Package Insert: Information for the Patient

Notus Mucus 600 mg Effervescent Tablets, Lemon Flavor

Acetylcysteine

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

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

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

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

• You should consult a doctor if your condition worsens or does not improve after 4-5 days.

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

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

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 contained in this medication, Notus Mucus should not be used in children under 14 years old. 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. Rarely, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome have been reported in association with acetylcysteine administration. Therefore, if you experience skin or mucous membrane changes, seek medical advice quickly 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 gastrointestinal tract mucosa.
• Have histamine intolerance. Long-term treatment should be avoided in these patients, as acetylcysteine affects histamine metabolism and may lead to intolerance symptoms (e.g., headache, nasal secretion, itching).
• Cannot effectively cough up liquid mucus. The use of acetylcysteine, especially at the beginning of treatment, may make mucus more fluid and, therefore, increase bronchial secretion volume. If the patient is unable to cough up enough mucus, your doctor will take the necessary measures.

Children and adolescents

Mucolytic medications can obstruct the airways of children under 2 years old 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 old.

Taking Notus Mucus with other medications

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

Only studies of interaction have been conducted in adults.

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

• Cough medications (antitussives) as it 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.
• Antibiotics (e.g., tetracycline, aminoglycosides, penicillins) as studies have shown 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 trinitroglycerin (nitroglycerin), which may 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 effectiveness of carbamazepine due to reduced carbamazepine plasma levels.

Changes in laboratory parameter determination.

Acetylcysteine may affect salicylate testing.

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

It is not recommended to dissolve acetylcysteine with other medications.

Pregnancy, lactation, and fertility

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

Pregnancy

Since there is not enough experience with the use of acetylcysteine in pregnant women, its use during pregnancy should only be made if your doctor considers it absolutely necessary.

Lactation

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

Therefore, acetylcysteine should only be used during lactation if your doctor considers it absolutely necessary.

Driving and operating machinery

There is no evidence of effects on the ability to drive and operate machinery.

Notus Mucus contains sodium

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

Notus Mucus contains aspartame

This medication contains 20 mg of aspartame in each effervescent tablet.

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

Notus Mucus contains saccharose 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.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The following information applies unless your doctor has prescribed taking Notus Mucus in a different way. Follow the usage instructions, otherwise, Notus Mucus will not function correctly.

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

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

If you take more Notus Mucus than you should

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

Up to the present, no severe side effects of signs of intoxication have been observed, even after a massive overdose of acetilcysteine tablets. However, in case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Notus Mucus

Do not take a double dose to compensate for the missed doses. In case of forgotten dose, wait for the next dose according to the usage instructions.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Notus Mucus and see a doctor immediately if you experience any of these rare side effects(which 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*. Symptoms may include rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue.

*In most reported cases, at least another pharmaceutical substance was being taken, which 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 mucous membranes of the mouth, 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 an overactive bronchial system in bronchial asthma.
• Acid reflux

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 severe changes occur in the skin and mucous membranes. Do not continue taking Notus Mucus.

Several studies have confirmed a decrease in platelet aggregation (agglutination of certain blood components) during acetylcysteine administration. The clinical importance of this is still unclear.

Contraindications

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use Website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 or EXP. The expiration date is the last day of the month indicated.

Storage Conditions

Do not store at a temperature above 25°C.

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

This medication should be used within 12 months after the first opening of the container.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Notus Mucus

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

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

Appearance of the product and content of the container

White to slightly yellowish effervescent tablets, round and flat on both sides, and lemon-scented.

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

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

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva B.V.

Swensweg, 5

2031GA Haarlem, Netherlands

Responsible for manufacturing

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 with the following names:

DE:NAC AbZ 600 mg Brausetabletten

ES:Notus Mucus 600 mg effervescent tablets, lemon flavor

FI:Mucoratio 600 mg poretabletti

PL:Acetylocysteinum Flegamina

Revision date of this leaflet: 03/2024

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