Claritine Active

Leaflet attached to the packaging: patient information

Claritine Active, 5 mg + 120 mg, prolonged-release tablets

Loratadine + Pseudoephedrine sulfate

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 10 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Claritine Active and what is it used for

What is Claritine Active

Claritine Active is a prolonged-release medicine containing 2 active substances: loratadine with anti-allergic action and pseudoephedrine with decongestant action on the nasal mucosa.

How Claritine Active works

• Loratadine helps reduce allergic symptoms by inhibiting the action of a substance called histamine in the body (it has anti-allergic effects).
• Pseudoephedrine helps reduce nasal congestion (it decongests the nose).

When to use Claritine Active

Claritine Active is indicated for the treatment of symptoms of seasonal, allergic rhinitis, accompanied by nasal congestion. Claritine Active reduces the following symptoms: nasal congestion, sneezing, runny nose (rhinorrhea), nasal and eye itching, tearing, burning, and redness of the eyes.

2. Important information before taking Claritine Active

When not to take Claritine Active:

• if the patient is allergic to loratadine, pseudoephedrine, or any of the other ingredients of this medicine (listed in section 6) or other decongestant medicines for the nasal mucosa. Symptoms of an allergic reaction include difficulty breathing, wheezing, itching, hives, swelling;
• if the patient has narrow-angle glaucoma, hyperthyroidism, difficulty urinating, urinary retention, high blood pressure, heart disease, or vascular disease;
• if the patient has had a stroke or is at risk of stroke;
• if the patient is currently taking or has taken within the last 14 days monoamine oxidase inhibitor (MAOI) antidepressants;
• if the patient has difficulty swallowing tablets, narrowing of the upper gastrointestinal tract, or abnormal esophageal function;
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension;
• if the patient has severe, acute (sudden), or chronic (long-term) kidney disease or kidney failure; in children under 12 years of age;
• in pregnant women.

Warnings and precautions

Before starting Claritine Active, you should discuss it with your doctor or pharmacist:

• If the patient has: chronic eye disorders, diabetes, gastrointestinal disorders, bladder or prostate disorders, or has had breathing difficulties (bronchospasm) or a heart attack in the past;
• Before surgery: you should stop taking Claritine Active 24 hours before the procedure;
• You should stop treatment and consult your doctor if you experience: high blood pressure, rapid heartbeat or palpitations, irregular heartbeat, malaise, nausea, and headache or worsening headache while taking Claritine Active.
• Do not take Claritine Active for more than 10 days without consulting a doctor.
• Claritine Active may be addictive, which can occur if the patient takes the medicine for a longer period than recommended. In such a case, sudden withdrawal of Claritine Active may cause depression.
• Taking higher doses than recommended may cause poisoning.

If the patient experiences fever with generalized skin redness and pustular rash, they should stop taking Claritine Active and consult their doctor or seek medical attention immediately. See section 4.
During treatment with Claritine Active, sudden abdominal pain or rectal bleeding may occur due to inflammation of the large intestine (ischemic colitis). If such gastrointestinal symptoms occur, the patient should stop taking Claritine Active and seek medical attention immediately.
See section 4.
During treatment with Claritine Active, decreased blood flow in the optic nerve may occur. If sudden vision loss occurs, the patient should stop taking Claritine Active and seek medical attention immediately.
See section 4.
After taking pseudoephedrine-containing medicines, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported.
PRES and RCVS are rare conditions that may be associated with decreased blood flow to the brain.
If symptoms occur that may be symptoms of PRES or RCVS, the patient should immediately stop taking Claritine Active and seek medical attention (symptoms, see section 4 "Possible side effects").

Lab tests:

The patient should stop taking Claritine Active at least 48 hours before undergoing skin allergy tests.

Information for athletes:

Taking Claritine Active may cause positive results in doping tests.

Children and adolescents

Claritine Active should not be used in children under 12 years of age.

Claritine Active and other medicines

• The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, as many medicines taken with Claritine Active may cause: increased or decreased blood pressure, heart rhythm disturbances, reduced treatment efficacy, or may require a change in dosage.
• Claritine Active should not be taken at the same time or within 14 days of stopping treatment with monoamine oxidase inhibitor (MAOI) antidepressants.

There may be an interaction between Claritine Active and the following medicines: digitalis glycosides (heart medicines); blood pressure-lowering medicines such as: α-methyldopa, mecamylamine, reserpine, or guanethidine; oral or nasal decongestants such as: phenylpropanolamine, phenylephrine, ephedrine; appetite suppressants; amphetamine derivatives; tricyclic antidepressants; migraine medicines such as: dihydroergotamine, ergotamine, or methysergide; linezolid (antibiotic); bromocriptine (medicine used for infertility or Parkinson's disease); Parkinson's disease medicines such as: cabergoline, lisuride, and pergolide; antacids; kaolin (medicine used for diarrhea).

Claritine Active with food and drink

The medicine can be taken independently of meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Claritine Active should not be used during pregnancy.
If a woman is breastfeeding, she should not take Claritine Active.

Driving and using machines

The patient should refrain from driving and operating machines before checking their individual reaction to taking Claritine Active. They should not drive or operate machines if they experience symptoms such as: drowsiness, dizziness, disorientation, headache, which may impair their ability to drive or operate machines.

Claritine Active contains lactose and sucrose

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

3. How to take Claritine Active

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Recommended dose

The recommended dose of Claritine Active is 1 tablet twice a day (every 12 hours).
The tablet should be swallowed whole with a glass of water. The tablets should not be divided, crushed, broken, or chewed.
Claritine Active can be taken independently of meals.
Do not take more tablets of Claritine Active than recommended in the patient leaflet.
Without a doctor's recommendation, do not take the medicine for more than 10 days.
If the patient feels that the effect of Claritine Active is too strong or too weak, they should consult their doctor or pharmacist.

Use in children and adolescents

Claritine Active is intended for use in adults and children over 12 years of age.

Use of Claritine Active in patients with renal and/or hepatic impairment:

Claritine Active should not be used in patients with renal and/or hepatic impairment or renal tubular acidosis (tubular acidosis).

Use of Claritine Active in patients over 60 years of age:

Claritine Active should not be used in people over 60 years of age.

Taking a higher dose of Claritine Active than recommended

In case of taking a higher dose of Claritine Active than recommended, the patient should immediately consult their doctor, as dangerous overdose symptoms may occur, such as: respiratory failure, cyanosis, coma, collapse, loss of consciousness, seizures. Other symptoms that may occur after an overdose include: hallucinations, high fever, irregular or slow heart rate, changes in consciousness and mood, severe drowsiness or confusion, nervousness or excitement, vomiting, joint pain, blurred vision, high or low blood pressure.

Missing a dose of Claritine Active

Do not take a double dose to make up for a missed dose. If a dose is missed, it should be taken later, maintaining a 12-hour interval between doses.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Claritine Active can cause side effects, although not everybody gets them.

If the following side effects occur, which may indicate a severe allergic reaction: difficulty breathing, wheezing, itching, hives, swelling, dizziness, high blood pressure, urinary retention, fever,

or a rash or small pustules all over the body, the patient should stop taking Claritine Active immediately and consult their doctor.

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Side effects of unknown frequency (frequency cannot be estimated from available data):

• severe conditions affecting the blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

The patient should immediately stop taking Claritine Active and seek medical attention if they experience symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), including:

• severe headache with sudden onset,
• nausea,
• vomiting,
• confusion,
• seizures,
• changes in vision.
• weight gain, decreased blood flow in the optic nerve (ischemic optic neuropathy), inflammation of the large intestine due to insufficient blood flow (ischemic colitis). Sudden fever, skin redness, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of taking Claritine Active. See section 2. If such symptoms occur, the patient should stop taking Claritine Active and consult their doctor or seek medical attention immediately.

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Very common side effects associated with taking Claritine Active (more than 1 in 10 patients taking the medicine): insomnia.
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Common side effects associated with taking Claritine Active (between 1 in 100 and 1 in 10 patients taking the medicine): thirst, nervousness, drowsiness, depression, excitement, loss of appetite, dizziness, dry mouth, palpitations (rapid heartbeat), pharyngitis, rhinitis, constipation, nausea, headache, feeling tired.
➢
Uncommon side effects associated with taking Claritine Active (between 1 in 1000 and 1 in 100 patients taking the medicine): disorientation, tremors, increased sweating, hot flashes, taste disturbances, increased tearing, tinnitus, palpitations, nosebleeds, frequent urination, and urinary disorders, itching.
➢
Rare side effects associated with taking Claritine Active (less than 1 in 1000 patients taking the medicine): severe allergic reactions, including rash, hives, angioedema (swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing and swallowing), dizziness, seizures, irregular heartbeat, high blood pressure, cough, breathing difficulties (bronchospasm), abnormal liver function, urinary retention, hair loss.
Other side effects observed in clinical trials and after the medicine was marketed, associated with loratadine use, include: increased appetite, rash, and gastritis.
Some people may experience other side effects while taking Claritine Active.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 gather more information on the safety of the medicine.

5. How to store Claritine Active

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: Expiry date (EXP) or EXP. The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Blisters should be stored in the original packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Claritine Active contains

• The active substances of Claritine Active are loratadine and pseudoephedrine sulfate. One tablet contains 5 mg of loratadine and 120 mg of pseudoephedrine sulfate (60 mg of pseudoephedrine sulfate in the coating and core of the tablet).
• The other ingredients (excipients) are: lactose monohydrate, cornstarch, povidone, magnesium stearate. The coating ingredients include: acacia gum, sucrose, calcium sulfate dihydrate, calcium sulfate anhydrous, cellulose, zein, oleic acid, neutral soap, talc, microcrystalline cellulose, titanium dioxide, white wax, carnauba wax.

What Claritine Active looks like and contents of the pack

Claritine Active is a white or almost white, round, biconvex, film-coated tablet.
Claritine Active tablets are packaged in blisters of 6 tablets, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Bayer Sp. z o.o.
Jerozolimskie Avenue 158
02-326 Warsaw
Phone: +48 22 572 35 00
Manufacturer:
SAG Manufacturing SLU
Carretera N-1, km 36
28750 San Agustin de Guadalix
Spain
Date of last revision of the leaflet:04/2024