CLARITYNE PLUS 10mg/240mg PROLONGED-RELEASE TABLETS

2. What you need to know before you start taking Clarityne Plus

Do not take Clarityne Plus:

• if you are allergic (hypersensitive) to loratadine, pseudoephedrine or any of the other components of this medicine (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, obstruction of the urinary tract, very high blood pressure (severe hypertension) or uncontrolled hypertension, heart or blood vessel disease, have had or have a brain hemorrhage, or hyperthyroidism,
• if you are being treated for depression with monoamine oxidase inhibitors (MAOIs) or during the 2 weeks following such treatment,
• if you have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure.

Warnings and precautions

Certain diseases may make you unusually sensitive to the decongestant pseudoephedrine, contained in this medicine.

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 medicine,
• if you have diabetes mellitus, stomach ulcers, small intestine, or esophagus (peptic ulcer), intestinal obstruction (pyloroduodenal obstruction), obstruction of the urinary bladder neck (obstruction of the bladder neck), if you have ever had difficulty breathing due to narrowing of the airways (bronchospasm), or liver, kidney, or bladder problems,
• if you are going to have 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 a dose adjustment
• if you are taking α-methyldopa, mecamylamine, reserpine, and guanethidine for blood pressure, as you may need a dose adjustment
• if you are taking decongestants (oral or nasal), appetite suppressants (diet pills), or amphetamines, as these medications can increase your blood pressure when taken with Clarityne Plus
• if you are taking medications with ergotamine alkaloids (such as dihydroergotamine, ergotamine, or methylergometrine) for the treatment of migraines, as these medications can 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, and pergolide (for Parkinson's disease). Taking any of these medications while being treated with Clarityne Plus may increase your blood pressure.
• if you are going to have skin allergy tests, do not take Clarityne Plus during the 2 days prior to the tests, as this medicine may alter the results.

Tell 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 interrupt treatment.

One of the active substances of Clarityne Plus, pseudoephedrine sulfate, can cause dependence and large amounts of pseudoephedrine sulfate can be toxic.

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

Sudden abdominal pain or rectal bleeding may occur with the use of Clarityne Plus, due to inflammation of the colon (ischemic colitis). If these gastrointestinal symptoms appear, stop taking Clarityne Plus and contact your doctor or seek immediate medical attention. See section 4.

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

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

Children

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

Taking Clarityne Plus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those obtained without a prescription.

Taking Clarityne Plus with alcohol

It has not been shown that Clarityne Plus enhances 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 medicine.

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. A decrease in milk production has been reported in breastfeeding mothers with the use of pseudoephedrine, a component of Clarityne Plus.

Driving and using machines

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

Clarityne Plus contains sucrose

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

Information for athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

3. How to take Clarityne Plus

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take:

Adults and adolescents from 12 years old:

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

This medicine 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 recommended in this package leaflet, or more frequently than recommended.

The duration of treatment 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, you should consult your doctor.

In case you experience high blood pressure, tachycardia, palpitations, nausea during treatment with this medicine, you should stop 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. Drowsiness, palpitations, and headache have been reported with overdose of loratadine, a component of Clarityne Plus. Convulsions, palpitations, nausea, and nervousness have been reported with overdose of pseudoephedrine, a component of Clarityne Plus.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service; Telephone 91 562 04 20 indicating the medicine 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 make up for forgotten doses.

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

4. Possible side effects

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

Frequency not known: cannot be estimated from the available data

• serious diseases affecting the blood vessels of the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

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

• sudden severe headache
• malaise
• vomiting
• confusion
• seizures
• changes in vision

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

Uncommon side effects (may affect up to 1 in 100 patients) include:

tachycardia, palpitations, nosebleeds, rhinitis, constipation, nausea.

During the marketing of Clarityne Plus, the following side effects have occurred with a very rare frequency (may affect up to 1 in 10,000 patients): severe allergic reaction including rash, urticaria, and swelling of the face, 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 not known:

• weight gain
• sudden onset of fever, skin redness, or many small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) that may occur within 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.

• inflammation of the colon due to decreased blood circulation (ischemic colitis).
• decreased blood flow to the optic nerve (ischemic optic neuropathy).

Reporting of side effects:

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

5. Storage of Clarityne Plus

• Keep this medicine out of the sight and reach of children.
• This medicine does not require any special storage temperature. Store in the original packaging to protect it from moisture. Do not freeze.
• Do not use this medicine after the expiration date stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.
• Do not use this medicine if you notice any change in the appearance of the tablet.
• Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clarityne Plus

• The active substances are loratadine 10 mg and pseudoephedrine sulfate 240 mg.
• The other components are: core - hypromellose; ethylcellulose; calcium hydrogen 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 contents of the pack

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.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bayer Hispania, S.L.

Avda. Baix Llobregat 3 y 5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

SAG Manufacturing S.L.U.

Km. 36, Carretera Nacional 1

28750 San Agustín de Guadalix

Madrid (Spain)

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Clarinase Once Daily

Denmark, Iceland: Clarinase

Portugal: Claridon QD

Spain: Clarityne Plus 10mg/240mg

Date of last revision of this package leaflet:04/2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/