CLARITYNE 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Clarityne 10 mg Tablets

Loratadine

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 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 it worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What is Clarityne 10 mg Tablets and what is it used for
2. What you need to know before taking Clarityne 10 mg Tablets
3. How to take Clarityne 10 mg Tablets
4. Possible side effects

5 Conservation of Clarityne 10 mg Tablets

1. Contents of the pack and further information

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

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

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

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

Do not take Clarityne if:

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Clarityne if:

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

If any of the above conditions affect you (or you are not sure), consult your doctor, pharmacist, or nurse before taking Clarityne.

Children and adolescents

Do not give Clarityne tablets to children under 6 years or children who weigh less than 30 kg. There are other formulations more suitable for children under 6 years or weighing 30 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 medicines

The side effects of Clarityne may increase when used with medicines 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 the side effects of loratadine was observed with medicines that altered the performance of these enzymes.

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine, including medicines not requiring a prescription.

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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Driving and using machines

In clinical trials that evaluated driving ability, no reduced function was observed in patients who received loratadine. At the recommended dose, it is not expected that Clarityne will cause drowsiness or reduced alertness. However, in very rare cases, some people may experience drowsiness, which may affect their ability to drive or use machines.

Clarityne contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Clarityne 10 mg Tablets

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

The score line on the tablet is only to facilitate breaking the tablet if you find it difficult to swallow it whole.

The recommended dose is:

Adults and children over 6 years 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 formulations more suitable for children under 6 years or weighing 30 kg or less.

Children under 2 years:

Clarityne is not recommended for children under 2 years.

Adults and children with severe liver problems:

Adults and children who weigh more than 30 kg:

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

However, you should consult your doctor, pharmacist, or nurse before taking this medicine.

If it worsens or the symptoms persist after 7 days of treatment, you should consult a doctor.

If you take more Clarityne than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone (91) 562 04 20, indicating the medicine 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 make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• drowsiness
• headache
• increased appetite
• difficulty sleeping.

The most frequently reported side effects in children from 6 to 12 years are:

• headache
• nervousness
• fatigue.

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

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

The frequency of the following side effect is not known:

• weight gain

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Clarityne 10 mg Tablets

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

• This medicine does not require special storage conditions.
• Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.
• Do not use this medicine if you notice any change in the appearance of the tablet.
• Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Clarityne

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

Appearance of the product and contents of the pack

Tablet.

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Bayer Bitterfeld GmbH

OT Greppin

Salegaster Chaussee 1

06803 Bitterfeld-Wolfen

Germany

This medicine is authorised in the Member States of the European Economic Area under 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)

Date of the last revision of this leaflet: December 2017

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/