Sinumedin Tabs

Leaflet attached to the packaging: patient information

Sinumedin Tabs

650 mg + 10 mg + 4 mg, coated tablets

Paracetamol + Phenylephrine hydrochloride + Chlorphenamine maleate

Read the 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 a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If a fever persists for more than 3 days of treatment, pain or other symptoms for more than 5 days, or if symptoms worsen or new ones appear, a doctor should be consulted.

Table of contents of the leaflet

• 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 packaging and other information

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

Sinumedin Tabs is a combination of paracetamol, a fever-reducing and pain-relieving substance, chlorphenamine, an antihistamine that reduces nasal discharge, and phenylephrine, which reduces swelling of the nasal mucosa.

Indications for use

Symptomatic treatment of conditions associated with acute rhinosinusitis:

• headache caused by nasal congestion,
• swelling of the nasal mucosa and sinuses causing a feeling of a blocked nose,
• excessive nasal discharge (rhinitis). It alleviates symptoms of colds and flu (fever, general weakness, and fatigue).

If a fever persists for more than 3 days of treatment, pain or other symptoms for more than 5 days, or if symptoms worsen or new ones appear, a doctor should be consulted.

2. Important information before taking Sinumedin Tabs

When not to take Sinumedin Tabs

• if the patient is allergic to paracetamol, phenylephrine hydrochloride, chlorphenamine maleate, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe liver or kidney failure;
• if the patient has high blood pressure;
• if the patient has any severe heart or blood vessel disease (such as coronary artery disease or angina pectoris);
• if the patient has tachycardia (rapid heart rate);
• if the patient has heart rhythm disorders;
• 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 impaired or lost vision);
• if the patient is being treated with monoamine oxidase inhibitors (MAOIs) (such as certain antidepressants or drugs used to treat Parkinson's disease, or others) and for 2 weeks after their discontinuation;
• in children under 12 years of age;
• in pregnant or breastfeeding women.

Warnings and precautions

Before starting Sinumedin Tabs, the patient should discuss it with their doctor or pharmacist if they:

• have heart disease (should then avoid long-term treatment with paracetamol);
• are allergic to antihistamines, as they may also be allergic to chlorphenamine;
• have kidney disease, prostate enlargement, diabetes, asthma, chronic bronchitis, pulmonary emphysema, very slow heart rate, thromboembolic disease (e.g., Raynaud's syndrome), pancreatitis, narrowing of the pyloric and duodenal junction (between the stomach and intestine), thyroid diseases;
• are being treated with tricyclic antidepressants or other drugs with similar effects and experience gastrointestinal symptoms, as these may be a sign of a life-threatening paralytic ileus (cessation of intestinal peristalsis);
• have a congenital deficiency of glucose-6-phosphate dehydrogenase (G6PD) (may lead to methemoglobinemia and hemolytic anemia) and methemoglobin reductase;
• are at increased risk of liver damage due to paracetamol use:
• are taking carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's Wort, or other liver enzyme-inducing drugs;
• have eating disorders, are HIV-infected, are dehydrated, starved, or emaciated;
• regularly consume alcohol. In patients with chronic alcoholism, paracetamol should not be taken in doses exceeding 2 g per day. Alcohol should be avoided during treatment with this medicine;
• have liver disease, including Gilbert's syndrome (congenital hyperbilirubinemia - elevated bilirubin levels in the blood);
• are taking blood pressure-lowering medications;
• are sensitive to the effects of sedatives or have epilepsy, as they may interact with medications used to treat these conditions.

Care should be taken in patients with asthma, hypersensitivity to acetylsalicylic acid, and other nonsteroidal anti-inflammatory drugs, as less than 5% of patients have been observed to experience bronchospasm after taking paracetamol.
Prolonged use of paracetamol in combination with acetylsalicylic acid may lead to permanent kidney damage and an increased risk of kidney failure (analgesic nephropathy).
In case of overdose, medical advice should be sought immediately, even if the patient's condition is good, due to the risk of irreversible liver damage.
The daily dose of the medicine should not be exceeded. Higher doses than recommended will not ensure stronger pain relief; they may, however, cause very severe liver damage. Symptoms of liver damage usually appear within a few days. In case of overdose, a doctor should be consulted immediately, even if the patient does not experience any symptoms of overdose.
No other products containing paracetamol should be taken concurrently with this medicine due to the risk of exceeding the maximum daily dose of paracetamol. When taking this medicine, the composition of other medications should be checked before taking them.
During treatment with Sinumedin Tabs, the doctor should be informed immediately if:

• the patient has severe diseases, including severe kidney or liver disorders, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe condition called metabolic acidosis (a blood and body fluid disorder), when they took paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Children

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

Elderly patients (over 65 years)

Elderly patients should not take the medicine without consulting a doctor.
Due to the presence of phenylephrine and chlorphenamine, elderly patients may experience side effects such as bradycardia (slow heart rate) or decreased cardiac minute volume.
Blood pressure should be monitored, especially in patients with heart disease.
Elderly patients are more likely to experience symptoms such as dizziness, sedation, confusion, hypotension (low blood pressure), or agitation, dry mouth, and urinary retention.

Sinumedin Tabs and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
This medicine should not be taken concurrently with other medicines containing:

• paracetamol (the active substance found in many cold and flu medicines), as paracetamol overdose may occur;
• phenylephrine (sympathomimetic drugs - medicines that reduce nasal congestion, appetite suppressants, or psychostimulants with effects similar to amphetamines, used in the symptomatic treatment of rhinitis);
• antihistamines (medicines used to treat allergic diseases);
• monoamine oxidase inhibitors (MAOIs) (medicines used, among others, in the treatment of depression and Parkinson's disease). Sinumedin Tabs should be discontinued at least 15 days after the end of treatment with these medicines;
• tricyclic or tetracyclic antidepressants.

Due to the presence of paracetamol
If the patient is taking any of the following medicines, it may be necessary to change the dose or discontinue Sinumedin Tabs:

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

The doctor or pharmacist should be informed 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 treated urgently (see section 2).

Due to the presence of phenylephrine
If the patient is taking any of the following medicines, it may be necessary to discontinue treatment or delay administration for at least 15 days:

• tricyclic antidepressants;
• inhalational anesthetics;
• antihypertensive drugs (blood pressure-lowering medications);
• potassium-losing drugs (such as diuretics used to treat hypertension and others);
• drugs affecting heart conduction (used in heart diseases), such as cardiac glycosides;
• atropine sulfate (used, among others, in heart and gastrointestinal diseases).

Due to the presence of chlorphenamine
Concomitant use of the following medicines may increase the risk of side effects:

• drugs that cause central nervous system depression (such as sleep aids or anxiolytics).

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 increased 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Sinumedin Tabs is contraindicated during pregnancy.
Breastfeeding
Sinumedin Tabs is contraindicated during breastfeeding.

Driving and using machines

The medicine may affect the ability to drive and use machines. If drowsiness and sedation occur, the patient should not drive or operate machinery.

The medicine contains sunset yellow FCF, brown HT, and sodium

Sunset yellow FCF (E 110) and brown HT (E 155)
The medicine may cause allergic reactions.
Sodium
Each tablet contains 0.633 mg of sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

Effect on laboratory test results

If the patient is to undergo diagnostic tests (blood tests, including glucose and alanine aminotransferase (ALT) tests, urine tests, skin tests using allergens, etc.), they should inform their doctor that they are taking Sinumedin Tabs, as this medicine may affect 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 a doctor or pharmacist. If in doubt, the doctor or pharmacist should be consulted.
Method of administration
The medicine is for oral use.
Recommended dose
Adults and children over 12 years of age:
1 tablet, which can be repeated if necessary, but not more frequently than every 4-6 hours.
No more than 6 tablets should be taken in 24 hours.
Duration of treatment
If a fever persists for more than 3 days of treatment, pain or other symptoms for more than 5 days, or if symptoms worsen or new ones appear, a doctor should be consulted.
Treatment with Sinumedin Tabs should be discontinued when pain or fever subsides.
Patients with kidney or liver disease
Medical advice should be sought before taking the medicine.
Elderly patients (over 65 years)
Elderly patients should not take the medicine without consulting a doctor. See section 2.
Use in children
The medicine should not be used in children under 12 years of age due to the paracetamol dose and the presence of other active substances.

Overdose of Sinumedin Tabs

If an overdose has occurred, a doctor should be consulted immediately, as symptoms often appear after 3 days, even in cases of severe poisoning.

Overdose symptoms:

• caused by paracetamol: nausea, vomiting, loss of appetite, pallor, and abdominal pain usually occur within the first 24 hours. Significant overdose can cause severe liver toxicity, leading to liver failure, metabolic acidosis, and encephalopathy, which can result in coma and death. Overdose may also cause: coagulation disorders (blood clotting and bleeding). In case of overdose, medical advice should be sought immediately, even if no symptoms are present.

Treatment of paracetamol overdose is more effective if started within 4 hours of ingestion.
Patients treated with barbiturates or alcoholics may be more susceptible to paracetamol overdose.

• caused by phenylephrine: excessive nervous system stimulation with symptoms such as: anxiety, fear, agitation, headaches (which may be symptoms of hypertension), seizures, insomnia, confusion, irritability, tremors, loss of appetite, nausea, vomiting, psychosis with hallucinations (more common in children), hypertension (sometimes with cerebral hemorrhage or pulmonary edema), cardiac arrhythmias, palpitations, vasoconstriction with possible reduced blood flow to vital organs.

Severe symptoms are more likely to occur in patients with reduced blood volume due to bleeding, dehydration, etc., with slow, irregular, or rapid heart rate, with increased heart rate, decreased urine output, metabolic acidosis (excessive accumulation of acidic substances in the blood), and paresthesia (tingling and numbness sensations in different parts of the body).

• caused by chlorphenamine: stiffness, instability, increased drowsiness, dryness of the oral, nasal, or pharyngeal mucosa, facial flushing, dyspnea (breathing difficulties), cardiac arrhythmias (irregular or rapid heart rate), hallucinations, seizures, insomnia, hypotension (low blood pressure) - may occur late.

In cases of chlorphenamine and phenylephrine overdose, symptomatic and supportive treatment is used.
In case of overdose or accidental ingestion, a doctor should be consulted immediately.

Missed dose of Sinumedin Tabs

A double dose should not be taken to make up for a missed dose.
If there are any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Sinumedin Tabs can cause side effects, although not everybody gets them.

The doctor or the nearest hospital should be informed immediately if the following occur:

• allergic reactions (cough, difficulty swallowing, rapid heart rate, itching, swelling of the eyelids or eyes, face, tongue, dyspnea) - occur in 1 to 10 people out of 1,000 - "uncommon" or in 1 to 10 people out of 10,000 - "rare";
• angioedema (severe allergic reaction - sudden swelling of the face, limbs, or joints without itching and pain). Swelling in the head and neck area may cause difficulty swallowing and breathing - occurs "rarely";
• Stevens-Johnson syndrome (blisters on the skin and/or mucous membranes that form painful sores when they rupture, often accompanied by fever, muscle and joint pain) - occurs with an unknown frequency - the frequency cannot be determined based on available data;
• bronchospasm - occurs with an unknown frequency;
• renal failure (reduced urine output, edema, dyspnea, loss of appetite, nausea, and vomiting, diarrhea, skin itching) - occurs with an unknown frequency;
• liver failure (nausea, vomiting, abdominal distension, yellowing of the skin and eyes, liver tenderness) - occurs with an unknown frequency;
• metabolic acidosis (deepened, accelerated, and labored breathing, nausea, vomiting, loss of appetite) - occurs with an unknown frequency;
• pulmonary edema (rapidly worsening dyspnea, sometimes with audible bubbling, crackling, or wheezing in the lungs, cough, sometimes with bloody sputum) - occurs "rarely".

Possible side effects that may occur in patients taking Sinumedin Tabs include:
Common(occur in 1 to 10 people out of 100):

• drowsiness, nausea, and muscle weakness (which may resolve after 2-3 days of treatment);
• facial movement problems, stiffness, tremors, paresthesia (tingling and numbness sensations), changes in sensation and perception;
• dry mouth, loss of appetite, changes in taste and smell;
• gastrointestinal disorders, such as: nausea, vomiting, diarrhea, constipation, abdominal pain (which may be alleviated by taking the medicine with food);
• urinary retention;
• dryness and dryness of the nasal and pharyngeal mucosa;
• increased sweating;
• blurred or double vision.

Uncommon(occur in 1 to 10 people out of 1,000) or rare(occur in 1 to 10 people out of 10,000):

• nervous stimulation (manifested by anxiety, insomnia, hallucinations, palpitations, nervousness, and seizures);
• chest tightness, wheezing;
• rapid or irregular heart rate (usually in case of overdose);
• liver function disorders (which may manifest as abdominal pain or liver tenderness and dark urine);
• photosensitivity;
• cross-allergy to chlorphenamine-like drugs;
• blood morphology changes (such as agranulocytosis, leukopenia, aplastic anemia, or thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue;
• decreased or increased blood pressure;
• edema (swelling);
• tinnitus, acute labyrinthitis (a part of the ear);
• impotence;
• intermenstrual bleeding.

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

• allergic skin rash (skin eruptions);
• jaundice (yellowing of the skin);
• hypoglycemia (low blood sugar levels);
• myocardial infarction;
• ventricular arrhythmias (heart rhythm disorders);
• pulmonary edema;
• intracranial hemorrhage;
• hypersensitivity reactions (pruritic urticarial rash, angioedema, anaphylactoid reactions);
• abdominal pain, nausea, vomiting, diarrhea;
• low neutrophil count (neutropenia).

Paracetamol may cause liver damage in case of high doses or prolonged treatment.
Unknown frequency(frequency cannot be determined based on available data):

• anxiety, weakness, hypertension (high blood pressure), headaches, dizziness;
• chest pain or discomfort;
• severe bradycardia (very slow heart rate);
• vasoconstriction, increased cardiac workload (affecting patients with heart disease);
• breathing difficulties;
• pallor;
• hair loss;
• decreased potassium levels in the blood;
• cold extremities (feet or hands);
• hypotension (low blood pressure);
• increased liver enzyme levels, increased bilirubin levels;
• a serious condition that can cause blood acidification (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

When taking high doses, the following may occur: palpitations, psychotic states with hallucinations.
With prolonged use of the medicine, a deficiency of circulating blood volume may develop.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Sinumedin Tabs

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the blister pack and carton after EXP. The expiration date refers to the last day of the month.
Store at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. 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). One coated tablet contains: 650 mg of paracetamol, 10 mg of phenylephrine hydrochloride, and 4 mg of chlorphenamine maleate.
• Other ingredients are: tablet core: povidone 30, croscarmellose sodium, magnesium stearate, Prosolv Easy tab SP: microcrystalline cellulose, anhydrous colloidal silica, sodium stearyl fumarate, sodium carboxymethylcellulose (type A), tablet coating: hypromellose, hydroxypropylcellulose, brown HT (E 155), sunset yellow FCF (E 110), Capol 1295 (white wax and carnauba wax).

What Sinumedin Tabs looks like and contents of the pack

Sinumedin Tabs are oblong, biconvex, coated tablets, brown in color.
The packaging contains 6, 10, or 20 tablets. The blisters are packed in a cardboard box with a patient leaflet.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka 133/151
95-200 Pabianice
Phone: +48 42 22-53-100

Manufacturer

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

Date of the last revision of the leaflet: