Carbinoxamine; Phenylephrine extended-release tablets

What are Carbinoxamine; Phenylephrine extended-release tablets?

CARBINOXAMINE; PHENYLEPHRINE (Norel® LA) treats symptoms caused by allergies. Carbinoxamine is an antihistamine that helps stop a runny nose and sneezing. Phenylephrine is a decongestant that helps with nasal stuffiness.

What should my health care professional know before I receive Carbinoxamine; Phenylephrine?

They need to know if you have any of these conditions:

• asthma, emphysema, chronic bronchitis, or breathing problems

• bladder disease

• constipation

• diabetes

• glaucoma

• heart disease including angina (chest pain), heart attack, irregular heart beat, enlarged heart, blockage in heart vessels, heart failure

• high or low blood pressure

• kidney disease

• liver disease

• pain or difficulty passing urine

• poor circulation (example: peripheral vascular disease)

• prostate trouble

• history of stroke, mini-strokes (TIAs), or aneurysm (enlarged blood vessel)

• thyroid disease (overactive thyroid)

• ulcers or other stomach or intestine problems (example: ulcerative colitis)

• an unusual reaction to Carbinoxamine, Diphenhydramine, Clemastine, Tripelennamine, Phenylephrine, Pseudoephedrine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should this medicine be used?

Take this medicine by mouth. Follow the directions on the prescription label. Do not crush or chew the tablets; you may split them in half for taking smaller doses. Swallow tablets with plenty of water. This medicine may be taken with food or milk if upset stomach occurs. Do not take it more often than directed. Do not share this medicine with anyone.

Patients over 60 years old may have a stronger reaction to this medicine. Smaller doses may be needed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with Carbinoxamine; Phenylephrine?

• amphetamine, cocaine, or other stimulant drugs

• atomoxetine

• atropine

• bretylium

• bromocriptine

• caffeine

• cyclopropane

• digoxin

• furazolidone

• linezolid

• mecamylamine

• medicines known as MAO inhibitors, such as phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), and selegiline (Carbex®, Eldepryl®)

• medicines for depression or other mental problems, especially tricyclic antidepressants (e.g., Elavil®, Pamelor®)

• medicines for chest pain, heart disease, high blood pressure or heart rhythm problems

• medicines for diabetes

• some medicines used for migraine (ergotamine, dihydroergotamine, ergonovine, methysergide)

• medicines for mental problems and psychotic disturbances

• medicines for movement abnormalities such as Parkinson's disease

• medicines for weight loss (including some herbal products, ephedrine, dextroamphetamine)

• midodrine

• procarbazine

• St. John's wort

• theophylline

• thyroid hormones

Because this product can cause drowsiness, other medicines that also cause drowsiness may increase this effect. Some medicines that cause drowsiness are:

• alcohol and alcohol-containing medicines

• barbiturate medicines for inducing sleep or treating seizures (convulsions)

• medicines for anxiety or sleeping problems, such as diazepam or temazepam

• other medicines for colds, or allergies, such as antihistamines or decongestants

• medicines for motion sickness

• muscle relaxers

• prescription pain medicines

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Carbinoxamine; Phenylephrine?

Tell your prescriber if your symptoms do not improve in 7 days. If you have a high fever, skin rash, or headache, see your prescriber right away.

This medicine may make you drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Stand or sit up slowly to reduce the risk of dizziness or fainting spells. The drowsiness should decrease after a few days. Alcohol can increase the chance of drowsiness, dizziness, or confusion from this medicine. Do not drink alcoholic beverages.

Your mouth may get dry. Drinking plenty of water, chewing sugarless gum, or sucking on hard candy may help. You may get dry eyes. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See an eye doctor if the problem continues or is severe.

If this medicine makes it difficult for you to sleep at night, take your last dose at least 2 hours before bedtime. If nervousness, dizziness, or sleeplessness occur, stop using this medicine and consult your health-care provider.

If you are going to have surgery, tell your prescriber or health care professional that you are taking this medicine.

Your skin may become more sensitive to the sun while taking this medicine. Avoid prolonged sun exposure and use sunscreen.

What side effects may I notice from receiving Carbinoxamine; Phenylephrine?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• agitation, nervousness, excitability, not able to sleep (these are more likely in children)

• blurred vision or changes in your eyesight

• chest pain

• confusion

• difficulty or pain passing urine

• difficulty breathing, wheezing, or shortness of breath

• fainting spells, or dizziness that does not go away

• fast, slow, or irregular heartbeat

• hallucinations

• high or low blood pressure

• seizures (convulsions)

• severe, persistent, or worsening headache

• skin rash, hives, or itching

• vomiting

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• constipation or diarrhea

• dry mouth or eyes

• frequent urination

• heartburn

• loss of appetite

• stomach upset, nausea

• tiredness or drowsiness

• tremor

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 20—25 degrees C (68—77 degrees F). Protect from light. Throw away any unused medicine after the expiration date.

Carbinoxamine; Phenylephrine oral drops

What are Carbinoxamine; Phenylephrine oral drops?

CARBINOXAMINE; PHENYLEPHRINE (HistamaxD® drops, XiraHist™ pediatric drops) treats the symptoms of the common cold or allergies. Oral drops are usually used for treating infants and small children. Carbinoxamine is an antihistamine that helps stop a runny nose, and phenylephrine is a decongestant that helps with nasal stuffiness.

What should my health care professional know before I receive Carbinoxamine; Phenylephrine?

They need to know if you have any of these conditions:

• asthma, emphysema, chronic bronchitis, or breathing problems

• bladder disease

• constipation

• diabetes mellitus

• glaucoma

• heart disease including angina (chest pain), heart attack, irregular heart beat, enlarged heart, blockage in heart vessels, heart failure

• high or low blood pressure

• kidney disease

• liver disease

• pain or difficulty passing urine

• poor circulation (example: peripheral vascular disease)

• prostate trouble

• history of stroke, mini-strokes (TIAs), or aneurysm (enlarged blood vessel)

• thyroid disease (overactive thyroid)

• ulcers or other stomach or intestine problems (example: ulcerative colitis)

• an unusual reaction to Carbinoxamine, Diphenhydramine, Clemastine, Tripelennamine, Phenylephrine, Pseudoephedrine, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should this medicine be used?

Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked dropper, spoon, or container to measure your medicine. Ask your pharmacist if you do not have one; household spoons are not always accurate. This medicine may be taken with food or milk if upset stomach occurs. Do not take it more often than directed. Do not share this medicine with anyone.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed

What if I miss a dose?

If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What drug(s) may interact with Carbinoxamine; Phenylephrine?

• amphetamine, cocaine, or other stimulant drugs

• atomoxetine

• atropine

• bretylium

• bromocriptine

• caffeine

• cyclopropane

• digoxin

• furazolidone

• linezolid

• mecamylamine

• medicines known as MAO inhibitors, such as phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), and selegiline (Carbex®, Eldepryl®)

• medicines for depression or other mental problems, especially tricyclic antidepressants (e.g., Elavil®, Pamelor®)

• medicines for chest pain, heart disease, high blood pressure or heart rhythm problems

• medicines for diabetes

• some medicines used for migraine (ergotamine, dihydroergotamine, ergonovine, methysergide)

• medicines for mental problems and psychotic disturbances

• medicines for movement abnormalities such as Parkinson's disease

• medicines for weight loss (including some herbal products, ephedrine, dextroamphetamine)

• midodrine

• procarbazine

• St. John's wort

• theophylline

• thyroid hormones

Because this product can cause drowsiness, other medicines that also cause drowsiness may increase this effect. Some medicines that cause drowsiness are:

• alcohol and alcohol-containing medicines

• barbiturate medicines for inducing sleep or treating seizures (convulsions)

• medicines for anxiety or sleeping problems, such as diazepam or temazepam

• other medicines for colds, or allergies, such as antihistamines or decongestants

• medicines for motion sickness

• muscle relaxers

• prescription pain medicines

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Carbinoxamine; Phenylephrine?

Tell your prescriber if your symptoms do not improve in 7 days. If you have a high fever, skin rash, or headache, see your prescriber right away.

This medicine may make you drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Stand or sit up slowly to reduce the risk of dizziness or fainting spells. The drowsiness should decrease after a few days. Alcohol can increase the chance of drowsiness, dizziness or confusion from this medicine. Do not drink alcoholic beverages.

Your mouth may get dry. Drinking plenty of water, chewing sugarless gum, or sucking on hard candy may help. You may get dry eyes. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See an eye doctor if the problem continues or is severe.

If this medicine makes it difficult for you to sleep at night, take your last dose at least 2 hours before bedtime. If nervousness, dizziness, or sleeplessness occur, stop using this medicine and consult your health-care provider.

If you are going to have surgery, tell your prescriber or health care professional that you are taking this medicine.

Your skin may become more sensitive to the sun while taking this medicine. Avoid prolonged sun exposure and use sunscreen.

What side effects may I notice from receiving Carbinoxamine; Phenylephrine?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• agitation, nervousness, excitability, not able to sleep (these are more likely in children)

• blurred vision or changes in your eyesight

• chest pain

• confusion

• difficulty or pain passing urine

• difficulty breathing, wheezing, or shortness of breath

• fainting spells, or dizziness that does not go away

• fast, slow, or irregular heartbeat

• hallucinations

• high or low blood pressure

• seizures (convulsions)

• severe, persistent, or worsening headache

• skin rash, hives, or itching

• vomiting

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• anxiety or nervousness

• constipation or diarrhea

• dry mouth or eyes

• frequent urination

• headache (mild)

• heartburn

• loss of appetite

• sleeplessness (insomnia)

• stomach upset, nausea

• tiredness or drowsiness

• tremor

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15—30 degrees C (59—86 degrees F). Do not transfer liquid preparations to another bottle or container. Protect from light. Throw away any unused medicine after the expiration date.