Cetirizine and pseudoephedrine

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 cetirizine and pseudoephedrine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to cetirizine and pseudoephedrine 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

Use is not recommended in infants and children up to 12 years of age. In children 12 years of age and older, cetirizine and pseudoephedrine is not expected to cause different side effects or problems than it does in adults.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of cetirizine and pseudoephedrine in the elderly with use in other age groups.

Pregnancy

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 cetirizine and pseudoephedrine, 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 cetirizine and pseudoephedrine 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 cetirizine and pseudoephedrine with any of the following medicines is usually not recommended, but may be required 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.

• Guanethidine
• Iobenguane I 123
• Methyldopa
• Midodrine

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of cetirizine and pseudoephedrine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—Removal of cetirizine and pseudoephedrine from the body may be reduced

For cetirizine
• Liver disease—May be worsened by cetirizine

For pseudoephedrine
• Diabetes or
• Heart disease or
• High blood pressure or
• Inner eye pressure or
• Narrow-angle glaucoma or
• Urination difficulties or
• Prostate, enlarged or
• Thyroid problems—May be worsened by pseudoephedrine

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.

Get emergency help immediately if any of the following symptoms of overdose occur:

• Changes in mood, irrational behavior, depersonalization hallucinations
• convulsions (seizures)
• extreme sleepiness or unusual drowsiness
• fast, slow, pounding, or irregular heartbeat or pulse
• feeling anxious
• giddiness
• headache
• irritability
• muscle weakness or tenderness
• nausea
• restlessness
• shallow, irregular, fast, or slow breathing
• sleeplessness or trouble in sleeping
• abdominal and/or chest pain
• thirst

Check with your doctor as soon as possible if any of the following side effects occur:

• Breathing, troubled
• back, leg, or stomach pain
• blurred vision
• bloody, cloudy, or dark urine, sudden decrease in amount of urine
• black, tarry stools, diarrhea, light-colored stools
• confusion
• dizziness, feeling faint, or lightheaded
• fever or chills
• increased blood pressure
• rapid weight gain
• skin rash or hives
• swelling of face, mouth, throat, fingers, glands, feet, and/or lower legs
• stillbirth
• twitching, twisting, or uncontrolled repetitive movements of the face
• sudden sweating
• vomiting blood, bleeding gums, nosebleeds, unusual bleeding or bruising
• pale or yellow eyes or skin
• unusual tiredness or weakness

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:

• Sleepiness or unusual drowsiness, extreme tiredness

• Dry mouth
• weakness

• Dizziness
• sore throat

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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take cetirizine and pseudoephedrine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to cetirizine and pseudoephedrine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Antihistamine

Nasal decongestant

NDC 0781-5285-31

Cetirizine HCl and

Pseudoephedrine HCl

Extended Release Tablets

5 mg/120 mg

antihistamine/

nasal decongestant

Indoor & Outdoor Allergies

ALLERGY & CONGESTION

12 hour Relief of

Runny Nose Itchy, Watery Eyes Sinus Pressure

Sneezing Itchy Throat or Nose Nasal Congestion

SANDOZ

30 Tablets

Cetirizine HCl and

Pseudoephedrine

HCl Extended

Release Tablet

5 mg/120 mg

Sandoz Inc., Princeton, NJ 08540

• Alpha/Beta Agonist
• Decongestant
• Histamine H1 Antagonist
• Histamine H1 Antagonist, Second Generation
• Piperazine Derivative

See individual agents.

Applies to cetirizine / pseudoephedrine: oral tablet extended release

Dermatologic

Dermatologic side effects have included maculopapular and urticarial eruptions.[Ref]

Gastrointestinal

Gastrointestinal side effects of cetirizine have included dry mouth (5.7%) and nausea or vomiting (2.2%). Pharyngitis, dyspepsia, and increased appetite have occasionally been reported.

Gastrointestinal adverse effects of pseudoephedrine have included anorexia and gastric irritation (5%). Dry mouth, nose, or throat have occurred in up to 15% of patients.[Ref]

Hepatic

Hepatic side effects have included rare liver function test abnormalities which resolved spontaneously following discontinuation of cetirizine therapy.[Ref]

Nervous system

Cetirizine appears to be more sedating than terfenadine, astemizole, and loratadine.[Ref]

Nervous system side effects of cetirizine administration have included headache (16%), fatigue (5.6%), and somnolence (5% to 20%). Somnolence tends to be dose-related and generally occurs more frequently with doses higher than 10 mg per day. Other nervous system side effects include dizziness (1.8%), insomnia (1.5%), and nervousness (1.1%). Post marketing reports have included aggression reaction and convulsions.

Nervous system side effects of pseudoephedrine have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported.[Ref]

Respiratory

Respiratory side effects have included wheezing, coughing, bronchitis, sinusitis, and asthma.[Ref]

Hypersensitivity

Hypersensitivity reactions have included fixed drug eruptions with pseudoephedrine use.[Ref]

Cardiovascular

Cardiovascular side effects have included tachycardia. Some patients have developed hypertension and/or arrhythmias.[Ref]

General

General side effects have included epistaxis (1.1%) and accidental injury (1.1%).[Ref]

Some side effects of cetirizine / pseudoephedrine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.