Acetylcysteine 200mg Powder for Oral Solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Acetylcysteine 200 mg Powder is and what it is used for
2. What you need to know before you take Acetylcysteine 200 mg Powder
3. How to take Acetylcysteine 200 mg Powder
4. Possible side effects
5. How to store Acetylcysteine 200 mg Powder
6. Contents of the pack and other information

• if you are allergic (hypersensitive) to acetylcysteine, other similar medicines (such as carbocisteine, erdosteine or mecysteine), or any of the other ingredients of this medicine (listed in section 6).
• if you have a genetic condition called phenylketonuria where you are unable to break down a substance called phenylalanine.

Talk to your doctor or pharmacist before taking Acetylcysteine 200 mg Powder:

• if you suffer from asthma, as you may need to be monitored closely whilst taking this medicine
• if, before you start taking this medicine, you have a reduced ability or inability to cough, then it may be necessary to remove the mucus by suction after this medicine has loosened it
• if you are due to have any blood or urine tests, as acetylcysteine can interfere with some laboratory tests.

Acetylcysteine 200 mg Powder On opening the sachet, Acetylcysteine 200 mg Powder may smell of sulphur (rotten eggs). This is a normal characteristic of this medicine and does not mean that it is not safe to use. Upon addition of water the solution will have a citrus odour.

Do not use in children under the age of 12 years.

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

This includes any medicines which you have bought without a prescription.

You must tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines to treat coughs (e.g. cough syrup)
• activated charcoal, used to treat poisoning
• drugs used to treat bacterial infections, antibiotics (e.g.cefalexin, cefuroxime, cefadroxil, cefaclor, ceftriaxone). This medicine can prevent some antibiotics from working properly if they are taken at the same time as it. If you have been told this applies to you, you should take this medicine either two hours before or two hours after taking your antibiotics. If you are not sure if this applies to you, talk to your doctor or pharmacist.
• medicines to treat angina attacks, (tightness in your chest, neck and arm) (e.g.glyceryl trinitrate)

There are no special requirements to consider when taking this medicine with food, drink or alcohol.

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.

Acetylcysteine 200 mg Powder should not affect your ability to drive or operate machinery. If you experience side effects which may affect these abilities, do not drive or operate machinery until the effects have completely disappeared.

• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
• Aspartame is a source of phenylalanine. Phenylalanine can be harmful to people with a condition called phenylketonuria.
• Sunset yellow (a food colouring) may cause allergic reactions.

The recommended dose is 1 sachet 3 times a day, or as prescribed by your doctor.

Empty the sachet contents into a small amount of water in a glass and stir until it dissolves (mixes) completely, just before drinking. It is important to drink all of the mixture.

Abundant fluid intake supports the mucolytic effect of acetylcysteine.

If you accidentally take more Acetylcysteine 200 mg Powder than you have been prescribed, contact your doctor or get medical advice immediately. If possible, take the sachets, the box and this leaflet with you to show the doctor.

The following are all symptoms of an overdose:

• Feeling or being sick and diarrhoea.

If you forget to take a dose, take it as soon as possible. Take the next dose at the correct time, in accordance with the instructions given by your doctor. However, if it is almost time to take the next dose, do not take the dose you have missed; only take the next dose as normal.

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

Uncommon side effects

(affecting less than 1 in 100 people)

• Headache
• A ringing sound in the ears (tinnitus)
• A fast heart rate
• Feeling or being sick
• Diarrhoea
• Inflammation of the skin in your mouth and on your lips
• Pain in your abdomen (tummy)
• An itchy raised rash
• Swelling of the deeper layers of skin, caused by a build up of fluid
• Itchy skin
• Fever
• Low blood pressure, this could cause dizziness when standing up quickly from a lying/seated position

Rare side effects

(affecting less than 1 in 1,000 people)

• Tightness of your airways
• Shortness of breath
• Indigestion

Not known

(this means the frequency cannot be estimated from the information available)

• Swelling of the face

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the relevant medicines authority (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is acetylcysteine.
  Each sachet contains 200 mg acetylcysteine.
• The other ingredients (excipients) are aspartame, sorbitol, lemon flavour (contains maltodextrin, a form of glucose) and sunset yellow.

Acetylcysteine 200 mg Powder is a white to slightly pink coloured powder.

Acetylcysteine 200 mg Powder is available in boxes of 10, 18, 20 or 30 sachets.

Not all pack sizes may be marketed.

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Manufacturer