Claritin active

Package leaflet: Information for the patient

Claritine Active, 5 mg + 120 mg, prolonged-release tablets
Loratadine + Pseudoephedrine sulfate
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 10 days of treatment, or if you feel worse, consult your doctor.

Table of contents of the leaflet

1. What Claritine Active is and what it is 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 package and other information

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

What is Claritine Active?
Claritine Active is a prolonged-release medicine containing two active substances:
loratadine, which has antihistamine (antiallergic) properties, and pseudoephedrine, which has a mucosa-constricting effect.

How Claritine Active works

• Loratadine helps reduce allergic symptoms by blocking the action in the body of a substance called histamine (antihistamine effect).
• Pseudoephedrine helps reduce nasal mucosa congestion (decongestant effect).

When to use Claritine Active
Claritine Active is indicated for the treatment of symptoms of seasonal allergic rhinitis associated with nasal mucosa congestion. Claritine Active relieves the following symptoms: nasal congestion, sneezing, watery nasal discharge (runny nose), itching of the nose and eyes, tearing, burning, and redness of the eyes.

2. Important information before using Claritine Active

When not to use Claritine Active:

• if the patient is allergic to loratadine, pseudoephedrine, or any of the other ingredients of this medicine (listed in section 6), or to other medicines that constrict blood vessels of the mucous membranes. Allergic reactions may include, among others, difficulty breathing, wheezing, itching, hives, swelling;
• if the patient has narrow-angle glaucoma, hyperthyroidism, difficulty urinating, urinary retention, high blood pressure, heart or blood vessel disease;
• if the patient has previously had a stroke or is at risk of stroke;
• if the patient is currently taking or has taken within the last 14 days antidepressant medicines known as monoamine oxidase inhibitors (MAO inhibitors);
• 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 hypertension that cannot be controlled with medication;
• 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, discuss this with your doctor or pharmacist:

• If the patient has: ➢ chronic eye disorders, ➢ diabetes, ➢ gastrointestinal diseases, bladder disorders, prostate gland (prostate) disorders, ➢ previously experienced breathing difficulties (bronchospasm) or heart attack;
• Before undergoing surgery: Claritine Active should be discontinued 24 hours before such a procedure;
• Discontinue treatment and contact your doctor if any of the following occur: ➢ high blood pressure, ➢ rapid heartbeat or palpitations, ➢ irregular heartbeat, ➢ malaise, nausea and headache, or worsening headache during treatment with Claritine Active.
• Do not use Claritine Active for longer than 10 days without consulting a doctor.
• Claritine Active has addictive properties that may occur if the patient takes the medicine for longer than recommended. In such cases, sudden discontinuation of Claritine Active may lead to depression.
• Taking higher than recommended doses may cause poisoning.

If the patient develops fever with generalized skin redness and blistering rash,
stop taking Claritine Active and contact a doctor or seek immediate medical help. 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, discontinue use of Claritine Active and seek immediate medical advice or assistance.
See section 4.
During treatment with Claritine Active, reduced blood flow to the optic nerve may occur.
If sudden vision loss occurs, discontinue use of Claritine Active and immediately contact a doctor or
seek immediate medical help. See section 4.
Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following use of medicines containing pseudoephedrine.
PRES and RCVS are rare conditions that may involve reduced blood flow to the brain.
If symptoms occur that may indicate PRES or RCVS, immediately discontinue Claritine Active and seek immediate medical help (symptoms, see section 4 "Possible side effects").

Laboratory tests:
Discontinue use of Claritine Active at least 48 hours before undergoing skin allergy tests.

Information for athletes:
Use of Claritine Active may result in positive anti-doping test results.

Children and adolescents
Do not use Claritine Active in children under 12 years of age.

Claritine Active and other medicines

• Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take, because many medicines taken simultaneously with Claritine Active may cause, among others: ➢ increased or decreased blood pressure, ➢ heart rhythm disturbances, ➢ reduced treatment effectiveness, ➢ possible need to adjust dosage.
• Do not take Claritine Active at the same time as, or within 14 days after stopping treatment with antidepressant medicines known as monoamine oxidase inhibitors (MAO inhibitors).

Claritine Active may interact with the following medicines: cardiac glycosides (medicines used in heart diseases); blood pressure-lowering medicines such as: methyldopa, mecamylamine, reserpine, or guanethidine; medicines reducing nasal mucosal congestion taken orally or nasally, such as: phenylpropanolamine, phenylephrine, ephedrine; appetite-reducing medicines; amphetamine derivatives; tricyclic antidepressants; medicines used for migraine such as: dihydroergotamine, ergotamine, or methylergonovine; linezolid (an antibiotic); bromocriptine (used in infertility or Parkinson's disease); medicines used in Parkinson's disease such as: cabergoline, lisuride, and pergolide; antacids (medicines that neutralize stomach acid); kaolin (a medicine used in diarrhea).

Claritine Active with food and drink
The medicine may be taken regardless of meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use Claritine Active during pregnancy.
If a woman is breastfeeding, she should not take Claritine Active.

Driving and operating machinery
Patients should refrain from driving and operating machinery until they have assessed their individual response to Claritine Active. Do not drive or operate machinery if symptoms such as drowsiness, dizziness, disorientation, or headache occur, as these may impair the ability to drive and operate machinery.

Claritine Active contains lactose and sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking Claritine Active.

3. How to use 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, consult a doctor or pharmacist.
Recommended dose
The recommended dose of Claritine Active is 1 tablet twice daily (every 12 hours).
The tablet should be swallowed whole with a glass of water. Tablets must not be divided, crushed, chewed, or sucked.
Claritine Active may 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 this medicine for longer than 10 days.
If you feel that the effect of Claritine Active is too strong or too weak, consult a 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 must not be used in patients with renal and/or hepatic impairment or with renal tubular acidosis (tubular acidosis).
Use of Claritine Active in patients over 60 years of age:
This medicine must not be used in individuals over 60 years of age.
Taking more Claritine Active than recommended
If you take more Claritine Active than recommended, seek medical advice immediately, as dangerous symptoms of overdose may occur, such as: apnea, cyanosis, coma, collapse, loss of consciousness, seizures. Other symptoms that may occur after overdose include: hallucinations, high fever, irregular or slow or rapid heartbeat, disturbances in consciousness and mood, severe drowsiness or dizziness, nervousness or agitation, vomiting, epigastric pain, blurred vision, high or low blood pressure.
Missed dose of Claritine Active
Do not take a double dose to make up for a missed dose. If a dose is missed, take it as soon as possible, ensuring that a 12-hour interval is maintained between consecutive doses.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, which may indicate a severe allergic reaction: difficulty breathing, wheezing, itching, hives, swelling, dizziness, high blood pressure, urinary retention, fever, rash, or small pustules all over the body, you must stop taking the medicine immediately and contact a doctor.
➢ Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

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

You must stop taking Claritine Active immediately and seek immediate medical help if symptoms indicating posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) occur. These include:

• Sudden, severe headache,
• Nausea,
• Vomiting,
• Confusion,
• Seizures,
• Visual disturbances.
  • Weight gain, reduced blood flow in the optic nerve (ischaemic optic neuropathy), inflammation of the large intestine due to insufficient blood supply (ischaemic 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, discontinue use of Claritine Active and contact a doctor or seek immediate medical help.

➢ Very common adverse reactions associated with taking Claritine Active (occurring in more than 1 in 10 patients using the medicine): insomnia.
➢ Common adverse reactions associated with taking Claritine Active (occurring in 1 to 10 out of 100 patients using the medicine): thirst, nervousness, drowsiness, depression, agitation, loss of appetite, dizziness, dry mouth, palpitations (rapid heartbeat), sore throat, nasal mucosal inflammation, constipation, nausea, headache, feeling of fatigue.
➢ Uncommon adverse reactions associated with taking Claritine Active (occurring in 1 to 10 out of 1,000 patients using the medicine): disorientation, tremor, increased sweating, hot flushes, taste disturbances, excessive tearing, tinnitus, heart palpitations, nosebleeds, frequent urination and urinary disorders, itching.
➢ Very rare adverse reactions associated with taking Claritine Active (occurring in fewer than 1 in 10,000 patients using 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 adverse reactions observed in clinical trials and after marketing of the medicine, associated with loratadine use, include: increased appetite, rash, and gastritis.
Other adverse reactions may occur in some individuals during treatment with Claritine Active.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Claritine Active

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
Expiry date (EXP) or EXP. The expiry date refers to the last day of the stated month.
Store below 25°C.
Keep blisters in the original packaging.
Medicines must 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 Claritine Active contains

• The active substances in this medicine are loratadine and pseudoephedrine sulfate. One tablet contains 5 mg of loratadine and 120 mg of pseudoephedrine sulfate (60 mg of pseudoephedrine sulfate is contained in both the coating and the core of the tablet).
• The other ingredients (excipients) are: monohydrate lactose, corn starch, povidone, magnesium stearate. The coating contains: acacia gum, sucrose, calcium sulfate dihydrate, anhydrous calcium sulfate, rosin, 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 coated tablet.
Claritine Active tablets are packed in blisters of 6 tablets, in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bayer Sp. z o.o.
Al. 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