Package Leaflet: Information for the User

Loratadine Sandoz 10 mg Tablets EFG

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

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

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

2.What you need to know before you start taking Loratadine Sandoz

3.How to take Loratadine Sandoz

4.Possible side effects

5Storage of Loratadine Sandoz

6.Contents of the pack and additional information

Loratadina Sandoz contains the active ingredient loratadine, which belongs to a class of medications called “antihistamines”.

Loratadina 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.

Loratadina relieves symptoms associated with allergic rhinitis (such as hay fever) such as sneezing, runny or itchy nose and eye itching in adults and children over 6 years old, weighing 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 hives).

Do not take Loratadina Sandoz:

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take loratadine if:

- You have a liver disease (see section 3 “how to take loratadina Sandoz”).

- You are to undergo any type of skin tests for allergy. Do not take loratadine during the 2 days prior to the performance of these tests, as this medication may alter the results of the same.

If any of the above conditions affect 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 or children aged 6 to 12 years weighing less than 30 kg. There are other formulations more suitable for children aged 6 to 12 years weighing less than 30 kg.

Taking Loratadina Sandoz with other medications

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may have to take any other medication, including non-prescription medications.

The side effects of loratadine may increase when used with medications 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 medications that altered the performance of these enzymes. However, it is essential to inform your pharmacist about any other medication you are taking while taking loratadine.

Taking Loratadina Sandoz with food, drinks, and alcohol

Loratadina Sandoz can be taken with and without food.

No increase in the effects of alcoholic beverages has been demonstrated with loratadine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

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

Breastfeeding:

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

Driving and operating machinery

At the recommended dose, loratadine is not expected to produce drowsiness or decreased alertness. However, in very rare cases, some people may experience drowsiness, which may affect your ability to drive or operate machinery.

Loratadina Sandoz contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of 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 aged 6 to 12 years 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 more suitable presentations for children aged 6 to 12 years who weigh 30 kg or less.

Do not recommend loratadine in children under 6 years old.

Patients with severe liver problems with a body 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.

Administration form:

The tablets can be taken regardless of meals.

If you take more Loratadina Sandoz than you should

No serious problems are expected, however, you may experience headaches, palpitations, or feel drowsy.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Loratadina Sandoz

Do not take a double dose to compensate for the missed doses.

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

• drowsiness
• headache
• increased appetite
• difficulty sleeping

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

• headache
• anxiety
• fatigue

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

• severe allergic reaction (including swelling)

• dizziness
• seizure
• irregular or rapid heartbeats
• nausea (urge to vomit)
• dry mouth
• stomach discomfort
• liver problems
• hair loss
• skin rash
• fatigue

Unknown frequency:

• weight gain

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging and the blister pack after CAD.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Loratadina Sandoz

- The active ingredient is loratadine. Each tablet contains 10 mg of loratadine.

- The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch and magnesium stearate.

Appearance of the product and contents of the packaging

Loratadina Sandoz is presented in the form of scored tablets on one of its faces, round, white or off-white.

Loratadina Sandoz is available in a pack of 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Laboratorios Farmalider, S.A.

C/ Aragoneses, 2

28108Alcobendas(Madrid)

Spain

Toll Manufacturing services, S.L.

C/ Aragoneses, 2

28108Alcobendas(Madrid)

Spain

Last review date of this leaflet: June 2018

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/