Loratadine Tarbis 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Loratadine Tarbis 10 mg tablets EFG

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Leaflet contents

1. What Loratadine Tarbis is and what it is used for
2. What you need to know before taking Loratadine Tarbis
3. How to take Loratadine Tarbis
4. Possible adverse effects
5. How to store Loratadine Tarbis
6. Contents of the pack and other information

1. What Loratadina Tarbis is and what it is used for

Loratadina Tarbis belongs to a class of medicines called antihistamines, used for the treatment of various allergic conditions.

Loratadina Tarbis is indicated for the relief of symptoms associated with seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis (allergy symptoms throughout the year).

These symptoms may include sneezing, runny nose, nasal itching, as well as eye burning, itching, and tearing.

Loratadina Tarbis is also indicated for the relief of symptoms of chronic idiopathic urticaria (skin rash characterized by hives and wheals).

2. What you need to know before taking Loratadine Tarbis

Do not take Loratadine Tarbis 10 mg tablets:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Loratadine Tarbis:

• if you have severe liver disease

Interference with diagnostic tests

If you are due to undergo any type of skin allergy testing, do not take Loratadine Tarbis during the 2 days prior to the test, and inform your doctor, as this medicine may alter the test results.

Use of Loratadine Tarbis with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

When taken simultaneously, some medicines may increase the blood levels of loratadine and may cause adverse effects.

Interactions may occur with all inhibitors of CYP3A4 or CYP2D6, such as the following:

• Ketoconazole (used to treat fungal infections)
• Erythromycin (an antibiotic)
• Cimetidine (used to treat stomach acidity)

Taking Loratadine Tarbis with food, drinks and alcohol

Loratadine Tarbis can be taken with or without food. Avoid consuming 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.

Loratadine Tarbis is not recommended if you are pregnant or breastfeeding, as loratadine passes into breast milk.

Driving and using machines

Very rarely, this medicine may cause drowsiness or may reduce reaction time in some individuals. Therefore, it is recommended not to perform tasks requiring special attention (such as driving vehicles or operating machinery) until you know how this medicine affects you.

Loratadine Tarbis contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Loratadine Tarbis

Follow exactly the dosage instructions given by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose

Adults/Children over 12 years: 10 mg once daily (one tablet once daily).

Children between 2 and 12 years of age and weighing more than 30 kg: 10 mg once daily (one tablet once daily).

Children over 2 years of age but weighing 30 kg or less must not take this medicine.

These tablets must not be given to children under 2 years of age.

Patients with severe liver problems:

Patients with severe liver problems

Your doctor may prescribe you a different dose if you have severe liver problems.

If you take more Loratadine Tarbis 10 mg tablets than you should

If you take more Loratadine Tarbis than you should, you may experience drowsiness, rapid heartbeat, and headache.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91562 04 20, indicating the medicine and the amount ingested.

If you forget to take Loratadine Tarbis

If you forget to take your dose on time, take it as soon as possible, then return to your usual dosing schedule. Do not take a double dose to make up for missed doses.

If you stop taking Loratadine Tarbis

Your doctor will advise you on how long to take the treatment. Do not stop the treatment if you start feeling better, as symptoms may return.

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

4. Possible adverse effects

Like all medicines, Loratadine Tarbis may cause adverse effects, although not everyone will experience them.

If you develop an allergic reaction to this medicine, you must stop treatment with Loratadine Tarbis immediately and consult your doctor.

This allergic reaction may include:

• skin rash (including inside the mouth)
• itching
• swelling of the face/tongue/lips/hands/feet
• difficulty breathing

Rarely, some patients may experience nausea (feeling sick), fatigue, headache, drowsiness, nervousness, dry mouth, and hair loss. These adverse reactions are generally mild and resolve spontaneously.

Other adverse reactions reported with loratadine include dizziness, increased heart rate, palpitations (awareness of increased heart rate), irritation of the stomach lining (gastritis), increased appetite, insomnia, skin rashes, and liver disorders.

Adverse effects with unknown frequency (cannot be estimated from the available data) have included cases of weight gain.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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 Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Loratadine Tarbis

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 after EXP.

The expiry date refers to 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 the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Loratadine Tarbis 10 mg tablets

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

Appearance of the product and contents of the pack

The tablets are white, round, flat, and scored.

Each pack contains 20 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tarbis Farma, S.L.

Gran Via Carlos III, 94

08028 - Barcelona

Spain

Manufacturer:

Actavis Ltd.

BLB 015-016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Date of the most recent review of this leaflet: January 2018

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/.