Fiorinal with codeine (oral)

Fiorinal with codeine (oral)

Fiorinal with codeine (oral) Oral (capsule)

Addiction, Abuse and Abuse:

Butalbital/aspirin/caffeine/codeine phosphate exposes patients and other users to the risk of opioid dependence, opioid abuse, and misuse, which may result in overdose and death. Assess each patient's risk before prescribing codeine sulfate and monitor all patients regularly for the development of these behaviors or conditions.

Opioid Analgesics Risk Assessment and Mitigation Strategy (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, misuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. REMS requirements require pharmaceutical companies with approved opioid analgesics to provide healthcare providers with REMS-compliant training programs. Healthcare providers are strongly encouraged to complete a REMS-compliant training program, counsel patients and/or their caregivers on the safe use, serious risks, storage, and disposal of these products with each prescription, and advise patients and their caregivers of the importance of these products. Read the Medication Guide each time it is provided by your pharmacist and consider other resources to improve patient, household, and community safety.

Life-threatening respiratory depression:

Serious, life-threatening, or fatal respiratory depression may occur with use of butalbital/aspirin/caffeine/codeine phosphate. Monitor for respiratory depression, particularly when starting butalbital/aspirin/caffeine/codeine phosphate or after a dose increase.

Accidental ingestion:

Accidental ingestion of even one dose of butalbital/aspirin/caffeine/codeine phosphate, especially by children, can result in a fatal overdose of butalbital/aspirin/caffeine/codeine phosphate.

Risks when used concurrently with benzodiazepines or other CNS depressants:

Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may cause profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of butalbital/aspirin/caffeine/codeine phosphate and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and duration to the minimum necessary. Observe patients for signs and symptoms of respiratory depression and sedation.

Ultrarapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children:

Life-threatening respiratory depression and death have occurred in children receiving codeine. Most of the reported cases occurred after tonsillectomy and/or adenoidectomy, and many of the children had evidence of extremely rapid metabolization of codeine due to a CYP2D6 polymorphism. Butalbital/aspirin/caffeine/codeine phosphate is contraindicated in children younger than 12 years and in children younger than 18 years after tonsillectomy and/or adenoidectomy. Avoid use of butalbital/aspirin/caffeine/codeine phosphate in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine

Neonatal opioid withdrawal syndrome:

Prolonged use of butalbital/aspirin/caffeine/codeine phosphate during pregnancy may result in neonatal opioid withdrawal syndrome, which can be life-threatening if not recognized and treated and requires treatment according to protocols developed by neonatology experts. If prolonged opioid use is required in a pregnant woman, inform the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment is available.

Interactions with drugs affecting cytochrome P450 isoenzymes:

The effects of concomitant use or discontinuation of CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. The use of CYP3A4 inducers, 3A4 inhibitors or 2D6 inhibitors with butalbital/aspirin/caffeine/codeine phosphate requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine.

Used for Fiorinal with codeine

Butalbital belongs to the barbiturate group of medicines. Barbiturates exert their effects in the central nervous system (CNS).

Aspirin is used in patients to relieve pain and reduce fever. It belongs to the group of salicylates and has an anti-inflammatory effect on the immune system. It is also known as an anti-inflammatory analgesic.

Caffeine is a CNS stimulant that is used with painkillers to enhance their effects. It has also been used for migraine headaches. Codeine belongs to a group of medicines called narcotic analgesics (pain relievers). It acts on the central nervous system (CNS) and relieves pain.

When taken for a long time or in large doses, butalbital or codeine may form a habit that leads to mental or physical dependence. Physical dependence can lead to withdrawal symptoms if you suddenly stop taking the drug. In patients suffering from headaches, the first withdrawal symptoms may be new (rebound) headaches.

This medicine is available only through a restricted distribution program called Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy).

Before using Fiorinal with codeine

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

No appropriate studies have been conducted on the relationship between age and the effects of the combination of butalbital, aspirin, caffeine and codeine in children and adolescents. It should not be used in children under 12 years of age. Safety and effectiveness have not been established.

Fiorinal® with codeine should not be used to relieve pain after surgery to remove tonsils or adenoids in children. Severe breathing problems and death have been reported in some children who received codeine after tonsillectomy or adenoid surgery.

geriatrics

Studies conducted to date have not shown any geriatric-specific problems that would limit the benefit of the combination of butalbital, aspirin, caffeine and codeine in the elderly. However, older patients are at higher risk of age-related lung, liver, kidney, or heart problems, which may require caution and dose adjustment in patients receiving this drug.

Breastfeeding

Studies of breastfeeding women have shown harmful effects on infants. An alternative to this medication should be prescribed or you should stop breast-feeding while using this medication.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are taking this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or to change some of the other medications you are taking.

• Abrocitinib
• Defibrotid
• Dichlorphenamid
• Furazolidon
• Influenzavirus-Impfstoff, lebend
• Iproniazid
• Isocarboxazid
• Ketorolac
• Linezolid
• Methylenblau
• Moclobemid
• Nalmefen
• Naltrexon
• Nialamid
• Ozanimod
• Phenelzin
• Procarbazin
• Rasagilin
• Riociguat
• Safinamid
• Samidorphan
• Selegilin
• Toloxaton
• Tranylcypromin
• Viloxazin

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

• Abametapir
• Abirateronacetat
• Acarbose
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Acepromazin
• Acetazolamid
• Aclidinium
• Alclometason
• Aldosteron
• Alfentanil
• Alipogene Tiparvovec
• Almotriptan
• Alosetron
• Alprazolam
• Alteplase, rekombinant
• Amantadin
• Amcinonid
• Amifampridin
• Amikacin
• Amilorid
• Amineptin
• Amiodaron
• Amitriptylin
• Amitriptylinoxid
• Amobarbital
• Amoxapin
• Amphetamin
• Amphotericin B
• Amprenavir
• Amtolmetin Guacil
• Anagrelid
• Anileridin
• Anisindion
• Apalutamid
• Apixaban
• Aprepitant
• Aprobarbital
• Ardeparin
• Argatroban
• Aripiprazol
• Aripiprazol Lauroxil
• Armodafinil
• Asenapin
• Atazanavir
• Atropin
• Bacitracin
• Baclofen
• Barbital
• Beclomethason
• Belladonna
• Bemetizid
• Bemiparin
• Benazepril
• Bendroflumethiazid
• Benperidol
• Bentazepam
• Benzhydrocodon
• Benzphetamin
• Benzthiazid
• Benztropin
• Betamethason
• Betrixaban
• Biperiden
• Bivalirudin
• Boceprevir
• Bosentan
• Brinzolamid
• Bromazepam
• Bromfenac
• Bromoprid
• Brompheniramin
• Budesonid
• Bufexamac
• Bumetanid
• Buprenorphin
• Bupropion
• Buspiron
• Butabarbital
• Butorphanol
• Calciumoxybat
• Cannabidiol
• Cannabis
• Canrenoate
• Canrenone
• Caplacizumab-yhdp
• Capmatinib
• Capreomycin
• Captopril
• Carbamazepin
• Carbinoxamin
• Carisoprodol
• Carphenazin
• Celecoxib
• Cenobamat
• Certoparin
• Cetirizin
• Chloralhydrat
• Chlordiazepoxid
• Chlorthiazid
• Chlorpheniramin
• Chlorpromazin
• Chlorpropamid
• Chlorthalidon
• Chlorzoxazon
• Cholinsalicylat
• Ciclesonid
• Cilostazol
• Cimetidin
• Cinacalcet
• Ciprofloxacin
• Cisplatin
• Citalopram
• Clarithromycin
• Clemastine
• Clidinium
• Clobazam
• Clobetasol
• Clobetason
• Clocortolon
• Clomipramin
• Clonazepam
• Clonixin
• Clopamid
• Clopidogrel
• Clorazepat
• Cloxazolam
• Clozapin
• Cobicistat
• Kokain
• Conivaptan
• Kortison
• Crizotinib
• Curcumin
• Cyclobenzaprin
• Cyclopenthiazid
• Cyclopentolat
• Cyclosporin
• Cyclothiazid
• Cyproheptadin
• Dabigatranetexilat
• Dalteparin
• Danaparoid
• Dantrolen
• Daridorexant
• Darifenacin
• Darunavir
• Deflazacort
• Delavirdin
• Delorazepam
• Desipramin
• Desirudin
• Desmopressin
• Desonide
• Desoximetason
• Desvenlafaxin
• Dexamethason
• Dexibuprofen
• Dexketoprofen
• Dexmedetomidin
• Dextroamphetamin
• Dextromethorphan
• Dezocine
• Diacetylmorphin
• Diazepam
• Diazoxid
• Dibenzepin
• Dichloralphenazon
• Diclofenac
• Dicumarol
• Dicyclomin
• Difenoxin
• Diflorason
• Diflucortolon
• Diflunisal
• Difluprednat
• Digoxin
• Dihydrocodein
• Diltiazem
• Dimenhydrinat
• Diphenhydramin
• Diphenoxylat
• Dipyron
• Dolasetron
• Donepezil
• Dorzolamid
• Dothiepin
• Doxepin
• Doxorubicin
• Doxorubicin-Hydrochlorid-Liposom
• Doxylamin
• Dronedaron
• Droperidol
• Drospirenon
• Droxicam
• Duloxetin
• Edoxaban
• Efavirenz
• Elagolix
• Eletriptan
• Emtricitabin
• Enalapril
• Enalaprilat
• Enfluran
• Enoxaparin
• Enzalutamid
• Eplerenon
• Eptifibatid
• Erythromycin
• Escitalopram
• Esketamin
• Eslicarbazepinacetat
• Estazolam
• Eszopiclon
• Eterobarb
• Ethacrynsäure
• Ethchlorvinyl
• Ethinylestradiol
• Ethopropazin
• Ethylmorphin
• Etodolac
• Etofenamat
• Etonogestrel
• Etoricoxib
• Etozolin
• Etravirin
• Fedratinib
• Felbinac
• Fenfluramin
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazon
• Fesoterodin
• Mutterkraut
• Fexinidazol
• Flavoxat
• Flibanserin
• Floctafenin
• Flucloronid
• Fluconazol
• Fludrocortison
• Flufenaminsäure
• Flumethason
• Flunisolid
• Flunitrazepam
• Fluocinolon
• Fluocinonid
• Fluocortin
• Fluocortolon
• Fluormetholon
• Fluoxetin
• Fluphenazin
• Flurandrenolid
• Flurazepam
• Flurbiprofen
• Fluspirilene
• Fluticason
• Fluvoxamin
• Fondaparinux
• Fosamprenavir
• Fosaprepitant
• Foscarnet
• Fosinopril
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furosemid
• Gabapentin
• Gabapentin Enacarbil
• Gentamicin
• Gepiron
• Ginkgo
• Givosiran
• Glimepirid
• Glipizid
• Glyburid
• Glycopyrrolat
• Glycopyrroniumtosylat
• Gossypol
• Granisetron
• Halazepam
• Halcinonid
• Halobetasol
• Haloperidol
• Halothan
• Heparin
• Heptabarbital
• Hexobarbital
• Homatropin
• Hydrochlorothiazid
• Hydrocodon
• Hydrocortison
• Hydroflumethiazid
• Hydromorphon
• Hydroxytryptophan
• Hydroxyzin
• Hyoscyamin
• Ibrutinib
• Ibuprofen
• Idelalisib
• Imatinib
• Imipramin
• Indapamid
• Indinavir
• Indomethacin
• Inotersen
• Iobenguane I 131
• Ipratropium
• Isocarboxazid
• Isofluran
• Itraconazol
• Ivacaftor
• Kanamycin
• Ketamin
• Ketazolam
• Ketobemidon
• Ketoconazol
• Ketoprofen
• Lacosamid
• Larotrectinib
• Lasmiditan
• Lemborexant
• Lenacapavir
• Lepirudin
• Letermovir
• Levocetirizin
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamin
• Lisinopril
• Lithium
• Lofepramin
• Lofexidin
• Lomitapid
• Lopinavir
• Loprazolam
• Lorazepam
• Lorcaserin
• Lorlatinib
• Lormetazepam
• Lornoxicam
• Loteprednol
• Loxapin
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Macimorelin
• Magnesiumoxybat
• Mavacamten
• Meclizin
• Meclofenamat
• Medazepam
• Medryson
• Mefenaminsäure
• Melitracen
• Meloxicam
• Melperon
• Melphalan
• Mepenzolat
• Meperidin
• Mephenesin
• Mephobarbital
• Meprobamat
• Meptazinol
• Mesoridazin
• Metaclazepam
• Metaxalone
• Metformin
• Methadon
• Methamphetamin
• Methazolamid
• Methdilazin
• Methocarbamol
• Methohexital
• Methotrexat
• Methotrimeprazin
• Methyclothiazid
• Methylenblau
• Methylprednisolon
• Metoclopramid
• Metolazon
• Mibefradil
• Midazolam
• Mifepriston
• Milnacipran
• Mirabegron
• Mirtazapin
• Mitotan
• Modafinil
• Moexipril
• Molindon
• Mometason
• Moricizin
• Morniflumate
• Morphium
• Morphinsulfat-Liposom
• Nabumeton
• Nadroparin
• Nafcillin
• Nalbuphin
• Naproxen
• Naratriptan
• Nateglinid
• Nefazodon
• Nelfinavir
• Neomycin
• Nepafenac
• Netilmicin
• Netupitant
• Nevirapin
• Nicomorphin
• Nicorandil
• Nifedipin
• Nifluminsäure
• Nilotinib
• Nimesulid
• Nimesulid Beta Cyclodextrin
• Nitrazepam
• Lachgas
• Nordazepam
• Norethindron
• Norgestimate
• Norgestrel
• Nortriptylin
• Olanzapin
• Omaveloxolon
• Ondansetron
• Opipramol
• Opium
• Opiumalkaloide
• Orphenadrin
• Oxaprozin
• Oxazepam
• Oxcarbazepin
• Oxitropiumbromid
• Oxybutynin
• Oxycodon
• Oxymorphon
• Oxyphenbutazon
• Ozanimod
• Palbociclib
• Palonosetron
• Papaveretum
• Paramethason
• Parecoxib
• Paregorisch
• Parnaparin
• Paromomycin
• Paroxetin
• Peginterferon Alfa-2b
• Pemetrexed
• Pentazocin
• Pentobarbital
• Pentosanpolysulfat-Natrium
• Pentoxifyllin
• Perampanel
• Perazin
• Periciazin
• Perindopril
• Perphenazin
• Phenelzin
• Phenindion
• Phenobarbital
• Phenprocoumon
• Phenylbutazon
• Phenytoin
• Piketoprofen
• Pinazepam
• Pipenzolatbromid
• Piperacetazin
• Piperaquin
• Pipotiazin
• Piracetam
• Pirenzepin
• Piretanid
• Piritramid
• Piroxicam
• Pixantrone
• Plazomicin
• Polythiazid
• Posaconazol
• Kaliumcitrat
• Kaliumoxybat
• Pranoprofen
• Prasugrel
• Prazepam
• Prednicarbat
• Prednisolon
• Prednison
• Pregabalin
• Primidon
• Procarbazin
• Prochlorperazin
• Procyclidin
• Proglumetacin
• Promazin
• Promethazin
• Propanthelin
• Propiverin
• Propofol
• Propyphenazon
• Proquazone
• Protein C
• Protriptylin
• Quazepam
• Quetiapin
• Quinapril
• Quinethazon
• Chinidin
• Chinin
• Ramelteon
• Ramipril
• Ranitidin
• Ranolazin
• Rasagilin
• Remifentanil
• Remimazolam
• Remoxiprid
• Repaglinid
• Reteplase, rekombinant
• Reviparin
• Rifabutin
• Rifampin
• Rifapentin
• Rimexolon
• Ritlecitinib
• Ritonavir
• Rivaroxaban
• Rizatriptan
• Rofecoxib
• Rolapitant
• Ropeginterferon Alfa-2b-njft
• Safinamid
• Salicylsäure
• Salsalat
• Saquinavir
• Scopolamin
• Secobarbital
• Selegilin
• Selumetinib
• Sertindol
• Sertralin
• Sibutramin
• Natriumoxybat
• Natriumsalicylat
• Solifenacin
• Spectinomycin
• Spirapril
• Spironolacton
• Johanniskraut
• Stramonium
• Streptomycin
• Sufentanil
• Sulindac
• Sulodexid
• Sulpirid
• Sumatriptan
• Suvorexant
• Tacrolimus
• Tapentadol
• Telaprevir
• Telithromycin
• Temazepam
• Tenofoviralafenamid
• Tenofovirdisoproxilfumarat
• Tenoxicam
• Terbinafin
• Terodilin
• Tetrazepam
• Thiethylperazin
• Thiopental
• Thiopropazat
• Thioridazin
• Thiothixen
• Tianeptin
• Tiaprofensäure
• Ticagrelor
• Ticlopidin
• Tilidin
• Tinzaparin
• Tiotropium
• Tirofiban
• Tizanidin
• Tobramycin
• Tocilizumab
• Tolazamid
• Tolbutamid
• Tolfenaminsäure
• Tolmetin
• Toloniumchlorid
• Tolterodin
• Topiramat
• Torsemid
• Tramadol
• Trandolapril
• Tranylcypromin
• Trazodon
• Treprostinil
• Triamcinolon
• Triamteren
• Triazolam
• Trichlormethiazid
• Trifluoperazin
• Trifluperidol
• Triflupromazin
• Trihexyphenidyl
• Trimeprazin
• Trimipramin
• Tropicamid
• Trospium
• Tryptophan
• Kurkuma
• Ulipristal
• Umeclidinium
• Valdecoxib
• Valproinsäure
• Vancomycin
• Varizellenvirus-Impfstoff, lebend
• Venlafaxin
• Verapamil
• Vilazodon
• Voriconazol
• Vortioxetin
• Voxelotor
• Warfarin
• Xipamid
• Zaleplon
• Ziprasidon
• Zolmitriptan
• Zolpidem
• Zopiclon
• Zotepin
• Zuranolon

Using this medicine with any of the following medicines may result in an increased risk of certain side effects, but using both medicines 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 medicines.

• Acebutolol
• Atenolol
• Betaxolol
• Bisoprolol
• Carteolol
• Carvedilol
• Celiprolol
• Delapril
• Esmolol
• Imidapril
• Labetalol
• Levobunolol
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Nitroglycerin
• Ospemifen
• Oxprenolol
• Penbutolol
• Pindolol
• Prednison
• Probenecid
• Propranolol
• Sotalol
• Johanniskraut
• Streptokinase
• Tamarinde
• Temocapril
• Tenecteplase
• Timolol
• Warfarin

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine for any of the following conditions is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of use of this medication, or give you special instructions about food, alcohol, or tobacco consumption.

• Ethanol
• Tabak

Using this medicine with any of the following medicines may result in an increased risk of certain side effects, but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of use of this medication, or give you special instructions about food, alcohol, or tobacco consumption.

• Ethanol

Other medical problems

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

• Morbus Addison (ein Nebennierenproblem) oder
• Alkoholmissbrauch oder Vorgeschichte von oder
• Hirntumor, Vorgeschichte von oder
• Atemprobleme (z. B. COPD, Hyperkapnie, Hypoxie, Schlafapnoe) oder
• Cor pulmonale (schwere Herzerkrankung) oder
• Depression oder Vorgeschichte von oder
• Drogenabhängigkeit, insbesondere bei Drogenmissbrauch oder -abhängigkeit, oder Vorgeschichte von oder
• Vergrößerte Prostata bzw
• Kopfverletzung oder Vorgeschichte von oder
• Hypothyreose (Unterfunktion der Schilddrüse) oder
• Erhöhter Druck im Kopf bzw
• Adipositas (Übergewicht) bzw
• Magen- oder Verdauungsprobleme bzw
• Probleme beim Wasserlassen bzw
• Geschwächte körperliche Verfassung – Mit Vorsicht verwenden. Kann das Risiko schwerwiegenderer Nebenwirkungen erhöhen.

• Asthma mit Nasenpolypen und Rhinitis, Vorgeschichte von oder
• Hämophilie (Blutungsproblem) oder
• Hypoprothrombinämie (niedriger Prothrombinspiegel im Blut) oder
• Leberschäden, schwere oder
• Lungen- oder Atemprobleme (z. B. Asthma, Atemdepression), schwere oder
• Porphyrie (Enzymproblem) oder
• Reye-Syndrom oder
• Magen- oder Darmprobleme (z. B. paralytischer Ileus, Magengeschwür, Läsionen) oder
• Chirurgie (z. B. Nasen-Rachen-Mandeln, Gaumenmandeln) oder
• Thrombasthenie (eine Störung der Blutplättchen) oder
• Thrombozytopenie (niedrige Blutplättchenzahl) oder
• Vitamin-K-Mangel bzw
• Von-Willebrand-Krankheit (Blutgerinnungsstörung) – Sollte bei Patienten mit diesen Erkrankungen nicht angewendet werden.

• Windpocken bzw
• Grippe – Mit Vorsicht verwenden. Kann das Risiko einer Erkrankung namens Reye-Syndrom erhöhen.

• Gallenblasenprobleme bzw
• Hypotonie (niedriger Blutdruck) oder
• Pankreatitis (Schwellung der Bauchspeicheldrüse) oder
• Anfälle, Vorgeschichte oder – Mit Vorsicht anwenden. Kann diese Bedingungen verschlimmern.

• Nierenerkrankung bzw
• Lebererkrankung – Mit Vorsicht anwenden. Die Wirkung kann durch die langsamere Entfernung des Arzneimittels aus dem Körper verstärkt werden.

Proper use of Fiorinal with codeine

Only take this medicine as directed by your doctor. Do not take more of it, do not take it more often, or take it for longer than your doctor prescribed. If too much of this medicine is taken over a long period of time, it may become habit-forming and lead to mental or physical dependence.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, misuse and misuse of the combination of Butalbital, Aspirin, Caffeine and Codeine. This medicine should also come with a medication guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

Drink plenty of fluids to prevent constipation.

dosage

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

The amount of medicine you take depends on the strength of the medicine. In addition, the number of doses you take each day, the time between doses, and how long you take the medicine depend on the medical problem for which you are using the medicine.

• Für orale Darreichungsform (Kapseln):
  • Bei Spannungskopfschmerzen:
    • Erwachsene – je nach Bedarf alle 4 Stunden 1 oder 2 Kapseln. Nehmen Sie nicht mehr als 6 Kapseln pro Tag ein.
    • Kinder ab 12 Jahren – Anwendung und Dosierung müssen von Ihrem Arzt festgelegt werden.
    • Kinder unter 12 Jahren – sollte bei diesen Patienten nicht angewendet werden.

Missed dose

If you miss a dose of this medication, skip the missed dose and return to your regular dosing schedule. Do not double the dose.

storage

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

Keep away from children.

Do not keep medications that are outdated or no longer needed.

Return unused narcotics immediately to a drug collection point. If you don't have a drug take-back location near you, flush unused narcotics down the toilet. Check with your local drugstore and clinic for take-back locations. You can also search for locations on the DEA website. Here is the link to the FDA website on safe drug disposal: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm.

Precautions when using Fiorinal with codeine

It is very important that your doctor check you or your child's progress while using this medicine, especially within the first 24 to 72 hours of treatment. This will help your doctor determine whether the medicine is working properly and decide whether you should continue taking it. Blood and urine tests may be needed to check for adverse effects.

Do not use this medicine if you are taking or have taken an MAOI (MAOI) such as isocarboxazid [Marplan®]linezolid [Zyvox®]phenelzine [Nardil®]selegiline [Eldepryl®]tranylcypromine [Parnate®]) within the last 14 days.

Do not change your dose or suddenly stop using this medication without first checking with your doctor. Your doctor may want you to gradually reduce the amount you take before stopping it completely. This can help prevent your condition from worsening and reduce the possibility of withdrawal symptoms such as stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or difficulty sleeping.

Using this drug during pregnancy, especially in the later part of pregnancy, may cause serious adverse effects, including neonatal withdrawal syndrome in your newborn. Tell your doctor immediately if you think you may be pregnant or plan to become pregnant while using this medication.

Codeine is converted into morphine in the body. Some people convert codeine to morphine more quickly than others. These individuals are referred to as “ultrarapid metabolizers of codeine.” Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an “ultra-rapid codeine metabolizer.” As a result, there is too much morphine in the body and you experience more morphine side effects than usual. Children may be particularly sensitive to this effect. Do not give this medicine to:

• Kinder unter 12 Jahren.
• Kinder unter 18 Jahren, bei denen eine Mandel- oder Adenoidoperation operativ entfernt wurde.
• Kinder im Alter von 12 bis 18 Jahren, bei denen ein hohes Risiko für Atemprobleme besteht (z. B. obstruktive Schlafapnoe, Fettleibigkeit, Lungenerkrankung).

If a nursing mother metabolizes codeine extremely quickly, this could result in a morphine overdose in the nursing baby and cause very serious side effects.

For nursing mothers using this medicine:

• Sprechen Sie mit Ihrem Arzt, wenn Sie Fragen zur Anwendung von Codein oder zu den möglichen Auswirkungen dieses Arzneimittels auf Ihr Baby haben.
• Rufen Sie Ihren Arzt an, wenn Sie extrem müde werden und Schwierigkeiten haben, sich um Ihr Baby zu kümmern.
• Ihr Baby sollte im Allgemeinen alle 2 bis 3 Stunden gestillt werden und nicht länger als 4 Stunden am Stück schlafen.
• Fragen Sie sofort Ihren Arzt oder die Notaufnahme des Krankenhauses, wenn Ihr Baby Anzeichen von erhöhter Schläfrigkeit (mehr als üblich), Schwierigkeiten beim Stillen, Atembeschwerden oder Schlaffheit zeigt. Dies können Symptome einer Überdosierung sein und erfordern sofortige ärztliche Hilfe.

Aspirin can cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor immediately if you or your child have rash, hives, itching, trouble breathing, trouble swallowing, or swelling of the hands, face, or mouth while using this medication.

This medicine can be habit forming. If you feel that the medicine is not working as well, do not take more than the prescribed dose. Call your doctor for instructions.

This medicine can cause adrenal gland problems. Contact your doctor immediately if you experience darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, depression, nausea, rash, unusual tiredness or weakness, or vomiting.

Dizziness, lightheadedness, or fainting may occur if you suddenly stand up from lying or sitting. Getting up slowly can be helpful. Lying down for a long time can also relieve dizziness or lightheadedness. If this problem persists or worsens, contact your doctor immediately.

This medicine may cause bleeding in your stomach or intestines. This problem can occur without any warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, are in poor health, or are taking certain other medicines (such as steroids or a blood glucose diluent).

This medicine may cause dizziness, sleepiness, confusion, or disorientation. Do not drive or do other dangerous activities until you know how this medicine affects you.

Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers or white spots on the lips or in the mouth, swollen glands, difficulty breathing, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of a serious skin reaction, including drug reaction with eosinophilia and systemic symptoms (DRESS).

This medicine increases the effects of alcohol and other CNS depressants (medicines that can make you sleepy or less alert). Some examples of CNS depressants include antihistamines or allergy or cold medications, sedatives, sedatives or sleeping pills, other prescription painkillers or narcotics, antiseizure medications or barbiturates, muscle relaxants or anesthetics, including some dental anesthetics. Consult your doctor before taking any of these medicines while using this medicine.

If you think you or someone else may have taken an overdose of this medicine, get emergency help immediately. Your doctor may also prescribe naloxone to treat an overdose. Signs of overdose include: cold, clammy skin, cough that sometimes produces pink, frothy sputum, seizures, difficulty breathing or difficulty breathing, irregular, fast or slow or shallow breathing, nausea or vomiting, pain in the upper abdomen, pale or blue lips, fingernails or skin, pinpoint eye pupils, swelling in the legs and ankles, or difficulty sleeping.

Taking narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink plenty of fluids, or increase the amount of fiber in your diet. Be sure to follow the instructions carefully as persistent constipation can lead to more serious problems.

Before you have a medical examination, tell your doctor that you are taking this medicine. The results of some tests may be affected by this medicine.

Contact your doctor immediately if you or your child have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle cramps, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Taking too much of this medicine may cause infertility (inability to have children) or delay in ovulation in women and affect their ability to have children. If you plan to have children, talk to your doctor before using this medicine.

Do not take any other medicines unless you have discussed this with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medications and herbal or vitamin supplements.

Side effects of Fiorinal with codeine

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

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

Rarely

• Rücken-, Bein- oder Bauchschmerzen
• schwarzer, teeriger Stuhl
• Zahnfleischbluten
• Blasenbildung, Abschälen oder Lockerung der Haut
• blutiger Urin
• verschwommene Sicht
• Brustschmerzen oder Engegefühl
• Schüttelfrost
• Verwirrung
• Husten
• dunkler Urin
• verminderte Häufigkeit oder Menge des Urins
• Durchfall
• Schwierigkeiten beim Atmen
• Schluckbeschwerden
• Schwindel, Ohnmacht oder Benommenheit beim plötzlichen Aufstehen aus einer liegenden oder sitzenden Position
• schneller, unregelmäßiger, hämmernder oder rasender Herzschlag oder Puls
• Fieber
• allgemeine Müdigkeit und Schwäche
• Kopfschmerzen
• Nesselsucht, Juckreiz oder Hautausschlag
• Erhöhter Durst
• Gelenk- oder Muskelschmerzen
• heller Stuhlgang
• Schmerzen im unteren Rücken oder an der Seite
• Brechreiz
• Nasenbluten
• Schwellungen oder Schwellungen der Augenlider oder um die Augen, das Gesicht, die Lippen oder die Zunge
• rote Hautläsionen, oft mit violettem Zentrum
• rote, gereizte Augen
• Zittern in den Beinen, Armen, Händen oder Füßen
• Wunden, Geschwüre oder weiße Flecken im Mund oder auf den Lippen
• Schwitzen
• Schwellung des Gesichts, der Finger oder der Unterschenkel
• Zittern oder Zittern der Hände oder Füße
• Schmerzen im oberen rechten Bauch oder Magen
• Erbrechen
• Blut erbrechen
• Gewichtszunahme
• gelbe Augen und Haut

Incident not known

• Agitation
• blutige Nase
• Verwirrung
• verengte, punktförmige oder kleine Pupillen (schwarzer Teil des Auges)
• Verdunkelung der Haut
• Appetitverlust
• mentale Depression
• überaktive Reflexe
• schlechte Koordination
• Unruhe
• Dinge sehen, hören oder fühlen, die nicht da sind
• Zittern
• Schlafstörungen
• Zucken
• ungewöhnliche Müdigkeit oder Schwäche

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Kalte und feuchte Haut
• Verwirrung hinsichtlich Zeit, Ort oder Person
• anhaltendes Klingeln oder Summen oder andere unerklärliche Geräusche in den Ohren
• Husten, der manchmal einen rosafarbenen, schaumigen Auswurf erzeugt
• Atembeschwerden oder Schwierigkeiten beim Atmen
• Schläfrigkeit
• extrem hohes Fieber oder hohe Körpertemperatur
• Schwerhörigkeit
• falsche Überzeugungen vertreten, die nicht durch Tatsachen geändert werden können
• vermehrtes Schwitzen
• unregelmäßige, schnelle oder langsame oder flache Atmung
• Bewusstlosigkeit
• Muskelkrämpfe
• blasse oder blaue Lippen, Fingernägel oder Haut
• punktförmige Pupillen (schwarzer Teil der Augen)
• Unruhe
• Dinge sehen, hören oder fühlen, die nicht da sind
• Anfälle
• Schwellungen in den Beinen und Knöcheln
• Schlafstörungen
• ungewöhnliche Blutungen oder Blutergüsse

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

Rarely

• Angst
• verschwommene Sicht
• Brennen, Kribbeln, Taubheitsgefühl oder Schmerzen in Händen, Armen, Füßen oder Beinen
• Verwirrung über Identität, Ort und Zeit
• verengte, punktförmige oder kleine Pupillen (schwarzer Teil des Auges)
• tiefes oder schnelles Atmen mit Schwindel
• Depression
• Schwierigkeiten beim Stuhlgang
• trockener Mund
• Gefühl der ständigen Bewegung von sich selbst oder der Umgebung
• Gefühl von Wärme
• das Gefühl, dass andere Sie beobachten oder Ihr Verhalten kontrollieren
• das Gefühl, dass andere deine Gedanken hören können
• Sodbrennen
• hohe Energie
• Herzrhythmusstörung
• Reizbarkeit
• Verlust der sexuellen Fähigkeiten, des Verlangens, des Antriebs oder der Leistung
• Taubheitsgefühl in den Füßen, Händen und im Mundbereich
• Schmerzen in den Beinen
• Rötung des Gesichts, des Halses, der Arme und gelegentlich der oberen Brust
• Gefühl des Drehens
• schwere Stimmungsschwankungen oder mentale Veränderungen
• zittern
• Schläfrigkeit
• Trägheit
• undeutliches Sprechen
• Schwierigkeiten, still zu sitzen
• unerklärlicher Gewichtsverlust
• ungewöhnliches Verhalten
• Schwäche

Incident not known

• Vermindertes Interesse am Geschlechtsverkehr
• Unfähigkeit, eine Erektion zu haben oder aufrechtzuerhalten
• Verlust der sexuellen Fähigkeiten, des Verlangens, des Antriebs oder der Leistung

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

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

Commonly used brand names

In the USA

• Ascomp mit Codein
• Fiorinal mit Codein

In Canada

• Fiorinal-C 1/2
• Fiorinal-C 1/4
• Teva-Tecnal C1/2
• Teva-Tecnal C1/4
• Testversion C1/2
• Testversion C1/4

Available dosage forms:

• Kapsel

Therapeutic class: Opioid/barbiturate combination

Pharmacological class: Barbiturate

Chemical Class: Salicylate, Aspirin

More information