Talert Syrup 1mg/ml (120 ml)

Side effects:

Like all medicines, Talert syrup can cause side effects, although not everybody gets them.
The following adverse reactions were observed in the post-marketing setting. Their frequency is defined as follows:

• common: from 1 patient per 100 to 1 per 10;
• uncommon: 1 patient in 1,000 to 1 in 100;
• rare: from 1 patient in 10,000 to 1 in 1,000;
• very rare: less than 1 in 10,000

Blood and lymphatic system disorders: 

• very rare – thrombocytopenia (low levels of platelets in the blood);

Cardiac disorders:

• rare – tachycardia (rapid heartbeat);

Eye disorders: 

• very rare – accommodation disorder, blurred vision, uncontrolled eye movements;

Gastrointestinal disorders: 

• common – dry mouth, nausea;
• uncommon – abdominal pain, diarrhea;

General disorders and administration site conditions: 

• common – fatigue;
• uncommon: asthenia (complete exhaustion), malaise;
• rare – swelling (swelling);

Immune system disorders: 

• rare – allergic reactions, some of which are severe (very rare);

Hepatobiliary disorders: 

• rare – impaired liver function;

Research: 

• rare – weight gain;

Nervous system disorders: 

• common – dizziness, headache;
• uncommon – paresthesia (unusual skin sensations);
• rare – convulsions, movement disorders;
• very rare – syncope (fainting), tremor (shaking of the limbs), dysgeusia (altered taste);

Mental disorders: 

• frequent – drowsiness;
• uncommon – anxiety;
• rare – aggression, confusion, depression (depression), hallucinations, insomnia;
• very rare – tics;

Renal and urinary disorders: 

• very rare – burning and soreness when urinating, nocturnal urination;

Respiratory disorders: 

• common – pharyngitis (sore throat), rhinitis (runny nose);

Skin and subcutaneous tissue disorders: 

• uncommon – pruritus, rash;
• rare – urticaria (hives);
• very rare – edema, fixed drug rash.

Tell your doctor if you get any of these side effects. At the first sign of a hypersensitivity reaction, stop taking Talert. Your doctor will assess the severity of the condition and decide what next steps need to be taken.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Do not take Talert syrup

• if you are allergic (hypersensitive) to cetirizine, hydroxyzine or other piperazine derivatives (similar active substances to other medicines) or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe kidney failure and creatine below 10 ml / min).

Warnings and precautions

Talk to your doctor or pharmacist before taking Talert syrup.

• If you have kidney failure, ask your doctor for advice; if necessary, he will prescribe a lower dose;
• If you have epilepsy and risk of seizures, you should consult your doctor before using this medicine;

No clinically significant interactions of cetirizine with alcohol were observed at usual doses (at a blood alcohol concentration of 0.5 g / l corresponding to a glass of wine). However, as with all antihistamines, concomitant use of alcohol is not recommended.

Special instructions:

The syrup contains as excipients methyl and propyl parahydroxybenzoate, which, although rare, can cause allergic reactions (possibly delayed).

The syrup contains aspartame, a source of phenylalanine. It can be harmful for people with phenylketonuria.

Storage:

Store in the original package, in a dark place, at a temperature below 30 ° C. Do not freeze.
Keep out of reach of children.

The syrup can be used up to 1 month after opening the bottle.

Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

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

Other medicines and Thalert syrup:

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

No interactions with other drugs are expected with cetirizine.

Tolerate syrup with food and drink:
Food has no significant effect on the absorption of cetirizine.

Pregnancy, breast-feeding and fertility:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of Thalert syrup is not recommended during pregnancy.

Breast-feeding

Due to the release of cetirizine in breast milk, the use of Talert syrup during breast-feeding is undesirable. In cases of emergency use, breast-feeding should be discontinued.

Driving and using machines:

Clinical studies have not shown impairment of attention, alertness and ability to drive after taking Thalert syrup in the recommended doses.

If you intend to drive, perform potentially dangerous activities or operate machinery, you should not exceed the recommended dose. Carefully consider the effect of the drug.

If you are in the group of sensitive patients, you are likely to find that concomitant use of alcohol or other drugs with a depressant effect on the nervous system may cause a further decrease in attention and affect your ability to react.

Overdose:

If you take more Talert syrup than you should If you think you have overdosed on Talert syrup, please tell your doctor. He will consider what measures to take if necessary.
Following an overdose, the following side effects may occur with increased frequency. The following side effects have been reported: confusion, diarrhea, dizziness, tiredness, headache, malaise, dilated pupils, itching, restlessness, sedation, drowsiness, stupor (numbness), abnormally fast heartbeat, tremors and urinary retention.

If you forget to take Talert syrup

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

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

TALERT syrup 10 mg / 10 ml 120 ml SOPHARMA

Package leaflet: user information

TALERT 10 mg/ml syrup

cetirizine dihydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
Keep this leaflet. You may have to read it again.
If you need further information or advice, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
If after 3 days you do not feel better or your condition worsens, you should seek medical attention.

What is in this leaflet
1. What Talert syrup is and what it is used for
2. What you need to know before you take Talert syrup
3. How to take Talert syrup
4. Possible side effects
5. How to store Talert syrup
6. Contents of the pack and other information

1. What Talert syrup is and what it is used
for Talert syrup contains the active substance cetirizine dihydrochloride. Talert syrup is an antiallergic drug.
Talert syrup is used in adults and children over 2 years of age:

• for relief of nasal (nasal) and eye symptoms in seasonal and perennial allergic rhinitis;
• for relief in chronic hives (chronic idiopathic urticaria).

If after 3 days you do not feel better or 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 (similar active substances to other medicines) or to any of the other ingredients of this medicine (listed in section 6);
• • if you have severe renal impairment (severe renal failure and creatine less than 10 ml/min).

Warnings and precautions
Talk to your doctor or pharmacist before taking Talert syrup.

• If you have kidney failure, ask your doctor for advice; if necessary, he will appoint a lower dose;
• If you have epilepsy and a risk of seizures, you should consult your doctor before using this drug;
• At usual doses, no clinically relevant interactions of cetirizine with alcohol were observed (at a blood alcohol concentration of 0.5 g/l corresponding to a glass of wine). However, as with all antihistamines, simultaneous use of alcohol is not recommended.

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 with cetirizine.

Talert ​​​​​​​syrup with food and drink
Food does not significantly affect the resorption of cetirizine.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The use of Talert syrup is not recommended during pregnancy.

Due
to the release of cetirizine in breast milk, the use of Talert syrup during breastfeeding is undesirable. In cases of imperative use, breast-feeding should be discontinued.

Clinical
studies have shown no impairment of attention, alertness or ability to drive after taking Talert syrup at the recommended doses.
If you intend to drive, perform potentially dangerous activities or use machines, you should not exceed the recommended dose. Carefully consider the effect of the drug.
If you’re in the sensitive patient group, chances are you’ll find that concomitant use of alcohol or other drugs with a depressing effect on the nervous system may cause further attention loss and affect your ability to respond.

The
syrup contains as excipients methyl- and propyl parahydroxybenzoate, which, although rare, can cause allergic reactions (possibly of the delayed type).
The syrup contains aspartame, a source of phenylalanine. It may be harmful for people with phenylketonuria.

3. How to take Talert syrup
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor or pharmacist if you are not sure.
Follow the recommendations below unless your doctor has given you other instructions on the use of Talert syrup.
Children aged 2 to 6 years: 2.5 ml (2.5 mg) 2 times a day.
Children aged 6 to 12 years: 5 ml (5 mg) 2 times a day.
Adults and children over 12 years of age: 10 ml (10 mg) once a day.
Patients with moderate to severe renal impairment: In patients with moderate renal impairment, it is recommended to take 5 ml of syrup once a day.
If you consider that the effect of Talert is too weak or too strong, please consult your doctor.

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

If you take more Talert ​​​​​​​syrup than you should
If you think you have overdosed on Talert syrup, please tell your doctor. He will decide what measures to take if necessary.
After The side effects described below may occur with increased frequency. The following side effects have been observed: confusion, diarrhoea, dizziness, fatigue, headache, malaise, pupillary dilation, itching, restlessness, calmness, drowsiness, stupor (numbness), abnormally rapid heart rate, trembling and urinary retention.

If you forget to take Talert syrup
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects Like all medicines, Talert syrup can cause side effects
, although not everybody gets them.
Subsequent adverse reactions were observed in the post-marketing period. Their frequency is defined as follows: common: from 1 patient in 100 to 1 in 10; uncommon: from 1 patient in 1,000 to 1 in 100; rare: from 1 patient in 10,000 to 1 in 1,000; very rare: less than 1 in 10,000.

Disorders of the blood and lymphatic system:
very rare – thrombocytopenia (low levels of platelets in the blood);

Heart disorders:
rare – tachycardia (rapid heartbeat);

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

Gastrointestinal disorders:
common – dry mouth, nausea;
uncommon – pain in the abdomen, diarrhea;

General disorders and effects at the site of application:
common — fatigue;
uncommon: asthenia (complete exhaustion), malaise;
rare – edema (swelling);

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

Hepatobiliary disorders:
rare – impaired liver function;

Research:
rare – weight gain;

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

Psychiatric disorders:
common — drowsiness;
uncommon – anxiety;
rare – aggressiveness, confusion, depression (depression), hallucinations, insomnia;
very rare – tics;

Disorders of the kidneys and urinary tract:
very rareand – burning and soreness when urinating, bedwetting;

Disorders of the respiratory system:
common – pharyngitis (sore throat), rhinitis (runny nose);

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

Tell your doctor if any of these side effects occur. At the first sign of a hypersensitivity reaction, stop taking Talert. Your doctor will assess the severity of the condition and decide what next measures need to be taken.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Talert syrup
Store in the original package, in a place protected from light, at a temperature below 30°C. Do not freeze.
Keep out of the reach of children.
The syrup can be used up to 1 month after opening the bottle.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Talert syrup contains The active substance is cetirizine dihydrochloride 1 mg in 1 ml syrup
.
The other ingredients are sodium acetate trihydrate, glacial acetic acid, glycerol, propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), aspartame (E951), liquid essence “exotic”.

Marketing Authorisation Holder and Manufacturer:

SOPHARMA AD, Bulgaria.