Sinumedin tabs

Package leaflet: Information for the patient

Sinumedin Tabs
650 mg + 10 mg + 4 mg, coated tablets
Paracetamolum + Phenylephrini hydrochloridum + Chlorphenamini maleas
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If fever persists for more than 3 days of treatment, pain or other symptoms for more than 5 days, or if symptoms worsen or new symptoms appear, consult your doctor.

Leaflet contents

1. What Sinumedin Tabs is and what it is used for
2. Important information before taking Sinumedin Tabs
3. How to take Sinumedin Tabs
4. Possible side effects
5. How to store Sinumedin Tabs
6. Contents of the pack and other information

1. What Sinumedin Tabs is and what it is used for

Sinumedin Tabs is a combination medicine containing paracetamol – an antipyretic and analgesic substance,
chlorphenamine – an antihistamine substance which reduces nasal discharge, and
phenylephrine – which acts by reducing nasal mucosal swelling.
Indications
Symptomatic treatment of conditions associated with acute sinusitis:

• Headache caused by blocked sinuses,
• Swelling of the nasal and paranasal sinus mucosa causing nasal congestion,
• Excessive nasal discharge (rhinitis). Alleviates symptoms of cold and flu (fever, general malaise and weakness).

If fever persists for more than 3 days of treatment, pain or other symptoms for more than 5 days, or if symptoms worsen or new symptoms appear, consult your doctor.

2. Important information before taking Sinumedin Tabs

When not to take Sinumedin Tabs

• if the patient is allergic to paracetamol, phenylephrine hydrochloride, chlorpheniramine maleate, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe liver and/or kidney failure;
• if the patient has hypertension (high blood pressure);
• if the patient has any severe heart or arterial disease (such as coronary artery disease or angina pectoris);
• if the patient has tachycardia (rapid heartbeat);
• if the patient has cardiac arrhythmias;
• if the patient has hyperthyroidism;
• if the patient has glaucoma (an eye disease characterized by progressive and irreversible damage to the optic nerve leading to worsening or loss of vision);
• if the patient is being treated with monoamine oxidase inhibitors (MAOIs) (such as certain antidepressants or drugs used in Parkinson's disease, or others), or within 2 weeks after discontinuation of such treatment;
• in children under 12 years of age;
• in pregnant and breastfeeding women.

Warnings and precautions
Before starting treatment with Sinumedin Tabs, consult a doctor or
pharmacist if the patient:

• has heart disease (long-term treatment with paracetamol should be avoided);
• is allergic to antihistamines, as they may also be allergic to chlorpheniramine;
• has kidney disease, benign prostatic hyperplasia, diabetes, bronchial asthma, chronic bronchitis, pulmonary emphysema, very slow heartbeat, vascular occlusive disease (e.g. Raynaud's syndrome), pancreatitis, pyloroduodenal stenosis (narrowing between the stomach and intestine), or thyroid disorders;
• is being treated with tricyclic antidepressants or other drugs with similar effects and develops gastrointestinal symptoms, as these may indicate a life-threatening intestinal paralysis (paralytic ileus) due to impaired peristalsis;
• has congenital glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may lead to methemoglobinemia and hemolytic anemia) or methemoglobin reductase deficiency;
• is in a group at increased risk of liver damage from paracetamol:
• is taking long-term carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort, or other drugs that induce liver enzymes;
• has eating disorders, is infected with HIV, is dehydrated, fasting, or malnourished;
• regularly consumes alcohol. In patients with chronic alcoholism, no more than 2 g of paracetamol per day should be used. Alcohol consumption should be avoided during treatment with this medicine;
• has liver disease, including Gilbert's syndrome (inherited hyperbilirubinemia - increased bilirubin levels in blood);
• is taking antihypertensive drugs;
• is sensitive to sedative drugs or has epilepsy, as interactions may occur with medications used to treat these conditions.

Caution is advised in patients with asthma or hypersensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs, as bronchospasm has been observed in less than 5% of patients after administration of paracetamol.
Long-term use of paracetamol in combination with acetylsalicylic acid may lead to permanent kidney damage and risk of kidney failure (analgesic nephropathy).
In case of overdose, seek immediate medical advice, even if the patient feels well, due to the risk of irreversible liver damage.
Do not exceed the daily dose of the medicine stated in section 3. Higher doses than recommended will not provide stronger pain relief; however, they may cause severe liver damage. Symptoms of liver damage usually appear within a few days. In case of overdose, contact a doctor immediately, even if the patient has no symptoms.
Do not take any other products containing paracetamol simultaneously, due to the risk of exceeding the maximum daily dose of paracetamol. When using the medicine, always check the composition of other medicines before taking them.
During treatment with Sinumedin Tabs, inform the doctor immediately if:

• the patient has severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, or is also taking flucloxacillin (an antibiotic). In these situations, patients taking paracetamol regularly over a long period or taking paracetamol together with flucloxacillin have developed a serious condition called metabolic acidosis (abnormality in blood and body fluids). Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Children
Do not use in children under 12 years of age due to the dose of paracetamol and the presence of other active ingredients.
Elderly patients (over 65 years of age)
Elderly patients should not take this medicine without consulting a doctor.
Due to the presence of phenylephrine and chlorpheniramine, adverse effects such as bradycardia (slow heartbeat) or reduced cardiac output may occur in elderly patients.
Blood pressure should be monitored, especially in patients with heart disease.
In elderly patients, symptoms such as dizziness, sedation, confusion, hypotension (low blood pressure), excitation, dry mouth, and urinary retention are more likely to occur.
Sinumedin Tabs and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
This medicine should not be taken simultaneously with other medicines containing:

• paracetamol (the active ingredient found in many cold and flu remedies), because paracetamol overdose may occur;
• phenylephrine (sympathomimetic drugs - medications that reduce nasal mucosal congestion, appetite suppressants, or psychostimulants with amphetamine-like effects, used symptomatically for nasal mucosal inflammation, i.e. cold);
• antihistamines (medicines used in the treatment of allergic diseases);
• monoamine oxidase inhibitors (MAOIs) (medicines used, among others, in the treatment of depression and Parkinson's disease). Administration of Sinumedin Tabs should be delayed for at least 15 days after discontinuation of these medicines;
• tricyclic or tetracyclic antidepressants.

Due to the presence of paracetamol
If the patient is taking any of the following medicines, a dose adjustment or discontinuation of Sinumedin Tabs may be necessary:

• oral anticoagulants (acenocoumarol, warfarin);
• antiepileptic drugs (lamotrigine, phenytoin and other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine);
• antituberculosis drugs (isoniazid, rifampicin);
• barbiturates (used as general anesthetics, sedatives, and anticonvulsants);
• activated charcoal (adsorbent);
• cholestyramine (used to reduce blood cholesterol levels);
• medicines used in the treatment of gout (probenecid and sulfinpyrazone);
• cardiac glycosides (heart medications);
• antiemetic drugs (metoclopramide and domperidone);
• zidovudine (used in the treatment of HIV infections).

Inform the doctor or pharmacist if the patient is taking:

• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be urgently treated (see section 2).

Due to the presence of phenylephrine
If the patient is taking any of the following medicines, treatment may need to be discontinued or administration of the medicine delayed by at least 15 days:

• tricyclic antidepressants;
• inhaled anesthetics;
• antihypertensive drugs (lowering blood pressure);
• drugs causing potassium loss (such as diuretics used in hypertension treatment and others);
• drugs affecting cardiac conduction (used in heart diseases), such as cardiac glycosides;
• atropine sulfate (used, among others, in heart and gastrointestinal diseases).

Due to the presence of chlorpheniramine
Concomitant use of the following medicines may increase the occurrence of adverse effects:

• medicines causing central nervous system depression (such as medicines used to treat insomnia or anxiety).

Sinumedin Tabs with food, drink, and alcohol
During treatment with Sinumedin Tabs, alcohol should not be consumed, as it may cause overdose symptoms, such as enhanced sedative effects.
Taking Sinumedin Tabs by patients who regularly consume alcohol may lead to liver damage.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a baby, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Sinumedin Tabs is contraindicated during pregnancy.
Breastfeeding
Sinumedin Tabs is contraindicated during breastfeeding.
Driving and operating machinery
The medicine may affect the ability to drive and operate machinery. If drowsiness or sedation occurs, do not drive or operate machinery.
The medicine contains carmine red, brown HT, and sodium
Carmine red (E 124) and brown HT (E 155)
The medicine may cause allergic reactions.
Sodium
The medicine contains 0.633 mg of sodium per tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Effect on laboratory test results
If the patient is undergoing diagnostic tests (blood tests, including glucose and alanine aminotransferase (ALT) levels, urine tests, skin tests using allergens, etc.), inform the doctor that the patient is currently taking Sinumedin Tabs, as this medicine may alter laboratory test results.

3. How to take Sinumedin Tabs

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Method of administration
For oral use.

Recommended dose
Adults and adolescents over 12 years of age:
1 tablet. The dose may be repeated if necessary, but no more frequently than every 4–6 hours.
Do not take more than 6 tablets in 24 hours.

Duration of treatment
If fever persists for longer than 3 days of treatment, or pain or other symptoms persist for longer than 5 days, or if symptoms worsen or new symptoms appear, consult a doctor.
If pain or fever subsides, discontinue taking Sinumedin Tabs.

Patients with kidney or liver disease
Consult a doctor before taking this medicine.

Elderly patients (over 65 years of age)
Elderly patients should not take this medicine without consulting a doctor. See section 2.

Use in children
This medicine must not be used in children under 12 years of age due to the paracetamol dosage and the presence of other active substances.

Accidental overdose of Sinumedin Tabs
If a dose higher than recommended has been swallowed, seek immediate medical advice, as symptoms may not appear until three days after ingestion, even in cases of severe poisoning.

Symptoms of overdose:

• Caused by paracetamol: nausea, vomiting, loss of appetite, pallor, and abdominal pain, usually within the first 24 hours. Significant overdose may cause severe hepatotoxic effects, leading to liver failure, metabolic acidosis, and encephalopathy, which may result in coma and death. Overdose may also lead to coagulation disorders (impaired blood clotting and bleeding). In case of overdose, seek immediate medical advice even if no symptoms are present.

Treatment of paracetamol overdose is most effective if started within 4 hours of ingestion.

Patients undergoing treatment with barbiturates or alcoholics may be more susceptible to paracetamol overdose.

• Caused by phenylephrine: excessive stimulation of the nervous system with symptoms such as restlessness, anxiety, agitation, headache (possibly indicating hypertension), seizures, insomnia, confusion, irritability, tremors, loss of appetite, nausea, vomiting, psychosis with hallucinations (more frequent in children), hypertension (sometimes associated with intracerebral hemorrhage, pulmonary edema), cardiac arrhythmias, palpitations, and vasoconstriction possibly leading to reduced blood flow to vital organs.

Severe symptoms are more likely in patients with reduced blood volume due to hemorrhage, dehydration, etc., with slow, irregular, or rapid heartbeat, tachycardia, decreased urine output, metabolic acidosis (excessive accumulation of acidic substances in the blood), and paresthesia (tingling and burning sensations in various parts of the body).

• Caused by chlorphenamine: muscle rigidity, instability, pronounced drowsiness, dryness of the mucous membranes of the mouth, nose, or throat, facial flushing, dyspnea (difficulty breathing), cardiac arrhythmias (irregular or rapid heartbeat), hallucinations, seizures, insomnia, hypotension (low blood pressure – feeling of fainting), which may occur as a delayed reaction.

In cases of chlorphenamine or phenylephrine overdose, symptomatic and supportive treatment is applied.
In case of overdose or accidental ingestion, seek immediate medical attention.

Missed dose of Sinumedin Tabs
Do not take a double dose to make up for a missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Immediately contact a doctor or go to the nearest hospital if any of the following occur:

• allergic reactions (cough, difficulty swallowing, rapid heartbeat, itching, swelling of the eyelids or areas around the eyes, face, tongue, shortness of breath) – occur in 1 to 10 out of 1,000 people – "uncommonly" or in 1 to 10 out of 10,000 people – "rarely";
• angioedema (severe allergic reaction – sudden swelling of the face, limbs or joints without itching or pain). Swelling in the head and neck area may cause difficulty swallowing and breathing – occurs "rarely";
• Stevens-Johnson syndrome (appearance of blisters on the skin and/or mucous membranes which, when ruptured, form painful sores; often accompanied by fever, muscle and joint pain) – occurs "with unknown frequency" – frequency cannot be estimated based on available data;
• bronchospasm – occurs "with unknown frequency";
• renal failure (reduced urine output, swelling, shortness of breath, loss of appetite, nausea and vomiting, diarrhoea, itchy skin, small skin hemorrhages) – occurs "with unknown frequency";
• liver failure (nausea, vomiting, fullness in the upper abdomen, yellowing of the skin and eyes, liver tenderness) – occurs "with unknown frequency";
• metabolic acidosis (deepened, rapid and laboured breathing, nausea, vomiting, loss of appetite) – occurs "with unknown frequency";
• pulmonary edema (rapidly worsening shortness of breath, sometimes audible bubbling, crackling or wheezing in the lungs, cough, sometimes with expectoration of yellowish sputum tinged with blood) – occurs "rarely".

The following adverse reactions may occur in patients taking Sinumedin Tabs:
Common (occur in 1 out of 10 people):

• drowsiness, nausea and muscle weakness (which may resolve after 2-3 days of treatment);
• movement disorders in the face, stiffness, tremors, tingling or numbness in the limbs (paresthesia), altered perception of sensations and sounds;
• dry mouth, loss of appetite, changes in taste and smell;
• gastrointestinal disturbances such as nausea, vomiting, diarrhoea, constipation, upper abdominal pain (these may be alleviated by taking the medicine with food);
• urinary retention;
• dryness and drying of the nasal and throat mucous membranes;
• excessive sweating;
• blurred or double vision.

Uncommonly (occur in 1 out of 1,000 people) or rarely (occur in 1 out of 10,000 people):

• nervous excitation (manifested by anxiety, insomnia, delirium, palpitations, nervousness, and seizures);
• chest tightness, laboured breathing;
• rapid or irregular heartbeat (usually in cases of overdose);
• liver function disorders (which may present with, among others, upper abdominal or abdominal pain and dark urine);
• photosensitivity;
• cross-allergy to drugs similar to chlorpheniramine;
• blood morphology changes (such as agranulocytosis, leukopenia, aplastic anaemia or thrombocytopenia) with symptoms such as unusual bleeding, sore throat or fatigue;
• low or high blood pressure;
• swelling (edema);
• tinnitus, acute labyrinthitis (part of the ear);
• impotence;
• intermenstrual bleeding.

Rarely (occur in 1 out of 10,000 people):

• allergic dermatitis (skin rashes);
• jaundice (yellowing of the skin);
• hypoglycemia (reduced blood sugar concentration);
• myocardial infarction;
• cardiac arrhythmias (ventricular);
• pulmonary edema;
• intracerebral hemorrhage;
• hypersensitivity reactions (itchy maculopapular rash, urticaria, laryngeal edema, anaphylactoid reactions);
• abdominal pain, indigestion, nausea, diarrhoea;
• low neutrophil count responsible for immunity (neutropenia).

Paracetamol may cause liver damage when taken in large doses or during prolonged treatment.
Frequency unknown (frequency cannot be estimated based on available data):

• anxiety, weakness, hypertension (elevated blood pressure), headache, dizziness;
• chest pain or discomfort;
• severe bradycardia (very slow heartbeat);
• vasoconstriction, increased cardiac workload (particularly affecting elderly patients or those with cerebral or coronary circulation disorders). May provoke or exacerbate heart disease;
• breathing difficulties;
• pallor;
• hair standing on end;
• decreased potassium concentration in blood;
• cold extremities (feet or hands);
• hypotension (low blood pressure);
• elevated liver aminotransferase levels, elevated bilirubin levels;
• serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

When high doses are used, palpitations and psychotic states with hallucinations may occur.
With prolonged use of the medicine, plasma volume deficiency may develop.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Sinumedin Tabs

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date refers to the last day of the specified month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Sinumedin Tabs contains

• The active substances of the medicine are: paracetamol (Paracetamolum), phenylephrine hydrochloride (Phenylephrini hydrochloridum) and chlorphenamine maleate (Chlorphenamini maleas). Each coated tablet contains: 650 mg paracetamol, 10 mg phenylephrine hydrochloride, 4 mg chlorphenamine maleate.
• Other ingredients are: tablet core: povidone 30, sodium croscarmellose, magnesium stearate, Prosolv Easy tab SP: microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate, sodium carboxymethyl starch (type A); tablet coating: hypromellose, hydroxypropylcellulose, brown HT (E 155), carmine red (E 124), Capol 1295 (white wax and carnauba wax).

What Sinumedin Tabs looks like and contents of the pack
Sinumedin Tabs are biconvex, film-coated tablets, bean-shaped, of brick-red colour.
The packaging contains 6 tablets, 10 tablets or 20 tablets. The blisters are packed in a cardboard box together with the leaflet.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel: +48 42 22-53-100

Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów