Loratadin 10 mg. 10 tablets

1. What Loratadine is and what it is used for

Loratadine contains the active substance loratadine, which belongs to a group of medicines called antihistamines (anti-allergy medicines). It is used to treat the symptoms of certain allergic conditions caused by the increased release of histamine. Loratadine Sopharma is used to relieve the symptoms of allergic rhinitis (itchy nose, sneezing and watery discharge, red eyes) and chronic idiopathic urticaria (itching, redness, and swelling of the skin).

If you do not feel better or if your condition worsens after 10 days, you must seek medical advice.

2. What you need to know before you take Loratadine

Do not take Loratadine

if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Loratadine

if you suffer from liver disease; if you are due to have a skin allergy test. Use of the product should be stopped at least 48 hours before the skin test, as antihistamines, such as loratadine, can affect or mask an otherwise positive skin test reaction.

Other medicines and Loratadine

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. When loratadine is taken concomitantly with erythromycin (an antibiotic), cimetidine, or ketoconazole (antifungal agents), an increase in blood concentrations of loratadine is observed; however, this does not result in clinical changes (including changes in the electrocardiogram).

Loratadine Sopharma with food, drink, and alcohol

The tablets may be taken with or without food. The effects of alcohol are not potentiated by taking Loratadine Sopharma.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Use of Loratadine Sopharma during pregnancy is not recommended.

Breast-feeding

Taking Loratadine Sopharma while breast-feeding is not recommended, as loratadine passes into breast milk.

Driving and using machines

Although rare, drowsiness may occur, which could adversely affect your ability to drive or operate machinery. Therefore, it is advisable to wait and assess your individual reaction before driving or operating machinery.

Loratadine Sopharma contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this product. 3. How to take Loratadine Sopharma

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure about anything, ask your doctor or pharmacist.

Loratadine Sopharma tablets are taken by mouth with a sufficient amount of water (e.g., a glass of water), with or without food.

Maximum daily

The recommended dose is:

Adults and children over 12 years of age – 1 tablet daily.

Children aged 6 to 12 years

with a body weight over 30 kg – 1 tablet daily.

with a body weight under 30 kg – use of the syrup formulation is recommended, or 1/2 tablet is administered daily.

Children aged 2 to 6 years

Use of the syrup formulation is recommended.

Children under 2 years of age

The safety and efficacy of Loratadine Sopharma in children under 2 years of age have not been established.

Patients with impaired liver or kidney function

In patients with severe liver impairment, a lower initial dose is administered.

For adults and children weighing over 30 kg, 1 tablet every other day is recommended.

For children weighing under 30 kg, 1/2 tablet every other day is recommended.

For patients with kidney impairment – ​​1 tablet daily.

Patients over 65 years of age – 1 tablet daily.

Treatment with loratadine may be prolonged – from 2 to 6 months.

If you have taken more Loratadine Sopharma than required

If you have taken a higher dose than prescribed, drowsiness, dizziness, nausea, or vomiting may occur. In case of overdose, seek medical advice. If you forget to take Loratadine Sopharma

If you miss a dose, take it as soon as possible. If it is almost time for your next dose, take it as usual. Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Headache, nervousness, and fatigue are most commonly observed in children aged 2 to 12 years. In adults and adolescents, the most common side effects are drowsiness, headache, increased appetite, and insomnia. Adverse reactions are classified by frequency as follows:

Very rare (may affect up to 1 in 10,000 people)

hypersensitivity reaction – angioedema (severe allergic reaction causing swelling of the face or throat) and anaphylaxis (severe allergic reaction causing difficulty breathing or dizziness), dizziness, convulsions

palpitations, rapid heart rate

nausea, dry mouth, inflammation of the stomach

impaired liver function

rash, hair loss, fatigue

Not known (frequency cannot be estimated from the available data)

weight gain (in children).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Bulgarian Drug Agency: 8 Damyan Gruev St., 1303 Sofia. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Loratadine Sopharma

Store in a dry place protected from light, at a temperature below 25°C.

Keep out of the reach of children.

Do not use Loratadine Sopharma after the expiry date stated on the carton. The expiry date refers to the last day of the month indicated.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Loratadine Sopharma contains

The active substance is: each tablet contains 10 mg of loratadine.

The other ingredients are: lactose monohydrate; maize starch; microcrystalline cellulose; povidone; colloidal anhydrous silica; magnesium stearate.

What Loratadine Sopharma looks like and contents of the pack

White to almost white, round, flat tablets with beveled edges and a score line on one side, and a diameter of 7 mm.