TABCIN 250 mg/30 mg /2 Mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the User
2. TABCIN TREND
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Tabcin Trend and what is it used for
   1. Indications
4. Important information before taking Tabcin Trend
   1. When not to take Tabcin Trend
   2. Warnings and precautions
   3. Tabcin Trend and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
   6. Tabcin Trend contains propylene glycol and sorbitol
5. How to take Tabcin Trend
   1. Taking a higher dose of Tabcin Trend than recommended
   2. Missing a dose of Tabcin Trend
6. Possible side effects
   1. Reporting side effects
7. How to store Tabcin Trend
8. Contents of the pack and other information
   1. What Tabcin Trend contains
   2. What Tabcin Trend looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Package Leaflet: Information for the User

TABCIN TREND

250 mg + 30 mg +2 mg, soft capsules
Paracetamol + Pseudoephedrine hydrochloride + Chlorpheniramine maleate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 days there is no improvement or if the fever persists for more than 3 days from the start of taking the medicine, or if you feel worse, contact a doctor.

Table of Contents of the Package Leaflet

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

1. What is Tabcin Trend and what is it used for

Tabcin Trend is a combination medicine with a synergistic effect of its components.
Chlorpheniramine, an antihistamine, relieves symptoms of rhinitis (cold and sneezing) in the course of flu and colds.
Pseudoephedrine, a vasoconstrictor, reduces swelling of the nasal mucosa and sinuses in the course of a cold and flu, thereby facilitating breathing.
Paracetamol, a substance with analgesic and antipyretic effects, relieves pains accompanying infections, such as headache, sore throat, and general discomfort accompanying flu and colds.

Indications

Relieving symptoms of flu and colds accompanied by fever, runny nose, sore throat, and cough, sneezing, headache, swelling of the nasal mucosa and sinuses, and a feeling of general malaise.

2. Important information before taking Tabcin Trend

When not to take Tabcin Trend

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if you have a respiratory disease, such as chronic bronchitis or emphysema;
• if you have glaucoma, prostatic hyperplasia, heart disease, hypertension, diabetes, or hyperthyroidism;
• if you have been diagnosed with a congenital deficiency of glucose-6-phosphate dehydrogenase;
• if you are taking or have taken within the last 2 weeks monoamine oxidase inhibitors (MAOIs) or are taking AZT (zidovudine). If in doubt whether the medicine you are taking contains MAOIs or AZT, consult a doctor;
• if you have severe liver failure (Child-Pugh > 9);
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension;
• if you have severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• in children under 15 years of age.

Warnings and precautions

Do not take other medicines containing paracetamol and/or sympathomimetics (such as decongestants, appetite suppressants, or psychostimulants with an amphetamine-like effect) at the same time.
In case of overdose, contact a doctor immediately, even if no symptoms have occurred, as this may lead to life-threatening liver damage.
Before taking Tabcin Trend, discuss it with your doctor or pharmacist if:

• you abuse alcohol. In such cases, taking paracetamol even in small doses may increase the risk of liver damage;
• you have liver failure (Child-Pugh <9), viral hepatitis, or other liver diseases. For these patients, during high-dose or long-term treatment, the doctor will recommend regular liver function tests. Long-term use of paracetamol may lead to severe liver failure (e.g., liver cirrhosis). During therapeutic doses of paracetamol, an increase in alanine aminotransferase (ALT) levels in serum may occur;
• you have kidney disease, as dose adjustment may be necessary. In patients with severe kidney failure (creatinine clearance <10 ml min), the doctor should assess benefit-risk ratio of using paracetamol. long-term use paracetamol with other painkillers may lead to permanent kidney damage and an increased risk failure;< li>
• you are taking other medicines, abusing alcohol, have sepsis, or diabetes;
• you have a hereditary deficiency of glucose-6-phosphate dehydrogenase, as there is a risk of hemolytic anemia (accelerated breakdown of red blood cells);
• you have liver failure (e.g., due to alcohol abuse or jaundice) or Gilbert's syndrome (a congenital hyperbilirubinemia). Patients should consult a doctor before taking the medicine, who may decide to reduce the dose or extend the time between doses.

Contact a doctor immediately if:

• you have a severe sore throat that does not improve within 2 days, is accompanied by fever, headache, rash, nausea, or vomiting;
• you experience skin redness, blisters on the mouth, eyes, or oral cavity, or skin peeling;
• you have a fever with generalized skin rash and pustular rash. You should then stop taking the medicine. See section 4;
• you are taking alcohol or sedatives while taking the medicine, as it may cause drowsiness, and alcohol and sedatives may enhance this effect;
• you experience gastrointestinal symptoms such as sudden abdominal pain or rectal bleeding due to inflammatory bowel disease (ischemic colitis). You should then stop taking the medicine. See section 4;
• you experience sudden vision loss due to decreased blood flow in the optic nerve. You should then stop taking the medicine. See section 4;
• you have severe diseases, including severe kidney or liver dysfunction, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or are taking flucloxacillin (an antibiotic). There have been reports of a severe disease called metabolic acidosis (a blood and fluid disorder) in patients taking paracetamol regularly for a long time or taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

After taking pseudoephedrine-containing medicines, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported.
PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain.
If symptoms occur that may be symptoms of PRES or RCVS, you should immediately stop taking Tabcin Trend and seek medical help (symptoms, see section 4 "Possible side effects").

Tabcin Trend and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

• The medicine should not be taken with monoamine oxidase inhibitors (MAOIs) during treatment with them or for at least 2 weeks after stopping treatment. Monoamine oxidase inhibitors (substances found in many psychiatric medicines - in the course of depression, Parkinson's disease, and others) enhance the effects of chlorpheniramine and pseudoephedrine.
• Medicines that delay gastric emptying, such as propanteline, may slow down the absorption of paracetamol (one of the active substances of Tabcin Trend) and delay its effect. Medicines that accelerate gastric emptying, such as metoclopramide, increase the absorption of Tabcin Trend.
• Concomitant administration of liver enzyme-inducing drugs, such as sedatives and antiepileptics (glutethimide, phenobarbital, phenytoin, carbamazepine), or rifampicin may lead to liver failure even when taking paracetamol doses that do not normally cause such effects. A similar effect may occur after alcohol consumption.
• The interaction between paracetamol and warfarin or coumarin is not yet known. Therefore, patients taking oral anticoagulants should not take paracetamol for a long time without consulting a doctor.
• Taking the medicine with chloramphenicol may prolong the effect of chloramphenicol.
• Concomitant administration of paracetamol and AZT (zidovudine) may cause a decrease in the number of white blood cells (neutropenia).
• Concomitant use of paracetamol and flucloxacillin (an antibiotic) is associated with a serious risk of a blood and fluid disorder (called metabolic acidosis), which requires urgent treatment (see section 2).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Tabcin Trend during pregnancy, especially in the first trimester.
Do not take Tabcin Trend during pregnancy due to the lack of data on the safety of its use during this period.
Breastfeeding
The ingredients of the medicine pass into breast milk, so do not take the medicine during breastfeeding.
Fertility
Paracetamol may affect fertility. This effect is reversible after stopping paracetamol.

Driving and using machines

Do not drive vehicles, as the medicine may impair psychophysical fitness.
Do not operate any machinery and use hazardous tools.

Tabcin Trend contains propylene glycol and sorbitol

The medicine contains 46 mg of propylene glycol in each capsule.
The medicine contains 54.88 - 64.42 mg of sorbitol in each capsule. Sorbitol is a source of fructose. If you have previously been diagnosed with intolerance to some sugars or have previously been diagnosed with hereditary fructose intolerance, a rare genetic disease in which the patient's body does not break down fructose, you should consult a doctor before taking the medicine.

3. How to take Tabcin Trend

Always take this medicine exactly as described in the package leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and adolescents (15 years and older)
Recommended dose
Take two capsules with a small amount of water.
If necessary, the above dose can be repeated but not more than every 4 hours or more than 3 times in 24 hours.
Do not exceed the recommended dose due to possible difficulties in falling asleep, dizziness, and increased nervous excitability (especially in children).
Do not take the medicine for more than 5 days. If the fever persists for more than 3 days from the start of taking the medicine, consult a doctor.
If you feel that the effect of the medicine is too strong or too weak, consult a doctor.

Taking a higher dose of Tabcin Trend than recommended

The following symptoms may occur: nausea, vomiting, dizziness, drowsiness, coma, fear, tremors, hallucinations, agitation with seizures, breathing problems, difficulties with urination. The following may occur: increased blood pressure, irregular heartbeat with a frequency of over 100/min (tachyarrhythmia), palpitations, restlessness, insomnia.
In children, dry mouth, facial flushing, agitation, dilated fixed pupils, fever, uncontrolled movements, and seizures are observed.
The first symptoms of paracetamol overdose are: nausea, vomiting, increased sweating, general malaise; after 3-5 days, jaundice, fever, hemorrhagic syndrome, hypoglycemia (low blood sugar), metabolic acidosis, including lactic acidosis (decreased blood pH), hypokalemia (decreased potassium levels in the blood), liver odor, hepatic encephalopathy (brain function disorders due to liver failure).
Treatment: symptomatic, including gastric lavage and administration of activated charcoal within the first 6 hours of taking the medicine. Hemodialysis and hemoperfusion support the elimination of the medicine. The doctor may prescribe intravenous administration of methionine, cystamine, or N-acetylcysteine, which are specific antidotes in case of paracetamol overdose; their administration is recommended within 10 hours of poisoning.
If you have taken a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately. Providing prompt assistance is crucial for both children and adults, even if no symptoms of poisoning have been observed yet.

Missing a dose of Tabcin Trend

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects occur with an unknown frequency (frequency cannot be estimated from the available data), unless otherwise stated.

• severe vascular disorders of the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

Stop taking Tabcin Trend immediately and seek medical help if you experience symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), including:

• sudden severe headache,
• nausea,
• vomiting,
• confusion,
• seizures,
• vision changes.

Immediatelystop taking the medicine and consult a doctor if you experience:

• allergic reactions (rarely reported), such as: skin rash or itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat, or face (allergic edema and angioedema), increased sweating, nausea, drop in blood pressure, or shock;
• breathing difficulties (bronchospasm), in patients allergic to painkillers and anti-rheumatic drugs, e.g., acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, may sometimes experience an exacerbation of asthma symptoms ("analgesic asthma");
• skin rash or severe skin reaction (in the case of paracetamol, very rare, i.e., less than 1 in 10,000 patients): acute generalized exanthematous pustulosis (AGEP), characterized by sudden fever, skin redness, or numerous small pustules, which may occur within the first 2 days of taking Tabcin Trend. See section 2; Stevens-Johnson syndrome, characterized by blisters and erosions on the skin, mouth, eyes, and genitals, fever, and joint pain; toxic epidermal necrolysis (potentially fatal) characterized by bursting giant blisters under the skin, extensive erosions on the skin, shedding of large skin flakes, and fever; drug rash; erythema multiforme; acute generalized exanthematous pustulosis; erythema; very rarely, allergic reactions with inflammatory skin changes; rash; itching; urticaria;
• bleeding (due to a decrease in platelet count),
• seizures
• inflammatory bowel disease (ischemic colitis) (see section 2),
• liver function disorders (nausea, vomiting, abdominal distension, yellowing of the skin and eyes, liver tenderness due to liver failure, hepatitis, as well as dose-dependent liver failure, liver necrosis - potentially fatal);
• heart rate and rhythm disorders (reflex bradycardia, hypertension, tachycardia, palpitations);
• blood disorders, such as: decreased granulocyte count - a type of white blood cell (agranulocytosis), leading to a tendency to infections, decreased count of all blood cells - pancytopenia, decreased platelet count (thrombocytopenia) leading to decreased blood clotting, bruising, and petechiae, decreased white blood cell count (leukopenia) associated with paracetamol use, aplastic anemia (significant decrease in blood cell count, due to bone marrow disorders, which can cause weakness, easy bruising, or a tendency to infections);
• kidney damage, especially in case of overdose, difficulties with urination,
• decreased blood flow in the optic nerve (ischemic optic neuropathy), see section 2;
• a serious condition that can make the blood more acidic (metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Tabcin Trend may also cause the following side effects: drowsiness, dry mouth, agitation, restlessness, dizziness, insomnia, fear, tremors, hallucinations, nausea, vomiting, stomach upset, diarrhea, abdominal pain, headaches.
Long-term uncontrolled use of the medicine may lead to liver fibrosis, cirrhosis, and even death.
In some people, during the use of Tabcin Trend, other side effects may occur.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Tabcin Trend

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Medicines should 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 pack and other information

What Tabcin Trend contains

• The active substances of the medicine are:

250 mg of paracetamol (Paracetamolum),30 mg of pseudoephedrine hydrochloride (Pseudoephedrini hydrochloridum)and 2 mg of chlorpheniramine maleate (Chlorpheniramini maleas).

• The other ingredients (excipients) are: polyethylene glycol 400, propylene glycol, purified water, povidone K30; capsule shell: sorbitol 70%, glycerol 85%, gelatin, koschenille red A (E124), brilliant blue FCF (E 133).

What Tabcin Trend looks like and contents of the pack

The pack contains 6, 12, 20, or 24 soft capsules.

Marketing authorization holder

Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw
Tel.: +48 22 572 35 00

Manufacturer

Catalent Germany Eberbach GmbH
Gammelsbacher Str. 2

• D - 69412 Eberbach, Germany

Date of last revision of the leaflet:01/2025