LORATADINE TARBIS 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Loratadine Tarbis 10 mg Tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet

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

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

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

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

These symptoms may include sneezing, runny nose, nasal itching as well as itching, redness, and tearing of the eyes.

Loratadine Tarbis is also indicated for the relief of symptoms of chronic idiopathic urticaria (skin rash consisting of hives and papules).

2. What you need to know before you take Loratadine Tarbis

Do not take Loratadine Tarbis 10 mg tablets:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Loratadine Tarbis:

• If you have severe liver disease.

Interference with analytical tests

If you are going to have any type of skin test for allergies, do not take Loratadine Tarbis for 2 days before the test, and inform your doctor because this medicine may alter the results of the test.

Use of Loratadine Tarbis with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

When taken simultaneously, some medicines may increase the level of loratadine in the blood and may produce side effects.

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

• 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is not recommended to take Loratadine Tarbis 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 people. Therefore, it is recommended not to perform tasks that require special attention (such as driving cars or using machines) until you know how this medicine affects you.

Loratadine Tarbis contains lactose

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

3. How to take Loratadine Tarbis

Follow exactly the administration instructions of the medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Usual dose

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

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

Children over 2 years but weighing no more than 30 kg must nottake this medicine.

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

Patient with severe liver problems:

Patient with severe liver problems

Your doctor may prescribe 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 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, and then return to your usual dosing schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Loratadine Tarbis

Your doctor will indicate the duration of the treatment. Do not interrupt the treatment if you feel better, as the symptoms may reappear.

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

4. Possible side effects

Like all medicines, Loratadine Tarbis can cause side effects, although not everybody gets 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 consist of:

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

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

Other adverse reactions described when taking Loratadine were dizziness, increased heart rate, palpitations (feeling of increased heart rate), stomach irritation (gastritis), increased appetite, insomnia, skin rashes, and liver disorders.

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

If you experience side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet.

Reporting of side effects

If you experience any type of side effect, talk to your doctor or pharmacist or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: http://www.aemps.gob.es/. By reporting side 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 special storage conditions.

Do not use this medicine after the expiry date stated on the carton after EXP.

The expiry date is the last day of the month indicated.

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. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Loratadine Tarbis 10 mg tablets

• The active ingredient is loratadine. Each tablet contains 10 mg of loratadine.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, cornstarch, and magnesium stearate.

Appearance of the product and pack contents

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

Each pack contains 20 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last revision of this leaflet:January 2018

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/.