Nossin

Package leaflet: Information for the patient

Nossin, 5 mg, film-coated tablets
Levocetirizini dihydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Nossin is and what it is used for
2. Important information before taking Nossin
3. How to take Nossin
4. Possible side effects
5. How to store Nossin
6. Contents of the pack and other information

1. What Nossin is and what it is used for
The active substance in Nossin is levocetirizine dihydrochloride.
Nossin is an antiallergic medicine.
Nossin is used to treat symptoms associated with:

• allergic rhinitis (including perennial allergic rhinitis)
• urticaria.

2. Important information before taking Nossin

When not to take Nossin

• if you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, any other piperazine derivatives, or to any of the excipients listed in section 6.
• if you have severe renal function impairment (severe renal failure with creatinine clearance less than 10 ml/min).

Warnings and precautions
Before starting Nossin, discuss it with your doctor or pharmacist.
If you may have difficulty emptying your bladder (e.g. due to spinal cord injury or benign prostatic hyperplasia), consult your doctor.
Nossin may increase the risk of seizures; therefore, consult your doctor if you have epilepsy or are at risk of seizures.
If you have planned allergy testing, ask your doctor whether you should stop taking Nossin a few days before the test. Nossin may affect the results of allergy tests.

Children
Nossin film-coated tablets are not recommended for children under 6 years of age, as appropriate dose adjustment is not feasible with this formulation.

Nossin with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Taking Nossin with food, drink and alcohol
Exercise caution when taking Nossin together with alcohol or other substances affecting brain function.
In sensitive individuals, concomitant use of Nossin with alcohol or other centrally acting substances may additionally reduce alertness and reaction ability.
Nossin may be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.

Driving and using machines
Some patients treated with Nossin may experience drowsiness, somnolence, fatigue, or exhaustion.
Exercise caution when driving or operating machinery until you know how you react to the medicine. However, specific studies conducted in healthy volunteers taking levocetirizine at the recommended dose did not show any effect on attention, reaction ability, or driving performance.

Nossin contains lactose
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Nossin

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose for adults and children aged 6 years and older is 1 tablet per day.
Dosing in special patient groups:
Renal and hepatic impairment
In patients with impaired kidney function, a dose reduction may be necessary depending
on the severity of kidney disease. In children, the dose should also be adjusted according to body weight; the dose will be determined by the doctor.
Nossin must not be used in patients with severe renal impairment.
Patients with impaired liver function alone should usually receive the recommended dose.
In patients with both impaired liver and kidney function, a lower dose may be required depending on the severity of kidney disease. In children, the dose should also be adjusted according to body weight; the dose will be determined by the doctor.
Elderly patients (aged 65 years and above)
Dose adjustment is not necessary in elderly patients if kidney function is normal.
Use in children
Nossin tablets are not recommended for children under 6 years of age.
How and when to take Nossin?
For oral use only.
Nossin tablets should be swallowed whole with water. The medicine may be taken during or between meals.
How long to take Nossin?
The duration of treatment depends on the type, duration, and severity of the disease symptoms and is determined by the doctor.
Use of a higher than recommended dose of Nossin
In adults, taking a higher than recommended dose of Nossin may cause drowsiness. In children, initial excitation and restlessness, especially motor restlessness, may occur, followed by drowsiness.
If an overdose of Nossin is suspected, consult a doctor who will decide on the necessary actions.
Missed dose of Nossin
If a dose of Nossin is missed or a lower than recommended dose is taken, do not take a double dose to make up for the missed dose. Instead, take the next dose at the usual time.
Discontinuation of Nossin
Stopping treatment with Nossin should not cause harmful effects. However, in rare cases, itching (intense pruritus) may occur after discontinuation of Nossin, even if these symptoms were not present before starting treatment. These symptoms may resolve spontaneously. In some cases, symptoms may be severe and treatment may need to be resumed. These symptoms should resolve upon resumption of treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Common: may occur in less than 1 in 10 patients
Dry mouth, headache, fatigue and drowsiness / somnolence
Uncommon: may occur in less than 1 in 100 patients
Feeling of exhaustion and abdominal pain
Frequency unknown: cannot be estimated from the available data
Other adverse effects reported include: palpitations, increased heart rate, convulsions, tingling, dizziness, fainting, tremor, taste disturbances (altered sense of taste), sensation of spinning or swaying, visual disturbances, blurred vision, rotatory eye movements (uncontrolled circular eye movements), painful or difficult urination, inability to completely empty the urinary bladder, swelling, itching, rash, urticaria (skin swelling, redness and itching), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, restlessness and aggressive behaviour, hallucinations, depression, insomnia, recurring suicidal thoughts or interest in suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhoea.
Itching (intense pruritus) after discontinuation of the medicine.

If the first symptoms of hypersensitivity reactions occur, treatment with Nossin should be discontinued and the doctor should be informed immediately. Symptoms of hypersensitivity reactions may include: swelling of the lips, tongue, face and (or) throat, difficulty breathing or swallowing (chest tightness or wheezing), urticaria, sudden drop in blood pressure leading to collapse or shock, which may result in death.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nossin

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after:
"EXP". The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Nossin contains

• The active substance is levocetirizine. Levocetirizine is present in the form of levocetirizine dihydrochloride (5 mg), equivalent to 4.2 mg of levocetirizine.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, magnesium stearate (tablet core), and hypromellose, titanium dioxide (E 171), and macrogol 400 (coating).

What Nossin looks like and contents of the pack
White or almost white, oval, film-coated tablets, biconvex on both sides, with the imprint
‘L9CZ’ on one side and ‘5’ on the other side.
Pack contents: 28 or 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lok. 27
01-909 Warszawa
Poland

Manufacturer
Synthon B.V.
Microweg 22,
6545CM Nijmegen
The Netherlands
Synthon Hispania SL
Castelló 1, Polígono Las Salinas,
08830 Sant Boi de Llobregat
Spain