Get emergency medical help if you have signs of an allergic reaction to Hatric 3: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using Hatric 3 and call your doctor at once if you have:
painful or difficult urination;
little or no urinating;
pain or fullness in your ear, hearing problems;
a light-headed feeling, like you might pass out;
worsening allergy or urticaria symptoms.
Common Hatric 3 side effects may include:
stuffy nose, sinus pain, sore throat, cough;
vomiting, diarrhea, constipation;
dry mouth; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Hatric 3 in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
Use of Hatric 3 has been associated with somnolence, fatigue, asthenia, and urinary retention.
Clinical Trials Experience
The safety data described below reflect exposure to Hatric 3 in 2708 patients with seasonal or perennial allergic rhinitis or chronic idiopathic urticaria in 14 controlled clinical trials of 1 week to 6 months duration.
The short-term (exposure up to 6 weeks) safety data for adults and adolescents are based upon eight clinical trials in which 1896 patients (825 males and 1071 females aged 12 years and older) were treated with Hatric 3 2.5, 5, or 10 mg once daily in the evening.
The short-term safety data from pediatric patients are based upon two clinical trials in which 243 children with seasonal or perennial allergic rhinitis (162 males and 81 females 6 to 12 years of age) were treated with Hatric 3 5 mg once daily for 4 to 6 weeks, one clinical trial in which 114 children (65 males and 49 females 1 to 5 years of age) with allergic rhinitis or chronic idiopathic urticaria were treated with Hatric 3 1.25 mg twice daily for 2 weeks, and one clinical trial in which 45 children (28 males and 17 females 6 to 11 months of age) with symptoms of allergic rhinitis or chronic urticaria were treated with Hatric 3 1.25 mg once daily for 2 weeks.
The long-term (exposure of 4 or 6 months) safety data in adults and adolescents are based upon two clinical trials in which 428 patients (190 males and 238 females) with allergic rhinitis were exposed to treatment with Hatric 3 5 mg once daily. Long term safety data are also available from an 18-month trial in 255 Hatric 3-treated subjects 12-24 months of age.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
Adults and Adolescents 12 years of Age and Older
In studies up to 6 weeks in duration, the mean age of the adult and adolescent patients was 32 years, 44% of the patients were men and 56% were women, and the large majority (more than 90%) was Caucasian.
In these trials 43% and 42% of the subjects in the Hatric 3 2.5 mg and 5 mg groups, respectively, had at least one adverse event compared to 43% in the placebo group.
In placebo-controlled trials of 1-6 weeks in duration, the most common adverse reactions were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis, and most were mild to moderate in intensity. Somnolence with Hatric 3 showed dose ordering between tested doses of 2.5, 5 and 10 mg and was the most common adverse reaction leading to discontinuation (0.5%).
Table 1 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 12 years and older exposed to Hatric 3 2.5 mg or 5 mg in eight placebo-controlled clinical trials and that were more common with Hatric 3 than placebo.
Table 1 : Adverse Reactions Reported in ≥ 2%* of Subjects Aged 12 Years and Older Exposed to Hatric 3 2.5 mg or 5 mg Once Daily in Placebo-Controlled Clinical Trials 1-6 Weeks in Duration
Hatric 3 2.5 mg
(n = 421)
Hatric 3 5 mg
(n = 1070)
(n = 912)
*Rounded to the closest unit percentage
Additional adverse reactions of medical significance observed at a higher incidence than in placebo in adults and adolescents aged 12 years and older exposed to Hatric 3 are syncope (0.2%) and weight increased (0.5%).
Pediatric Patients 6 To 12 Years Of Age
A total of 243 pediatric patients 6 to 12 years of age received Hatric 3 5 mg once daily in two short-term placebo controlled double-blind trials. The mean age of the patients was 9.8 years, 79 (32%) were 6 to 8 years of age, and 50% were Caucasian. Table 2 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 6 to 12 years exposed to Hatric 3 5 mg in placebo-controlled clinical trials and that were more common with Hatric 3 than placebo.
Table 2 : Adverse Reactions Reported in ≥ 2%* of Subjects Aged 6-12 Years Exposed to Hatric 3 5 mg Once Daily in Placebo-Controlled Clinical Trials 4 and 6 Weeks in Duration
Hatric 3 5 mg
(n = 243)
(n = 240)
2 ( < 1%)
1 ( < 1%)
1 ( < 1%)
*Rounded to the closest unit percentage
Pediatric Patients 1 To 5 Years Of Age
A total of 114 pediatric patients 1 to 5 years of age received Hatric 3 1.25 mg twice daily in a two week placebo-controlled double-blind safety trial. The mean age of the patients was 3.8 years, 32% were 1 to 2 years of age, 71% were Caucasian and 18% were Black. Table 3 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 1 to 5 years exposed to Hatric 3 1.25 mg twice daily in the placebo-controlled safety trial and that were more common with Hatric 3 than placebo.
Table 3 : Adverse Reactions Reported in ≥ 2%* of Subjects Aged 1-5 Years Exposed to Hatric 3 1.25 mg Twice Daily in a 2-Week Placebo-Controlled Clinical Trial
Hatric 3 1.25 mg Twice Daily
(n = 114)
(n = 59)
*Rounded to the closest unit percentage
Pediatric Patients 6 To 11 Months Of Age
A total of 45 pediatric patients 6 to 11 months of age received Hatric 3 1.25 mg once daily in a two week placebo-controlled double-blind safety trial. The mean age of the patients was 9 months, 51% were Caucasian and 31% were Black. Adverse reactions that were reported in more than 1 subject (i.e. greater than or equal to 3% of subjects) aged 6 to 11 months exposed to Hatric 3 1.25 mg once daily in the placebo-controlled safety trial and that were more common with Hatric 3 than placebo included diarrhea and constipation which were reported in 6 (13%) and 1 (4%) and 3 (7%) and 1 (4%) children in the Hatric 3 and placebo-treated groups, respectively.
Long-Term Clinical Trials Experience
In two controlled clinical trials, 428 patients (190 males and 238 females) aged 12 years and older were treated with Hatric 3 5 mg once daily for 4 or 6 months. The patient characteristics and the safety profile were similar to that seen in the short-term studies. Ten (2.3%) patients treated with Hatric 3 discontinued because of somnolence, fatigue or asthenia compared to 2 ( < 1%) in the placebo group.
There are no long term clinical trials in children below 12 years of age with allergic rhinitis or chronic idiopathic urticaria.
Laboratory Test Abnormalities
Elevations of blood bilirubin and transaminases were reported in < 1% of patients in the clinical trials. The elevations were transient and did not lead to discontinuation in any patient.
In addition to the adverse reactions reported during clinical trials and listed above, adverse reactions have also been identified during post-approval use of Hatric 3. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions of hypersensitivity and anaphylaxis, increased appetite, angioedema, fixed drug eruption, pruritus, rash and urticaria, convulsion, paraesthesia, dizziness, tremor, dysgeusia, vertigo, movement disorders (including dystonia and oculogyric crisis), aggression and agitation, hallucinations, depression, insomnia, suicidal ideation, visual disturbances, blurred vision, palpitations, tachycardia, dyspnea, nausea, vomiting, hepatitis, dysuria, urinary retention, myalgia, arthralgia, and edema have been reported.
Besides these reactions reported under treatment with Hatric 3, other potentially severe adverse events have been reported from the post-marketing experience with cetirizine. Since Hatric 3 is the principal pharmacologically active component of cetirizine, one should take into account the fact that the following adverse events could also potentially occur under treatment with Hatric 3: orofacial dyskinesia, severe hypotension, cholestasis, glomerulonephritis, still birth, tic, myoclonus, and extrapyramidal symptoms.
What is the most important information I should know about Hatric 3?
Hatric 3 solution may cause drowsiness, tiredness, or weakness. These effects may be worse if you take it with alcohol or certain medicines. Use Hatric 3 solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Hatric 3 solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
The risk of drowsiness may be greater if you take Hatric 3 solution in high doses. Do NOT take more than the recommended dose without checking with your doctor.
Use Hatric 3 solution with caution in the ELDERLY; they may be more sensitive to its effects.
CHILDREN younger than 6 years old may be more likely to experience constipation, diarrhea, vomiting, or ear infection while taking Hatric 3 solution.
Hatric 3 solution should be used with extreme caution in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hatric 3 solution while you are pregnant. Hatric 3 solution is found in breast milk. Do not breast-feed while taking Hatric 3 solution.
Hatric 3 contraindications
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
You should not use this medication if you are allergic to Hatric 3 or cetirizine (Zyrtec).
Do not take Hatric 3 if you have end-stage kidney disease or if you are on dialysis. Any child younger than 12 years old with kidney disease should not take Hatric 3.
Before taking Hatric 3, tell your doctor if you have liver disease, kidney disease, or gallbladder problems.
It is very important not to give a child more than the prescribed dose of this medication. A child's body absorbs twice as much of the same dose size of Hatric 3 as an adult's body.
Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.
DailyMed. "CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
DailyMed. "PSEUDOEPHEDRINE SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
European Chemicals Agency - ECHA. "Pseudoephedrine hydrochloride: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Hatric 3 are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Hatric 3. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported side effects
No survey data has been collected yet
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