Nakys

Patient Information Leaflet: Information for the User

Nakys 200 mg granules for oral solution in sachet, 600 mg granules for oral solution in sachet

Equivalent medicine
[For packages subject to medical prescription]
Please read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

[For packages not subject to medical prescription (OTC)]
Please read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, ask your pharmacist.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 4-5 days.

Contents of this leaflet:

1. What Nakys is and what it is used for
2. What you need to know before taking Nakys
3. How to take Nakys
4. Possible side effects
5. How to store Nakys
6. Contents of the pack and other information

1. What Nakys is and what it is used for

Nakys contains the active substance acetylcysteine, which helps to fluidify thick mucus in the airways.
Nakys 200 mg granules for oral solution are indicated in adults and adolescents from 12 years of age as an adjunctive treatment for acute respiratory conditions associated with excessive mucus in the lungs and airways, when the mucus is too thick and viscous to be easily expelled by coughing.
Nakys 600 mg granules for oral solution are indicated in adults as an adjunctive treatment for acute respiratory conditions associated with excessive mucus in the lungs and airways, when the mucus is too thick and viscous to be easily expelled by coughing.

2. What you need to know before taking Nakys

Do not take Nakys:

• If you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6).
• Children under 2 years of age must not use this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nakys if you have:

• Skin and mucous membrane disorders. If new skin or mucous membrane reactions occur, you must consult a doctor immediately and stop using acetylcysteine.
• Bronchial asthma.
• A history of stomach or intestinal ulcers, or if you currently suffer from them.
• Histamine hypersensitivity. In these patients, long-term therapy should be avoided, as Nakys affects histamine metabolism and may lead to intolerance symptoms (e.g. headache, runny nose, itching).
• Inability to expel mucus.
• Acetylcysteine may increase the intensity of vomiting.

Children
200 mg:
Nakys is not recommended for children under 12 years of age (due to the high content of active substance).
600 mg:
Nakys is not recommended for children and adolescents (due to the high content of active substance). Other medicines with a lower amount of active substance are available for them.

Other medicines and Nakys
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This particularly applies to:

• Cough suppressants. The combined use of Nakys with cough suppressants may cause dangerous accumulation of secretions due to reduced cough reflex. This combination therapy requires particularly careful diagnosis. Consult your doctor before using this combination.
• Antibiotics. Experimental studies show evidence that acetylcysteine may weaken the effect of antibiotics (tetracyclines, aminoglycosides, penicillins). For safety reasons, antibiotics should be taken separately, with an interval of at least 2 hours.
• Activated charcoal.
• Glyceryl trinitrate: a medicine also known as nitroglycerin, used to dilate blood vessels. Your doctor will monitor you for low blood pressure, which could be severe and may present as headache.
• Carbamazepine: when used concomitantly, the effects of carbamazepine may be reduced due to decreased plasma levels.
• Nakys may interfere with heavy metal salts, such as gold and iron salts, and with calcium salts. Therefore, it is advisable to separate the administration of acetylcysteine and these salts, or to choose an alternative route of administration.

Laboratory tests
Inform your doctor that you are taking Nakys if you are due to undergo any of the following tests; it may affect the measurement of:

• Salicylates: medicines used to treat pain, inflammation, or rheumatic conditions;
• Urinary ketone bodies.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There are insufficient data on the use of acetylcysteine in pregnant women. Acetylcysteine has not been shown to have harmful effects on the fetus; however, as a precautionary measure, the use of Nakys during pregnancy is not recommended. Nakys should be used during pregnancy only if your doctor considers it absolutely necessary.
Breastfeeding
There is no information available on the excretion of acetylcysteine in breast milk. A potential risk to the newborn/infant cannot be excluded. Therefore, Nakys should be used during breastfeeding only if your doctor considers it absolutely necessary.
Fertility
Limited data are available on the effect of acetylcysteine on male fertility. Animal studies have not shown harmful effects on fertility at recommended doses.

Driving and using machines
Nakys is not known to affect the ability to drive or operate machinery.

Nakys contains sucrose
Nakys 200 mg oral granules for solution contain 0.66 g of sucrose per dose (0.66 g/1 sachet).
Nakys 600 mg oral granules for solution contain 1.98 g of sucrose per dose (1.98 g/1 sachet).
If your doctor has diagnosed you with an intolerance to certain sugars, please contact them before taking this medicine.

Nakys contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. it is essentially ‘sodium-free’.

3. How to take Nakys

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dose is:
200 mg:
Adults and adolescents from 12 years of age:
Take 200 mg (1 sachet) of Nakys every 8 hours, 3 times a day. Do not take more than 600 mg per day.
Use in children:
Do not use in children under 12 years of age.
Other formulations better suited for this population are available.
600 mg:
Adults:
Take 600 mg of Nakys (1 sachet) once daily. Do not take more than one sachet per day.
Use in children and adolescents:
Do not use in children and adolescents.
Other formulations better suited for this population are available.
Method of administration
Nakys 200 mg and 600 mg granules for oral solution can be taken during or apart from meals.
Dissolve the granules contained in one sachet in half a glass of water or another liquid, and stir until the solution becomes homogeneous. Use a glass or plastic cup (never use rubber or metal containers). The reconstituted solution should be administered immediately after preparation. Partially used sachets may be stored until the next dose (it is recommended to use the remaining half within 24 hours). However, prepared solutions must be administered immediately.
Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Upon opening the package, you may notice a slight sulfur-like odor (rotten eggs). This is a normal characteristic of this medicine and does not indicate that it is unsafe to use.
Duration of use
If symptoms worsen or do not improve after 5 days, consult your doctor.
If you take more Nakys than you should
In case of overdose, gastrointestinal irritation may occur, such as abdominal pain, nausea, vomiting, and diarrhea.
To date, no serious adverse effects or symptoms of poisoning have been observed, even in cases of significant overdose. However, if you suspect an overdose with Nakys, inform your doctor.
If you forget to take Nakys
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nakys can cause side effects, although not everyone experiences them.
Stop taking Nakys and contact your doctor if you notice signs of an allergic skin reaction or severe reaction.

Uncommon (may affect up to 1 in 100 people)

• Allergic reactions.

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

• Severe allergic reactions, such as rash, itching, fluid accumulation (oedema), difficulty breathing and loss of consciousness.

Other possible side effects may occur with the following frequencies:
Uncommon (may affect up to 1 in 100 people)

• Headache
• Fever
• Inflammation of the inner lining of the mouth
• Abdominal pain
• Nausea, vomiting
• Diarrhoea
• Ringing or buzzing in the ears
• Increased heart rate
• Decreased blood pressure
• Itching, blistering, rash
• Generalised rash
• Severe swelling, mostly painful, of the deeper layers of the skin, mainly of the face.

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

• Shortness of breath
• Bronchospasm
• Indigestion.

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

• Bleeding
• Dizziness.

Not known (frequency cannot be estimated from the available data)

• Swelling of facial tissues due to fluid retention
• Reduced platelet aggregation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nakys

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and the carton after EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nakys contains

• The active substance is acetylcysteine. Each sachet contains 200 mg of acetylcysteine. Each sachet contains 600 mg of acetylcysteine.
• The other components are: Sucrose, sodium saccharin, orange flavour (corn syrup, natural and artificial flavouring substances, gum arabic).

Description of the appearance of Nakys and contents of the pack
Granules for oral solution.
White to off-white granular powder in sachets.
Packs:
200 mg: 14, 18, 20, 24, 30 and 60 sachets.
600 mg: 10, 14, 20, 30 and 60 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturers
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta

Generis Farmacêutica S.A.
Rua João de Deus, 19, Venda Nova,
2700-487 Amadora
Portugal

Arrow Generiques
26 Avenue Tony Garnier, 69007 Lyon
France

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Acetylcysteine AB 200 mg/600 mg granulaat voor drank in sachet/granulés pour solution buvable en sachet/Granulat zur Herstellung einer Lösung zum Einnehmen im Beutel
France: Acetylcysteine Arrow 200 mg, granulés pour solution buvable en sachet
Italy: Nakys
Portugal: Acetilcisteína Generis
Spain: Acetilcisteína Aurovitas 200 mg/600 mg granulado para solución oral EFG