INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo LORALEX (Tablets)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

LORALEX (Tablets)

COMPOSITION:
Each LORALEX tablet contains
desloratadine 5 mg.
Inactive ingredients are anhydrous colloidal silica, hydrogenated castor oil, low-substituted hydroxypropyl cellulose, mannitol, Opadry blue (containing hypromellose, indigo carmine aluminium lake, macrogol, sodium lauryl sulphate and titanium dioxide), and siliconised talc 3%.

PHARMACOLOGICAL CLASSIFICATION:
A.5.7.1 Antihistaminics

PHARMACOLOGICAL ACTION:
Pharmacodynamic properties:
Desloratadine is a histamine antagonist which is long-acting and non-sedating. Desloratadine blocks peripheral histamine H1-receptors selectively following oral administration. The central nervous system is not readily penetrated by desloratadine.
Desloratadine has displayed anti-inflammatory and anti-allergic activity in addition to antihistaminic activity. The broad cascade of events that sets off and promotes allergic inflammation is inhibited by desloratadine.
Pharmacokinetic Properties:
Within 30 minutes of desloratadine administration, the plasma concentration of desloratadine can be detected. Desloratadine is well absorbed. After approximately 3 hours maximum concentration is achieved; the terminal phase half-life is about 27 hours. The degree of desloratadine accumulation is consistent with a once daily dosing frequency and its half-life (about 27 hours). Over the range of 5 to 20 mg the bioavailability of desloratadine is dose proportional. Desloratadine is bound moderately to plasma proteins (83 - 87%). Following once daily dosing of 5 to 20 mg desloratadine for 14 days, there is no evidence of clinically relevant medicine accumulation.
As demonstrated by in vitro studies with CYP3A4 and CYP2D6 specific inhibitors, these enzymes are not important in the metabolism of desloratadine. Desloratadine is neither an inhibitor nor a substrate of P-glycoprotein and does not inhibit CYP3A4 or CYP2D6.
There is no effect of food or grapefruit juice on the disposition of desloratadine.

INDICATIONS:
LORALEX
tablets are indicated for:
Relief of symptoms associated with allergic rhinitis.
Short-term relief of symptoms associated with chronic idiopathic urticaria.

CONTRAINDICATIONS:
LORALEX
is contraindicated in:
Hypersensitivity reactions to the active substance, desloratadine, or to any of the excipients of LORALEX.

WARNINGS:
Although LORALEX tablets do not have significant sedative effects, patients should be warned that sedation may be experienced by a small number of individuals. Therefore, it is advisable to determine individual response before performing complicated tasks or driving (see "Effects on the ability to drive or use machinery").

INTERACTIONS:
The intake of food or grapefruit juice with LORALEX tablets has no effect on the disposition of desloratadine. The performance impairing effects of alcohol are not potentiated by the concomitant use of alcohol and LORALEX tablets.
Co-administration of ketoconazole with desloratadine increases the area under the time-concentration curve (AUC) by 37% and the maximum desloratadine concentration (C
max) by 45%.
Co-administration of erythromycin with desloratadine increased the AUC of desloratadine by 14% and the C
max by 24%.
Co-administration of azithromycin with desloratadine resulted in an increase of AUC (12%) and C
max (31%) of azithromycin.
When co-administered with either erythromycin or ketoconazole, the increase in AUC and C
max of desloratadine did not cause any clinically relevant adverse events in the populations studied. The pharmacokinetics of desloratadine were not significantly affected by co-administration of desloratadine with cimetidine.
Co-administration of desloratadine with fluoxetine caused a 15% increase in the C
max of desloratadine and an increase of 17% in Cmax and 13% in AUC of 3-OH desloratadine, respectively.
The C
max of fluoxetine was reduced by 9% and the AUC by 11%. With co-administration of desloratadine and fluoxetine, the corresponding norfluoxetine mean parameters increased by 23% and 18%, respectively.

PREGNANCY AND LACTATION:
LORALEX
tablets are not recommended for use in pregnant women, as the safe use of LORALEX during pregnancy has not been established. LORALEX tablets are not recommended in breastfeeding women, since desloratadine is excreted into breast milk.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children (>12 years of age): One LORALEX 5 mg tablet taken orally once a day with or without meals.
Initially, patients with renal or hepatic impairment should take LORALEX 5 mg orally on alternative days.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-Effects
:
The following side-effects may occur with the use of LORALEX:
Immune system disorders:
Less frequent: Hypersensitivity reactions (such as anaphylaxis, angioedema).
Nervous system disorders:
Frequent:        Headache.
Less frequent:         Dizziness, somnolence.
Cardiac disorders:
Frequency unknown: Tachycardia, palpitations.
Respiratory, thoracic and mediastinal disorders:
Frequent:        Pharyngitis.
Frequency unknown: Dyspnoea.
Gastrointestinal disorders:
Less frequent:        Dyspepsia, nausea, dry mouth, vomiting, diarrhoea, abdominal pain.
Hepatobiliary disorders:
Less frequent:        Elevations of liver enzymes, increased bilirubin, jaundice, hepatic necrosis, hepatitis.
Skin and subcutaneous tissue disorders:
Frequency unknown: Pruritus, rash, urticaria.
Musculoskeletal, connective tissue and bone disorders:
Less frequent:        Myalgia.
Reproductive system and breast disorders:
Less frequent:        Dysmenorrhoea.
General disorders and administrative site conditions:
Less frequent:        Fatigue.
Frequency unknown:         Oedema.

Special Precautions
In children under 12 years of age the safety and efficacy of LORALEX have not been established.
Safety and efficacy have not been established for LORALEX treatment periods in excess of 4 weeks.
Effects on the ability to drive or use machinery:
A few patients treated with a non-sedating antihistamine, such as LORALEX, have experienced drowsiness. Therefore, it is prudent to exercise caution before driving or operating machinery; the effect of LORALEX on a particular patient can be ascertained after the first few doses.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Standard measures to remove unabsorbed active substance must be considered in the event of overdose. Symptomatic and supportive treatment is suggested. It is not known if desloratadine is eliminated by peritoneal dialysis. Desloratadine is not eliminated by haemodialysis.

IDENTIFICATION:
Light blue coloured, circular, biconvex, film coated tablets plain on both sides.

PRESENTATION:
LORALEX
tablets are packed in plain aluminium foil and PVC/Aclar film blister strips. Blisters are packed in cartons of 7, 10 or 30 tablets.

STORAGE INSTRUCTIONS:
Store at or below 25ºC. Protect from moisture.
KEEP THIS MEDICINE OUT OF REACH OF CHILDREN.
Keep the blisters in the outer carton until required for use.

REGISTRATION NUMBER:
43/5.7.1/1150

NAME AND BUSINESS ADDRESS OF THE HOLDER OF CERTIFICATE OF REGISTRATION:
CIPLA MEDPRO (PTY) LTD
Building 9, Parc du Cap
Mispel Street, Bellville, 7530, RSA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
6 March 2014

© CIPLA MEDPRO (PTY) LTD

Namibia [NS1] 10/5.7.1/0410

Patient Information Leaflet
Information for the Patient about

LORALEX (Tablets)

SCHEDULING STATUS: S2

PROPRIETARY NAME STRENGTH AND PHARMACEUTICAL FORM:
LORALEX
containing desloratadine 5 mg (Tablets)

Read all of this leaflet carefully because it contains important information for you. LORALEX is available without a doctor's prescription, for you to treat a mild illness. Nevertheless you still need to use LORALEX carefully to get the best results from it.
•        Keep this leaflet, you may need to read it again.
•        Do not share LORALEX with any other person.
•        Ask your pharmacist if you need more information or advice.
•        You must see a doctor if your symptoms worsen or do not improve after 5 days.

WHAT LORALEX TABLETS CONTAIN:
The active substance is desloratadine 5 mg.
Inactive ingredients are anhydrous colloidal silica, hydrogenated castor oil, low-substituted hydroxypropyl cellulose, mannitol, Opadry blue (containing hypromellose, indigo carmine aluminium lake, macrogol, sodium lauryl sulphate and titanium dioxide), and siliconised talc 3%.

WHAT LORALEX TABLETS ARE USED FOR:
LORALEX tablets belong to a class of medicines called antihistamines.
LORALEX tablets are used for:
Relief of symptoms associated with hayfever.
Short-term relief of symptoms associated with chronic (longstanding or recurring) hives of unknown cause (known as chronic idiopathic urticaria).

BEFORE YOU TAKE LORALEX TABLETS
Do not take LORALEX tablets if you have:
Hypersensitivity (allergic) reactions to the active substance, desloratadine, or to any of the other ingredients of LORALEX.
Take special care with LORALEX tablets:
A small number of individuals may experience sleepiness / drowsiness (sedation) while taking LORALEX.
You should refrain from driving a car or operating machinery until you know how LORALEX affects you (see "Driving and using machinery").
Do not give LORALEX to children under 12 years of age, since it is not known whether it is safe and effective to do so.
Do not use LORALEX continuously for longer than 4 weeks. because it is not known whether it is safe and effective to do so.

Taking LORALEX tablets with food and drink:
You may take LORALEX with or without food (see "HOW TO TAKE LORALEX").
You may take LORALEX with grapefruit juice.
Taking LORALEX with alcohol will not worsen sleepiness / drowsiness caused by the use of alcohol.

Pregnancy and breastfeeding:
The safe use of LORALEX tablets during pregnancy has not been established and you should therefore not take LORALEX if you are pregnant.
Desloratadine is excreted into breast milk, and you should therefor not take LORALEX tablets if you are breastfeeding.
If you are pregnant or breastfeeding your baby while taking LORALEX, please consult your doctor, pharmacist or other healthcare professional for advice.

Driving or using machinery:
A small number of individuals may experience sedation (sleepiness / drowsiness) with LORALEX tablets even though LORALEX does not normally have significant sedative effects. It is therefore advisable to determine your individual response before driving or performing complicated tasks. You will know if LORALEX makes you sleepy or impairs your ability to concentrate after the first few doses.

Taking other medicines with LORALEX tablets:
If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of LORALEX tablets with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional for advice.Please discuss the use of the following medicines in combination with LORALEX with your doctor or pharmacist, as you may require special precautions or dosage adjustments:
Ketoconazole for fungal infections, as combined use may increase your risk of experiencing side-effects due to LORALEX.
Erythromycin and azithromycin (antibiotics), as erythromycin may increase your risk of experiencing side-effects due to LORALEX and LORALEX may increase your risk of experiencing side-effects due to azithromycin.
Fluoxetine, an antidepressant, as combined use may increase your risk of experiencing side-effects due to LORALEX and may render fluoxetine less effective.

HOW TO TAKE LORAI.EX TABLETS:
Do not share your medicines with any other person
Always take LORALEX tablets exactly as directed. You should check with your doctor or pharmacist if you are unsure.
Adults and children (>12 years of age): One LORALEX 5 mg tablet taken orally once a day with or without meals.
If you have liver or kidney function impairment, please discuss the use of LORALEX with your doctor or pharmacist, because you will require a dosage adjustment. If you have the impression that the effect of LORALEX tablets is too strong or too weak, talk to your doctor or pharmacist.

If you take more LORALEX tablets than you should:
In the event of an overdose, you may experience any of the side-effects listed below (see "POSSIBLE SIDE-EFFECTS").
In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison centre.

If you forget to take LORALEX tablets:
Always take LORALEX as directed. If you miss a dose, take it as soon as you remember. If you do not remember the missed dose until the next dose is due, skip the missed dose and go back to your regular dosing schedule of one tablet once daily (every 24 hours). Do not take a double dose to make up for forgotten individual doses.

POSSIBLE SIDE-EFFECTS:
LORALEX
tablets can have side-effects.
Not all side-effects reported for LORALEX are included in this leaflet. Should your general health worsen while taking LORALEX, please consult your doctor, pharmacist or other healthcare professional for advice.
Serious side-effects that you, or a family member, should report to your doctor immediately include:
Those that occur less frequently.
o Severe allergic reactions presenting with wheezing, hives or itching, swelling of the face, lips, tongue, or whole body, tightness of the chest, or skin rash.
o Yellow discolouration of the whites of the eyes or the skin (jaundice), pain over the liver area, nausea, and vomiting.
Those that occur with unknown frequency:
o Shortness of breath.
Side-effects that you should report to your doctor as soon as possible:
Those that occur frequently:
o Sore throat.
Those that occur less frequently:
o Muscle pain.
Those that occur with unknown frequency:
o Increased heartbeat, pounding heartbeat.
o Swelling of your ankles or feet.
Side-effects that you should report to your doctor if they continue or become bothersome include:
Those that occur frequently:
o Headache.
Those that occur less frequently:
o Dizziness, sleepiness.
o Indigestion, dry mouth, diarrhoea (loose stools), stomach pain.
o Painful menstruation.
o Fatigue.
Please tell your doctor or pharmacist of any other undesirable effects that you think may be due to taking LORALEX, especially if not mentioned in this leaflet.

STORAGE AND DISPOSING OF LORALEX TABLETS:
Store at or below 25ºC. Protect from moisture.
KEEP THIS MEDICINE OUT OF REACH OF CHILDREN.
Keep the blisters in the outer carton until required for use.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

PRESENTATION OF LORALEX TABLETS:
LORALEX
tablets are packed in plain aluminium foil and PVC/Aclar film blister strips. Blisters are packed in cartons of 7, 10 or 30 tablets.

IDENTIFICATION OF LORALEX TABLETS:
Light blue coloured, circular, biconvex, film coated tablets plain on both sides.

REGISTRATION NUMBER:
43/5.7.1/1150

NAME AND BUSINESS ADDRESS OF THE HOLDER CERTIFICATE OF REGISIRATION:
CIPLA MEDPRO (PTY) LTD
Building 9, Parc du Cap
Mispel Street, Bellville, 7530, RSA

DATE OF PUBLICATI0N OF THIS PATIENT INFORMATION LEAFLET:
6 March 2014

© CIPLA MEDPRO (PTY) LTD

LB18 B

Namibia [NS1] 10/5.7.1/0410

New addition to this site: January 2017
Source: Pharmaceutical Industry
http://www.cipla.co.za/wp-content/uploads/2014/05/loralex-PI.pdf

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