Consumer medicine information

Claratyne-D with Decongestant

Loratadine; Pseudoephedrine sulfate

BRAND INFORMATION

Brand name

Claratyne-D with Decongestant Repetabs

Active ingredient

Loratadine; Pseudoephedrine sulfate

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Claratyne-D with Decongestant.

What is in this leaflet

This leaflet answers some common questions about Claratyne-D with Decongestant. It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking Claratyne-D with Decongestant against the benefits it is expected to have for you.

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 Claratyne-D with Decongestant is used for

Claratyne-D with Decongestant relieves symptoms associated with allergic rhinitis (hayfever), such as:

  • nasal and sinus congestion
  • sneezing
  • runny nose
  • watery, itchy eyes

Claratyne-D with Decongestant contains a combination of two medicines, loratadine (an antihistamine) and pseudoephedrine (a decongestant).

Antihistamines help reduce allergic symptoms by preventing the effects of a substance called histamine. Histamine is produced by the body in response to foreign substances which the body is allergic to. Decongestants produce narrowing of blood vessels. This leads to clearing of the stuffy or blocked nose.

Your doctor or pharmacist, however, may prescribe Claratyne-D with Decongestant for another purpose. Ask your doctor or pharmacist if you have any questions about why Claratyne-D with Decongestant has been prescribed for you.

Claratyne-D with Decongestant is available from pharmacy without a prescription.

Before you take Claratyne-D with Decongestant

When you must not take it

Do not take Claratyne-D with Decongestant if:

  • you have an allergy to Claratyne-D with Decongestant or any of the ingredients listed at the end of this leaflet.

Do not take Claratyne-D with Decongestant if you have, or have had, any of the following medical conditions:

  • glaucoma
  • difficulty passing urine
  • severe high blood pressure
  • severe blood vessel disease
  • an overactive thyroid gland

Do not take Claratyne-D with Decongestant if you are taking or within 14 days of discontinuing monoamine oxidase inhibitors (MAOIs), medicines used to treat depression.

Do not take Claratyne-D with Decongestant if you are pregnant or breastfeeding unless you have discussed the risks and benefits involved with your doctor or pharmacist.

Do not give Claratyne-D with Decongestant to children under 12 years of age.

Do not take Claratyne-D with Decongestant after the expiry date printed on the pack.

Do not take Claratyne-D with Decongestant if the packaging is torn or shows signs of tampering.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to:

  • any other medicines
  • any other substances, such as foods, preservatives or dyes

Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:

  • eye problems (such as high pressure in the eye or glaucoma)
  • stomach ulcer
  • intestinal obstruction
  • prostate or urinary bladder problems
  • heart disease
  • diabetes
  • if you are 60 years of age or older, because older adults may be more sensitive to the effects of the medicine.

If you have not told your doctor or pharmacist about any of the above, tell them before you take Claratyne-D with Decongestant. The pseudoephedrine in Claratyne-D with Decongestant is considered a stimulant by sporting bodies. Its use in competing athletes is not recommended.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines should not be taken with Claratyne-D with Decongestant . These include:

  • heart or blood pressure medicines
  • monoamine oxidase inhibitors, medicines used to treat depression
  • antacids
  • kaolin

These medicines may be affected by Claratyne-D with Decongestant , or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you.

How to take Claratyne-D with Decongestant

How much to take

The recommended dose of Claratyne-D with Decongestant in adults and children over 12 years is one tablet every 12 hours.

It does not matter if you take Claratyne-D with Decongestant before or after food.

Do not use in children under 12 years of age.

Be sure to take Claratyne-D with Decongestant exactly as your doctor or pharmacist has told you to. If you do not follow their instructions, you may not get relief from your symptoms.

Do not take more Claratyne-D with Decongestant than recommended by your doctor or pharmacist.

How to take it

Swallow the tablet whole with a glass of water. Do not crush, break or chew the tablet before swallowing.

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.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (13 11 26) for advice or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much Claratyne-D with Decongestant. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places handy.

While you are taking Claratyne-D with Decongestant

Things you must do

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Claratyne-D with Decongestant.

Tell your doctor or pharmacist if you become pregnant while you are taking Claratyne-D with Decongestant.

Things you must not do

Do not give Claratyne-D with Decongestant to anyone else, even if their symptoms seem similar to yours.

Do not use it to treat any other complaints unless your doctor or pharmacist says to.

Things to be careful of

Make sure you know how you react to Claratyne-D with Decongestant before you drive a car or operate machinery. Claratyne-D with Decongestant is unlikely to make you drowsy. If you are drowsy, do not drive a car or work with machinery.

Stop taking Claratyne-D with Decongestant 48 hours before you have any skin tests. Antihistamines may interfere with the results of skin tests.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Claratyne-D with Decongestant. Claratyne-D with Decongestant helps most people with allergies, but it may have unwanted effects in a few people.

Like other medicines, Claratyne-D with Decongestant can cause some side effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

Ask your doctor or pharmacist to answer any questions you may have.

Most unwanted effects seen with Claratyne-D with Decongestant have been mild to moderate. These include:

  • trouble sleeping
  • dry mouth
  • headache
  • sleepiness
  • nervousness
  • dizziness
  • fatigue

Other unwanted effects may also occur in some people taking Claratyne-D with Decongestant.

Tell your doctor if you notice any other effects.

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

After using Claratyne-D with Decongestant

Storage

Keep your tablets in the blister pack in a dry place until it is time to take them. If you take your tablets out of the blister pack they will not keep well.

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

Do not store them or any other medicine in the bathroom or near a sink.

Do not leave them in the car on hot days or on window sills.

Keep the tablets where children cannot reach them.

Disposal

If your doctor or pharmacist tells you to stop taking Claratyne-D with Decongestant or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.

Product description

What it looks like

Claratyne-D with Decongestant tablets are white round tablets. Claratyne-D with Decongestant is available in packs of 6 tablets.

Ingredients

Active ingredients:

  • loratadine 5mg
  • pseudoephedrine sulfate 120mg

Other ingredients:

  • lactose
  • sucrose
  • maize starch
  • povidone
  • magnesium stearate
  • acacia
  • calcium sulfate
  • carnauba wax
  • titanium dioxide
  • microcrystalline cellulose
  • colophony
  • oleic acid
  • soap
  • talc
  • zein
  • white beeswax

Claratyne-D with Decongestant does not contain gluten.

Sponsor

Bayer Australia Limited
875 Pacific Highway, Pymble NSW
2073
Ph: 1800 023 884
AUSTRALIA

Australian Registration Number
AUST R 53516

Date of Preparation
22 March 2016

Published by MIMS March 2022

BRAND INFORMATION

Brand name

Claratyne-D with Decongestant Repetabs

Active ingredient

Loratadine; Pseudoephedrine sulfate

Schedule

S3

 

Name of the medicine

Loratadine and pseudoephedrine sulfate.

Excipients.

Lactose, povidone, magnesium stearate, acacia, dried calcium sulfate, carnauba wax, oleic acid, purified talc, maize starch, sucrose, microcrystalline cellulose, neutral white soap - Polaris 134, colophony, zein, titanium dioxide and white beeswax.

Description

Loratadine.

MW: 382.89. CAS: 79794-75-5.

Pseudoephredrine sulfate.

MW: 428.54. CAS: 7460-12-0.
Each Claratyne-D with Decongestant Repetabs Tablet contains loratadine 5 mg and pseudoephedrine sulfate 60 mg in the tablet coating, as well as pseudoephedrine sulfate 60 mg in the barrier-coated core. The active components in the coating are quickly liberated; release of the decongestant in the core is delayed for several hours. Each tablet also contains lactose, povidone, magnesium stearate, acacia, dried calcium sulfate, carnauba wax, oleic acid, purified talc, maize starch, sucrose, microcrystalline cellulose, neutral white soap – Polaris 134, colophony, zein, titanium dioxide and white beeswax.

Pharmacology

Loratadine is a potent long acting tricyclic antihistamine with relative selectivity for peripheral H1-receptors. 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.
Specific clinical pharmacology studies were conducted with concomitant administration of loratadine with therapeutic doses of erythromycin, ketoconazole, and cimetidine for 10 days in healthy subjects. Although increased plasma concentrations (AUC0-24hrs) of loratadine and/or its active metabolite descarboethoxyloratadine 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).
Pseudoephedrine sulfate, one of the naturally occurring alkaloids of Ephedra and an orally administered vasoconstrictor, produces a gradual but sustained decongestant effect, facilitating shrinkage of congested mucosa in upper respiratory areas. The mucous membrane of the respiratory tract is decongested through the action on the sympathetic nerves.

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, descarboethoxyloratadine (SCH34117); this metabolite corresponds to 1% to 2% of the dose. In man, loratadine is extensively bound to plasma protein (97 to 99%) and SCH34117 moderately bound (73 to 76%). Approximately 40% of the dose is excreted in the urine and 42% in the faeces in a 10 day period. Concomitant ingestion of food with loratadine may delay absorption (by approximately one hour), and may increase the AUC for both loratadine (40%) and its active metabolite SCH34117 (approximately 15%). These differences would not be expected to be clinically important.
The pseudoephedrine component of Claratyne-D with Decongestant Repetabs tablets was absorbed at a similar rate and was equally available from the combination tablet as from a pseudoephedrine sulfate 120 mg Repetabs tablet. Mean (% CV) steady-state peak plasma concentration of 464 nanogram/mL (22) was attained at 3.9 hours (50). The terminal half-life of pseudoephedrine from Claratyne-D with Decongestant administered twice daily was 6.3 hours (23). Loratadine and pseudoephedrine sulfate do not influence the pharmacokinetics of each other when administered concomitantly.

Indications

Claratyne-D with Decongestant Repetabs tablets are indicated for the relief of symptoms associated with acute seasonal allergic rhinitis, including nasal congestion, sneezing, rhinorrhoea, pruritus and lacrimation.

Contraindications

Claratyne-D with Decongestant Repetabs tablets are contraindicated in those who have shown sensitivity or idiosyncrasy to their components, to adrenergic agents or to other drugs of similar chemical structure. Claratyne-D with Decongestant Repetabs tablets are also contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen days of discontinuing such treatment and in patients with narrow angle glaucoma, urinary retention, severe hypertension, severe coronary artery disease and hyperthyroidism.

Precautions

Sympathomimetics should be used with caution in patients with glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy or bladder neck obstruction, cardiovascular disease, increased intraocular pressure or diabetes mellitus.
Sympathomimetics should be used with caution in patients receiving digitalis.
Sympathomimetics may cause central nervous system (CNS) stimulation, excitability, convulsions and/or cardiovascular collapse with accompanying hypotension.
In patients 60 years of age or older, sympathomimetics are also more likely to cause adverse reactions such as confusion, hallucination, convulsions, CNS depression and death. No studies have been conducted with Claratyne-D with Decongestant Repetabs tablets in patients over 60 years of age. Consequently, caution should be exercised when administering a repeat action formulation to elderly patients.

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.

Cardiovascular.

No studies have been conducted in patients with cardiovascular disease. Caution should be used with products containing sympathomimetics in patients with cardiovascular disease.

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 2 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.

Drug abuse and dependence.

There are no data available to indicate that abuse or dependency occurs with loratadine.
Pseudoephedrine sulfate, like other CNS stimulants, has been abused. At high doses, subjects commonly experience an elevation of mood, decreased appetite and a sense of increased physical energy, mental capacity and alertness. Anxiety, irritability and loquacity also have been experienced. Continued use of any CNS stimulant results in tolerance. Increased doses ultimately produce toxicity. Depression may follow rapid withdrawal.

Use in children.

Safety and efficacy of Claratyne-D with Decongestant Repetabs tablets in children younger than 12 years of age have not yet been established.

Use in pregnancy.

(Category B2)
The safe use of Claratyne-D with Decongestant Repetabs tablets during pregnancy has not been established. Therefore, the product should only be used if the potential benefit justifies the potential risk to the foetus.
Reproductive studies in pregnant rats and rabbits showed no evidence of teratogenic activity at doses of the combination of up to 150 and 120 mg/kg/day, respectively. 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 foetal tissues in a pattern similar to that in maternal tissues but at lower concentrations. Similar data on the effect of pseudoephedrine on the foetus are unavailable.

Use in lactation.

The safe use of loratadine during lactation has not been established. 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 adults of the corresponding species. Pseudoephedrine sulfate is also excreted in breast milk. The use of Claratyne-D with Decongestant by breastfeeding mothers is therefore not recommended.

Interactions

When administered concomitantly with alcohol, loratadine has no potentiating effect 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 (AUC0-24hrs) of loratadine and/or descarboethoxyloratadine 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).
When sympathomimetics are given to patients receiving MAO inhibitors, hypertensive reactions including hypertensive crises may occur. The antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids may be reduced by sympathomimetics. Beta-adrenergic blocking agents may also interact with sympathomimetics. Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis. Antacids increase the rate of pseudoephedrine absorption; kaolin decreases it.

Ischaemic colitis.

Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.

Laboratory interactions.

Antihistamines should be discontinued approximately 48 hours prior to skin testing procedures since these drugs may prevent or diminish otherwise positive reactions to dermal reactivity indicators.
The in vitro addition of pseudoephedrine to sera containing the cardiac isoenzyme MB of serum creatine phosphokinase progressively inhibits the activity of the enzyme. The inhibition becomes complete over six hours.

Adverse Effects

During controlled clinical studies with the recommended dosage, the incidence of adverse effects associated with Claratyne-D with Decongestant Repetabs tablets was comparable to that of placebo, with the exception of insomnia (16% vs placebo 3%) and dry mouth (14% vs placebo 4%). Other most frequently reported side effects include headache (10% vs placebo 10%), sedation (6% vs placebo 4%), nervousness (5% vs placebo 1%), dizziness (4% vs placebo 1%) and fatigue (4% vs placebo 2%).
Rare adverse reactions in decreasing order of frequency included nausea, abdominal distress, anorexia, thirst, tachycardia, pharyngitis, rhinitis, acne, pruritus, rash, urticaria, arthralgia, confusion, dysphonia, hyperkinesia, hypoaesthesia, decreased libido, paraesthesia, tremor, vertigo, flushing, postural hypotension, increased sweating, eye disorders, earache, tinnitus, taste abnormality, agitation, apathy, depression, euphoria, nightmares, increased appetite, change in bowel habits, dyspepsia, eructation, haemorrhoids, tongue discolouration, tongue disorder, vomiting, transient abnormal hepatic function, dehydration, increased weight, hypertension, palpitation, migraine, bronchospasm, coughing, dyspnoea, epistaxis, nasal congestion, sneezing, nasal irritation, dysuria, micturition disorder, nocturia, polyuria, urinary retention, asthenia, back pain, leg cramps, malaise and rigors.
During the marketing of loratadine, alopecia, anaphylaxis, abnormal hepatic function, supraventricular tachyarrhythmias, dizziness and convulsion have been reported rarely.
Ischaemic colitis - frequency unknown.

Dosage and Administration

Adults and children 12 years of age and over.

One Claratyne-D with Decongestant Repetabs tablet every 12 hours.
For patients with severe hepatic impairment a lower initial dose of one tablet daily is recommended.

Overdosage

In the event of overdosage, general symptomatic and supportive treatment should be started immediately and maintained for as long as necessary.

Manifestations.

These may vary from CNS depression (sedation, apnoea, diminished mental alertness, cyanosis, coma, cardiovascular collapse) to stimulation (insomnia, hallucination, tremors or convulsions) to death. Other signs and symptoms may be euphoria, excitement, tachycardia, palpitations, thirst, perspiration, nausea, dizziness, tinnitus, ataxia, blurred vision and hypertension or hypotension. Stimulation is particularly likely in children, as are atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing; hyperthermia; and gastrointestinal symptoms).
In large doses sympathomimetics may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tenseness, anxiety, restlessness and insomnia. Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma and respiratory failure.

Treatment.

Treatment of the signs and symptoms of overdosage is symptomatic and supportive. Stimulants (analeptic agents) should not be used. Vasopressors may be used to treat hypotension. Short acting barbiturates, diazepam or paraldehyde may be administered to control seizures. Hyperpyrexia, especially in children, may require treatment with tepid water sponge baths or hypothermic blanket. Apnoea is treated with ventilatory support.

Presentation

Repetabs tablets - Loratadine 5 mg and pseudoephedrine sulfate 120 mg (white, round, biconvex coated tablet): 6's.

Storage

Store below 25°C. Protect from excessive moisture.

Poison Schedule

S3 - Pharmacist Only Medicine.