Clarityne Plus 10 mg/240 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clarityne Plus 10 mg/240 mg prolonged-release tablets

loratadine/pseudoephedrine sulfate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

• Keep this leaflet as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 7 days.

What this leaflet contains

1.- What Clarityne Plus is and what it is used for

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

3.- How to take Clarityne Plus

4.- Possible side effects

5.- How to store Clarityne Plus

6.- Contents of the pack and other information

1. What Clarityne Plus is and what it is used for

What Clarityne Plus is

Clarityne Plus contains a combination of two active substances (loratadine and pseudoephedrine sulfate).

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

How Clarityne Plus works

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

When to use Clarityne Plus

This medicine is indicated for the treatment of nasal congestion and other symptoms associated with seasonal allergic rhinitis (hay fever), such as sneezing, eye irritation, runny nose, nasal and ocular itching, caused by plant pollen in adults and adolescents aged 12 years and older.

2. What you need to know before 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 medications,
• if you have glaucoma, difficulty urinating, urinary tract obstruction, very high blood pressure (severe hypertension) or uncontrolled hypertension, heart or blood vessel diseases, have had or currently have cerebral haemorrhage, or hyperthyroidism,
• if you are being treated for depression with monoamine oxidase inhibitors (MAOIs) or within 2 weeks after stopping such treatment,
• if you have severe, acute (sudden) or chronic (long-term) kidney disease, or kidney failure.

Warnings and precautions

Certain medical conditions 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 of age, as you may be more sensitive to the effects of this medicine,
• if you have diabetes mellitus, a peptic ulcer causing narrowing of the stomach, small intestine, or oesophagus (stenosing peptic ulcer), intestinal obstruction (pyloro-duodenal obstruction), obstruction of the bladder neck (vesical neck obstruction), if you have ever experienced breathing difficulty due to narrowing of the airways (bronchospasm), or have liver, kidney, or bladder problems,
• if you are scheduled for 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 require a dose adjustment,
• if you are taking α-methyldopa, mecamylamine, reserpine, or guanethidine for blood pressure, as you may require a dose adjustment,
• if you are taking decongestants (oral or nasal), appetite suppressants (diet pills), or amphetamines, as these medicines together with Clarityne Plus may increase your blood pressure,
• if you are taking ergot alkaloid medications (such as dihydroergotamine, ergotamine, or methylergometrine) for migraine treatment, as these medicines together with Clarityne Plus may increase your blood pressure,
• 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 while on Clarityne Plus may increase your blood pressure.
• if you are scheduled for allergy skin tests, do not take Clarityne Plus during the 2 days prior to the tests, as this medicine may alter the test results.

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

• high blood pressure,
• rapid or strong heartbeat (tachycardia),
• irregular heartbeat (arrhythmias),
• nausea and headache or worsening of headache while using Clarityne Plus. Your doctor may advise you to stop treatment.

One of the active ingredients in Clarityne Plus, pseudoephedrine sulfate, may lead to dependence, and large amounts of pseudoephedrine sulfate may be toxic.

If you develop a generalized feverish rash 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 Clarityne Plus use, due to inflammation of the colon (ischaemic colitis). If these gastrointestinal symptoms occur, stop taking Clarityne Plus and contact your doctor or seek immediate medical attention. See section 4.

Reduced 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.

Cases of reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine. RPES and RCVS are rare conditions that may involve reduced blood flow to the brain. Stop using Clarityne Plus immediately and seek immediate medical assistance if you experience symptoms that could be signs of RPES or RCVS (for symptoms, see section 4 "Possible side effects").

Children

Do not give this medicine to children under 12 years of age.

Taking Clarityne Plus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, 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 are planning 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 reduction in milk supply has been reported in breastfeeding mothers using pseudoephedrine, a component of Clarityne Plus.

Driving and using machines

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

Clarityne Plus contains sucrose

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

Information for athletes

Athletes are advised that this medicine contains a component that may result in a positive analytical finding in doping control tests.

3. How to take Clarityne Plus

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage:

Adults and adolescents aged 12 years and older:

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

This medicine is for oral use.

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 leaflet, or more frequently than recommended.

Treatment duration should be as short as possible, and the medicine should be discontinued once symptoms have resolved.

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

If during treatment with this medicine you experience high blood pressure, tachycardia, palpitations, or nausea, discontinue use and consult your doctor.

If you take more Clarityne Plus than you should

If you take more Clarityne Plus than recommended, contact your doctor or pharmacist immediately. Cases of somnolence, palpitations, and headache have been reported with overdose of loratadine, a component of Clarityne Plus. Seizures, palpitations, nausea, and nervousness have been reported with overdose of pseudoephedrine, a component of Clarityne Plus.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service; Telephone 91 562 04 20, stating 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Frequency not known: cannot be estimated from the available data

• serious conditions affecting the blood vessels in the brain known as reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS)

Stop using Clarityne Plus immediately and seek urgent medical help if you develop symptoms that could be signs of reversible posterior encephalopathy syndrome (RPES) or reversible cerebral vasoconstriction syndrome (RCVS). These include:

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

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

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

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

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

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

The frequency of the following adverse effects is unknown:

• Weight gain
• Sudden onset of fever, skin redness, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) which may occur within the first 2 days of treatment with Clarityne Plus. See section 2.

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

• Inflammation of the colon due to reduced blood flow (ischaemic colitis).
• Reduced blood flow to the optic nerve (ischaemic optic neuropathy).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 special storage temperature conditions. Store in the original packaging to protect from moisture. Do not freeze.
• Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.
• Do not use this medicine if you notice any changes in the appearance of the tablet.
• Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. 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 pack sizes

Clarityne Plus 10 mg/240 mg prolonged-release tablets are available in blister packs containing 1, 7, 10, 14, 20, 28, 30, 50 or 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bayer Hispania, S.L.

Avda. Baix Llobregat 3 and 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 medicinal product 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 the most recent review of this leaflet: 04/2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/