Claritin allergy
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Claritine Allergy (Clarityne), 10 mg, tablets
Loratadine
Claritine Allergy and Clarityne are different trade names for the same medicine.
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.
- Keep this leaflet, so you can read it again if necessary.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 3 days, or if you feel worse, consult your doctor.
Table of contents of the leaflet
- What Claritine Allergy is and what it is used for
- Important information before taking Claritine Allergy
- How to take Claritine Allergy
- Possible side effects
- How to store Claritine Allergy
- Contents of the pack and other information
1. What Claritine Allergy is and what it is used for
The active substance in Claritine Allergy, loratadine, is a tricyclic antihistamine and a selective peripheral H\ histamine receptor antagonist. Claritine Allergy is an antiallergic medicine that does not cause drowsiness. Claritine Allergy is indicated for the treatment of symptoms of allergic rhinitis (such as sneezing, runny nose, itchy nose, and itchy, burning eyes) and chronic idiopathic urticaria.
2. Important information before using Claritine Allergy
When not to use Claritine Allergy:
- if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting Claritine Allergy, discuss this with a doctor or pharmacist:
- if the patient has severe liver impairment (see section 3. How to use Claritine Allergy).
Treatment with loratadine without medical advice should not exceed 10 days.
Skin tests:
Claritine Allergy should be discontinued approximately 48 hours before planned skin testing, as antihistamines may cause false-negative results in these tests (they may reduce or completely suppress the skin reaction which would normally be positive).
Claritine Allergy and other medicines
Adverse effects may be intensified when Claritine Allergy is used concomitantly with medicines affecting certain liver enzymes responsible for drug metabolism. However, in clinical studies, no increase in adverse effects has been observed during concomitant use of loratadine with medicines affecting these enzymes. Concurrent administration of loratadine with ketoconazole, erythromycin, or cimetidine increases the plasma concentration of loratadine, but without clinical consequences. Concomitant use of loratadine with medicines affecting hepatic metabolism should be carried out under medical supervision.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take. This includes also medicines available without a prescription.
Use of Claritine Allergy with food, drink and alcohol
The medicine can be taken independently of meals.
When taken together with alcohol, Claritine Allergy does not enhance its effects to a degree detectable by psychomotor tests.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
As a precautionary measure, use of Claritine Allergy during pregnancy is not recommended.
Loratadine passes into breast milk; therefore, use of Claritine Allergy is not recommended 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 had negligible effect on the ability to drive and operate machinery. In some individuals, somnolence has very rarely occurred, which may impair the ability to drive and operate machinery.
Claritine Allergy contains lactose monohydrate
The medicine contains, as an excipient, lactose monohydrate. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
3. How to use Claritine Allergy
This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The break line on the tablet is only intended to facilitate splitting the tablet for easier swallowing.
Recommended dose
Adults and children over 12 years of age:
1 tablet (10 mg) once daily. The medicine can be taken with or without food.
Children aged 6 to 12 years:
Body weight above 30 kg: 1 tablet (10 mg) once daily.
The use of 10 mg tablets is not recommended in children with body weight below 30 kg.
Patients with liver function disorders:
In patients with severe hepatic insufficiency, a reduced initial dose should be used, as loratadine clearance may be reduced in these individuals. In such cases, adults and children with body weight above 30 kg should receive 1 tablet (10 mg loratadine) every other day.
Dosage adjustment is not required in elderly patients or in patients with renal impairment.
In case of doubt regarding dosage, consult your doctor.
If you feel the effect of Claritine Allergy is too strong or too weak, consult your doctor.
Taking more Claritine Allergy than recommended
If you take more Claritine Allergy than recommended, contact your doctor or pharmacist immediately.
Overdose symptoms observed with loratadine include: drowsiness, tachycardia, and headache.
In case of overdose, symptomatic and supportive treatment should be initiated immediately and continued as long as necessary. Activated charcoal may be administered as an aqueous suspension. Gastric lavage may also be performed. Loratadine cannot be removed from the body by hemodialysis; it is unknown whether peritoneal dialysis can eliminate it.
After administering treatment, the patient should continue to be monitored.
There is no evidence indicating that loratadine causes abuse or dependence.
Missing a dose of Claritine Allergy
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 side effects
Like all medicines, this medicine may cause side effects, although not everybody will experience them.
Common side effects associated with the use of Claritine Allergy (occurring in 1 to 10 out of 100 patients taking the medicine) are:
- in children aged 2 to 12 years – headache, nervousness, and fatigue.
- in adults and adolescents – drowsiness.
Uncommon side effects associated with the use of Claritine Allergy (occurring in 1 to 10 out of 1,000 patients taking the medicine) in adults and adolescents are:
- headache, increased appetite, insomnia, fatigue, gastrointestinal disorders such as nausea, dry mouth, gastritis, and allergic reactions such as rash.
Very rare side effects (occurring in fewer than 1 out of 10,000 patients taking the medicine), observed after the medicine was placed on the market, include:
- severe allergic reaction (including difficulty breathing, wheezing, itching, urticaria, swelling). If a severe allergic reaction occurs, stop taking the medicine immediately and contact a doctor without delay.
- dizziness, convulsions, increased heart rate, palpitations, abnormal liver function, hair loss.
Side effect with unknown frequency (frequency cannot be estimated from available data): weight gain.
Other side effects may occur in some individuals during treatment with Claritine Allergy.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects helps to provide more information on the safety of this medicine.
5. How to store Claritine Allergy
Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Contents of the pack and other information
What Claritine Allergy contains
- The active substance is loratadine. One tablet contains 10 mg of loratadine.
- The other ingredients (excipients) are: monohydrate lactose, corn starch, magnesium stearate.
What Claritine Allergy looks like and contents of the pack
Claritine Allergy is a white or almost white, oval-shaped tablet, free from impurities, with a division line on one side and smooth on the other.
Tablets are available in blisters (7, 10 tablets) packed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Greece, country of export:
Bayer Hellas ABEE
Sorou 18-20, 151 25 Marousi
Athens, Greece
Manufacturer:
Bayer Bitterfeld GmbH
OT Greppin, Salegaster Chaussee 1
06803 Bitterfeld-Wolfen, Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Greece, country of export: 65448/2-10-2015
Parallel import authorization number: 329/18