Semprex-D (Oral)

Acrivastine and pseudoephedrine combination is used to treat an itchy or runny nose, sneezing, or other symptoms caused by seasonal hay fever (allergic rhinitis).

Acrivastine is an antihistamine. It works by stopping the effects of a substance called histamine, which the body produces. Histamine can cause itching, sneezing, a runny nose, and watery eyes. Pseudoephedrine is a decongestant that reduces nasal congestion by narrowing the blood vessels and lowering blood flow to the nasal passage.

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

It is very important that your doctor check your progress at regular visits. This will help you see if the medicine is working properly and to decide if you should continue to take it.

Do not use this medicine and an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within 14 days of each other.

This medicine may cause some people to feel dizzy, drowsy, or less alert than usual. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates, medicine for seizures, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it provides. 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 inform your healthcare 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

Appropriate studies performed to date have not shown pediatric-specific problems that would limit the usefulness of Semprex®-D capsules in children 12 years of age and older. However, safety and effectiveness have not been established in children younger than 12 years of age.

Geriatric

Appropriate studies performed to date have not shown geriatric-specific problems that would limit the usefulness of Semprex®-D capsules in older adults. However, older patients are more likely to experience unwanted effects (e.g., dizziness, drowsiness, fainting, lightheadedness, or trouble urinating) and age-related kidney issues, which may require caution and an adjustment in the dose for patients taking this medicine.

Breast Feeding

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

Interactions with Medicines

Although some 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 situations, 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 knows if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

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

• Dihydroergotamine
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Tranylcypromine

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 use one or both of the medicines.

• Amifampridine
• Bupropion
• Donepezil
• Guanethidine
• Iobenguane I 123
• Iobenguane I 131
• Methyldopa
• Midodrine
• Pitolisant
• Zavegepant

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or specific types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

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 issues, especially:

• Allergy to phenylpropanolamine, history of or
• Allergy to triprolidine, history of or
• Severe coronary artery disease or
• Severe hypertension (high blood pressure)—Should not be used in patients with these conditions.

• Diabetes or
• Enlarged prostate or
• Hypertension or
• Hyperthyroidism (overactive thyroid gland) or
• Increased intraocular pressure or
• Ischemic heart disease or
• Stomach or bowel problems (e.g., blockage, ulcers)—Use with caution. May worsen these conditions.

• Kidney disease—Use with caution. The effects may be increased due to slower removal of the medicine from the body.

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

Get emergency help right away if you notice any of these overdose symptoms:

Symptoms of overdose

• Blurred vision
• chest pain or discomfort
• cold, clammy, or pale skin
• confusion
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from lying down or sitting
• irregular heartbeats
• seizures
• shortness of breath
• slow heart rate
• sweating
• unusual tiredness or weakness

Some side effects may happen that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your healthcare professional may also have ways to help prevent or reduce some of these side effects. Talk to your healthcare professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Dry mouth
• headache
• sleepiness or unusual drowsiness

Less common

• Acid or sour stomach
• belching
• body aches or pain
• congestion
• cough
• dryness or soreness of the throat
• fever
• heartburn
• hoarseness
• indigestion
• lack or loss of strength
• nausea
• nervousness
• runny nose
• stomach discomfort, upset, or pain
• tender, swollen glands in the neck
• trouble sleeping
• trouble swallowing
• voice changes

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.

In the U.S.

• Semprex-D

Pharmacologic Class: Antihistamine, Less-Sedating

Chemical Class: Alkylamine

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

Swallow the capsule whole. Do not crush, break, or chew it. You may take this medicine with or without food.

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 (capsules):For treatment of seasonal allergic rhinitis: Adults and children 12 years of age and older—One capsule four times a day (taken every 4 to 6 hours per day). Children younger than 12 years of age—Use and dose must be determined by your doctor.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.