Gripex hot intense

Patient Information Leaflet Included in the Package

Gripex HOT Intense
(1000 mg + 50 mg + 12.2 mg)/sachet, effervescent powder for oral solution, in sachet
Paracetamolum + Coffeinum + Phenylephrini hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if your condition worsens, contact your doctor.

Table of Contents:

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

1. What is Gripex Hot Intense and what is it used for
Gripex Hot Intense is a combination medicine. It contains three active substances: paracetamol, caffeine, and phenylephrine. Paracetamol has antipyretic and analgesic effects, phenylephrine reduces swelling and congestion of the mucous membranes, thereby restoring nasal and sinus patency. Caffeine exerts a stimulant effect on the central nervous system, resulting in a subjective feeling of reduced fatigue, improved coordination, and faster cognitive processing.
Gripex Hot Intense is indicated for short-term symptomatic treatment of symptoms associated with rhinitis and sinusitis, such as nasal and sinus congestion, nasal mucosal hyperemia and swelling, nasal obstruction, rhinitis, headache, pain related to sinus obstruction, fever, general malaise, and fatigue.
Gripex Hot Intense is an analgesic and antipyretic medicine used for colds and flu.

2. Important information before taking Gripex Hot Intense

Do not use Gripex Hot Intense:

• if you are allergic (hypersensitive) to paracetamol, caffeine, phenylephrine, or other drugs with similar actions, or to any of the other ingredients of this medicine (listed in section 6),
• if you are taking other medicines containing paracetamol, caffeine, or phenylephrine,
• if you have severe liver or kidney impairment,
• if you have ever had peptic ulcer disease,
• if you have cardiovascular disorders,
• if you have cardiac arrhythmias,
• if you have arterial hypertension,
• if you have diabetes,
• if you have been diagnosed with pheochromocytoma,
• if you have been diagnosed with narrow-angle glaucoma,
• if you have hyperthyroidism,
• if you have been diagnosed with benign prostatic hyperplasia,
• if you have congenital glucose-6-phosphate dehydrogenase deficiency or methemoglobin reductase deficiency,
• if you are taking monoamine oxidase inhibitors (MAOIs) (used in the treatment of hypotension and depression) or within 14 days after discontinuation of such treatment,
• if you are taking tricyclic antidepressants (used in psychiatric disorders) or zidovudine (AZT, used in HIV infection),
• during pregnancy and breastfeeding,
• in children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before starting treatment.
Gripex Hot Intense contains paracetamol. Do not exceed the recommended dose. Due to the risk of overdose, check whether other medicines you are taking contain paracetamol. Do not take this medicine simultaneously with other medicines containing paracetamol, such as analgesics, antipyretics, or medicines used to treat flu and cold symptoms. Overdose of paracetamol may lead to severe liver damage and even death.
Do not consume alcohol while taking this medicine. Use of this medicine in patients with liver impairment, chronic alcohol abuse, or fasting increases the risk of hepatotoxic liver damage.
Use with caution in:

• patients with liver or kidney impairment (liver enzyme activity and kidney function should be monitored),
• patients with arteriosclerosis,
• patients with Raynaud's syndrome (characterized by pallor followed by cyanosis of fingers, toes, earlobes, and nose tip, often triggered by cold or stress),
• patients with stable coronary artery disease,
• patients with respiratory insufficiency,
• patients with bronchial asthma,
• patients with increased intraocular pressure,
• patients taking anxiolytics,
• patients taking beta-blockers (medicines used, e.g., in the treatment of arterial hypertension),
• patients taking anticoagulants.

During treatment with Gripex Hot Intense, immediately inform your doctor if you have severe illnesses, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a serious condition called metabolic acidosis (an abnormality in blood and body fluids) when taking paracetamol regularly for a prolonged period or when taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
If symptoms worsen or do not improve after 3 days, contact your doctor.
Consult your doctor even if the above warnings refer to conditions that occurred in the past.

Gripex Hot Intense and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Interactions of Gripex Hot Intense with other medicines result from interactions of the active substances contained in the medicine.

Paracetamol

• Do not take this medicine simultaneously with other medicines containing paracetamol.
• Medicines that accelerate gastric emptying (e.g., metoclopramide) accelerate the absorption of paracetamol.
• Medicines that delay gastric emptying (e.g., propantheline) may delay the absorption of paracetamol.
• Concurrent use of paracetamol with monoamine oxidase inhibitors (MAOIs) (used, among others, in the treatment of hypotension and depression) and within 14 days after discontinuation of such treatment may cause a state of excitation and fever.
• Concurrent use of paracetamol with zidovudine (AZT, used in HIV infection) may enhance the toxic effect of zidovudine on bone marrow.
• Paracetamol may enhance the effect of anticoagulants (coumarin derivatives).
• Concurrent use of paracetamol with medicines that increase hepatic metabolism, such as certain sedatives or antiepileptic drugs (e.g., phenobarbital, phenytoin, carbamazepine), as well as rifampicin (used, among others, in the treatment of tuberculosis), may lead to liver damage, even when recommended doses of paracetamol are used. Therefore, consult your pharmacist or doctor before using this medicine.
• Alcohol consumption during paracetamol treatment may lead to liver failure.
• Cholestyramine reduces the absorption of paracetamol and therefore should not be taken within the first hour after paracetamol administration.
• Concurrent use of probenecid reduces the excretion of paracetamol and prolongs its duration of action.
• Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).

Caffeine
Exercise special caution when using Gripex Hot Intense with the following medicines:

• sedatives and hypnotics (e.g., barbituric acid derivatives or antihistamines), as caffeine inhibits their effect,
• medicines causing increased heart rate (e.g., thyroxine), as caffeine enhances their effect,
• theophylline (a medicine used in asthma and allergic conditions), as caffeine inhibits its excretion,
• oral contraceptives, cimetidine, and disulfiram, as they inhibit caffeine metabolism in the liver,
• barbituric acid derivatives (hypnotics), as they accelerate caffeine metabolism,
• certain antibiotics, as they may delay caffeine and its metabolite excretion.

Smoking accelerates caffeine metabolism.
Caffeine increases the risk of dependence on substances with effects similar to ephedrine (contained in cardiac medicines).

Phenylephrine

• Monoamine oxidase inhibitors (MAOIs) (used in hypotension and depression) may enhance the effect of phenylephrine. Avoid simultaneous use of MAOIs with phenylephrine or administer phenylephrine at least 14 days after discontinuation of MAOIs.
• Phenylephrine may enhance the anticholinergic effect of tricyclic antidepressants (medicines used in psychiatric disorders).
• Phenylephrine may reduce the antihypertensive effect of guanethidine, mecamylamine, methyldopa, and reserpine (medicines used in the treatment of hypertension).
• Phenylephrine used concurrently with indomethacin (an analgesic and anti-inflammatory medicine used in rheumatic diseases), beta-adrenergic receptor antagonists (medicines used, e.g., in the treatment of arterial hypertension), or methyldopa (a medicine used, e.g., in the treatment of arterial hypertension) may cause a hypertensive crisis.

Children and adolescents
Do not use in children under 12 years of age.

Gripex Hot Intense with food, drink, and alcohol
This medicine can be taken regardless of meals.
Do not consume alcohol while taking this medicine.
Alcohol consumption during paracetamol treatment leads to the formation of a toxic metabolite causing necrosis of liver cells, which may subsequently lead to liver failure.

Pregnancy and breastfeeding
Do not use this medicine during pregnancy and breastfeeding.

Driving and operating machinery
This medicine may reduce concentration and impair reaction time. Exercise caution when driving motor vehicles and operating machinery during treatment with Gripex Hot Intense.

Warnings regarding excipients

The medicine contains 1.875 g of sucrose per sachet and glucose (component of maltodextrin and anhydrous corn syrup glucose).
This should be taken into account in patients with diabetes. If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

The medicine contains 33 mg of aspartame (E 951) per sachet.
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 improper excretion.

The medicine contains 2.5 mg of sorbitol (component of sorbitol syrup) per sachet, corresponding to 10 mg in 4 sachets (4 sachets is the maximum daily dose).

The medicine contains 117.2 mg of sodium (main component of table salt) per sachet. This corresponds to 5.9% of the maximum recommended daily sodium intake in the diet of adults.

The medicine contains Sunset Yellow (E110).
The medicine may cause allergic reactions.

The medicine contains sulphites (sulfur dioxide (E220)).
The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

The medicine contains 0.0033 mg of benzyl alcohol per sachet.
Benzyl alcohol may cause allergic reactions.
Patients with liver or kidney disease should consult their doctor before using this medicine, as a large amount of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).

3. How to take Gripex Hot Intense
This medicine should always be used exactly as described in this patient leaflet or as advised by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is taken orally.
Dissolve the contents of one sachet in a glass of hot, but not boiling, water. Stir until dissolved. Allow to cool to a drinkable temperature. The solution should be consumed while warm, in small sips.

After dissolution, the liquid forms an opalescent yellow solution with a characteristic mint-lemon odor, free of sediment.

Recommended dose:
Adults and adolescents over 12 years of age (with body weight over 50 kg): 1 sachet. The dose may be repeated if necessary, but no more frequently than every 4-6 hours.
Do not take more than 4 sachets per day. Use the lowest effective dose.
Do not exceed the recommended dose.
Do not use for longer than 3 days without consulting a doctor.

Use in children
Do not use in children under 12 years of age.

Overdose of Gripex Hot Intense
Seek immediate medical advice from a doctor or pharmacist. The medicine contains three active substances. Symptoms of overdose may result from the action of one or all active substances.
Accidental or intentional overdose may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, general weakness, restlessness, tremor, nystagmus, increased blood pressure, seizures, difficulty urinating, and dyspnea within several to several dozen hours. These symptoms may subside the next day, despite the onset of liver damage, which subsequently manifests as epigastric discomfort, recurrence of nausea, and jaundice. Paracetamol overdose may lead to liver failure, which may result in liver transplantation or death.
In case of overdose, seek immediate medical help.
Treatment should be carried out in a hospital. It involves accelerating the elimination of the medicine's components from the body and supporting vital functions. In case of paracetamol overdose, an antidote (N-acetylcysteine and/or methionine) may be necessary.

Missed dose of Gripex Hot Intense
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 will experience them.
The frequency of side effects is classified as follows:
Common - may occur in 1-10 out of 100 patients treated;
Rare - may occur in 1-10 out of 10,000 patients treated;
Very rare - may occur in less than 1 out of 10,000 patients;
Frequency not known - cannot be estimated from available data.
If any of the side effects occur or worsen, or if any side effects not listed in this leaflet occur, inform your doctor.

Possible side effects of the medicine due to the presence of paracetamol:
Rare:

• anemia, bone marrow suppression, thrombocytopenia (low platelet count), agranulocytosis (lack of granulocytes in blood), leukopenia (reduced white blood cell count), neutropenia (reduced number of neutrophils),
• edema,
• acute and chronic pancreatitis, hemorrhage, abdominal pain, diarrhea, nausea, vomiting,
• itching, rash, sweating, purpura, angioedema, urticaria,
• nephropathies and tubulopathies (kidney and urinary tract diseases).

Nephrotoxic effects are rare; no association with therapeutic doses has been reported, except in cases of chronic use.

Very rare:

• liver failure, liver necrosis, jaundice.

Very rare cases of severe skin reactions have been reported, including single cases of epidermal necrolysis (toxic necrotic separation of the epidermis), Stevens-Johnson syndrome, erythema multiforme, laryngeal edema, anaphylactic shock, and dizziness.

Frequency not known:

• serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Possible side effects of the medicine due to the presence of phenylephrine:
Common:

• nausea, vomiting, digestive disturbances, anorexia.

Rare:

• itching, urticaria,
• allergic reactions and hypersensitivity up to symptoms of anaphylactic shock and bronchospasm,
• increased blood pressure, tachycardia, cardiac arrhythmias, palpitations, skin pallor.

Very rare:

• anxiety, restlessness, tremors, nervousness, insomnia, irritability, dizziness, and headache, hallucinations.

Frequency not known:

• urinary retention.

After administration of caffeine occurred: Frequency not known: palpitations, sudden flushing, high blood pressure, tachycardia.

Reporting of adverse reactions
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309.
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Gripex Hot Intense
Store below 25°C. Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (month/year).
Do not dispose of medicines via the wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use.
Such measures will help protect the environment.

6. Contents of the package and other information

What Gripex Hot Intense contains
Each sachet contains the active substances: paracetamol 1000 mg, caffeine 50 mg and phenylephrine
hydrochloride 12.2 mg.
The other ingredients are: sucrose, sodium citrate, citric acid, acesulfame potassium (E 950),
aspartame (E 951), quinoline yellow (E 104), lemon flavour 87A069 (containing: sulphites, citral,
citronellol, geraniol, limonene, linalool, anhydrous glucose syrup), lemon flavour 875060 (containing: citral, citronellol, geraniol, limonene, linalool, anhydrous glucose syrup), corn maltodextrin, gum arabic (E 414), lemon flavour 501.476 AP0504 (containing: limonene, citral, linalool, geraniol, citronellol, farnesol, corn maltodextrin (containing glucose)), menthol flavour 550469 TP0300 (containing: limonene), peppermint flavour SC447995 (containing: limonene, linalool, citronellol, eugenol, geraniol, benzyl alcohol, corn maltodextrin (containing glucose), sorbitol syrup, sulphites), orange-yellow FCF (E 110).
What Gripex Hot Intense looks like and contents of the pack
Gripex Hot Intense is a yellow, effervescent powder with a characteristic mint-lemon odour.
Pack sizes: 5, 8, 12 sachets in a cardboard box.
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Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
Ziębicka 40,
50-507 Wrocław
For further information regarding this medicinal product, please contact:
USP Zdrowie Sp. z o.o.
Poleczki 35
02-822 Warsaw
tel.: +48 (22) 543 60 00
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