Claritine

Package Leaflet: Information for the Patient

CLARITINE, 1 mg/ml, Syrup

Loratadine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Claritine and what is it used for
• 2. Important information before taking Claritine
• 3. How to take Claritine
• 4. Possible side effects
• 5. How to store Claritine
• 6. Contents of the pack and other information

1. What is Claritine and what is it used for

Claritine belongs to a group of antihistamine medicines. These medicines reduce allergy symptoms by preventing the actions caused by a substance called histamine, which is produced in the body. Claritine relieves symptoms associated with allergic rhinitis (allergic rhinitis, e.g., hay fever), such as sneezing, itching, and runny nose, itching, and burning eyes. The medicine can also be used to relieve symptoms of urticaria (hives, itching, skin redness). The therapeutic effect of relieving these symptoms lasts all day, making it easier to return to normal daily activities and normal sleep.

2. Important information before taking Claritine

When not to take Claritine:

Warnings and precautions

Before taking Claritine, discuss it with your doctor or pharmacist:

Skin tests

You should stop taking Claritine about 48 hours before scheduled skin tests, as antihistamines may cause false-negative results of these tests (may reduce or completely inhibit the skin reaction that would normally be positive).

Claritine and other medicines

Side effects may be exacerbated when taking Claritine with medicines that affect the action of certain enzymes responsible for drug metabolism in the liver. However, clinical studies have not shown an increase in side effects when loratadine is taken with medicines that affect the action of these enzymes. Concurrent administration of loratadine with ketoconazole, erythromycin, or cimetidine increases the concentration of loratadine in the blood, but without clinical consequences. Concurrent use of loratadine with medicines that affect liver metabolism should be done under medical supervision. Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. This also applies to over-the-counter medicines.

Taking Claritine with food, drink, and alcohol

The medicine can be taken regardless of meals. The medicine taken with alcohol does not enhance its effects to a degree that can be assessed by psychomotor tests.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. As a precaution, it is recommended to avoid taking Claritine during pregnancy. Loratadine passes into breast milk, so it is not recommended to take the medicine during breastfeeding. There are no data on fertility in men and women.

Driving and using machines

In clinical studies, loratadine had no effect or an insignificant effect on the ability to drive and use machines. In some people, very rare cases of drowsiness occurred, which could impair the ability to drive and use machines.

Claritine contains maltitol liquid, sorbitol liquid crystallizing, propylene glycol, sodium benzoate

The medicine contains 2.5 mg of sodium benzoate in 5 ml of syrup, which corresponds to 0.5 mg/ml. The medicine contains 250 mg of propylene glycol in 5 ml of syrup, which corresponds to 50 mg/ml. The medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of syrup, which means the medicine is considered "sodium-free". The medicine contains 1 g of sorbitol in 5 ml of syrup, which corresponds to 200 mg/ml. Sorbitol is a source of fructose. If you or your child have previously been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disease in which the body does not break down fructose, you should consult your doctor before taking the medicine or giving it to your child.

3. How to take Claritine

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. Recommended dose

Adults and children over 12 years:

10 ml of syrup once a day. The medicine 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 from 2 to 12 years - dosing depends on body weight:

Body weight over 30 kg:

10 ml of syrup once a day. The medicine 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 a day. The medicine 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 the medicine in children under 2 years of age have not been established.

Patients with severe liver function disorders:

Adults and children with a body weight over 30 kg:10 ml of syrup every other day. Children with a body weight of 30 kg or less:5 ml of syrup every other day. There is no need to adjust the dose in elderly patients and patients with renal impairment. If you feel that the effect of Claritine is too strong or too weak, consult your doctor.

Taking a higher dose of Claritine than recommended

If you take more Claritine than recommended, contact your doctor or pharmacist immediately. After an overdose of Claritine, the following have been observed: drowsiness, increased heart rate, and headache. In case of an overdose, symptomatic and supportive treatment should be applied immediately and continued as long as necessary. Activated charcoal can be given as a water suspension. The doctor may also perform gastric lavage. Loratadine cannot be removed from the body by hemodialysis, and it is not known whether it can be removed by peritoneal dialysis. There are no data indicating that loratadine causes abuse or dependence.

Missing a dose of Claritine

If you forget to take your dose at the usual time, take it as soon as possible and then return to your normal dosing schedule. Do not take a double dose to make up for a missed dose. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Claritine can cause side effects, although not everybody gets them. Frequent side effectsassociated with taking Claritine (in 1 to 10 out of 100 patients taking the medicine) are:

• in children from 2 to 12 years - headache, nervousness, and fatigue.
• in adults and adolescents - drowsiness.

Uncommon side effectsassociated with taking Claritine (in 1 to 10 out of 1000 patients taking the medicine) in adults and adolescents are:

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

Rare side effects(less than 1 in 10,000 patients taking the medicine), observed after the medicine was introduced to the market, are:

• severe allergic reactions (including difficulty breathing, wheezing, itching, hives, swelling). If severe allergic reactions occur, stop taking the medicine and contact your doctor immediately.
• dizziness, seizures, irregular or rapid heartbeat, liver function disorders, hair loss.

Side effects of unknown frequency(frequency cannot be estimated from available data): weight gain. Some people may experience other side effects when taking Claritine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Claritine

Store in a temperature below 25°C. Keep the medicine out of the 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 month stated. Shelf life after first opening the bottle: 1 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 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, sorbitol liquid crystallizing, grape flavor 936.1368U, sodium dihydrogen phosphate dihydrate, phosphoric acid, disodium edetate, purified water.

What Claritine looks like and contents of the pack

The medicine is in a plastic bottle made of polyethylene terephthalate (PET) with a polypropylene (PP) cap with a child-resistant closure, placed in a cardboard box. The bottle contains 120 ml or 150 ml of syrup. The syrup is clear, colorless to light yellow. A measuring cup with 5 ml and 10 ml markings is attached to the bottle.

Marketing authorization holder and manufacturer

Marketing authorization 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

Date of last revision of the leaflet: