Se-Donna PB Hyos (Oral)

Belladonna alkaloids and phenobarbital combination is used to treat cramping and spasms in the stomach and intestines. It may also be used for stomach ulcers.

This medicine is available only with your doctor's prescription.

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

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

Belladonna alkaloids may cause you to sweat less, which can lead to an increase in your body temperature. Be extra cautious not to overheat during exercise or in hot weather while you are taking this medicine, as overheating could potentially lead to heat stroke. This is particularly important for children taking belladonna alkaloids.

This medicine may make your eyes more sensitive to light than usual. Wearing sunglasses and limiting exposure to bright light may help reduce discomfort.

This medicine may cause some people to experience blurred vision or feel drowsy, dizzy, or less alert than normal. Be sure you know how this medicine affects you before driving, using machines, or doing anything else that could be dangerous if you are not alert or able to see clearly.

This medicine may cause a dry mouth, nose, or throat. For temporary relief of mouth dryness, try using sugarless candy or gum, melting bits of ice in your mouth, or using a saliva substitute. However, if your mouth remains dry for more than 2 weeks, consult your dentist. Ongoing dryness of the mouth may increase the risk of dental problems, including tooth decay, gum disease, and fungal infections.

In deciding to use a drug, the chances of using the medication must be weighed against the good it will do. This is a decision you and your physician will make. For this medication, the following should be considered:

Allergies

Inform your clinician if you have ever had any unusual or allergic reaction to this medication or any other drugs. As well 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

Serious 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. Additionally, when belladonna alkaloids are given to children during hot weather, a rapid raise 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; sleepiness; 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 normally 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.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medication during breastfeeding. Weigh the potential benefits against the potential chances prior to 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 clinician may want to change the dose, or other precautions may be necessary. When you are using this medication, it is especially critical 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 medication with any of the following medicines is not advised. Your physician may decide not to treat you with this medicine or change some of the other medications you take.

• Ambenonium
• Atazanavir
• Boceprevir
• Cabotegravir
• Cobicistat
• Darunavir
• Dasabuvir
• Delamanid
• Doravirine
• Elvitegravir
• Maraviroc
• Mavacamten
• Nirmatrelvir
• Ombitasvir
• Paritaprevir
• Potassium Citrate
• Praziquantel
• Ranolazine
• Rilpivirine
• Ritonavir
• Rivaroxaban
• Telaprevir
• Tenofovir Alafenamide
• Voriconazole

Using this drug with any of the following drugs is typically not advised, but may be required in some cases. If both medications are prescribed together, your clinician may change the dose or how often you use one or both of the medications.

• Abemaciclib
• Abiraterone Acetate
• Abrocitinib
• Acalabrutinib
• Acenocoumarol
• Acepromazine
• Aclidinium
• Alfentanil
• Alfuzosin
• Alprazolam
• Amantadine
• Amifampridine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amlodipine
• Amobarbital
• Amoxapine
• Amprenavir
• Anagrelide
• Anileridine
• Anisindione
• Apalutamide
• Apixaban
• Apomorphine
• Aprepitant
• Aprobarbital
• Aripiprazole
• Aripiprazole Lauroxil
• Armodafinil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atogepant
• Atorvastatin
• Atropine
• Avacopan
• Avanafil
• Avapritinib
• Avatrombopag
• Axitinib
• Azithromycin
• Baclofen
• Bedaquiline
• Belladonna
• Belumosudil
• Benperidol
• Benzhydrocodone
• Benztropine
• Bepridil
• Bictegravir
• Biperiden
• Bosutinib
• Brigatinib
• Bromazepam
• Bromocriptine
• Bromopride
• Brompheniramine
• Budesonide
• Buprenorphine
• Bupropion
• Buserelin
• Buspirone
• Butabarbital
• Butalbital
• Butorphanol
• Cabozantinib
• Calcifediol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Capmatinib
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carmustine
• Carphenazine
• Carvedilol
• Celecoxib
• Cenobamate
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chloroquine
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Cilostazol
• Ciprofloxacin
• Cisapride
• Citalopram
• Clarithromycin
• Clemastine
• Clidinium
• Clindamycin
• Clobazam
• Clofazimine
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Clozapine
• Cobimetinib
• Codeine
• Colchicine
• Conivaptan
• Copanlisib
• Crizotinib
• Cyclobenzaprine
• Cyclopentolate
• Cyclophosphamide
• Cyclosporine
• Cyproheptadine
• Dabigatran Etexilate
• Dabrafenib
• Daclatasvir
• Dantrolene
• Daridorexant
• Darifenacin
• Darolutamide
• Dasatinib
• Deferasirox
• Deflazacort
• Degarelix
• Delavirdine
• Desipramine
• Deslorelin
• Desogestrel
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dichloralphenazone
• Dicumarol
• Dicyclomine
• Dienogest
• Difenoxin
• Dihydrocodeine
• Dihydroergotamine
• Diltiazem
• Dimenhydrinate
• Diphenhydramine
• Diphenoxylate
• Disopyramide
• Disulfiram
• Ditiocarb Sodium
• Docetaxel
• Dofetilide
• Dolasetron
• Dolutegravir
• Domperidone
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Doxylamine
• Dronedarone
• Droperidol
• Drospirenone
• Duvelisib
• Ebastine
• Edoxaban
• Efavirenz
• Elacestrant
• Elagolix
• Elbasvir
• Eletriptan
• Elexacaftor
• Encorafenib
• Enflurane
• Entrectinib
• Enzalutamide
• Eplerenone
• Eravacycline
• Erdafitinib
• Ergotamine
• Eribulin
• Erlotinib
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Esomeprazole
• Estazolam
• Estetrol
• Estradiol
• Eszopiclone
• Ethchlorvynol
• Ethinyl Estradiol
• Ethopropazine
• Ethylmorphine
• Ethynodiol
• Etonogestrel
• Etravirine
• Everolimus
• Famotidine
• Fedratinib
• Felbamate
• Felodipine
• Fentanyl
• Fesoterodine
• Fexinidazole
• Finerenone
• Fingolimod
• Flavoxate
• Flecainide
• Fluconazole
• Flunitrazepam
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluticasone
• Fluvastatin
• Fluvoxamine
• Formoterol
• Fosamprenavir
• Fosaprepitant
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Fostamatinib
• Fostemsavir
• Gabapentin
• Gabapentin Enacarbil
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gestodene
• Gilteritinib
• Glasdegib
• Glimepiride
• Glucagon
• Glyburide
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gonadorelin
• Goserelin
• Granisetron
• Grazoprevir
• Halazepam
• Halofantrine
• Haloperidol
• Halothane
• Hemin
• Hexobarbital
• Histrelin
• Homatropine
• Hydrocodone
• Hydrocortisone
• Hydromorphone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Hyoscyamine
• Ibrexafungerp
• Ibrutinib
• Ibutilide
• Idelalisib
• Ifosfamide
• Iloperidone
• Imatinib
• Imipramine
• Indinavir
• Infigratinib
• Inotuzumab Ozogamicin
• Ipratropium
• Irbesartan
• Irinotecan
• Irinotecan Liposome
• Isoflurane
• Istradefylline
• Itraconazole
• Ivabradine
• Ivacaftor
• Ivosidenib
• Ixazomib
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lamotrigine
• Lansoprazole
• Lapatinib
• Larotrectinib
• Ledipasvir
• Lefamulin
• Lemborexant
• Lenacapavir
• Leniolisib
• Lenvatinib
• Lercanidipine
• Leuprolide
• Levamlodipine
• Levocetirizine
• Levofloxacin
• Levoleucovorin
• Levonorgestrel
• Levorphanol
• Lofexidine
• Lomitapide
• Lopinavir
• Lorazepam
• Lorlatinib
• Lormetazepam
• Losartan
• Lovastatin
• Loxapine
• Lumateperone
• Lumefantrine
• Lurasidone
• Macimorelin
• Magnesium Oxybate
• Maribavir
• Meclizine
• Medazepam
• Medroxyprogesterone
• Mefloquine
• Melperone
• Mepenzolate
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Mestranol
• Metaxalone
• Methacholine
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methoxyflurane
• Methylene Blue
• Methylphenidate
• Metoclopramide
• Metronidazole
• Miconazole
• Midazolam
• Mifepristone
• Mitapivat
• Mizolastine
• Mobocertinib
• Moclobemide
• Molindone
• Montelukast
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nalbuphine
• Naldemedine
• Naloxegol
• Nateglinide
• Nelfinavir
• Neratinib
• Netupitant
• Nicomorphine
• Nifedipine
• Nilotinib
• Nimodipine
• Nintedanib
• Nisoldipine
• Nitisinone
• Nitrazepam
• Nitrous Oxide
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Olaparib
• Olutasidenib
• Omaveloxolone
• Omeprazole
• Ondansetron
• Opium
• Opium Alkaloids
• Orlistat
• Orphenadrine
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxazepam
• Oxcarbazepine
• Oxitropium Bromide
• Oxybutynin
• Oxycodone
• Oxymorphone
• Ozanimod
• Paclitaxel
• Pacritinib
• Palbociclib
• Paliperidone
• Palovarotene
• Panobinostat
• Pantoprazole
• Papaveretum
• Papaverine
• Paregoric
• Paroxetine
• Pasireotide
• Pazopanib
• Pemigatinib
• Pentamidine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenindione
• Phenobarbital
• Phenprocoumon
• Phenytoin
• Pimavanserin
• Pimozide
• Pioglitazone
• Pipamperone
• Pipenzolate Bromide
• Piperacetazine
• Piperaquine
• Pipotiazine
• Pirenzepine
• Piritramide
• Pirtobrutinib
• Pitolisant
• Ponesimod
• Posaconazole
• Potassium Oxybate
• Pralsetinib
• Prazepam
• Pregabalin
• Pretomanid
• Primidone
• Probenecid
• Probucol
• Procainamide
• Procarbazine
• Prochlorperazine
• Procyclidine
• Progesterone
• Promazine
• Promethazine
• Propafenone
• Propantheline
• Propiverine
• Propofol
• Protriptyline
• Quazepam
• Quercetin
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ramelteon
• Reboxetine
• Remifentanil
• Remimazolam
• Remoxipride
• Repaglinide
• Revefenacin
• Ribociclib
• Rifabutin
• Rifampin
• Rimegepant
• Ripretinib
• Risperidone
• Rolapitant
• Ropeginterferon Alfa-2b-njft
• Rosiglitazone
• Salmeterol
• Samidorphan
• Saquinavir
• Saxagliptin
• Scopolamine
• Secobarbital
• Secretin Human
• Segesterone
• Selexipag
• Selpercatinib
• Selumetinib
• Sertindole
• Sertraline
• Sevoflurane
• Sildenafil
• Simeprevir
• Simvastatin
• Siponimod
• Sirolimus
• Sodium Oxybate
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sonidegib
• Sorafenib
• Sotalol
• Sparfloxacin
• St John's Wort
• Stramonium
• Sufentanil
• Sulfaphenazole
• Sulpiride
• Sultopride
• Sunitinib
• Suvorexant
• Tacrolimus
• Tamoxifen
• Tamsulosin
• Tapentadol
• Tazemetostat
• Telavancin
• Telithromycin
• Temazepam
• Temsirolimus
• Teniposide
• Tepotinib
• Terfenadine
• Terodiline
• Tetrabenazine
• Tezacaftor
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Thiotepa
• Thiothixene
• Ticagrelor
• Ticlopidine
• Tilidine
• Tiotropium
• Tipranavir
• Tivozanib
• Tizanidine
• Tolbutamide
• Tolonium Chloride
• Tolterodine
• Tolvaptan
• Topiramate
• Toremifene
• Torsemide
• Trabectedin
• Tramadol
• Trazodone
• Triazolam
• Triclabendazole
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trihexyphenidyl
• Trimeprazine
• Trimipramine
• Triptorelin
• Tropicamide
• Trospium
• Tucatinib
• Ubrogepant
• Ulipristal
• Umeclidinium
• Upadacitinib
• Valproic Acid
• Vandetanib
• Vardenafil
• Velpatasvir
• Vemurafenib
• Venetoclax
• Venlafaxine
• Verapamil
• Vilanterol
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Vinorelbine
• Voclosporin
• Vonoprazan
• Vorapaxar
• Vorinostat
• Voxelotor
• Voxilaprevir
• Warfarin
• Zaleplon
• Zanubrutinib
• Ziprasidone
• Zolpidem
• Zopiclone
• Zotepine
• Zuclopenthixol
• Zuranolone

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

• Arbutamine
• Betamethasone
• Bexarotene
• Cortisone
• Digitoxin
• Ethosuximide
• Ginkgo
• Griseofulvin
• Leucovorin
• Levomethadyl
• Methylprednisolone
• Metoprolol
• Ospemifene
• Prednisone
• Rufinamide
• Theophylline
• Tiagabine
• Topiramate

Interactions with Food/Tobacco/Alcohol

Certain drugs 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 additionally 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 drug. Make sure you inform your physician if you have any other medical issues, 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 adverse effects worse.

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects happen:

Rare

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

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also provide ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have 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 can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Antispasmodic
• Belladonna/Phenobarbital
• Donnatal
• RE-PB Hyos
• Se-Donna PB Hyos

Available Dosage Forms:

• Tablet
• Elixir

Therapeutic Class: Antimuscarinic Combination

Pharmacologic Class: Atropine

Take this medicine about 30 minutes to 1 hour before meals, unless otherwise directed by your doctor.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For stomach or intestine problems: For oral dosage forms (capsules or tablets): Older adults, adults, and teenagers—1 or 2 capsules 2 to 4 times a day. Your doctor may adjust the dose if needed. Children—Dose must be determined by your doctor. For oral dosage form (solution): Adults and teenagers—The usual dose is 1 to 2 teaspoons (5 to 10 milliliters (mL)) 3 or 4 times a day. Your doctor may adjust the dose if needed. Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.5 to 7.5 mL every 4 to 6 hours. Your doctor may adjust the dose if needed. For oral dosage form (chewable tablets): Older adults, adults, and teenagers—Chew 1 or 2 tablets 3 or 4 times a day. Your doctor may adjust the dose if needed. Children 2 to 12 years of age—Chew one-half to 1 tablet 3 or 4 times a day. Your doctor may adjust the dose if needed. Children up to 2 years of age—Use is not recommended. For long-acting oral dosage form (extended-release tablets): Older adults, adults, and teenagers—1 tablet every 8 to 12 hours. Your doctor may adjust the dose if needed. Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.