ACTALOR

ACTALOR 10 mg tablets contain loratadine, an antihistamine used to relieve symptoms of allergic rhinitis such as sneezing, a runny or itchy nose, and itchy, burning or watery eyes. It may also relieve itching and redness associated with chronic idiopathic urticaria, commonly known as hives.

Each tablet contains 10 mg of loratadine. The pack contains one blister of 10 tablets. The effect of the recommended dose lasts throughout the day.

ACTALOR 10 mg – uses, dosage and precautions

What is ACTALOR used for?

• allergic rhinitis and hay fever;
• sneezing and a watery, itchy nose;
• itching, burning and watering of the eyes;
• chronic idiopathic urticaria;
• itching and redness associated with hives.

Loratadine blocks the action of histamine released during an allergic reaction. At the recommended dose, it generally causes less drowsiness than older antihistamines, although individual reactions remain possible.

Dosage

• Adults and adolescents: one tablet once daily.
• Children aged six years and over who weigh more than 30 kg: one tablet once daily.
• Swallow with sufficient water.
• It may be taken with or without food.
• Do not take more than one tablet daily unless specifically instructed.

The score line is intended only to make the tablet easier to break and swallow. It does not divide the tablet into equal doses.

Severe liver impairment

An initial dose of one tablet every other day may be recommended for adults and children weighing more than 30 kg with severe liver impairment.

Kidney impairment and older people

Dose adjustment is generally not required in renal impairment or solely because a patient is older.

Children

ACTALOR tablets are not suitable for children under six years of age or weighing 30 kg or less. Safety and efficacy have not been established in children under two years.

When must it not be taken?

Do not take ACTALOR if you are allergic to loratadine or another ingredient.

Warnings

• Use with caution in severe liver impairment.
• Stop taking it at least 48 hours before skin allergy testing.
• The medicine contains lactose.
• Tell a doctor or pharmacist about all other medicines and supplements.

Interactions

Medicines affecting CYP3A4 or CYP2D6 enzymes may increase loratadine concentrations. Examples include ketoconazole, erythromycin and cimetidine.

Pregnancy and breastfeeding

As a precaution, loratadine should be avoided during pregnancy unless professionally recommended. It passes into breast milk and is not recommended during breastfeeding.

Driving

Loratadine usually has no or negligible effect on driving. Rare drowsiness may occur, so assess your reaction before driving or operating machinery.

Possible side effects

The most commonly reported effects in adults and adolescents include drowsiness, headache, increased appetite and insomnia. Headache, nervousness and tiredness have been reported in children.

Very rare effects include severe hypersensitivity reactions, angioedema, anaphylaxis, dizziness, seizures, palpitations, rapid heartbeat, nausea, dry mouth, gastritis, liver dysfunction, rash, hair loss and fatigue. Weight gain has been reported with an unknown frequency.

Overdose and missed dose

Excessive doses may cause drowsiness, headache and rapid heartbeat. Contact a doctor or pharmacist after an overdose. Do not take a double dose to replace a missed tablet.

Ingredients

Each tablet contains 10 mg loratadine and 75 mg lactose monohydrate. Other ingredients are microcrystalline cellulose, maize starch and magnesium stearate.

Storage

• Store below 25 °C.
• Keep in the original package to protect from light and moisture.
• Keep out of the sight and reach of children.
• Do not use after the expiry date or if the tablet appearance has changed.

Frequently asked questions