Para-Time S.R. (Oral)

Papaverine is part of a group of medicines known as vasodilators. Vasodilators help blood vessels widen, which increases blood flow. This medicine is used to treat issues caused by poor blood circulation.

You can only get Papaverine with a prescription from your doctor.

It may take some time for this medicine to work. If you feel that the medicine is not working, do not stop taking it on your own. Instead, check with your doctor.

The helpful effects of this medicine may be decreased if you smoke. If you have any questions about this, check with your doctor.

Dizziness may occur, especially when you get up from a lying or sitting position or climb stairs. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine against the benefits it will provide.

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing the use of papaverine in children to its use in other age groups, but this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Papaverine may make elderly patients less tolerant to cold temperatures.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines can be used together even if an interaction might happen. In these situations, your doctor may adjust the dose, or other precautions may be necessary. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when using this medicine. The following interactions are noteworthy but may not be a complete list.

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

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Piperaquine
• Riociguat
• Terfenadine

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

• Adagrasib
• Amiodarone
• Amisulpride
• Apomorphine
• Aripiprazole Lauroxil
• Atazanavir
• Buprenorphine
• Ceritinib
• Chloroquine
• Citalopram
• Clofazimine
• Clothiapine
• Clozapine
• Crizotinib
• Dabrafenib
• Dasatinib
• Deutetrabenazine
• Dexmedetomidine
• Efavirenz
• Encorafenib
• Entrectinib
• Escitalopram
• Etrasimod
• Fexinidazole
• Fingolimod
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fostemsavir
• Gepirone
• Glasdegib
• Hydroxychloroquine
• Hydroxyzine
• Inotuzumab Ozogamicin
• Ivosidenib
• Ketoconazole
• Lefamulin
• Lenvatinib
• Leuprolide
• Lofexidine
• Macimorelin
• Methadone
• Metronidazole
• Mirtazapine
• Mobocertinib
• Nilotinib
• Olanzapine
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paroxetine
• Phenobarbital
• Pimavanserin
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Quetiapine
• Quizartinib
• Relugolix
• Ribociclib
• Selpercatinib
• Sertraline
• Siponimod
• Solifenacin
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Trazodone
• Triclabendazole
• Vardenafil
• Vemurafenib
• Vilanterol
• Vinflunine
• Voclosporin
• Zuclopenthixol

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

• Ginkgo

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you use this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Angina (chest pain) or
• Glaucoma or
• Heart disease or
• Recent myocardial infarction (heart attack) or
• Recent stroke—The chance of unwanted effects may be increased.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

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

Rare

• Abdominal pain or tenderness
• blurred or double vision
• change in ability to see colors, especially blue or yellow
• clay-colored stools
• dark urine
• decreased appetite
• deep, slow breathing
• drowsiness
• fatigue
• fever
• headache
• insomnia
• itching
• loss of appetite
• nausea and vomiting
• painful or prolonged erection of the penis
• skin rash
• swelling of the feet or lower legs
• trouble with breathing
• unusual tiredness or weakness
• vomiting
• weakness
• 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. Your health care professional may be able to tell you 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 any questions about them:

Less common

• Constipation
• diarrhea
• dizziness or lightheadedness
• fainting
• fast, pounding, or irregular heartbeat or pulse
• feeling of constant movement of self or surroundings
• flushed face
• itching skin
• nervousness
• palpitations
• pounding in the ears
• sensation of spinning
• sleepiness or unusual drowsiness
• slow or fast heartbeat

Other side effects not listed may also happen 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.

In the U.S.

• Papacon
• Para-Time S.R.
• Pavacot

If this medicine upsets your stomach, it may be taken with meals, milk, or antacids.

For patients taking the extended-release capsule form of this medicine:

• Swallow the capsule whole. Do not crush, break, or chew before swallowing. However, if the capsule is too large to swallow, you may mix the contents with jam or jelly and swallow without chewing.

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 oral dosage form (extended-release capsules): Adults: 150 milligrams (mg) every twelve hours. The dose may be increased to 150 mg every eight hours or 300 mg every twelve hours.
• For oral dosage form (tablets): Adults: 100 to 300 milligrams (mg) three to five times a day.

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

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.