Para-Time S.R.

Generic Name: papaverine (Oral route)

pa-PAV-er-een

Commonly used brand name(s)

In the U.S.

• Papacon


• Para-Time S.R.


• Pavacot

Available Dosage Forms:

• Capsule, Extended Release


• Tablet

Therapeutic Class: Peripheral Vasodilator

Uses For Para-Time S.R.

Papaverine belongs to the group of medicines called vasodilators. Vasodilators cause blood vessels to expand, thereby increasing blood flow. This medicine is used to treat problems resulting from poor blood circulation.

Papaverine is available only with your doctor's prescription.

Before Using Para-Time S.R.

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

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

Geriatric

Papaverine may reduce tolerance to cold temperatures in elderly patients.

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 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.

• Ginkgo

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Angina (chest pain) or


• Glaucoma or


• Heart disease or


• Myocardial infarction (heart attack), recent, or


• Stroke, recent—The chance of unwanted effects may be increased.

Proper Use of papaverine

This section provides information on the proper use of a number of products that contain papaverine. It may not be specific to Para-Time S.R.. Please read with care.

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.

Precautions While Using Para-Time S.R.

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.

Para-Time S.R. Side Effects

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

• 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. 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:

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 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.

See also: Para-Time S.R. side effects (in more detail)

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More Para-Time S.R. resources

• Para-Time S.R. Side Effects (in more detail)
• Para-Time S.R. Use in Pregnancy & Breastfeeding
• Drug Images
• Para-Time S.R. Drug Interactions
• Para-Time S.R. Support Group
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