SMAT Granules for Oral Solution

2. What you need to know before taking Smat

Do not take Smat

• If you are allergic to the active substances or to any of the other components of this medication (listed in section 6).
• If you have arterial hypertension.
• If you have hyperthyroidism.
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeats).
• If you are being treated with a monoamine oxidase inhibitor (MAOI) medication (such as some antidepressants or medications for Parkinson's disease).
• If you are being treated with sympathomimetic medications (medications used to treat asthma or to accelerate heart rate).
• If you are being treated with beta-blocker medications (medications for the heart or to treat arterial diseases) (see: Warnings and precautions).
• If you have glaucoma (high eye pressure).
• If you have a severe heart or arterial disease (such as coronary artery disease or angina pectoris).
• If you have a severe liver or kidney disease.

Patient under 18 years old cannot take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• Do not take more medication than recommended by your doctor (see section 3: How to take Smat).

• Chronic alcoholics should be cautious not to take more than 2 sachets of Smat per day.

• While taking this medication, you should not take other medications that contain paracetamol, as this can cause a paracetamol overdose that could damage the liver.

• The following patients should consult their doctor before taking this medication:
  • Patient with kidney, liver, heart, or lung diseases, and patients with anemia.
  • Asthmatic patients sensitive to acetylsalicylic acid.
  • Patient sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).
  • Patient being treated with medications for: prostate hypertrophy, bronchial asthma, very slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, thyroid diseases, patients sensitive to the sedative effects of some medications.

During treatment with this medication, inform your doctor immediately if:

• You have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

If you are being treated with tricyclic antidepressants or medications with a similar effect and you experience gastrointestinal problems, you should stop taking this medication and consult a doctor immediately, as you may develop paralytic ileus (the normal movements of a part of the intestine stop).

Children and adolescents

Patient under 18 years old cannot take this medication.

Other medications and Smat

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

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or interrupt treatment:

• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications for treating tuberculosis: (isoniazid, rifampicin).
• Medications for treating convulsions and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medications to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications used to increase urine elimination (diuretics such as furosemide, or others) and other diuretics that cause potassium loss (such as diuretics for treating hypertension or others).
• Medications used to prevent nausea and vomiting (metoclopramide and domperidone).
• Medications used to treat gout (probenecid and sulfinpyrazone).
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (propranolol).
• Medications used to lower cholesterol levels in the blood (cholestyramine).
• Medications used to treat depression, Parkinson's disease, or other diseases (monoamine oxidase inhibitors (MAOIs)). Smat should be taken at least 15 days after finishing treatment with these medications.
• Medications used to treat migraines; medications taken for childbirth; medications taken to treat blood pressure or other diseases (alpha-adrenergic blocking medications).
• Alpha and beta-adrenergic blocking medications (labetalol and carvedilol) used for the heart or to treat arterial diseases.
• Medications used to treat depression of the tricyclic and tetracyclic type.
• Medications used for general anesthesia.
• Antihypertensive medications used to lower blood pressure.
• Medications used for heart diseases of the type of cardiac glycosides and antiarrhythmics.
• Medications containing thyroid hormones (used to treat thyroid diseases).
• Medications used for heart or digestive diseases of the type of atropine sulfate.
• Medications that cause depression of the central nervous system, such as those used for insomnia or anxiety.
• Ototoxic medications (which have the adverse effect of damaging the ear).
• Photosensitizing medications (which have the adverse effect of causing allergy to light).
• Medication used in the treatment of infections: Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Interference with analytical tests

If you are going to have any analytical tests (including blood tests, urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Taking Smat with food, drinks, and alcohol

While being treated with this medication, you should not consume alcoholic beverages, as this may increase the risk of side effects.

Additionally, the use of medications containing paracetamol by patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, etc. per day) may cause liver damage.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

This medication should not be taken during pregnancy unless your doctor considers it strictly necessary.

This medication should not be taken by breastfeeding mothers, as it may cause side effects in the baby.

Driving and using machines

This medication may cause drowsiness. If you experience drowsiness while taking this medication, avoid driving vehicles or using machines.

Smat contains mannitol:

This medication may have a mild laxative effect because it contains mannitol.

3. How to take Smat

Follow the administration instructions of this medication indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults from 18 years old: 1 sachet every 6-8 hours as needed (3 or 4 sachets per day). Do not take more than 4 sachets in 24 hours.

Patient with liver disease: These patients can only take 1 sachet every 12 hours if necessary (2 sachets per day maximum).

Patient with kidney disease: These patients should not take this medication due to the paracetamol dose.

In patients with chronic alcoholism, do not administer more than 2 sachets per day.

Use in children

This medication is contraindicated in patients under 18 years old.

Use in elderly patients

Your doctor will recommend a lower dose.

Smat is taken orally. Dissolve the contents of the sachet completely in a little liquid, preferably half a glass of water, and then drink.

If you take more Smat than you should

If you have ingested an overdose, go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

The symptoms of overdose may include: dizziness, vomiting, loss of appetite, dry mouth, difficulty and pain when urinating, blurred vision, rapid and difficult breathing, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment of overdose is more effective if started within 4 hours after taking the overdose of the medication.

Patient being treated with barbiturates or chronic alcoholics may be more susceptible to paracetamol toxicity.

In case of overdose or accidental ingestion, go to a medical center immediately or call the Toxicological Information Service (Telephone 91 562 04 20), indicating the medication and the amount ingested.

If you forget to take Smat

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

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the forgotten dose.

If you stop taking Smat

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

4. Possible side effects

Like all medications, Smat can cause side effects, although not everyone will experience them.

During the use of paracetamol, phenylephrine, and chlorphenamine, the following side effects have been reported, whose frequency has not been established with precision:

• The side effects that may occur frequently (may affect up to 1 in 10 patients) are:

Mild drowsiness, dizziness, muscle weakness: these side effects may disappear after 2-3 days of treatment. Difficulty in facial movements, clumsiness, tremors, alterations in sensations and tingling, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal disorders (which may decrease if the medication is administered with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucus, sweating, blurred vision or other vision disorders.

• The side effects that may occur infrequently (rare) (may affect up to 1 in 1,000 patients) are:

Malaise, low blood pressure (hypotension), and increased transaminase levels in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increased fluid volume in the lungs), and cerebral hemorrhage (at high doses or in sensitive patients), nervous excitement (generally with high doses, and is more frequent in the elderly and children), which may include symptoms such as: restlessness, insomnia, nervousness, and even convulsions. Other side effects that may occur infrequently are: chest tightness, lung noises, rapid or irregular heartbeats (generally with overdose), liver disorders (which may present with stomach pain or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeats, itching, swelling of the eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medications related to chlorphenamine. Blood disorders (changes in the blood cell formula, such as agranulocytosis, leukopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), ear disorders, impotence, menstrual disorders.

• The side effects that may occur very infrequently (very rare) (may affect up to 1 in 10,000 patients) are:

Kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Paracetamol may damage the liver when taken in high doses or for prolonged treatment.

• The side effects whose frequency of occurrence is not known (cannot be estimated from the available data) are:

Anxiety, irritability, weakness, high blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeats (severe bradycardia), reduction of blood vessel caliber (peripheral vasoconstriction), reduction of heart output that affects especially the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of heart disease, urinary retention, paleness, hair standing on end, high blood sugar (hyperglycemia), low potassium levels in the blood, a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2), cold in the extremities (legs or arms), flushing, feeling of fainting (hypotension). With high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, a decrease in blood volume may occur.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this package leaflet. You can also report them directly through the notification system included in the Spanish Pharmacovigilance System for Human Use Medications. Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Smat

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

Do not use Smat after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition ofSmat

Each sachet contains:

• As active ingredients: 1 g of paracetamol, 15.58 mg of phenylephrine bitartrate (equivalent to 8.21 mg of phenylephrine) and 4 mg of chlorphenamine maleate (equivalent to 2.8 mg of chlorphenamine).
• The other components (excipients) are: Mannitol (E-421), sodium saccharin, anhydrous colloidal silica, orange flavor (containing maltodextrin, which is a corn starch derivative) and povidone.

Appearance of the Product and Packaging Content

Smat is a granulate for oral solution, white or yellowish-white in color and orange in flavor, presented in sachets packaged in cardboard boxes containing 10 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82,

28802 Alcalá de Henares (Madrid)

Date of the Last Revision of this Leaflet:January 2025

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