Neoclarityn Tablets

What is Neoclarityn?

Neoclarityn is an antihistamine medication containing the active ingredient desloratadine. It belongs to the drug class of selective peripheral H1-receptor antagonists, which are modern, second-generation antihistamines according to the official Neoclarityn, INN-desloratadine SMPC.

Mechanism of Action

Neoclarityn works by selectively blocking histamine H1 receptors in the body. Histamine is a chemical released by the immune system during an allergic reaction, causing symptoms like itching, sneezing, runny nose, and watery eyes. By blocking these receptors, Neoclarityn prevents histamine from binding and triggering allergy symptoms.

Patient-friendly analogy: Think of histamine receptors as locks and histamine as keys that open them to cause allergy symptoms. Neoclarityn acts as a protective cover over these locks, preventing the histamine keys from fitting, thus stopping the allergic reaction chain.

Biological Pathway

When your body encounters an allergen (like pollen or dust mites), mast cells release histamine. Histamine binds to H1 receptors in various tissues:

• In nasal passages: Causes itching, sneezing, and increased mucus
• In eyes: Leads to redness, itching, and tearing
• In skin: Results in hives, itching, and swelling

Desloratadine competitively inhibits histamine binding with high specificity for peripheral H1 receptors, providing symptom relief without significant central nervous system effects (minimal drowsiness).

What is Neoclarityn Used For?

Neoclarityn is indicated for the relief of symptoms associated with:

Allergic Rhinitis

This includes seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis (year-round allergies such as to dust mites or pet dander). Symptoms treated include:

• Sneezing
• Runny or itchy nose
• Itchy palate
• Itchy, red, or watery eyes
• Nasal congestion

Urticaria (Hives)

Neoclarityn provides relief from symptoms of urticaria, including:

• Itching
• Hives (raised, red, itchy welts on the skin)

Before Using Neoclarityn

Essential considerations before initiating treatment:

Medical History Assessment

• History of allergy to desloratadine, loratadine, or any tablet ingredients
• Kidney function status (poor kidney function requires caution)
• History of seizures (personal or family history)
• Lactose intolerance (tablets contain lactose)
• Pregnancy, planning pregnancy, or breastfeeding
• Liver function issues

Required Baseline Considerations

1. Assessment of allergy symptoms and triggers
2. Review of current medications to avoid interactions
3. Evaluation of kidney function if impairment is suspected
4. Pregnancy test if applicable

Neoclarityn Contraindications

Absolute contraindications where Neoclarityn must not be used:

Absolute Contraindications

• Allergy to desloratadine or any of the other ingredients
• Allergy to loratadine (related antihistamine)
• Severe lactose intolerance (tablets contain lactose)

Special Warnings

Special Population Considerations

Elderly Patients (≥65 years)

• No dose adjustment generally required for elderly patients with normal kidney function
• Caution advised due to potential age-related decline in kidney function

Renal Impairment

• Patients with poor kidney function should use Neoclarityn with caution
• While specific dose adjustments aren't provided in the PIL, your doctor may recommend reduced frequency or alternative treatments

Hepatic Impairment

• Limited data available
• Use with caution in patients with liver impairment

Pediatric and Adolescent Patients

• Neoclarityn is not recommended for children under 12 years of age.
• For adolescents aged 12-17 years, the adult dose of one 5mg tablet daily is appropriate

Neoclarityn and Other Medicines

According to the official product information (Neoclarityn SMPC), there are no known clinically significant interactions of Neoclarityn with other medicines.

Important Considerations

• Always inform your doctor or pharmacist about all medicines you are taking
• Include prescription medications, over-the-counter medicines, herbal supplements, and vitamins

Precautionary Advice

While no specific high-risk combinations are identified, use caution with:

1. CNS depressants: Although desloratadine has minimal sedative effects, combining with alcohol or other sedating medications may increase drowsiness.
2. Enzyme inducers/inhibitors: Desloratadine is metabolized in the liver, so potent enzyme inducers or inhibitors could theoretically affect levels.

Pregnancy & Breastfeeding

Pregnancy

• Neoclarityn is not recommended during pregnancy
• There is limited data on the use of desloratadine in pregnancy
• Animal studies have shown no direct harmful effects, but human data is insufficient
• Consult your doctor before taking if pregnant or planning pregnancy

Breastfeeding

• Desloratadine passes into breast milk in small amounts
• The effects on nursing infants are unknown
• Use during breastfeeding is not recommended

Driving & Machine Operation

• At the recommended dose, Neoclarityn is not expected to affect your ability to drive or use machinery
• Clinical studies show it has minimal sedative effects compared to older antihistamines
• Most people do not experience drowsiness with Neoclarityn
• Caution advised due to possible:
  • Fatigue or tiredness
  • Drowsiness (in some individuals)
  • Dizziness
• Until you know how Neoclarityn affects you, avoid activities requiring mental alertness such as driving or operating machinery.

Neoclarityn Ingredients

Active Substance

• Desloratadine 5mg per tablet

Excipients

Allergen Warning

• Neoclarityn contains lactose (approximately 124mg per tablet)
• If you have lactose intolerance, consult your doctor before taking this medicine

How to Use Neoclarityn

Preparation Steps

1. Wash hands thoroughly
2. Remove one tablet from the blister pack
3. Have a glass of water ready
4. Take tablet with or without food as per your preference

Administration Technique

• Route: Oral administration
• Method: Swallow tablet whole with water
• Do not: Crush, chew, or break the tablet
• Timing: Take at approximately the same time each day for consistent effect

Neoclarityn Dosage Guidelines

Standard Dosage Schedule

Duration of Treatment

For Allergic Rhinitis

For Urticaria

• Duration varies from patient to patient
• Follow your doctor's instructions regarding treatment length

Administration Instructions

Step-by-step administration guide:

Daily Routine

1. Take one tablet from the blister pack
2. Swallow whole with a full glass of water
3. Do not crush, chew, or break the tablet
4. Can be taken with or without food
5. Take at approximately the same time each day

Important Notes

• Neoclarityn is for oral use only
• The tablet should be swallowed whole
• No need to adjust timing for meals
• Consistent timing recommended for optimal symptom control

Missed Dose Management

General Principles

• Do NOT double doses
• Take missed dose as soon as remembered
• If almost time for next dose, skip missed dose

Time-Based Guidance

Overdose Information

Symptoms

• Headache
• Drowsiness
• Rapid heartbeat
• General malaise

Management

1. Seek immediate medical attention if overdose suspected
2. Contact doctor, pharmacist, or emergency services
3. Bring medication packaging
4. Do not induce vomiting unless instructed by medical personnel

Important Notes

• No serious problems are expected with accidental overdose based on clinical data
• There is no specific antidote for desloratadine overdose
• Treatment is supportive and symptomatic

Possible Side Effects

Common (may affect up to 1 in 10 people)

• Fatigue
• Dry mouth
• Headache

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

• Severe allergic reactions
• Skin rash
• Pounding or irregular heartbeat
• Fast heartbeat
• Stomach ache, nausea, vomiting, upset stomach, diarrhoea
• Dizziness, drowsiness, inability to sleep
• Muscle pain
• Hallucinations
• Seizures
• Restlessness with increased body movement
• Liver inflammation, abnormal liver function tests

Frequency Not Known

• Unusual weakness
• Yellowing of skin/eyes (jaundice)
• Increased skin sensitivity to sun/UV light
• Changes in heart rhythm
• Abnormal behaviour, aggression
• Weight increased, increased appetite

Serious Side Effects Requiring Immediate Action

Reporting Side Effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed. You can report side effects directly via the UK Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

How to Store Neoclarityn

Storage Conditions

• Keep out of sight and reach of children.
• Do not store above 30°C
• Store in the original package to protect from moisture
• Do not use after the expiry date printed on the carton and blister

Visual Inspection

• Do not use Neoclarityn if you notice any change in the appearance of the tablets
• The tablets are blue, film-coated, and round

Disposal

• Do not throw away medicines via wastewater or household waste
• Ask your pharmacist how to dispose of medicines you no longer use
• Proper disposal helps protect the environment

Pack Information

Pack Sizes

• 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, or 100 tablets
• Not all pack sizes may be marketed or available through Chemist Doctor

Components

• Tablets in blister packs
• Carton with product information

Appearance

• Blue film-coated tablets
• Round shape

Marketing Authorisation Holder

Organon Pharma (UK) Limited
Hertford Road, Hoddesdon
Hertfordshire EN11 9BU, United Kingdom

Manufacturer

Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg, Belgium

Contact Information

For any information about this medicine, please contact:
Organon Pharma (UK) Limited
Email: medicalinformationuk@organon.com

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