if needed. Any new spotting or breakthrough bleeding should be reported, as these might indicate reduced contraceptive effectiveness.

The risk of severe side effects, including slow or shallow breathing and extreme drowsiness, increases if phenobarbital is taken with other substances that cause drowsiness or breathing issues, such as opioid pain relievers, alcohol, marijuana, sleep aids, muscle relaxants, and certain antihistamines. Always inform your doctor or pharmacist about all medications and substances you are using to ensure safe use.

Check all medication labels for ingredients that may cause drowsiness or increase heart rate. Consult your pharmacist for guidance on safe use. Since phenobarbital is similar to Primidone, avoid using both medications simultaneously. Lastly, phenobarbital may interfere with certain lab tests, leading to inaccurate results. Ensure all healthcare professionals and lab technicians are aware of your phenobarbital use.