Loratadine Stada 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

LORATADINE STADA 10 mg film-coated tablets EFG

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

• Keep this leaflet. 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 and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Loratadine STADA belongs to a class of medicines known as antihistamines.

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

Loratadine STADA may 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 starting to take Loratadine STADA

Do not take Loratadine STADA:

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

Warnings and precautions

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

• If you have severe liver disease (see section 3, "How to take Loratadine STADA").
• If you are due to undergo any type of skin allergy testing. Do not take Loratadine STADA during the 2 days prior to such tests, as this medicine may interfere with the test results.

Taking Loratadine STADA with other medicines

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

No interactions between Loratadine STADA and other medicines are known.

Taking Loratadine STADA with food and drinks

Loratadine STADA may be taken with or without food.

Pregnancy and lactation

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

Loratadina STADA is not recommended if you are pregnant or breastfeeding.

Driving and operating machinery

At normal doses, Loratadina STADA does not affect your ability to drive or operate machinery.

If you experience symptoms of drowsiness, do not drive or operate machinery. However, avoid performing tasks that may require special attention until you know how you tolerate the medicine.

Loratadina STADA contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Loratadine STADA

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

Remember to take your medicine.

Your doctor will advise you on how long to continue treatment with Loratadine STADA. Do not stop treatment earlier.

Adults and children over 2 years of age weighing more than 30 kg:

Take one tablet (10 mg) once daily.

Patients with severe liver problems weighing more than 30 kg:

Take one tablet (10 mg) every other day.

Loratadine STADA 10 mg tablets are not suitable for:

• administering doses lower than 10 mg;
• administration in patients weighing less than 30 kg;
• patients who have difficulty swallowing.

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

If you take more Loratadine STADA than you should

If you have taken more Loratadine STADA than you should, contact your doctor or pharmacist immediately.

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

If you forget to take Loratadine STADA

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

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

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

4. Possible adverse effects

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

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

The adverse effects reported very rarely (less than 1 in 10,000 patients) have included cases of severe allergic reaction, dizziness, irregular or rapid heartbeat, nausea (feeling sick), dry mouth, stomach discomfort, liver problems, hair loss, skin rash, fatigue, and seizures.

Frequency not known (frequency cannot be estimated from available data):

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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Loratadine STADA

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Loratadine STADA after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

Do not use Loratadine STADA if you notice any changes in the appearance of the tablet.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Loratadine STADA

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

Appearance of the product and contents of the pack

Loratadine STADA is presented as white, round, biconvex, film-coated tablets, with a score on one side and the imprint “LR 10” on the other. Each pack contains 20 tablets in a blister.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L
Frederic Mompou, 5
08960 San Just Desvern (Barcelona)
[email protected]

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 San Joan Despí

Date of the most recent review of this leaflet: December 2017

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/