Gripex Hot Intense

Leaflet attached to the packaging: patient information

Gripex HOT Intense

(1000 mg + 50 mg + 12.2 mg)/sachet, powder for oral solution, in a sachet
Paracetamol + Caffeine + Phenylephrine hydrochloride

You should carefully read the contents of the leaflet 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 directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 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 packaging 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 acts as an antipyretic and analgesic, phenylephrine reduces swelling and congestion of the mucous membrane, thereby restoring nasal and sinus patency. Caffeine has a stimulating effect on the central nervous system, resulting in a subjective feeling of reduced fatigue, improved coordination, and faster thinking.
The indication for using Gripex Hot Intense is the short-term symptomatic treatment of conditions associated with nasal mucous membrane inflammation and sinusitis, such as nasal and sinus congestion, mucous membrane swelling and congestion, feeling of a blocked nose, nasal mucous membrane inflammation, headache, pains related to sinus congestion, and fever, feeling of general malaise, fatigue.
Gripex Hot Intense is a pain reliever and antipyretic for use in colds and flu.

2. Important information before taking Gripex Hot Intense

When not to take Gripex Hot Intense:

• if the patient is allergic (hypersensitive) to paracetamol, caffeine, phenylephrine, or other medicines with similar effects or to any of the other ingredients of this medicine (listed in section 6),
• if the patient is taking other medicines containing paracetamol, caffeine, or phenylephrine,
• if the patient has severe liver or kidney failure,

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• if the patient has ever had stomach ulcers,
• if the patient has been diagnosed with cardiovascular disorders,
• if the patient has heart rhythm disorders,
• if the patient has high blood pressure,
• if the patient has diabetes,
• if the patient has been diagnosed with a pheochromocytoma (a tumor of the adrenal gland),
• if the patient has been diagnosed with angle-closure glaucoma,
• if the patient has hyperthyroidism,
• if the patient has been diagnosed with prostate enlargement,
• if the patient has a congenital deficiency of glucose-6-phosphate dehydrogenase or methemoglobin reductase,
• in the case of using monoamine oxidase inhibitors (MAOIs) (used in the treatment of low blood pressure and depression) and within 14 days of stopping their use,
• in the case of using tricyclic antidepressants (used in the treatment of mental disorders) or zidovudine (AZT, a medicine used in HIV infection),
• during pregnancy and breastfeeding,
• in children under 12 years of age.

Warnings and precautions

Before starting treatment with the medicine, you should consult a doctor or pharmacist.
Gripex Hot Intense contains paracetamol. Do not take a higher dose than recommended. Due to the risk of overdose, check if other medicines being taken contain paracetamol. Overdose of paracetamol can lead to severe liver damage and even death. The medicine should not be taken simultaneously with other medicines containing paracetamol, such as pain relievers, antipyretics used in the treatment of flu and cold symptoms.
Do not drink alcohol during treatment with the medicine. Taking the medicine by people with liver failure, alcohol abusers, or fasting individuals poses a risk of toxic liver damage.

Use with caution in:

• patients with liver or kidney failure (should monitor liver enzyme activity and kidney function),
• patients with atherosclerotic disease,
• patients with Raynaud's syndrome (characterized by pallor, followed by cyanosis of fingers, toes, earlobes, and nose tip, often caused by cold or emotions),
• patients with stable coronary artery disease,
• patients with respiratory failure,
• patients with asthma,
• patients with increased intraocular pressure,
• patients taking anxiolytics,
• patients taking beta-adrenergic blockers (used, for example, in the treatment of high blood pressure),
• patients taking anticoagulants.

During treatment with Gripex Hot Intense, you should immediately inform your doctor if you experience severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In these situations, patients have reported a serious condition called metabolic acidosis (a blood and body fluid disorder), which must be treated urgently (see section 2).
If symptoms worsen or do not improve after 3 days, you should contact your doctor.
You should consult a doctor even if the above warnings refer to past situations.

Gripex Hot Intense and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Interaction of Gripex Hot Intense with other medicines results from the interaction of the active substances contained in the medicine.

Paracetamol

• The medicine should not be taken simultaneously with other medicines containing paracetamol.
• Medicines that accelerate gastric emptying (e.g., metoclopramide) accelerate paracetamol absorption.
• Medicines that delay gastric emptying (e.g., propanteline) may delay paracetamol absorption.
• Taking paracetamol simultaneously with monoamine oxidase inhibitors (MAOIs) (used in the treatment of, among other things, low blood pressure and depression) and within 14 days of stopping their use may cause a state of excitement and fever.
• Simultaneous use of paracetamol and zidovudine (AZT, a medicine used in HIV infection) may enhance the toxic effect of zidovudine on the bone marrow.
• Paracetamol may enhance the effect of anticoagulant medicines (coumarin derivatives).
• Simultaneous use of paracetamol and medicines that increase liver metabolism, such as certain sedatives or antiepileptic drugs (e.g., phenobarbital, phenytoin, carbamazepine), as well as rifampicin (used in the treatment of, among other things, tuberculosis), may lead to liver damage, even when taking recommended doses of paracetamol. Therefore, before using the medicine, you should consult a pharmacist or doctor.
• Drinking alcohol during paracetamol treatment may lead to liver failure.
• Cholestyramine reduces paracetamol absorption and should not be taken within the first hour after paracetamol administration.
• Simultaneous use of probenecid reduces paracetamol excretion and prolongs its action.
• You should 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 must be treated urgently (see section 2).

Caffeine

Particular caution should be exercised when taking Gripex Hot Intense with the following medicines:

• sedatives and hypnotics (e.g., barbituric acid derivatives or antihistamines), as caffeine inhibits their effect,
• medicines that cause more frequent heart contractions (e.g., thyroxine), as caffeine enhances their effect,
• theophylline (a medicine used in the treatment of 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 (sedatives), as they accelerate caffeine metabolism,
• certain antibiotics, as they may delay caffeine excretion and its metabolite.

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

Phenylephrine

• MAOIs (used in low blood pressure and depression) may enhance the effect of phenylephrine. You should avoid taking them simultaneously with phenylephrine or administer phenylephrine after at least 14 days from stopping MAOIs.
• Phenylephrine may enhance the anticholinergic effect of tricyclic antidepressants (used in mental disorders).
• Phenylephrine may weaken the hypotensive effect of guanethidine, mecamylamine, methyldopa, reserpine (used in the treatment of high blood pressure).
• Phenylephrine taken simultaneously with indomethacin (a pain reliever and anti-inflammatory used in rheumatic diseases), beta-adrenergic receptor antagonists (used, for example, in the treatment of high blood pressure), or methyldopa (used, for example, in the treatment of high blood pressure) 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

The medicine can be taken regardless of meals.
Do not drink alcohol during treatment with the medicine.
Drinking alcohol during paracetamol treatment leads to the formation of a toxic metabolite causing liver cell necrosis, which may result in liver failure.

Pregnancy and breastfeeding

Do not use during pregnancy and breastfeeding.

Driving and using machines

The medicine may reduce concentration and impair reaction time. During treatment with Gripex Hot Intense, you should exercise caution when driving vehicles and operating machinery.

Warnings regarding excipients

The medicine contains 1.875 g of sucrose in one sachet and glucose (a component of maltodextrin and anhydrous corn glucose syrup).

This should be taken into account in patients with diabetes. If a patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine.

The medicine contains 33 mg of aspartame (E 951) in one 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 its impaired excretion.
The medicine contains 2.5 mg of sorbitol (a component of sorbitol syrup) in one sachet, which corresponds to 10 mg in 4 sachets (4 sachets are the maximum daily dose).
The medicine contains 117.2 mg of sodium (the main component of common salt) in one sachet. This corresponds to 5.9% of the maximum recommended daily dose of sodium in the diet for adults.
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The medicine contains orange yellow FCF (E 110).
The medicine may cause allergic reactions.

The medicine contains sulfites (sulfur dioxide (E 220)).

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

The medicine contains 0.0033 mg of benzyl alcohol in one sachet.

Benzyl alcohol may cause allergic reactions.
Patients with liver or kidney disease should consult a doctor before using the 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 the patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.
The medicine is taken orally.
The contents of one sachet should be dissolved in a glass of hot, but not boiling, water. Stir until dissolved. Let it cool to a temperature that allows drinking. The solution should be drunk when it is warm, in small sips.
After dissolution, the liquid has the form of an opalescent solution with a yellow color, a characteristic mint-citrus flavor, and no sediment.

Recommended dose:

Adults and adolescents over 12 years of age (with a body weight over 50 kg): 1 sachet, if necessary, the dose can be repeated, but not more often than every 4-6 hours.
Do not take more than 4 sachets per day. You should use the smallest effective dose.
Do not take a higher dose than recommended.
Do not use for more than 3 days without consulting a doctor.

Use in children

Do not use in children under 12 years of age.

Taking a higher dose of Gripex Hot Intense than recommended

You should immediately consult a doctor or pharmacist. The medicine contains three active substances.
Symptoms of overdose may result from the action of one or all of the active substances.

Accidental or intentional overdose of the medicine may cause, within a few or several hours, symptoms such as

nausea, vomiting, excessive sweating, drowsiness, general weakness, anxiety, tremors, and difficulty urinating, as well as shortness of breath. These symptoms may subside the next day, despite the fact that liver damage is developing, which will later manifest as abdominal distension, return of nausea, and jaundice. Overdose of paracetamol can lead to liver failure, which may result in liver transplantation or death.

In case of overdose, you should immediately call a doctor.

Treatment should be carried out in a hospital. It involves accelerating the removal of the medicine's components from the body and maintaining vital functions. In the case of paracetamol overdose, it may be necessary to administer an antidote: N-acetylcysteine and/or methionine.

Missing a dose of Gripex Hot Intense

Do not take a double dose to make up for a missed dose.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequency of side effects has been classified as follows:
Common - may occur in 1-10 out of 100 treated patients;
Rare - may occur in 1-10 out of 10,000 treated patients;
Very rare - may occur in less than 1 out of 10,000 patients;
Frequency not known - cannot be estimated from available data.

If you experience any side effects or if any side effects get worse or if you notice any side effects not listed in this leaflet, you should tell 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 the blood), leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count),
• edema,
• acute and chronic pancreatitis, bleeding, abdominal pain, diarrhea, nausea, vomiting,
• itching, rash, sweating, urticaria, angioedema,
• nephropathy and tubulopathy (kidney and urinary tract diseases).

Nephrotoxic effects are rare and have not been reported with therapeutic doses, except in cases of chronic use of the medicine.

Very rare:

• liver failure, liver necrosis, jaundice.

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

Frequency not known:

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

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

Common:

• nausea, vomiting, digestive disorders, anorexia.

Rare:

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

Very rare:

• anxiety, nervousness, tremors, irritability, insomnia, agitation, dizziness, and headaches, hallucinations.

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Frequency not known:

• urinary retention. After taking caffeine, the following have been reported: Frequency not known:palpitations, flushing, high blood pressure, tachycardia.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Gripex Hot Intense

Store in a temperature below 25°C. The medicine should be stored in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (month/year).
Medicines should not be disposed of via wastewater or household waste.
You should ask your 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 Intense contains

One sachet contains the active substances: paracetamol 1000 mg, caffeine 50 mg, and phenylephrine hydrochloride 12.2 mg.
Other ingredients are: sucrose, sodium citrate, citric acid, acesulfame potassium (E 950), aspartame (E 951), quinoline yellow (E 104), citrus flavor 87A069 (including sulfites, citral, citronellol, geraniol, limonene, linalool, anhydrous corn glucose syrup), citrus flavor 875060 (including citral, citronellol, geraniol, limonene, linalool, anhydrous corn glucose syrup), corn maltodextrin, acacia gum (E 414), citrus flavor 501.476 AP0504 (including limonene, citral, linalool, geraniol, citronellol, farnesol, corn maltodextrin (contains glucose)), peppermint flavor 550469 TP0300 (including limonene), peppermint flavor SC447995 (including limonene, linalool, citronellol, eugenol, geraniol, benzyl alcohol, corn maltodextrin (contains glucose)), sorbitol syrup, sulfites, orange yellow FCF (E 110).

What Gripex Hot Intense looks like and what the packaging contains

Gripex Hot Intense is a yellow, powdery powder with a characteristic mint-citrus flavor.
Packaging:5, 8, 12 sachets in a cardboard box.
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Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet:

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