Flucontrol Max

Leaflet attached to the packaging: patient information

FluControl MAX650 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 advised 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 those 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 persist 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 is FluControl Max and what is it used for
• 2. Important information before taking FluControl Max
• 3. How to take FluControl Max
• 4. Possible side effects
• 5. How to store FluControl Max
• 6. Contents of the pack and other information

1. What is FluControl Max and what is it used for

FluControl Max is a combination of paracetamol - an antipyretic and analgesic substance,
chlorphenamine - an antihistamine substance that reduces nasal discharge, and
phenylephrine, which reduces swelling of the nasal mucosa.

Indications for use

Symptomatic treatment of colds and flu, accompanied by fever, mild or moderate pain, and swelling of the nasal mucosa with discharge formation.
If a fever persists for more than 3 days of treatment, and no improvement occurs after 5 days, or if the patient feels worse, a doctor should be consulted.

2. Important information before taking FluControl Max

When not to take FluControl Max

• 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 hypertension;
• 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 disturbances;
• 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 other conditions) and for 2 weeks after their discontinuation;
• in children under 12 years of age;
• in pregnant or breastfeeding women.

Warnings and precautions

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

• are allergic to antihistamines, as they may also be allergic to chlorphenamine;
• have heart disease (should avoid long-term treatment with paracetamol);
• 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, congenital glucose-6-phosphate dehydrogenase deficiency (G6PD) (may lead to methemoglobinemia and hemolytic anemia), and methemoglobin reductase deficiency;
• are taking tricyclic antidepressants or other drugs with similar effects, and gastrointestinal symptoms occur, as these may be due to life-threatening paralytic ileus (cessation of intestinal movements that propel food through the digestive system);
• are at increased risk of liver damage due to paracetamol use: o taking carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort, or other liver enzyme-inducing drugs; o having appetite disorders, being infected with HIV, being dehydrated, starved, or emaciated; o regularly consuming alcohol (three or more alcoholic beverages daily). In alcoholics, paracetamol should not be taken in doses exceeding 2 g per day; o having liver disease (including Gilbert's syndrome);
• are taking blood pressure-lowering medications;
• are sensitive to the effects of sedatives or have epilepsy, as interactions with medications used to treat these conditions may occur. Caution should be exercised in patients with asthma, hypersensitivity to acetylsalicylic acid, and other nonsteroidal anti-inflammatory drugs, as bronchospasm has been observed in less than 5% of patients after paracetamol administration. 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.

During FluControl Max treatment, the doctor should be informed immediately if:

• the patient has severe diseases, including severe kidney or liver dysfunction, sepsis (when bacteria and their toxins are present in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or is taking flucloxacillin (an antibiotic). In these situations, patients have developed a severe condition called metabolic acidosis (a blood and body fluid disorder), which requires emergency treatment, when they took paracetamol in regular doses for an extended period or took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea (nausea) and vomiting.

Children

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

Elderly

Not to be used in elderly patients 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 excitement, dry mouth, and urinary retention.

FluControl Max and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The medicine should not be taken with other medicines containing:

• paracetamol (the active substance found in many cold and flu medicines), as paracetamol overdose may occur;
• phenylephrine (sympathomimetic drugs - decongestants, appetite suppressants, or psychostimulants with effects similar to amphetamines, used in the symptomatic treatment of rhinitis);
• antihistamines;
• monoamine oxidase inhibitors (MAOIs) (drugs used, among others, in the treatment of depression and Parkinson's disease). FluControl Max should not be taken for at least 15 days after discontinuation of these drugs;
• tricyclic or tetracyclic antidepressants.

Due to the presence of paracetamol
If the patient is taking any of the following medicines, a dose change or treatment interruption may be necessary:

• 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 blood cholesterol levels);
• 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 patient should inform their doctor or pharmacist if they are taking:

• flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (metabolic acidosis), which require emergency treatment (see section 2).

Due to the presence of phenylephrine
If the patient is taking any of the following medicines, treatment interruption or delayed administration may be necessary:

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

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

• drugs that cause central nervous system depression (such as drugs used to treat insomnia or anxiety).

Taking FluControl Max with food, drink, and alcohol

Taking paracetamol in patients who regularly consume alcohol (three or more alcoholic beverages

• daily) may lead to liver damage. During FluControl Max treatment, alcohol should not be consumed, as it may cause symptoms of chlorphenamine overdose, such as increased sedation.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Taking medicines during pregnancy may be harmful to the fetus.
FluControl Max is contraindicated during pregnancy.
Breastfeeding
Paracetamol and chlorphenamine pass into breast milk. The medicine 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 machines.

The medicine contains caramelloso, brown HT, and sodium

Caramelloso and brown HT

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, which means it is considered "sodium-free".

Effect on laboratory tests

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 FluControl Max, as the medicine may affect laboratory test results.

3. How to take FluControl Max

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
Method of administration
The medicine is for oral use.
Recommended dose
Adults and children over 12 years: one tablet, which can be repeated if necessary, but not more frequently than every 4-6 hours.
Not more than 6 tablets should be taken in 24 hours (corresponding to 3900 mg of paracetamol, 60 mg of phenylephrine, and 24 mg of chlorphenamine).
Duration of treatment
Treatment with FluControl Max should be stopped when pain or fever subsides.
If a fever persists for more than 3 days of treatment, pain or other symptoms persist for more than 5 days, or if symptoms worsen or new ones appear, a doctor should be consulted.
Patients with kidney or liver disease
Medical advice should be sought before taking the medicine.
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.

Taking a higher dose of FluControl Max than recommended

If an overdose has occurred, a doctor should be consulted immediately, as symptoms often appear after three days of ingestion, even in cases of severe poisoning.
Symptoms of overdose
Caused by paracetamol:
nausea, vomiting, loss of appetite, pallor, abdominal pain, usually occurring 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 lead to: coagulation disorders (blood clotting and bleeding).
In case of overdose, medical advice should be sought immediately, even if no symptoms occur.
Treatment of paracetamol overdose is more effective when 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, excitement, 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 (with cerebral hemorrhage, pulmonary edema), heart rhythm disturbances, palpitations, vasoconstriction with possible reduced blood flow to vital organs.
The occurrence of severe symptoms is more likely 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), paresthesia (tingling and burning 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), heart rhythm disturbances (irregular or rapid heart rate), hallucinations, seizures, insomnia, hypotension (low blood pressure - fainting) - may occur late.
In cases of chlorphenamine and phenylephrine overdose, symptomatic and supportive treatment is used.
In case of overdose or accidental use of the medicine, a doctor should be consulted immediately.

Missing a dose of FluControl Max

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

4. Possible side effects

Like all medicines, FluControl Max can cause side effects, although not everybody gets them.

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

• allergic reactions (cough, difficulty swallowing, rapid heart rate, itching, swelling of the eyelids or eyes, face, tongue, dyspnea), occurring not very often or rarely;
• 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, occurring rarely;
• Stevens-Johnson syndrome (blisters on the skin and/or mucous membranes that form painful sores after rupture, often accompanied by fever, muscle and joint pain), occurring with unknown frequency;
• bronchospasm, occurring with unknown frequency;
• kidney failure (reduced urine output, edema, dyspnea, loss of appetite, nausea, vomiting, diarrhea, skin itching, small petechiae on the skin), occurring with unknown frequency;
• liver failure (nausea, vomiting, abdominal distension, jaundice, liver tenderness), occurring with unknown frequency;
• metabolic acidosis (deepened, accelerated, and difficult breathing, nausea, vomiting, loss of appetite), occurring with unknown frequency;
• pulmonary edema (rapidly progressing dyspnea, sometimes with audible gurgling, crackling, or wheezing in the lungs, cough, sometimes with expectoration of yellowish discharge tinged with blood), occurring rarely.

In patients taking FluControl Max, the following side effects may occur:
Frequently(occurring 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, changes in sensation and hearing;
• dry mouth, loss of appetite, changes in taste and smell;
• gastrointestinal disorders such as: nausea, vomiting, diarrhea, constipation, abdominal pain (which may decrease when the medicine is taken with food);
• urinary retention;
• dryness and dryness of the nasal and pharyngeal mucosa;
• increased sweating;
• blurred and double vision.

Not very often(occurring in 1 to 10 people out of 1,000) or rarely(occurring in 1 to 10 people out of 10,000)

• nervous excitement (manifested by anxiety, insomnia, 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 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.

Rarely(occurring in 1 to 10 people out of 10,000)

• allergic skin inflammation (skin rashes);
• jaundice (yellowing of the skin);
• hypoglycemia (low blood sugar);
• myocardial infarction;
• ventricular arrhythmias (heart rhythm disturbances);
• pulmonary edema;
• cerebral hemorrhage;
• hypersensitivity reactions (pruritic urticarial papules, angioedema, laryngeal edema, anaphylactoid reactions);
• abdominal pain, nausea, vomiting, diarrhea.

Paracetamol may cause liver damage in case of high doses or prolonged treatment.

Unknown frequency (frequency cannot be estimated from 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 especially elderly patients or those with cerebral or coronary circulation disorders). It is possible to induce or exacerbate heart disease, breathing difficulties;
• pallor;
• hair loss;
• decreased potassium levels in the blood;
• cold limbs (feet or hands);
• elevated liver enzyme levels, elevated bilirubin levels;
• a serious condition that can cause blood acidification (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, and in case of prolonged use, hypovolemia 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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store FluControl Max

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month.
EXP - means expiry date
Lot - means batch number
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 pack and other information

What FluControl Max contains

• The active substances of the medicine are: paracetamol, phenylephrine hydrochloride, and chlorphenamine maleate. One tablet contains: 650 mg of paracetamol (Paracetamolum),10 mg of phenylephrine hydrochloride (Phenylephrini hydrochloridum),4 mg of chlorphenamine maleate (Chlorphenamini maleas).
• Other ingredients are: tablet core: povidone K 30, sodium croscarmellose, magnesium stearate, Prosolv Easy tab SP: microcrystalline cellulose, anhydrous colloidal silica, sodium stearylfumarate, sodium carboxymethylcellulose A, tablet coating: hypromellose, hydroxypropylcellulose, brown HT (E155), caramelloso (E124), Capol 1295 (white wax + carnauba wax).

What FluControl Max looks like and what the pack contains

FluControl Max is a biconvex, bean-shaped, coated tablet with a reddish-brown color.
The pack contains 6, 10, or 20 tablets. The blisters are packaged in a cardboard box with a leaflet.

Marketing authorization holder

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

Manufacturer

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

Date of the last leaflet update: