Gripex Hot Max

Leaflet attached to the packaging: patient information

Gripex Hot Max

(1000 mg + 100 mg + 12.2 mg)/sachet, powder for oral solution preparation
(Paracetamol + Ascorbic Acid + Phenylephrine Hydrochloride)

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

This medicine should always be used exactly as described in the 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 any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 to 5 days, they should contact their doctor.

Table of contents of the leaflet

1. What is Gripex Hot Max and what is it used for

2. Important information before taking Gripex Hot Max

3. How to take Gripex Hot Max

4. Possible side effects

5. How to store Gripex Hot Max

6. Contents of the packaging and other information

1. WHAT IS GRIPex Hot Max AND WHAT IS IT USED FOR

Gripex Hot Max, a powder for oral solution preparation, is a multi-component medicine with antipyretic, analgesic, and nasal decongestant effects. It alleviates severe symptoms of colds and flu.
The indication for use is the short-term alleviation of severe symptoms of colds, flu, and flu-like infections, such as fever, headaches, sore throats, muscle and bone pain, and symptoms of nasal congestion.
If there is no improvement or the patient feels worse after 3 to 5 days, they should consult a doctor.

2. IMPORTANT INFORMATION BEFORE TAKING GRIPex Hot Max

When not to take Gripex Hot Max

• If the patient is allergic to the active substances or sympathomimetic amines or to any of the other components of this medicine (listed in section 6).
• If the following conditions occur:
• unstable coronary artery disease,
• heart rhythm disorders,
• high blood pressure,
• congenital glucose-6-phosphate dehydrogenase deficiency and methemoglobin reductase deficiency,
• severe liver or kidney failure,
• viral hepatitis,
• alcoholic disease,
• phenylketonuria,
• glaucoma with a narrow angle of filtration,
• hyperthyroidism.
• During the use of MAO inhibitor drugs and for up to 2 weeks after stopping these drugs.
• In combination with tricyclic antidepressant drugs.
• During the administration of zidovudine (a drug used to treat HIV infection).
• In children under 12 years of age.
• During pregnancy.

Warnings and precautions

Before starting Gripex Hot Max, the patient should discuss it with their doctor or pharmacist.

The medicine contains paracetamol.

Due to the risk of overdose, the patient should check if other medicines they are taking contain paracetamol. Paracetamol overdose can lead to life-threatening liver damage.

• The patient should not take other flu, cold, or nasal decongestant medicines at the same time.
• The patient should not drink alcohol while taking the medicine due to the risk of toxic liver damage.

The patient should contact their doctor if:

• The patient has liver or kidney failure, asthma, prostate enlargement, Raynaud's syndrome (pallor, followed by cyanosis of the fingers, toes, earlobes, and nose tip, often occurring under the influence of cold or emotions), coronary artery disease, or diabetes.
• The patient is taking anticoagulant medicines.
• The patient is taking beta-adrenergic receptor antagonist medicines - the medicine should be used with caution.

During the use of Gripex Hot Max, the patient should immediately inform their doctor if they experience 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 if they are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe disease called metabolic acidosis (a blood and body fluid disorder), which requires immediate treatment (see section 2). Symptoms of metabolic acidosis may include severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Children and adolescents

The medicine should not be used in children under 12 years of age.

Gripex Hot Max and other medicines

The patient should tell 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 used at the same time as other medicines containing:

• paracetamol (an active substance found in many preparations used for colds and flu);
• phenylephrine or pseudoephedrine (used in the symptomatic treatment of rhinitis, i.e., runny nose);
• other sympathomimetics or MAO inhibitors (used in the treatment of hypotension or depression);
• zidovudine (an antiviral drug used to treat HIV infections).

The patient should consult their doctor or pharmacist before taking the medicine with:

• anticoagulant medicines (warfarin, coumarin);
• antiepileptic drugs;
• barbiturates (sedative and hypnotic drugs);
• flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated immediately (see section 2).
• medicines that lower blood pressure (guanethidine, mecamylamine, methyldopa, reserpine);
• indomethacin (a pain reliever and anti-inflammatory drug);
• beta-adrenergic receptor antagonists (drugs used in hypertension and cardiovascular diseases);
• tricyclic antidepressant drugs.

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 (called metabolic acidosis), which must be treated immediately (see section 2).

The ascorbic acid contained in the medicine increases the absorption of:

• aluminum (found in antacids);
• iron.

Gripex Hot Max with food, drink, or alcohol

The medicine can be taken independently of meals.
The patient should not drink alcohol while taking the medicine due to the risk of toxic liver damage.

Pregnancy, breastfeeding, and fertility

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.
The medicine should not be used during pregnancy and breastfeeding.

Driving and using machines

The medicine may reduce concentration and impair reaction time. Therefore, the patient should be cautious while driving and operating machinery.

The medicine contains sucrose.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine contains 1.94 g of sucrose in one sachet and 7.74 g of sucrose in the daily dose (four sachets). This should be taken into account in patients with diabetes.
The medicine contains 25 mg of aspartame in each sachet, which corresponds to 100 mg in four sachets (the maximum daily dose). Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
The medicine contains 117.54 mg of sodium (the main component of common salt) in each sachet, which corresponds to 5.9 times the maximum recommended daily dose of sodium in the diet for adults.

3. HOW TO TAKE GRIPex Hot Max

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Adults and adolescents over 12 years of age:1 sachet every 4 to 6 hours (maximum 4 sachets per day).
The contents of the sachet should be dissolved in a glass of hot water.
The medicine can be taken independently of meals.
Gripex Hot Max should not be used for more than 3 to 5 days without consulting a doctor.

Taking a higher dose of Gripex Hot Max than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor, even if they feel well. If the overdose occurred no more than 1 hour ago, the patient should induce vomiting. The patient should immediately contact their doctor, as specialized treatment in a hospital may be necessary.
Symptoms may include nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may resolve the next day, despite the onset of liver damage, which will later manifest as abdominal distension, return of nausea, and jaundice.
Symptoms may also include tremors, anxiety, insomnia, increased blood pressure, significant acceleration of heart rate, pallor, and urinary retention. Paracetamol overdose can lead to liver failure, which may result in liver transplantation or death.

Missing a dose of Gripex Hot Max

The patient should not take a double dose to make up for a missed dose.

Stopping the use of Gripex Hot Max

Gripex Hot Max is intended for short-term alleviation of cold, flu, and flu-like symptoms. If the treatment is stopped and the symptoms persist, the patient should take the next dose or consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Gripex Hot Max can cause side effects, although not everybody gets them.
These include:

• skin and subcutaneous tissue disorders:allergic reactions (itching, hives);
• immune system disorders:hypersensitivity reactions up to anaphylactic shock symptoms (manifested as impaired consciousness, pallor, blood pressure drop, sweating, oliguria, accelerated breathing, edema);
• gastrointestinal disorders:nausea, vomiting, digestive disorders, heartburn, dry mouth;
• cardiovascular disorders:increased blood pressure, tachycardia (rapid heart rate), arrhythmias, pallor;
• respiratory, thoracic, and mediastinal disorders:breathing disorders, asthma attacks;
• renal and urinary disorders:urinary disorders, renal colic, renal papillary necrosis;
• nervous system disorders:anxiety, insomnia;
• psychiatric disorders:hallucinations, anxiety, nervousness;
• blood and lymphatic system disorders:granulocytopenia (reduced number of one type of white blood cell), agranulocytosis (absence of one type of white blood cell), thrombocytopenia (reduced platelet count).

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

• a serious disease that can cause blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
phone: +48 (22) 492 13 01, fax: +48 (22) 492 13 09
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 GRIPex Hot Max

The medicine should be stored at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste.
The patient should ask their pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What Gripex Hot Max contains

The active substances of the medicine are: paracetamol 1000 mg, ascorbic acid 100 mg, phenylephrine hydrochloride 12.2 mg.
The excipients are: sucrose, citric acid, sodium citrate, potassium acesulfame (E 950),
lemon flavor 87A069 (including citral), lemon flavor 875060 (including citral and linalol), lemon flavor 501.476/AP0504, lemon flavor 875928, aspartame (E 951), quinoline yellow (E 104).

What Gripex Hot Max looks like and what the packaging contains

The medicine is a powder for oral solution preparation; it is packaged in sachets.
Packaging:5, 8, 12, or 20 sachets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław
To obtain more detailed information about this medicine, the patient should contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
phone: +48 (22) 543 60 00.

Date of last revision of the leaflet: