Bismuth subcitrate, metronidazole and tetracycline (oral)

Bismuth subcitrate, metronidazole and tetracycline (oral)

Bismuth subcitrate, metronidazole and tetracycline (oral) Oral route (capsule)

Potential for carcinogenicity

Metronidazole has been shown to be carcinogenic in mice and rats. It is not known whether metronidazole is carcinogenic in humans.

Used for bismuth subcitrate, metronidazole and tetracycline

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

Before using bismuth subcitrate, metronidazole and tetracycline

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

Due to the toxicity of tetracycline, its use in children younger than 8 years is not recommended. Tetracycline can cause permanent tooth discoloration. Safety and effectiveness have not been established in this age group.

geriatrics

Related studies conducted to date have not shown any geriatric-specific problems that would limit the benefit of Pylera® in older people. However, older patients are at higher risk of age-related kidney, liver, or heart problems, which may require caution and dose adjustment in patients receiving this drug.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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.

• Acitretin
• Amprenavir
• Bepridil
• Cisaprid
• Disulfiram
• Dronabinol
• Dronedaron
• Levoketoconazol
• Mesoridazin
• Methoxyfluran
• Pimozid
• Saquinavir
• Sparfloxacin
• Terfenadin
• Thioridazin
• Ziprasidon

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.

• Acenocoumarol
• Adagrasib
• Alfuzosin
• Amiodaron
• Amitriptylin
• Amoxicillin
• Ampicillin
• Anagrelid
• Apomorphin
• Aripiprazol
• Aripiprazol Lauroxil
• Arsentrioxid
• Asenapin
• Astemizol
• Atazanavir
• Azithromycin
• Bacampicillin
• Bedaquilin
• Bexaroten
• Buprenorphin
• Bupropion
• Buserelin
• Busulfan
• Capecitabin
• Ceritinib
• Chloroquin
• Chlorpromazin
• Cholera-Impfstoff, lebend
• Cimetidin
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimin
• Clomipramin
• Clotiapin
• Cloxacillin
• Clozapin
• Crizotinib
• Cyclobenzaprin
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramin
• Deslorelin
• Desogestrel
• Deutetrabenazin
• Dexmedetomidin
• Dicloxacillin
• Dienogest
• Digoxin
• Disopyramid
• Dofetilid
• Dolasetron
• Domperidon
• Donepezil
• Doxepin
• Doxifluridin
• Droperidol
• Drospirenon
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Östradiol
• Ethinylestradiol
• Ethynodiol
• Etretinat
• Famotidin
• Felbamat
• Fexinidazol
• Fingolimod
• Flecainid
• Fluconazol
• Fluoruracil
• Fluoxetin
• Formoterol
• Foscarnet
• Fosphenytoin
• Galantamin
• Gatifloxacin
• Gemifloxacin
• Gestoden
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrin
• Haloperidol
• Histrelin
• Hydrochinidin
• Hydroxychloroquin
• Hydroxyzin
• Ibutilid
• Iloperidon
• Imipramin
• Inotuzumab Ozogamicin
• Isotretinoin
• Itraconazol
• Ivabradin
• Ivosidenib
• Ketoconazol
• Lapatinib
• Leuprolid
• Levofloxacin
• Levonorgestrel
• Lithium
• Lofexidin
• Lumefantrin
• Macimorelin
• Magnesiumsulfat
• Mebendazol
• Mefloquin
• Mestranol
• Methadon
• Methicillin
• Methotrexat
• Methotrimeprazin
• Mifepriston
• Mizolastin
• Mobocertinib
• Moricizin
• Moxifloxacin
• Mycophenolatmofetil
• Mycophenolsäure
• Nafarelin
• Nafcillin
• Nelfinavir
• Nilotinib
• Nomegestrol
• Norethindron
• Norfloxacin
• Norgestimate
• Norgestrel
• Octreotid
• Ofloxacin
• Olanzapin
• Ondansetron
• Osimertinib
• Oxacillin
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidon
• Palovaroten
• Panobinostat
• Papaverinhydrochlorid
• Paroxetin
• Pasireotid
• Pazopanib
• Penicillin G
• Penicillin G Benzathin
• Penicillin G Procain
• Penicillin V
• Pentamidin
• Perphenazin
• Phenobarbital
• Phenprocoumon
• Phenytoin
• Pimavanserin
• Pipamperon
• Piperacillin
• Piperaquin
• Pitolisant
• Pivampicillin
• Ponesimod
• Porfimer
• Posaconazol
• Primidon
• Probukol
• Procainamid
• Prochlorperazin
• Promethazin
• Propafenon
• Protriptylin
• Quetiapin
• Chinidin
• Chinin
• Ranolazin
• Relugolix
• Ribociclib
• Risperidon
• Ritonavir
• Selpercatinib
• Sertindol
• Sertralin
• Sevofluran
• Siponimod
• Natriumphosphat
• Natriumphosphat, zweibasisch
• Natriumphosphat, einbasisch
• Solifenacin
• Sorafenib
• Sotalol
• Sulpirid
• Sultamicillin
• Sultoprid
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tegafur
• Telaprevir
• Telavancin
• Telithromycin
• Temocillin
• Tetrabenazin
• Tolterodin
• Toremifen
• Trazodon
• Tretinoin
• Trimipramin
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxin
• Vilanterol
• Vinflunin
• Voclosporin
• Voriconazol
• Vorinostat
• Warfarin
• Zotepin
• Zuclopenthixol

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.

• Aluminiumcarbonat, basisch
• Aluminiumhydroxid
• Aluminiumphosphat
• Aminolävulinsäure
• Atovaquon
• Kalzium
• Carbamazepin
• Cholestyramin
• Colestipol
• Cyclosporin
• Dihydroxyaluminiumaminoacetat
• Dihydroxyaluminium-Natriumcarbonat
• Eisen
• Magaldrat
• Magnesiumcarbonat
• Magnesiumhydroxid
• Magnesiumoxid
• Magnesiumtrisilikat
• Mariendistel
• Chinin

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 in conjunction with the following conditions is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medications you are taking, or give you special instructions about the consumption of food, alcohol, or tobacco.

• Ethanol

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.

• Milchprodukt

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:

• Blutprobleme, Vorgeschichte (z. B. Leukopenie) oder
• Enzephalopathie oder
• Pilzinfektion (z. B. Candidiasis) oder
• Periphere Neuropathie oder
• Anfälle, Anamnese: Mit Vorsicht verwenden. Kann diese Bedingungen verschlimmern.

• Cockayne-Syndrom (genetische Störung) oder
• Nierenerkrankung, schwere oder
• Schwere Lebererkrankung: Sollte bei Patienten mit diesen Erkrankungen nicht angewendet werden.

Proper use of bismuth subcitrate, metronidazole and tetracycline

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.

Your doctor will also prescribe another medicine called omeprazole to be taken with this medicine.

Swallow the capsules whole with a full glass (8 ounces) of water. Do not crush, break or chew the capsules.

Drink more fluids to prevent irritation or ulcers in the esophagus (the tube between the throat and stomach).

Continue taking this medicine throughout treatment, even if you feel better after the first few doses. Your infection may not clear if you stop using the medicine too soon.

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):
  • Zur Behandlung einer H. pylori-Infektion und eines Zwölffingerdarmgeschwürs (zusammen mit Omeprazol eingenommen):
    • Erwachsene – 3 Kapseln 4-mal täglich, nach den Mahlzeiten und vor dem Schlafengehen, 10 Tage lang.
    • Kinder – Anwendung und Dosis müssen von Ihrem Arzt festgelegt werden.

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 return to your regular dosing schedule. Do not double the dose.

If you miss more than 4 doses of this medicine, contact your doctor immediately.

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.

Ask your doctor how to throw away medicines you don't use.

Precautions when using bismuth subcitrate, metronidazole and tetracycline

It is very important that your doctor check your progress at regular visits for any problems or unwanted effects that may be caused by this medicine.

Do not use this medicine if you are also taking methoxyflurane or have taken disulfiram in the last 2 weeks. Do not drink alcohol while using this medication and for at least 3 days after the last dose.

Using this medicine during pregnancy may harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you have become pregnant while using this medicine, tell your doctor immediately.

Birth control pills may not work properly if you take them while using this medication. You should use an alternative or additional method of contraception (e.g. condoms, diaphragm, or contraceptive foam or gel) while using this medication. If you have any questions about this, contact your doctor.

Bismuth subcitrate can cause your tongue to become darker or even black. It can also cause your stool to turn black. This is only temporary and will not harm you. Your tongue and bowel movements will return to normal when you stop taking this medicine. Ask your doctor about this if you have any concerns.

Do not drink milk or eat dairy products with this medicine.

Consult your doctor immediately if you experience a stiff neck, drowsiness, fever, severe headache, nausea, vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).

Consult your doctor immediately if you experience burning, numbness, tingling, or painful sensations in your arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Tetracycline can make your skin more sensitive to sunlight. Even short-term exposure to the sun can cause a rash, itching, redness or other discoloration of the skin, or severe sunburn. Use sunscreen when you are outdoors. Avoid sun lamps and tanning beds.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), may occur with this drug. Contact your doctor immediately if you experience black, tarry stools, blistering, peeling or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, painful or difficult urination, red, irritated eyes, red skin lesions, severe acne or rash, sore throat, sores or ulcers, or white patches in the mouth or lips, swollen glands or unusual tiredness or weakness while using this medicine.

Tell your doctor that you are using this medicine before having a medical examination or x-ray. The results of some tests may be affected by this medicine.

You should not drink alcoholic beverages or take other preparations containing alcohol while using this medication and for at least one day after stopping the medication.

If your symptoms do not improve within a few days or worsen, contact your doctor.

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 bismuth subcitrate, metronidazole and tetracycline

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:

More common

• Aufstoßen
• Schüttelfrost
• Husten
• dunkler Urin
• Durchfall
• Fieber
• allgemeines Unwohlsein oder Krankheitsgefühl
• Kopfschmerzen
• Sodbrennen
• Verdauungsstörungen
• Gelenkschmerzen
• Appetitverlust
• Muskelschmerzen und Schmerzen
• Brechreiz
• Schmerzen im Magen, in der Seite oder im Unterleib, die möglicherweise in den Rücken ausstrahlen
• laufende Nase
• Zittern
• wunder oder trockener Hals
• Magenbeschwerden, Magenverstimmung oder Schmerzen
• Schwitzen
• Schlafstörungen
• ungewöhnliche Müdigkeit oder Schwäche
• Erbrechen
• gelbe Augen oder Haut

Less common

• Rückenschmerzen
• schwarzer, teeriger Stuhl
• Körperschmerzen oder Schmerzen
• brennendes Gefühl in der Brust oder im Magen
• Brennen beim Wasserlassen
• Brustschmerzen
• Schwindel
• schneller, unregelmäßiger, hämmernder oder rasender Herzschlag oder Puls
• häufiges Wasserlassen
• Heiserkeit
• erhöhte Menge an hellem, verdünntem Urin
• Juckreiz der Vagina oder des Genitalbereichs
• Mangel oder Verlust der Kraft
• Schmerzen im unteren Rücken oder an der Seite
• Schmerzen beim Geschlechtsverkehr
• schmerzhaftes oder schwieriges Wasserlassen
• blasse Haut
• Hautausschlag mit flachen oder kleinen erhabenen Läsionen auf der Haut
• niesen
• verstopfte Nase
• empfindliche, geschwollene Drüsen im Nacken
• Druckempfindlichkeit im Magenbereich
• dicker, weißer Vaginalausfluss ohne Geruch oder mit mildem Geruch
• Schwierigkeiten beim Schlucken
• ungewöhnliche Blutungen oder Blutergüsse
• Stimme verändert sich

Rarely

• Völlegefühl
• überschüssige Luft oder Gas im Magen oder Darm
• Gefühl der Fülle
• Schmerzen oder Druckempfindlichkeit um die Augen und Wangenknochen
• Gas geben
• Hautausschlag
• Engegefühl in der Brust
• Atembeschwerden

Incident not known

• Blasenbildung, Peeling, Lockerung der Haut
• verschwommenes oder vermindertes Sehen
• Brennen, Taubheitsgefühl, Kribbeln oder schmerzhafte Empfindungen
• Ungeschicklichkeit
• Juckreiz
• Druck im Magen
• rote, gereizte Augen
• rote Hautläsionen, oft mit violettem Zentrum
• Wunden, Geschwüre oder weiße Flecken im Mund oder auf den Lippen
• Schwellung des Magenbereichs
• Unsicherheit oder Unbeholfenheit
• Schwäche in den Armen, Händen, Beinen oder Füßen
• weiße Flecken im Mund, Rachen oder auf der Zunge

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:

More common

• Schwarze oder dunkle Zunge
• schwarzer Stuhlgang

Less common

• Geschmacksveränderung oder schlechter, ungewöhnlicher oder unangenehmer Nachgeschmack
• trockener Mund
• Angst oder Nervosität

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

• Pylera

Available dosage forms:

• Kapsel

Therapeutic class: Antiulcer, Helicobacter Pylori

Chemical Class: Nitroimidazole

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