Contrahist Allergi

Package Leaflet: Information for the Patient

Contrahist Allergy, 5 mg, Film-Coated Tablets

Levocetirizine Dihydrochloride
For adults, adolescents, and children from 6 years of age

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by the doctor or pharmacist.
Keep this package leaflet, you may need to read it again.
If you need advice or additional information, consult a pharmacist.
If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

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

• 2. Important information before taking Contrahist Allergy
• 3. How to take Contrahist Allergy
• 4. Possible side effects
• 5. How to store Contrahist Allergy
• 6. Contents of the pack and other information

1.

What is Contrahist Allergy and what is it used for

The active substance of Contrahist Allergy is levocetirizine dihydrochloride.
Contrahist Allergy is an antiallergic medicine.
Contrahist Allergy is indicated for use in adults, adolescents, and children from 6 years of age for the treatment of symptoms associated with:

• allergic rhinitis (including chronic allergic rhinitis),
• chronic idiopathic urticaria.

If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking Contrahist Allergy

When not to take Contrahist Allergy:

• if the patient is hypersensitive to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe renal impairment (severe renal failure with creatinine clearance less than 10 ml/min),
• if the patient has hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome. See also the subsection: “Contrahist Allergy contains lactose”.

Warnings and precautions

Before taking Contrahist Allergy, the patient should discuss it with their doctor or pharmacist.
If the patient has renal impairment, they should consult their doctor before taking this medicine; a lower dose may be necessary. The dose of the medicine will be determined by the doctor.
If the patient may have difficulty urinating (e.g., due to spinal cord injury or enlarged prostate), they should consult their doctor.
Contrahist Allergy may exacerbate seizure disorders, so the patient should consult their doctor if they have a history of seizure disorders or are at risk of seizures.
Contrahist Allergy may affect the results of skin allergy tests. If the patient is scheduled to undergo allergy testing, they should ask their doctor whether they should stop taking Contrahist Allergy a few days before the test.

Children

It is not recommended to give Contrahist Allergy film-coated tablets to children under 6 years of age, as it is not possible to adjust the dose appropriately for this form of the medicine.

Contrahist Allergy and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Contrahist Allergy with food, drink, and alcohol

Care should be taken when taking Contrahist Allergy with alcohol or other substances that affect brain function.
In sensitive patients, taking Contrahist Allergy with alcohol or other substances that affect brain function may cause additional decreased alertness and reaction ability.
Contrahist Allergy can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Some patients taking Contrahist Allergy may experience drowsiness, fatigue, tiredness, and weakness. If the patient plans to drive, perform potentially hazardous activities, or operate machinery, they should first determine their reaction to the medicine.
However, special tests conducted with healthy volunteers after taking levocetirizine at the recommended dose did not show an effect on attention, reaction ability, or driving ability.

Contrahist Allergy contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Contrahist Allergy

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine can only be used in patients with allergic rhinitis or chronic idiopathic urticaria diagnosed by a doctor and according to the principles determined by the doctor.
The recommended dose of the medicine for adults, adolescents, and children from 6 years of age is 1 film-coated tablet (5 mg) per day.
It is recommended to take a single dose once a day.

How and when to take Contrahist Allergy

The medicine is for oral use only.
The tablet should be swallowed whole with water. The medicine can be taken with or without food.

How long to take Contrahist Allergy

The treatment period depends on the type, duration, and severity of the disease symptoms and is determined by the doctor.
The medicine should not be taken for more than 10 days without consulting a doctor.
If after 3 days of treatment there is no improvement or the patient feels worse, they should consult their doctor.

Dosing in special patient groups:

Renal and hepatic impairment
In patients with renal impairment, it may be necessary to reduce the dose of the medicine depending on the severity of the kidney disease. In children, the dose should also be adjusted according to body weight. The dose of the medicine will be determined by the doctor.
In patients with severe renal impairment, Contrahist Allergy should not be taken (see the section “When not to take Contrahist Allergy”).
Patients with only hepatic impairment should take the usual recommended dose of the medicine.
In patients with both hepatic and renal impairment, a lower dose may be necessary depending on the severity of the kidney disease. In children with both hepatic and renal impairment, the dose should also be adjusted according to body weight. In such cases, the dose of the medicine should be determined by the doctor.
Elderly patients (65 years and older)
In elderly patients, there is no need to adjust the dose if kidney function is normal.

Use in children

It is not recommended to give Contrahist Allergy tablets to children under 6 years of age.

Overdose of Contrahist Allergy

In case of overdose of Contrahist Allergy in adults, drowsiness may occur. In children, initial excitement and restlessness, especially motor, and then drowsiness may occur.
In case of suspected overdose of Contrahist Allergy, the patient should immediately consult a doctor, who will decide what actions should be taken.

Missed dose of Contrahist Allergy

In case of a missed dose of Contrahist Allergy or a dose lower than recommended, the patient should not take a double dose to make up for the missed dose.
Instead, the patient should wait until the next dose is due and take the recommended dose.

Stopping treatment with Contrahist Allergy

Stopping treatment with Contrahist Allergy should not cause any harmful effects.
The symptoms of the disease may gradually return, but their severity should not be greater than before starting treatment with Contrahist Allergy.
However, in rare cases, itching (intense itching) may occur after stopping treatment with Contrahist Allergy, even if these symptoms did not occur before starting treatment. These symptoms may resolve on their own. In some cases, these symptoms may be intense and treatment may need to be resumed. These symptoms should resolve after resuming treatment.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Contrahist Allergy can cause side effects, although not everybody gets them.
In case of the first symptoms of a hypersensitivity reaction, the patient should stop taking Contrahist Allergy and inform their doctor.
The symptoms of a hypersensitivity reaction include: swelling of the lips, tongue, face, and (or) throat, difficulty breathing or swallowing (chest tightness or wheezing), urticaria, angioedema, sudden drop in blood pressure leading to fainting or shock, which can lead to death.
Frequent (occurring in less than 1 in 10 people, but more than 1 in 100 people) side effects reported include dry mouth, headache, fatigue, drowsiness, somnolence.
Uncommon (occurring in less than 1 in 100 people, but more than 1 in 1000 people) side effects observed include feeling of tiredness and abdominal pain.
Frequency not known (cannot be estimated from the available data) side effects reported include palpitations, increased heart rate, seizures, tingling, dizziness, fainting, tremors, taste disturbances (altered taste perception), feeling of spinning or swaying, vision disturbances, blurred vision, rotational eye movements (uncontrolled rotary movement of the eyeballs), painful or difficult urination, inability to completely empty the bladder, edema, itching, rash, urticaria (swelling, redness, and itching of the skin), skin eruptions, dyspnea, weight gain, muscle pain, joint pain, excitement or aggressive behavior, hallucinations, depression, insomnia, recurrent suicidal thoughts or interest in suicide, nightmares, hepatitis, abnormal liver function, increased appetite, nausea, vomiting, and diarrhea, itching (intense itching) after stopping treatment with Contrahist Allergy.

Reporting side effects

If the patient experiences any side effects, including those not listed in the package leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Contrahist Allergy

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack after “EXP” and the carton after “Expiry date (EXP)”. The expiry date refers to the last day of the month.
There are no special precautions for storage of the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Contrahist Allergy contains

• The active substance is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride, which corresponds to 4.2 mg of levocetirizine.
• The other ingredients are: microcrystalline cellulose (type 102), lactose monohydrate, magnesium stearate, hypromellose, titanium dioxide (E 171), macrogol 400.

What Contrahist Allergy looks like and contents of the pack

Contrahist Allergy tablets are white, film-coated, biconvex, and oblong with the marking “^ 11” on one side.
The pack contains 7 or 10 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
phone: +48 22 732 77 00

Manufacturer:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Importer:

Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Poland

Date of last revision of the package leaflet: