Loratadine CINFA 10 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
loratadine cinfa 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 or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What loratadine cinfa is and what it is used for
- What you need to know before taking loratadine cinfa
- How to take loratadine cinfa
- Possible side effects
- How to store loratadine cinfa
Pack contents and other information
1. What loratadina cinfa is and what it is used for
Loratadina cinfa belongs to a class of medicines known as antihistamines.
Loratadine helps reduce your allergy symptoms by blocking the effects of a substance called "histamine", which is produced by the body when you are allergic to something.
Loratadina cinfa relieves symptoms associated with allergic rhinitis (e.g., hay fever), such as sneezing, runny or itchy nose, and eye irritation or itching, in adults and children over 6 years of age who weigh more than 30 kg.
Loratadine can also be used to help relieve symptoms of urticaria (such as itching, redness, and the number and size of skin wheals).
You should consult your doctor if your condition worsens or does not improve after 7 days.
2. What you need to know before taking loratadina cinfa
Do not take loratadina cinfa
- If you are allergic to loratadine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking loratadina cinfa:
- If you have liver disease.
- If you are scheduled to undergo any type of skin allergy testing. Do not take loratadine during the 2 days prior to such tests, as this medicine may interfere with the test results.
If any of the above conditions apply to you (or if you are unsure), consult your doctor, pharmacist, or nurse before taking loratadina.
Children and adolescents
Do not administer loratadine 10 mg to children under 6 years of age or to children aged 6 to 12 years who weigh less than 30 kg. Other formulations more suitable for children aged 6 to 12 years who weigh less than 30 kg are available.
Children under 2 years of age
The safety and efficacy of loratadine have not been established. No data are available.
Other medicines and loratadina cinfa
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
The side effects of loratadine may increase when used together with medicines that affect the function of certain liver enzymes, or if your liver is not functioning properly. In clinical studies, no increase in loratadine side effects was observed with medicines affecting these enzymes. However, it is important that you inform your pharmacist about any other medicines you are taking while on loratadine.
Taking loratadina cinfa with food, drinks, and alcohol
Loratadine may be taken with or without food.
It has not been shown that loratadine increases the effects of alcoholic beverages.
Pregnancy and breastfeeding
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.
Pregnancy
As a precautionary measure, loratadine is not recommended during pregnancy.
Breastfeeding
Do not take loratadine if you are breastfeeding, as loratadine is excreted in breast milk.
Driving and using machines
In clinical trials assessing driving ability, no impairment of function was observed in patients receiving loratadine.
At the recommended dose, loratadine is not expected to cause drowsiness or reduced alertness. However, very rarely, some individuals may experience drowsiness, which could affect their ability to drive or operate machinery.
loratadina cinfa contains lactose
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
3. How to take loratadine cinfa
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose is:
Adults and children over 12 years of age
Take 1 tablet once daily with a glass of water, with or without food.
Children aged 6 to 12 years, dosed by weight
- Body weight greater than 30 kg:
Take 1 tablet once daily with a glass of water, with or without food.
- Body weight of 30 kg or less:
Do not administer loratadine 10 mg. There are other formulations more suitable for children aged 6 to 12 years weighing 30 kg or less.
Loratadine is not recommended in children under 6 years of age.
Patients with severe liver problems and body weight above 30 kg:
Take one tablet (10 mg) once daily on alternate days with a glass of water, with or without food.
Method of administration
The tablets may be taken independently of meals.
The tablet can be divided into equal doses.
If you take more loratadine cinfa than you should
Serious problems are not expected; however, you may experience headache, palpitations, or drowsiness.
In case of overdose or accidental ingestion, consult 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 cinfa
Do not take a double dose to make up for missed doses.
If you forget to take your dose on time, take it as soon as possible, then return to your regular dosing schedule.
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 everybody gets them.
The most frequently reported adverse effects (may affect more than 1 in 10 people) in adults and adolescents over 12 years of age include:
- drowsiness,
- headache,
- increased appetite,
- difficulty sleeping.
The most frequently reported adverse effects (may affect more than 1 in 10 people) in children aged 6 to 12 years are:
- headache,
- nervousness,
- fatigue.
During post-marketing experience with loratadine, the following very rare adverse effects have also been reported (may affect up to 1 in 10,000 people):
- severe allergic reaction (including swelling),
- dizziness,
- seizures,
- irregular or rapid heartbeat,
- nausea (feeling sick),
- dry mouth,
- stomach discomfort,
- liver problems,
- hair loss,
- skin rash,
- fatigue.
Frequency not known (cannot be estimated from the available data):
- Weight gain.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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. Loratadine Cinfa Storage
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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.
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 in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of loratadina cinfa
- The active substance is loratadine. Each tablet contains 10 mg of loratadine.
- The other components are: monohydrate lactose, corn starch, povidone, and magnesium stearate.
Nature of the product and contents of the container
loratadina cinfa are tablets, scored on one side, round, white or almost white, marked with the code "L" on the other side.
Presented in PVC/Al blisters. Each container contains 20 tablets.
Marketing Authorization Holder and Manufacturer
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Date of the most recent review of this leaflet: September 2021
Detailed 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/
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63696/P_63696.html
QR code to: https://cima.aemps.es/cima/dochtml/p/63696/P_63696.html