Se-Donna PB Hyos

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Severe side effects may be more likely to occur in infants and children, especially those with spastic paralysis or brain damage. Unusual excitement, nervousness, restlessness, or irritability and unusual warmth, dryness, and flushing of skin are more likely to occur in children, who are usually more sensitive to the effects of belladonna alkaloids. Also, when belladonna alkaloids are given to children during hot weather, a rapid increase in body temperature may occur. In addition, the barbiturate in this medicine could cause some children to become hyperactive.

Geriatric

Confusion or memory loss; constipation; difficult urination; drowsiness; dryness of mouth, nose, throat, or skin; and unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of belladonna alkaloids and barbiturates. Also, eye pain may occur, which may be a sign of glaucoma.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ambenonium
• Atazanavir
• Boceprevir
• Cobicistat
• Darunavir
• Dasabuvir
• Elvitegravir
• Ombitasvir
• Paritaprevir
• Potassium
• Ranolazine
• Rilpivirine
• Ritonavir
• Telaprevir
• Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Alfentanil
• Alprazolam
• Amobarbital
• Anisindione
• Aprobarbital
• Axitinib
• Bosutinib
• Bromazepam
• Bromopride
• Buprenorphine
• Bupropion
• Butabarbital
• Butalbital
• Butorphanol
• Calcifediol
• Carbinoxamine
• Carisoprodol
• Carmustine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorzoxazone
• Clarithromycin
• Clobazam
• Clonazepam
• Clorazepate
• Clozapine
• Cobimetinib
• Codeine
• Daclatasvir
• Dantrolene
• Deferasirox
• Deflazacort
• Delavirdine
• Diazepam
• Dicumarol
• Dihydrocodeine
• Donepezil
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Doxylamine
• Dronedarone
• Elbasvir
• Erlotinib
• Eslicarbazepine Acetate
• Estazolam
• Ethchlorvynol
• Etonogestrel
• Etravirine
• Fentanyl
• Fluconazole
• Flunitrazepam
• Flurazepam
• Grazoprevir
• Halazepam
• Hydrocodone
• Hydromorphone
• Ifosfamide
• Imatinib
• Ketazolam
• Ledipasvir
• Levorphanol
• Lopinavir
• Lorazepam
• Lormetazepam
• Meclizine
• Medazepam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Methoxyflurane
• Midazolam
• Mifepristone
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nifedipine
• Nimodipine
• Nitrazepam
• Olaparib
• Orlistat
• Oxazepam
• Oxycodone
• Oxymorphone
• Pentazocine
• Pentobarbital
• Periciazine
• Phenindione
• Phenobarbital
• Phenprocoumon
• Piperaquine
• Prazepam
• Primidone
• Quazepam
• Remifentanil
• Saquinavir
• Secobarbital
• Simeprevir
• Sirolimus
• Sodium Oxybate
• Sonidegib
• Sufentanil
• Sunitinib
• Tacrolimus
• Tapentadol
• Temazepam
• Teniposide
• Tenofovir Alafenamide
• Thiopental
• Tiotropium
• Tolvaptan
• Tramadol
• Triazolam
• Ulipristal
• Velpatasvir
• Venetoclax
• Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amprenavir
• Arbutamine
• Betamethasone
• Bexarotene
• Cannabis
• Carbamazepine
• Chlorpromazine
• Cortisone
• Dexamethasone
• Digitoxin
• Ethosuximide
• Felodipine
• Ginkgo
• Granisetron
• Griseofulvin
• Lamotrigine
• Leucovorin
• Levomethadyl
• Methylprednisolone
• Metoprolol
• Ospemifene
• Oxcarbazepine
• Prednisone
• Quinidine
• Quinine
• Risperidone
• Rufinamide
• Telithromycin
• Theophylline
• Thioridazine
• Tiagabine
• Topiramate
• Valproic Acid
• Verapamil
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or
• Dry mouth or
• Emphysema (type of lung disease) or
• Enlarged prostate or
• Glaucoma or
• Heart disease or
• Hyperactivity (in children) or
• Intestinal blockage or
• Ulcerative colitis or
• Urinary tract blockage or difficult urination—Use with caution. May make these conditions worse.

• Down's syndrome—Use with caution. May make the side effects worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

Do not take this medicine within 1 hour of taking antacids or medicine for diarrhea. Taking them too close together will make the belladonna alkaloids less effective.

Belladonna alkaloids will often make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, as overheating could possibly result in heat stroke. This is especially important in children taking belladonna alkaloids.

This medicine may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.

This medicine may cause some people to have blurred vision or to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see well.

This medicine may cause a dry mouth, nose, or throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Eye pain
• skin rash or hives
• sore throat and fever
• unusual bleeding or bruising
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Constipation
• decreased sweating
• dizziness
• dry mouth, nose, throat, or skin

Less common or rare

• Bloated feeling
• blurred vision
• decreased flow of breast milk
• difficult urination
• difficulty in swallowing
• headache
• increased sensitivity of eyes to sunlight
• loss of memory
• nausea or vomiting
• unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Phenobarbital is a barbiturate, nonselective central nervous system depressant which is primarily used as a sedative hypnotic and also as an anticonvulsant in subhypnotic doses.  Atropine Sulfate, Hyoscyamine Sulfate and Scopolamine Hydrobromide are belladonna alkaloids classified as anticholinergic, antimuscarinic drugs and act to inhibit muscarinic actions of acetylcholine at postganglionic parasympathetic neuron effector sites.  These drugs are also used as antispasmodics due to their anticholinergic action and produce the effect in the body of reduced muscle spasms in the digestive or urinary tract, and reduced fluid secretions from certain glands or organs.  This drug combination provides peripheral anticholinergic/antispasmodic action and mild sedation.

FDA has classified the following indications as "possibly" effective:  For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.  May also be useful as adjunctive therapy in the treatment of duodenal ulcer.
IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AND IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATION.

Heat prostration can occur with belladonna alkaloids in high temperatures.
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy.  In this instance, treatment with this drug could be harmful.

Se-Donna Pb Hyos Elixir may produce drowsiness and blurred vision.  The patient should be warned about engaging in hazardous work or activities requiring mental alertness, such as operating a motor vehicle or other machinery.  Phenobarbital may decrease the effect of anticoagulants, and larger doses of the anticoagulant may be needed for optimal effect.  When phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased.  Phenobarbital may be habit forming and should not be administered to patients who are susceptible to addiction or to those with a history of physical and/or psychological drug dependence.

Barbiturates should be used with caution in patients with hepatic dysfunction.

May be habit forming.

GENERAL: 
Use with caution in patients with:  prostatic hypertrophy, autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension.

Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer.  Do not rely on the use of the drug in the presence of complication of biliary tract disease.  Theoretically, with overdosage, a curare-like action may occur.

INFORMATION FOR PATIENTS:
Practitioners should give the following information and instructions to patients:

• Do not increase the dose of this drug without consulting a physician.
• Do not share this medication with others.

The use of this product carries with it an associated risk of psychological and/or physical dependence.
The use of this product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving or operating machinery.

Use of this product with alcohol may result in additional central nervous system depressant effects.
Tell your doctor or pharmacist if you also take antihistamines, anti-seizure drugs, medicine for sleep or anxiety, muscle relaxants, narcotic pain relievers, or psychiatric medicines.

This drug may increase the risk for heat stroke because it decreases sweating.  Avoid becoming overheated in hot weather, saunas, and during exercise or other strenuous activity.

DRUG INTERACTIONS:
Do not take this medicine with the following medications:

• voriconazole
• pramlintide.

Some of the medicines that may interact with Se-Donna Pb Hyos Elixir include, but are not limited to:
CNS depressants
cyclosporine
female hormones, like estrogens or progestins and birth control pills
medicines for HIV infectionlike indinavir, nelfinavir, ritonavir, and saquinavi
warfarin
amantadine
anti-Parkinson's drugs levodopa, benztropine, trihexyphenidyl
antispasmodic drugs clidinium, dicyclomine, propantheline
MAO inhibitors furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine
anti-arrhythmic drugs disopyramide, procainamide, quinidine
azole anti-fungal drugs ketoconazole, itraconazole
bisphosphonate drugs alendronate, risedronate
corticosteroid prednisone
digoxin (slow-dissolving tablets)
phenothiazines (Promethazine)
potassium tablets/capsules
anti-seizure drug carbamazepine
anti-anxiety drugs alprazolam, diazepam, zolpidem
narcotic pain relievers
psychiatric drugs chlorpromazine, haloperidol, amitriptyline, risperidone
certain antihistamines diphenhydramine, meclizine
muscle relaxants

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:
Long-term studies in animals have not been performed to evaluate carcinogenic potential.

PREGNANCY TERATOGENIC EFFECTS:
Pregnancy Category D.
Se-Donna Pb Hyos Elixir can cause fetal harm when administered to pregnant woman.  Retrospective case-controlled studies have suggested a connection between the maternal consumption of phenobarbital and higher than expected incidence of fetal abnormalities.  Following oral administration, phenobarbital readily crosses the placental barrier and is distributed throughout fetal tissues with highest concentrations found in the placenta, fetal liver, and brain.  If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

NONTERATOGENIC EFFECTS:
Reports of infants suffering from long-term phenobarbital exposure in utero included the acute withdrawal syndrome of seizures and hyperirritability from birth to a delayed onset of up to 14 days.

LABOR AND DELIVERY:
Administration of Se-Donna Pb Hyos Elixir to the mother during labor may result in respiratory depression in the newborn.  Premature infants are particularly susceptible to the depressant effects.

NURSING MOTHERS:
Caution should be exercised when Se-Donna Pb Hyos Elixir is administered to a nursing woman.  The active ingredients contained in this drug product are known to be excreted in human milk.

SPECIAL PATIENT POPULATION:
Dosage should be reduced in the debilitated because these patients may be more sensitive to phenobarbital.  Dosage should be reduced for patients with impaired renal function or hepatic disease.

PEDIATRIC USE:
Use Se-Donna HYOS Elixir with caution in children as they may be more susceptible to the effects of this product especially infants, children with Down's syndrome, spastic paralysis or brain damage.

GERIATRIC USE:
Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Se-Donna PBHYOS Elixir and observed closely.  The phenobarbital used in Se-Donna Pb Hyos Elixir is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.  Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse reactions associated with anticholinergics and/or anticonvulsants are:  dry mouth; tachycardia; urinary hesitancy and retention; palpitation; blurred vision; prolonged pupil dilation; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, hives and/or other dermal manifestations; decreased sweating; impotence; suppression of lactation; constipation; bloated feeling and musculoskeletal pain.  Elderly patients may react with symptoms of excitement, agitation and drowsiness to even small doses of the drug.  Phenobarbital may produce excitement in some patients, rather than a sedative effect.  In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

Call your doctor for medical advice about side effects.  You may report side effects to the FDA at 1-800-FDA-1088.

This product is subject to the provisions of the Controlled Substance Act and has been placed in Schedule IV.  Phenobarbital may be habit-forming.  Tolerance, psychological dependence, and physical dependence may occur following prolonged use.