Package leaflet: Information for the patient

CLARITINE, 1 mg/ml, syrup
Loratadinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Claritine is and what it is used for
Important information before taking Claritine
How to take Claritine
Possible side effects
How to store Claritine
Contents of the pack and other information

1. What Claritine is and what it is used for

Claritine belongs to a group of medicines called antihistamines. These medicines reduce allergic symptoms by preventing the effects of a substance called histamine, which is produced in the body.
Claritine relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by allergy, e.g. hay fever), such as sneezing, itching and watery nasal discharge, as well as itching and burning eyes.
The medicine may also be used to relieve symptoms of urticaria (itching, skin redness).
The therapeutic effect, which involves relief of these symptoms, lasts throughout the day, helping the patient return to normal daily activities and normal sleep.

2. Important information before using Claritine

When not to use Claritine:

if the patient is allergic to loratadine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before taking Claritine, consult your doctor or pharmacist:

if the patient has liver function disorders (see section 3. How to take Claritine).

Skin tests
Claritine should be discontinued approximately 48 hours before planned skin testing, as antihistamines may cause false negative results (they may reduce or completely suppress the skin reaction which would normally be positive).

Claritine and other medicines
Adverse effects may be intensified when Claritine is taken together with medicines affecting certain liver enzymes responsible for drug metabolism. However, in clinical studies, no increase in adverse effects has been observed when loratadine was used concomitantly with drugs affecting these enzymes.
Concomitant administration of loratadine with ketoconazole, erythromycin or cimetidine increases loratadine plasma concentration, but without clinical consequences. Concurrent use of loratadine with drugs affecting hepatic metabolism should be performed under medical supervision.
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use, including those available without a prescription.

Taking Claritine with food, drink and alcohol
This medicine may be taken regardless of meals.
Concomitant intake of Claritine with alcohol does not intensify its effects to a degree detectable by psychomotor tests.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
As a precautionary measure, it is recommended to avoid using Claritine during pregnancy.
Loratadine passes into breast milk; therefore, use of Claritine is not recommended during breastfeeding.
There is no data available regarding fertility in men and women.

Driving and operating machinery
In clinical studies, loratadine had no effect or only a negligible effect on the ability to drive and operate machinery. However, somnolence has very rarely occurred in some individuals, which may impair the ability to drive and operate machinery.

Claritine contains liquid maltitol, crystallizing liquid sorbitol, propylene glycol, sodium benzoate
The medicine contains 2.5 mg of sodium benzoate in 5 ml of syrup, equivalent to 0.5 mg/ml.
The medicine contains 250 mg of propylene glycol in 5 ml of syrup, equivalent to 50 mg/ml.
The medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of syrup, meaning the medicine is considered "sodium-free".
The medicine contains 1 g of sorbitol in 5 ml of syrup, equivalent to 200 mg/ml.
Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or his/her child), or if hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot metabolize fructose, has been diagnosed, the patient should consult a doctor before taking the medicine or giving it to the child.

3. How to take Claritine

This medicine should always be taken according to the doctor's instructions. If in doubt, consult your
doctor.
Recommended dose
Adults and children aged 12 years and older:
10 ml of syrup once daily. Claritine can be taken regardless of meals. It is not necessary to drink water or other fluids after taking the syrup.
Claritine is also available in tablet form.
Children aged 2 to 12 years – dosage depends on body weight:
Body weight greater than 30 kg:
10 ml of syrup once daily. Claritine can be taken regardless of meals. It is not necessary to drink water or other fluids after taking the syrup.
Body weight 30 kg or less:
5 ml of syrup once daily. Claritine can be taken regardless of meals. It is not necessary to drink water or other fluids after taking the syrup.
The safety and efficacy of Claritine in children under 2 years of age have not been established.
Patients with severe hepatic impairment:
Adults and children weighing more than 30 kg: 10 ml of syrup every other day.
Children weighing 30 kg or less: 5 ml of syrup every other day.
Dose adjustment is not required in elderly patients or patients with renal impairment.
If you feel that the effect of Claritine is too strong or too weak, consult your doctor.
Taking more Claritine than recommended
If you take more Claritine than you should, contact your doctor or pharmacist immediately.
Overdose symptoms observed with Claritine 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 in aqueous suspension may be administered. The doctor may also perform gastric lavage. Loratadine cannot be removed from the body by hemodialysis; it is not known whether it can be removed by peritoneal dialysis.
There is no evidence indicating that loratadine causes abuse or dependence.
Missing a dose of Claritine
If a dose is missed, take it as soon as possible, then return to the usual dosing schedule. 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 associated with taking Claritine (occurring in 1 to 10 out of 100 patients using the medicine):

In children aged 2 to 12 years – headache, nervousness, and fatigue.
In adults and adolescents – drowsiness.

Uncommon adverse reactions associated with taking Claritine (occurring in 1 to 10 out of 1,000 patients using the medicine) in adults and adolescents:

Headache, increased appetite, sleep problems, fatigue, dry mouth, gastrointestinal disorders such as nausea, gastritis, and allergic symptoms such as rash.

Very rare adverse reactions (occurring in fewer than 1 out of 10,000 patients using the medicine), observed after the medicine was placed on the market:

Severe allergic reactions (including difficulty breathing, wheezing, itching, urticaria, swelling). If severe allergic reactions occur, discontinue use of the medicine immediately and contact your doctor without delay.
Dizziness, convulsions, irregular or rapid heartbeat, liver function disorders, hair loss.

Adverse reaction of unknown frequency (frequency cannot be determined from available data): weight gain.

Other adverse reactions may occur in some individuals during treatment with Claritine.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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 49 21 301, Fax: + 48 22 49 21 309, e-mail: [email protected].
Adverse reactions can also be reported directly to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Claritine

Store below 25°C.
Keep the 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 stated month.
Period of validity after first opening the bottle: 1 month.
Medicines must 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 package and other information

What Claritine contains

The active substance is loratadine. 1 ml of syrup contains 1 mg of loratadine. 5 ml of syrup contains 5 mg of loratadine. 10 ml of syrup contains 10 mg of loratadine.
The other ingredients (excipients) are: propylene glycol, glycerol, sodium benzoate, sucralose, maltitol liquid, liquid crystallizing sorbitol, grape flavour 936.1368U, disodium dihydrogen phosphate dihydrate, phosphoric acid, disodium edetate, purified water.

What Claritine looks like and contents of the pack
The medicine is contained in a plastic bottle made of polyethylene terephthalate (PET) with a cap made of polypropylene (PP) and child-resistant closure, placed in a cardboard box. The bottle contains 120 ml or 150 ml of syrup. The syrup is clear, colourless to pale yellow. A measuring cup marked for 5 ml and 10 ml is supplied with the bottle.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw
Tel.: +48 22 572 35 00

Importer:
BerliMed S.A.
Poligono Industrial Santa Rosa
Calle Francisco Alonso No.7
28806 Alcalá de Henares (Madrid)
Spain