Consumer medicine information

Lorano

Loratadine

BRAND INFORMATION

Brand name

Lorano

Active ingredient

Loratadine

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Lorano.

What is in this leaflet

This leaflet answers some common questions about Lorano.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again.

What Lorano is used for

The name of your medicine is Lorano. It contains the active ingredient loratadine.

Lorano:

  • Relieves the symptoms that are often related to seasonal allergic rhinitis (hayfever) and perennial allergic rhinitis, such as sneezing, runny or itchy nose, and burning or itchy eyes.
  • Can also be used to relieve the symptoms associated with a skin condition called chronic urticaria (also called "hives") such as itching, redness and lumps on the skin.

How Lorano works

Lorano belongs to a group of medicines called antihistamines.

Lorano helps relieve allergic symptoms by preventing the effects of a substance called histamine which is produced by the body in response to foreign substances which the body is allergic to.

There is no evidence that Lorano is addictive.

Before you take Lorano

When you must not take Lorano

Do not take Lorano if:

  • you are allergic to medicines containing loratadine (eg, Claratyne) or desloratadine (eg, Claramax), or to any of the ingredients listed at the end of this leaflet under 'Product Description'. Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
  • it is past its expiry date or the packaging appears to have been tampered with
  • you are pregnant, trying to become pregnant or breastfeeding, check with your doctor or pharmacist before using this medicine.

Do not give Lorano to children under 12 years of age.

Before you start to take Lorano

Ask your doctor or pharmacist for advice before taking Lorano if you:

  • have allergies to any other medicines, especially if they are in the same drug class as loratadine
  • have allergies to any other substances, including foods, preservatives or dyes
  • have liver problems
  • have any other serious medical conditions.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicine, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. These medicines may be affected by Lorano, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take Lorano

How much to take

Adults and children 12 years and over:
Take one tablet daily. Do not take more than one tablet in a 24-hour period.

The tablets should be swallowed whole with liquid and can be taken with or without food.

When to take Lorano

Lorano can be taken when allergic symptoms start appearing:

  • Hayfever may begin with an itchiness in the throat, nose or eyes.
  • Hives will usually cause your skin to itch and you may notice pink lumps appearing.

How long to take Lorano

You can stop taking Lorano when you obtain relief from your symptoms. It can be restarted if the symptoms recur.

If your condition does not improve or is not well controlled by Lorano, please see your doctor or pharmacist.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose you missed. This may increase the chance of getting an unwanted side effect.

If you take too much

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26) or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else has taken too much Lorano. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using Lorano

Things you must do

  • Tell all doctors, dentists and pharmacists who are treating you that you are taking Lorano.
  • Tell your doctor or pharmacist if you become pregnant while taking Lorano.
  • If you are about to start taking a new medicine, tell your doctor or pharmacist that you are taking Lorano.
  • Stop taking Lorano 48 hours before you have any skin tests. Antihistamines may interfere with the results of skin tests.

Things you must not do

  • Do not use Lorano to treat any other complaint unless recommended by your doctor or pharmacist.
  • Do not give this medication to anyone else, even if their symptoms seem similar to yours.

Things to be careful of

Be careful driving or operating machinery until you know how Lorano affects you. Lorano is unlikely to make you drowsy but if you are drowsy, do not drive a car or operate machinery.

If you already know which substances you are allergic to, try to avoid contact with these substances.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Lorano.

All medicines can have unwanted effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • headache
  • sleepiness
  • fatigue
  • dry mouth.

If any of the following happen, stop taking Lorano, and tell your doctor or pharmacist immediately, or go to Accident and Emergency at your nearest hospital:

  • Swelling of the limbs, face, lips, mouth or throat which may cause difficulty in swallowing or breathing, itchy rash or hives. These are the symptoms of an allergic reaction.

These are very serious side effects. You may need urgent medical attention or hospitalisation. All of these side effects are rare.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After taking Lorano

Storage

Keep your medicine in the original container.

If you take it out of its original container it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25°C.

Do not store Lorano or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

Return any unused or out of date medicine to your pharmacist.

Product description

Lorano can be bought without a doctor's prescription.

What Lorano looks like

Lorano: White, oval tablets, scored with a notch and code LT10 on one side.

Available in blisters of 10, 30 and 50 tablets.

Ingredients

Active Ingredient:

Lorano 10mg tablet contains 10mg loratadine.

Inactive Ingredients:

  • lactose
  • maize starch
  • colloidal anhydrous silica
  • magnesium stearate.

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Lorano is supplied in Australia by:

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Australia
Tel: 1800 634 500

This leaflet was revised in March 2016.

Australian Register Number

Lorano 10mg tablets: AUST R 119753 (blisters)

Published by MIMS January 2017

BRAND INFORMATION

Brand name

Lorano

Active ingredient

Loratadine

Schedule

S2

 

Name of the medicine

Loratadine.

Excipients.

Lactose, maize starch, colloidal anhydrous silica and magnesium stearate.

Description

Chemical name: ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]- cyclohepta[1,2-b] pyridin-11- ylidene)-1-piperidinecarboxylate. Molecular formula: C22H23N2ClO2. MW: 382.9. A white to off white crystalline powder that is freely soluble in methanol, ethanol and chloroform, soluble in ether and practically insoluble in water.
In addition to loratadine, Lorano also contains lactose, maize starch, colloidal anhydrous silica and magnesium stearate.

Pharmacology

Pharmacodynamics.

Loratadine is a potent, long acting antihistamine with relative selectivity for peripheral H1-receptors. Loratadine does not readily penetrate into the CNS. It exhibits greater affinity for peripheral H1-receptors than for central H1-receptors. These properties account for the observed lack of sedation. The incidence of sedation with loratadine is comparable to that of placebo.
Loratadine has a rapid onset of action after oral administration, usually within one hour. Specific studies involving sleep tests with EEG tracings, motor car driving under actual driving conditions, as well as psychomotor performance tests, have not shown any significant difference between loratadine 10 mg and placebo with respect to interaction with the central nervous system or impairment of performance.
Specific clinical pharmacology studies were conducted with concomitant administration of loratadine with therapeutic doses of erythromycin, ketoconazole and cimetidine for ten days in healthy subjects. Although increased plasma concentrations (AUC 0 to 24 hours) of loratadine and/or its active metabolite desloratadine were observed, there were no clinically relevant changes in the safety profile of loratadine as assessed by electrocardiographic parameters including QTc interval, clinical laboratory tests, vital signs and adverse events. Additionally, cardiac repolarisation was not altered, nor were other electrocardiographic parameters (see Interactions with Other Medicines).

Pharmacokinetics.

Loratadine is well absorbed with peak plasma levels occurring at approximately one or two hours after dosing. The drug is almost totally metabolised. It has an active metabolite (desloratadine).
In humans, loratadine is extensively bound to plasma protein (97 to 99%), and desloratadine is moderately bound (73 to 76%).
Approximately 40% of the dose is excreted in the urine and 42% in the faeces in a ten day period. Approximately 27% of the dose is eliminated in the urine during the first 24 hours. The mean elimination half-life of loratadine in normal volunteers is approximately 12 hours, while that of desloratadine is approximately 20 hours. Renal impairment has no significant effect on loratadine clearance. Concomitant ingestion of food and loratadine may delay absorption (by approximately one hour) and may increase the AUC (area under the curve) for both loratadine (40%) and its active metabolite desloratadine (approximately 15%). These differences would not be expected to be clinically important.

Indications

Treatment of seasonal and perennial allergic rhinitis in adults and children 12 years of age and older.
Relief of symptoms and signs of chronic urticaria in adults and children 12 years of age and older.

Contraindications

Hypersensitivity or idiosyncrasy to loratadine, desloratadine or any of the excipients in Lorano.

Precautions

Immune system.

In a 17 month study in monkeys, loratadine demonstrated no functional impairment of the immune system, as indicated by mortality, peripheral leucocyte count or incidences of inflammatory reactions, autoimmune disease and malignancy. Specific studies investigating the effect of loratadine on immune function in humans have not been performed.

Impaired hepatic function.

As with all drugs metabolised by the liver, loratadine should be used with caution in patients with severe liver dysfunction.

Carcinogenesis, mutagenesis, impairment of fertility.

Loratadine administered in the diet to mice for 18 months at doses greater than 12 mg/kg/day resulted in an increased incidence of benign hepatic tumours. A two year study in rats showed no increase in the incidence of carcinogenicity in loratadine treated animals compared with control animals at dietary doses up to 25 mg/kg/day.
Animal studies showed that loratadine had an adverse effect on male fertility when administered to rats at doses greater than 24 mg/kg/day. The clinical relevance of this observation is unknown at this time.

Use in pregnancy.

(Category B1)
The safe use of loratadine during pregnancy has not been established. Therefore the compound should be used only if the potential benefit justifies the potential risk to the fetus.
Reproductive studies in pregnant rats and rabbits showed no evidence of embryotoxic or teratogenic activity at loratadine doses up to 96 mg/kg/day. In pregnant rats, loratadine and its metabolite crossed the placental barrier, distributing in fetal tissues in a pattern similar to that in maternal tissues but at lower concentrations.

Use in lactation.

The safe use of loratadine during lactation has not been established. Therefore the compound should be used only if the potential benefit justifies the potential risk to the infant.
A study in lactating women showed that breast milk levels of loratadine and its active metabolite parallel their respective plasma concentrations after oral administration. Acute toxicity studies have demonstrated that neonatal rats and mice are more sensitive to loratadine than the adults of the corresponding species. The use of loratadine by breastfeeding mothers is not recommended.

Interactions

Various tests (psychomotor tests, wakefulness tests, cognitive function and mood tests and driving tests) have shown that loratadine does not interact with alcohol.
When administered concomitantly with diazepam, loratadine has no potentiating effects as measured by psychomotor performance studies.
Loratadine (10 mg once daily) has been safely coadministered with therapeutic doses of erythromycin, cimetidine and ketoconazole in controlled clinical pharmacology studies. Although increased plasma concentrations (AUC 0 to 24 hours) of loratadine and/or desloratadine were observed following coadministration of loratadine with each of these drugs in normal volunteers, there were no clinically relevant changes in the safety profile of loratadine and no reports of sedation or syncope (see Pharmacology, Pharmacodynamics).

Laboratory tests.

Loratadine should be discontinued approximately 48 hours prior to skin testing procedures, since antihistamines may prevent or diminish otherwise positive reactions to dermal reactivity indicators.

Adverse Effects

In worldwide controlled clinical studies, the incidence of adverse effects associated with loratadine tablets has been comparable to that of placebo. In these trials, loratadine has shown no clinically significant sedative or anticholinergic properties.
Most commonly reported side effects for loratadine tablets include headache (12% versus placebo 11%), sedation (8% versus placebo 6%), fatigue (4% versus placebo 3%), and dry mouth (3% versus placebo 2%).
Adverse experiences occurring in less than 1% of patients are listed below.

Cardiovascular.

Hypertension, hypotension, syncope, palpitations, tachycardia, chest pain, epistaxis.

Gastrointestinal.

Dyspepsia, diarrhoea, constipation, abdominal/ gastric pain, nausea.

Renal.

Increased frequency of urination, urine discolouration.

Respiratory.

Nasal dryness, pharyngitis, coughing.

Other.

Depression, dizziness, fever, nervousness, viral infection, insomnia, menstruation delay, myalgia, pruritus, altered taste, paroniria, tinnitus, rash on face, increased saliva, increased appetite, paraesthesia, malaise and alopecia.
The incidence and general nature of these rarer reports were similar in both placebo treated and loratadine treated patients.
During the marketing of loratadine, alopecia, anaphylaxis and abnormal hepatic function have been reported rarely.

Dosage and Administration

Adults, children 12 years and older.

Take one Lorano (loratadine 10 mg) tablet once daily.

Impaired hepatic function.

For patients with severe hepatic impairment, a lower initial dose (5 mg daily) is recommended.

Overdosage

Symptoms.

Somnolence, tachycardia and headache have been reported with overdoses. In volunteer studies, single doses of up to 160 mg have been administered without any untoward effects.

Treatment.

In the event of overdosage, consideration should be given to adsorption of any unabsorbed loratadine by use of activated charcoal. Otherwise, treatment, which should be started immediately, is symptomatic and supportive. Loratadine is not eliminated by haemodialysis; it is not known if loratadine is eliminated by peritoneal dialysis. After emergency treatment, the patient should continue to be medically monitored.
For further information in case of overdose or suspected overdose, contact the Poisons Information Centre on 13 11 26.

Presentation

Tablets, 10 mg (white, oval tablets, scored with a notch and code LT10 on one side): 10's, 30's, 50's.

Storage

Store below 25°C.

Poison Schedule

Schedule 2 - Pharmacy Medicine.