Leaflet: information for the user

Loratadine Almus 10 mg tablets EFG

Read this 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 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 is Loratadine Almus and what it is used for

2.What you need to know before starting to take Loratadine Almus

3.How to take Loratadine Almus

4.Possible side effects

5Storage of Loratadine Almus

6.Contents of the pack and additional information

Loratadina belongs to a class of medications known as antihistamines.

Loratadina relieves symptoms associated with allergic rhinitis (such as sneezing, runny or itchy nose and eye burning or itching).

Loratadina 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 Almus:

• If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Loratadina Almus.

• If you have severe liver disease (see section 3).
• If you are to undergo any type of skin test for allergy. Do not take loratadine for 2 days before the test, as this medication may alter the test results.

Taking Loratadina Almus with other medications:

No interactions of loratadine with other medications are known.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Taking Loratadina Almus with food and drinks:

Loratadine can be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

It is preferable to avoid using this medication if you are pregnant.

Do not take this medication if you are breastfeeding. Loratadine is excreted in breast milk.

Driving and operating machinery:

At normal doses, loratadine does not affect the ability to drive or operate machinery. If you experience drowsiness, do not drive or operate machinery. However, avoid tasks that require special attention until you know how you tolerate the medication.

Loratadina Almus 10 mg tablets contain lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with this medication. Do not discontinue treatment before.

Adults and children over 2 years of age with a weight of more than 30 kg:

Take one tablet (10 mg) once a day.

Patients with severe liver problems with a weight of more than 30 kg:

Take one tablet (10 mg) once a day and on alternate days.

Loratadina Almus 10 mg tablets are not suitable for:

• administration of doses less than 10 mg.
• administration in patients with a weight of less than 30 kg.
• patients who have difficulty swallowing.

This medication is not recommended for children under 2 years of age.

If you take more Loratadina Almus than you should:

If you take more loratadine than you should, consult your doctor or pharmacist immediately or go to the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91562 04 20, indicating the medication and the amount ingested.

If you forgot to take Loratadina Almus:

If you forgot 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 compensate for the missed doses.

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

The most frequently reported adverse effects (less than 1 in 10 patients but more than 1 in 100 patients) include drowsiness, headache, nervousness, fatigue, increased appetite, and difficulty sleeping.

The very rare adverse effects (less than 1 in 10,000 patients) reported have been cases of severe allergic reaction, dizziness, seizures, irregular or rapid heartbeats, nausea (urge to vomit), dry mouth, stomach upset, liver problems, hair loss, skin rash, and fatigue.

The adverse effects of unknown frequency (cannot be estimated from available data) have been cases of weight gain.

Reporting Adverse Effects

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

Keep out of the sight and reach of children.

Store in the original packaging.

Do not use this medication after the expiration date indicated on the carton and on the blister pack. The expiration date is the last day of the month indicated.

Do not use this medication if you observe any change in the appearance of the tablet.

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 Almus

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 Almus 10 mg tablets are presented in the form of white, round, scored tablets on one side. Each package contains 20 tablets in blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email:[email protected]

Responsible for manufacturing:

Teva Pharma, S.L.U.

Polígono Malpica C/ C, 4

50016 Zaragoza.

Last review date of this leaflet: November 2017

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