Package leaflet: Information for the patient

Contrahist, 5 mg, film-coated tablets
Levocetirizini dihydrochloridum
For adults and children aged 6 years and older
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Contrahist is and what it is used for
Important information before taking Contrahist
How to take Contrahist
Possible side effects
How to store Contrahist
Contents of the pack and other information

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

allergic rhinitis (including perennial allergic rhinitis);
urticaria.

2. Important information before taking Contrahist

When not to take Contrahist

if the patient is allergic 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).

Warnings and precautions
Before starting treatment with Contrahist, discuss it with your doctor or pharmacist.
If the patient may have difficulty emptying the bladder (in conditions such as: spinal cord injury or benign prostatic hyperplasia), medical advice should be sought.
Contrahist 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 the patient should stop taking Contrahist a few days before the tests. Contrahist may affect the results of allergy tests.
Children
It is not recommended to administer Contrahist film-coated tablets to children under 6 years of age, as appropriate dose adjustment is not possible with this formulation.
Contrahist with other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Taking Contrahist with food, drink and alcohol
Exercise caution when taking Contrahist together with alcohol or other substances affecting brain function.
In sensitive patients, concomitant use of Contrahist with alcohol or other substances affecting brain function may additionally reduce alertness and reaction ability.
Contrahist can 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 her doctor or pharmacist before using this medicine.
Driving and operating machinery
Some patients treated with Contrahist may experience drowsiness / somnolence, fatigue, and exhaustion. If the patient intends to drive, perform potentially dangerous activities, or operate machinery, he or she should first assess their individual response to the medicine. However, specific tests conducted in healthy volunteers taking levocetirizine at the recommended dose did not show any effect on attention, reaction ability, or driving performance.
Contrahist contains lactose; therefore, if the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

3. How to use the medicine Contrahist

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 doctor determines the appropriate dose.
Contrahist must not be used in patients with severe renal impairment.
Patients with impaired liver function alone should usually receive the standard 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 determines the appropriate dose.
Elderly patients (65 years and older)
Dose adjustment is not necessary in elderly patients if kidney function is normal.
Use in children
Contrahist tablets are not recommended for children under 6 years of age.
How and when to take Contrahist
For oral use only.
Tablets should be swallowed whole with water. The medicine may be taken during or between meals.
How long to take Contrahist
The duration of treatment depends on the type, duration, and severity of disease symptoms and is determined by the doctor.
Taking more Contrahist than recommended
In adults, taking more than the recommended dose of Contrahist may cause drowsiness. In children, initial excitation and restlessness, especially motor restlessness, may occur, followed by drowsiness.
If an overdose of Contrahist is suspected, consult a doctor, who will decide on the necessary actions.
Missing a dose of Contrahist
If a dose of Contrahist 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.
Stopping Contrahist
Stopping treatment with Contrahist should not cause harmful effects. However, in rare cases, itching (intense pruritus) may occur after discontinuation of Contrahist, 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 restarted. Symptoms should resolve upon resuming 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.
Common: may occur in less than 1 in 10 patients
Dry mouth, headache, fatigue and drowsiness/sleepiness.
Uncommon: may occur in less than 1 in 100 patients
Feeling of exhaustion and abdominal pain.
Frequency not known: cannot be estimated from the available data
Other adverse reactions reported include: palpitations, increased heart rate, convulsions, tingling, dizziness, fainting, tremor, taste disturbances (altered sense of taste), sensation of spinning or swaying, visual disturbances, rotatory eye movements (involuntary circular eye movements), blurred vision, 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 suicidal ideation, 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 reaction occur, stop taking Contrahist and inform your doctor.
Symptoms of hypersensitivity reaction 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.
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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 49 21 301, fax: +48 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 Contrahist

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack following the abbreviation "EXP". The expiry date refers to the last day of the specified month.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Proper disposal helps protect the environment.

6. Contents of the pack and other information
What Contrahist contains

The active substance is levocetirizine dihydrochloride. Each coated tablet contains 5 mg of levocetirizine dihydrochloride.
Other ingredients are: microcrystalline cellulose (type 102), monohydrate lactose, magnesium stearate, hypromellose 6 cP, titanium dioxide (E 171), polyethylene glycol 400.

What Contrahist looks like and contents of the pack
Contrahist coated tablets are white, film-coated, biconvex, elongated tablets with the imprint ‘^ 11’ on one side.
Pack contents: 7, 10, 14, 15, 21, 28, 30, 50, 56, 60, 84, 90, 98 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów, Poland

Manufacturer/Importer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów, Poland

This medicinal product is authorised in the European Economic Area under the following names:
Poland: Contrahist
Greece: Contrahist 5 mg επικαλυμμένα με λεπτό υμένιο δισκία