NARINE REPETABS 5 mg/120 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Narine Repetabs

Do not take Narine Repetabs

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

Due to its pseudoephedrine content, do not take Narine Repetabs

Warnings and precautions

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

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

Tell 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, can cause dependence and large amounts of pseudoephedrine sulfate can be toxic.

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

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

A reduction in blood flow to the optic nerve may occur with Narine Repetabs. If you experience sudden loss of vision, stop taking Narine Repetabs 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 can involve a reduction in blood flow to the brain. Stop using Narine Repetabs immediately and seek immediate medical attention if you experience symptoms that may be signs of PRES or RCVS (to learn about the symptoms, see section 4 "Possible side effects").

Children

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

Taking Narine Repetabs withother medicines

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

Taking Narine Repetabs with alcohol

It has not been shown that Narine Repetabs 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 Narine Repetabs if you are pregnant.

Breastfeeding

Do not take Narine Repetabs 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 Narine Repetabs.

Driving and using machines

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

Narine Repetabs contains lactose and sucrose

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

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

3. How to take Narine Repetabs

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

How to take

Adults and adolescents aged 12years and over:

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

This medicine 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 medicine for more than 10 consecutive days unless your doctor tells you to do so.

If you take more Narine Repetabs than you should

If you take more Narine Repetabs than you should, consult your doctor or pharmacist immediately. Drowsiness, 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 Toxicology Information Service; Telephone 91 562 04 20 indicating the medicine 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 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 you think 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 Narine Repetabs 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

The side effects that occur very frequently with Narine Repetabs (may affect more than 1 in 10 patients) include: insomnia.

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

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

During the marketing of Narine Repetabs, the following side effects have occurred with a very rarefrequency (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, bronchial constriction, liver problems, difficulty urinating, 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 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 Narine Repetabs. See section 2.

Stop taking Narine Repetabs 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 effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 Narine Repetabs

• Keep this medicine out of the sight and reach of children.

• This medicine does not require any special storage temperature. Keep in the original packaging to protect from moisture. Do not freeze.

• Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.

The expiry date is the last day of the month stated.

• 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 further information

Composition of Narine Repetabs

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

Appearance of the product and pack size

Narine Repetabs 5 mg/120 mg prolonged-release tablets are presented in blisters in pack sizes of 1, 7, 10, 14, 20, 28, 30, 50, and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

SAG Manufacturing, S.L.U.

Carretera N-1, Km 36

28750, San Agustín de Guadalix (Madrid)

Spain

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

Austria: Clarinase

Belgium: Clarinase Repetabs

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

Greece: Clarityne-D 120/5

Portugal: Claridon

Date of last revision of this leaflet: 10/2024

Other sources of information

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/