Allefin allergy

Package leaflet: Information for the patient

Allefin Allergy, 5 mg, film-coated tablets
Levocetirizini dihydrochloridum
For adults, adolescents and children aged 6 years and older
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

Contents of the leaflet

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

1. What Allefin Allergy is and what it is used for

The active substance in Allefin Allergy is levocetirizine dihydrochloride.
Allefin Allergy is an antiallergy medicine.
Allefin Allergy is used to treat symptoms associated with:

• allergic rhinitis (including chronic allergic rhinitis);
• urticaria.

Allefin Allergy in the form of film-coated tablets is indicated for use in adults, adolescents and children aged 6 years and older.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

2. Important information before using Allefin Allergy

When not to use Allefin Allergy

• if the patient is allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any other piperazine derivatives (substances with a similar structure), or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe kidney function impairment (severe renal insufficiency with creatinine clearance less than 10 ml/min).

Warnings and precautions
Before starting treatment with Allefin Allergy, discuss this with a doctor or pharmacist.
If the patient may have difficulties emptying the bladder (e.g. due to spinal cord injury or prostate enlargement), medical advice should be sought.
Allefin Allergy may increase the frequency of epileptic seizures; therefore, consult a doctor if the patient has epilepsy or is at risk of seizures.
If the patient has planned allergy testing, ask the doctor whether treatment with Allefin Allergy should be discontinued a few days before the tests. Allefin Allergy may affect the results of allergy tests.

Children
Allefin Allergy coated tablets are not recommended for children under 6 years of age, as appropriate dose adjustment is not possible with this formulation.

Allefin Allergy and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Allefin Allergy with food, drink and alcohol
Exercise caution when taking Allefin Allergy together with alcohol or other substances affecting brain function.
In sensitive patients, concomitant use of Allefin Allergy with alcohol or other centrally acting substances may additionally reduce alertness and reaction ability.
Allefin Allergy may be taken during or between meals.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Some patients treated with Allefin Allergy may experience drowsiness, somnolence, fatigue, or exhaustion. Caution should be exercised when driving or operating machinery until the patient's response to the medicine is known. However, specific studies conducted in healthy subjects taking levocetirizine at the recommended dose did not show any effect of the medicine on attention, reaction ability, or driving performance.

Allefin Allergy contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before using this medicine.

3. How to use Allefin Allergy

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose for adults, adolescents, and children aged 6 years and older is 1 tablet per day.

Dosage 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 doctor will determine the appropriate dose.

Allefin Allergy 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 hepatic and renal impairment, a lower dose may be necessary depending on the severity of kidney disease. In children, the dose should also be adjusted according to body weight; the doctor will determine the appropriate dose.

Elderly patients (65 years and older)

In elderly patients, dose adjustment is not required if kidney function is normal.

Use in children

Allefin Allergy tablets are not recommended for children under 6 years of age.

How and when to take Allefin Allergy

This medicine is for oral use only.

The tablets should be swallowed whole with water. The medicine may be taken during or between meals.

How long to take Allefin Allergy

Do not use this medicine for longer than 10 days without consulting a doctor.

If there is no improvement after 3 days, or if symptoms worsen, consult a doctor.

Overdose of Allefin Allergy

In adults, taking a higher than recommended dose of Allefin Allergy may cause drowsiness.

In children, initial symptoms may include agitation and restlessness, especially motor restlessness, followed by drowsiness.

If an overdose is suspected, consult a doctor immediately, who will decide on the necessary actions.

Missed dose of Allefin Allergy

If a dose of Allefin Allergy is missed or a lower than recommended dose has been taken, do not take a double dose to make up for the missed dose. Take the next dose at the usual time.

Discontinuation of Allefin Allergy

Stopping treatment with Allefin Allergy should not cause harmful effects. However, in rare cases, itching (intense pruritus) may occur after discontinuation of Allefin Allergy, 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the first symptoms of hypersensitivity reactions occur, stop taking
Allefin Allergy and inform your doctor 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 lead to death (frequency unknown).
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Common (may occur in less than 1 in 10 patients): Dry mouth, headache, fatigue and drowsiness/sedation.
Uncommon (may occur in less than 1 in 100 patients): Feeling of exhaustion and abdominal pain.
Frequency not known (cannot be estimated from available data): Other adverse reactions reported include: palpitations, increased heart rate, convulsions, tingling, dizziness, fainting, tremor, taste disturbances (altered taste perception), sensation of spinning or swaying, visual disturbances, blurred vision, nystagmus (uncontrolled circular eye movements), painful or difficult urination, inability to completely empty the bladder, swelling, itching, rash, urticaria (skin swelling, redness and itching), shortness of breath, weight gain, muscle pain, joint pain, restlessness and aggressive behaviour, hallucinations, depression, insomnia, recurrent suicidal thoughts or suicidal ideation, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhoea.
Itching (intense pruritus) after discontinuation of the medicine.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49 21 301, fax: 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Allefin Allergy

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Allefin Allergy contains

• The active substance is levocetirizine dihydrochloride. Each coated tablet contains 5 mg of levocetirizine dihydrochloride.
• The other ingredients (excipients) are: monohydrate lactose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, and Opadry II White 85F18422 coating: polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E 171), talc.

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What Allefin Allergy looks like and contents of the pack
Allefin Allergy is a white, round, biconvex coated tablet with a diameter of approximately 6 mm.
One pack contains 7, 10 or 20 coated tablets in blister packs within a cardboard box.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information on the medicinal product
tel.: 22 742 00 22
e-mail: [email protected]
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