Talert 10 mg (20 tablets)

Do not take Talert:

If you are allergic (hypersensitive) to the active substance or to any of the excipients, to hydroxyzine or to other piperazine derivatives (similar active substances to other medicines), if you have severe kidney problems (severe kidney failure and creatinine clearance).

Take special care with Talert:

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 drug; at normal doses, no clinically significant interactions of cetirizine with alcohol have been observed (at alcohol concentrations). in the blood 0.5 g / l, corresponding to a glass of wine).

However, as with all antihistamines, concomitant use of alcohol is not recommended.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

No interactions with other drugs are expected with cetirizine.

Taking Talert with food and drink:

Food has no significant effect on the absorption of cetirizine.

Pregnancy and breast-feeding:

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

The use of Talert is not recommended during pregnancy. Accidental use by pregnant women should not lead to fetal harm, but the drug should be discontinued.

Breast-feeding

Due to the release of cetirizine in breast milk, the use of Talert 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 alertness, alertness and ability to drive after taking Talert at 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.

The following side effects may occur with the use of Talert:

• Blood and lymphatic system disorders: very rare – thrombocytopenia (low levels of platelets in the blood); Whole body: frequent – fatigue;
• Heart disorders: rare – tachycardia (rapid heartbeat);
• Eye disorders: very rare – accommodation disorder, blurred vision, uncontrolled eye movements;

Side effects:

• Gastrointestinal disorders: common – dry mouth, nausea, diarrhea: uncommon – abdominal pain;
• General disorders and administration site conditions: uncommon: asthenia (complete exhaustion), malaise; rare – swelling (swelling);
• Immune system disorders: rare – allergic reactions, some of which are severe (very rare);
• Hepato-biliary 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, tremor, dysgeusia (altered taste);
• Mental disorders: common – drowsiness: uncommon – anxiety: rare – aggression, confusion, depression, hallucinations, insomnia: very rare – tics;
• Disorders of the kidneys and urinary tract: very rare – pathological urination, Disorders of the respiratory system: common – pharyngitis, rhinitis;
• Skin and subcutaneous tissue disorders: uncommon – pruritus, rash: rare – urticaria (hives): very rare – edema, fixed drug rash.

TALERT tablets 10 mg * 20 SOPHARMA

PACKAGE LEAFLET: INFORMATION FOR THE USER

Talert 10 mg film-coated tablets

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 or pharmacist has told you.

• Keep this leaflet. You may have to read it again.
• If you need further information or advice, ask your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• 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 is and what it is used for

2. What you need to know before you take Talert

3. How to take Talert

4. Possible side effects

5. How to store Talert

6. Contents of the pack and other information

1. What Talert is and what it is used for

Talert is an antiallergic medicine that contains the active substance cetirizine dihydrochloride.

Talert is used in adults and children over 6 years of age:

– to relieve nasal (nasal) and eye symptoms in seasonal and perennial allergic rhinitis;

– to relieve 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

Do not take Talert

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

– if you have severe renal impairment (severe renal failure and creatinine clearance below 10 ml/min).

Warnings and precautions

Talk to your doctor or pharmacist before taking Talert

• If you have kidney failure, ask your doctor for advice;
• If necessary, he will appoint a lower dose.
• If you have problems urinating (due to problems with the spinal cord prostate or bladder), ask your doctor for advice.
• If you have epilepsy and a risk of seizures, you should consult your doctor before using this medication.
• At usual doses, no clinically relevant interactions of cetirizine with alcohol were observed (at a blood alcohol concentration of 0.5 g/1 corresponding to a glass of wine). No safety data are available for concomitant doses of cetirizine and alcohol. Therefore, as with all antihistamines, simultaneous use of alcohol is not recommended.
• If you have an allergy test planned, ask your doctor about the need to stop Talert for a few days before the test. This medicine may affect your allergy test results.

Other medicines and Talert

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. No interactions with other medicines are expected with cetirizine.

Talert ​​​​​​​with food and drink

Food had no significant influence on the resorption of cetirizine. Pregnancy and breast-feeding

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 is not recommended during pregnancy. Occasional use by pregnant women should not lead to harm to the fetus, but, nevertheless, the drug should be administered only necessarily and after consulting a doctor. Lactation

Cetirizine passes into breast milk. Do not take Talert during breast-feeding, except on prescription.

Driving and using machines

Clinical studies have not shown any impairment of attention, alertness or driving ability after taking Talert at the recommended doses.

If you intend to drive, perform potentially dangerous activities or use machines, you should carefully consider the impact of the medicine after taking Talert. Do not exceed the recommended dose.

Talert ​​​​​​​contains lactose and wheat starch

The medicinal product contains, as an excipient layugose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Wheat starch is included in the composition of the medicinal product. It does not pose a risk to people with coeliac disease. Patients with wheat allergy (other than celiac disease) should not take this medicine.

3 How to take Talert

Always take Talert exactly as described in this leaflet or as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Tablets should be taken with a glass of liquid. The tablet can be divided into two equal doses.
Adults and children over 12 years: 10 mg once a day (1 tablet).

Depots aged 6 to 12 years: 5 mg twice a day (1/2 tablet twice a day).

Patients with renal impairment: In patients with moderate renal impairment, 5 mg once daily is recommended.

If you suffer from serious kidney disease, please contact your doctor, who may adjust the dose accordingly.

If your child suffers from kidney disease, please contact your doctor, who can adjust the dose according to your child’s needs.

If you consider 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 to complaints and is determined by your doctor.

If you take more Talert than you should

If you think you have overdosed on Talert, please tell your doctor. He will decide what measures to take if necessary.

Following an overdose, the side effects described below may occur with increased frequency. The following side effects have been observed:

• confusion
• Diarrhea
• dizziness
• fatigue
• headache
• malaise
• pupil dilation,
• itch
• anxiety
• unnatural tranquility,
• drowsiness, stupor (numbness),
• abnormally rapid heart rate,
• trembling and urinary retention.

If you forget to take Talert

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

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

4. Possible side effects

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

The following side effects are rare or very rare, but you should stop taking the medicine and tell your doctor as soon as you notice them:

Allergic reactions, including serious reactions and angioedema (a serious allergic reaction that causes swelling of the face or throat).

These reactions may occur as soon as you take the medicine for the first time or over time.

Common side effects (may affect up to 1 in 10 people)

-Drowsiness

– Dizziness, headache

– Pharyngitis, rhinitis

– Diarrhoea, nausea, dry mouth

-Fatigue

Uncommon side effects (may affect up to 1 in 100 people)

-Anxiety

– Paresthesia (unusual sensations on the skin)

– Pain in the abdomen

– Itching, rash

– Asthenia (exhaustion), malaise

Rare side effects (may affect up to 1 in 1,000 people)

– Allergic reactions, some of which serious (very rarely)

– Depression, hallucinations, aggressiveness, confusion, insomnia

-Convulsions

– Tachycardia (fast heartbeat)

– Impaired liver function

-Urticaria

– Edema (swelling)

– Weight gain

Very rare side effects (may affect up to 1 in 10,000 people)

– Thrombocytopenia (low platelets in the blood)

– Tics (involuntary and unconscious contractions of the muscles, especially the face)

– Syncope (fainting), dyskinesia (involuntary movements), dystonia (impaired muscle tone), trembling, dysgeusia (altered taste)

– Blurred vision, accommodation impairment, oculogation (uncontrolled circular eye movements)

– Angioedema (a serious allergic reaction that causes swelling of the face or throat), fixed drug rash

– Pathological urine output (bedwetting, pain and/or difficulty urinating)

Side effects not known (frequency cannot be estimated from the available data)

– Increased appetite

Recurrent suicidal thoughts or ideas

– Amnesia, memory impairment

-Vertigo

– Urinary retention (inability of the bladder to empty completely)

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.

Reporting of adverse reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Talert

Store in the original package, in a dry and protected from light place at a temperature below 30°C.

Keep out of the reach of children.
Do not use Talert 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 contains

The active substance is cetirizine dihydrochloride 10 mg per tablet. The other ingredients are: lactose monohydrate, wheat starch, magnesium stearate, povidone, opadaray (polyvinyl alcohol; titanium dioxide E171; macrogol; talc).

What Talert looks like and contents of the pack

White to off-white, round, biconvex film-coated tablets, with a score on one side and a diameter of 7 mm.

The tablet can be divided into two equal doses.

10 film-coated tablets of 10 mg per PVC/aluminium foil blister, 1 or 2 blisters per carton, together with a package leaflet.

Marketing Authorisation Holder and Manufacturer

SOPHARMA AD, Bulgaria