Aleric lora
Poland
Table of Contents
Package leaflet: Information for the patient
Aleric Lora
10 mg, tablets
Loratadine
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
- If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Leaflet contents
- What Aleric Lora is and what it is used for
- Important information before taking Aleric Lora
- How to take Aleric Lora
- Possible side effects
- How to store Aleric Lora
- Contents of the pack and other information
1. What Aleric Lora is and what it is used for
The active substance in Aleric Lora, loratadine, is a tricyclic antihistamine and a selective peripheral H\₁ histamine receptor antagonist.
Aleric Lora is an antiallergic medicine that does not cause drowsiness.
Aleric Lora is indicated for the treatment of symptoms of allergic rhinitis (such as sneezing, runny nose, nasal itching, and eye itching and burning) and chronic idiopathic urticaria.
2. Important information before taking Aleric Lora
When not to use Aleric Lora:
- if the patient is allergic to loratadine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Aleric Lora, discuss this with your doctor or pharmacist.
- if the patient has severe hepatic impairment (see section 3. How to take Aleric Lora).
Skin tests:
Treatment should be discontinued approximately 48 hours before planned allergic skin tests, as antihistamines may cause false-negative results (they may reduce or completely suppress the skin reaction which would normally be positive).
Children
Aleric Lora must not be used in children under 2 years of age.
The use of tablets (10 mg) is not recommended in children with body weight below 30 kg.
Aleric Lora and other medicines
Tell your doctor or pharmacist if the patient is currently taking, has recently taken or might take any other medicines. This includes medicines obtained without a prescription.
Adverse effects may be intensified when taken concomitantly with drugs affecting the activity of certain liver enzymes responsible for drug metabolism.
However, in clinical studies, no increase in adverse effects was observed during concomitant use of loratadine with drugs affecting these enzymes.
When loratadine is used concomitantly with antibiotics (erythromycin), antifungal drugs (ketoconazole), or cimetidine (used in peptic ulcer disease), increased blood concentration of loratadine may occur, but without clinical consequences. Concomitant use of drugs affecting hepatic metabolism with loratadine should be under medical supervision.
Aleric Lora, food, drink and alcohol
This medicine may be taken regardless of meals.
Loratadine administered together with alcohol does not enhance its effects, as demonstrated in psychomotor performance studies.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
As a precautionary measure, it is recommended to avoid using Aleric Lora during pregnancy.
Loratadine passes into breast milk; therefore, Aleric Lora should not be used during breastfeeding.
There are no data available on fertility in men and women.
Driving and operating machinery
In clinical studies, loratadine had no effect or a negligible effect on the ability to drive and operate machinery. However, very rarely, somnolence has been reported in some individuals, which may impair the ability to drive or operate machinery.
Aleric Lora contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
3. How to use Aleric Lora
This medicine should always be used as directed by the physician. If in doubt, consult your doctor.
The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing.
Recommended dose
Adults and adolescents aged 12 years and above: 10 mg (1 tablet) once daily.
The medicine should be taken orally. It may be taken with or without food.
Use in children
Children aged 2 to 12 years:
- Body weight over 30 kg: 10 mg (1 tablet) once daily.
The use of tablets (10 mg) is not recommended in children with body weight below 30 kg.
In such children, loratadine in syrup form may be used. This medicine is intended for children who are able to swallow tablets.
The safety and efficacy of this medicine have not been established in children under 2 years of age.
Patients with hepatic impairment
In patients with severe liver impairment, a lower initial dose should be used, as loratadine clearance may be reduced in these individuals. In such cases, adults and children with body weight over 30 kg should receive 10 mg loratadine (1 tablet) every other day.
No dose adjustment is necessary in elderly patients or in patients with renal impairment.
If you feel that the effect of Aleric Lora is too strong or too weak, consult your doctor.
Overdose of Aleric Lora
If you take more than the recommended dose of Aleric Lora, seek immediate medical advice from a doctor or pharmacist.
Symptoms observed after loratadine overdose include: drowsiness, tachycardia, and headache.
The physician will determine the appropriate treatment.
In case of overdose, symptomatic and supportive treatment should be initiated immediately and maintained as long as necessary. Activated charcoal in aqueous suspension may be administered. Gastric lavage may also be performed. Loratadine cannot be removed from the body by hemodialysis. It is unknown whether it can be removed by peritoneal dialysis.
After administering treatment, the patient should continue to be monitored.
There is no evidence indicating that loratadine causes abuse or dependence.
Missed dose of Aleric Lora
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Common adverse reactions (may occur in fewer than 1 in 10 people):
- in children aged 2 to 12 years: headache, nervousness, and fatigue;
- in adults and adolescents: drowsiness.
Uncommon adverse reactions (may occur in fewer than 1 in 100 people):
- in adults and adolescents: headache, increased appetite, insomnia, fatigue, dry mouth, gastrointestinal disorders such as nausea, gastric mucosal inflammation, and allergic reactions such as rash.
Very rare adverse reactions (may occur in fewer than 1 in 10,000 people):
- severe allergic reaction (including difficulty breathing, wheezing, itching, urticaria, swelling). If a severe allergic reaction occurs, discontinue taking the medicine immediately and contact your doctor without delay.
- dizziness, convulsions;
- increased heart rate, palpitations;
- liver function abnormalities;
- hair loss.
Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
- weight gain.
Other adverse reactions may occur in some individuals during treatment with Aleric Lora.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: +48 (22) 492 13 01,
fax: +48 (22) 492 13 09,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.
5. How to store Aleric Lora
Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
What Aleric Lora contains
- The active substance is loratadine. One tablet contains 10 mg of loratadine.
- The other ingredients (excipients) are: microcrystalline cellulose, lactose, colloidal anhydrous silica, magnesium stearate, crospovidone, pregelatinized starch, stearic acid.
What Aleric Lora looks like and contents of the pack
Uncoated white tablets, round, biconvex, smooth, with a central dividing groove.
Available pack sizes:
Aluminium-PVC/PVDC blisters in cardboard boxes:
2 tablets (1 blister with 2 tablets);
4 tablets (1 blister with 4 tablets);
7 tablets (1 blister with 7 tablets);
10 tablets (1 blister with 10 tablets).
Marketing Authorisation Holder and Manufacturer:
US Pharmacia Sp. z o.o.
Ziębicka Street 40
50-507 Wrocław
For further information, please contact:
USP Zdrowie Sp. z o.o.
Poleczki 35 Street
02-822 Warsaw
tel.: +48 (22) 543 60 00