Donnatal Extentabs

DRUG DESCRIPTION

Each Donnatal Extentabs® (belladonna alkaloids, phenobarbital) tablet contains:

Phenobarbital, USP (3/4 gr.) ................................ 48.6 mg
Hyoscyamine Sulfate, USP ................................... 0.3111 mg
Atropine Sulfate, USP ............................................ 0.0582 mg
Scopolamine Hydrobromide, USP ...................... 0.0195 mg

Each Donnatal Extentabs® (belladonna alkaloids, phenobarbital) tablet contains the equivalent of three Donnatal® tablets. Extentabs® are designed to release the ingredients gradually to provide effects for up to twelve (12) hours.

In addition, each tablet contains the following inactive ingredients: Anhydrous Lactose, Calcium Sulfate Granular, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Lactose Monohydrate, Magnesium Stearate, and Stearic Acid. Film Coating and Polishing Solution contains: D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, Hydroxypropyl Methylcellulose, Polydextrose, Polyethylene Glycol, Titanium Dioxide, and Triacetin. The printing ink contains Titanium Dioxide.

What are the possible side effects of belladonna alkaloids and phenobarbital (Bellatal, Donnatal, D-Tal)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • diarrhea;
  • painful or difficult urination;
  • fast or pounding heartbeats;
  • blurred vision with eye pain, or seeing halos around lights;
  • feeling like you might pass out; or
  • ...

Read All Potential Side Effects and See Pictures of Donnatal Extentabs »

What are the precautions when taking belladonna alkaloids, phenobarbital (Donnatal Extentabs)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to hyoscyamine, atropine, scopolamine, or phenobarbital; 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: glaucoma, enlarged prostate, problems with urination due to 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, congestive heart failure, fast/irregular...

Read All Potential Precautions of Donnatal Extentabs »


Donnatal Extentabs Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, weakness, blurred vision, dry eyes, dry mouth, nausea, constipation, and abdominal bloating may occur. If any of these effects persist or worsen, 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 a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: decreased sweating, dry/hot/flushed skin, fast/irregular heartbeat, loss of coordination, slurred speech, fainting, mental/mood changes (such as confusion, agitation, unusual excitement, depression, rare thoughts of suicide), eye pain, vision changes, difficulty urinating, decreased sexual ability, slow/shallow breathing.

Tell your doctor immediately if any of these rare but serious side effects occur: signs of anemia (such as unusual tiredness, pale skin), signs of infection (such as fever, persistent sore throat), easy bruising/bleeding.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to hyoscyamine, atropine, scopolamine, or phenobarbital; 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: glaucoma, enlarged prostate, problems with urination due to 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, congestive 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, drug/alcohol abuse, mental/mood conditions (such as depression, thoughts of suicide, psychosis).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

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 which can increase your risk for heat stroke, a very serious condition. Avoid activities that might cause you to overheat (such as doing strenuous work/exercise in hot weather, using hot tubs). Drink plenty of fluids, and dress lightly while in hot weather or when exercising. If you become overheated, stop exercising and promptly seek cooler shelter. Seek immediate medical attention if you develop a fever, 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.

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

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for details. Hormonal birth control products (such as pills, patch, ring) may not be effective if taken with this medication (see also Drug Interactions section). Discuss reliable forms of birth control with your doctor.

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


Donnatal Extentabs Patient Information Including Side Effects

Brand Names: Bellatal, Donnatal, D-Tal

Generic Name: belladonna alkaloids and phenobarbital (Pronunciation: BEL a DON a AL ka loids and FEEN oh BAR bi tal)

  • What is belladonna alkaloids and phenobarbital (Donnatal Extentabs)?
  • What are the possible side effects of belladonna alkaloids and phenobarbital (Donnatal Extentabs)?
  • What is the most important information I should know about belladonna alkaloids and phenobarbital (Donnatal Extentabs)?
  • What should I discuss with my healthcare provider before taking belladonna alkaloids and phenobarbital (Donnatal Extentabs)?
  • How should I take belladonna alkaloids and phenobarbital (Donnatal Extentabs)?
  • What happens if I miss a dose (Donnatal Extentabs)?
  • What happens if I overdose (Donnatal Extentabs)?
  • What should I avoid while taking belladonna alkaloids and phenobarbital (Donnatal Extentabs)?
  • What other drugs will affect belladonna alkaloids and phenobarbital (Donnatal Extentabs)?
  • Where can I get more information?

What is belladonna alkaloids and phenobarbital (Donnatal Extentabs)?

Phenobarbital is in a group of drugs called barbiturates (bar-BIT-chur-ates). Phenobarbital slows the activity of your brain and nervous system.

Belladonna alkaloids produce many effects in the body, including reduced muscle spasms in the digestive or urinary tract, and reduced fluid secretions from certain glands or organs.

The belladonna alkaloids included in this medication include atropine, hyoscyamine, and scopolamine.

The combination of belladonna alkaloids and phenobarbital is used to treat irritable bowel syndrome and ulcers in the intestine.

Belladonna alkaloids and phenobarbital may also be used for other purposes not listed in this medication guide.

What are the possible side effects of belladonna alkaloids and phenobarbital (Donnatal Extentabs)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • diarrhea;
  • painful or difficult urination;
  • fast or pounding heartbeats;
  • blurred vision with eye pain, or seeing halos around lights;
  • feeling like you might pass out; or
  • mouth sores, red or bleeding gums, or tooth decay (with long-term use).

Less serious side effects may include:

  • drowsiness;
  • blurred vision, increased sensitivity to light;
  • dry mouth;
  • decreased taste sensation;
  • decreased sweating or urination;
  • headache, dizziness, weakness;
  • sleep problems (insomnia);
  • nausea, vomiting, constipation, bloating;
  • feeling restless or excited; or
  • impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about belladonna alkaloids and phenobarbital (Donnatal Extentabs)?

Phenobarbital may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Do not take this medication together with a potassium supplement unless your doctor has told you to.

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by belladonna alkaloids and phenobarbital.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol while taking this medication or you could have increased dizziness and drowsiness.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Belladonna alkaloids and phenobarbital can decrease perspiration and you may be more prone to heat stroke.

Call your doctor if your symptoms do not improve, or if they get worse.

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