Naproxen; Pseudoephedrine extended-release caplets and tablets

What are Naproxen; Pseudoephedrine extended-release caplets and tablets?

NAPROXEN; PSEUDOEPHEDRINE (Aleve® Cold & Sinus, Aleve® Sinus and Headache) is a combination of 2 medicines to help relieve symptoms of the common cold, flu, or sinus problems, like nasal or sinus stuffiness, fever, body aches or mild pain, sinus pressure, and headache. Generic naproxen; pseudoephedrine tablets are available.

What should I tell my health care provider before I take this medicine?

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

• anemia or blood disease

• asthma

• cigarette smoker

• colon problems, like ulcerative colitis

• coronary artery bypass graft (CABG) surgery within the past 2 weeks

• diabetes

• difficulty urinating

• drink more than 3 alcohol-containing beverages a day

• glaucoma

• heart or circulation problems like angina, high blood pressure, heart failure, heart rhythm problems, history of heart attack, history of blood clots

• problems with immune system

• kidney disease

• liver disease

• lupus

• over active thyroid

• prostate trouble

• rheumatoid arthritis

• stomach ulcers or bleeding

• history of stroke

• an unusual or allergic reaction to naproxen, pseudoephedrine, aspirin, ibuprofen or similar medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should this medicine be used?

Take this medicines by mouth. Swallow the caplets or tablets whole with a full glass of water; do not crush or chew. This medicine may be taken with food if it upsets your stomach. Follow the directions on the package label. Take your doses at regular intervals. Do not take your medicine more often than directed.

Do not smoke cigarettes or drink alcohol; these may increase the irritation to your stomach when taking this medicine.

Elderly patients over 60 years old may have a stronger reaction to this medicine and need smaller doses.

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 you miss a dose, and you are taking it on a regular schedule, take it as soon as you can. 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 Naproxen; Pseudoephedrine?

• ammonium chloride

• amphetamine or other stimulant drugs

• antacids

• anti-inflammatory drugs such as aspirin, Motrin® or prednisone

• atomoxetine

• bretylium

• bromocriptine

• caffeine

• cyclosporine

• drospirenone; ethinyl estradiol (Yasmin®)

• leflunomide

• lithium

• medicines for Alzheimer's disease

• medicines for colds and breathing difficulties

• medicines for cancer

• medicines for diabetes

• medicines for certain infections like linezolid, adefovir, cidofovir, entecavir, foscarnet, ganciclovir, tenofovir, voriconazole

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

• medicines for migraine headaches

• medicines that treat or prevent blood clots such as warfarin, and other blood thinners

• methotrexate

• pemetrexed

• probenecid

• procarbazine

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

• some medicines for mental depression

• some medicines for osteoporosis (alendronate, pamidronate, risedronate, zoledronic acid)

• some medicines for seizures

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

• St. John's wort

• tacrolimus

• theophylline

• thyroid hormones

• water pills (diuretics)

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 Naproxen; Pseudoephedrine?

Check with your prescriber if your symptoms have not improved within 7 days, or if you have a high fever. Do not treat yourself for a fever for more than 3 days, or for nasal congestion for more than 7 days without asking your prescriber for advice.

If this medicine makes it difficult for you to sleep at night; take your last dose at least a few hours before bedtime.

If you are going to have surgery, tell your prescriber or health care professional that you are taking naproxen; pseudoephedrine. You may bleed more easily while taking naproxen.

Problems can arise if you need dental work, and in the daily care of your teeth. Try to avoid damage to your teeth and gums when you brush or floss your teeth.

To reduce unpleasant effects on your throat and stomach, take this medicine with a full glass of water and never just before lying down. If you notice black, tarry stools or experience severe stomach pain and vomit blood or what looks like coffee grounds, notify your health care prescriber immediately.

Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not sit or stand up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

It is especially important not to use naproxen products during the last 3 months of pregnancy unless specifically directed to do so by your health care provider. Naproxen may cause problems in the unborn child or complications during delivery.

What side effects may I notice from receiving Naproxen; Pseudoephedrine?

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

• blurred vision or visual changes

• chest pain

• confusion or depression

• difficulty swallowing

• dizziness or fainting spells

• fever, chills, muscle aches and pains

• severe, persistent, or worsening headache

• high blood pressure

• irregular heartbeat (fast or slow heartbeat), palpitations

• muscle spasms or weakness

• neck stiffness

• numbness or tingling in the hands or feet

• pain or difficulty passing urine

• ringing in the ears or hearing loss

• seizures

• signs of bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine or stools, unusual tiredness or weakness

• severe allergic reaction - difficulty breathing, wheezing, rash, redness, blistering, peeling or itching, swelling of eyelids, throat, lips or feet

• stomach pain, cramps, vomiting

• unexplained weight gain or fluid retention

• yellowing of the skin or eyes

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

• drowsiness

• heartburn

• increased sweating

• increased sensitivity to sunlight

• loss of appetite

• restlessness

• 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 and 25 degrees C (68 and 77 degrees F). Protect from heat and moisture. Throw away any unused medicine after the expiration date.