Sandoz AS

Effervescent tablet 200 mg 
(white, round, smooth with a notch on one side, blackberry flavor, the notch is not for dividing the effervescent tablet in equal 

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Acetylcysteine ​​1A Farma is and what it is used for 
2. What you need to know before you use Acetylcysteine ​​1A Farma 
3. How to use Acetylcysteine ​​1A Farma 
4. Possible side effects 
5. How to store Acetylcysteine ​​1A Farma 
6. Contents of the pack and other information 

1. What Acetylcysteine ​​1A Farma is and what it is used for

Acetylcysteine ​​1A Farma dissolves tough mucus so that it becomes thinner and thus easier to cough up.

Acetylcysteine ​​1A Farma is used for prolonged tracheal problems with viscous mucus ( chronic bronchitis ).

Acetylcysteine ​​contained in Acetylcysteine ​​1A Farma may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Acetylcysteine ​​1A Farma

Do not use Acetylcysteine ​​1A Farma

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

Warnings and cautions

Talk to your doctor or pharmacist before using Acetylcysteine ​​1A Farma

  • if you have asthma and/or have previously had cramps in the trachea, tell your doctor before using Acetylcysteine ​​1A Farma.
  • if you get a new skin and mucous membrane reactions. Discontinue use of Acetylcysteine ​​1A Farma and consult a physician.
  • if you have histamine intolerance.

Children and young people

There is no relevant use of Acetylcysteine ​​1A Farma for children and adolescents.

Other medicines and Acetylcysteine ​​1A Farma

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

As there is a lack of experience in the use of Acetylcysteine ​​1A Farma during pregnancy and lactation, the drug should not be taken during pregnancy and lactation.

Driving and using machines

Treatment with Acetylcysteine ​​1A Farma does not affect your ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Acetylcysteine ​​1A Farma contains excipients

Acetylcysteine ​​1A Farma contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Acetylcysteine ​​1A Farma contains sodium

Acetylcysteine ​​1A Farma 200 mg contains 99 mg sodium (the main ingredient in table salt/table salt) per effervescent tablet. This corresponds to 5% of the highest recommended daily intake of sodium for adults. Acetylcysteine ​​1A Farma 600 mg contains 139 mg sodium per effervescent tablet. This corresponds to 7% of the highest recommended daily intake of sodium for adults.

Acetylcysteine ​​1A Farma contains sorbitol

Acetylcysteine ​​1A Farma 200 mg contains less than 20 mg sorbitol per effervescent tablet.

Acetylcysteine ​​1A Farma 600 mg contains less than 40 mg sorbitol per effervescent tablet .

3. How to use Acetylcysteine ​​1A Farma

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will decide which dose is right for you. 

The recommended dose for Acetylcysteine ​​1A Farma is 200 mg is 1 effervescent tablet dissolved in ½ ‑ 1 glass of water 2-3 times a day. The notch is not intended for splitting effervescent tablet one.

The recommended dose for Acetylcysteine ​​1A Farma 600 mg is 1 effervescent tablet dissolved in ½ ‑ 1 glass of water once a day. Effervescent tablet one can be divided into two equal doses.

The symptoms you might experience if you take more doses of acetylcysteine 1A Farma include dizziness, rashes, cramping of the bronchial muscles, nausea, and vomiting.

If you forget to take Acetylcysteine ​​1A Farma

Do not take a double dose to make up for a forgotten dose .

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Acetylcysteine ​​1A Farma and contact your doctor immediately if you experience any of the following rare symptoms ( angioedema ):

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing.

Other side effects that may occur:

Common (may affect up to 1 in 10 people): diarrhea, nausea.

Uncommon (may affect up to 1 in 100 people): abdominal pain, bronchospasm.

Rare (may affect up to 1 in 1,000 people): allergic swelling ( angioedema ), rash, itching, hives.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Acetylcysteine ​​1A Farma

Plastic pipes:

200 mg: Do not store above 25 ° C.

600 mg: Do not store above 30 ° C

Bags:

200 mg: Do not store above 30 ° C.

600 mg: No special storage instructions.

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

1 effervescent tablet contains:

  • The active substance is acetylcysteine ​​200 mg and 600 mg respectively.
  • The other ingredients are anhydrous citric acid, sodium bicarbonate, anhydrous sodium carbonate, anhydrous lactose, mannitol, ascorbic acid, saccharin sodium, sodium citrate dihydrate, blackberry flavor (contains sorbitol). 600 mg effervescent tablet one also contains sodium cyclamate.

What the medicine looks like and the contents of the pack

Acetylcysteine ​​1A Farma 200 mg is a white, round, smooth effervescent tablet with a notch on one side and a blackberry flavor. The notch is not intended for splitting effervescent tablet one.

Acetylcysteine ​​1A Farma 600 mg is a white, round, smooth effervescent tablet with a notch and blackberry flavor. Effervescent tablet one can be divided into two equal doses.

Plastic pipes:

200 mg: 25, 100 (4×25) and 300 (12×25) effervescent tablet s

600 mg: 25 and 100 (4×25) effervescent tablet s

Bags:

200 mg: 25×1, 100×1 300×1 and effervescent tablet s

600 mg: 25×1 and 100×1 effervescent tablet s

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

1A Farma A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer:

Salutas Pharma GmbH, Otto von Guericke Allee 1, D-39179 Barleben, Germany

Muhammad Nadeem

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