Package Leaflet: Information for the user

LORATADINE STADA 10 mg film-coated 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, 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Loratadina STADA belongs to a class of medications known as antihistamines.

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

Loratadina STADA may 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 STADA:

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

Warnings and precautions

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

• If you have severe liver disease (see section 3, “How to take Loratadina STADA”).
• If you are to undergo any type of skin test for allergy. Do not take Loratadina STADA during the 2 days prior to the performance of these tests, as this medication may alter the results of the same.

Use ofLoratadina STADA withother medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

No interactions of Loratadina STADA with other medications are known.

Taking Loratadina STADA with food and drinks

Loratadina STADA can be taken with or without food.

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.

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with Loratadina STADA. Do not discontinue treatment prematurely.

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 STADA 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.

Loratadina STADA is not recommended for children under 2 years of age.

If you take more Loratadina STADA than you should

If you have taken more Loratadina STADA than you should, consult your doctor or pharmacist immediately.

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

If you forgot to take Loratadina STADA

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 missed doses.

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

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 every 10 patients but more than 1 in every 100 patients) include drowsiness, headache, nervousness, fatigue, increased appetite, and difficulty sleeping.

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

Unknown frequency (frequency cannot be estimated from available data):

Weight gain

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://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.

No special storage conditions are required.

Do not use Loratadina STADA after the expiration date appearing on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not use Loratadina STADA 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 of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Loratadina STADA

• The active ingredient is loratadine. Each film-coated tablet contains 10 mg of loratadine.
• The other components are: lactose monohydrate, microcrystalline cellulose, cornstarch, pregelatinized cornstarch, hydrated colloidal silica, magnesium stearate, hypromellose, macrogol 400, macrogol 6000, carnauba wax, and talc.

Appearance of the product and contents of the packaging

Loratadina STADA is presented in the form of film-coated tablets, white, round, biconvex, with a notch on one face and the inscription “LR 10” on the other. Each package contains 20 tablets in a blister.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization:

STADA Laboratory, S.L

Frederic Mompou, 5

08960 San Just Desvern (Barcelona)

[email protected]

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 San Joan Despí

Date of the last review of this leaflet:December 2017

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