Talert syrup 1 mg / 1 ml. 120 ml.

1. What Talert Syrup is and what it is used for

Talert Syrup contains the active substance cetirizine dihydrochloride. Talert Syrup is an anti-allergy medication.

Talert Syrup is used in adults and children over 2 years of age:

for the relief of nasal and ocular symptoms associated with seasonal and perennial allergic rhinitis;

for the relief of chronic hives (chronic idiopathic urticaria).

If you do not feel better after 3 days, or if your condition worsens, you should seek medical attention.

2. What you need to know before you take Talert Syrup

Do not take Talert Syrup

if you are allergic (hypersensitive) to cetirizine, hydroxyzine, or other piperazine derivatives (substances similar to the active ingredient in other medicines), or to any of the other ingredients of this medicine (listed in section 6).

if you have severe kidney impairment (severe renal failure with a creatinine clearance below 10 ml/min).

Warnings and precautions

Talk to your doctor or pharmacist before taking Talert Syrup.

If you have kidney failure, consult your doctor; if necessary, they will prescribe a lower dose.

If you have epilepsy or are at risk of seizures, you should consult your doctor before using this medicine. Other medicines and Talert Syrup

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

No interactions with other medicines are expected when using cetirizine.

Talert Syrup with food, drink, and alcohol

Food does not significantly affect the absorption of cetirizine.

At usual doses, no clinically significant interactions between cetirizine and alcohol have been observed (at a blood alcohol concentration of 0.5 g/l, corresponding to a glass of wine). However, as with all antihistamines, the concurrent use of alcohol is not recommended.

Pregnancy, breastfeeding, and fertility

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.

Pregnancy

The use of Talert Syrup is not recommended during pregnancy.

Breastfeeding:

Because cetirizine passes into breast milk, the use of Talert Syrup while breastfeeding is not advisable. If use is considered necessary, breastfeeding should be discontinued.

Driving and using machines

Clinical studies have shown no impairment of attention, alertness, or the ability to drive after taking Talert Syrup at the recommended doses. If you intend to drive, engage in potentially hazardous activities, or operate machinery, you must not exceed the recommended dose. Carefully assess the effect the medication has on you.

If you are a sensitive individual, be aware that the concurrent use of alcohol or other substances that depress the nervous system may lead to a further reduction in alertness and impair your ability to react.

Talert Syrup contains:

The syrup contains methyl parahydroxybenzoate and propyl parahydroxybenzoate as excipients; although rare, these may cause allergic reactions (which can be of a delayed type). The syrup also contains aspartame, a source of phenylalanine. It may be harmful to individuals with phenylketonuria.

3. How to take Talert Syrup

Always take this medicine exactly as described in this leaflet or as instructed by your doctor, pharmacist, or nurse. If you are unsure about anything, consult your doctor or pharmacist.

Follow the recommendations below, unless your doctor has provided different instructions regarding the use of Talert Syrup.

Children aged 2 to 6 years: 2.5 ml (2.5 mg) twice daily.

Children aged 6 to 12 years: 5 ml (5 mg) twice daily. Adults and children over 12 years of age: 10 ml (10 mg) once daily.

Patients with moderate to severe renal impairment.

For patients with moderate renal impairment, a dose of 5 ml of syrup once daily is recommended.

If you feel that the effect of Talert is too weak or too strong, please consult your doctor.

Duration of treatment

The duration of treatment depends on the type, duration, and response of your symptoms, and is determined by your doctor.

If you have taken more Talert syrup than you should

If you think you have taken an overdose of Talert syrup, please inform your doctor. They will decide what measures, if any, need to be taken.

Following an overdose, the adverse reactions described below may occur more frequently. The following adverse reactions have been observed: confusion, diarrhea, dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness, sedation, drowsiness, stupor (numbness/unresponsiveness), abnormally rapid heart rate, tremors, and urinary retention.

If you have missed a dose of Talert syrup

Do not take a double dose to make up for a forgotten dose.

If you have any further questions regarding the use of this product, please ask your doctor or pharmacist. 4.

Possible side effects

Like all medicines, Talert syrup can cause side effects, although not everybody gets them.

The following side effects have been observed during the post-marketing period. Their frequency is defined as follows: common: from 1 in 100 to 1 in 10 patients; uncommon: from 1 in 1,000 to 1 in 100 patients; rare: from 1 in 10,000 to 1 in 1,000 patients; very rare: less than 1 in 10,000 patients.

Blood and lymphatic system disorders: very rare – thrombocytopenia (low platelet count in the blood);

Cardiac disorders: rare – tachycardia (rapid heart rate);

Eye disorders: very rare – accommodation disorders, blurred vision, uncontrolled eye movements;

Gastrointestinal disorders: common – dry mouth, nausea; uncommon – abdominal pain, diarrhoea;

General disorders and administration site conditions: common – fatigue; uncommon – asthenia (profound exhaustion), malaise; rare – oedema (swelling);

Immune system disorders: rare – allergic reactions, some of which are severe (very rare);

Hepatobiliary disorders: rare – impaired liver function; Investigations: rare – weight gain;

Nervous system disorders: common – dizziness, headache; uncommon – paraesthesia (unusual sensations on the skin); rare – convulsions, movement disorders; very rare – syncope (fainting), tremor (shaking of the limbs), dysgeusia (altered taste);

Psychiatric disorders: common – drowsiness; uncommon – anxiety; rare – aggression, confusion, depression (feeling down), hallucinations, insomnia; very rare – tics;

Renal and urinary disorders: very rare – burning and pain during urination, bedwetting (nocturnal enuresis);

Respiratory disorders: common – pharyngitis (sore throat), rhinitis (runny nose);

Skin and subcutaneous tissue disorders: uncommon – itching, rash; rare – urticaria (hives); very rare – oedema (swelling), fixed drug eruption.

Inform your doctor if any of the listed adverse reactions occur. At the first signs of a hypersensitivity reaction, stop taking Talert. Your doctor will assess the severity of the condition and decide on the necessary further steps.

5. How to store Talert syrup

This medicinal product does not require any special storage conditions.

Keep out of the reach of children. The syrup can be used for up to 6 months after opening the bottle.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These measures will help to protect the environment.

What Talert syrup contains

The active substance is cetirizine dihydrochloride, 1 mg per 1 ml of syrup.

The other ingredients are: sodium acetate trihydrate, glacial acetic acid, glycerol, propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), aspartame (E951), and liquid "exotic" flavoring.

What Talert syrup looks like and contents of the pack

Talert syrup is a clear, colorless liquid.

120 ml of syrup in a dark glass bottle with an aluminum or polyethylene cap, or in a dark polyethylene terephthalate (PET) bottle with a polyethylene cap, supplied with a measuring cup and a package leaflet in a cardboard box.