Acc optima Hot

Leaflet attached to the packaging: patient information

ACC optima Hot, 600 mg/3 g, powder for oral solution

Acetylcysteine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 4 to 5 days, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is ACC optima Hot and what is it used for
• 2. Important information before taking ACC optima Hot
• 3. How to take ACC optima Hot
• 4. Possible side effects
• 5. How to store ACC optima Hot
• 6. Contents of the pack and other information

1. What is ACC optima Hot and what is it used for

ACC optima Hot contains the active substance acetylcysteine. Acetylcysteine reduces the viscosity of bronchial secretions and makes them easier to cough up. ACC optima Hot is used as a mucolytic agent to facilitate expectoration in patients with bronchitis associated with a cold.

2. Important information before taking ACC optima Hot

When not to take ACC optima Hot

if the patient is allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include: itching, hives, rash, bronchospasm (shortness of breath), rapid heartbeat, and low blood pressure. If any of these symptoms occur, the patient should stop taking ACC optima Hot and consult a doctor immediately. if the patient has active gastric or duodenal ulcer. if the patient has acute asthma (exacerbation of bronchial asthma or chronic obstructive pulmonary disease). if the patient has been diagnosed with fructose intolerance (see section "ACC optima Hot contains sucrose and sodium"). The medicine should not be taken by children under 14 years of age.

Warnings and precautions

Before taking ACC optima Hot, the patient should discuss it with their doctor or pharmacist if: they have had asthma or currently have chronic asthma, as the medicine may cause bronchospasm and shortness of breath; they have had a stomach ulcer in the past; they currently have or have had respiratory failure; they have a problem with expectoration (physiotherapy may be necessary - the doctor will provide information on what it entails); they have been diagnosed with histamine intolerance (long-term use of the medicine may cause symptoms of intolerance, such as headache, nasal discharge, itching); they are elderly (over 65 years of age). If skin or mucous membrane changes occur during treatment, the patient should stop taking the medicine and consult a doctor immediately (see section 4).

ACC optima Hot and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. ACC optima Hot should not be taken with cough suppressants, as they may weaken the cough reflex and make it difficult to expectorate the secretions thinned by ACC optima Hot. Acetylcysteine (the active substance of ACC optima Hot) may reduce the effectiveness of some antibiotics (especially semi-synthetic penicillins, tetracyclines, cephalosporins, and aminoglycosides). To avoid this, ACC optima Hot should be taken 2 hours after taking the antibiotic. This does not apply to antibiotics such as cefixime, loracarbef, amoxicillin, doxycycline, erythromycin, thiamphenicol, and cefuroxime. In case of doubt, the patient should consult their doctor. ACC optima Hot may enhance the effect of nitroglycerin and other nitrates (medicines used in cardiovascular diseases and coronary heart disease). During concurrent use of these medicines, the doctor will monitor whether the patient develops hypotension. Headache may occur. If the patient is taking nitroglycerin or another similarly acting medicine from the nitrate group, they should consult their doctor before taking ACC optima Hot. Large amounts of activated charcoal may reduce the effectiveness of ACC optima Hot. It is not recommended to dissolve ACC optima Hot in solutions containing other medicines. Effect of ACC optima Hot on laboratory tests If the patient is to have a blood or urine test for salicylates or a urine test for ketone bodies, they should inform their doctor and medical staff about taking ACC optima Hot.

ACC optima Hot with food and drink

The medicine should be taken after a meal. During treatment, the patient should drink a sufficient amount of fluids (at least 1.5 liters per day).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. ACC optima Hot can be used during pregnancy and breastfeeding only if the doctor considers it necessary.

Driving and using machines

The effect of ACC optima Hot on the ability to drive and use machines is not known.

ACC optima Hot contains sucrose and sodium

ACC optima Hot contains sucrose, which includes fructose and glucose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means it is considered "sodium-free". Information for diabetic patients: 3 g of powder (1 sachet) contains 0.17 WW (carbohydrate exchange units).

3. How to take ACC optima Hot

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist. Adults and adolescents over 14 years of ageThe contents of 1 sachet of ACC optima Hot once a day (which corresponds to 600 mg of acetylcysteine per day). ACC optima Hot should not be taken by children under 14 years of age. Without a doctor's recommendation, the medicine should not be taken for more than 4 to 5 days. Method of administration: The medicine should be taken after a meal (see "ACC optima Hot with food and drink"). The contents of the sachet should be poured into a glass of hot water, mixed well, and the warm liquid should be drunk. The contents of the sachet should not be dissolved in solutions containing other medicines. The medicine should not be taken before bedtime due to the difficulty in expectorating thinned secretions during sleep. The last dose of ACC optima Hot should be taken no later than 4 hours before bedtime. The patient should avoid prolonged contact between the prepared oral solution and metals or rubber.

Taking a higher dose of ACC optima Hot than recommended

In case of taking a higher dose of the medicine than recommended, the patient should consult their doctor or pharmacist. Gastrointestinal symptoms such as nausea, vomiting, diarrhea, abdominal pain, or oral inflammation may occur.

Missing a dose of ACC optima Hot

If the medicine is taken regularly and it is almost time for the next dose, the missed dose should be taken as soon as possible. If it is already close to the time for the next dose, the patient should take the next dose at the usual time. A double dose should not be taken to make up for the missed dose. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, ACC optima Hot can cause side effects, although not everybody gets them.

If the patient experiences any of the following symptoms, they should stop taking ACC optima Hot and seek medical help immediately:

Anaphylactic reaction or a reaction similar to anaphylaxis, with symptoms such as:

sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat, hives, itching; angioedema (severe allergic reaction) with swelling of the skin and/or mucous membranes, e.g., in the face, limbs, or joints; skin and mucous membrane changes, which may be accompanied by fever and joint pain; bronchospasm (sudden shortness of breath). Less common side effects (may occur in less than 1 in 100 people): allergic reactions, headache, tinnitus, rapid heartbeat (tachycardia), low blood pressure, nausea, vomiting, diarrhea, abdominal pain, oral inflammation, hives, rash, itching, angioedema, fever. Rare side effects (may occur in less than 1 in 1,000 people): indigestion, shortness of breath, bronchospasm. Very rare side effects (may occur in less than 1 in 10,000 people): anaphylactic reaction or a reaction similar to anaphylaxis, up to anaphylactic shock (see above); severe skin and mucous membrane reactions, which may indicate Stevens-Johnson syndrome and toxic epidermal necrolysis (see above); bleeding. Side effects with unknown frequency (frequency cannot be estimated from available data): facial swelling. Reporting side effects If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store ACC optima Hot

The medicine should be stored out of sight and reach of children. There are no special storage requirements. The medicine should not be taken after the expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What ACC optima Hot contains

• The active substance of ACC optima Hot is acetylcysteine. 1 sachet (3 g of powder) contains 600 mg of acetylcysteine.
• The other ingredients of the medicine are: sucrose, ascorbic acid, sodium saccharin, lemon flavor (Permaseal No. 10964-51), honey flavor (Permaseal No. 73425-31).

What ACC optima Hot looks like and contents of the pack

ACC optima Hot is a white to yellowish powder with partial agglomeration. The cardboard box contains 10 sachets of 3 g each.

Marketing authorization holder

Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben, Germany For more information, please contact: Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. 22 209 70 00

Date of last revision of the leaflet:

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