LORATADINE SANDOZ 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Loratadine Sandoz 10 mg Tablets EFG

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

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package 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 give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Loratadine Sandoz and what is it used for
2. What you need to know before taking Loratadine Sandoz
3. How to take Loratadine Sandoz
4. Possible side effects

5 Storage of Loratadine Sandoz

1. Contents of the pack and further information

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

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

Loratadine 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.

Loratadine relieves the symptoms associated with allergic rhinitis (e.g., hay fever) such as sneezing, runny or itchy nose, and itchy or red eyes in adults and children over 6 years old, weighing more than 30 kg.

Loratadine Sandoz can also be used to help relieve the symptoms of urticaria (such as itching, redness, and the number and size of skin wheals).

2. What you need to know before taking Loratadine Sandoz

Do not take Loratadine Sandoz:

• 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 starting to take loratadine if:

• you have liver disease (see section 3 "How to take Loratadine Sandoz").
• you are going to undergo any type of skin tests for allergies. Do not take loratadine during the 2 days prior to the test, as this medicine may alter the test results.

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

Children and adolescents

Do not give loratadine to children under 6 years old or children from 6 to 12 years old who weigh less than 30 kg. There are other formulations more suitable for children from 6 to 12 years old who weigh less than 30 kg.

Taking Loratadine Sandoz with other medicines

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those not prescribed by a doctor.

The side effects of loratadine 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 loratadine side effects was observed with medicines that altered the performance of these enzymes. However, it is essential that you inform your pharmacist about any other medicine you are taking while taking loratadine.

Taking Loratadine Sandoz with food, drinks, and alcohol

Loratadine Sandoz can be taken with or without food.

It has not been shown that loratadine increases the effects of alcoholic beverages.

Pregnancy and breastfeeding

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

Pregnancy:

As a precaution, it is not recommended to take loratadine if you are pregnant.

Breastfeeding:

Do not take loratadine if you are breastfeeding, as loratadine is excreted in breast milk.

Driving and using machines

At the recommended dose, loratadine is not expected to cause drowsiness or decreased alertness. However, in very rare cases, some people may experience drowsiness, which may affect their ability to drive or use machines.

Loratadine Sandoz contains lactose

This medicine 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 Sandoz

Follow the administration instructions of this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children over 12 years old:

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

Children from 6 to 12 years old will be dosed by weight:

Body weight over 30 kg:

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

Body weight of 30 kg or less:

Do not give loratadine 10 mg. There are other presentations more suitable for children from 6 to 12 years old who weigh 30 kg or less.

Loratadine is not recommended for children under 6 years old.

Patient with severe hepatic impairment with a weight over 30 kg:

Take 1 tablet (10 mg) once a day and on alternate days with a glass of water, with or without food.

Method of administration:

The tablets can be taken independently of meals.

If you take more Loratadine Sandoz 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, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Loratadine Sandoz

Do not take a double dose to make up for forgotten doses.

If you forget to take your dose, take it as soon as possible, or then return to your usual dosing schedule.

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

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 old are:

• drowsiness
• headache
• increased appetite
• difficulty sleeping

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

• headache
• nervousness
• fatigue.

During the marketing of loratadine, the following side effects have also been reported as very rare(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.

Frequency not known:

• weight gain

Reporting of side effects

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

5. Storage of Loratadine Sandoz 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 stated on the packaging and blister after CAD.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of 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 further information

Composition of Loratadine Sandoz

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

Appearance of the product and contents of the pack

Loratadine Sandoz is presented in the form of scored tablets, round, white or almost white

Loratadine Sandoz is available in packs of 20 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Laboratorios Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Toll Manufacturing services, S.L.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of the last revision of this package leaflet: June 2018

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