Acetylcysteine Ratiopharm

Package leaflet: Information for the user

Acetilcisteina ratiopharm 600 mg effervescent tablets

Generic medicine
Please read all of this leaflet carefully before 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, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Acetilcisteina ratiopharm is and what it is used for

Acetilcisteina ratiopharm belongs to a group of medicines called mucolytics, which work mainly by thinning mucus in the respiratory tract.
Acetilcisteina ratiopharm is used:

• in the treatment of respiratory disorders characterized by thick and sticky mucus secretions, such as acute bronchitis, chronic bronchitis and any worsening of these conditions, pulmonary emphysema, cystic fibrosis, and bronchiectasis (lung diseases in which the airways are abnormally dilated);
• as an antidote:
• if you have taken too much paracetamol (see section 3);
• in case of uropathy (a disease of the urinary system) associated with the use of isophosphamide and cyclophosphamide (a medicine used in the treatment of cancer).

2. What you need to know before taking Acetilcisteina ratiopharm

Do not take Acetilcisteina ratiopharm:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are a child or adolescent under 14 years of age, unless you are receiving it as an antidote for paracetamol poisoning (see section 3);
• it is contraindicated during pregnancy and breastfeeding (see section "Pregnancy and breastfeeding");
• if you suffer from hepatic or renal insufficiency (a condition in which your liver or kidneys are unable to perform their normal functions).

Warnings and precautions
Talk to your doctor or pharmacist before taking Acetilcisteina ratiopharm if:

• you suffer from bronchial asthma. During treatment, you must be closely monitored by your doctor. If you experience an asthma attack (wheezing, coughing, or difficulty breathing), stop taking Acetilcisteina ratiopharm immediately;

• you have or have had a history of gastric or duodenal ulcers (lesions in the wall of the stomach or
  duodenum), especially if you are taking other medicines that are harmful to the stomach;

• you notice any skin reactions (such as skin rashes). In this case, stop taking Acetilcisteina ratiopharm immediately and contact your doctor (see section 4);

• if you are histamine-intolerant, so that it can be determined whether and for how long you may take the medicine.

Especially at the beginning of treatment, Acetilcisteina ratiopharm may increase the volume of bronchial mucus (bronchial secretions). If you are unable to clear this mucus by coughing, consult your doctor. To prevent mucus accumulation, your doctor may recommend the following:

• postural drainage (a sitting or lying position advised by your doctor to help drain mucus);
• bronchial aspiration (removal of mucus using a specific device).

Children and adolescents
This medicine must NOT be used in children and adolescents under 14 years of age, except as an antidote for paracetamol poisoning (see section 3).
Other medicines and Acetilcisteina ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important to inform your doctor if you are taking/using:

• cough suppressants. Taking these medicines together with Acetilcisteina ratiopharm may cause mucus accumulation and congestion due to reduced cough reflex. If you take these medicines in combination with Acetilcisteina ratiopharm, your doctor will monitor you closely;
• activated charcoal. Taking it together with Acetilcisteina ratiopharm may reduce the effect of Acetilcisteina ratiopharm;
• antibiotics. Experimental studies show that Acetilcisteina ratiopharm may affect how certain antibiotics work when these substances are mixed in the same solution. These include penicillins, tetracyclines, cephalosporins, aminoglycosides, macrolides, and amphotericin B. You should wait at least 2 hours between taking any oral antibiotic and Acetilcisteina ratiopharm. This does NOT apply to cefixime and loracarbef;
• nitroglycerin. If taken simultaneously with Acetilcisteina ratiopharm, it may cause a decrease in blood pressure, even severe, and headache. Inform your doctor if you begin to experience headaches. If you need to take these medicines together, your doctor must monitor your blood pressure;
• heavy metal salts. To prevent acetylcysteine from reducing the effect of these substances, your doctor will advise you on how and when to take the different medicines.

This medicine may interfere with tests for the detection of:

• salicylates (medicines used to treat pain, inflammation, or rheumatism);
• ketones (substances produced when the body breaks down fats to produce energy) in urine.

DO NOT dissolve Acetilcisteina ratiopharm tablets and mix them with any other medicinal product.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Acetilcisteina ratiopharm should be used during pregnancy or breastfeeding only if the benefits outweigh the potential risks and only under the direct supervision of a doctor.
Driving and using machines
Acetilcisteina ratiopharm does not impair the ability to drive vehicles or operate machinery.
Acetilcisteina ratiopharm contains aspartame
This medicine contains 20 mg of aspartame per tablet. Aspartame is a source of phenylalanine.
It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine accumulation because the body cannot properly eliminate it.
Acetilcisteina ratiopharm contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Acetilcisteina ratiopharm contains sodium
This medicine contains 150 mg of sodium (a key component of table salt) per tablet. This corresponds to 7.5% of the maximum daily dietary intake recommended for an adult.

3. How to take Acetylcysteine ratiopharm

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Method of administration
Dissolve one tablet in a glass containing a small amount of water, stirring with a teaspoon as needed. While the tablet dissolves, the solution may have a sulfurous odor.
The tablet may be divided into equal parts.

Treatment of respiratory disorders

• Take either half a tablet twice daily or one whole tablet once daily (preferably in the evening). Your doctor may adjust the dose depending on your health condition.
• The maximum daily dose is 600 mg (one tablet).
• Treatment usually lasts 5 to 10 days. However, for severe and chronic conditions, your doctor will decide the duration of treatment, which may continue for several months.

Paracetamol poisoning

• If you think you have taken too much paracetamol, contact your doctor or go immediately to the nearest Emergency Department.
• The dosage of Acetylcysteine ratiopharm will depend on your body weight.
• An initial dose of 140 mg/kg body weight must be taken orally as soon as possible, within 10 hours of ingestion of the toxic agent. This should then be followed by doses of 70 mg/kg body weight, taken every 4 hours for 1–3 days.

Uropathy associated with isophosphamide and cyclophosphamide therapy

• During chemotherapy with isophosphamide and cyclophosphamide, you must take this medicine orally at a dosage of 4 grams per day on chemotherapy days.
• The dose should be divided into four equal doses of 1 gram each.

If you take more Acetylcysteine ratiopharm than you should
Inform your doctor or contact the nearest hospital immediately. Symptoms of overdose may include gastrointestinal problems such as nausea (feeling unwell), vomiting, and diarrhea. Newborns are at higher risk of hypersecretion (excessive mucus accumulation).

If you forget to take Acetylcysteine ratiopharm
Do not take a double dose to make up for the forgotten tablet.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If you experience any of the following symptoms, STOP taking Acetylcysteine ratiopharm and contact your doctor or go to the nearest Emergency Room IMMEDIATELY:
Uncommon (may affect up to 1 in 100 people)

• Allergic reactions (hypersensitivity) such as:
  • itching;
  • hives, skin rash;
  • rapid heartbeat (tachycardia);
  • drop in blood pressure;
  • swelling of the face, lips, eyes, and tongue with breathing difficulties (angioedema).

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

• Severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
• Stevens-Johnson syndrome and Lyell's syndrome, life-threatening skin conditions causing detachment of the outer layer of the skin (epidermis) from the underlying skin layers (dermis). Symptoms may include:
  • severe skin lesions appearing as blisters;
  • flu-like symptoms such as fever, muscle pain, runny nose, cough, and sore throat.

Other side effects of Acetylcysteine ratiopharm include:
Uncommon (may affect up to 1 in 100 people)

• ringing in the ears (tinnitus);
• inflammation of the oral mucosa (stomatitis);
• abdominal pain;
• heartburn (pyrosis);
• feeling unwell (nausea);
• vomiting;
• diarrhoea;
• headache;
• fever.

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

• breathing difficulties (dyspnoea);
• tightening of the chest muscles causing wheezing, cough, and breathing difficulties (bronchospasm);
• digestive difficulties (dyspepsia).

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

• bleeding associated with hypersensitivity (allergic) reactions.

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

• swelling of the face (facial oedema);
• reduced ability of blood cells called platelets to clump together (reduced platelet aggregation).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://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 Acetylcysteine ratiopharm

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Acetilcisteina ratiopharm contains

• The active substance is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.
• The other ingredients are sodium bicarbonate, citric acid, lemon flavour (containing sucrose), aspartame, povidone and adipic acid.

Description of the appearance of Acetilcisteina ratiopharm and pack contents
Effervescent tablets; pack containing 30 tablets. 3 tubes made of polypropylene with caps made of
polyethylene.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ratiopharm GmbH
Graf-Arco Strasse 3
D-89079 Ulm
Germany
Manufacturer
Merckle GmbH
Ludwig Merckle-Strasse 3
89143 Blaubeuren
Germany