Prospect: Information for the User

Minustosan 1.5 mg/ml Syrup EFG

Dextromethorphan Hydrobromide

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3-5 days.

1.What Minustosan is and for what it is used

2.What you need to know before starting to take Minustosan

3.How to take Minustosan

4.Possible adverse effects

5.Storage of Minustosan

6.Contents of the package and additional information

Minustosan is a medication used to help relieve dry and irritating coughs. The syrup contains dextromethorphan hydrobromide, which is an antitussive that inhibits the cough reflex.

The medication is for use in adults and children over 12 years old.

Consult a doctor if symptoms worsen or do not improve after 3-5 days of treatment.

This medicine may cause dependence. Therefore, treatment should be of short duration.

Do not takeMinustosan:

• if you are allergic to dextromethorphan hydrobromide or any of the other components of this medicine (listed in section 6);
• if you have a lung disease;
• if you are being treated or have been treated in the last 2 weeks with any monoamine oxidase inhibitor (MAOI) used for the treatment of depression;
• if you are being treated with selective serotonin reuptake inhibitors (used to treat depression and anxiety, such as fluoxetine, paroxetine, and sertraline)

Do not use Minustosan in children under 12 years (see section 3).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Minustosan:

• if you have liver or kidney problems;
• if you have bronchitis, emphysema, or asthma or have had coughing for several weeks or a cough that produces a lot of mucus (phlegm);
• if you have a dependence on alcohol;
• if you have intolerance to some sugars;
• if you are taking other medicines for cough and cold that contain dextromethorphan;
• if your child is susceptible to developing certain allergic reactions (e.g. atopic reactions);
• if you have a history of drug abuse;
• if your doctor has told you that you are a slow metabolizer of CYP2D6.
• If you are taking other medicines such as antidepressants or antipsychotics,Minustosanmay interact with these medicines and you may experience changes in your mental state (e.g. agitation, hallucinations, coma) and other effects such as a body temperature above 38°C, increased heart rate,unstable blood pressureand exaggerated reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

If the cough persists for more than a week or is accompanied by high fever, skin eruptions, or persistent headache, you should consult a doctor.

Taking Minustosan with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including:

• Certain medicines for depression, such as noradrenaline-dopamine reuptake inhibitors (IRND), which include bupropion.
• Antipsychotics (medicines used to treat mood disorders, such as haloperidol, thioridazine, and perphenazine).
• Antiarrhythmic agents (medicines used to treat irregular heartbeat, such as amiodarone, propafenone, quinidine, and flecainide).
• Calcimimetics (medicines used to treat secondary hyperparathyroidism, elevated parathyroid hormone levels, such as cinacalcet).
• Metoprolol (medicine used to treat high blood pressure, chest pain, or rapid heart rate).
• Antifungals (terbinafine, isavuconazole).
• Opioid analgesics (medicines used to relieve pain, e.g., codeine, tramadol, morphine, methadone).
• Antihistamines (medicines used to treat allergic reaction symptoms).
• Hypnotics (sleeping pills that include barbiturates).
• Tranquilizers (medicines to relax muscles or reduce anxiety).

If you are unsure about any of the medicines you are taking, show the bottle or packaging to your pharmacist.

If any of these points apply to you now or in the past, speak with a doctor or pharmacist.

Consuming alcohol during treatment with Minustosan may increase the occurrence of unwanted effects. Therefore, alcohol consumption should be avoided during this period.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

This medicine may cause drowsiness or dizziness. If affected, do not drive or operate machinery. Avoid alcoholic beverages.

Important information about some of the excipients of Minustosan

Minustosan contains sucrose, liquid sorbitol, liquid glucose, ethanol, sodium, sodium benzoate, propylene glycol, and benzyl alcohol.

This medicine contains 3.25 g of sucrose per dose (10 ml). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine. This should be taken into account by patients with diabetes mellitus.

This medicine contains 0.65 g of sorbitol per dose (10 ml). Sorbitol is a source of fructose. If your doctor has told you that you (or your child) has an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, speak with your doctor before you (or your child) take or receive this medicine.

This medicine contains 3.95 g of glucose per dose of 10 ml. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine. This should be taken into account by patients with diabetes mellitus.

This medicine contains 503 mg of alcohol (ethanol) in each 10 ml, which corresponds to a volume of 5.03% per dose. The amount in 10 ml of this medicine is equivalent to less than 10 ml of beer or 4.5 ml of wine. The small amount of alcohol in this medicine will have no notable effect.

This medicine contains less than 1 mmol of sodium (23 mg) per dose, so it is essentially "sodium-free".

This medicine contains 6 mg ofsodium benzoatein each 10 ml.

This medicine contains 26.52 mg of propylene glycol (E1520) in each 10 ml.

This medicine contains an insignificant amount of benzyl alcohol as part of the flavorings in each 10 ml. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding or have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in the body and cause adverse effects (metabolic acidosis).

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

See below to view the amount of medication you should take.

• For oral use only.
• Do not take more than the indicated dose shown below.
• Do not take more than 4 doses in 24 hours.
• The maximum duration of treatment without medical advice is one week.
• If your symptoms persist or worsen after 3-5 days, speak with your doctor or pharmacist.

The recommended dose is:

Adults

10 ml of syrup (15 mg of dextromethorphan) 3-4 times a day.

Use in children and adolescents

Children 12 years and older: as for adults.

Children under 12 years: do not administer Minustosan to children under 12 years.

Senior patients (65 years and older)

As for adults.

If you take more Minustosan than you should

If you take more Minustosan than you should, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, altered consciousness, rapid eye movements, cardiac disturbances (rapid heartbeats), coordination disturbances, psychosis with visual hallucinations and hyperexcitability.

Additionally, other types of hallucinations, clumsiness, dizziness, speech problems, lack of energy, high blood pressure, tremors, constricted or dilated pupils, difficulty urinating, sudden abdominal pain or ischemic colitis.

Other symptoms in case of massive overdose may be: coma, severe respiratory problems, and seizures.

Immediately contact your doctor or hospital if you experience any of the above symptoms.Immediately contact your doctor or hospital if you experience any of the mentioned symptoms orcall the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Minustosan

You should only take this medication as needed, following carefully the previous dosing instructions. If you forget to take a dose, take the next dose when needed.

Do not take a double dose to compensate for missed doses.

If you have any doubts about the use of this medication, consult your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

If you experience any of the following symptoms, stop taking the medication and seek immediate medical attention:

• Swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing.
• Seizures

If you experience any of the following symptoms, stop taking the medication and speak with your doctor:

• Itching, skin rash, urticaria.

Other effects that may occur include:

• Dizziness, somnolence.
• Nausea, vomiting, diarrhea.
• Stomach discomfort or abdominal pain.
• Difficulty sleeping or feeling restless or confused.
• Shallow breathing.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the bottle after CAD. The expiration date is the last day of the month indicated

After opening the bottle for the first time, the medication can be used until the expiration date indicated on the label.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the Sigre Point of the pharmacy. Ask your pharmacist how to dispose of containers and medications you no longer need. This way, you will help protect the environment.

Composition of Minustosan

• The active principle is dextromethorphan hydrobromide. Each ml contains 1.5 mg of dextromethorphan hydrobromide.
• The other components are: sodium saccharin (E 954), sodium benzoate (E 211), sucrose, liquid glucose (atomized), liquid sorbitol (E 420) (without crystallization), glycerol (E 422), anhydrous ethanol, levomenthol, citric acid, caramel flavor (contains propylene glycol (E 1520), benzyl alcohol), peach flavor (contains propylene glycol (E 1520), sodium citrate, benzyl alcohol, limonene), purified water (see section 2).

Appearance of the product and contents of the container

Light yellow, transparent syrup with a peach flavor.

Brown glass bottles of 150 ml or 200 ml Type III (Ph.Eur) closed with one of the following caps:

• Aluminum cap. As part of the packaging, a plastic dosing spoon with graduations of 2.5 ml and 5 ml is provided.
• Child-resistant plastic cap. As part of the packaging, a plastic dosing cup with graduations of 5 ml, 10 ml, 15 ml, and 20 ml is provided.
• Child-resistant plastic cap. As part of the packaging, a plastic dosing cup with graduations of 2 ml, 2.5 ml, 3 ml, 4 ml, 5 ml, 6 ml, 7 ml, 7.5 ml, 8 ml, 9 ml, 10 ml, 11 ml, 12 ml, 12.5 ml, and 15 ml is provided.

Marketing Authorization Holder

Medochemie Ltd

1-10 Constantinoupoleos Street

3011, Limassol

Cyprus

Responsible for manufacturing

Medochemie Ltd

1-10 Constantinoupoleos Street

3011, Limassol

Cyprus

Last review date of this leafletJanuary2023.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/).