CLARITYNE 10 MG TABLETS

Package leaflet: Information for the user

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 instructions for taking this medicine as described in this leaflet or as given by your doctor, pharmacist, or nurse.

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

Contents of the leaflet

1. What Clarityne 10 mg tablets are and what they are 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. How to store Clarityne 10 mg tablets
6. Contents of the pack and other information

1. What Clarityne 10 mg tablets are and what they are used for

What Clarityne is

Clarityne contains the active substance loratadine, which belongs to a class of medicines called "antihistamines".

How Clarityne works

Clarityne helps reduce your allergy symptoms by blocking the effects of a substance called "histamine", which is produced by 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 burning or itchy eyes.

You should consult a doctor if your condition 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 to 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 due to undergo any type of skin allergy tests. Do not take Clarityne during the 2 days prior to these tests. This is because this medicine may alter the results of such tests.

If any of the above conditions apply to 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 of age or to children weighing less than 30 kg. Other formulations are more suitable for children under 6 years of age 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 together with medicines that affect the function of certain liver enzymes, or if your liver is not functioning properly. In clinical studies, no increase in side effects of loratadine was observed when taken with medicines that affect these enzymes.

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines, including those 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

As a precautionary measure, it is preferable to avoid taking Clarityne during pregnancy.

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

Driving and using machines

In clinical trials assessing driving ability, no impaired function was observed in patients who received loratadine. At the recommended dose, Clarityne is not expected to cause drowsiness or reduced alertness. However, very rarely, some individuals may experience drowsiness, which could affect their ability to drive or operate machinery.

Clarityne contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Clarityne 10 mg tablets

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

The tablet's score line is intended only for dividing the tablet if you have difficulty swallowing it whole.

Recommended dose:

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

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

Body weight of 30 kg or less:

Do not give Clarityne. There are other more appropriate formulations available for children under 6 years of age who weigh 30 kg or less.

Children under 2 years of age:

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

Adults and children with severe liver problems:

Adults and children weighing more than 30 kg:

Take 1 tablet once daily, alternating days, with a glass of water, with or without food.

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

If your symptoms worsen or persist for more than 7 days of treatment, consult a doctor.

If you take more Clarityne than you should

Serious problems are not expected; however, you may experience headache, palpitations, or drowsiness.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone (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 make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• drowsiness
• headache
• increased appetite
• difficulty sleeping.

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

• headache
• nervousness
• fatigue.

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

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

The frequency of the following adverse effect is unknown:

• weight gain

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clarityne 10 mg tablets

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

• This medicine does not require any special storage conditions.

• Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

• Do not use this medicine if you notice any changes in the appearance of the tablet.

• Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Clarityne

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

Appearance of the product and contents of the pack

Tablet.

White to almost white, oval, biconvex tablet, scored on one side and smooth on the other.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medicinal product is authorized in the European Economic Area member states 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 most recent review of this leaflet: December 2017

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/