Loratadine Combix 10 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Loratadine Combix 10 mg tablets EFG
Read the entire 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, pharmacist or nurse.
- 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, since it could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Loratadine Combix is and what it is used for
- What you need to know before taking Loratadine Combix
- How to take Loratadine Combix
- Possible adverse effects
- How to store Loratadine Combix
- Contents of the pack and other information
1. What Loratadina Combix is and what it is used for
Loratadina Combix belongs to a class of medicines known as antihistamines.
Loratadina Combix relieves symptoms associated with allergic rhinitis (such as sneezing, runny or itchy nose, and burning or itchy eyes).
Loratadina Combix may also be used to help relieve symptoms of urticaria (such as itching, redness, and the number and size of skin rashes).
2. What you need to know before taking Loratadine
Do not take Loratadine Combix
- If you are allergic (hypersensitive) to the active substance loratadine or to any of the other components of this medicine.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take Loratadine Combix:
- if you have severe liver disease (see section 3. How to take Loratadine Combix).
- if you are due to undergo any type of skin allergy testing. Do not take Loratadine Combix during the 2 days prior to such tests, as this medicine may alter the test results.
Interaction of Loratadine Combix with other medicines
Inform your doctor or pharmacist if you are taking, or have recently taken any other medicines, including those obtained without a prescription.
No interactions between Loratadine Combix and other medicines are known. Nevertheless, inform your doctor or pharmacist if you are using or have recently used other medicines.
Loratadine Combix with food, drink and alcohol
Loratadine Combix may be taken with or without food.
Pregnancy, breastfeeding and fertility
Consult your doctor or pharmacist before taking any medicine.
Loratadine Combix is not recommended if you are pregnant or breastfeeding.
Driving and using machines
At normal doses, Loratadine Combix does not affect the ability to drive or operate machinery. If you experience symptoms of drowsiness, do not drive or use machinery. However, avoid performing tasks that may require special attention until you know how you tolerate the medicine.
Important information about some of the components of Loratadine Combix
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Loratadina Combix
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 determine the duration of treatment with Loratadina Combix. Do not stop treatment prematurely.
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) once daily, on alternate days.
Loratadina Combix is not suitable for:
- administration of doses lower than 10 mg.
- administration in patients weighing 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, contact the Toxicology 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, then return to your usual dosing schedule. Do not take a double dose to make up for missed doses.
If you stop treatment with Loratadina Combix
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, Loratadina Combix may cause adverse effects, although not everyone experiences 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 rarely reported adverse effects (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 pain or acidity, liver problems, hair loss, skin rash, and tiredness.
An adverse effect with frequency "not known" is 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 directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Loratadine Combix
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Loratadina Combix
The active substance is Loratadine. Each Loratadina Combix tablet contains 10 mg of loratadine.
The other components are monohydrate lactose, corn starch, and magnesium stearate.
Appearance of the product and contents of the pack
Loratadina Combix tablets are white, round, flat tablets, with a score on one side and smooth on the other.
The tablet can be divided into equal halves.
Loratadina Combix is available in packs containing 2, 5, 7, 10, 14, 15, 20, 21, 28, 30, 50 or 100 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Combix, S.L.U.
C/ Badajoz 2. Edificio 2
28223 Pozuelo de Alarcón (Madrid)
Manufacturer
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
The most recent revision of this leaflet was in January 2018
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/