Cetirizine Sandoz 10 mg - 10 film-coated tablets

Cetirizine dihydrochloride is the active ingredient in Cetirizine Sandoz. Cetirizine Sandoz is an anti-allergic drug.

Cetirizine Sandoz is indicated in adults and children aged 6 years and over for:

• Relief of nasal and eye symptoms in seasonal and perennial allergic rhinitis
• Relief from chronic hives (chronic idiopathic urticaria)

If you don't feel better or feel worse after 3 days, contact your doctor.

Contraindications

Cetirizin Sandoz must not be taken

• if you have severe kidney disease (severe impairment of kidney function with a creatinine clearance below 10 ml/min).
• if you are allergic to cetirizine dihydrochloride, hydroxyzine, other piperazine derivatives (closely related active ingredients of other medicines) or any of the other ingredients of this medicine listed in section 6.

Interactions

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

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.
The use of Cetirizine Sandoz should be avoided by pregnant women. Accidental use of this medication by pregnant women should not cause adverse health effects to the fetus. However, this medicine should only be taken on medical advice and when absolutely necessary.
Cetirizine passes into breast milk. Therefore, Cetirizine Sandoz should not be taken if you are breast-feeding without consulting a doctor.

Ability to drive and use machines
In clinical studies, Cetirizine Sandoz at the recommended dose did not produce any signs of impairment of attention, alertness or ability to drive.
After taking Cetirizin Sandoz, you should carefully monitor your reaction to the medicine if you plan to drive, take part in potentially dangerous activities or operate machines. Do not take more than the recommended dose.

Application

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.

The tablets must be taken with a glass of liquid.
The tablet can be divided into equal doses.

Adults and adolescents over 12 years of age
The recommended dose is 10 mg once daily as 1 tablet.
Other forms of this medicine may be better for your child; please ask your doctor or pharmacist.

Children 6 to 12 years of age
The recommended dose is 5 mg twice daily as half a tablet twice daily.
Other forms of this medicine may be better for your child; please ask your doctor or pharmacist.

Patients with impaired kidney function
Patients with moderate kidney failure are recommended to take 5 mg once daily.
If you have severe kidney disease, please talk to your doctor or pharmacist, who will adjust your dose accordingly.
If your child has kidney disease, please talk to your doctor or pharmacist, who will adjust the dose according to the child's needs.
If you feel that the effect of Cetirizin Sandoz is too weak or too strong, please contact your doctor.

Duration of treatment
The duration of treatment depends on the type, duration and course of your symptoms.

Side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Cetirizin Sandoz and seek medical help immediately if you notice any of the following:

• Swelling in your mouth, face and/or neck
• Difficulty breathing (tightness or wheezing in the chest)
• a sudden drop in your blood pressure followed by fainting or shock

The symptoms can include signs of an allergic reaction, anaphylactic shock and angioedema. These reactions may occur shortly after the first dose or a little later.
The following list includes other side effects, listed according to their frequency.

Common (may affect up to 1 in 10 people)

• fatigue
• dry mouth, nausea, diarrhea
• Dizziness, headache
• Somnolence (sleepiness)
• Pharyngitis (sore throat), rhinitis (swelling and irritation in the nose)

Uncommon (may affect up to 1 in 100 people)

• excitement
• stomach pain
• Asthenia (extreme fatigue), malaise (feeling of general malaise)
• Paresthesia (unusual skin sensations)
• Pruritus (itching), rash

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

• Tachycardia (heartbeat too fast)
• Edema (swelling)
• abnormal liver function
• Weight gain
• cramps
• Aggressiveness, confusion, depression, hallucination, sleep disorder
• Hives (urticaria)

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

• Thrombocytopenia (reduced number of platelets in the blood, which can cause bleeding or bruising more quickly)
• Accommodation disorder (disturbances in the eye's close/distance adjustment), blurred vision, oculogyration (uncontrollable circular movement of the eyes)
• Syncope (fainting), tremor (shaking), dysgeusia (altered sense of taste), dyskinesia (involuntary movements), dystonia (abnormal, persistent, involuntary muscle tension)
• Ticks (recurrent, nervous muscle twitches and vocalizations)
• abnormal urine output (bedwetting, pain and/or difficulty urinating)
• recurring drug eruption (skin rash)

Not known (frequency cannot be estimated from available data)

• Memory loss, memory impairment
• increased appetite
• Dizziness (feeling of spinning or movement)
• Urinary retention (inability to completely empty the bladder)
• nightmares
• Hepatitis (inflammation of the liver)
• Joint pain
• Rash with blisters containing pus
• Pruritus (severe itching) and/or urticaria (hives) when stopping treatment
• Suicidal thoughts (recurrent thoughts or preoccupation with suicide). If you feel this way, stop taking the tablets and see your doctor.

composition

The active ingredient is cetirizine dihydrochloride.
Each film-coated tablet contains 10 mg cetirizine dihydrochloride.

The other ingredients are:
Tablet core: microcrystalline cellulose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, anhydrous
Tablet coating: hypromellose, lactose monohydrate, titanium dioxide (E 171) and macrogol 4000

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