Label: Information for the User

Clarityne Plus 10 mg/240 mg Extended-Release Tablets

loratadine/pseudoephedrine sulfate

Read this label carefully before taking this medicine, as it contains

important information for you.

This medicine can be purchased without a prescription. However, to achieve the best results, it must

be used properly.

-Keep this label, as you may need to refer to it again.

-For advice or more information, consult your pharmacist.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

-You should consult a doctor if your symptoms worsen or do not improve after 7 days.

1.- What is Clarityne Plus and how is it used

2.- What you need to know before starting to take Clarityne Plus

3.- How to take Clarityne Plus

4.- Possible side effects

5.- Storage of Clarityne Plus

6.- Contents of the package and additional information

What is Clarityne Plus

Clarityne Plus contains an association of two active principles (loratadine and pseudoephedrine sulfate).

Loratadine is an antihistamine (antiallergic) and pseudoephedrine sulfate is a nasal decongestant.

How Clarityne Plus works

Clarityne Plus helps to reduce the symptoms of allergy or common cold by blocking the effects of a substance called “histamine”, which the body produces when it is allergic to something. Decongestants help to clear nasal congestion.

When to use Clarityne Plus

This medication is indicated for the treatment of symptoms of nasal congestion and other symptoms associated with seasonal allergy (hay fever) such as sneezing, eye irritation, runny nose, nasal and eye itching, produced by plant pollen in adults or adolescents from 12 years old.

Do not take Clarityne Plus:

-if you are allergic (hypersensitive) to loratadine, pseudoephedrine, or any of the other components of this medication (listed in section 6).

Due to its pseudoephedrine content, do not take Clarityne Plus

-if you are also being treated with any heart or blood pressure medication.

-if you have glaucoma, difficulty urinating, urinary tract obstruction, severe high blood pressure (hypertension), uncontrolled hypertension, heart disease, or blood vessel disease, have or have had a cerebral hemorrhage, or hyperthyroidism.

-if you are being treated for depression with monoamine oxidase inhibitors (MAOIs) or within 2 weeks of such treatment.

-if you have severe, acute, or chronic kidney disease, or kidney failure.

Warnings and precautions

Certain diseases may make you abnormally sensitive to the pseudoephedrine decongestant in this medication.

Consult your doctor or pharmacist before starting to take Clarityne Plus:

-if you are over 60 years old, as you may be more sensitive to the effects of this medication.

-if you have diabetes mellitus, stomach ulcers that cause narrowing, intestinal narrowing, or esophageal narrowing (peptic ulcer stenosis), intestinal obstruction (pyloroduodenal obstruction), bladder neck obstruction, if you have ever had difficulty breathing due to airway narrowing (bronchospasm), or liver, kidney, or bladder problems.

-if you are about to undergo surgery, as you may need to stop taking Clarityne Plus.

-if you are taking digitalis medications used to treat certain heart problems, as you may need to adjust your dosage.

-if you are taking α-metildopa, mecamilamine, reserpine, or guanetidine for high blood pressure, as you may need to adjust your dosage.

-if you are taking oral or nasal decongestants, appetite suppressants (diet pills), or amphetamines, as these medications may increase your blood pressure when taken with Clarityne Plus.

-if you are taking ergotamine alkaloid medications (such as dihydroergotamine, ergotamine, or methylergometrine) for migraines, as these medications may increase your blood pressure when taken with Clarityne Plus.

-if you are taking linezolid (an antibiotic), bromocriptine (used to treat infertility or Parkinson's disease), cabergoline, lisuride, or pergolide (for Parkinson's disease). Taking any of these medications with Clarityne Plus may increase your blood pressure.

-if you are about to undergo skin allergy tests, do not take Clarityne Plus for 2 days before the tests, as this medication may affect the results.

Inform your doctor if you notice or are diagnosed with any of the following:

•high blood pressure,

•rapid or strong heartbeats (tachycardia),

•abnormal heart rhythm (arrhythmias),

•nausea and headache or increased headache when using Clarityne Plus. Your doctor may tell you to stop treatment.

One of the active ingredients in Clarityne Plus, pseudoephedrine sulfate, may cause dependence and

large amounts of pseudoephedrine sulfate can be toxic.

If you develop a generalized fever rash associated with pustules, stop taking Clarityne Plus and contact your doctor or seek medical attention immediately. See section 4.

Abdominal pain or rectal bleeding may occur with the use of Clarityne Plus due to ischemic colitis. If these gastrointestinal symptoms appear, stop taking Clarityne Plus and contact your doctor or seek medical attention immediately. See section 4.

Clarityne Plus may cause a reduction in blood flow to the optic nerve. If you experience sudden vision loss, stop taking Clarityne Plus and contact your doctor or seek medical attention immediately. See section 4.

There have been reports of reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS) after use of pseudoephedrine-containing medications. RPES and RCVS are rare diseases that may involve reduced blood flow to the brain. Stop using Clarityne Plus immediately and seek medical attention if you experience symptoms that may be signs of RPES or RCVS (see section 4 "Possible side effects").

Children

Do not give this medication to children under 12 years old.

Clarityne Plus with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Clarityne Plus with alcohol

Clarityne Plus has not been shown to potentiate the effects of alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take Clarityne Plus if you are pregnant.

Breastfeeding

Do not take Clarityne Plus if you are breastfeeding.Loratadine and pseudoephedrine are excreted in breast milk. There have been reports of a decrease in milk production in breastfeeding mothers taking pseudoephedrine, a component of Clarityne Plus.

Driving and operating machinery

At the recommended dose, Clarityne Plus is not expected to cause drowsiness or decreased alertness. However, very rarely, some people may experience drowsiness, which may affect their ability to drive or operate machinery.

Clarityne Plus contains saccharose

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Information for athletes

Notify athletes that this medication contains a component that may result in a positive analytical result for doping control.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take:

Adults and adolescents 12 years and older:

The recommended dose is 1 tablet, once a day with a glass of water, with or without food.

This medication is taken orally.

Swallow the tablet whole; do not crush, break, or chew the tablet before swallowing.

Do not take more Clarityne Plus tablets than those recommended in this leaflet, or more frequently than recommended.

The treatment duration should be as short as possible and should be discontinued once symptoms have disappeared.

If symptoms worsen or do not improve after 7 days of treatment, consult your doctor.

If you experience high blood pressure, rapid heartbeat, palpitations, nausea during treatment with this medication, discontinue it and consult your doctor.

If you take more Clarityne Plus than you should:

If you take more Clarityne Plus than you should, consult your doctor or pharmacist immediately. Somnolence, palpitations, and headache have been reported with loratadine overdose, a component of Clarityne Plus. Convulsions, palpitations, nausea, and nervousness have been reported with pseudoephedrine overdose, a component of Clarityne Plus.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service; Telephone 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take Clarityne Plus:

• If you forget to take a dose, take it as soon as you remember, and then continue taking it as usual.
• Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Contact your doctor or pharmacist immediately if you experience a side effect that does not go away, is bothersome, or if you consider it to be important.

Unknown frequency: cannot be estimated from available data

- severe diseases affecting blood vessels in the brain known as reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS)

Stop using Clarityne Plus immediately and seek urgent medical assistance if you experience symptoms that may be signs of reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden onset of severe headache

• discomfort

• vomiting

• confusion

• seizures

• changes in vision

The common side effects (may affect up to 1 in 10 patients) associated with Clarityne Plus are: nervousness, anorexia, drowsiness, insomnia, dizziness, restlessness, dry mouth, fatigue.

The less common side effects (may affect up to 1 in 100 patients) include:

tachycardia, palpitations, nasal bleeding, rhinitis, constipation, nausea.

During the marketing of Clarityne Plus, the following side effects have occurred with very rare frequency(may affect up to 1 in 10,000 patients): severe allergic reaction including rash, urticaria, and facial swelling, vertigo, seizures, abnormal heart rhythms, increased blood pressure, cough, narrowing of the airways, liver problems, difficulty urinating, and hair loss.

Other side effects that only occur due to loratadine in clinical trials and during marketing include: increased appetite, rash, and stomach discomfort.

The frequency of the following side effect is unknown:

• Weight gain
• Sudden onset of fever, skin redness, or many small pustules (possible symptoms of acute generalized pustular psoriasis - AGPP) that may occur in the first 2 days of treatment with Clarityne Plus. See section 2.

Stop taking Clarityne Plus if these symptoms appear and contact your doctor or seek immediate medical attention.

• Colitis due to decreased blood circulation.
• Optic neuropathy due to decreased blood flow to the optic nerve.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• This medication does not require any special storage temperature.Store in the original packaging to protect it from moisture. Do not freeze.
• Do not use this medication after the expiration date that appears on the box and on the blister after CAD.The expiration date is the last day of the month indicated.
• Do not use this medication if you observe any change in the appearance of the tablet.
• Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Clarityne Plus

-The active principles are loratadine 10 mg and pseudoephedrine sulfate 240 mg.

-The other components are: core - hypromellose; ethylcellulose; calcium dihydrogen phosphate dihydrate; povidone; silicon dioxide; magnesium stearate; coating - macrogol 3350; hypromellose 2910; OPASPRAY white K-1-7000 (titanium dioxide E-171, hydroxypropylcellulose E-463); sucrose; macrogol 400; carnauba wax and white beeswax.See section 2 “Clarityne Plus contains sucrose”

Appearance of the product and content of the container

Clarityne Plus 10 mg/240 mg prolonged-release tablets are presented in blisters with 1, 7, 10, 14, 20, 28, 30, 50 or 100 tablets.

Only some container sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Bayer Hispania, S.L.

Avda. Baix Llobregat 3 y 5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible manufacturer

SAG Manufacturing S.L.U.

Km. 36, National Highway 1

28750 San Agustín de Guadalix

Madrid (Spain)

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Bélgica: Clarinase Once Daily

Dinamarca, Islandia: Clarinase

Portugal: Claridon QD

España: Clarityne Plus 10mg/240mg

Last review date of this leaflet:04/2024

The detailed and updated information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/