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Desloratadine Genepharm

Desloratadine Genepharm

desloratadine

Manufacturer:

Genepharm

Distributor:

SB Pharma
Full Prescribing Info
Contents
Desloratadine.
Description
The active substance is desloratadine 5 mg.
Excipients/Inactive Ingredients: The other ingredients are: Tablet core: Microcrystalline cellulose, Partially pregelatinised maize starch, Magnesium stearate, Colloidal anhydrous silica.
Film-coating: Hypromellose 6cP, Titanium dioxide (E171), Microcrystalline cellulose, Stearic acid, Indigotine [Indigo Carmine (E132)].
Action
Desloratadine Genepharm is an antiallergy medicine that does not make the patient drowsy. It helps control allergic reaction and its symptoms.
Indications/Uses
Desloratadine Genepharm tablet contains desloratadine which is an antihistamine.
Desloratadine Genepharm relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Desloratadine Genepharm is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.
Relief of these symptoms lasts a full day and helps the patient to resume normal daily activities and sleep.
Dosage/Direction for Use
This medicine should always be taken exactly as prescribed. Patients must be advised to check with the doctor or pharmacist if they are not sure.
Adults and adolescents 12 years of age and over: The recommended dose is one tablet once a day with water, with or without food.
This medicine is for oral use.
The tablet should be swallowed whole.
Regarding the duration of treatment, the physician will determine the type of allergic rhinitis the patient is suffering from and will determine for how long Desloratadine Genepharm should be taken.
If the allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), the physician will recommend a treatment schedule that will depend on the evaluation of the history of the disease.
If the allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), the physician may recommend a longer term treatment.
For urticaria, the duration of treatment may be variable from patient to patient and therefore, the patient should follow the instructions of the physician.
Forgotten intake of Desloratadine Genepharm: If the patient forgets to take the dose on time, it should be taken as soon as possible and then the patient should go back to the regular dosing schedule. A double dose should not be taken to make up for a forgotten dose.
Stopping intake of Desloratadine Genepharm: Patients must be advised to ask the doctor, pharmacist or nurse if they have any further questions on the use of this medicine.
Overdosage
Desloratadine Genepharm should be taken only as it is prescribed. No serious problems are expected with accidental overdose. However, patients must be advised to inform the doctor, pharmacist or nurse immediately if they take more Desloratadine Genepharm than they were told to.
Contraindications
Desloratadine Genepharm should not be taken: If the patient is allergic to desloratadine, or any of the other ingredients of this medicine (listed in Description) or to loratadine.
Special Precautions
Patients must be advised to inform the doctor, pharmacist or nurse before taking Desloratadine Genepharm: If the patient has poor kidney function; If the patient has medical or familial history of seizures.
Desloratadine Genepharm with food, drink and alcohol: Desloratadine Genepharm may be taken with or without a meal.
Use caution when taking Desloratadine Genepharm with alcohol.
Driving and using machines: At the recommended dose, this medicine is not expected to affect the ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery until the patient has established their own response to the medicine.
Use in Children: This medicine should not be given to children less than 12 years of age.
Use In Pregnancy & Lactation
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, she must be advised to ask the doctor or pharmacist before taking this medicine.
Caution: Safe use of this product during pregnancy has not been established.
Taking Desloratadine Genepharm is not recommended if the patient is pregnant or nursing a baby.
There is no data available on male/female fertility.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the marketing of desloratadine, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely. If the patient notices any of these serious side effects, the patient must be advised to stop taking the medicine and to seek urgent medical advice straight away.
In clinical studies in adults, side effects were about the same as with a dummy tablet. However, fatigue, dry mouth and headache were reported more often than with a dummy tablet. In adolescents, headache was the most commonly reported side effect.
In clinical studies with desloratadine, the following side effects were reported as: Common: the following may affect up to 1 in 10 people: Fatigue; Dry mouth; Headache.
During the marketing of desloratadine, the following side effects were reported as: Very rare: the following may affect up to 1 in 10,000 people: Severe allergic reactions; Fast heartbeat; Vomiting; Dizziness; Rash; Stomach ache; Upset stomach; Drowsiness; Pounding or irregular heartbeat; Feeling sick (nausea); Diarrhoea; Inability to sleep; Muscle pain; Restlessness with increased body movement; Hallucinations; Liver inflammation; Seizures; Abnormal liver function tests.
Not known: frequency cannot be estimated from the available data: Unusual weakness; Yellowing of the skin and/or eyes; Increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium; Changes in the way the heart beats; Abnormal behaviour; Aggression; Weight increased, increased appetite; Depressed mood; Dry eyes.
Children: Not known: frequency cannot be estimated from the available data: Slow heartbeat; Abnormal behaviour; Aggression; Change in the way the heart beats.
Reporting of side effects: Patients must be advised to talk to the doctor, pharmacist or nurse if they get any side effects. This includes any possible side effects not listed in this monograph. Reporting side effects can help provide more information on the safety of this medicine.
Drug Interactions
There are no known interactions of desloratadine with other medicines.
Patients must be advised to inform the doctor or pharmacist if they are taking, have recently taken or might take any other medicines.
Storage
Store at temperature ≤25°C. Store in the original package.
Do not use this medicine if there is any change in the appearance of the tablets.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R06AX27 - desloratadine ; Belongs to the class of other antihistamines for systemic use.
Presentation/Packing
Form
Desloratadine Genepharm FC tab 5 mg
Packing/Price
2 × 15's
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