Contrahist

Package Leaflet: Information for the Patient

Contrahist, 5 mg, Film-Coated Tablets

Levocetirizine Dihydrochloride
For adults and children from 6 years of age

Read the Package Leaflet Carefully Before Taking the Medicinal Product

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicinal product 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 Package 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 medicinal product.
Contrahist is used for the treatment of 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 medicinal product (listed in section 6),
• if you have severe renal impairment (severe renal failure with creatinine clearance less than 10 ml/min).

Warnings and Precautions

Before taking Contrahist, you should 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), you should consult your doctor.
Contrahist may increase the risk of seizures, so you should consult your doctor if you have a history of seizures or are at risk of seizures.
If you are scheduled to undergo allergy testing, you should ask your doctor whether you should stop taking Contrahist a few days before the test. Contrahist may affect the results of allergy tests.

Children

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

Contrahist and Other Medicinal Products

You should inform your doctor or pharmacist about all medicinal products you are taking or have recently taken, as well as any medicinal products you plan to take.

Taking Contrahist with Food, Drink, and Alcohol

You should 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 drowsiness and impaired reaction.
Contrahist can be taken with or without food.

Pregnancy, Breast-Feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicinal product.

Driving and Using Machines

Some patients taking Contrahist may experience drowsiness, fatigue, and exhaustion. If you plan to drive, perform potentially hazardous activities, or operate machinery, you should first determine your reaction to the medicinal product. However, special tests conducted with healthy volunteers after taking levocetirizine at the recommended dose did not show an effect on attention, reaction, or driving ability.
Contrahist contains lactose, so if you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicinal product.

3. How to Take Contrahist

This medicinal product should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The recommended dose for adults and children from 6 years of age is 1 tablet per day.

Dosing in Special Patient Groups:

Renal and Hepatic Impairment
In patients with renal impairment, it may be necessary to reduce the dose of Contrahist depending on the severity of the renal disease; in children, the dose should also be adjusted according to body weight; the dose of the medicinal product is determined by the doctor.
Patient with severe renal impairment should not take Contrahist.
Patient with hepatic impairment only should take the usual recommended dose of Contrahist.
In patients with both hepatic and renal impairment, it may be necessary to use a lower dose depending on the severity of the renal disease; in children, the dose should also be adjusted according to body weight; the dose of the medicinal product is determined by the doctor.
Elderly Patients (65 years and older)
In elderly patients, there is no need to adjust the dose if renal function is normal.

Use in Children

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

How and When to Take Contrahist?

The medicinal product is for oral use only.
Tablets should be swallowed whole with water. The medicinal product can be taken with or without food.

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.

Overdose of Contrahist

In adults, in case of overdose of Contrahist, drowsiness may occur. In children, initially, there may be excitement and restlessness, especially motor, and then drowsiness.
In case of suspected overdose of Contrahist, you should consult a doctor, who will decide what actions should be taken.

Missed Dose of Contrahist

In case of missed dose of Contrahist or taking a lower dose than recommended by the doctor, you should not take a double dose to make up for the missed dose.
In such a case, you should take the next dose at the usual time.

Stopping Treatment with Contrahist

Stopping treatment with Contrahist should not cause any harmful effects. However, in rare cases, itching (intense itching) may occur after stopping treatment with Contrahist, 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 it may be necessary to resume treatment. These symptoms should resolve after resuming treatment.
If you have any further questions about the use of this medicinal product, you should consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, Contrahist can cause side effects, although not everybody gets them.
Common: may affect up to 1 in 10 people
Dry mouth, headache, fatigue, and drowsiness/somnolence.
Uncommon: may affect up to 1 in 100 people
Feeling of 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 disturbances (altered taste perception), feeling of spinning or swaying, vision disturbances, rotational eye movements (uncontrolled circular eye movement), blurred vision, painful or difficult urination, inability to fully empty the bladder, edema, itching, rash, urticaria (swelling, redness, and itching of the skin), skin eruptions, dyspnea, weight gain, muscle pain, joint pain, excitement and aggressive behavior, hallucinations, depression, insomnia, recurrent suicidal thoughts or interest in suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea.
Itching (intense itching) after stopping treatment with Contrahist.

If You Notice the First Symptoms of a Hypersensitivity Reaction, You Should 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 (chest tightness or wheezing), urticaria, 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, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 medicinal product.

5. How to Store Contrahist

Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton or blister after: "EXP". The expiry date refers to the last day of that month.
There are no special precautions for storage.
Medicinal products should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicinal products you no longer use. This will help protect the environment.

6. Contents of the Pack and Other Information

What Contrahist Contains

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

What Contrahist Looks Like and Contents of the Pack

Contrahist film-coated tablets are white, film-coated, biconvex, and oblong with the marking "11" on one side.
The pack contains: 7, 10, 14, 15, 21, 28, 30, 50, 56, 60, 84, 90, 98, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization 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 Authorized in the Member States of the European Economic Area

Under the Following Names:

Poland
Contrahist
Greece
Contrahist 5 mg film-coated tablets
Date of Revision of the Leaflet:June 2023