Clarityne 10 mg comprimidos

Package Leaflet: Information for the User

Clarityne 10 mg Tablets

Loratadine

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days.

1.What is Clarityne 10 mg Tablets and what it is used for

2.What you need to know before starting to take Clarityne 10 mg Tablets

3.How to take Clarityne 10 mg Tablets

4.Possible side effects

5Storage of Clarityne 10 mg Tablets

6.Contents of the pack and additional information

What is Clarityne

Clarityne contains the active ingredient loratadine, which belongs to a class of medicines called “antihistamines”.

How Clarityne works

Clarityne helps to reduce your allergy symptoms by blocking the effects of a substance called “histamine”, which is produced in the body when you are allergic to something.

What Clarityne is used for

Clarityne relieves symptoms of allergic rhinitis (e.g. hay fever) such as sneezing, runny or itchy nose and itchy or watery eyes.

You should consult a doctor if it worsens or does not improve after 7 days.

Do not take Clarityne if:

-you are allergic (hypersensitive) to loratadine or to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Clarityne if:

• you have liver disease
• you are to undergo any type of skin allergy tests. Do not take Clarityne during the 2 days prior to the tests. This is because this medication may alter the test results.

If any of the above conditions affect you (or you are unsure), consult your doctor, pharmacist, or nurse before taking Clarityne.

Children and adolescents

Do not administer Clarityne tablets to children under 6 years old or children weighing less than30 kg. There are other formulations more suitable for children under 6 years old or weighing30 kg or less.

Children under 2 years

The safety and efficacy of Clarityne have not been established. No data are available.

Taking Clarityne with other medications

The side effects of Clarityne may increase when used with medications that alter the performance of certain enzymes found in the liver, or if your liver is not functioning properly. In clinical studies, no increase in loratadine side effects was observed with medications that altered the performance of these enzymes.

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication, including non-prescription medications.

Taking Clarityne with alcohol

It has not been demonstrated that Clarityne increases the effects of alcoholic beverages.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

As a precaution, it is recommended to avoid taking Clarityne if you are pregnant.

Do not take Clarityne if you are breastfeeding. Loratadine is excreted in breast milk.

Driving and operating machinery

In clinical studies evaluating driving ability, no reduced function was observed in patients who received loratadine. At the recommended dose, Clarityne is not expected to produce drowsiness or decreased alertness. However, in very rare cases, some people may experience drowsiness, which may affect their ability to drive or operate machinery.

Clarityne contains lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult your doctor before taking this medication.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

The groove on the tablet is only for breaking the tablet if it is difficult to swallow whole.

The recommended dose is:

Adults and children over 6 years of age with a body weight over 30 kg:

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

Body weight of30 kgor less:

Do not give Clarityne. There are other more suitable presentations for children under 6 years of age weighing30 kgor less.

Children under 2 years:

Clarityne is not recommended for children under 2 years of age.

Adults and children with severe liver problems:

Adults and children weighing over 30 kg:

Take 1 tablet once a day and on alternate days with a glass of water, with or without food.

However, you must consult your doctor, pharmacist, or nurse before taking this medication.

If symptoms worsen, or symptoms persist after 7 days of treatment, you must consult a doctor.

If you take more Clarityne than you should

No serious problems are expected, however, you may experience headaches, palpitations, or feel drowsy.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone (91) 562 04 20 indicating the medication and the amount ingested.

If you forget to take Clarityne

• If you forget to take your dose, take it as soon as you remember, then continue taking it as usual.
• Do not take a double dose to compensate for missed doses.

If you have any other questions about the use of this medication, consult your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The most frequently reported adverse effects in adults and adolescents over 12 years old are:

• drowsiness
• headache
• increased appetite
• difficulty sleeping.

The most frequently reported adverse effects in children aged 6 to 12 years are:

• headache
• anxiety
• fatigue.

During the marketing of loratadine, the following adverse effects have also been reported, which are very rare (may affect up to 1 in 10,000 patients):(may affect up to 1 in 10,000 patients):

• severe allergic reaction (including swelling)
• dizziness
• seizure
• irregular or rapid heartbeats
• nausea (urge to vomit)
• dry mouth
• stomach discomfort
• liver problems
• hair loss
• skin rash
• fatigue.

The frequency of the following adverse effect is unknown:

• weight gain

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

• Keep this medication out of the sight and reach of children.

• This medication does not require special conditions for conservation.
• Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.
• Do not use this medication if you observe any change in the appearance of the tablet.
• Medicines should not be thrown into the drains or trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Clarityne

• The active ingredient is loratadine. Each tablet contains 10 mg of loratadine.
• The other components (excipients) are: lactose monohydrate, cornstarch, and magnesium stearate.

Appearance of the product and contents of the packaging

Tablet.

White to off-white, oval scored tablet on one face and smooth on the other face.

Clarityne is available in packaging of 7, 10, 14, 20, 30, or 60 tablets.

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible manufacturer

Bayer Bitterfeld GmbH

OT Greppin

Salegaster Chaussee 1

06803 Bitterfeld-Wolfen

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria, Denmark, Finland, Iceland, Ireland, Norway, Sweden: Clarityn

Belgium, Netherlands, Luxembourg: Claritine

Italy: Clarityn

France, Greece, Spain: Clarityne

Germany: Lisino S

Portugal: Claritine, Alertrin

United Kingdom: Clarityn (Allergy)

Last review date of this leaflet: December 2017

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/