Golasept cough sedative

Package leaflet: Information for the patient

Golasept antitussive 30 mg/10 ml syrup, 15 mg/ml oral drops, solution

Dextromethorphan hydrobromide
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after 5 days.

Contents of this leaflet:

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

1. What Golasept cough suppressant is and what it is used for

Golasept cough suppressant contains the active substance dextromethorphan, which belongs to the group of
medicines used to treat dry cough.
Consult your doctor if you do not feel better or if you feel worse after 5 days.

2. What you need to know before taking Golasept cough suppressant

Do not take Golasept cough suppressant

• if you are allergic to dextromethorphan or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from respiratory disorders (bronchial asthma, chronic obstructive bronchopulmonary disease);
• if you have difficulty breathing (including respiratory depression);
• if you have pneumonia, a lung infection;
• if you suffer from circulatory or heart disorders (cardiovascular diseases);
• if you have high blood pressure (hypertension);
• if you suffer from thyroid disorders (hyperthyroidism);
• if you have diabetes;
• if you have an eye disorder (glaucoma);
• if you suffer from prostate problems (prostatic hypertrophy);
• if you suffer from gastrointestinal, intestinal or urinary tract disorders (gastrointestinal and urogenital stenosis);
• if you suffer from epilepsy;
• if you have severe liver disease;
• if the patient is a child under 12 years of age;
• if you are taking medicines used to treat depression (MAO inhibitor antidepressants); (see section “Other medicines and Golasept cough suppressant”);
• if you are in the first trimester of pregnancy or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Golasept cough suppressant.
The duration of treatment with this medicine should not exceed 5–7 days.
The use of Golasept cough suppressant, especially for prolonged treatments, may lead to reduced effectiveness and the need to continue using the medicine (habituation, tolerance, mental and physical dependence). Therefore, short-term treatment under strict medical supervision is recommended, especially if you are predisposed to such conditions.
This medicine is not indicated for the treatment of persistent cough (chronic cough), which may be due to smoking or lung disorders (emphysema) or breathing disorders (asthma). If you have a persistent cough, stop treatment and consult your doctor, as it may be a symptom of respiratory disorders (asthma).
Do not take this medicine if your cough is accompanied by abundant mucus. If your cough causes pain and discomfort (irritating cough) and is associated with mucus, consult your doctor, who will carefully evaluate whether treatment with this medicine is necessary. If your doctor considers treatment essential, you must be closely monitored during therapy.
Take this medicine with caution if you experience fever, skin irritation (rash), headache, nausea, and vomiting.
You may start treatment with Golasept cough suppressant only after careful evaluation by your doctor and under strict medical supervision if:

• you suffer from circulatory or heart disorders (cardiovascular diseases);
• you have high blood pressure (hypertension);
• you suffer from thyroid disorders (hyperthyroidism);
• you have diabetes;
• you have an eye disorder (glaucoma);
• you suffer from prostate problems (prostatic hypertrophy);
• you suffer from gastrointestinal, intestinal or urinary tract disorders (gastrointestinal and urogenital stenosis);
• you suffer from epilepsy;
• you have severe liver disease;
• you are taking medicines used to treat depression (MAO inhibitor antidepressants) (see section “Other medicines and Golasept cough suppressant”). In all the above situations, taking this medicine is not recommended and should be reserved only for cases of absolute necessity (see also section “Do not take Golasept cough suppressant”).

For individuals engaged in sports, the use of Golasept cough suppressant 15 mg/ml oral drops, solution containing ethyl alcohol, may result in a positive anti-doping test, depending on the alcohol concentration limits set by certain sports federations.

Children and adolescents
The use of this medicine is contraindicated in children under 12 years of age.

Other medicines and Golasept cough suppressant
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine if you are taking medicines used to treat depression (MAO inhibitor antidepressants); at least two weeks must have passed since the last dose of antidepressant medicine before starting Golasept cough suppressant.
In particular, inform your doctor if you are taking or have recently taken:

• antidepressant medicines (MAO inhibitors);
• linezolid, a medicine used to treat bacterial infections;
• sibutramine, a medicine used to treat obesity;
• medicines to treat depression such as fluoxetine, paroxetine, sertraline and bupropion (see section 2. “Do not take Golasept cough suppressant”);
• medicines to treat severe pain or to reduce withdrawal symptoms in cases of dependence (methadone);
• medicines to treat psychiatric disorders (haloperidol, thioridazine, perphenazine);
• medicines to treat heart rhythm disorders (amiodarone, quinidine, propafenone);
• medicines to treat cardiac arrhythmias (flecainide);
• medicines to reduce blood calcium levels and treat dysfunction due to reduced secretion of the hormone regulating these levels (hyperparathyroidism), such as cinacalcet;
• antifungal medicines (terbinafine).
  Because taking these medicines together with Golasept cough suppressant may cause a potentially fatal condition called serotonin syndrome, whose symptoms include:
• nausea;
• low blood pressure;
• tremors and muscle disorders (clonic spasms, myoclonus, increased reflex response, and pyramidal rigidity);
• nervous system disorders (autonomic nervous system hyperactivity), fever, rapid heartbeat (tachycardia), shortness of breath (tachypnea), pupil dilation (mydriasis);
• excessive sweating (diaphoresis);
• mental disturbances (agitation, excitement, confusion);
• cardiac arrest and death.

Talk to your doctor and take this medicine with caution if you are taking:

• medicines used to treat insomnia and anxiety (hypnotic, sedative and anxiolytic medicines);
• medicines used to treat certain heart disorders (amiodarone, quinidine, propafenone);
• medicines used to treat depression (fluoxetine, paroxetine);
• antipsychotic medicines used to treat certain mental disorders (haloperidol, thioridazine);
• cimetidine, a medicine used to treat stomach disorders due to high acidity;
• ritonavir, a medicine used to treat AIDS;
• medicines used to facilitate mucus elimination (secretolytic medicines).

Concomitant use of Golasept cough suppressant and sedative medicines such as benzodiazepines or related substances 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 available.
However, if your doctor prescribes Golasept cough suppressant together with sedative medicines, the dose and duration of concomitant treatment must be strictly limited by your doctor.
Inform your doctor about all sedative medicines you are taking and follow your doctor’s dosage recommendations carefully.
It may be helpful to inform friends or family members to watch for the signs and symptoms listed above.
Contact your doctor if you experience any of these symptoms.

Golasept cough suppressant with beverages and alcohol
Avoid drinking grapefruit juice during treatment with this medicine, as it may increase toxic effects or reduce effectiveness.
Avoid consuming alcohol during treatment with this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during the first three months of pregnancy.
After the third month of pregnancy, you may take this medicine only in cases of absolute necessity and under strict medical supervision, as breathing problems (respiratory depression) may occur in the newborn, especially at high doses and even after short treatment periods.
Breastfeeding
Do not take this medicine while breastfeeding.

Driving and using machines
Golasept cough suppressant may impair your ability to drive or operate machinery, as it may cause drowsiness, especially if you consume alcohol at the same time (see section “Golasept cough suppressant with beverages and alcohol”).

Golasept cough suppressant 30 mg/10 ml syrup contains sucrose, sodium benzoate, propylene glycol and parahydroxybenzoates
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
This medicine contains 2 mg of sodium benzoate per 3 ml dose and 16 mg per maximum daily dose.
This medicine contains 0.69 mg of propylene glycol per 3 ml dose and 5.52 mg per maximum daily dose.
This medicine contains parahydroxybenzoates (methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate) which may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per the maximum recommended dose, i.e. essentially 'sodium-free'.

Golasept cough suppressant 15 mg/ml oral drops, solution contains sorbitol, sodium benzoate, ethanol, propylene glycol and parahydroxybenzoates
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per maximum daily dose.
This medicine contains 67.5 mg of sorbitol per 10 mg dose (equivalent to 27 drops) and 540 mg per maximum daily dose. Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, talk to your doctor before taking this medicine.
This medicine contains 2.15 mg of sodium benzoate per 10 mg dose (equivalent to 27 drops) and 17.2 mg per maximum daily dose.
This medicine contains 0.16 mg of propylene glycol per 10 mg dose (equivalent to 27 drops) and 1.28 mg per maximum daily dose.
This medicine contains parahydroxybenzoates (methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate) which may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e. essentially 'sodium-free'.

3. How to take Golasept cough sedative

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Golasept cough sedative 30 mg/10 ml syrup
To open the container, press and unscrew at the same time.
In adults and adolescents (aged 12 to 18 years), the recommended dose ranges from 10 mg of
dextromethorphan (equivalent to one teaspoon of syrup, approximately 3 ml) to 20 mg of
dextromethorphan (equivalent to two teaspoons of syrup, approximately 6 ml), every 6 hours.
The maximum recommended daily dose is 80 mg.
Golasept cough sedative 15 mg/ml oral drops, solution
To open the container, press and unscrew at the same time.
In adults and adolescents (aged 12 to 18 years), the recommended dose ranges from 10 mg of
dextromethorphan (approximately 27 drops) to 20 mg of dextromethorphan (approximately 53 drops), every 6 hours.
The maximum recommended daily dose is 80 mg (approximately 213 drops).
If you take more Golasept cough sedative than you should
If you have taken or ingested an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
In case of overdose, symptoms may include:

• nausea, vomiting;
• visual disturbances;
• movement coordination disorders (ataxia);
• dizziness;
• excitation, muscle disorders (increased muscle tone);
• mental confusion;
• decreased blood pressure (hypotension);
• increased heart rate (tachycardia);
• reduced urine output and breathing difficulties (respiratory depression) in more severe cases.

If you forget to take Golasept cough sedative
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

• drowsiness, fatigue;
• involuntary and rapid eye movements (nystagmus);
• movement difficulties (dystonia);
• dizziness;
• mental confusion and behavioural changes (foul language);
• serotonin syndrome (see section “Warnings and precautions”), characterised by nausea, decreased blood pressure, tremors and muscle disorders (clonic spasms, myoclonus, increased reflex response and pyramidal origin rigidity), nervous system disorders (autonomic nervous system hyperactivity, fever, increased heart rate (tachycardia), shortness of breath (tachypnea), pupil dilation (mydriasis), excessive sweating (diaphoresis), mental disturbances (agitation, excitement, confusion), cardiac arrest and death;
• mental disorders (psychosis), hallucinations;
• need to continue taking the medicine (psychic dependence);
• severe allergic reactions (anaphylactic and anaphylactoid reactions);
• elevated body temperature, high fever;
• type 2 diabetes;
• nausea and vomiting;
• stomach and intestinal disorders, loss of appetite;
• skin allergic reactions and skin rashes.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.
Following the instructions contained in this leaflet reduces the risk of side effects.

5. How to store Golasept cough suppressant

Keep this medicine out of the sight and reach of children.
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.
Keep the medicine in the original packaging to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Golasept cough suppressant contains
Golasept cough suppressant 30 mg/10 ml syrup

• The active substance is levodropropizine. 10 ml of syrup contain 30 mg of levodropropizine.
• The other components are sucrose, citric acid monohydrate, sodium benzoate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium hydroxide, propylene glycol, bitter orange flavour, purified water.

Golasept cough suppressant 15 mg/ml oral drops, solution

• The active substance is levodropropizine. Each ml of solution contains 15 mg of levodropropizine.
• The other components are liquid sorbitol, glycerol, citric acid monohydrate, sodium benzoate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, sodium hydroxide, vanillin, ethanol, sodium saccharin, purified water.

Description of the appearance of Golasept cough suppressant and contents of the pack
Golasept cough suppressant 30 mg/10 ml syrup
Pack containing one 150 ml bottle.
Golasept cough suppressant 15 mg/ml oral drops, solution
Pack containing one 20 ml bottle with dropper.
Marketing Authorization Holder
Zeta Farmaceutici S.p.A. Via Mentana, 38 - 36100 Vicenza
Manufacturer
Zeta Farmaceutici S.p.A. Via Galvani, 10 - 36066 Sandrigo (VI)