MUNTEL 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Muntel 5 mg Film-Coated Tablets

Levocetirizine Dihydrochloride

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

• Keep this package leaflet, 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 only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Package Leaflet Contents

1. What is Muntel and what is it used for
2. What you need to know before taking Muntel
3. How to take Muntel
4. Possible side effects
5. Storage of Muntel
6. Package Contents and Additional Information

1. What is Muntel and what is it used for

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

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

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

2. What you need to know before taking Muntel

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).

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

Children

Muntel is not recommended for children under 6 years of age, 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 recently used, or may need to use any other medication.

Taking Muntel with food, beverages, and alcohol

Caution is recommended if you take Muntel and alcohol or other substances that act on the brain at the same time.

In sensitive patients, taking Muntel with alcohol or other substances that act on the brain may cause an additional decrease in attention and reduce performance.

Muntel can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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

Be careful if you are going to drive or use machinery until you know how this medication affects you. However, in special tests performed 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 told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Muntel

Follow your doctor's instructions for taking this medication exactly. If you have any doubts, consult your doctor or pharmacist again.

The recommended dose for adults and children over 6 years of age is one tablet per day.

Use in special populations

Patient with renal insufficiency

Patient with renal insufficiency should receive a lower dose. The dose will be decided by your doctor.

Patient with severe renal insufficiency should not take this medication.

Patient with hepatic insufficiency

In patient with only hepatic insufficiency, it is not necessary to adjust the dose.

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

Patient over 65 years of age

In elderly patient, it is not necessary to adjust the dose if renal function is normal.

Use in children

Muntel is not recommended for children under 6 years of age, as it does not allow for dose adjustment.

How and when should you take Muntel?

For oral use only.

Muntel tablets should be swallowed whole with water and can be taken with or without 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 lower dose than prescribed by your doctor, do not take a double dose to make up for the missed doses. Continue taking your normal dose when it is due.

If you stop taking Muntel

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Common: may affect up to 1 in 10 people

Dry mouth, headache, fatigue, and drowsiness.

Uncommon: may affect up to 1 in 100 people

Exhaustion and abdominal pain.

Frequency not known: cannot be estimated from available data

Other side effects have also been reported, such as palpitations, increased heart rate (tachycardia), seizures, tingling, dizziness, syncope, tremors, dysgeusia (altered sense of taste), sensation of rotation or movement, visual disturbances, blurred vision, oculogyric crisis (uncontrolled circular movements of the eyes), pain or difficulty urinating, inability to urinate, edema, pruritus (itching) (which may also appear after stopping Muntel), rash, urticaria (swelling, redness, and itching of the skin), skin eruption, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucination, depression, insomnia, recurrent thoughts or concerns about suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea, and diarrhea.

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Muntel

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

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Muntel Composition

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.

Product Appearance and Package Contents

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

Marketing Authorization Holder and Manufacturer

Holder

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Manufacturer

Aesica Pharmaceuticals, S.r.l.

Via Praglia 15

I-10044 Pianezza (TO) - Italy

Date of the last revision of this package leaflet: May 2018

Detailed information about this medication is available on the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.aemps.gob.es/