Package Insert: Information for the Patient

Muntel 5 mg Film-Coated Tablets

Levocetirizine Dihydrochloride

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

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

1. What is Muntel and for what it is used

2. What you need to know before starting to take Muntel

3. How to take Muntel

4. Possible adverse effects

5. Storage of Muntel

6. Contents of the package and additional information

The active ingredient of Muntel is levocetirizine dihydrochloride. Muntel is an antihistamine medication.

For the treatment of signs of disease (symptoms) associated with:

• Allergic rhinitis (including persistent allergic rhinitis).
• Urticaria.

Do not take Muntel:

• If you are allergic to levocetirizine dihydrochloride, cetirizine, hydroxyzine, or

any of the other components of this medication (listed in section 6).

• If you have severe kidney impairment (severe renal insufficiency with a creatinine clearance of less than 10 ml/min).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Muntel.

• If you have any condition that prevents you from emptying your bladder (such as spinal cord damage or enlarged prostate), please inform your doctor.
• If you are epileptic or at risk of seizures, please consult your doctor as the use of Muntel may worsen the seizures.
• If you are to undergo an allergy test, ask your doctor if you need to stop taking Muntel several days beforehand. This medication may affect the results of the allergy test.

Children

Muntel is not recommended for children under 6 years old as the film-coated tablets do not allow for dose adjustment.

Taking Muntel with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Taking Muntel with food, drinks, and alcohol

Caution is advised if Muntel is taken and alcohol or other central nervous system agents are consumed at the same time.

In sensitive patients, the simultaneous intake of Muntel with alcohol or other central nervous system agents may cause additional decreased attention capacity and reduced performance.

Muntel can be taken both on an empty stomach and with food.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

Some patients treated with Muntel may experience drowsiness/drowsiness, fatigue, and exhaustion.

Be cautious if you are to drive or operate machinery until you know how this medication affects you. Nevertheless, in special tests conducted on healthy individuals, no alterations in attention, reaction capacity, or driving ability were detected after taking levocetirizine at the recommended dose.

Muntel contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

The recommended dose for adults and children aged 6 years and above is one tablet per day.

Use in special populations

Patients with renal insufficiency

Patients with renal insufficiency should receive a lower dose. The dose will be determined by your doctor.

Patients with severe renal insufficiency should not take this medication.

Patients with hepatic insufficiency

In patients with only hepatic insufficiency, no dose adjustment is necessary.

However, patients with both renal and hepatic insufficiency should take a lower dose. The dose to be taken will be determined by your doctor.

Patients aged 65 years and above

In elderly patients with normal renal function, no dose adjustment is necessary.

Use in children

The use of Muntel in children under 6 years is not recommended as it does not allow for adequate dose adjustment.

How and when to take Muntel

Only for oral use.

Muntel tablets should be swallowed whole with water and can be taken either on an empty stomach or with food.

How long should your treatment with Muntel last?

The duration of treatment depends on the type, duration, and course of symptoms and will be determined by your doctor.

If you take more Muntel than you should

If you take more Muntel than you should, in adults it may cause drowsiness. In children, it may initially cause agitation and restlessness followed by drowsiness.

In case of overdose or accidental ingestion of Muntel, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 915 62 04 20.

If you forget to take Muntel

If you have forgotten to take Muntel, or if you take a dose lower than prescribed by your doctor, do not take a double dose to compensate for the missed doses. Continue taking your normal dose when it is due.

If you interrupt treatment with Muntel

Stopping treatment should not have negative effects. However, rarely, intense itching may appear when stopping Muntel, even if these symptoms were not present at the start of treatment. Symptoms may disappear spontaneously. In some cases, symptoms may be intense and require restarting treatment. Symptoms usually disappear when treatment is restarted.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent: may affect up to 1 in 10 people

Dry mouth, headache, fatigue, and drowsiness.

Infrequent: may affect up to 1 in 100 people

Exhaustion and abdominal pain.

Unknown frequency: cannot be estimated from available data

Other adverse effects have also been described, such as palpitations, increased heart rate (tachycardia), seizures, paresthesia,

vertigo, syncope, tremor, dysgeusia (alteration of the sense of taste), sensation of rotation or

movement, visual disturbances, blurred vision, ocular crisis (uncontrolled circular movements of the eyes), pain or difficulty urinating, inability to urinate, edema, pruritus (itching) (which may also appear after stopping Muntel), urticaria (hives), skin rash, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucinations, depression, insomnia, recurring thoughts or concern about suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea.

Immediately stop taking Muntel and inform your doctor if you experience the first signs of hypersensitivity reaction. Symptoms of hypersensitivity reaction may include: swelling of the mouth, tongue, face, and/or neck, difficulty breathing or swallowing (chest tightness or wheezing), hoarseness, sudden decrease in blood pressure that may lead to collapse or shock, which can be fatal.

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the

medicines you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines you no longer need. By doing so, you will help protect the environment.

Composition of Muntel

The active ingredient is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.

The other components are lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171), and macrogol 400.

Appearance of the product and contents of the packaging

Muntel film-coated tablets are white to off-white, oval-shaped, and have the mark “Y” engraved on one of their faces. Each package contains 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Responsible for manufacturing

Aesica Pharmaceuticals, S.rl.

Via Praglia 15

I-10044 Pianezza (TO) - Italy

Last review date of this leaflet: May 2018

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