Contrahist

Package Leaflet: Information for the Patient

Contrahist, 0.5 mg/ml, Oral Solution

Levocetirizine Dihydrochloride
For adults and children from 2 years of age

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

• Keep this leaflet, 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

The active substance of Contrahist is levocetirizine dihydrochloride.
Contrahist is an antiallergic medicine.
Contrahist is used to treat symptoms associated with:

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

2. Important information before taking Contrahist

When not to take Contrahist

if you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine or
any of the other ingredients of this medicine (listed in section 6)
if you have severe kidney problems (severe renal impairment with creatinine clearance less than 10 ml/min).

Warnings and precautions

Before taking Contrahist, discuss it with your doctor or pharmacist.
If you may have difficulty emptying your bladder (in conditions such as: spinal cord injury or prostate enlargement), consult your doctor.
Contrahist may increase the severity of epileptic seizures, therefore consult your doctor if you have epilepsy or are at risk of seizures.
If you are scheduled to undergo allergy testing, ask your doctor if you should stop taking Contrahist a few days before the test. Contrahist may affect the results of allergy tests.

Children

Contrahist is not recommended for infants and young children under 2 years of age.

Contrahist and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Taking Contrahist with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Some patients taking Contrahist may experience drowsiness, fatigue, and exhaustion. Be cautious when driving or operating machinery until you know your reaction to the medicine. However, special tests conducted with healthy individuals after taking levocetirizine at the recommended dose did not show an effect on attention, reaction ability, or driving ability.

Contrahist contains maltitol liquid, sodium benzoate, and sodium

• The medicine contains maltitol liquid. If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.
• The medicine contains 4 mg of sodium benzoate in 1 ml of solution.
• This medicine contains less than 1 mmol (23 mg) of sodium in 1 ml of solution, which means the medicine is considered "sodium-free".

3. How to take Contrahist

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 12 years of age: 10 ml of solution once a day.

Dosing in special patient groups:

Kidney and liver function disorders
In patients with kidney function disorders, the dose of the medicine may need to be reduced 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.
Patient with severe kidney function disorders should not take Contrahist.
Patient with liver function disorders only should take the usual recommended dose of the medicine.
In patients with both liver and kidney function disorders, a lower dose may be necessary 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.
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

Children from 6 to 12 years of age: 10 ml of solution once a day.
Children from 2 to 6 years of age: 2.5 ml of solution twice a day.
Contrahist is not recommended for infants and young children under 2 years of age.

How and when to take Contrahist?

This medicine is for oral use only.
A measuring cup is included with the packaging (see the illustration for use). The solution can be taken undiluted or diluted in a glass of water.
Contrahist can be taken with or without food.
How to use the measuring cup
Place the measuring cup in the bottle and pull the plunger to the mark on the scale corresponding to the dose prescribed by your doctor in milliliters (ml). For children under 6 years of age, the daily dose of 5 ml given in two divided doses should be measured by taking 2.5 ml of solution from the bottle twice a day (the dose should be measured accurately using the measuring cup with the scale).
Remove the measuring cup from the bottle and empty its contents into a spoon or a glass of water by pressing the plunger. The medicine should be taken orally immediately after dilution.
After each use, rinse the plunger with water.

How long to take Contrahist?

The duration of treatment depends on the type, duration, and severity of the disease symptoms and is determined by the doctor.

Taking a higher dose of Contrahist than recommended

In adults, taking a higher dose of Contrahist than recommended may cause drowsiness. In children, it may initially cause agitation and restlessness, especially motor, and then drowsiness.
If you suspect an overdose of Contrahist, seek medical attention immediately, and the doctor will decide what actions should be taken.

Missing a dose of Contrahist

If you miss a dose of Contrahist or take a lower dose than recommended by your doctor, do not take a double dose to make up for the missed dose.
Take the next dose at the usual time.

Stopping treatment with Contrahist

Stopping treatment with Contrahist earlier than recommended should not cause any harm. In the sense that the symptoms of the disease may gradually return, but their severity should not be greater than before starting treatment with Contrahist.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common: may affect up to 1 in 10 people
Dry mouth, headache, fatigue, and drowsiness/dizziness.
Uncommon: may affect up to 1 in 100 people
Exhaustion and abdominal pain.
Frequency not known: cannot be estimated from the available data.
Other side effects have also been reported, such as: palpitations, increased heart rate, seizures, tingling, dizziness, fainting, tremors, taste disorders (altered taste perception), feeling of spinning or swaying, vision disorders, rotational eye movements (uncontrolled circular eye movement), blurred vision, painful or difficult urination, inability to fully empty the bladder, swelling, itching, rash, urticaria (swelling, redness, and itching of the skin), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, agitation and aggressive behavior, hallucinations, depression, insomnia, recurring suicidal thoughts or interest in suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea. Itching (intense itching) after stopping treatment with the medicine.

If you notice the first symptoms of a hypersensitivity reaction, stop

taking Contrahist and inform your doctor.The symptoms of a hypersensitivity reaction may include: swelling of the lips, tongue, face, and (or) throat, difficulty breathing or swallowing with urticaria (angioedema), sudden drop in blood pressure leading to fainting or shock, which can be fatal.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. 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, tel: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Contrahist

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of that month.
Do not store above 25°C. Keep the bottle tightly closed.
Store in the original packaging to protect from light.
Do not use after 3 months from the date of first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Contrahist contains

• The active substance is levocetirizine dihydrochloride. 1 ml of oral solution contains 0.5 mg of levocetirizine dihydrochloride.
• The other ingredients are: maltitol liquid (E 965), glycerol (E 422), sodium saccharin, sodium acetate trihydrate, glacial acetic acid, sodium benzoate (E 211), strawberry flavor: flavoring substances, natural flavoring substances, propylene glycol (E 1520); purified water.

What Contrahist looks like and contents of the pack

The oral solution is a clear and colorless solution with a strawberry flavor and odor, in a 200 ml bottle.
The bottle with the solution is placed in a cardboard box, which also contains a measuring cup and a patient information leaflet.

Marketing authorization holder and manufacturer:

Marketing authorization holder

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

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. W. Łokietka 10
98-200 Sieradz, Poland
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów, Poland

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Poland
Contrahist
Greece
Contrahist 0.5 mg oral solution
Date of revision of the leaflet:April 2021