Package Insert: Information for the Patient

Loratadine Combix 10 mg Tablets EFG

Read this entire package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

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

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

Loratadina Combix 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 Combix

- If you are allergic (hypersensitive) to the active ingredient loratadine or to any of the other components of this medication.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Loratadina Combix:

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

Loratadina Combix interaction with other medications

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medication, including those acquired without a prescription.

No interactions of Loratadina Combix with other medications are known. However, inform your doctor or pharmacist if you are using or have recently used other medications.

Loratadina Combix with food, drink, and alcohol

Loratadina Combix may be taken with or without food.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before taking a medication.

It is not recommended that you take Loratadina Combix if you are pregnant or breastfeeding.

Driving and operating machinery

At normal doses, Loratadina Combix does not affect the ability to drive or operate machinery. If you experience drowsiness symptoms, do not drive or operate machinery, however, try not to perform tasks that may require special attention until you know how you tolerate the medication.

Important information about some of the components of Loratadina Combix

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow the administration instructions for Loratadina Combix as indicated by your doctor.

Remember to take your medication. Consult your doctor or pharmacist if you have any doubts.

Your doctor will inform you of the duration of treatment with Loratadina Combix. 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 Combix is 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.

Use in children and adolescents

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

If you take more Loratadina Combix than you should

If you take more Loratadina Combix than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service; Telephone 91562 04 20 indicating the medication and the amount ingested.

If you forget to take Loratadina Combix

If you forget 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 interrupt treatment with Loratadina Combix

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

Like all medications, Loratadina Combix 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.

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

A «not known» frequency adverse effect is 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 not listed in this prospectus. You can also report them directly 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 this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

Composition of Loratadina Combix

The active ingredient is Loratadine. Each Loratadina Combix tablet contains 10 mg of loratadine.

The other components are lactose monohydrate, cornstarch and magnesium stearate.

Appearance of the product and content of the packaging

Loratadina Combix tablets are white, round, flat tablets with a notch on one face and smooth on the other.

The tablet can be divided into two equal halves.

Loratadina Combix is available in packaging containing 2, 5, 7, 10, 14, 15, 20, 21, 28, 30, 50 or 100 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Responsible for manufacturing

Zydus France

25, parc d’activités des Peupliers, Bâtiment L

92000 Nanterre

France

or

Centre Specialites Pharmaceutiques

ZAC du Suzot

35 rue de la Chapelle

63450 St Amant Tallende

France

Last review of this leaflet was in January 2018

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/