Minustosan 1.5 mg/ml syrup EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Minustosan 1.5 mg/ml syrup EFG

Dextromethorphan hydrobromide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for taking this medicine as described in this leaflet or as directed by your doctor or pharmacist.

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

Contents of the leaflet

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

1. What Minustosan is and what it is used for

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

This medicine is intended for use in adults and children over 12 years of age.

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

2. What you need to know before taking Minustosan

This medicine may cause dependence. Therefore, treatment should be short-term.

Do not take Minustosan:

• if you are allergic to dextromethorphan hydrobromide or to any of the other ingredients of this medicine (listed in section 6);
• if you have a lung disease;
• if you are currently receiving, or have received within the previous 2 weeks, treatment with monoamine oxidase inhibitors (MAOIs) used to treat depression;
• if you are currently taking selective serotonin reuptake inhibitors (SSRIs) (used to treat depression and anxiety, such as fluoxetine, paroxetine, and sertraline).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Minustosan:

• if you have liver or kidney problems;
• if you have bronchitis, emphysema, or asthma, or if you have had a cough lasting several weeks or a cough producing a lot of mucus (phlegm);
• if you are dependent on alcohol;
• if you have intolerance to certain sugars;
• if you are taking other cough and cold medicines containing dextromethorphan;
• if your child is prone to 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, Minustosan may interact with these medicines and you may experience changes in your mental state (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, and diarrhea).

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

Taking Minustosan with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including:

• Certain antidepressants, such as dopamine-norepinephrine reuptake inhibitors (DNRI), including bupropion.
• Antipsychotics (medicines used to treat mood disorders, such as haloperidol, thioridazine, perphenazine).
• Antiarrhythmics (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 (a medicine used to treat high blood pressure, chest pain, or rapid heartbeat).
• Antifungals (terbinafine, isavuconazole).
• Opioid analgesics (medicines used to relieve pain, e.g., codeine, tramadol, morphine, methadone).
• Antihistamines (medicines used to treat symptoms of allergic reactions).
• Hypnotics (sleeping tablets, including barbiturates).
• Tranquilizers (medicines to relax muscles or reduce anxiety).

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

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

Drinking alcohol during treatment with Minustosan may increase the risk 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and use of machines

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 in 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 advised you that you have an intolerance to certain sugars, consult with them 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) have intolerance to certain sugars or 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 10 ml dose. If your doctor has advised you that you have an intolerance to certain sugars, consult with them 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, corresponding to 5.03% v/v 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 significant effect.

This medicine contains less than 1 mmol of sodium (23 mg) per dose and is therefore considered essentially "sodium-free."

This medicine contains 6 mg of sodium benzoate in each 10 ml.

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

This medicine contains a negligible amount of benzyl alcohol as part of the flavoring agents 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 may accumulate in the body and cause adverse effects (metabolic acidosis).

3. How to take Minustosan

Follow exactly the administration instructions provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

See below for the amount of medicine 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 daily.

Use in children and adolescents

Children aged 12 years and over: same as adults.

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

Elderly patients (over 65 years of age)

Same 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, disturbances in consciousness, rapid and involuntary eye movements, cardiac disorders (fast heartbeat), coordination disorders, psychosis with visual hallucinations and hyperexcitability.

In addition, other types of hallucinations, clumsiness, dizziness, speech problems, lack of energy, high blood pressure, tremor, constricted or dilated pupils, difficulty urinating, sudden abdominal pain or rectal bleeding due to inflammation of the colon (ischaemic colitis).

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

Contact your doctor or hospital immediately if you experience any of the above symptoms. Contact your doctor or hospital immediately if you experience any of the symptoms mentioned, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Minustosan

This medicine should only be taken when needed, carefully following the dosage instructions above. If you forget to take a dose, take the next dose when needed.

Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

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

• Itching, skin rash, hives.

Other possible side effects include:

• Dizziness, drowsiness.
• Nausea, vomiting, diarrhoea.
• Stomach discomfort or stomach pain.
• Difficulty sleeping or feeling restless or confused.
• Shallow breathing.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Minustosan

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the bottle following EXP. The expiry date refers to the last day of the month indicated.

After first opening the bottle, the medicine may be used until the expiry date indicated on the label.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the Sigre Point located at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Minustosan

• The active substance 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 (spray dried), liquid sorbitol (E 420) (non-crystallising), glycerol (E 422), anhydrous ethanol, levomenthol, citric acid, caramel flavour (contains propylene glycol (E 1520), benzyl alcohol), peach flavour (contains propylene glycol (E 1520), sodium citrate, benzyl alcohol, limonene), purified water (see section 2).

Nature and contents of the container

Yellowish, transparent syrup with peach flavour.

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

• Aluminium cap. A plastic dosing spoon graduated at 2.5 ml and 5 ml is supplied with the pack.
• Tamper-proof plastic cap. A plastic dosing cup graduated at 5 ml, 10 ml, 15 ml and 20 ml is supplied with the pack.
• Child-resistant plastic cap. A plastic dosing cup graduated at 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 supplied with the pack.

Marketing Authorisation Holder

Medochemie Ltd

1-10 Constantinoupoleos Street

3011, Limassol

Cyprus

Manufacturer

Medochemie Ltd

1-10 Constantinoupoleos Street

3011, Limassol

Cyprus

Date of the most recent revision of this leaflet: January 2023.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).