NOTUS MUCUS 600 MG EFFERVSCENT LEMON FLAVORED TABLETS

Introduction

Package Leaflet: Information for the Patient

Notus Mucus 600 mg Effervescent Lemon-Flavored Tablets

Acetylcysteine

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

• You should consult a doctor if your symptoms worsen or do not improve after 4-5 days.

Package Leaflet Contents

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

1. What is Notus Mucus and what is it used for

Notus Mucus contains the active ingredient acetylcysteine, which is a medication that thins out the mucus accumulated in the respiratory tract.

Notus Mucus is indicated to thin out mucus and facilitate coughing in bronchitis induced by a cold, characterized by accumulation and decreased elimination of mucus in adolescents over 14 years of age and adults.

2. What you need to know before taking Notus Mucus

Do not take Notus Mucus:

• if you are allergic to acetylcysteine or any of the other components of this medication (listed in section 6).

Due to the high amount of active ingredient in this medication, Notus Mucus should not be used in children under 14 years of age. There are other medications with suitable doses for them.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Notus Mucus if you:

• Suffer from skin changes. Very rare cases of severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome have been reported, associated with the administration of acetylcysteine. Therefore, if you experience skin or mucous membrane changes, you should seek medical advice immediately and stop taking acetylcysteine.
• Have bronchial asthma
• Have a history of gastric or duodenal ulcers, especially when used concomitantly with other medications that are known to irritate the mucosa of the gastrointestinal tract.
• Have histamine intolerance. Long-term treatment should be avoided in these patients, as acetylcysteine has an effect on histamine metabolism and may lead to intolerance symptoms (e.g., headache, nasal discharge, itching).
• Are unable to cough up liquid mucus effectively. The use of acetylcysteine, especially at the start of treatment, may make the mucus more fluid and, therefore, produce an increase in the volume of bronchial secretions. If the patient is unable to cough effectively, their doctor will take the necessary measures.

Children and Adolescents

Mucolytic medications may obstruct the airways of children under 2 years of age due to the physiological characteristics of the airways in this age group. The ability to cough up mucus may be limited. Therefore, mucolytic medications should not be used in children under 2 years of age.

Taking Notus Mucus with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Only interaction studies have been conducted in adults.

You should inform your doctor or pharmacist if you are taking any of the following medications:

• Medications for treating cough (antitussives), as they may cause a dangerous accumulation of secretions due to the deterioration of the cough reflex.
• Activated charcoal, used in the treatment of poisoning, may reduce the effect of acetylcysteine.
• Medications for treating infections (antibiotics) such as tetracycline, aminoglycosides, penicillins. Clinical studies show that acetylcysteine attenuates the effect of antibiotics. Therefore, for safety reasons, antibiotics should be taken separately, with an interval of at least two hours between their administration and the administration of this medication.

This does not apply to medications containing the active ingredient cefixime or loracarbef. These medications can be taken at the same time as acetylcysteine.

• Medications for treating angina attacks; chest, neck, and arm oppression (e.g., nitroglycerin).

The concomitant use of acetylcysteine and nitroglycerin may cause a potentiated vasodilatory effect of glyceryl trinitrate (nitroglycerin), which could be due to a possible anticoagulant effect.

If your doctor considers it necessary to treat you with nitroglycerin and acetylcysteine at the same time, they will monitor you for low blood pressure (hypotension), which can be severe and cause headaches.

• Medications for treating epilepsy and nerve pain (carbamazepine).

The concomitant use of acetylcysteine and carbamazepine may reduce the efficacy of carbamazepine due to the reduction of carbamazepine plasma levels.

Changes in laboratory test parameters.

Acetylcysteine may affect salicylate tests.

In urine tests, acetylcysteine may influence the results of ketone body determination.

It is not recommended to dissolve acetylcysteine with other medications.

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

Due to the lack of experience with the use of acetylcysteine in pregnant women, its use during pregnancy should only be done if your doctor considers it absolutely necessary.

Breastfeeding

No information is available on the excretion of acetylcysteine in breast milk.

For this reason, acetylcysteine should only be used during breastfeeding if your doctor considers it absolutely necessary.

Driving and Using Machines

There is no evidence of effects on the ability to drive and use machines.

Notus Mucus contains sodium

This medication contains 150 mg of sodium (main component of table salt/cooking salt) per effervescent tablet. This is equivalent to 7.65% of the maximum recommended daily sodium intake for an adult. This should be particularly taken into account for patients on a controlled sodium diet.

Notus Mucus contains aspartame

This medication contains 20 mg of aspartame per effervescent tablet.

Aspartame contains a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the body's inability to eliminate it properly.

Notus Mucus contains sucrose and glucose (component of maltodextrin)

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 Notus Mucus

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The following information applies unless your doctor has prescribed a different way of taking Notus Mucus. Follow the instructions for use; otherwise, Notus Mucus may not work properly.

Form and duration of administration

Dissolve the effervescent tablet in a glass of water and drink the contents of the entire glass.

Take Notus Mucus after meals.

If your symptoms worsen or do not improve after 4-5 days, you should consult your doctor.

Talk to your doctor or pharmacist if you think the effect of Notus Mucus is too strong or too weak.

If you take more Notus Mucus than you should

An overdose may cause gastrointestinal irritation (e.g., abdominal pain, nausea, vomiting, diarrhea).

To date, no serious side effects have been observed, even after a massive overdose of acetylcysteine tablets. However, in case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Notus Mucus

Do not take a double dose to make up for forgotten doses. In case of forgotten dose, wait for the next scheduled dose as described in the instructions for use.

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 may experience them.

Stop taking Notus Mucus and see a doctor immediately if you experience any of these very rare side effects(may affect up to 1 in 10,000 people):

• Severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome with a temporal connection to acetylcysteine*. The symptoms may include rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

*In most reported cases, at least one other pharmaceutical substance was being taken that may have potentiated the described mucocutaneous effects.

The following side effects may occur:

Uncommon (may affect up to 1 in 100 people)

• Hypersensitivity reactions
• Headache
• Tinnitus (ringing in the ears)
• Palpitations
• Vomiting, diarrhea, inflammation of the mouth mucosa, abdominal pain, nausea.
• Allergic reactions: hives, itching, skin rash, swelling of the skin and mucous membranes.
• Fever
• Low blood pressure

Rare (may affect up to 1 in 1,000 people)

• Dyspnea, bronchospasm, mainly in patients with a hyperactive bronchial system in bronchial asthma.
• Acidity

Very rare (may affect up to 1 in 10,000 people)

• Hypersensitivity reactions up to shock.
• Bleeding

Frequency not known (cannot be estimated from available data)

• Facial fluid retention

You should consult a doctor and stop taking Notus Mucus if you experience new, severe changes in the skin and mucous membranes. You should not continue taking Notus Mucus.

Several studies have confirmed a decrease in platelet aggregation (clumping of certain blood components) during the administration of acetylcysteine. The clinical significance of this is not yet clear.

Countermeasures

Stop taking Notus Mucus at the first signs of a hypersensitivity reaction (see above). In this case, contact a doctor.

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 Agency's website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Notus Mucus

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

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

Storage conditions

Do not store above 25°C.

Keep the plastic container tightly closed to protect it from moisture.

This medication should be used within 12 months of opening the packaging.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Notus Mucus

• The active ingredient is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.

• Other components: citric acid, sodium bicarbonate, aspartame (E951), lemon flavor (contains maltodextrin, sucrose, gum arabic (E414), triacetin (E1518), alpha-tocopherol (E307), adipic acid, povidone K-25.

Appearance of the product and package contents

Effervescent tablets are white to slightly yellowish, round, and flat on both sides, with a lemon odor.

The effervescent tablets are packaged in polypropylene tubes closed with a polyethylene cap, with a desiccant (60% molecular sieve and 40% silica gel).

Notus Mucus is available in packages of 10 and 20 effervescent tablets.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg, 5

2031GA Haarlem, Netherlands

Manufacturer

Merckle GmbH

Graf-Arco Str. 3

89079 Ulm

Germany

You can request more information about this medication by contacting the local representative of the Marketing Authorization Holder:

Teva Pharma S.L.U.

C/Anabel Segura 11,

Edificio Albatros B, 1st floor,

28108 Alcobendas, Madrid (Spain)

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

DE: NAC AbZ 600 mg Brausetabletten

ES: Notus Mucus 600 mg effervescent lemon-flavored tablets

FI: Mucoratio 600 mg poretabletti

PL: Acetylocysteinum Flegamina

Date of the last revision of this package leaflet: 03/2024

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