NOTICE
ANSM - Last updated: 11/05/2017
Name of the medicinal product
HUMEX ALLERGY LORATADINE 10 mg tablet
loratadine
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.
· If symptoms persist after 3 days of treatment, if they become worse or if new symptoms appear, seek the advice of your pharmacist or doctor.
· This leaflet is designed to help you use this medicine. Keep it, you may need to reread it.
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
Review summary
In this notice :
1. WHAT IS HUMEX ALLERGY LORATADINE 10 mg tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE HUMEX ALLERGY LORATADINE 10 mg tablet?
3. HOW TO TAKE HUMEX ALLERGY LORATADINE 10 mg tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE HUMEX ALLERGY LORATADINE 10 mg tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS HUMEX ALLERGY LORATADINE 10 mg tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
HUMEX ALLERGY LORATADINE 10 mg tablet is a medication that belongs to the class of antihistamines. Antihistamines help reduce the symptoms of allergy by preventing the effects of a substance, histamine, which is produced by your body when you make an allergic reaction.
Therapeutic indications
HUMEX ALLERGY LORATADINE is indicated in adults and children over 30 kg (approximately 12 years): it relieves symptoms associated with allergic rhinitis (eg hay fever) such as sneezing, runny nose clear, nose and / or eyes that itch, tearing.
2. BEFORE YOU TAKE HUMEX ALLERGY LORATADINE 10 mg tablet?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Never HUMEX ALLERGY Loratadine 10 mg Tablets if you are allergic (hypersensitive) to loratadine or any of the other ingredients in HUMEX ALLERGY Loratadine 10 mg tablet ( see composition ).
Precautions for use; special warnings
Take special care with HUMEX ALLERGY LORATADINE 10 mg tablet:
Tell your doctor if you have severe liver disease.
The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Tell your doctor that you are taking this medication if you are prescribed a skin test for the diagnosis of an allergy. In this case, treatment should be discontinued 48 hours before the test because this drug may cause a false positive result.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Laboratory Test:
Tell your doctor that you are taking this medication if you are prescribed a skin test for the diagnosis of an allergy. In this case, treatment should be discontinued 48 hours before the test because this drug may cause a false positive result.
Interactions with food and beverages
Food and drinks
HUMEX ALLERGY LORATADINE 10 mg tablet can be taken during or outside meals.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
The use of this medication is not recommended unless your doctor tells you otherwise during pregnancy. If you discover that you are pregnant during treatment, consult your doctor promptly: he or she will be able to judge the appropriate treatment for your condition.
feeding
This drug passes into breast milk. Therefore, the use of this medication is not recommended in case of breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
At the therapeutic dose, HUMEX ALLERGY LORATADINE 10 mg, tablet does not generally make drowsy and does not diminish alertness. However, very rarely have there been reported cases of drowsiness likely to affect the ability to drive or use machines.
List of excipients with known effect
Important information about some of the ingredients of HUMEX ALLERGIE LORATADINE 10 mg tablet.
This medicine contains lactose.
3. HOW TO TAKE HUMEX ALLERGY LORATADINE 10 mg tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Reserved ONLY for adults and children over 30 kg (about 12 years).
Take 1 tablet once a day.
Swallow the tablet with a glass of water, at or away from meals.
This 10 mg tablet is not suitable for children under 30 kg.
The dosage should be adjusted for severe hepatic impairment.
Increased dosage does not increase the effectiveness of this medication
Duration of the treatment:
If symptoms worsen or persist after 3 days, consult a physician.
Symptoms and Instructions for Overdose
If you take more HUMEX ALLERGY LORATADINE 10 Mg, tablet than you should:
Immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take HUMEX ALLERGY LORATADINE 10 Mg, tablet:
If you forget to take your dose on time, take it as soon as possible, then continue your treatment as usual. Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, HUMEX ALLERGY LORATADINE 10 mg tablet is likely to have side effects, although not everyone is subject to it.
The most frequently reported adverse reactions are drowsiness, headache, increased appetite and difficulty sleeping.
Severe allergic reactions, dizziness, acceleration or irregular heartbeat, nausea, dry mouth, stomach pain, liver problems, hair loss, rash or redness of the skin were very rarely reported.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE HUMEX ALLERGY LORATADINE 10 mg tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use HUMEX ALLERGY LORATADINE 10 mg, tablet after the expiry date which is stated on the carton, bottle or blister. The expiry date refers to the last day of the month.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Do not use HUMEX ALLERGY LORATADINE 10 mg if you notice a change in the appearance of the tablets.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What contains HUMEX ALLERGY LORATADINE 10 mg tablet?
The active substance is:
Loratadine ................................................. .................................................. ...................................... 10 mg
For a tablet.
The other components are:
Lactose monohydrate, microcrystalline cellulose, corn starch, magnesium stearate.
Pharmaceutical form and content
What is HUMEX ALLERGY LORATADINE 10 mg tablet and contents of the pack?
This medication is in the form of a white, round tablet with a break bar.
Box of 5, 6 or 7 tablets in blister packs or bottle of 5 or 7 tablets.
Not all pack sizes may be marketed.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
URGO HEALTHCARE LABORATORIES
42 RUE DE LONGVIC
21300 CHENOVE
exploiting
URGO HEALTHCARE LABORATORIES
42 RUE DE LONGVIC
21300 CHENOVE
Maker
ACTAVIS HF
REYKJAVIKURVEGUR 76-78
IS 220 HAFNARFJORDUR
ICELAND
or
ACTAVIS LTD
BLB016 BULEBEL INDUSTRIAL ESTATE
ZEJTUN ZTN 3000
MALTA
or
URGO LABORATORIES
2 AVENUE DE STRASBOURG
ZONE EXCELLENCE 2000
21800 CHEVIGNY-SAINT-SAUVEUR
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
ADVICE / HEALTH EDUCATION |
a) What is an allergy, what is an allergic reaction?
Allergy is an overreaction of our body to substances it considers harmful, allergens. Allergens are the factors and substances triggering allergy and associated disorders.
During repeated and intensive contacts of our body with the allergen, an allergic reaction is triggered.
The allergic reaction refers to all symptoms appearing a few minutes or hours after exposure to allergens. These allergens come from plants, animal hair, food, dust mites, molds or are substances of occupational origin.
This allergic reaction causes the release in the body of substances such as the histamine responsible for the disorders felt.
As with any allergic disease, it is important to consult a doctor at least once.
IT SHALL DETERMINE IN PARTICULAR THE NEED TO CARRY OUT AN ALLERGOLOGICAL BALANCE SHEET.
b) How to recognize allergic rhinitis?
Allergic rhinitis results in the following symptoms: successive sneezing, colorless nasal discharge, nasal obstruction (stuffy nose), itching and tingling of the nose. It may be accompanied by irritations of both eyes (tearing, redness), throat and nose.
We distinguish:
· Seasonal allergic rhinitis or hay fever: frequent, they occur every year in the same season, when pollen concentration increases in the air, and usually occur for the first time during adolescence. However, you may not be allergic to all pollens, but to one or more of them only.
· Perennial allergic rhinitis occurs throughout the year and most often depends on domestic allergens such as dust mites, molds, and domestic animals.
c) Some practical tips
Removing the allergen (foreclosure) is the measure of choice to suppress or reduce the symptoms of allergy.
For household allergens: measures to reduce the presence of allergens are essential:
· The mattress should be completely surrounded by a plastic dust mite cover as well as the pillows. The bed base, unless it is in slats or metal, shall be surrounded by a plastic. All bedding should be washed twice a month at 60 ° C if possible,
· The room must be ventilated and cleaned regularly,
· On the floor, one will avoid the descent of bed and the carpets,
· Avoid pets,
During the pollen season it is possible to reduce the exposure to pollen:
· In your garden, diversify the plantations avoiding the most allergenic species (cypress, thuja, birch ...).
· Avoid mowing the lawn yourself during the pollen season.
· Garde preferably with glasses and a protective mask.