Instructions for Loratadine Tablets
Please read the instructions carefully and use according to the instructions or buy and use under the guidance of a pharmacist.
Drug Name
Generic name: Loratadine Tablets
Trade name: Benadryl
English name: Loratadine Tablets
Hanyu Pinyin: Lüleitading Pian
Ingredients
Each tablet contains 10 mg of loratadine. Excipients are starch, lactose, magnesium stearate.
Properties
This product is a white or off-white tablet.
Specification
10mg
Acting category
This product is a non-prescription drug in the category of ENT and dermatology.
Indications】
It is used to relieve symptoms related to allergic rhinitis, such as sneezing, runny nose, nasal itching, nasal congestion, as well as eye itching and burning sensation. After oral administration, the nasal and ocular signs and symptoms can be relieved rapidly. It is also used to relieve the symptoms and signs of chronic urticaria, pruritic skin disease and other allergic skin diseases.
Specification
10 mg
Dosage]
Take orally.
Adults and children over 12 years of age: 1 tablet (10 mg) once a day.
Children 2-12 years old: weight > 30 kg: 1 tablet (10 mg) once a day.
Body weight ≤ 30 kg: 1 half tablet (5 mg) once a day.
[Adverse Reactions].
At the recommended dose of 10 mg per day, no significant sedative effect has been seen with this product.
Common adverse reactions include malaise, headache, drowsiness, dry mouth, gastrointestinal discomfort including nausea, gastritis, and rash.
Rare adverse reactions include alopecia, allergic reactions, abnormal liver function, tachycardia, and palpitations.
In clinical trials involving approximately 90,000 patients, the following adverse reactions also occurred with an incidence of less than 2%.
Autonomic nervous system: lacrimation, salivation, flushing, dullness of sensation, phimosis, excessive sweating.
General conditions: angioneurotic edema, weakness, back pain, blurred vision, chest pain, ear pain, eye pain, leg cramps, depression, chills, tinnitus, viral infections, weight gain.
Cardiovascular system: hypertension, hypotension, supraventricular tachyarrhythmias, syncope.
central and peripheral nervous system: blepharospasm, vertigo, sensory abnormalities, tremors
gastrointestinal system: dyspepsia, gastric distention, altered taste, decreased appetite, constipation, diarrhea, eructation, increased appetite, toothache, vomiting
musculoskeletal system: arthritis, myalgia.
psychoneurological system: agitation, forgetfulness, anxiety, confusion, decreased libido, depression, inattention, insomnia, irritability
Reproductive system: breast pain, dysmenorrhea, excessive menstruation, vaginitis
Respiratory system: bronchitis, bronchospasm, cough, dyspnea, rhinorrhea, hemoptysis, laryngitis, dry nose, pharyngitis, sinusitis, sneezing.
Skin and appendages: dermatitis, dry hair, dry skin, photosensitivity reactions, pruritus, purpura, rubella.
Urinary system: urinary frequency, change in color of urine appearance, urinary incontinence, urinary retention.
In addition, the use of this product may also occasionally mastocytosis, erythema multiforme, peripheral edema, epilepsy.
[Contraindication].
Known hypersensitivity to loratadine or other ingredients in this product is contraindicated.
Precautions】
This product is not recommended for children under 6 years of age or over 6 years of age but weighing ≤ 30 kg. Other suitable dosage forms are recommended.
The clearance of loratadine is reduced in persons with impaired hepatic function and the initial dose should be reduced. Half dose daily or full dose every other day is recommended.
Use under medical supervision in patients with hepatic insufficiency.
Use with caution in women during pregnancy and lactation. No teratogenic effects have been found in animal studies and the safety of this product has not been investigated in pregnant and lactating women. Use this product only when the potential benefit outweighs the potential risk to the fetus or newborn. Loratadine is excreted in breast milk, so a decision needs to be made in nursing women to stop breastfeeding or to discontinue the product.
This product should be discontinued approximately 48 hours prior to skin testing, as antihistamines can prevent or reduce the occurrence of positive skin test reactions.
This product is contraindicated in patients with hypersensitivity and should be used with caution in allergic individuals.
Do not use if there is any change in the properties of this product.
Keep this product out of the reach of children.
Children must be used under adult supervision.
If you are using other drugs, consult your physician or pharmacist before using this product.
Reported adverse reactions to overdose include drowsiness, tachycardia, and headache. In case of overdose, seek immediate medical attention and develop appropriate treatment. Loratadine is not cleared by hemodialysis and it is uncertain if it can be cleared by peritoneal dialysis.
When taken concomitantly with alcohol, loratadine has been shown to have no pharmacodynamic synergistic effect based on psychomotor test studies.
There is no evidence of abuse or drug dependence of this product.
Drowsiness, cardiac arrhythmias, and headache can occur in adults with overdose (40-180 mg). Symptomatic and supportive therapy is given immediately upon onset of these symptoms. Treatment consists of emetic, followed by the administration of activated carbon to adsorb the unabsorbed drug. If emesis is unsuccessful, gastric lavage with saline and catheterization to dilute the drug concentration in the intestine. Hemodialysis does not clear loratadine, and it has not been determined whether peritoneal dialysis can clear this product.
Drug Interactions]
Concomitant administration of ketoconazole, macrolide antibiotics, cimetidine, theophylline and other drugs will increase the concentration of loratadine in the plasma and should be used with caution. Other drugs known to inhibit hepatic metabolism should be combined with caution until the interaction with loratadine is clarified.
If drug interactions may occur with other drugs, consult your physician or pharmacist for details.
Pharmacological effects]
This product is a highly effective and long-lasting tricyclic antihistamine, which is a selective peripheral H1 receptor antagonist. It can relieve various symptoms caused by allergic reactions.
Storage
Keep it under shade and sealed.
Package
Aluminum-plastic packaging, 2 tablets/plate x 1 plate/box, 4 tablets/plate x 1 plate/box, 6 tablets/plate x 1 plate/box, 10 tablets/plate x 1 plate/box, 12 tablets/plate x 1 plate/box.
[Expiration date
24 months
【Execution standard
Approval number】
Date of revision of instruction
Marketing authorization holder
Name: Wante Pharma (Hainan) Co.
Registered address: No. 279 Nanhai Avenue, Haikou City
Postal Code: 570314
Contact: 0898-68666600
Fax number: 0898-68653736
Manufacturer
Company name: Wante Pharmaceutical (Hainan) Co.
Production Address: No. 279, Nanhai Avenue, Haikou City
Postal code：570314
Telephone number: 0898-68666600
Fax number: 0898-68653736
Website: http://www.vtpharm.com
If you have any questions, please contact with the manufacturer