Claritine Duo

Leaflet attached to the packaging: patient information

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

Loratadine + Pseudoephedrine sulfate

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• 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.

Table of contents of the leaflet

• 1. What is Claritine Duo and what is it used for
• 2. Important information before taking Claritine Duo
• 3. How to take Claritine Duo
• 4. Possible side effects
• 5. How to store Claritine Duo
• 6. Package contents and other information

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

What is Claritine Duo

Claritine Duo is a prolonged-release medicine containing 2 active substances: loratadine with anti-allergic action and pseudoephedrine with decongestant action on the mucous membrane.

How Claritine Duo 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 clears the nose).

When to use Claritine Duo

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

2. Important information before taking Claritine Duo

When not to take Claritine Duo:

• if the patient is allergic to loratadine, pseudoephedrine, or any of the other ingredients of this medicine (listed in section 6) or other medicines with decongestant action on the mucous membrane. 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 blood vessel 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 Duo, discuss it with your doctor or pharmacist:

• If the patient has: chronic eye disorders, diabetes, gastrointestinal disorders, bladder disorders, prostate disorders (in the past, there were difficulties in breathing (bronchospasm) or heart attack;
• Before surgery: you should stop taking Claritine Duo 24 hours before such surgery;
• You should stop treatment and contact your doctor if you experience: high blood pressure, rapid heartbeat or palpitations, irregular heartbeat, malaise, nausea, and headache or worsening headache while taking Claritine Duo.
• Do not take Claritine Duo for more than 10 days.
• Claritine Duo 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 Duo 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 Duo and contact their doctor or seek medical help immediately. See section 4.
During treatment with Claritine Duo, 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 Duo and seek medical help immediately.
See section 4.
During treatment with Claritine Duo, a decrease in blood flow in the optic nerve may occur. If sudden vision loss occurs, the patient should stop taking Claritine Duo and contact their doctor or seek medical help 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 reduced blood flow to the brain.
If symptoms occur that may be symptoms of PRES or RCVS, the patient should immediately stop taking Claritine Duo and seek medical help (symptoms, see section 4 "Possible side effects").

Laboratory tests:

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

Information for athletes:

Taking Claritine Duo may cause positive doping test results.

Children and adolescents

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

Claritine Duo 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 Duo may cause, among other things: increased or decreased blood pressure, heart rhythm disturbances, reduced treatment efficacy, and may require a change in dosage.
• Claritine Duo 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 Duo 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 Duo 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 Duo should not be used during pregnancy.
If a woman is breastfeeding, she should not take Claritine Duo.

Driving and using machines

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

Claritine Duo contains lactose and sucrose

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

3. How to take Claritine Duo

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

Recommended dose

The recommended dose of Claritine Duo 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 Duo can be taken independently of meals.
Do not take more tablets of Claritine Duo than recommended in the patient information leaflet.
The duration of treatment should be as short as possible.
Do not take the medicine for more than 10 days.
If the patient feels that the effect of Claritine Duo is too strong or too weak, they should consult their doctor or pharmacist.

Use in children and adolescents

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

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

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

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

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

Taking a higher dose of Claritine Duo than recommended

In case of taking a higher dose of Claritine Duo than recommended, the patient should immediately consult a doctor, as dangerous overdose symptoms may occur, such as: apnea, cyanosis, coma, collapse, loss of consciousness, seizures. Other symptoms that may occur after an overdose include: hallucinations, high fever, irregular or slow heartbeat, 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 Duo

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.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

If any of 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 Duo immediately and contact their doctor.

Unknown frequency (frequency cannot be estimated from the 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 Duo and seek medical help if they experience symptoms indicating PRES or 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), colitis caused by 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 Duo. See section 2. If such symptoms occur, the patient should stop taking Claritine Duo and contact their doctor or seek medical help immediately.

Very common side effects of taking Claritine Duo (more than 1 in 10 patients taking the medicine): insomnia.
Common side effects of taking Claritine Duo (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, fatigue.
Uncommon side effects of taking Claritine Duo (between 1 in 1000 and 1 in 100 patients taking the medicine): disorientation, tremors, increased sweating, hot flashes, taste disturbances, increased tearing, tinnitus, palpitations, epistaxis, frequent urination, and urinary disorders, pruritus.
Rare side effects of taking Claritine Duo (less than 1 in 1000 patients taking the medicine): severe allergic reactions, including rash, urticaria, 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, alopecia.
Other side effects observed in clinical trials and after the medicine was marketed, related to the use of loratadine, include: increased appetite, rash, and gastritis.
Some people may experience other side effects while taking Claritine Duo.

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:
Aleje Jerozolimskie 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 Duo

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 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. Package contents and other information

What Claritine Duo contains

• The active substances of Claritine Duo 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 contains: gum arabic, sucrose, calcium sulfate dihydrate, calcium sulfate anhydrous, cellulose, zein, oleic acid, neutral soap, talc, microcrystalline cellulose, titanium dioxide, white wax, carnauba wax.

What Claritine Duo looks like and what the pack contains

Claritine Duo is a white or almost white, round, biconvex, film-coated tablet.
Claritine Duo tablets are packaged in blisters of 6, 10, or 20 tablets, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Bayer Sp. z o.o.
Aleje Jerozolimskie 158
02-326 Warsaw
Tel.: +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