Muntel 5 mg film-coated tablets
SpainTable of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Muntel 5 mg film-coated tablets
Levocetirizine dihydrochloride
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Muntel is and what it is used for
- What you need to know before taking Muntel
- How to take Muntel
- Possible side effects
- How to store Muntel
- Contents of the pack and other information
1. What Muntel is and what it is used for
The active substance of Muntel is levocetirizine dihydrochloride. Muntel is an antiallergic medicine.
For the treatment of signs of disease (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 ingredients of this medicine (listed in section 6). -
If you have severe renal impairment (severe renal insufficiency with creatinine clearance less than 10 ml/min).
Warnings and precautions
Talk to your doctor or pharmacist before taking Muntel.
- If you have any condition impairing bladder emptying (such as spinal cord damage or enlarged prostate), please inform your doctor.
- If you have epilepsy or are at risk of seizures, please consult your doctor, as the use of Muntel may worsen seizures.
- If you are undergoing allergy testing, ask your doctor whether you need to discontinue Muntel treatment several days beforehand. This medicine may affect the results of allergy testing.
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 medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Taking Muntel with food, drinks and alcohol
Caution is recommended if taking Muntel together with alcohol or other agents acting on the brain.
In sensitive patients, concomitant use of Muntel with alcohol or other central nervous system-acting agents may cause an additional decrease in attention capacity and reduced performance.
Muntel can be taken either on an empty stomach or with food.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Some patients treated with Muntel may experience drowsiness/sedation, fatigue, and exhaustion.
Be cautious when driving or operating machinery until you know how this medication affects you. However, in special tests conducted in healthy individuals, no impairment of attention, reaction ability, or driving skills was detected after taking levocetirizine at the recommended dose.
Muntel contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Muntel
Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose for adults and children from 6 years of age is one tablet daily.
Use in special populations
Patients with renal impairment
Patients with renal impairment should receive a reduced dose. The dose will be determined by your doctor.
Patients with severe renal impairment must not take this medicine.
Patients with hepatic impairment
In patients with hepatic impairment alone, no dose adjustment is necessary.
However, patients with both renal and hepatic impairment must take a lower dose. The dose will be determined by your doctor.
Patients aged 65 years and older
In elderly patients, no dose adjustment is necessary if renal function is normal.
Use in children
The use of Muntel is not recommended in children under 6 years of age, as it does not allow appropriate dose adjustment.
How and when should you take Muntel?
For oral use only.
Muntel tablets should be swallowed whole with water and may 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 must be determined by your doctor.
If you take more Muntel than you should
If you take more Muntel than you should, somnolence may occur in adults. In children, initial agitation and restlessness may occur, followed by somnolence.
In case of overdose or accidental ingestion of Muntel, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone 915 62 04 20.
If you forget to take Muntel
If you forget to take Muntel or 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 at the next scheduled time.
If you stop taking Muntel
Stopping treatment should not have negative effects. However, rarely, pruritus (intense itching) may appear when stopping Muntel, even if these symptoms were not present at the beginning of treatment. Symptoms may disappear spontaneously. In some cases, symptoms may be severe and require restarting treatment. Symptoms usually resolve when treatment is restarted.
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.
Frequent: 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 the available data
Other adverse effects that have also been reported include palpitations, increased heart rate (tachycardia), seizures, tingling sensations, dizziness, fainting, tremor, dysgeusia (altered sense of taste), sensation of spinning or movement, visual disturbances, blurred vision, oculogyric crisis (involuntary circular eye movements), pain or difficulty urinating, inability to urinate, edema, pruritus (itching) (which may also occur after stopping Muntel), rash, urticaria (skin swelling, redness and itching), skin eruptions, shortness of breath, weight gain, muscle pain, joint pain, aggressive or agitated behavior, hallucinations, depression, insomnia, recurring thoughts or preoccupation with suicide, nightmares, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhea.
At the first signs of a hypersensitivity reaction, stop taking Muntel and inform your doctor immediately. Symptoms of a hypersensitivity reaction may include: swelling of the mouth, tongue, face and/or neck, difficulty breathing or swallowing (chest tightness or whistling sounds), hives, sudden drop in blood pressure which may lead to collapse or shock, any of which could be fatal.
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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Muntel
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Muntel
The active substance is levocetirizine dihydrochloride. Each film-coated tablet contains 5 mg of levocetirizine dihydrochloride.
The other components are monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171), and macrogol 400.
Appearance of the product and contents of the pack
Muntel film-coated tablets are white to off-white, oval-shaped, and marked with the imprint “Y” on one side. Each pack contains 20 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 most recent review of this leaflet: May 2018
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)