Flucontrol Hot

Package Leaflet: Information for the Patient

FluControl Hot(1000 mg + 10 mg + 4 mg)/sachet, powder for oral solution preparation
Paracetamol + Phenylephrine hydrochloride + Chlorphenamine 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 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact a doctor.

Table of Contents of the Leaflet

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

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

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

Indications for use

Symptomatic treatment of colds and flu with fever, mild or moderate pain, nasal mucosa swelling with discharge formation.

2. Important information before taking FluControl Hot

When not to take FluControl Hot

• if the patient is allergic to paracetamol, phenylephrine hydrochloride, and chlorphenamine maleate or any other component of this medicine (listed in section 6);
• if the patient has liver failure or viral hepatitis;
• if the patient has hypertension;
• if the patient has hyperthyroidism;
• if the patient has severe heart or vascular disease (e.g., coronary artery disease or angina pectoris);
• if the patient has tachycardia (rapid heart rate);
• 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;
• if the patient has glaucoma (characterized by increased intraocular pressure);
• if the patient has severe renal impairment;
• in children under 12 years of age;
• in pregnant or breastfeeding women.

Warnings and precautions

The medicine contains paracetamol. Due to the risk of overdose, it should be checked if other medications being taken contain paracetamol. Concurrent use of FluControl Hot and paracetamol-containing medications may lead to overdose.
Before starting FluControl Hot, the patient should discuss it with their doctor or pharmacist:

• if the patient has kidney, heart, or lung disease;
• if the patient has anemia;
• if the patient has asthma and is allergic to acetylsalicylic acid;
• if the patient is allergic to antihistamines and other medications (such as chlorphenamine);
• if the patient is sensitive to the effects of sedatives;
• if the patient has epilepsy;
• if the patient has: prostate enlargement, diabetes, asthma, very slow heart rate, hypotension (low blood pressure), or atherosclerosis of cerebral vessels, pancreatitis, active peptic ulcer disease (gastric ulcer), narrowing of the pyloric and duodenal junction (between the stomach and intestine), thyroid diseases;
• if patients treated with tricyclic antidepressants or other similar-acting medications experience gastrointestinal disturbances. These disturbances may be due to the development of paralytic ileus (cessation of intestinal peristalsis, which moves food through the digestive system).
• Alcoholics should exercise caution and not take more than 2 sachets of FluControl Hot (2 grams of paracetamol) per day, as paracetamol may cause liver damage;
• in case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (may lead to methemoglobinemia and hemolytic anemia).

During FluControl Hot treatment, the patient should immediately inform their doctor if:

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

Children

Do not use in children under 12 years of age due to the paracetamol dose and the presence of other active substances.

FluControl Hot and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

The medicine should not be used concurrently with other medications containing:

• paracetamol (an active substance found in many cold and flu medications), as paracetamol overdose may occur;
• phenylephrine (sympathomimetic medications used for symptomatic treatment of nasal mucosa inflammation, i.e., colds);
• monoamine oxidase inhibitors (MAOIs) (medications used, among others, for depression and Parkinson's disease treatment). FluControl Hot should be discontinued at least 15 days after completing treatment with these medications.

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

• antibiotics (chloramphenicol);
• oral anticoagulants (acenocoumarol, warfarin);
• oral contraceptives and estrogen therapy;
• antiepileptic medications (lamotrigine, phenytoin, and other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine);
• antituberculosis medications (isoniazid, rifampicin);
• barbiturates (used as general anesthetics, sedatives, and anticonvulsants);
• activated charcoal (adsorbent);
• cholestyramine (used to reduce blood cholesterol levels);
• medications used to treat gout (probenecid and sulfinpyrazone);
• certain diuretics (loop diuretics, e.g., furosemide);
• medications used to relieve spasms or cramps of the stomach, intestines, and urinary bladder (anticholinergic medications, such as glycopyrrolate, propantheline);
• cardiac glycosides (digitalis glycosides);
• medications used to treat nausea and vomiting (metoclopramide and domperidone);
• propranolol used to treat high blood pressure and heart rhythm disorders (arrhythmias);
• zidovudine (used to treat HIV infections).

The patient should inform their doctor or pharmacist if they are taking:

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

Due to the presence of phenylephrine
If the patient is taking any of the following medications, treatment interruption may be necessary:

• alpha-adrenergic receptor blockers (medications used to treat migraines, induce labor, lower blood pressure, or treat other conditions);
• beta-adrenergic receptor blockers (medications that lower blood pressure);
• tricyclic or tetracyclic antidepressants (amitriptyline, amoxapine, clomipramine, desipramine, doxepin, and maprotiline);
• inhalational anesthetics;
• antihypertensive medications (lowering blood pressure, acting through the sympathetic nervous system, such as methyldopa, guanethidine);
• potassium-losing diuretics (diuretics used to treat hypertension and other conditions, e.g., furosemide);
• medications affecting heart conduction (used in heart conditions), such as digitalis glycosides and antiarrhythmic medications;
• thyroid hormones;
• medications blocking both alpha and beta adrenergic receptors, such as labetalol and carvedilol (used in heart and vascular conditions);
• atropine sulfate (used in heart and digestive system conditions).

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

• medications causing central nervous system depression (used to treat insomnia or anxiety);
• ototoxic medications (which may cause hearing loss as a side effect);
• photosensitizing medications (which may cause light allergy as a side effect).

FluControl Hot with food, drink, and alcohol

Using paracetamol in patients who regularly drink alcohol (three or more alcoholic beverages per day) may lead to liver damage.
During FluControl Hot treatment, the patient should not drink alcohol, as it may cause overdose symptoms, such as increased sedative effects.

Using FluControl Hot in the elderly

Do not use in elderly patients without consulting a doctor.
Due to the presence of phenylephrine and chlorphenamine, elderly patients may be more likely to 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.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
FluControl Hot is contraindicated during pregnancy.
Breastfeeding
Paracetamol and chlorphenamine pass into breast milk, so breastfeeding women should not take this medicine. 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 machinery.
FluControl Hot contains sucrose, sulfites, sodium, citral, citronellol, d-limonene, geraniol, linalol

Sucrose

The medicine contains 3.994 grams of sucrose per sachet. This should be considered in patients with diabetes.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.

Sulfites

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Sodium

The medicine contains 20.1 milligrams of sodium per sachet.
The medicine contains 80.4 milligrams of sodium (the main component of table salt) in 4 sachets. This corresponds to 4.02% of the maximum recommended daily sodium intake in the diet for adults.
Effect on laboratory test results
Before performing laboratory tests (blood tests, urine tests, skin tests using allergens, etc.), the patient should inform their doctor that they are taking FluControl Hot, as it may affect the results of some tests (e.g., glucose or uric acid levels in the blood).

3. How to take FluControl Hot

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Take orally.
Recommended dose
Adults and adolescents over 12 years: one sachet, but not more frequently than every 6-8 hours (3 or 4 times a day).
Do not take more than 4 sachets in 24 hours (corresponding to 4000 mg of paracetamol, 40 mg of phenylephrine, and 16 mg of chlorphenamine).
If pain or fever subsides, FluControl Hot treatment should be discontinued.
Administration method
Dissolve the sachet contents in a small amount of liquid, preferably in half a glass of water.
If fever persists for more than 3 days of treatment, pain, or other symptoms persist for more than 5 days, or symptoms worsen or new ones appear, the patient should consult their doctor. Taking the medicine depends on the presence of pain or fever symptoms. If they subside, the patient should stop taking the medicine.
Use the smallest effective dose. Do not exceed the recommended dose.
Patients with renal or hepatic impairment
FluControl Hot should not be used in patients with liver disease and severe renal impairment.
Use in children
FluControl Hot 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 FluControl Hot

If an overdose occurs, the patient should immediately consult their doctor, as symptoms often appear after 3 days of ingestion, 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 lead to: coagulation disorders (blood clotting and bleeding).
In case of overdose, the patient should immediately consult their doctor, 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 (with cerebral hemorrhage, pulmonary edema), cardiac arrhythmias, 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), cardiac arrhythmias (irregular or rapid heart rate), hallucinations, seizures, insomnia, hypotension (low blood pressure - feeling of fainting) - may occur late.
In case of chlorphenamine and phenylephrine overdose, symptomatic and supportive treatment is used.

In case of overdose or accidental use of the medicine, the patient should immediately consult their doctor.

Missing a dose of FluControl Hot

A missed dose should be taken as soon as possible. A double dose should not be taken to make up for a missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, FluControl Hot can cause side effects, although not everybody gets them.
The following side effects may occur:

Common (occurring in 1 to 10 people out of 100):

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

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

• nervous system stimulation (manifested by anxiety, insomnia, hallucinations, palpitations, nervousness, and seizures); - chest tightness, wheezing;
• rapid or irregular heart rate (usually due to overdose);
• liver function disorders (which may manifest as abdominal pain or dark urine);
• allergic reactions, severe allergic reactions (cough, swallowing difficulties, rapid heart rate, itching, swelling of the eyelids or eyes, face, tongue, dyspnea);
• photosensitivity;
• cross-allergy to medications similar to chlorphenamine;
• 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 (occurring in 1 to 10 people out of 10,000):

• kidney function disorders, cloudy urine;
• allergic skin inflammation (skin rashes);
• jaundice (yellow skin discoloration);
• hypoglycemia (low blood sugar levels);
• myocardial infarction;
• ventricular arrhythmias (heart rhythm disorders);
• pulmonary edema;
• cerebral hemorrhage;
• neutropenia, hemolytic anemia. Paracetamol may cause liver damage in case of high doses or prolonged treatment.

Frequency not known (frequency cannot be estimated from available data):

• anxiety, weakness, hypertension (high blood pressure), headaches;
• irritability;
• chest pain or discomfort;
• severe bradycardia (very slow heart rate);
• vasoconstriction, increased cardiac workload (affecting patients with advanced age or those with cerebral or coronary circulation disorders). This may cause or worsen heart disease;
• breathing difficulties;
• pallor;
• hair loss;
• hyperglycemia (high blood sugar levels);
• decreased potassium levels in the blood;
• cold extremities (feet or hands);
• flushing;
• liver failure;
• kidney failure;
• dyspnea;
• hypersensitivity reaction, hepatic encephalopathy;
• 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: vomiting, palpitations, psychotic states with hallucinations, and with prolonged use, hypovolemia may develop.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 FluControl Hot

The medicine should be stored out of sight and reach of children.
Store in the original packaging, at a temperature below 30°C.
Do not use this medicine after the expiration date stated on the sachet and carton. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What FluControl Hot contains

• The active substances of the medicine are: paracetamol, phenylephrine hydrochloride, and chlorphenamine maleate.
• Other ingredients are: colloidal anhydrous silica, citric acid (E 330), sodium saccharin (E 954), sucrose, sodium cyclamate (E 952), orange flavor PHS-003270 (contains, among others, sulfites, citral, citronellol, d-limonene, geraniol, linalol).

What FluControl Hot looks like and contents of the pack

FluControl Hot is a powder for oral solution preparation in a sachet.
One pack contains 4, 8, or 10 sachets.

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: