Components:
Loratadine
Method of action:
Antiallergic, Antiexudative, Antihistamines For Systemic Use, Antipruritic, H1-Antihistamine
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Name of the medicinal product

Genadine

Qualitative and quantitative composition

Loratadine

Therapeutic indications

The information provided in Therapeutic indications of Genadine is based on data of another medicine with exactly the same composition as the Genadine of the medicine (Loratadine). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Genadine directly from the package or from the pharmacist at the pharmacy.
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Pills; Substance-powder; Syrup
Capsule

Genadine 10mg Orodispersible Tablet is indicated for the symptomatic treatment of allergic rhinitis (AR) and chronic idiopathic urticaria (CIU).

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Genadine is based on data of another medicine with exactly the same composition as the Genadine of the medicine (Loratadine). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Genadine directly from the package or from the pharmacist at the pharmacy.
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Pills; Substance-powder; Syrup
Capsule

Posology

Adults and children over 12 years of age

10 mg once daily (one orodispersible tablet once daily).

Paediatric population

Children 2 to 12 years of age with body weight more than 30 kg: 10 mg once daily (one orodispersible tablet once daily).

The 10 mg strength orodispersible tablet is not appropriate in children with a body weight less than 30 kg.

Efficacy and safety of Genadine in children under 2 years of age has not been established.

Patients with hepatic impairment

Patients with severe hepatic impairment should be administered a lower initial dose because they may have reduced clearance of Genadine. An initial dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg.

Patients with renal impairment

No dosage adjustments are required in patients with renal insufficiency.

Elderly

No dosage adjustments are required in the elderly.

Method of administration

Genadine 10 mg orodispersible tablets should be handled with caution and with dry hands only.

Genadine 10 mg orodispersible tablets are intended for oral use.

The tablet shall be put on the tongue and wait until it is thoroughly disintegrated. Water or other liquid is not needed to swallow the dose.

The orodispersible tablet may be taken without regard to mealtime.

Directions

Use only with enclosed dosing cup

  • adults and children 6 years and over: 2 teaspoonfuls (TSP) daily; do not take more than 2 teaspoonfuls (TSP) in 24 hours
  • children 2 to under 6 years of age: 1 teaspoonful (TSP) daily; do not take more than 1 teaspoonful (TSP) in 24 hours
  • children under 2 years of age: ask a doctor
  • consumers with liver or kidney disease: ask a doctor

Contraindications

The information provided in Contraindications of Genadine is based on data of another medicine with exactly the same composition as the Genadine of the medicine (Loratadine). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Genadine directly from the package or from the pharmacist at the pharmacy.
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Pills; Substance-powder; Syrup
Capsule

Genadine 10 mg orodispersible tablets are contraindicated in patients who are hypersensitive to the active substance or to any of the excipients in these formulations.

No information provided.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Genadine is based on data of another medicine with exactly the same composition as the Genadine of the medicine (Loratadine). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Genadine directly from the package or from the pharmacist at the pharmacy.
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Pills; Substance-powder; Syrup
Capsule

Genadine should be administered with caution in patients with severe hepatic impairment .

This product contains lactose and sorbitol. Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This product contains aspartame. Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.

The administration of Genadine should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Genadine is based on data of another medicine with exactly the same composition as the Genadine of the medicine (Loratadine). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Genadine directly from the package or from the pharmacist at the pharmacy.
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In clinical trials that assessed driving ability, no impairment occurred in patients receiving Genadine. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

Undesirable effects

The information provided in Undesirable effects of Genadine is based on data of another medicine with exactly the same composition as the Genadine of the medicine (Loratadine). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Genadine directly from the package or from the pharmacist at the pharmacy.
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Pills; Substance-powder; Syrup
Capsule

Adverse events which have been associated with Genadine are given below. Frequencies are defined as:

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data).

In clinical trials in a paediatric population, children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%).

In clinical trials involving adults and adolescents in a range of indications including AR and CIU, at the recommended dose of 10 mg daily, adverse reactions with Genadine were reported in 2 % of patients in excess of those treated with placebo.

The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%).

Other adverse reactions reported during the post-marketing period are listed in the following table.

Organ

Frequency

Adverse reaction

Immune system disorders

Very rare

Hypersensitivity reactions (including angioedema and anaphylaxis)

Nervous system disorders

Very rare

Dizziness, convulsion

Cardiac disorders

Very rare

Tachycardia, palpitation

Gastrointestinal disorders

Very rare

Nausea, dry mouth, gastritis

Hepatobiliary disorders

Very rare

Abnormal hepatic function

Skin and subcutaneous tissue disorders

Very rare

Rash, alopecia

General disorders and administration site conditions

Very rare

Fatigue

Investigations

Not known

Weight increased

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

No information provided.

Overdose

The information provided in Overdose of Genadine is based on data of another medicine with exactly the same composition as the Genadine of the medicine (Loratadine). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Genadine directly from the package or from the pharmacist at the pharmacy.
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Pills; Substance-powder; Syrup
Capsule

Overdosage with Genadine increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia, and headache have been reported with overdoses.

In the event of overdose, general symptomatic and supportive measures are to be instituted and maintained for as long as necessary. Administration of activated charcoal as a slurry with water may be attempted. Gastric lavage may be considered. Genadine is not removed by haemodialysis and it is not known if Genadine is removed by peritoneal dialysis. Medical monitoring of the patient is to be continued after emergency treatment.

No information provided.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Genadine is based on data of another medicine with exactly the same composition as the Genadine of the medicine (Loratadine). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Genadine directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code: R06A X13.

Mechanism of action

Genadine, the active ingredient in the medicinal product, is a tricyclic antihistamine with selective, peripheral Hl-receptor activity.

Pharmacodynamic effects

Genadine has no clinically significant sedative or anticholinergic properties in the majority of the population and when used at the recommended dosage.

During long-term treatment there were no clinically significant changes in vital signs, laboratory test values, physical examinations or electrocardiograms.

Genadine has no significant H2-receptor activity. It does not inhibit norepinephrine uptake and has practically no influence on cardiovascular function or on intrinsic cardiac pacemaker activity.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Genadine is based on data of another medicine with exactly the same composition as the Genadine of the medicine (Loratadine). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Genadine directly from the package or from the pharmacist at the pharmacy.
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Absorption

Genadine is rapidly and well absorbed. Concomitant ingestion of food can delay slightly the absorption of Genadine but without influencing the clinical effect.

Distribution

Genadine is highly bound (97 % to 99 %) and its active metabolite moderately bound (73 % to 76 %) to plasma proteins.

In healthy subjects, plasma distribution half-lives of Genadine and its active metabolite are approximately 1 and 2 hours, respectively.

Biotransformation

After oral administration, Genadine is rapidly and well absorbed and undergoes an extensive first pass metabolism, mainly by CYP3A4 and CYP2D6. The major metabolite -desGenadine (DL)- is pharmacologically active and responsible for a large part of the clinical effect. Genadine and DL achieve maximum plasma concentrations (Tmax) between 1-1.5 hours and 1.5-3.7 hours after administration, respectively.

Increase in plasma concentrations of Genadine has been reported after concomitant use with ketoconazole, erythromycin, and cimetidine in controlled trials, but without clinically significant changes (including electrocardiographic).

Elimination

The mean elimination half-lives in healthy adult subjects were 8.4 hours (range = 3 to 20 hours) for Genadine and 28 hours (range = 8.8 to 92 hours) for the major active metabolite.

Approximately 40 % of the dose is excreted in the urine and 42 % in the faeces over a 10 day period and mainly in the form of conjugated metabolites. Approximately 27 % of the dose is eliminated in the urine during the first 24 hours. Less than 1 % of the active substance is excreted unchanged in active form, as Genadine or DL.

Linearity

The bioavailability parameters of Genadine and of the active metabolite are dose proportional.

Elderly

The pharmacokinetic profile of Genadine and its metabolites is comparable in healthy adult volunteers and in healthy geriatric volunteers.

Renal impairment

In patients with chronic renal impairment, both the AUC and peak plasma levels (Cmax) increased for Genadine and its metabolite as compared to the AUCs and peak plasma levels (Cmax) of patients with normal renal function. The mean elimination half-lives of Genadine and its metabolite were not significantly different from that observed in normal subjects. Haemodialysis does not have an effect on the pharmacokinetics of Genadine or its active metabolite in subjects with chronic renal impairment.

Hepatic impairment

In patients with chronic alcoholic liver disease, the AUC and peak plasma levels (Cmax) of Genadine were double while the pharmacokinetic profile of the active metabolite was not significantly changed from that in patients with normal liver function. The elimination half-lives for Genadine and its metabolite were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease.

Genadine and its active metabolite are excreted in the breast milk of lactating women.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Genadine is based on data of another medicine with exactly the same composition as the Genadine of the medicine (Loratadine). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Genadine directly from the package or from the pharmacist at the pharmacy.
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antihistamines – H1 antagonist, ATC code: R06A X13.

Preclinical safety data

The information provided in Preclinical safety data of Genadine is based on data of another medicine with exactly the same composition as the Genadine of the medicine (Loratadine). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Genadine directly from the package or from the pharmacist at the pharmacy.
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Preclinical data reveal no special hazard based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.

In reproductive toxicity studies, no teratogenic effects were observed. However, prolonged parturition and reduced viability of offspring were observed in rats at plasma levels (AUC) 10 times higher than those achieved with clinical doses.

No evidence of mucous membrane irritation was observed after daily administration of up to 12 tablets (120 mg) of oral lyophilisates into the hamster cheek pouch for five days.

Incompatibilities

The information provided in Incompatibilities of Genadine is based on data of another medicine with exactly the same composition as the Genadine of the medicine (Loratadine). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Genadine directly from the package or from the pharmacist at the pharmacy.
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Not applicable.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Genadine is based on data of another medicine with exactly the same composition as the Genadine of the medicine (Loratadine). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Genadine directly from the package or from the pharmacist at the pharmacy.
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No special requirements.