Alergo film-coated tablets 10 pieces
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Description
Alergo film-coated tablets 10 pieces
Description
Desloratadium
5 mg
film-coated tablets
Treatment of allergy symptoms such as:
- sneezing
- itching
- urticaria
- itching, redness or tearing of the eyes
- watery discharge or itching of the nose
OTC - Over-the-counter medication.
5 mg
film-coated tablets
Treatment of allergy symptoms such as:
- sneezing
- itching
- urticaria
- itching, redness or tearing of the eyes
- watery discharge or itching of the nose
OTC - Over-the-counter medication.
Storage and use
Swallow the tablet whole, drinking water.
Read the leaflet before using the drug.
Oral administration
Age Adults and children older than 12 years / Dosage Quantity 1 tablet Frequency 1 time per day.
Storage: Store at ambient temperature
Packaging: box
Read the leaflet before using the drug.
Oral administration
Age Adults and children older than 12 years / Dosage Quantity 1 tablet Frequency 1 time per day.
Storage: Store at ambient temperature
Packaging: box
Composition
Each tablet contains 5 mg of desloratadine
Manufacturer
Teva Pharmaceuticals Polska Sp. z o.o.
Manufacturer's address
Manufacturer
Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Safety warning
Actavis Ltd.
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Keep the drug out of sight and reach of children.
Number of units
Number of units: 10
General information
Carefully read the leaflet before using the drug, as it contains important information for the patient.
Always use this medication exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- If there is no improvement after 3 days, or if the patient feels worse, contact your doctor.
Table of contents of the leaflet
Always use this medication exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- If there is no improvement after 3 days, or if the patient feels worse, contact your doctor.
Table of contents of the leaflet
1 What AlergoTeva is and for what purpose it is used.
2. important information before using AlergoTeva drug
3. how to use AlergoTeva
4 Possible side effects
5. how to store the drug AlergoTeva
6. package contents and other information
Description and use
1 What AlergoTeva is and for what purpose it is used.
2. important information before using AlergoTeva drug
3. how to use AlergoTeva
4 Possible side effects
5. how to store the drug AlergoTeva
6. package contents and other information
1 What is AlergoTeva and for what purpose it is used.
What is AlergoTeva
AlergoTeva contains the active substance desloratadine, which has antihistamine effects.
How AlergoTeva works
AlergoTeva is an anti-allergic drug that does not cause drowsiness. It facilitates control of the allergic reaction and its symptoms.
When to use AlergoTeva
AlergoTeva relieves symptoms associated with allergic rhinosinusitis (inflammation of the nasal mucosa caused by an allergy, such as hay fever or mite allergy) in adults and adolescents aged 12 years and older. Symptoms include sneezing, watery discharge or itching of the nose, itchy palate, and itchy, red or watery eyes.
AlergoTeva is also used to relieve symptoms associated with urticaria (a skin condition caused by allergy). Symptoms of this condition include itchy skin and urticarial blisters.
The relief of these symptoms lasts throughout the day, making it easier to return to normal daily activities and normal sleep.
If there is no improvement after 3 days, or if the patient feels worse, see a doctor.
How to use the drug
What is AlergoTeva
AlergoTeva contains the active substance desloratadine, which has antihistamine effects.
How AlergoTeva works
AlergoTeva is an anti-allergic drug that does not cause drowsiness. It facilitates control of the allergic reaction and its symptoms.
When to use AlergoTeva
AlergoTeva relieves symptoms associated with allergic rhinosinusitis (inflammation of the nasal mucosa caused by an allergy, such as hay fever or mite allergy) in adults and adolescents aged 12 years and older. Symptoms include sneezing, watery discharge or itching of the nose, itchy palate, and itchy, red or watery eyes.
AlergoTeva is also used to relieve symptoms associated with urticaria (a skin condition caused by allergy). Symptoms of this condition include itchy skin and urticarial blisters.
The relief of these symptoms lasts throughout the day, making it easier to return to normal daily activities and normal sleep.
If there is no improvement after 3 days, or if the patient feels worse, see a doctor.
3 How to use AlergoTeva
This drug should always be used exactly as described in the patient leaflet or as prescribed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Adults and adolescents aged 12 years and older
The recommended dose is one tablet once daily sipped with water, taken with or without a meal.
This medication is intended for oral use.
The tablet should be swallowed whole.
Your doctor or pharmacist will determine the duration of treatment with AlergoTeva after determining the type of allergic rhinosinusitis you have.
If the patient has intermittent allergic rhinosinusitis (symptoms occur less than 4 days a week or for less than 4 weeks), the doctor or pharmacist will recommend a treatment regimen, taking into account the patient's previous history.
If you have chronic allergic rhinosinusitis (symptoms occur for 4 or more days a week and for more than 4 weeks), your doctor or pharmacist may recommend a longer course of treatment.
In urticaria, the duration of treatment may vary from patient to patient, so the patient should follow the advice of the doctor or pharmacist.
If there is no improvement after 3 days or the patient feels worse, see a doctor.
Do not take AlergoTeva for more than 10 days, unless otherwise instructed by your doctor.
Use a higher than recommended dose of AlergoTeva drug.
AlergoTeva should be taken as directed by your doctor or pharmacist. Accidental overdose of the drug should not be followed by severe disorders. However, if you take more than the recommended dose of AlergoTeva, tell your doctor, pharmacist or nurse immediately.
Omitting to take AlergoTeva medicine
If you miss taking a dose of the drug in a timely manner, take it as soon as possible and then return to your regular dosing schedule. Do not use a double dose to make up for a missed dose.
Discontinuation of AlergoTeva drug.
If you have any further doubts about the use of this medication, ask your doctor, pharmacist or nurse.
How to store the drug
This drug should always be used exactly as described in the patient leaflet or as prescribed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Adults and adolescents aged 12 years and older
The recommended dose is one tablet once daily sipped with water, taken with or without a meal.
This medication is intended for oral use.
The tablet should be swallowed whole.
Your doctor or pharmacist will determine the duration of treatment with AlergoTeva after determining the type of allergic rhinosinusitis you have.
If the patient has intermittent allergic rhinosinusitis (symptoms occur less than 4 days a week or for less than 4 weeks), the doctor or pharmacist will recommend a treatment regimen, taking into account the patient's previous history.
If you have chronic allergic rhinosinusitis (symptoms occur for 4 or more days a week and for more than 4 weeks), your doctor or pharmacist may recommend a longer course of treatment.
In urticaria, the duration of treatment may vary from patient to patient, so the patient should follow the advice of the doctor or pharmacist.
If there is no improvement after 3 days or the patient feels worse, see a doctor.
Do not take AlergoTeva for more than 10 days, unless otherwise instructed by your doctor.
Use a higher than recommended dose of AlergoTeva drug.
AlergoTeva should be taken as directed by your doctor or pharmacist. Accidental overdose of the drug should not be followed by severe disorders. However, if you take more than the recommended dose of AlergoTeva, tell your doctor, pharmacist or nurse immediately.
Omitting to take AlergoTeva medicine
If you miss taking a dose of the drug in a timely manner, take it as soon as possible and then return to your regular dosing schedule. Do not use a double dose to make up for a missed dose.
Discontinuation of AlergoTeva drug.
If you have any further doubts about the use of this medication, ask your doctor, pharmacist or nurse.
5 How to store the drug AlergoTeva
Store the drug out of sight and reach of children.
Do not use this medicine after the expiration date on the box and blister after: EXP. The expiration date means the last day of the month stated.
No special recommendations for storing the drug.
Tell your pharmacist if you notice any change in the appearance of the tablet.
Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use. Doing so will help protect the environment.
Possible side effects
Store the drug out of sight and reach of children.
Do not use this medicine after the expiration date on the box and blister after: EXP. The expiration date means the last day of the month stated.
No special recommendations for storing the drug.
Tell your pharmacist if you notice any change in the appearance of the tablet.
Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use. Doing so will help protect the environment.
4 Possible side effects
Like any medication, this drug may cause side effects, although they will not occur in everyone.
Following the marketing of desloratadine, cases of severe allergic reactions (difficulty breathing, wheezing, pruritus, urticaria and swelling) have been reported very rarely. If any of these severe side effects occur, discontinue the drug and seek immediate medical attention.
In clinical trials in adult patients, side effects were almost the same as after taking a non-active tablet. However, feelings of fatigue, dry mouth and headaches were reported more often than after the non-active substance tablet. In adolescents, the most commonly reported adverse reaction was headache.
The following adverse reactions were reported in clinical trials of desloratadine:
Common (may occur in no more than 1 in 10 patients):
- fatigue
- dry mouth
- headache.
After desloratadine was marketed, the following adverse reactions were reported:
Very rare (may occur in no more than 1 in 10,000 patients):
- severe allergic reactions
- rapid heartbeat
- vomiting
- dizziness
- muscle pain
- restlessness with excessive motor activity
- rash
- abdominal pain
- upset stomach
- somnolence
- hallucinations
- hepatitis
- palpitations or irregular heartbeat
- nausea
- diarrhea
- convulsions
- abnormal results of liver function tests.
Frequency unknown (frequency cannot be determined from available data):
- unusual weakness
- yellowing of the skin and/or eyeballs
- increased sensitivity of the skin to the sun, even when it is overcast, and to UV (ultraviolet) radiation, such as UV radiation in tanning beds
- changes in the way the heart beats
- unusual behavior
- aggressive behavior
- increased body weight
- increased appetite.
Additional adverse reactions occurring in children
Unknown (frequency cannot be determined from available data):
- slow heartbeat
- unusual behavior
- change in heartbeat pattern
- aggressive behavior.
Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or nurse. Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the responsible party.
By reporting side effects, it will be possible to gather more information on the safety of the drug.
Package contents and other information
Like any medication, this drug may cause side effects, although they will not occur in everyone.
Following the marketing of desloratadine, cases of severe allergic reactions (difficulty breathing, wheezing, pruritus, urticaria and swelling) have been reported very rarely. If any of these severe side effects occur, discontinue the drug and seek immediate medical attention.
In clinical trials in adult patients, side effects were almost the same as after taking a non-active tablet. However, feelings of fatigue, dry mouth and headaches were reported more often than after the non-active substance tablet. In adolescents, the most commonly reported adverse reaction was headache.
The following adverse reactions were reported in clinical trials of desloratadine:
Common (may occur in no more than 1 in 10 patients):
- fatigue
- dry mouth
- headache.
After desloratadine was marketed, the following adverse reactions were reported:
Very rare (may occur in no more than 1 in 10,000 patients):
- severe allergic reactions
- rapid heartbeat
- vomiting
- dizziness
- muscle pain
- restlessness with excessive motor activity
- rash
- abdominal pain
- upset stomach
- somnolence
- hallucinations
- hepatitis
- palpitations or irregular heartbeat
- nausea
- diarrhea
- convulsions
- abnormal results of liver function tests.
Frequency unknown (frequency cannot be determined from available data):
- unusual weakness
- yellowing of the skin and/or eyeballs
- increased sensitivity of the skin to the sun, even when it is overcast, and to UV (ultraviolet) radiation, such as UV radiation in tanning beds
- changes in the way the heart beats
- unusual behavior
- aggressive behavior
- increased body weight
- increased appetite.
Additional adverse reactions occurring in children
Unknown (frequency cannot be determined from available data):
- slow heartbeat
- unusual behavior
- change in heartbeat pattern
- aggressive behavior.
Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or nurse. Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the responsible party.
By reporting side effects, it will be possible to gather more information on the safety of the drug.
6 Contents of the package and other information
What the drug AlergoTeva contains
- The active substance of the drug is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
- The other ingredients are: tablet core: microcrystalline cellulose, gelatinized starch, cornstarch, mannitol, talc, magnesium stearate; tablet shell: hypromellose 6cP, titanium dioxide (E171), macrogol 6000, indigotine (E132), lacquer.
What the drug AlergoTeva looks like and what the packaging contains.
Blue, round film-coated tablets, 6 mm in diameter, convex on both sides, marked with "LT" embossed on one side.
AlergoTeva 5 mg, film-coated tablets are packaged in blisters containing: 7 or 10 tablets.
Important before use
What the drug AlergoTeva contains
- The active substance of the drug is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
- The other ingredients are: tablet core: microcrystalline cellulose, gelatinized starch, cornstarch, mannitol, talc, magnesium stearate; tablet shell: hypromellose 6cP, titanium dioxide (E171), macrogol 6000, indigotine (E132), lacquer.
What the drug AlergoTeva looks like and what the packaging contains.
Blue, round film-coated tablets, 6 mm in diameter, convex on both sides, marked with "LT" embossed on one side.
AlergoTeva 5 mg, film-coated tablets are packaged in blisters containing: 7 or 10 tablets.
2 Information important before using AlergoTeva drug.
When not to use AlergoTeva drug
- If the patient is allergic to desloratadine or any of the other ingredients of this drug (listed in section 6), or to loratadine.
Warnings and precautions
Discuss with your doctor, pharmacist or nurse before taking AlergoTeva:
- if the patient has renal impairment;
- if the patient has a medical or family history of seizures.
Children and adolescents
This drug should not be given to children under 12 years of age.
AlergoTeva and other drugs
There are no known interactions of AlergoTeva with other drugs.
Tell your doctor or pharmacist about all medicines you are currently or recently taking, as well as medicines you plan to take.
AlergoTeva with food, drink and alcohol
AlergoTeva can be taken with or without a meal.
Use caution when taking AlergoTeva with alcohol.
Pregnancy, breastfeeding and effects on fertility
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a baby, you should consult your doctor or pharmacist before taking this drug.
AlergoTeva is not recommended for use during pregnancy or breastfeeding.
Fertility
No data are available on the effect of the drug on female and male fertility.
Driving and operating machinery
This drug, when used at the recommended dose, is not thought to affect the ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended that they refrain from activities that require concentration of attention, such as driving or operating machinery, until it is determined how they respond to this drug.
Product identification
When not to use AlergoTeva drug
- If the patient is allergic to desloratadine or any of the other ingredients of this drug (listed in section 6), or to loratadine.
Warnings and precautions
Discuss with your doctor, pharmacist or nurse before taking AlergoTeva:
- if the patient has renal impairment;
- if the patient has a medical or family history of seizures.
Children and adolescents
This drug should not be given to children under 12 years of age.
AlergoTeva and other drugs
There are no known interactions of AlergoTeva with other drugs.
Tell your doctor or pharmacist about all medicines you are currently or recently taking, as well as medicines you plan to take.
AlergoTeva with food, drink and alcohol
AlergoTeva can be taken with or without a meal.
Use caution when taking AlergoTeva with alcohol.
Pregnancy, breastfeeding and effects on fertility
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a baby, you should consult your doctor or pharmacist before taking this drug.
AlergoTeva is not recommended for use during pregnancy or breastfeeding.
Fertility
No data are available on the effect of the drug on female and male fertility.
Driving and operating machinery
This drug, when used at the recommended dose, is not thought to affect the ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended that they refrain from activities that require concentration of attention, such as driving or operating machinery, until it is determined how they respond to this drug.
AlergoTeva, 5 mg, film-coated tablets
Desloratadinum
Desloratadinum
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