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Virlix

Virlix

cetirizine

Manufacturer:

Aesica Pharmaceuticals

Distributor:

GlaxoSmithKline
Full Prescribing Info
Contents
Cetirizine dihydrochloride.
Description
The active substance is cetirizine dihydrochloride.
Each tablet contains 10 mg of cetirizine dihydrochloride.
Each 1 mL of oral drops solution contains 10 mg cetirizine dihydrochloride.
Each 10 mL of oral solution contains 10 mg of cetirizine dihydrochloride.
Indications/Uses
Cetirizine (Virlix) contains active ingredient: cetirizine. Cetirizine belongs to a group of anti-allergic medicines called antihistamines.
Cetirizine (Virlix) is used to treat symptoms associated with allergic conditions, such as: nasal and ocular symptoms of seasonal and perennial allergic rhinitis, itchy rashes.
Dosage/Direction for Use
How much to take: Always take Cetirizine (Virlix) exactly as described in this monograph or as advised by the doctor or pharmacist. Check with the doctor or pharmacist if not sure.
Don't take more than the recommended dose.
Don't take Cetirizine (Virlix) for longer than 7 days, without advice of the doctor or pharmacist.
Contact the doctor if the symptoms worsen or do not improve after 3 days.
Adults and adolescents above 12 years old: Cetirizine (Virlix) 10 mg film-coated tablets: The usual dose of Cetirizine (Virlix) is one 10 mg tablet once a day.
Cetirizine (Virlix) 10 mg/mL oral drops solution: The usual dose of Cetirizine (Virlix) oral drops solution is 20 drops (10 mg) of oral drops solution once a day.
Cetirizine (Virlix) 1 mg/mL oral solution: The usual dose of Cetirizine (Virlix) oral solution is 10 mL (10 mg) once a day.
Children between 6 and 12 years old: Cetirizine (Virlix) 10 mg film-coated tablet: The usual dose of Cetirizine (Virlix) is half tablet (5 mg) twice a day.
Cetirizine (Virlix) 10 mg/mL oral drops solution: The usual dose of Cetirizine (Virlix) oral drops solution is 10 drops (5 mg) twice a day.
Cetirizine (Virlix) 1 mg/mL oral solution: The usual dose of Cetirizine (Virlix) oral solution is 5 mL (5 mg) twice a day.
Children between 2 and 6 years old: Cetirizine (Virlix) 10 mg film-coated tablets: Cetirizine (Virlix) film-coated tablets are not recommended for children under 6 years, as this formulation does not allow for appropriate dose adaptation.
Cetirizine (Virlix) 10 mg/mL oral drops solution: The usual dose of Cetirizine (Virlix) 5 drops (2.5 mg) twice a day.
Cetirizine (Virlix) 1 mg/mL oral solution: The usual dose of Cetirizine (Virlix) 2.5 mL (2.5 mg) twice a day.
Patients with kidney and liver disease: The doctor will decide on the correct dose of Cetirizine (Virlix) depending on the illness and the results of blood tests carried out before treatment. Patients who have end stage impairment of kidney function must not take Cetirizine (Virlix) (see Contraindications).
If the child suffers from kidney disease, contact the doctor or pharmacist who may adjust the dose accordingly.
How to take: Cetirizine (Virlix) 10 mg film-coated tablets: Swallow the tablet whole, with a glass of water. The patient can divide the tablet into two equal doses.
Cetirizine (Virlix) 10 mg/mL oral drops solution: Dilute drops in water. The diluted drops should be swallowed immediately.
Cetirizine (Virlix) 1 mg/mL oral solution: The solution can be swallowed as such.
A dosing oral syringe (for oral drops) with a 1 mL graduation or measuring cup (for oral solution) with a 10 mL graduation is supplied with the pack so the patient can measure the dose accurately. If not supplied with an oral syringe or measuring cup speak to the doctor or pharmacist.
If the patient forgets to take Cetirizine (Virlix): Don't take an extra dose to make up for a missed dose. Just take the next dose at the usual time.
If the patient is not sure what to do, ask the doctor or pharmacist.
If the patient stops taking Cetirizine (Virlix): Rarely, pruritus (intense itching) and/or urticaria may occur if the patient stops taking Cetirizine (Virlix).
Overdosage
If the patient takes too much Cetirizine (Virlix): If the patient takes too much Cetirizine (Virlix), contact the doctor or pharmacist for advice. If possible, show them the Cetirizine (Virlix) pack.
If the patient takes too much Cetirizine (Virlix) the patient may be more likely to have side effects such as: confusion, diarrhoea, dizziness, tiredness, headache, malaise, dilating of pupil, itching, restlessness, sedation, somnolence (feeling drowsy), stupor, abnormal rapid heart rate, tremor, urinary retention.
Contraindications
If the patient is allergic (hypersensitive) to cetirizine, hydroxyzine, any piperazine derivatives (closely related active ingredients of other medicines), or to any other ingredients of Cetirizine (Virlix).
If the patient has severe kidney disease (severe impairment of kidney function with creatinine clearance below 10 mL/min).
If the patient uses other antiallergic medicines.
If the patient thinks any of these apply, don't take Cetirizine (Virlix) until the patient has checked with the doctor.
Special Precautions
Talk to the doctor or pharmacist before using Cetirizine (Virlix): If the patient has kidney problems (the doctor may lower the dose of Cetirizine (Virlix).
If the patient has difficulty passing urine or the patient has conditions that makes him/her more likely to be unable to empty the bladder, such as spinal cord injury or enlarged prostate.
If the patient has epilepsy or the patient is at risk of convulsions (fits).
If the patient is pregnant of breast-feeding (see Use in Pregnancy & Lactation).
Check with the doctor if the patient thinks any of these may apply to him/her.
Cetirizine (Virlix) oral drops solution/oral solution is not recommended for infants and children under 2 years.
Cetirizine (Virlix) film-coated tablets are not recommended for children under 6 years, as this formulation does not allow for appropriate dose adaptation.
While the patient is taking Cetirizine (Virlix): Avoid alcohol while the patient is taking Cetirizine (Virlix).
Cetirizine (Virlix) may affect the allergy test results. If the patient is scheduled for allergy testing, ask the doctor if the patient should stop taking Cetirizine (Virlix) for several days before testing.
Contact the doctor if the patient has high temperature (fever), shivering or chills, as the patient may require other type of treatment.
Conditions the patient needs to look out for: Cetirizine (Virlix) can make some existing conditions worse, or cause severe allergic reactions or urinary retention. Some people may have suicidal thoughts when taking Cetirizine (Virlix). The patient must look out for certain symptoms while the patient is taking Cetirizine (Virlix), to reduce the risk of any problems, see Side Effects.
Excipients: Tablets 10 mg: This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Driving and using machines: Cetirizine (Virlix) at the recommended dose is unlikely to affect the ability to drive or use machines. However, some patients being treated with Cetirizine (Virlix) may feel drowsy, tired or weak (see Side Effects).
Don't drive or use machines unless the patient is sure he/she is not affected.
Use In Pregnancy & Lactation
Cetirizine (Virlix) should be avoided in pregnant women.
Tell the doctor if the patient is pregnant or planning to become pregnant.
If the patient becomes pregnant during treatment with Cetirizine (Virlix), tell the doctor.
The ingredients in Cetirizine (Virlix) can pass into breast milk. If the patient is breast-feeding, she must check with the doctor before she takes Cetirizine (Virlix).
Side Effects
Like all medicines, Cetirizine (Virlix) can cause side effects, but not everybody gets them.
Conditions the patient needs to look out for: Severe allergic reactions: Signs include: raised and itchy rash (hives); swelling, sometimes of the face or mouth (angioedema), causing difficulty in swallowing or breathing; collapse or loss of consciousness.
Urinary retention: Signs include: pain when passing urine or inability to pass urine.
Suicidal thoughts: Some people had suicidal thoughts when taking Cetirizine (Virlix).
Contact a doctor immediately if the patient gets these symptoms. Stop taking Cetirizine (Virlix).
Common side effects: These may affect up to 1 in 10 people: Somnolence (sleepiness); dizziness, headache; pharyngitis, rhinitis (in children); diarrhoea (in children), nausea, dry mouth; fatigue.
Uncommon side effects: These may affect up to 1 in 100 people: Agitation; paraesthesia (tingling or numbness of the hands or feet); diarrhoea; stomach pain; pruritus (itching), rash; asthenia (unusual weakness), malaise.
Rare side effects: These may affect up to 1 in 1,000 people: Hypersensitivity; aggression, confusion, depression, hallucination, insomnia (sleeplessness); convulsions; tachycardia (fast heart beat); liver function abnormal (reflected in the blood tests); urticaria; oedema (swelling); increased weight.
Very rare side effects: These may affect up to 1 in 10,000 people: Thrombocytopenia (low blood platelet count); anaphylactic shock (see 'Severe allergic reactions' as previously mentioned); tics (uncontrolled body movements); dysgeusia (taste disturbance or loss of taste), dyskinesia (uncontrollable movements), dystonia (uncontrolled circular movements); accommodation disorder (difficulty focusing), blurred vision, oculogyration (eyes having uncontrolled circular movements); angioedema (serious allergic reaction which causes swelling of the face or throat), fixed drug eruption; dysuria (pain when passing urine) (see 'Urinary retention' as previously mentioned), enuresis (bed wetting).
Other side effects: Have occurred but their exact frequency is unknown: Increased appetite; suicidal ideation (see 'Suicidal thoughts' as previously mentioned), nightmare; amnesia, memory impairment; vertigo (spinning sensation); inflammation of the liver; urinary retention (difficulty passing urine) (see 'Urinary retention' as previously mentioned); joint pain; rash with blisters containing pus; intense itching (pruritus) upon discontinuation.
Tell the doctor or pharmacist if any of the side effects listed becomes severe or troublesome, or if the patient notices side effects not listed in this monograph.
Drug Interactions
Other medicines and Cetirizine (Virlix): Tell the doctor or pharmacist if the patient is taking any other medicines, if the patient has taken any recently, or if the patient starts taking new ones. This includes medicines bought without a prescription. Some medicines may affect how Cetirizine (Virlix) works, or make it more likely that they'll have side effects. Cetirizine (Virlix) can also affect how some other medicines work. These include: medicines acting on the brain, for example other antihistamines such as hydroxizine, clemastine, medicines used to treat anxiety such as diazepam or sleeping pills such as zolpidem (concurrent administration of Cetirizine (Virlix) with other agents acting on the brain may cause additional reductions in alertness and impairment of performance, see 'Food and drink with Cetirizine (Virlix)' as follows).
Tell the doctor or pharmacist if the patient is taking any of these.
Food and drink with Cetirizine (Virlix): Avoid alcohol when the patient is taking Cetirizine (Virlix). In sensitive patients, the concurrent administration of Cetirizine (Virlix) and alcohol may cause additional reductions in alertness and impairment of performance.
Storage
Store in original packaging.
Don't store Cetirizine (Virlix) above 30°C.
Tablets: Don't dispose of medicines in wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. This will help to protect the environment.
Oral drops solution & oral solution: Throw away the bottle 90 days after first opening it, but don't dispose of the medicine in wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. This will help to protect the environment.
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R06AE07 - cetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.
Presentation/Packing
Form
Virlix FC tab 10 mg
Packing/Price
50's
Form
Virlix oral drops 10 mg/mL
Packing/Price
10 mL x 1's
Form
Virlix oral soln 1 mg/mL
Packing/Price
30 mL x 1's
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