1. Name of The Medicinal Product

Loratadine 5mg/5ml Syrup Taj Pharma

  1. Qualitative and Quantitative Composition

Each ml of syrup contains 1 mg of loratadine.

For the full list of excipients see section 6.1.

  1. Pharmaceutical Form

Syrup

Clear, slightly viscous solution.

  1. Clinical Particulars

4.1 Therapeutic indications

Loratadine syrup is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and children over the age of 2 years.

4.2 Posology and method of administration

Posology

Adults and children and adolescents over 12 years of age

10 ml (10 mg) of the syrup once daily.

Paediatric population (under 12 years of age)

Children 2 to 12 years of age are dosed by weight:

Body weight more than 30 kg: 10 ml (10 mg) of the syrup once daily.

Body weight 30 kg or less: 5 ml (5 mg) of the syrup once daily.

The safety and efficacy of loratadine syrup in children under 2 years of age has not been established. No data are available.

Patients with hepatic impairment

Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg and for children weighing 30 kg or less, 5 ml (5 mg) every other day is recommended.

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

For oral use.

The syrup may be taken without regard to mealtime.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Loratadine syrup should be administered with caution in patients with severe liver impairment (see section 4.2).

Loratadine syrup contains 600 mg of sucrose per ml. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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

4.5 Interaction with other medicinal products and other forms of interaction

When administered concomitantly with alcohol, loratadine syrup has no potentiating effects as measured by psychomotor performance studies.

Potential interaction may occur with all known inhibitors of CYP3A4 or CYP2D6 resulting in elevated levels of loratadine, which may cause an increase in adverse events (see sections 4.8 and 5.2).

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

Paediatric population

Interaction studies have only been performed in adults.

4.6 Fertility, pregnancy and lactation

Pregnancy

A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor foeto/ neonatal toxicity of loratadine. Animal studies do not indicate direct or indirect harmful effects with respect to reproduction toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of loratadine during pregnancy.

Breast-feeding

Loratadine is excreted in breast milk. A risk to the newborns/infants cannot be excluded. The use of loratadine is not recommended in breast-feeding women.

Fertility

There are no data available on male and female fertility.

4.7 Effects on ability to drive and use machines

In clinical trials that assessed driving ability, no impairment occurred in patients receiving loratadine.However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

4.8 Undesirable effects

Summary of the safety profile

In clinical trials involving adults and adolescents in a range of indications including allergic rhinitis (AR) and chronic idiopathic urticaria (CIU), at the recommended dose of 10 mg daily, adverse reactions with loratadine 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 very rarely during the post-marketing period are listed in the following table by System Organ Class.

Tabulated of list of adverse reactions

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 <1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

System organ classFrequencyAdverse Term
Immune system disordersVery rareHypersensitivity reactions (including angioedema and anaphylaxis)
Nervous system disordersVery rareDizziness, convulsion
Cardiac disordersVery rareTachycardia, palpitation
Gastrointestinal disordersVery rareNausea, dry mouth, gastritis
Hepatobiliary disordersVery rareAbnormal hepatic function
Skin and subcutaneous tissue disordersVery rareRash, alopecia
General disorders and administration site conditionsVery rareFatigue
InvestigationsNot knownWeight increased

Paediatric population

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%).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

Overdosage with loratadine 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. Loratadine is not removed by haemodialysis and it is not known if loratadine is removed by peritoneal dialysis. Medical monitoring of the patient is to be continued after emergency treatment.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antihistamines for systemic use, other antihistamines for systemic use.

Mechanism of action

Loratadine, the active ingredient in Loratadine syrup, is a tricyclic antihistamine with selective, peripheral H1-receptor activity.

Pharmacodynamic effects

Loratadine 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.

Loratadine 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.

Human histamine skin wheal studies following a single 10 mg dose has shown that the antihistamine effects are seen within 1-3 hours reaching a peak at 8-12 hours and lasting in excess of 24 hours. There was no evidence of tolerance to this effect after 28 days of dosing with loratadine.

Clinical efficacy and safety

Over 10,000 subjects (12 years and older) have been treated with loratadine 10 mg tablets in controlled clinical trials. Loratadine 10 mg tablets once daily was superior to placebo and similar to clemastine in improving the effects on nasal and non-nasal symptoms of AR. In these studies somnolence occurred less frequently with loratadine than with clemastine and about the same frequency as terfenadine and placebo.

Among these subjects (12 years and older), 1000 subjects with CIU were enrolled in placebo controlled studies. A once daily 10 mg dose of loratadine was superior to placebo in the management of CIU as demonstrated by the reduction of associated itching, erythema and hives. In these studies the incidence of somnolence with loratadine was similar to placebo.

Paediatric population

Approximately 200 paediatric subjects (6 to 12 years of age) with seasonal allergic rhinitis received doses of loratadine syrup up to 10 mg once daily in controlled clinical trials. In another study, 60 paediatric subjects (2 to 5 years of age) received 5 mg of loratadine syrup once daily. No unexpected adverse events were observed.

The paediatric efficacy was similar to the efficacy observed in adults.

5.2 Pharmacokinetic properties

Absorption

Loratadine is rapidly and well absorbed. Concomitant ingestion of food can delay slightly the absorption of loratadine but without influencing the clinical effect. The bioavailability parameters of loratadine and of the active metabolite are dose proportional.

Distribution

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

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

Biotransformation

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

Elimination

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 the active form, as loratadine or DL.

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

Elderly

The pharmacokinetic profile of loratadine and its active metabolite 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 loratadine and its active metabolite as compared to the AUCs and peak plasma levels (Cmax) of patients with normal renal function. The mean elimination half-lives of loratadine and its metabolite were not significantly different from that observed in normal subjects. Haemodialysis does not have an effect on the pharmacokinetics of loratadine 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 loratadine 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 loratadine and its active metabolite were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans 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.

  1. Pharmaceutical particulars

6.1 List of excipients

Propylene glycol, Glycerol, Citric acid monohydrate, Sucrose, Methyl parahydroxybenzoate

Propyl parahydroxybenzoate, Purified water, Artificial strawberry flavour, Components of flavour:

Flavouring substances and natural flavouring substances, Propylene glycol 70%, Water, Triacetin

Ethyl Alcohol, Butylated Hydroxyanisole, Alfa Tocopherol.

6.2 Incompatibilities

None known

6.3 Shelf life

3 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Type III amber glass bottles with polyethylene screw caps and polexan disc. The polexan disc is an EPE/PE sealing material that consists of an expanded polyethylene support and low-density compact polyethylene coating.

Pack sizes of 60 ml, 100 ml and 120 ml.

6.6 Special precautions for disposal and other handling

None

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

Loratadine 5mg/5ml Syrup Taj Pharma

Package leaflet: Information for the patient

(loratadine)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

  1. What Loratadine is and what it is used for
  2. What you need to know before you take Loratadine
  3. How to take Loratadine
  4. Possible side effects
  5. How to store Loratadine
  6. Contents of the pack and other information

 

  1. What Loratadine is and what it is used for

Loratadine syrup contains the active ingredient loratadine, which belongs to a group of medicines called antihistamines. Loratadine is an anti-allergy medicine. It helps relieve the symptoms of:

  • allergic skin reactions like rashes, hives or nettle rash.
  • allergic rhinitis (for example seasonal hayfever), such as sneezing, runny or itchy nose and burning or itchy eyes.
  1. What you need to know before you take Loratadine

Do not take Loratadine:

  • if you are allergic to loratadine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Loratadine:

  • if you have severe liver problems.
  • if you are diabetic, as this medicine contains sucrose (see section ‘Loratadine contains sucrose’ at the end of section 2).

During treatment

If you have an appointment for a skin allergy test, tell your doctor, nurse or hospital staff that you are taking this medicine. It may be necessary to stop taking loratadine for at least 2 days beforehand to make sure the test gives the correct result.

Other medicines and Loratadine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including the following:

  • Cimetidine used to treat heartburn or stomach ulcers.
  • Antibiotics such as erythromycin or antifungal medicines such as ketoconazole.

Loratadine with alcohol

Loratadine has not been shown to add to the effects of an alcoholic drink.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice.

Loratadine should not be taken if you are pregnant.

You should not breast-feed your baby, as small amounts of loratadine can pass into breast milk.

Driving and using machines

Do not drive or operate machinery if you feel dizzy or drowsy while taking this medicine.

Loratadine contains sucrose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Each 5 ml spoonful contains 3 g of sucrose. This should be taken into account in patients with diabetes mellitus.

Loratadine also contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).

  1. How to take Loratadine

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the dose of syrup, and then drink some water. You can take this medicine with or without food.

Adults and children and adolescents (older than the age of 12):

The recommended dose is 10 ml (two 5 ml spoonfuls) of syrup once a day.

Children 2 to 12 years of age

The amount to be taken depends on body weight:

Body weight more than 30 kg: the recommended dose is 10 ml (two 5 ml spoonfuls) of syrup once a day.

Body weight 30 kg or less: the recommended dose is 5 ml (one 5 ml spoonful) of syrup once a day.

Children under age of 2:

Loratadine is not recommended.

If you have liver problems

Your doctor may recommend that you take the medicine less often than recommended above.

If you take more Loratadine than you should

Contact your doctor or nearest hospital emergency department immediately. Take the bottle and any remaining syrup with you. Symptoms of overdose include sleepiness, headache or a rapid heart beat.

If you forget to take Loratadine

Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Loratadine

If you stop taking Loratadine, your symptoms of allergy may come back. Talk to your doctor or pharmacist first before stopping this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen, stop taking Loratadine and tell your doctor immediately or go to your nearest hospital emergency department:

  • Severe allergic reactions such as rash, itchy swollen skin, burning eyes, fever, tightness of the chest and difficulty breathing or swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing.
  • Fits

This side effect is very rare (may affect up to 1 in 10,000 people) but serious. You may need medical attention.

Other side effects:

Common (may affect up to 1 in 10 people)

  • Sleepiness

Uncommon (may affect up to 1 in 100 people)

  • Headache
  • Inability to sleep
  • An increased appetite

Very rare (may affect up to 1 in 10,000 people)

  • Irregular, missed heart beats (palpitations) or rapid heart beat
  • Feeling sick (nausea)
  • Dry mouth
  • Stomach upset
  • Changes in liver function, which may be seen in blood tests
  • Hair loss
  • Dizziness
  • Tiredness

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

  • Weight increased

Additional side effects in children (2 to 12 years of age)

The following additional side effect has been reported in children 2 to 12 years of age:

Common (may affect up to 1 in 10 children):

  • Feeling nervous

Headaches and tiredness were also reported more commonly.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

  1. How to store Loratadine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. Contents of the pack and other information

What Loratadine contains

The active substance is loratadine. Each 5 ml of syrup contains 5 mg of loratadine.

The other ingredients are propylene glycol, glycerol, citric acid monohydrate, sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water and artificial strawberry flavouring (which contains: Flavouring substances and natural flavouring substances, propylene glycol, water, Triacetin, Ethyl Alcohol, Butylated Hydroxyanisole (BHA) and Alfa Tocopherol.

What Loratadine looks like and contents of the pack

Your medicine comes as a clear, slightly viscous solution in glass bottles of 60 ml, 100 ml or 120 ml. Not all pack sizes may be marketed. A measuring device is also included. Your pharmacist will dispense the amount of syrup prescribed by your doctor.

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of  Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com