Loratadine Sandoz 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Loratadine Sandoz 10 mg tablets EFG

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

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse.

• 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 may harm them.

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

Contents of the leaflet

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

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

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

Loratadine 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.

Loratadine relieves symptoms associated with allergic rhinitis (e.g. hay fever), such as sneezing, runny or itchy nose, and burning or itchy eyes in adults and children over 6 years of age who weigh more than 30 kg.

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

2. What you need to know before taking Loratadina Sandoz

Do not take Loratadina Sandoz:

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking loratadine if:

• you have liver disease (see section 3 “How to take Loratadina Sandoz”).
• you are scheduled to undergo any type of skin allergy testing. Do not take loratadine within the 2 days prior to such tests, as this medicine may interfere with 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 administer loratadine to children under 6 years of age, or to children aged 6 to 12 years who weigh less than 30 kg. Other formulations more suitable for children aged 6 to 12 years weighing less than 30 kg are available.

Taking Loratadina Sandoz with other medicines

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

The side effects of loratadine 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 loratadine side effects was observed with medicines affecting these enzymes. Nevertheless, it is important to inform your pharmacist about any other medicines you are taking while on loratadine.

Taking Loratadina Sandoz with food, drinks, and alcohol

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

Pregnancy:

As a precautionary measure, loratadine is not recommended during pregnancy.

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 reduced alertness. However, very rarely, some individuals may experience drowsiness, which could affect their ability to drive or operate machinery.

Loratadina Sandoz contains lactose

This medicine 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 Sandoz

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults and children over 12 years of age:

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

Children 6 to 12 years of age, dosed by body weight:

Body weight greater 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 loratadine 10 mg. Other formulations more suitable for children aged 6 to 12 years who weigh 30 kg or less are available.

Loratadine is not recommended for children under 6 years of age.

Patients with severe liver problems weighing more than 30 kg:

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

Method of administration:

The tablets can be taken regardless of meals.

If you take more Loratadine Sandoz than you should

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Loratadine Sandoz

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

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• drowsiness
• headache
• increased appetite
• difficulty sleeping

The adverse effects most frequently reported 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.

Frequency not known:

• weight gain

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 Loratadine Sandoz 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 packaging and blister after EXP.

The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Instead, dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and additional information

Composition of Loratadine Sandoz

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

Appearance of the product and contents of the pack

Loratadine Sandoz is presented as tablets, scored on one side, round, white or almost white.

Loratadine Sandoz is available in packs of 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 most recent revision of this 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/