French pharmacy
The antiallergic action of HUMEX ALLERGIE CETIRIZINE is related to the antihistaminic properties of cetirizine. It acts for 24 hours on all the symptoms of rhinitis and / or allergic conjunctivitis seasonal or not (sneezing, runny nose, itchy eyes and / or nasal), as well as urticaria (itchy patches, redness, edema).
The antiallergic action of HUMEX ALLERGY CETIRIZINE is linked to the antihistamine properties of cetirizine . It acts for 24 hours on all symptoms of rhinitis and / or allergic conjunctivitis, seasonal or not (sneezing, runny nose, itchy eyes and / or nose), as well as hives (plaques with itching, redness, edemas).
Adults and children over 6 years old. Medical advice is recommended for chronic idiopathic urticaria. The duration of treatment depends on the type, duration and your symptoms and is determined by your doctor.
One film-coated tablet contains 10 mg cetirizine dihydrochloride.
Excipient: one film-coated tablet contains 80.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
Caution
Attention, the drug is not a product like the others. Read the package leaflet or the SPC carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Humex comes in tablet form.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 11/05/2017
HUMEX ALLERGY CETIRIZINE 10 mg film-coated tablet
Cetirizine dihydrochloride
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.
· However, given its indication in the treatment of symptoms of chronic urticaria, medical advice is recommended to help you use it well, at least the first time.
· 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 there, you might need to reread it.
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
In this notice :
1. WHAT IS HUMEX ALLERGY CETIRIZINE 10 mg film-coated, breakable tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE HUMEX ALLERGY CETIRIZINE 10 mg film-coated tablet?
3. HOW TO TAKE HUMEX ALLERGY CETIRIZINE 10 mg film-coated tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE HUMEX ALLERGY CETIRIZINE 10 mg film-coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS HUMEX ALLERGY CETIRIZINE 10 mg film-coated, breakable tablet AND WHAT IT IS USED FOR?
Cetirizine dihydrochloride is the active substance in HUMEX ALLERGY CETIRIZINE.
HUMEX ALLERGY CETIRIZINE is an antiallergic drug.
In adults and children from 6 years, HUMEX ALLERGY CETIRIZINE is indicated:
· for the treatment of nasal and ocular symptoms of seasonal or perennial allergic rhinitis,
· for the treatment of symptoms of chronic urticaria (idiopathic chronic urticaria).
A medical opinion is recommended for idiopathic chronic urticaria.
2. BEFORE YOU TAKE HUMEX ALLERGY CETIRIZINE 10 mg film-coated 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.
Do not take HUMEX ALLERGY CETIRIZINE 10 mg film-coated tablet in the following cases:
· if you have severe kidney disease (severe renal insufficiency with a creatinine clearance of less than 10 ml / min);
· if you are allergic to the active substance of HUMEX ALLERGY CETIRIZINE or any of the other ingredients (excipients), hydroxyzine or piperazine derivatives (related substances contained in other medicines).
Precautions for use; special warnings
Take special care with HUMEX ALLERGY CETIRIZINE 10 mg film-coated tablet:
If you have kidney failure, seek advice from your doctor; if necessary, you should take a lower dose. The appropriate dosage will be determined by your doctor.
If you are an epileptic or if you are at risk of seizures, ask your doctor for advice.
There is no description of any interaction that may have a particular effect in the concomitant use of cetirizine (used in normal doses) and alcohol (up to a blood concentration of 0.5 per thousand corresponding to a glass of wine). As with any other antihistamine, it is nevertheless recommended to avoid taking alcohol during treatment.
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).
Interaction with other medicines
Taking 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.
Due to the profile of cetirizine, no interaction with other drugs is expected.
Interactions with food and beverages
Food and drinks
Food intake does not significantly affect the absorption of cetirizine.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine.
As with other medicines, the use of HUMEX ALLERGY CETIRIZINE should be avoided during pregnancy.
Accidental use during pregnancy should not affect the fetus. However, it is preferable as a precautionary measure to avoid further treatment.
HUMEX ALLERGY CETIRIZINE should not be taken during breast-feeding because of its passage through breast milk.
Not applicable.
Effects on ability to drive or use machines
Driving and using machines:
Clinical studies did not demonstrate impaired vigilance, reaction time or ability to drive after administration of HUMEX ALLERGY CETIRIZINE at the recommended doses.
If you are likely to drive a vehicle or handle a potentially hazardous tool or machine, you should not exceed the recommended dose. You should carefully evaluate your response to cetirizine treatment beforehand.
In some susceptible patients, concomitant use of alcohol or other central nervous system depressants may result in decreased attention or ability to respond.
List of excipients with known effect
Important information about some of the ingredients of HUMEX ALLERGIE CETIRIZINE 10 mg film-coated tablet:
HUMEX ALLERGY CETIRIZINE contains lactose.
3. HOW TO TAKE HUMEX ALLERGY CETIRIZINE 10 mg film-coated tablet?
Not applicable.
How and when should you take HUMEX ALLERGY CETIRIZINE?
These instructions should be followed unless your doctor has given you different instructions on how to use HUMEX ALLERGY CETIRIZINE.
Follow these instructions, if not HUMEX ALLERGY CETIRIZINE may not be completely effective.
The tablets should be swallowed with a drink.
Adults and adolescents over 12 years:
10 mg once daily or 1 tablet.
Children from 6 to 12 years:
The use of this medication is not recommended in children under 6 years of age because this form does not allow dose adjustment in this age group.
5 mg twice daily, half a tablet twice daily.
Moderate to severe renal impairment:
In patients with moderate to severe renal impairment, the dose will be reduced to 5 mg once daily and 5 mg once every two days.
If you think the effect of HUMEX ALLERGY CETIRIZINE is too weak or too strong, talk to your doctor.
Duration of treatment
The duration of treatment depends on the type, duration and your symptoms and is determined by your doctor.
Symptoms and Instructions for Overdose
If you take more HUMEX ALLERGY CETIRIZINE 10 mg film-coated tablet you should not have:
Contact your doctor if you think you have taken more HUMEX CETIRIZINE ALLERGY tablets than you should. Your doctor will decide, if necessary, what to do.
In case of overdose, the side effects described below may occur with an increased intensity. Side effects such as confusion, diarrhea, dizziness, tiredness, headache, feeling sick, pupil dilation, itching, restlessness, sedation, drowsiness, stupor, abnormal increase in heart rate, tremors and urinary retention have been reported.
Instructions for omission of one or more doses
If you forget to take HUMEX ALLERGY CETIRIZINE 10 mg film-coated tablet:
Do not take a double dose to make up for a missed dose.
If you stop taking HUMEX ALLERGY CETIRIZINE 10 mg film-coated tablet:
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, HUMEX ALLERGY CETIRIZINE 10 mg film-coated tablet is likely to have side effects although not everyone is subject to it.
Since commercialization, the following adverse reactions have been reported. Their frequency was defined as: (Frequent: 1 in 100 to 1 in 10, uncommon: 1 in 1000 to 1 in 100, rare: 1 in 10,000 to 1 in 1,000, very rare: less than 1 out of 10,000).
· Blood and lymphatic system disorders:
Very rare: thrombocytopenia (decreased blood platelets)
· General condition disorders:
Common: fatigue
· Cardiac disorders:
Rare: tachycardia (heartbeat too fast)
· Eye disorders:
Very rare: disorders of accommodation, blurred vision, oculogyre crises (uncontrolled circular movements of the eyes)
· Gastrointestinal disorders:
Common: dry mouth, nausea, diarrhea
Uncommon: abdominal pain.
· General disorders and administration site conditions:
Uncommon: asthenia (extreme fatigue), malaise,
Rare: swelling (subcutaneous swelling)
· Immune system disorders:
Rare: allergic reactions, sometimes severe (very rare)
· Hepatobiliary disorders:
Rare: abnormal liver function (increased liver enzymes)
· investigations:
Rare: weight gain
· Nervous system disorders:
Common: vertigo, headache
Uncommon: paresthesia (abnormal sensation in the skin)
Rare: convulsions, abnormal movements
Very rare: syncope, tremor, dysgeusia (altered taste)
· Psychiatric disorders:
Common: somnolence
Uncommon: restlessness
Rare: aggressiveness, confusion, depression, hallucination, insomnia
Very rare: tic
· Renal and urinary disorders:
Very rare: difficulty passing urine
· Respiratory disorders:
Common: pharyngitis, rhinitis
· Skin and subcutaneous tissue disorders:
Uncommon: pruritus, rash
Rare: urticaria
Very rare: edema, fixed pigmented erythema
If you develop any of the side effects listed above, please tell your doctor. At the first signs of allergic reaction, stop taking HUMEX ALLERGY CETIRIZINE. Your doctor will assess the severity and decide what to do if necessary.
If you experience any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE HUMEX ALLERGY CETIRIZINE 10 mg film-coated tablet?
Keep out of the reach and sight of children.
Do not use HUMEX ALLERGY CETIRIZINE after the expiry date which is stated on the carton and the blister.
No special storage conditions.
If necessary, warnings against visible signs of deterioration
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.
Full list of active substances and excipients
What contains HUMEX ALLERGY CETIRIZINE 10 mg film-coated tablet?
The active substance of HUMEX ALLERGY CETIRIZINE is cetirizine dihydrochloride. A film-coated tablet contains 10 mg of cetirizine dihydrochloride.
The other components are:
Core : lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.
Coating: OPADRY WHITE (lactose monohydrate, titanium dioxide (E171), hypromellose (E464), macrogol 4000).
Pharmaceutical form and content
What is HUMEX ALLERGY CETIRIZINE 10 mg film-coated tablet and contents of the pack?
This medication is in the form of a scored film-coated tablet. Box of 6 or 7.
42 RUE DE LONGVIC
21300 CHENOVE
42 RUE DE LONGVIC
21300 CHENOVE
URGO LABORATORIES
AVENUE OF 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.
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
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.
Like 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, seasonal or non-seasonal allergic conjunctivitis, localized acute urticaria?
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 : occur every year in the same season, when the concentration of pollen increases in the air. These allergies due to pollen are very common and usually manifest for the first time during adolescence. They are repeated every year at the same time, depending on the presence of the responsible pollen (s). However, you are not 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, dust, mold, and domestic animals.
· Allergic conjunctivitis is characterized by tearing and tingling of both eyes.
· The localized acute urticaria results in plaques with itching, redness, edema (swelling).
c) Some practical tips
Removing the allergen (is 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 should be ventilated and cleaned regularly.
· On the floor, you will avoid bed runs and 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 lawn mowing yourself during the pollen season,
· Garde preferably with glasses and a protective mask.
Hypo-allergenic
This medication is a generic of ZYRTECSET.
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
HUMEX ALLERGY CÉTIRIZINE: scored tablet; box of 7.
-
Laboratory
| p cp | |
| Cetirizine dihydrochloride | 10 mg |
| Lactose | + |
Usual dosage:
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