Tuscalman

Package leaflet: Information for the patient

CORYFIN SEDATIVE EXPECTORANT 20 mg/g + 1 mg/g syrup
potassium guaiacolsulfonate + dextromethorphan hydrobromide
Please read carefully this leaflet before using this medicine because it contains important information for you.
Always use 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, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

1. What Coryfin Sedative Expectorant is and what it is used for
2. What you need to know before using Coryfin Sedative Expectorant
3. How to use Coryfin Sedative Expectorant
4. Possible side effects
5. How to store Coryfin Sedative Expectorant
6. Contents of the pack and other information

1. What Coryfin Sedative Expectorant is and what it is used for

Coryfin Sedative Expectorant contains dextromethorphan hydrobromide, a cough suppressant, and potassium guaiacolsulfonate, an expectorant.
This medicine is indicated for the treatment of cough symptoms.
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using Coryfin Sedative Expectorant

This medicine may lead to dependence. Therefore, treatment should be short-term.
Do not use Coryfin Sedative Expectorant

• if you are allergic to dextromethorphan or potassium guaiacolsulfonate or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking or have taken antidepressants (medicines used for depression) within the previous 2 weeks (see "Other medicines and Coryfin Sedative Expectorant");
• if you suffer from asthma (narrowing and inflammation of the bronchi);
• if you have a respiratory disease characterized by bronchial obstruction and inflammation of the bronchi and lungs (chronic obstructive pulmonary disease, COPD);
• if you have a lung infection (pneumonia);
• respiratory problems (difficulty or depression of breathing);
• if you suffer from heart or blood vessel problems (cardiovascular diseases);
• if you have high blood pressure (hypertension);
• if you have an overactive thyroid (hyperthyroidism);
• if you suffer from a disease causing increased pressure in the eye and vision problems (glaucoma);
• if you have an enlarged prostate (prostatic hypertrophy);
• if you have narrowing of the stomach or intestines (gastrointestinal tract stenosis);
• if you have narrowing of the urinary or genital tract (urogenital tract stenosis);
• if you suffer from a disease causing loss of consciousness and violent involuntary muscle contractions (epilepsy);
• if you suffer from severe liver disease;
• if you are pregnant, especially during the first trimester, or if you are breastfeeding (see "Pregnancy and breastfeeding");
• if the child to be treated is under two years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Coryfin Sedative Expectorant:

• if you have a history of drug or substance abuse (psychoactive substances capable of altering mental and physical state);
• if the person to be treated is an adolescent or young adult;
• if you have chronic or persistent cough (for example due to smoking or certain respiratory diseases such as emphysema/asthma);
• if your cough is accompanied by other symptoms such as fever, skin rash, headache, nausea, or vomiting;
• if your cough is irritating and associated with abundant mucus production;
• if you suffer from liver or kidney problems.

Other medicines and Coryfin Sedative Expectorant
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Talk to your doctor or pharmacist before taking Coryfin Sedative Expectorant if you are taking medicines such as certain antidepressants or antipsychotics: Coryfin Sedative Expectorant may interact with these medicines and may cause changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea).
Inform your doctor if you are being treated with:

• MAOIs, fluoxetine, paroxetine, sertraline, and bupropion (medicines used to treat depression);
• methadone (a medicine used to treat severe pain or to reduce withdrawal symptoms in case of substance dependence);
• haloperidol, thioridazine, perphenazine (medicines used to treat mental disorders);
• amiodarone, flecainide, quinidine, propafenone (medicines used to treat heart rhythm disorders);
• cinacalcet (a medicine used to reduce calcium levels in the blood);
• terbinafine (a medicine used to treat fungal infections);
• linezolid (an antibiotic, a medicine used to treat bacterial infections);
• sibutramine (a medicine used to reduce appetite);
• sedatives (medicines that induce unconsciousness);
• hypnotics (medicines used to treat insomnia);
• anxiolytics (medicines used to reduce anxiety). The concomitant use of Coryfin Sedative Expectorant with sedative medicines such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes Coryfin Sedative Expectorant together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor. Inform your doctor about all sedative medicines you are taking and follow carefully his or her recommendations regarding dosage. It may be helpful to inform friends or family members so they are aware of the signs and symptoms described above. If you experience these symptoms, contact your doctor. Coryfin Sedative Expectorant with alcohol It is recommended not to drink alcohol during treatment with Coryfin Sedative Expectorant.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Coryfin Sedative Expectorant must not be used during pregnancy, especially during the first trimester, or during breastfeeding (see "Do not use Coryfin Sedative Expectorant").

Driving and using machines
Coryfin Sedative Expectorant may cause drowsiness, especially when taken together with alcohol or other medicines that may reduce reaction time (see "Other medicines and Coryfin Sedative Expectorant").
Avoid driving, operating machinery, or performing other activities requiring special attention.

Coryfin Sedative Expectorant contains:

• sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine. This medicine contains 6.8 g of sucrose per dose (2 measuring cups = 20 ml, corresponding to the recommended dose for adolescents over 12 years of age). This should be taken into account in patients with diabetes mellitus.
• ethanol: This medicine contains 1.13 mg of alcohol (ethanol) in 20 ml. The volume amount (20 ml) contained in this medicine is equivalent to less than 28 ml of beer or 11 ml of wine. The amount of alcohol in this medicine does not appear to have an effect on adults and adolescents, and its effects in children are not evident. Some effects may occur in young children, for example feeling sleepy. The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines. If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine. If you are alcohol-dependent, talk to your doctor before taking this medicine.
• sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate: may cause allergic reactions (including delayed reactions).
• sodium: this medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to use Coryfin Sedative Expectorant

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 12 years of age
The recommended dose is 20 ml (equivalent to 2 measuring cups of 10 ml each), 1 to 3 times daily, taken apart from meals. The maximum daily dose is 60 ml. Do not exceed the recommended doses.
Children from 6 to 12 years of age
The recommended dose is 10 ml (equivalent to 1 measuring cup of 10 ml), 1 to 3 times daily, taken apart from meals. The maximum daily dose is 30 ml. Do not exceed the recommended doses.
Children from 2 to 6 years of age
The recommended dose is 5 ml (equivalent to half a measuring cup of 10 ml), 1 to 3 times daily, taken apart from meals.
The maximum daily dose is 15 ml. Do not exceed the recommended doses.
1 ml of syrup contains: 22.6 mg of potassium guaiacolsulfonate and 1.1 mg of dextromethorphan hydrobromide.
Duration of treatment
Do not use Coryfin Sedative Expectorant for more than 7 days.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Instructions for use:

For opening the bottle: press the cap downwards while unscrewing counterclockwise. For closing the bottle: screw the cap tightly clockwise. Use of the dosing cup: to administer the recommended dose, pour the syrup into the dosing cup until the desired mark corresponding to the dose is reached. Wash the device after each use.

If you use more Coryfin Sedative Fluidifier than you should
In case of accidental ingestion/overdose of Coryfin Sedative Fluidifier, contact your doctor immediately or go to the nearest hospital.

Children
In children, overdose may lead to serious adverse events, including neurological disorders. Caregivers of patients must not exceed the recommended dose.

If you take more Coryfin Sedative Fluidifier than you should, the following symptoms may occur: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, cognitive disturbances, involuntary and rapid eye movements, cardiac disorders (rapid heartbeat), coordination problems, psychosis with visual hallucinations, and hyperexcitability.

Additional symptoms in case of massive overdose may include: coma, severe breathing problems, and seizures.

Seek immediate medical attention at a doctor's office or hospital if any of the above symptoms occur.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine at an unknown frequency (frequency cannot be estimated from the available data):

• allergic reactions (hypersensitivity) including anaphylactic reaction (a severe, rapidly occurring allergic reaction that may be fatal), angioedema (swelling of the skin or mucous membranes), urticaria, pruritus, rash (skin eruptions), and erythema (redness of the skin);
• hallucinations (seeing or hearing things that do not exist);
• somnolence, dizziness;
• gastrointestinal disorders (stomach and intestinal disturbances), nausea, vomiting, and decreased appetite;
• fatigue, fever.

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 the following website: 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 Coryfin Expectorant Sedative

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Coryfin Sedative Expectorant contains
The active substances are potassium sulfoguaiacolate, dextromethorphan hydrobromide. 1 ml of syrup contains: 22.6 mg of potassium sulfoguaiacolate and 1.1 mg of dextromethorphan hydrobromide.

• Other components: sucrose, ethanol, sodium chloride, sodium methyl parahydroxybenzoate, monoammonium glycyrrhizinate, mint flavour, sodium propyl parahydroxybenzoate, purified water.

Description of the appearance of Coryfin Sedative Expectorant and pack contents
Coryfin Sedative Expectorant 20 mg/g + 1 mg/g syrup is available in a pack containing one amber glass bottle of 180 g with child-resistant cap and a graduated dosing spoon.
Marketing Authorization Holder
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Provinciale per Lecco, 78 - 22038 Tavernerio (CO)