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Here is important safety and warning information regarding the use of Donnatal. Please read carefully and discuss any concerns with your healthcare provider.

• Risks During Pregnancy: The use of Donnatal during pregnancy is generally discouraged unless a healthcare provider assesses that the benefits outweigh the risks. The medication contains phenobarbital, which may cause withdrawal symptoms such as weakness and sleep disturbances in newborns. If you are pregnant or planning to become pregnant, inform your healthcare team immediately.

• Body Temperature Regulation: Donnatal can impair your ability to sweat, increasing the risk of overheating, fever, or heatstroke, especially in warm environments. It is crucial to stay well-hydrated by drinking plenty of water while on this medication.

• Dependency and Withdrawal Risks: Phenobarbital, an ingredient in Donnatal, can lead to physical dependence. It is important to take the medication exactly as prescribed and to consult your prescriber before making any changes to the dosage. Risks of dependence increase with a history of substance use disorder, mental health issues, prolonged use of high doses, or abrupt discontinuation.

Contraindications: Do not use Donnatal if you have any of the following conditions, as it may pose significant health risks. Consultation with a healthcare provider is necessary if any of these apply:

• Glaucoma
• Urinary tract blockage
• Intestinal or stomach 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

This information is intended to ensure safe use of Donnatal and should be reviewed with your healthcare professional for personalized advice.

When taking this medication, you may experience some common side effects such as dizziness, drowsiness, weakness, blurred vision, dry eyes, and dry mouth. These effects are generally mild and manageable. To alleviate dry mouth, consider using sugarless candy, ice chips, or chewing gum, and stay hydrated. For dry eyes, artificial tears may provide relief. Constipation can also occur; increasing dietary fiber, staying hydrated, and regular exercise can help, and a pharmacist can advise on suitable laxatives.

While many people do not encounter serious issues, it's important to be aware of potential severe side effects. These include decreased sweating, dry or flushed skin, fast or irregular heartbeat, difficulty urinating, and decreased sexual ability. Mental changes like confusion, agitation, and rarely, thoughts of suicide, should also be noted. If you experience symptoms such as fainting, loss of coordination, or trouble speaking, contact a healthcare provider immediately.

There are very serious side effects that require urgent attention, including eye pain or changes in vision, slow or shallow breathing, or signs of a serious allergic reaction such as swelling of the face or throat, severe dizziness, or trouble breathing. In such cases, seek medical help without delay.

Additional side effects might include headaches, nervousness, nausea, vomiting, muscle pain, loss of taste, and trouble sleeping. Should you notice any unusual symptoms or side effects not listed, please consult with your healthcare provider for advice. Remember, while side effects can happen, they are not experienced by everyone and your health provider will have assessed that the benefits of this medication outweigh the risks.

Phenobarbital can interact with several other medications and substances, potentially altering their effectiveness or causing side effects. Medications such as darunavir, potassium tablets/capsules, sodium oxybate, and pramlintide can interact with phenobarbital. This drug may change how other medications are absorbed, including griseofulvin, and some azole antifungals like ketoconazole and itraconazole, as well as slow-dissolving forms of digoxin.

Certain drugs can impact how phenobarbital is removed from your body, which can affect its effectiveness. St. John's wort is one example. Conversely, phenobarbital can speed up the elimination of other drugs, potentially reducing their effectiveness. These include artemether/lumefantrine, atazanavir, cobicistat, etravirine, lurasidone, ranolazine, rilpivirine, sofosbuvir, sorafenib, voriconazole, and certain calcium channel blockers like felodipine and nimodipine.

Phenobarbital may also decrease the effectiveness of hormonal birth control methods such as pills, patches, or rings, which could result in pregnancy. It's important to talk with your doctor or pharmacist about using additional contraception methods. Report any unexpected spotting or bleeding to your doctor, as these could indicate reduced birth control effectiveness.

Taking phenobarbital with other substances that cause drowsiness or breathing problems can increase the risk of serious side effects like slow breathing or severe drowsiness. These substances include opioid pain or cough medications (e.g., codeine, hydrocodone), alcohol, marijuana, sleep or anxiety medications (e.g., alprazolam, lorazepam, zolpidem), muscle relaxants (e.g., carisoprodol, cyclobenzaprine), and antihistamines (e.g., cetirizine, diphenhydramine).

Be sure to check the labels on all your medications, including those for allergies, colds, and diet aids, as they might contain ingredients that cause drowsiness or a rapid heartbeat. Consult your pharmacist about safe use. Avoid using medications containing primidone while taking phenobarbital, as they are very similar.

Lastly, phenobarbital may interfere with certain laboratory tests, such as gastric secretion tests, leading to inaccurate results. Always inform your healthcare providers and lab personnel that you are using this medication.