LORATADINE VIATRIS 10 mg TABLETS
How to use LORATADINE VIATRIS 10 mg TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Patient Information Leaflet
Loratadina Viatris 10 mg tablets EFG
Read this leaflet carefully before you start taking this medicine, as 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Loratadina Viatris is and what it is used for
- What you need to know before taking Loratadina Viatris
- How to take Loratadina Viatris
- Possible side effects
- Storage of Loratadina Viatris
- Package contents and additional information
1. What Loratadina Viatris is and what it is used for
Loratadina Viatris contains the active substance loratadine, which belongs to a group of medicines known as antihistamines.
This medicine helps to reduce your allergy symptoms by blocking the effects of a substance called "histamine", which is produced in the body when you are allergic to something.
This medicine relieves symptoms associated with allergic rhinitis (e.g., hay fever), such as sneezing, runny or itchy nose, and itching or redness of the eyes.
You should consult a doctor if your symptoms worsen or do not improve after 7 days.
2. What you need to know before taking Loratadina Viatris
Do not take Loratadina Viatris:
- If you are allergic to loratadine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before taking this medicine.
Be particularly careful with loratadine if:
- You have liver disease.
- You are going to undergo any type of skin allergy test. Do not take this medicine during the 2 days prior to the test, as it may alter the results.
Children and adolescents
Do not give this medicine to children under 6 years of age or children who weigh less than 30 kg. There are other formulations more suitable for children under 6 years of age or weighing 30 kg or less.
Children under 2 years of age
The safety and efficacy of this medicine have not been established. No data are available.
Other medicines and Loratadina Viatris
The side effects of this medicine may increase when taken with medicines that alter the performance of certain enzymes in the liver, or if your liver is not functioning properly. In clinical studies, no increase in side effects was observed with loratadine and medicines that alter the performance of these enzymes.
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine, including those not requiring a prescription.
Taking Loratadina Viatris with food and alcohol
No interaction has been demonstrated between this medicine and alcoholic beverages.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine is not recommended during pregnancy or breastfeeding.
Driving and using machines
In clinical trials that evaluated driving ability, no reduced function was observed in patients taking loratadine. At the recommended dose, this medicine is not expected to cause drowsiness or reduced alertness. However, in rare cases, some people may experience drowsiness, which may affect their ability to drive or operate machinery.
Loratadina Viatris contains lactose
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.
3. How to take Loratadina Viatris
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
Your doctor will indicate the duration of treatment with this medicine. Do not stop treatment before completing it.
Adults and children over 6 years of age with a weight over 30 kg
Take 1 tablet once a day with a glass of water, with or without food.
Body weight of 30 kg or less
Do not give this medicine. There are other formulations more suitable for children under 6 years of age or weighing 30 kg or less.
Children under 2 years of age
This medicine is not recommended for children under 2 years of age.
Adults and children with severe liver problems
Adults and children weighing over 30 kg
Take 1 tablet once a day, every other day, with a glass of water, with or without food.
However, consult your doctor, pharmacist, or nurse before taking this medicine.
If your symptoms worsen or persist after 7 days of treatment, consult a doctor.
If you take more Loratadina Viatris than you should
If you take more loratadine than you should, consult your doctor or pharmacist immediately.
Somnolence, palpitations, and headache have been reported with overdose of this medicine.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medicine and the amount ingested.
If you forget to take Loratadina Viatris
If you forget to take your dose on time, take it as soon as possible, and then return to your regular dosing schedule. Do not take a double dose to make up for forgotten doses.
If you have any other questions about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most frequently reported side effects in adults and adolescents over 12 years are:
- Somnolence.
- Headache.
- Increased appetite.
- Difficulty sleeping.
The most frequently reported side effects in children from 6 to 12 years are:
- Headache.
- Nervousness.
- Fatigue.
During the marketing of loratadine, the following very rare side effects have also been reported (may affect up to 1 in 10,000 people):
- Severe allergic reaction (including swelling).
- Dizziness.
- Seizures.
- Irregular or rapid heartbeats.
- Nausea (vomiting).
- Dry mouth.
- Stomach upset.
- Liver problems.
- Hair loss.
- Rash.
- Fatigue.
Frequency not known(cannot be estimated from available data):
- Weight gain.
Reporting side effects
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Loratadina Viatris
Keep this medicine out of the sight and reach of children.
This medicine does not require special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after CAD or EXP. The expiry date is the last day of the month indicated.
Do not use this medicine if you notice any change in the appearance of the tablet.
Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.
6. Package contents and additional information
Composition of Loratadina Viatris
- The active substance is loratadine. Each tablet contains 10 mg of loratadine.
- The other excipients are: lactose monohydrate, corn starch, povidone, and magnesium stearate (E-470b).
Appearance of the product and package contents
Loratadina Viatris is presented in the form of tablets.
White, scored, round tablets.
Each package contains blisters of 20 tablets.
Marketing authorization holder and manufacturer
Marketing authorization holder
Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain
Manufacturer
Toll Manufacturing Services, S.L.
C/ Aragoneses, 2
28108 - Alcobendas (Madrid)
Spain
Date of the last revision of this leaflet:April 2022
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) https://www.aemps.gob.es/
- Country of registration
- Average pharmacy price3.11 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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