Clarityne™ 5 mg/10 mg Tablets

CLARITYNE ™ belongs to a class of medicines known as antihistamines. CLARITYNE ™ is an anti-allergy medicine. It helps control your allergic reaction and its symptoms. CLARITYNE ™ relieves symptoms associated with seasonal allergic rhinitis (e.g. hay fever), such as sneezing, runny or itchy nose and burning or itchy eyes. CLARITYNE ™ may also be used to relieve symptoms of chronic urticaria (itching, redness and number and size of hives) and other allergic skin disorders.

Do not use CLARITYNE ™:

• If you are hypersensitive (allergic) to loratadine or any other ingredients of CLARITYNE ™,
• In children under 2 years of age.

Take special care with CLARITYNE ™:

• Safety of CLARITYNE™ in the elderly has not been established.
• If you have liver disease.
• Weight gain has been reported with the use of loratadine, but the frequency is not known.

For oral use. Do not share CLARITYNE ™ with any other person. Always take CLARITYNE ™ exactly as your doctor or pharmacist has instructed you. You should check with your doctor or pharmacist if you are not sure.

CLARITYNE™ Syrup: The usual dose of CLARITYNE ™ Syrup is:

• Children 2 to 12 years of age: Body Weight equal to or less than 30 kg, take 5 ml (1 medicine measure) once a day. Body Weight more than 30 kg, take 10 ml (2 medicine measures) once a day.
• Adults and Children 12 years of age and over: Take 10 ml (2 medicine measures) once a day.

Do not take CLARITYNE ™ Syrup for longer than 14 days.

CLARITYNE™ Tablets: The usual dose is:

• Adults: Take one tablet once daily.

If you suffer from severe liver impairment you should be administered a lower initial dose because you may have reduced clearance of loratadine; an initial dose of 5 ml (or 5 mg tablet) once daily, or 10 ml (or 10 mg tablet) every other day is recommended.

If you have the feeling that CLARITYNE ™ is too strong or too weak, talk to your doctor or pharmacist.

If you take more CLARITYNE ™ than you should: If you take more CLARITYNE ™ than you were told to, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre. You may experience symptoms of sleepiness, irregular or rapid heartbeat and headache if you take more CLARITYNE ™ than you should. In the event of this happening, treatment should be started immediately. Treatment: Treatment is symptomatic and supportive. After emergency treatment, you should continue to be medically monitored.

If you forget to take CLARITYNE ™: If you forget to take your dose on time take it as soon as possible, then go back to your regular dosing schedule. Do not take a double dose, to make up for forgotten individual doses.

Effects when treatment with CLARITYNE ™ is stopped: There should be no symptoms from stopping taking CLARITYNE ™; if you experience some consult your doctor or pharmacist.

CLARITYNE ™ can have side effects. Not all side effects reported for CLARITYNE ™ are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CLARITYNE ™ please consult your doctor, pharmacist or other health care professional for advice. Contact a doctor or pharmacist if you have any reaction to CLARITYNE ™ that continues, is bothersome or that you think is serious.

Table 1: The following side - effects have been reported and the frequencies are unknown:

• Immune system disorders: Anaphylaxis (serious life-threatening allergic reaction) including swelling, angioedema (rapid swelling under the deeper skin layer)
• Metabolism and nutrition disorders: Increased appetite
• Neurological disorders: Headache, somnolence (Sleepiness, the state of feeling drowsy, ready to fall asleep), sedation (drowsiness), nervousness, dizziness, convulsion, difficulty sleeping
• Cardiovascular disorders: Palpitations (unpleasant sensation of irregular and/or forceful beating of the heart), tachycardia (period of very rapid and regular heartbeats that begins and ends suddenly)
• Gastro-intestinal disorders: Nausea (feeling sick), dry mouth, gastritis (Inflammation (swelling and redness) of the stomach lining), upset stomach
• Hepatobiliary disorders: Abnormal liver function (liver problems)
• Skin and subcutaneous tissue disorders: Rash, alopecia (hair loss)
• General disorders and administrative site conditions: Fatigue (tiredness)

For serious life-threatening allergic reaction, you may need urgent medical attention or hospitalisation.

Store all medicines out of reach of children.

Store at or below 25 °C.

Do not freeze. (Do not store in a bathroom or a refrigerator).

Protect from moisture.

Do not use this product after the expiry date that appears on the package.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).