10 mg film-coated tablets
cetirizine dihydrochloride
What Vialerg is and what it is used for
Cetirizine dihydrochloride is the active ingredient in Vialerg.
vialerg 10 mg film-coated tablets can be used in adults and children from 6 years of age for temporary allergic symptoms such as red, watery, and itchy eyes as well as runny nose, nasal congestion, and sneezing. The allergic problems can be caused by, among other things, pollen, fur animals, mites, or dust.
The cetirizine contained in Vialerg may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
You must talk to a doctor if you do not feel better or if you feel worse.
What you need to know before taking Vialerg
Do not take Vialerg:
- if you are allergic to cetirizine dihydrochloride or any other ingredient in this medicine (listed in section 6), hydroxyzine or piperazine derivatives (a closely related ingredient in other medicines).
- if you have severe kidney disease (severely impaired kidney function with creatinine clearance below 10 ml/min);
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Vialerg.
- If you have impaired kidney function, consult a doctor; possibly the dose may need to be adjusted. The new dose is determined by the doctor. If you are a patient at risk of urinary retention (urinary tract problems), because cetirizine may increase the risk of urinary retention.
- If you have epilepsy or are at risk of convulsions, consult your doctor. If you are going to undergo an allergy test, you should stop taking Vialerg at least 3 days before the test.
No clinically relevant interaction between alcohol (at 0.5 per thousand (g/l) in the blood, which is equivalent to a glass of wine) and cetirizine has been shown when cetirizine is taken in the recommended dose. However, as with all antihistamines, simultaneous consumption of Vialerg and alcohol should be avoided.
Children
The film-coated tablets are not recommended for children under 6 years of age as this formulation is not adapted for the necessary dose adjustment.
Other medicines and Vialerg
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Due to the properties of cetirizine, cetirizine is neither expected to affect other medicines nor for other medicines to affect cetirizine.
vialerg with food and alcohol
Absorption of Vialerg is not affected by food.
For information on consuming alcohol, see information on alcohol in the “Warnings and Precautions” section above.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
vialerg should be avoided by pregnant women. Accidental use of the drug by a pregnant woman should not cause any harmful effects on the fetus. However, the medicine should only be given if it is necessary and after the advice of a doctor.
Cetirizine passes into breast milk. Risk of side effects in breastfed infants cannot be excluded. Therefore, you should not use Vialerg during breastfeeding without consulting a doctor.
Driving ability and use of machinery
Clinical studies have not shown that Vialerg impairs attention, vigilance, or driving ability at normal doses.
If you intend to drive a motor vehicle, participate in potentially dangerous activities, or use machinery, do not exceed the recommended dose. You should know how you react to the medicine.
If you are sensitive, concomitant use of alcohol or other sedatives may further affect your alertness and responsiveness.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Vialerg contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
How to take Vialerg
Always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. Consult a doctor, pharmacist, or nurse if you are unsure.
How and when to take Vialerg
These guidelines apply unless your doctor has given you other instructions about how to use Vialerg.
Follow these instructions, otherwise, Vialerg may not have its full effect.
The tablets should be swallowed with a glass of liquid.
The tablet can be divided into two equal doses.
Adults and young people over 12 years of age
The recommended dose is 1 tablet (10 mg) once daily.
Other forms of medicine may be more suitable for children, ask the doctor or pharmacist.
Children between 6 and 12 years
The recommended dose is 5 mg 2 times daily as ½ tablet 2 times daily. Other forms of medicine may be more suitable for children, ask the doctor or pharmacist.
Patients with impaired renal function:
The recommended dose for patients with moderately impaired renal function is 5 mg once daily.
If you have a serious kidney disease, contact your doctor or pharmacist who can then adjust the dose.
If your child has kidney disease, contact a doctor or pharmacist who can then adjust the dose according to your child’s needs.
Treatment time
If you need to use Vialerg for longer than 14 days, you should contact a doctor to rule out a more serious cause of the symptoms.
If you have taken too much Vialerg
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
After an overdose, the side effects described below can occur with increased intensity. Side effects such as confusion, diarrhea, dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness, drowsiness, sleepiness, stiffness, abnormally high heart rate, tremors, and difficulty throwing water have been reported.
If you forget to take Vialerg
Do not take a double dose to make up for a missed tablet. Continue with the normal prescribed dose.
If you stop taking Vialerg
In rare cases, intense itching ( pruritus ) and/or hives may occur when you stop taking Vialerg.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
- Stop taking Vialerg and contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, or throat, difficulty swallowing, hives, and trouble breathing.
The following side effects have been reported after marketing.
Common side effects ( may affect up to 1 in 10 users)
- Dizziness
- Headache
- Somnolence
- Fatigue
- Dry mouth
- Nausea
- Diarrhea
- Inflammation of the throat
- Runny nose (swelling and irritation in the nose)
Uncommon side effects ( may affect up to 1 in 100 users)
- Restlessness
- Paresthesia (abnormal sensations in the skin)
- Rash
- Pruritus ( itching )
- Stomach ache
- General malaise
- Asthenia (extreme weakness)
Rare side effects ( may affect up to 1 in 1,000 users)
- Allergic reactions
- Aggressiveness
- Confusion
- Depression
- Insomnia _
- Hallucinations
- Seizures
- Palpitation
- Altered liver function
- Hives
- Swellings
- Weight gain
Very rare side effects ( may affect up to 1 in 10,000 users)
- Thrombocytopenia (bleeding and bruising easily)
- Life-threatening allergic reactions including angioedema (causing swelling of the face or throat)
- Fainting
- Tremors
- Involuntary movements
- Dysgeusia (altered sense of taste)
- Tics
- Difficulty focusing
- Blurred vision
- Oculogyric crisis (uncontrolled eye movements)
- Drug rash often recurs in the same place
- Abnormal urine output
Frequency unknown (cannot be calculated from available data)
- Memory loss, memory impairment
- Increased appetite
- Suicidal ideation (recurrent thoughts or preoccupation with suicide), nightmare
- Vertigo (sense of rotation or movement)
- Urinary retention (inability to empty the bladder)
- Intense itching and/or hives when treatment ends
- Joint pain
- Rash with blisters
- Hepatitis ( inflammation of the liver).
If you get any of the above side effects, you must inform the doctor. Stop taking Vialerg at the first sign of a hypersensitivity reaction. The doctor evaluates the severity and decides on possible measures.
How to store Vialerg
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is cetirizine dihydrochloride. 1 film-coated tablet contains 10 mg of cetirizine dihydrochloride.
- Other ingredients are lactose monohydrate, corn starch, pregelatinized corn starch, magnesium stearate, talc, hypromellose, macrogol 6000, and titanium dioxide (E 171).
Appearance and package sizes of the medicine
White to off-white, film-coated, capsule-shaped tablets with a score and debossed “10”. The tablet can be divided into two equal doses.
Package sizes (PVC-Aluminium blister): 10, 20, or 30 tablets.
Not all pack sizes may be marketed
Orifarm Generics A/S
Energizer 15
5260 Odense S
Denmark
Local representative:
Orifarm Generics AB,
Box 56048
102 17 Stockholm
info@orifarm.com
This medicine is approved in the European Economic Area under the names:
| Sweden, Denmark | Vial allergy |
| Norway | Cetirizine Orifarm |