Label: information for the user

Narine Repetabs5mg/120mg prolonged-release tablets

loratadine/pseudoephedrine sulfate

Read this label carefully before starting to takethis medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• Ifyou experience adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this label. See section 4.

What is Narine Repetabs

Narine Repetabs tablets contain a combination of two medications, an antihistamine (loratadine) and a decongestant (pseudoephedrine).

How Narine Repetabs works

Narine Repetabs 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 Narine Repetabs

Narine Repetabs tablets relieves symptoms associated with seasonal allergic rhinitis (hay fever), such as sneezing, runny or itchy nose or eyes when accompanied by nasal congestion in adults and adolescents 12 years and older.

Do not take Narine Repetabs

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

Do not take Narine Repetabs

• 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 high blood pressure, heart disease, or vascular disease, have or have had a cerebral hemorrhage, or hyperthyroidism.
• if you are being treated with monoamine oxidase inhibitors (MAO) or if you have stopped this treatment less than 14 days ago.
• if you have severe, acute (sudden), or chronic (long-term) kidney disease, or kidney failure.

Warnings and precautions

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

Consult your doctor or pharmacist before starting to take Narine Repetabs:

• if you are 60 years of age or older, as you may be more sensitive to the effects of this medication.
• if you have diabetes mellitus, peptic ulcer disease (ulcer that causes narrowing of the stomach, small intestine, or esophagus), pyloric obstruction (obstruction of the intestine), vesical neck obstruction (obstruction of the bladder neck), a history of bronchospasm (difficulty breathing due to narrowing of the lung muscles) or liver, kidney, or bladder problems.
• if you are scheduled for surgery, as you may need to stop taking Narine Repetabs for a few days.
• if you are taking digitalis, medications used to treat certain heart problems, as you may need to adjust your dosage.
• if you are taking alpha-methyldopa, mecamylamine, reserpine, and guanethidine 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 Narine Repetabs.
• if you are taking ergot alkaloids (such as dihydroergotamine, ergotamine, or methylergometrine) for migraines. When taken with Narine Repetabs, these medications may increase your blood pressure.
• if you are taking linezolid (an antibiotic), bromocriptine (for infertility or Parkinson's disease), cabergoline, lisuride, and pergolide (for Parkinson's disease). When taken with Narine Repetabs, these medications may increase your blood pressure.
• if you are scheduled for skin allergy tests, do not take Narine Repetabs for the two days prior to the tests, as this medication may alter the results.

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

• high blood pressure
• rapid or strong heartbeats
• abnormal heart rhythm
• nausea and headache or increased headache when using Narine Repetabs. Your doctor may tell you to stop treatment.

One of the active ingredients of Narine Repetabs, pseudoephedrine sulfate, may cause dependence and large amounts of pseudoephedrine sulfate may be toxic.

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

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

Narine Repetabs may cause a reduction in blood flow to the optic nerve. If you experience sudden vision loss, stop taking Narine Repetabs 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 the use of medications containing pseudoephedrine. RPES and RCVS are rare diseases that may involve a reduction in blood flow to the brain. Stop using Narine Repetabs 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 of age.

Taking Narine Repetabs 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.

Taking Narine Repetabs with alcohol

Narine Repetabs 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 Narine Repetabs if you are pregnant.

Breastfeeding

Do not take Narine Repetabs 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 using pseudoephedrine, a component of Narine Repetabs.

Driving and operating machinery

At the recommended dose, Narine Repetabs 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.

Narine Repetabs contains lactose and saccharose

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

Laboratory tests:This medication contains a component that may establish a positive analytical result for doping control.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How to Take

Adults and adolescents 12 years of age or older:

The recommended dose is one Narine Repetabs prolonged-release tablet twice a day with a glass of water, regardless of meals. twice with a glass of water, regardless of meals.

This medication is taken orally. Swallow the tablet whole; do not crush, break, or chew the tablet before swallowing.

Do not take more Narine Repetabs tablets than recommended in this leaflet, or more frequently than recommended.

Do not take this medication for more than 10 consecutive days unless your doctor tells you otherwise.

If you take more Narine Repetabs than you should

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

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 Narine Repetabs

• 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 the missed dose.

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

Like all medicines, this medicine may 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 you consider important.that does not go away, is bothersome, or you consider important.

Unknown frequency: cannot be estimated from available data

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

Stop using Narine Repetabs immediately and seek urgent medical assistance if you present 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 side effects that occur very frequently with Narine Repetabs (may affect more than1 in 10patients) include: insomnia.

The side effects that occur frequently with Narine Repetabs (may affect up to 1in 10patients)include: drowsiness, nervousness, drowsiness, depression, agitation, anorexia, dizziness, dry mouth, rapid heart rate, sore throat, nasal mucosa inflammation, constipation, nausea, headache, and fatigue.

The side effects that occur infrequently(may affect up to 1in 100patients)include: confusion, tremor, increased sweating, hot flashes, altered taste, abnormal tearing of the eyes, ringing in the ears, irregular heart rate, nasal bleeding, and frequent or abnormal urination and itching.

During the marketing of Narine Repetabsthe following side effects have occurred with very rarefrequencies(may affect up to 1 in 10,000patients): severe allergic reaction including rash, urticaria, and facial swelling, vertigo, seizures, abnormal heart rhythms, increased blood pressure, cough, bronchospasm, liver problems, urinary difficulties, and hair loss.

Other adverse reactions that were only reported for loratadine in clinical trials and during the post-marketing period include increased appetite, rash, and stomach discomfort.

The frequency of the following side effects is unknown:

• Weight gain

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

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

• Colon inflammation 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 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 the 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 pack 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 disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Narine Repetabs

• The active principles are loratadine 5 mg and pseudoephedrine sulfate 120 mg.
• The other components are: core - lactose monohydrate, cornstarch, povidone, and magnesium stearate; coating - gum arabic, anhydrous calcium sulfate, dihydrate calcium sulfate, carnauba wax, microcrystalline cellulose, oleic acid, colophony, soap powder, sucrose, talc, titanium dioxide, white wax, and zein. See section 2 “Narine Repetabs contains lactose and sucrose”

Appearance of the product and content of the container

Narine Repetabs 5 mg/120 mg prolonged-release tablets are presentedin blisters in container sizes of1, 7, 10, 14, 20, 28, 30, 50, and 100 tablets.

Only some container sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Bayer Hispania, S.L.

Avenida Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible manufacturer

SAG Manufacturing, S.L.U.

Carretera N-1, Km 36

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:

Austria: Clarinase

Belgium: Clarinase Repetabs

Spain: Narine Repetabs 5mg/120mg prolonged-release tablets

Greece: Clarityne-D 120/5

Portugal: Claridon

Last review date of this leaflet: 10/2024

Other sources of information

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