04 Mar CAN ALLERGEX NON-DROWSY BE USED TO TREAT SEASONAL ALLERGIC RHINITIS?

As we find ourselves on the brink of another change of season, we investigate whether over-the-counter medicine such as Allergex Non-Drowsy tablets can be used to treat seasonal allergic rhinitis. We also take a closer look at what exactly seasonal allergic rhinitis is, and whether there are ways to prevent it.

What exactly is seasonal allergic rhinitis?

Seasonal allergic rhinitis is a condition that presents with a series of symptoms as a result of your body’s immune system displaying a sensitivity to certain allergens.¹ These allergens usually surface in the environment at the dawn of a new season, and include the likes of pollen from grass, weeds and trees, as well as airborne mould spores. Symptoms of seasonal allergic rhinitis typically include sneezing fits and a stuffy or runny nose. Plus your eyes, mouth or skin can become itchy.¹ Seasonal allergic rhinitis is often also referred to as ‘hay fever,’ but interestingly, it is not necessarily caused by hay and you actually don’t develop a fever from it.¹ 1

Is it contagious?

Hay fever or allergic rhinitis is not contagious, because it does not originate from bacteria or a virus.¹ In fact, it is caused by your body’s immune system responding to environmental allergens that you are breathing in.¹ 1

Can it be prevented?

Because there is a multitude of allergens that cause seasonal allergic rhinitis or hay fever, it is not always possible to completely avoid it.¹ 1

There are however a number of ways in which you can reduce exposure to these allergens in high pollen seasons, such as:

• Closing the windows of your car and home and using air-conditioning instead¹ 1
• Avoiding time outdoors, when it is very windy¹ 1
• Putting on sunglasses to protect your eyes, when you have no choice but to be outside¹ 1
• Wearing a pollen mask, when you do gardening and taking anti-allergy medicine beforehand¹1
• Using mite-proof bedding to limit dust mites¹ 1
• Utilizing a dehumidifier to reduce mold spores ¹ 1

Hay fever facts that are not commonly known

Hay fever or allergic rhinitis can also cause a league of other issues, such as:

• Concentration problems¹ 1
• Poor hand-eye coordination¹ 1
• Limited ability to participate in activities¹ 1
• Reduced capacity to make decisions¹ 1
• Memory issues¹ 1
• Irritability¹ 1
• Sleep disorders and fatigue¹ 1

For this reason, hay fever or seasonal allergic rhinitis should never be taken lightly.

What are the best ways to treat it?

Antihistamines are commonly used to treat symptoms of hay fever or allergic rhinitis because it counteracts the irritating effects of histamine, which is the chemical that is released in your body when you have an allergic reaction to an element.¹ 1

The general consensus is that time-released antihistamines are more effective for long-term use, such as when you are exposed to allergens for several weeks or an entire pollen season.¹ A dose taken early, regularly, or as a preventative measure even before symptoms develop, is also found to be most effective in the treatment of seasonal allergic rhinitis.¹ 1

Is Allergex Non-Drowsy suitable to treat hay fever or seasonal allergic rhinitis?

Allergex Non-Drowsy effectively addresses the above-mentioned treatment prescriptions for seasonal allergic rhinitis, for the following reasons:

• It is indicated for the relief of symptoms associated with seasonal allergic rhinitis and chronic urticaria² 2
• It contains Loratadine, which is a long-acting piperidine antihistamine and a second generation H₁ antagonist² 2
• One only needs to take one tablet daily² 2
• It reaches peak plasma levels within one and a half hours, and the clinical effect is achieved within two hours² 2

References:

1. American College of Allergy, Asthma, and Immunology. Allergic Rhinitis. Updated on 02/06/2018. Accessed on 05/02/2019. Available at: https://acaai.org/allergies/types/hay-fever-rhinitis
2. Adcock Ingram. Allergex® Non-Drowsy packaging insert approved 6 February 2004.

S1 Allergex® Non-Drowsy Tablets. Each tablet contains loratadine 10 mg. Reg. No. 36/5.7.1/0286.

For full prescribing information, refer to the package insert approved by the medicines regulatory authority. 2019020710121613

Adcock Ingram Limited. Reg. No. 1949/034385/06. Private Bag X69, Bryanston, 2021, South Africa. Tel. +27 11 635 0000, www.adcock.com

BIBLIOGRAPHY

1. American College of Allergy, Asthma, and Immunology. Allergic Rhinitis. Updated on 02/06/2018. Accessed on 05/02/2019. Available at: https://acaai.org/allergies/types/hay-fever-rhinitis

Allergic Rhinitis

If you sneeze a lot, if your nose is often runny or stuffy, or if your eyes, mouth or skin often feels itchy, you may have allergic rhinitis, a condition that affects 40 million to 60 million Americans.

Overview

Allergic rhinitis – commonly known as hay fever – is a group of symptoms affecting the nose. But don’t be misled by the name – you don’t have to be exposed to hay to have symptoms. And hay fever doesn’t cause a fever. 1

Allergic rhinitis develops when the body’s immune system becomes sensitized and overreacts to something in the environment that typically causes no problems in most people. 1

Allergic rhinitis is commonly known as hay fever. But you don’t have to be exposed to hay to have symptoms. And contrary to what the name suggests, you don’t have to have a fever to have hay fever. 1

Allergic rhinitis takes two different forms:

• Seasonal: Symptoms of seasonal allergic rhinitis can occur in spring, summer and early fall. They are usually caused by allergic sensitivity to airborne mold spores or to pollens from grass, trees and weeds. 1
• Perennial: People with perennial allergic rhinitis experience symptoms year-round. It is generally caused by dust mites, pet hair or dander, cockroaches or mold. Underlying or hidden food allergies rarely cause perennial nasal symptoms.

Some people may experience both types of rhinitis, with perennial symptoms getting worse during specific pollen seasons. There are also nonallergic causes for rhinitis including irritants such as cigarette or other smoke, perfumes, cleaning products and other strong odors. It’s time to take control of your allergic rhinitis and start enjoying life again. It’s time to find an allergist.

Hay Fever Symptoms

• Runny nose
• Itchy eyes, mouth or skin
• Sneezing
• Stuffy nose due to blockage or congestion
• Fatigue (often reported due to poor quality sleep as a result of nasal obstruction)

For more information on hay fever symptoms click here.

Hay Fever Triggers

• Outdoor allergens, such as pollens from grass, trees and weeds
• Indoor allergens, such as pet hair or dander, dust mites and mold
• Irritants, such as cigarette smoke, perfume and diesel exhaust

Hay Fever Management and Treatment

Avoid triggers by making changes to your home and to your behavior.

• Keep windows closed during high pollen periods; use air conditioning in your home and car.
• Wear glasses or sunglasses when outdoors to keep pollen out of your eyes.
• Use “mite-proof” bedding covers to limit exposure to dust mites and a dehumidifier to control mold. (If you smell mildew, you likely have mold).
• Wash your hands after petting any animal and have a nonallergic person help with pet grooming, preferably in a well-ventilated area or outside. 1

Symptoms

Allergic rhinitis – commonly known as hay fever – is a group of symptoms affecting the nose. But don’t be misled by the name – you don’t have to be exposed to hay to have symptoms. And despite the name, it’s not usually accompanied by fever.

People with allergic rhinitis generally experience symptoms after breathing in an allergy-causing substance such as pollen or dust. In the fall, a common allergen is ragweed or other weed pollens or outdoor mold. In the spring, the most common triggers are grass and tree pollen.

When a sensitive person inhales an allergen, the body’s immune system may react with the following symptoms (listed in order of frequency):

• Stuffy nose due to blockage or congestion
• Itching, usually in the nose, mouth, eyes, or throat
• Puffy, swollen eyelids
• Sneezing
• Cough

Symptoms also may be triggered by common irritants such as:

• Cigarette smoke
• Strong odors, such as perfume, or hair spray and fumes
• Cosmetics
• Laundry detergents
• Cleaning solutions, pool chlorine, car exhaust and other air pollutants (i.e., ozone)

There are two types of allergic rhinitis:

• Seasonal: Symptoms can occur in spring, summer and early fall. They are usually caused by sensitivity to airborne mold spores or to pollens from trees, grasses or weeds.
• Perennial: Symptoms occur year-round and are generally caused by sensitivity to dust mites, pet hair or dander, cockroaches or mold.

Allergic rhinitis can be associated with:

• Decreased concentration and focus
• Limited activities
• Decreased decision-making capacity
• Impaired hand-eye coordination
• Problems remembering things
• Irritability
• Sleep disorders
• Fatigue
• Missed days of work or school
• More motor vehicle accidents
• More school or work injuries 1F

Many parents of children with allergic rhinitis have said that their children are more moody and irritable during allergy season. Since children cannot always express their symptoms verbally, they may express their discomfort by acting up at school and at home. In addition, some children feel that having an allergy is a stigma that separates them from others.

It is important that the irritability or other symptoms caused by ear, nose or throat trouble are not mistaken for attention deficit disorder. With proper treatment, symptoms can be kept under control and disruptions in learning and behavior can be avoided.

Symptoms of allergic rhinitis have other causes as well, the most customary being the common cold — an example of infectious rhinitis. Most infections are relatively short-lived, with symptoms improving in three to seven days.

Many people have recurrent or chronic nasal congestion, excess mucus production, itching and other nasal symptoms similar to those of allergic rhinitis. In those cases, an allergy may not be not the cause.

Diagnosing

Occasional allergies aren’t just something you have to live with. An allergist is the most effective way to treat allergic rhinitis symptoms and help you find relief.

Your allergist may start by taking a detailed history, looking for clues in your lifestyle that will help pinpoint the cause of your symptoms. You’ll be asked, among other things, about your work and home environments (including whether you have a pet) your family’s medical history and the frequency and severity of your symptoms.

Sometimes allergic rhinitis can be complicated by several medical conditions, such as a deviated septum (curvature of the bone and cartilage that separate the nostrils) or nasal polyps (abnormal growths inside the nose and sinuses). Any of these conditions will be made worse by catching a cold. Nasal symptoms caused by more than one problem can be difficult to treat, often requiring the cooperation of an allergist and another specialist, such as an otolaryngologist (ear, nose and throat specialist).

Your allergist may recommend a skin test, in which small amounts of suspected allergens are introduced into your skin. Skin testing is the easiest, most sensitive and generally least expensive way of identifying allergens.

Types of skin tests

• Prick or scratch test: In this test, a tiny drop of a possible allergen is pricked or scratched into the skin. Also known as a percutaneous test, this is the most common type of skin test. The results are known within 10 to 20 minutes.
• Intradermal test: A small amount of a possible allergen is injected under the skin using a thin needle. The site is checked for a reaction after about 20 minutes. This test is typically more sensitive than the prick or scratch test.

Management and Treatment

Avoidance

The first approach in managing seasonal or perennial forms of hay fever should be to avoid the allergens that trigger symptoms.

Outdoor exposure

• Stay indoors as much as possible when pollen counts are at their peak, usually during the midmorning and early evening (this may vary according to plant pollen), and when wind is blowing pollens around.
• Avoid using window fans that can draw pollens and molds into the house.
• Wear glasses or sunglasses when outdoors to minimize the amount of pollen getting into your eyes.
• Wear a pollen mask (such as a NIOSH-rated 95 filter mask) when mowing the lawn, raking leaves or gardening, and take appropriate medication beforehand. 1
• Don’t hang clothing outdoors to dry; pollen may cling to towels and sheets.
• Try not to rub your eyes; doing so will irritate them and could make your symptoms worse.

Indoor exposure

• Keep windows closed, and use air conditioning in your car and home. Make sure to keep your air conditioning unit clean.
• Reduce exposure to dust mites, especially in the bedroom. Use “mite-proof” covers for pillows, comforters and duvets, and mattresses and box springs. Wash your bedding frequently, using hot water (at least 130 degrees Fahrenheit).
• To limit exposure to mold, keep the humidity in your home low (between 30 and 50 percent) and clean your bathrooms, kitchen and basement regularly. Use a dehumidifier, especially in the basement and in other damp, humid places, and empty and clean it often. If mold is visible, clean it with mild detergent and a 5 percent bleach solution as directed by an allergist.
• Clean floors with a damp rag or mop, rather than dry-dusting or sweeping.

Exposure to pets

• Wash your hands immediately after petting any animals; wash your clothes after visiting friends with pets.
• If you are allergic to a household pet, keep the animal out of your home as much as possible. If the pet must be inside, keep it out of the bedroom so you are not exposed to animal allergens while you sleep.
• Close the air ducts to your bedroom if you have forced-air or central heating or cooling. Replace carpeting with hardwood, tile or linoleum, all of which are easier to keep dander-free.

Medications

Many allergens that trigger allergic rhinitis are airborne, so you can’t always avoid them. 1

If your symptoms can’t be well-controlled by simply avoiding triggers, your allergist may recommend medications that reduce nasal congestion, sneezing, and an itchy and runny nose. They are available in many forms — oral tablets, liquid medication, nasal sprays and eyedrops.

Some medications may have side effects, so discuss these treatments with your allergist so they can help you live the life you want.

Intranasal corticosteroids

Intranasal corticosteroids are the single most effective drug class for treating allergic rhinitis. They can significantly reduce nasal congestion as well as sneezing, itching and a runny nose.

Ask your allergist about whether these medications are appropriate and safe for you. These sprays are designed to avoid the side effects that may occur from steroids that are taken by mouth or injection. Take care not to spray the medication against the center portion of the nose (the nasal septum). The most common side effects are local irritation and nasal bleeding. Some older preparations have been shown to have some effect on children’s growth; data about some newer steroids don’t indicate an effect on growth.

Antihistamines

Antihistamines are commonly used to treat allergic rhinitis.

These medications counter the effects of histamine, the irritating chemical released within your body when an allergic reaction takes place. Although other chemicals are involved, histamine is primarily responsible for causing the symptoms.

Antihistamines are found in eyedrops, nasal sprays and, most commonly, oral tablets and syrup.

Antihistamines help to relieve nasal allergy symptoms such as:

• Sneezing and an itchy, runny nose
• Eye itching, burning, tearing and redness
• Itchy skin, hives and eczema 1

There are dozens of antihistamines; some are available over the counter, while others require a prescription. Patients respond to them in a wide variety of ways.

Generally, the newer (second-generation) products work well and produce only minor side effects. Some people find that an antihistamine becomes less effective as the allergy season worsens or as their allergies change over time. If you find that an antihistamine is becoming less effective, tell your allergist, who may recommend a different type or strength of antihistamine. If you have excessive nasal dryness or thick nasal mucus, consult an allergist before taking antihistamines. Contact your allergist for advice if an antihistamine causes drowsiness or other side effects.

Proper use: Short-acting antihistamines can be taken every four to six hours, while timed-release antihistamines are taken every 12 to 24 hours. The short-acting antihistamines are often most helpful if taken 30 minutes before an anticipated exposure to an allergen (such as at a picnic during ragweed season). Timed-release antihistamines are better suited to long-term use for those who need daily medications. Proper use of these drugs is just as important as their selection. The most effective way to use them is before symptoms develop. A dose taken early can eliminate the need for many later doses to reduce established symptoms. Many times a patient will say that he or she “took one, and it didn’t work.” If the patient had taken the antihistamine regularly for three to four days to build up blood levels of the medication, it might have been effective. 1

Side effects: Older (first-generation) antihistamines may cause drowsiness or performance impairment, which can lead to accidents and personal injury. Even when these medications are taken only at bedtime, they can still cause considerable impairment the following day, even in people who do not feel drowsy. For this reason, it is important that you do not drive a car or work with dangerous machinery when you take a potentially sedating antihistamine.

Some of the newer antihistamines do not cause drowsiness.

A frequent side effect is excessive dryness of the mouth, nose and eyes. Less common side effects include restlessness, nervousness, overexcitability, insomnia, dizziness, headaches, euphoria, fainting, visual disturbances, decreased appetite, nausea, vomiting, abdominal distress, constipation, diarrhea, increased or decreased urination, urinary retention, high or low blood pressure, nightmares (especially in children), sore throat, unusual bleeding or bruising, chest tightness or palpitations. Men with prostate enlargement may encounter urinary problems while on antihistamines. Consult your allergist if these reactions occur.

 Important precautions:

• Follow your allergist’s instructions.
• Alcohol and tranquilizers increase the sedation side effects of antihistamines.
• Do not use more than one antihistamine at a time, unless prescribed.
• Keep these medications out of the reach of children.
• Know how the medication affects you before working with heavy machinery, driving or doing other performance-intensive tasks; some products can slow your reaction time.
• Some antihistamines appear to be safe to take during pregnancy, but there have not been enough studies to determine the absolute safety of antihistamines in pregnancy. Again, consult your allergist or your obstetrician if you must take antihistamines.
• While antihistamines have been taken safely by millions of people in the last 50 years, don’t take antihistamines before telling your allergist if you are allergic to, or intolerant of, any medicine; are pregnant or intend to become pregnant while using this medication; are breast-feeding; have glaucoma or an enlarged prostate; or are ill.
• Never take anyone else’s medication.

Decongestants

Decongestants help relieve the stuffiness and pressure caused by swollen nasal tissue. They do not contain antihistamines, so they do not cause antihistaminic side effects. They do not relieve other symptoms of allergic rhinitis. Oral decongestants are available as prescription and nonprescription medications and are often found in combination with antihistamines or other medications. It is not uncommon for patients using decongestants to experience insomnia if they take the medication in the afternoon or evening. If this occurs, a dose reduction may be needed. At times, men with prostate enlargement may encounter urinary problems while on decongestants. Patients using medications to manage emotional or behavioral problems should discuss this with their allergist before using decongestants. Patients with high blood pressure or heart disease should check with their allergist before using. Pregnant patients should also check with their allergist before starting decongestants.

Nonprescription decongestant nasal sprays work within minutes and last for hours, but you should not use them for more than a few days at a time unless instructed by your allergist. Prolonged use can cause rhinitis medicamentosa, or rebound swelling of the nasal tissue. Stopping the use of the decongestant nasal spray will cure that swelling, provided that there is no underlying disorder.

Oral decongestants are found in many over-the-counter (OTC) and prescription medications, and may be the treatment of choice for nasal congestion. They don’t cause rhinitis medicamentosa but need to be avoided by some patients with high blood pressure. If you have high blood pressure or heart problems, check with your allergist before using them.

Nasal sprays

Nonprescription saline nasal sprays will help counteract symptoms such as dry nasal passages or thick nasal mucus. Unlike decongestant nasal sprays, a saline nasal spray can be used as often as it is needed. Sometimes an allergist may recommend washing (douching) the nasal passage. There are many OTC delivery systems for saline rinses, including neti pots and saline rinse bottles.

Nasal cromolyn blocks the body’s release of allergy-causing substances. It does not work in all patients. The full dose is four times daily, and improvement of symptoms may take several weeks. Nasal cromolyn can help prevent allergic nasal reactions if taken prior to an allergen exposure.

Nasal ipratropium bromide spray can help reduce nasal drainage from allergic rhinitis or some forms of nonallergic rhinitis.

Leukatriene pathway inhibitors

Leukotriene pathway inhibitors (montelukast, zafirlukast and zileuton) block the action of leukotriene, a substance in the body that can cause symptoms of allergic rhinitis. These drugs are also used to treat asthma.

Immunotherapy

Immunotherapy may be recommended for people who don’t respond well to treatment with medications or who experience side effects from medications, who have allergen exposure that is unavoidable or who desire a more permanent solution to their allergies. Immunotherapy can be very effective in controlling allergic symptoms, but it doesn’t help the symptoms produced by nonallergic rhinitis.

Two types of immunotherapy are available: allergy shots and sublingual (under-the-tongue) tablets.

• Allergy shots: A treatment program, which can take three to five years, consists of injections of a diluted allergy extract, administered frequently in increasing doses until a maintenance dose is reached. Then the injection schedule is changed so that the same dose is given with longer intervals between injections. Immunotherapy helps the body build resistance to the effects of the allergen, reduces the intensity of symptoms caused by allergen exposure and sometimes can actually make skin test reactions disappear. As resistance develops over several months, symptoms should improve.
• Sublingual tablets: This type of immunotherapy was approved by the Food and Drug Administration in 2014. Starting several months before allergy season begins, patients dissolve a tablet under the tongue daily. Treatment can continue for as long as three years. Only a few allergens (certain grass and ragweed pollens and house dust mite) can be treated now with this method, but it is a promising therapy for the future.

Eye allergy preparations and eyedrops

Eye allergy preparations may be helpful when the eyes are affected by the same allergens that trigger rhinitis, causing redness, swelling, watery eyes and itching. OTC eyedrops and oral medications are commonly used for short-term relief of some eye allergy symptoms. They may not relieve all symptoms, though, and prolonged use of some of these drops may actually cause your condition to worsen.

Prescription eyedrops and oral medications also are used to treat eye allergies. Prescription eyedrops provide both short- and long-term targeted relief of eye allergy symptoms, and can be used to manage them.

Check with your allergist or pharmacist if you are unsure about a specific drug or formula.

Treatments that are not recommended for allergic rhinitis

• Antibiotics: Effective for the treatment of bacterial infections, antibiotics do not affect the course of uncomplicated common colds (a viral infection) and are of no benefit for noninfectious rhinitis, including allergic rhinitis.
• Nasal surgery: Surgery is not a treatment for allergic rhinitis, but it may help if patients have nasal polyps or chronic sinusitis that is not responsive to antibiotics or nasal steroid sprays.

Occupational Rhinitis

If you develop symptoms that resemble those of hay fever and that appear or become more serious at work, you may be suffering from occupational rhinitis.

Occupational rhinitis, or work-related rhinitis, is a condition in which symptoms are triggered or further aggravated by allergens in the workplace. These symptoms can include sneezing, a runny nose and watering eyes. Common triggers include cleaning products, chemical fumes, certain types of dust, and corrosive gases.

If your allergy symptoms appear at work, or seem to get worse there, ask your allergist to help you identify potential triggers and develop a treatment plan.

FAQs

What is allergic rhinitis?

Allergic rhinitis is an allergic reaction to airborne allergens, like seasonal grass or ragweed pollen or year-round allergens like dust and animal dander. Allergic rhinitis is sometimes called “hay fever,” especially when caused by seasonal allergens. Hay fever shares many of the same symptoms as a common cold, but is not caused by a virus or bacteria. Instead, it is caused by your immune system reacting to allergens you breath into your body.

What is hay fever?

Hey fever is another name for allergic rhinitis, most commonly used to describe a seasonal allergic reaction to pollen such as ragweed. However, the term is often used to refer to nasal allergies caused by any inhaled allergen. Despite the name, hay fever is not necessarily a reaction to hay, and it does not cause a fever.

Is allergic rhinitis contagious?

No. Allergic rhinitis (or hay fever) is caused by your immune system’s response to allergens breathed into your body. It is not caused by a virus or bacteria and is not contagious. 1

What are hay fever symptoms?

Hay fever, or allergic rhinitis, symptoms are similar to the symptoms of a common cold. Some common symptoms include sneezing, congestion, coughing, sinus pressure, itchy watery eyes, and itchy nose, mouth, and throat, and fatigue. It can be difficult to tell the difference between a cold and hay fever. If you have hay fever, your runny nose will likely have a thin, watery discharge, and, despite the name, you will not have a fever. If you have a cold, you may have a thicker or yellowish discharge from your nose, and may have a low-grade fever. Hay fever symptoms can begin immediately after you are exposed to allergens like pollen or animal dander, and will continue as long as your exposure continues. A cold will most likely begin a day or two after exposure to the virus, and can last a few days to a week.

2. Adcock Ingram. Allergex® Non Drowsy packaging insert approved 6 February 2004.

 

Pharma Code 93

llllll

19380

 

SCHEDULING STATUS:         S2

PROPRIETARY NAME:           ALLERGEX^® NON DROWSY TABLETS

(AND DOSAGE FORM)           (TABLET)

 

COMPOSITION:

Each tablet contains:

Loratadine (micronised)          10 mg

Contains sugar:

Lactose monohydrate 75 mg

PHARMACOLOGICAL CLASSIFICATION:

A: 5.7.1 Antihistaminics

PHARMACOLOGICAL ACTION:

Loratadine is a long acting piperidine antihistamine. It is a selective H₁ receptor antagonist which is a reversible, competitive inhibitor of histamine at H₁ receptor sites.

Loratadine is a second generation H₁ antagonist.

It does not readily cross the blood brain barrier. 2

Pharmacokinetics:

Peak plasma levels are reached within 1,5 hours and the clinical effect is achieved within 2 hours 2

Excretion occurs equally via the feces and the urine.

INDICATIONS:

The relief of symptoms associated with seasonal allergic rhinitis and chronic urticaria. 2

CONTRAINDICATIONS:

ALLERGEX NON-DROWSY TABLETS is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

Safety in pregnancy and lactation has not been established.

The safe use of ALLERGEX NON-DROWSY TABLETS in the elderly has not been established.

DOSAGE AND DIRECTIONS FOR USE:

One tablet to be taken once daily. 2

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

Most commonly reported side effects include fatigue, headache, somnolence, and dry mouth.

Gastrointestinal side effects including nausea, vomiting, diarrhoea, gastritis or epigastric pain may occur.

Allergic symptoms like rashes and hypersensitivity reactions may occur.

Abnormal hepatic function, alopecia and anaphylaxis have also been reported.

Precautions:

ALLERGEX NON-DROWSY TABLETS lack significant sedative properties. However, patients should be advised that a small number of individuals may experience sedation. Therefore, the effect of the medicine on a particular patient should be ascertained before they drive or operate machinery. This effect can be compounded by the simultaneous intake of alcohol or other central nervous system depressants.

A lower dose should be administered to patients with hepatic impairment as they may have decreased clearance of loratadine; i.e. an initial dose of 5 mg once daily or 10 mg on alternate days.

Medicine/laboratory test interactions:

The use of ALLERGEX NON-DROWSY TABLETS should be stopped several days before skin testing as antihistamines may suppress the positive skin response to allergen extracts.

Medicines known to inhibit the hepatic metabolism of loratadine include cimetidine, erythromycin, ketoconazole, quinidine, fluconazole and fluoxetine. These medicines should therefore not be administered concomitantly with loratadine as they may raise the plasma concentrations of loratadine.

However, no clinically significant consequences have been observed when these medicines are administered concomitantly.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

See “SIDE EFFECTS AND SPECIAL PRECAUTIONS”.

Cardiac effects such as tachycardia have been reported.

Headache and somnolence have also been reported with overdoses.

In the event of overdosage, treatment should be started immediately.

Treatment is symptomatic and supportive. Haemodialysis is not an effective means of removing loratadine or its metabolite from the body.

IDENTIFICATION:

White, 8 mm, round, flat tablets, with a breakline.

PRESENTATION:

Glass-clear, rigid, glossy, PVC film and aluminium foil blister packs of 7, 10, 14, 21 and 30 tablets.

STORAGE INSTRUCTIONS:

Store below 25 ºC.

Protect from light.

Do not remove the blister pack from the outer carton until required for use.

KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:

36/ 5.7.1/0286 

NAME AND ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:

Adcock Ingram Limited

1 New Road

Erand Gardens

Midrand, 1685

Private Bag X69

Bryanston, 2021

www.adcock.com

DATE OF PUBLICATION OF THIS PACKAGE INSERT: 06 February 2004