Prospect: information for the user

Actithiol Mucolytic Antihistamine Oral Solution

carbocisteine/prometazine hydrochloride

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Actithiol Mucolytic Antihistamine and for what it is used

2. What you need to know before starting to take Actithiol Mucolytic Antihistamine

3. How to take Actithiol Mucolytic Antihistamine

4. Possible adverse effects

5. Storage of Actithiol Mucolytic Antihistamine

6. Contents of the package and additional information

Actithiol Mucolítico Antihistamínico contains carbocisteine and promethazine.

Carbocisteine is a mucolytic that liquefies and reduces the viscosity of mucus to facilitate its elimination and has anti-inflammatory action.

Promethazine is a phenothiazine with antihistamine properties that is effective in relieving symptoms of nasal and throat irritation.

This medication is used for symptomatic relief of allergic component respiratory conditions, such as sinusitis, rhinopharyngitis, acute, subacute, and chronic bronchitis.

Do not take Actithiol Mucolítico Antihistamínico

• if you are allergic to carbocisteína or prometazina or phenothiazines in general, or to any of the other components of this medication (listed in section 6).
• if you have a stomach or duodenal ulcer.
• if you have asthma or other severe respiratory disease.
• if you have a history of blood disorders (agranulocytosis: lack or decrease of white blood cells) or jaundice (yellowing of the skin and mucous membranes).
• if you have urinary or prostate problems due to the risk of urinary retention.
• if you have a risk of angle-closure glaucoma (eye disease that can cause blindness).
• if you have myasthenia (neuromuscular disease that causes muscle weakness).
• if you have taken an MAO inhibitor in the past two weeks (medications used to treat depression).
• if your bone marrow function is decreased.
• if your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
• if you are a child with severe dehydration or acute illness (chickenpox, measles, central nervous system infections, gastroenteritis) as you have a higher susceptibility to neuromuscular reactions that include abnormal movements (dystonias).

Actithiol Mucolítico Antihistamínico is contraindicated in children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Actithiol Mucolítico Antihistamínico.

• If you have hypothyroidism.
• If you have pyloric obstruction.
• If you have difficulty urinating.
• If you have porphyria (metabolic disorder that causes a disturbance of a component of red blood cells).
• In elderly patients who are especially sensitive to the adverse effects of carbocisteína or prometazina.
• In patients with cardiovascular diseases.
• In cases of severe liver and/or kidney failure.
• Do not take at the same time as a medication that inhibits the cough reflex or dries up bronchial secretions (for example, "atropinic" medications).
• Increased vigilance in people with epilepsy.
• Avoid taking alcoholic beverages during treatment.

• Avoid exposure to sunlight, as there is a risk of abnormal skin reactions caused by the sun (photosensitization).
• If you have any severe heart problems.
• If you have a personal or family history of heart disease.
• If you have irregular heartbeats

Interference with analytical tests

This medication may interfere with urine pregnancy tests, both to produce false positives and false negatives.

It should be discontinued at least 72 hours before the start of skin allergy tests as it inhibits the histamine response in the skin and may produce false negatives.

Other medications and Actithiol Mucolítico Antihistamínico

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

• Do not recommend taking carbocisteína with medications that inhibit the cough reflex or with substances that inhibit bronchial secretions (atropinic), as it may cause retention of these bronchial secretions and make it difficult to expel sputum.
• Do not take together with anticholinergic medications, such as imipramine antidepressants, monoamine oxidase inhibitors, antiparkinsonian anticholinergic medications, antispasmodic atropinic medications, disopyramide, or phenothiazine neuroleptics, as they may increase the adverse effects of prometazina (dry mouth, urinary retention, constipation).

• Do not take together with central nervous system depressants (sedatives, hypnotics, anxiolytics, analgesics), as they may potentiate the sedative effect of prometazina.

• Medications that may affect heart rhythm.

Taking Actithiol Mucolítico Antihistamínico with food, drinks, and alcohol

It is recommended to take this medication before meals (see section 3. How to take Actithiol Mucolítico Antihistamínico). It is not recommended to consume alcoholic beverages during treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Do not take Actithiol Mucolítico Antihistamínico if you are pregnant.

If you are breastfeeding, do not take Actithiol Mucolítico Antihistamínico as it is excreted in breast milk.

Driving and operating machinery

Actithiol Mucolítico Antihistamínico may cause drowsiness, especially at the beginning of treatment, which may affect your ability to drive and/or operate machinery. Patients should avoid operating hazardous machinery, including cars, until they know how they tolerate the medication.

Actithiol Mucolítico Antihistamínico contains saccharose, methylparahydroxybenzoate, propylparahydroxybenzoate, propylene glycol, ethanol, and sodium.

This medication containssaccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. Patients with diabetes mellitus should be aware that this medication contains 6 g of saccharose per 10 ml.

This medication may cause allergic reactions (possibly delayed) because it containsmethylparahydroxybenzoate(E-218) andpropylparahydroxybenzoate(E-216).

This medication contains 1.036 mg ofpropylene glycol(E-1520) in each 10 ml. If you are pregnant or breastfeeding, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication. If you have liver or kidney failure, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication. If the child is under 5 years old, consult your doctor or pharmacist, especially if other medications containing propylene glycol or alcohol have been administered.

This medication contains 2.4% ofethanol(alcohol), which corresponds to a quantity of 0.12 g per 5 ml of solution, equivalent to 2.4 ml of beer or 1 ml of wine. This medication is harmful to people with alcoholism. The alcohol content should be taken into account in the case of pregnant women, breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

This medication contains 27.6 mg ofsodium(main component of table salt/for cooking) per 10 ml. This corresponds to 1.38% of the maximum daily sodium intake recommended for an adult.

Actithiol Mucolítico Antihistamínico is administered orally.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

The recommended dose for children aged 2 to 5 years is:

1 dose of 5 ml from the measuring cup (100 mg of carbocisteine and 2.5 mg of promethazine) 2 to 3 times a day.

The recommended dose for children over 5 years is:

1 dose of 5 ml from the measuring cup (100 mg of carbocisteine and 2.5 mg of promethazine) 3 to 5 times a day.

The recommended dose for adolescents from 16 years and adults is:

1 dose of 10 ml from the measuring cup (200 mg of carbocisteine and 5 mg of promethazine) 3 to 5 times a day.

It is recommended to use the measuring cup included in the package for a correct dosing.

Actithiol Mucolítico Antihistamínico is used for short-term treatment.

It is recommended to take this medication before meals, and to divide the doses preferably in the afternoon or before bedtime due to the pronounced sedative effect of promethazine.

Do not take more doses than recommended.

Your doctor may increase the dose according to the clinical case.

If you estimate that the action of Actithiol Mucolítico Antihistamínico is too strong or weak, inform your doctor or pharmacist.

If you take more Actithiol Mucolítico Antihistamínico than you should

Consult your doctor or pharmacist immediately.

The signs of overdose in children may be various combinations of excitement, ataxia, atetosis, incoordination, and hallucinations, while in adults they may be somnolence and coma. Seizures, preceded by excitement or coma, may occur in both populations. In case of overdose or accidental ingestion, go immediately to a medical center or consult the Toxicology Information Service, phone 915 620 420, indicating the medication and the dose ingested.

If you forgot to take Actithiol Mucolítico Antihistamínico

If you forget to take a dose, take it as soon as you can. However, if it is already time for the next dose, wait for the next dose and take it at the usual time.

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

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

Sedation, drowsiness, dizziness, dry mouth, visual disturbances, constipation, and urinary retention may occur.

In some cases, allergic reactions such as skin rashes, urticaria, or asthma attacks may occur.

Gastrointestinal disturbances (gastric discomfort, diarrhea, nausea, vomiting, and rarely gastrointestinal bleeding), headache, vertigo, motor coordination disorders, tremors in elderly patients, postural hypotension (dizziness when standing up or getting up), bradycardia (slow heart rate), tachycardia (rapid heart rate), increased blood pressure, or jaundice (yellow discoloration of the skin and mucous membranes) may also appear.

Rarely, mental confusion or disorientation may occur, and very rarely, bronchospasm (narrowing of the bronchial airway) may occur.

In children, excitement may be observed.

Very rarely, hematological alterations (decreased platelets, red or white blood cells) may occur.

Extrapyramidal alterations (incoordinate movements) have also been described at high doses.

In these cases, it is recommended to reduce the dose or discontinue treatment.

With unknown frequency (cannot be estimated from available data), the following may occur:

• Abnormal heart electrical activity that affects its rhythm, including potentially fatal rhythm alterations
• Severe reaction with fever, muscle rigidity, changes in blood pressure, and coma (neuroleptic malignant syndrome)
• Low platelet counts in the blood (which may cause bleeding and hematomas)
• Anxiety
• Hallucinations
• Aggression

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on 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 packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Actithiol Mucolítico Antihistamínico Oral Solution

The active principles of Actithiol Mucolítico Antihistamínico are carbocisteine and prometazine.

Each 5 ml of oral solution contains 100 mg of carbocisteine and 2.5 mg of prometazine hydrochloride.

Each 10 ml of oral solution contains 200 mg of carbocisteine and 5 mg of prometazine hydrochloride.

The other components are: citric acid, sodium hydroxide, sucrose, ethanol, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), propylene glycol (E-1520), pineapple essence, peach essence, and purified water.

Appearance of the product and contents of the packaging

Actithiol Mucolítico Antihistamínico Oral Solution is presented in 200 ml bottles, with a measuring cup.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almirall, S.A. General Mitre, 151 08022 Barcelona (Spain)

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A., Ctra. de Martorell, 41-61, 08740 - Sant Andreu de la Barca – Barcelona (Spain).

or

Responsible for manufacturing

Almirall Hermal, GmbH, Scholtzstrasse, 3 D-21465 Reinbek (Germany)

Last review date of this leaflet: March 2025

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)