Loratadine 10 mg 7 tablets Mylan Viatris

Description:

LORATADINE MYLAN CONSEIL 10 mg, tablet is indicated for adults and children over 6 years of age and weighing more than 30 kg to relieve symptoms associated with allergic rhinitis (e.g. hay fever) such as sneezing, clear nasal discharge, itchy nose and/or eyes, watery eyes.

Please read this leaflet carefully before taking this medicine as it contains important information for you.

You must always take this medicine exactly as instructed in this leaflet or by your doctor, pharmacist or nurse.

- Keep this leaflet. You may need to read it again.

- Ask your pharmacist for advice and information.

- If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.

- You should contact your doctor if you do not feel any improvement or if you feel worse after 3 days.

What does this leaflet contain?

1. What is LORATADINE MYLAN CONSEIL 10 mg, tablet and what is it used for?

2. What you should know before taking LORATADINE MYLAN CONSEIL 10 mg, tablet

3. How do I take LORATADINE MYLAN CONSEIL 10 mg, tablet?

4. What are the possible side effects?

5. How do I keep LORATADINE MYLAN CONSEIL 10 mg, tablet?

6. What does the package contain and other information?

1. WHAT IS LORATADINE MYLAN CONSEIL 10 mg, tablet AND WHAT IS IT USED FOR? <

Pharmacotherapeutic class: antihistamines for systemic use - ATC code: R06AX13

LORATADINE MYLAN CONSEIL 10 mg, tablet is a drug that belongs to the antihistamine class. Antihistamines help to reduce allergy symptoms by preventing the effects of a substance, histamine, that is produced by your body when you have an allergic reaction.

LORATADINE MYLAN CONSEIL 10 mg, tablet is indicated for adults and children over 6 years of age and weighing more than 30 kg to relieve symptoms associated with allergic rhinitis (e.g. hay fever) such as sneezing, runny nose, itchy nose and/or eyes, watery eyes.

2. WHAT DO YOU KNOW BEFORE YOU TAKE LORATADINE MYLAN CONSEIL 10 mg, tablet? <

Never take LORATADINE MYLAN CONSEIL 10 mg, tablet:

- if you are allergic to loratadine or any of the other components contained in this medicine, mentioned in section 6.

IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking LORATADINE MYLAN CONSEIL 10 mg, tablet.

Tell your doctor if you have severe liver disease.

Tell your doctor that you are taking this medicine if he or she orders a skin test to diagnose an allergy. In this case, the treatment must be interrupted 48 hours before the test because this drug can distort the result.

IF IN DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Children

LORATADINE MYLAN CONSEIL 10 mg, tablet should not be given to children under 6 years of age or weighing 30 kg or less.

The efficacy and safety of LORATADINE MYLAN CONSEIL 10 mg, tablet in children under 2 years of age have not been established. No data are available.

Other drugs and LORATADINE MYLAN CONSEIL 10 mg, tablet

Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

LORATADINE MYLAN CONSEIL 10 mg, tablet with food and drink

LORATADINE MYLAN CONSEIL 10 mg, Tablet can be taken with or without meals.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

The use of this medication is not recommended during pregnancy unless your doctor advises otherwise. If you discover that you are pregnant during treatment, consult your doctor promptly: only he or she can decide on the appropriate treatment for your condition.

This medication passes into breast milk. Therefore, the use of this drug is not recommended if you are breastfeeding.

Driving and use of machinery

At the therapeutic dose, LORATADINE MYLAN CONSEIL 10 mg, Tablet does not generally make you drowsy and does not reduce your alertness. However, there have been very rare reports of drowsiness that may affect the ability to drive or operate machinery.

LORATADINE MYLAN CONSEIL 10 mg, tablet contains lactose

If your doctor has told you that you are intolerant to certain sugars, contact him or her before taking this medicine.

3. HOW TO TAKE LORATADINE MYLAN CONSEIL 10 mg, tablet? <

Always take this medicine exactly as directed in this leaflet or as instructed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if you are not sure.

Dosage

Adults and children over 6 years of age and weighing more than 30 kg:

1 tablet per day with a glass of water, with or without food.

Subjects weighing 30 kg or less

LORATADINE MYLAN CONSEIL 10 mg, tablet is not suitable for the treatment of subjects weighing 30 kg or less.

Children under 2 years of age

The use of LORATADINE MYLAN CONSEIL 10 mg, Tablet is not recommended in children under 2 years of age.

Adults and children with severe hepatic impairment:

Adults and children weighing more than 30 kg :

1 tablet every other day with a glass of water, with or without food. Please ask a doctor, pharmacist or nurse for advice before taking this medicine.

If you feel that the effect of LORATADINE MYLAN CONSEIL 10 mg, tablet is too strong or too weak, consult your doctor or pharmacist.

How to take it

Take by mouth.

Swallow the tablet with a glass of water.

This medication can be taken indifferently to meals (during or outside meals).

The break bar is only there to facilitate the taking of the tablet if you have difficulties to swallow it completely.

Increasing the dosage does not increase the effectiveness of this medication.

Duration of treatment

If symptoms worsen or persist after 3 days, consult a doctor.

If you have taken more LORATADINE MYLAN CONSEIL 10 mg, tablet than you should have :

Drowsiness, increased heart rate and headache have been reported with overdoses of LORATADINE MYLAN CONSEIL 10 mg, Tablet.

Consult your doctor or pharmacist immediately.

If you forget to take LORATADINE MYLAN CONSEIL 10 mg, tablet :

If you forget to take your dose on time, take it as soon as possible and then continue your treatment as usual. Do not take a double dose to make up for the tablet you forgot to take.

If you stop taking LORATADINE MYLAN CONSEIL 10 mg, tablet:

Not applicable.

If you have any further questions about using this medicine, ask your doctor, pharmacist or nurse.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS? <

Like all medications, this medication can cause side effects, but they do not occur consistently in everyone.

The most commonly reported side effects with loratadine in children 2 to 12 years of age are headache, nervousness, and fatigue.

The most frequently reported adverse reactions in adults and adolescents are drowsiness, headache, increased appetite and difficulty sleeping.

Since the marketing of LORATADINE MYLAN CONSEIL 10 mg, Tablet, there have been very rare reports of severe allergic reactions (including angioedema and anaphylaxis), dizziness, convulsion, rapid or irregular heartbeat, nausea, dry mouth, stomach upset, liver disorder, hair loss, skin rash or redness.

Undetermined frequency: the frequency of occurrence cannot be estimated on the basis of available data: weight gain (in children).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effect not mentioned in this leaflet. You can also report adverse reactions directly through the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres

By reporting adverse reactions, you contribute to providing more information on the safety of the drug.

5. HOW DO YOU USE LORATADINE MYLAN CONSEIL 10 mg, tablet? <

Keep this medicine out of the sight and reach of children.

Do not use this medication after the expiration date indicated on the box, blister strips. The expiration date refers to the last day of that month.

No particular precautions of conservation.

Do not dispose of any medication down the drain or with your regular garbage. Ask your pharmacist to dispose of medications you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION <

What LORATADINE MYLAN CONSEIL 10 mg, tablet contains <

- The active substance is:

Loratadine........................................................................................................................ 10 mg

For one tablet.

- The other components are:

Corn starch, magnesium stearate, microcrystalline cellulose, lactose monohydrate.

What is LORATADINE MYLAN CONSEIL 10 mg, tablet and what does it contain? <

This medicine is in tablet form. Box of 7 tablets.

All presentations may not be marketed.

Marketing Authorization Holder <

MYLAN S.A.S.

117 ALLEE DES PARCS

69800 SAINT-PRIEST

Operator of the marketing authorization <

MYLAN S.A.S.

117 ALLEE DES PARCS

69800 SAINT-PRIEST

Manufacturer <

ACTAVIS HF.

REYKJAVIKURVEGUR 78

220 HAFNARFJORDUR

ICELAND

or

ACTAVIS LTD

BLB 016 BULEBEL INDUSTRIAL ESTATE

ZEJTUN ZTN 3000

MALTA

Names of the drug in the member states of the European Economic Area <

Not applicable.

The last date on which this leaflet was revised is: <

[to be completed later by the holder]

Other <

Detailed information about this drug is available on the ANSM (France) website.

Health Education Tip:

a) What is allergy, what is an allergic reaction?

Allergy is an excessive reaction of our body to substances that it considers harmful, the allergens. Allergens are the factors and substances that trigger the allergy and the associated disorders.

During repeated and intensive contact of our body with the allergen, an allergic reaction is triggered.

The allergic reaction refers to the set of symptoms that appear 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 of substances such as histamine in the body, which is responsible for the problems experienced.

As with any disease of an allergic nature, it is important to consult a doctor at least once.

THE DOCTOR WILL DETERMINE IF AN ALLERGOLOGICAL TEST IS NECESSARY.

b) How to recognize allergic rhinitis?

Allergic rhinitis is characterized by the following symptoms: successive sneezing, colorless nasal discharge, nasal obstruction (blocked nose), itching and tingling of the nose. It may be accompanied by irritation of both eyes (watery eyes, redness), throat and nose.

We distinguish :

Seasonal allergic rhinitis or hay fever: common, it occurs every year in the same season, when the concentration of pollens in the air increases, and usually appears for the first time during adolescence. However, you may not be allergic to all pollens, but to one or more of them.

Perennial allergic rhinitis occurs throughout the year and is most often dependent on household allergens such as dust mites, molds and pets.

c) Some practical advice

Eliminating the allergen (eviction) is the measure of choice to eliminate or reduce the symptoms of the allergy.

For house allergens: it is essential to take measures to reduce the presence of the allergen:

- The mattress will need to be completely surrounded by a plastic anti-dust mite cover as well as the pillows. The bed base, unless it is made of slats or metal, should be surrounded by a plastic cover. All bedding should be washed twice a month at 60°C if possible.

- The room should be ventilated and cleaned regularly.

- On the floor, avoid bed slopes and carpets.

- Avoid pets.

During the pollen season, it is possible to reduce exposure to pollens:

- In your garden, diversify your plantings by avoiding the most allergenic species (cypress, cedar, birch...).

- Avoid mowing the lawn yourself during the pollen season.

- Garden preferably with protective glasses and mask.