Gripex hot max

Package leaflet: information for the patient

Gripex Hot Max
(1000 mg + 100 mg + 12.2 mg)/sachet, effervescent powder for oral solution
(Paracetamolum + Acidum ascorbicum + Phenylephrini hydrochloridum)
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3 to 5 days, contact your doctor.

Contents of the leaflet
1. What Gripex Hot Max is and what it is used for
2. What you need to know 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 pack and other information

1. WHAT Gripex Hot Max IS AND WHAT IT IS USED FOR
Gripex Hot Max, effervescent powder for oral solution, is a combination medicine with antipyretic, analgesic, and nasal decongestant properties. It relieves severe symptoms of cold and flu.
The indication for use is short-term relief of severe symptoms of cold, flu, and flu-like infections, such as fever, headache, sore throat, muscle and joint pain, and nasal mucosal swelling associated with cold and flu.
If there is no improvement or if you feel worse after 3 to 5 days, consult your doctor.

2. WHAT YOU NEED TO KNOW BEFORE TAKING Gripex Hot Max

When not to take Gripex Hot Max

• If you are allergic to the active substances, sympathomimetic amines, or any of the other ingredients of this medicine (listed in section 6).
• If you have any of the following conditions:
  • unstable coronary artery disease,
  • cardiac arrhythmias,
  • high blood pressure,
  • congenital glucose-6-phosphate dehydrogenase or methemoglobin reductase deficiency,
  • severe liver or kidney failure,
  • viral hepatitis,
  • alcoholic liver disease,
  • phenylketonuria,
  • narrow-angle glaucoma,
• hyperthyroidism.
  • During treatment with monoamine oxidase inhibitors (MAO inhibitors) or within 2 weeks after discontinuation of such treatment.
  • In combination with tricyclic antidepressants.
  • During treatment with zidovudine (a medicine used in the treatment of HIV infection).
  • In children under 12 years of age.
  • During pregnancy.

Warnings and precautions
Before taking Gripex Hot Max, discuss it with your doctor or pharmacist.
This medicine contains paracetamol.
Due to the risk of overdose, check whether other medicines you are taking also contain paracetamol. Paracetamol overdose may lead to life-threatening liver damage.

• Do not take other cold, flu, or nasal decongestant medicines (sympathomimetics) at the same time.
• Do not drink alcohol while taking this medicine due to the risk of toxic liver damage.

Contact your doctor if:

• You have liver or kidney impairment, bronchial asthma, benign prostatic hyperplasia, Raynaud's syndrome (pallor followed by cyanosis of fingers, toes, earlobes, and nose tip, often triggered by cold or stress), coronary artery disease, or diabetes.
• You are taking anticoagulant medicines.
• You are taking β-adrenergic receptor antagonists (beta-blockers) – use this medicine with caution.

During treatment with Gripex Hot Max, immediately inform your doctor if you have severe illnesses, including severe kidney dysfunction or sepsis (bacteria and their toxins circulating in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In such cases, patients have developed a serious condition called metabolic acidosis (abnormality in blood and body fluids) when taking paracetamol regularly over a long period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Children and adolescents
This medicine must not be used in children under 12 years of age.
Gripex Hot Max and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take this medicine simultaneously with other medicines containing:

• paracetamol (an active ingredient found in many cold and flu preparations);
• phenylephrine or pseudoephedrine (used in symptomatic treatment of rhinitis, i.e., nasal congestion);
• other sympathomimetics or MAO inhibitors (used in the treatment of hypotension or depression);
• zidovudine (an antiviral medicine used in the treatment of HIV infection).

Consult your doctor or pharmacist before taking the following medicines concomitantly:

• anticoagulants (warfarin, coumarin);
• antiepileptic medicines;
• barbiturates (sedative and calming medicines);
• flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2);
• antihypertensive medicines (guanethidine, mecamylamine, methyldopa, reserpine);
• indomethacin (a pain-relieving and anti-inflammatory medicine);
• β-adrenergic receptor antagonists (medicines used in hypertension and cardiovascular diseases);
• tricyclic antidepressants.

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).

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

• aluminium (found in antacids);
• iron.

Gripex Hot Max with food, drink, or alcohol
This medicine can be taken regardless of meals.
Do not drink alcohol while taking this medicine due to the risk of toxic liver damage.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Do not use during pregnancy or breastfeeding.
Driving and using machines
This medicine may reduce concentration ability and impair reaction time. Therefore, exercise caution when driving or operating machinery during treatment.
This medicine contains sucrose.
If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine. This medicine contains 1.94 g of sucrose per sachet and 7.74 g of sucrose in the daily dose (four sachets). This should be taken into account in patients with diabetes.
This medicine contains 25 mg of aspartame per sachet, equivalent to 100 mg in four sachets (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 improper excretion.
This medicine contains 117.54 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 for adults.

3. HOW TO USE THE MEDICINAL PRODUCT Gripex Hot Max

This medicine should always be used exactly as described in the patient leaflet or as directed by a physician or pharmacist. If in doubt, consult a physician or pharmacist.
Adults and adolescents aged 12 years and above: 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 may be taken regardless of meals.
Do not use Gripex Hot Max for longer than 3 to 5 days without medical advice.

Overdose of Gripex Hot Max
In case of overdose, seek immediate medical attention, even if the patient feels well. If less than 1 hour has passed since the overdose, induce vomiting. Immediate contact with a physician is essential, as hospitalization and specialized treatment may be necessary.
Symptoms may include: nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may subside the following day, despite the onset of liver damage, which may later manifest as upper abdominal discomfort, recurrence of nausea, and jaundice. Other possible symptoms include tremor, anxiety, insomnia, increased blood pressure, marked tachycardia, pallor, and urinary retention. Paracetamol overdose may lead to liver failure, which may result in liver transplantation or death.

Missed dose of Gripex Hot Max
Do not take a double dose to make up for a missed dose.

Discontinuation of treatment
Gripex Hot Max is intended for short-term relief of symptoms of cold, influenza, and influenza-like conditions. If treatment is interrupted and symptoms persist, take the next dose or consult a physician or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
These include:

• Skin and subcutaneous tissue disorders: allergic reactions (itching, urticaria);
• Immune system disorders: hypersensitivity reactions up to symptoms of anaphylactic shock (manifesting as disturbances of consciousness, skin pallor, drop in blood pressure, sweating, reduced urine output, rapid breathing, swelling);
• Gastrointestinal disorders: nausea, vomiting, digestive disturbances, epigastric burning, dryness of the oral cavity;
• Cardiovascular disorders: increased arterial pressure, tachycardia (accelerated heart rate), cardiac arrhythmias, skin pallor;
• Respiratory, thoracic and mediastinal disorders: breathing difficulties, bronchial asthma attack;
• Renal and urinary disorders: disturbances in urination, renal colic, renal papillary necrosis;
• Nervous system disorders: restlessness, insomnia;
• Psychiatric disorders: hallucinations, anxiety, nervousness;
• Blood and lymphatic system disorders: granulocytopenia (reduced number of one type of white blood cells in blood), agranulocytosis (absence of one type of white blood cells in blood), thrombocytopenia (reduced number of blood platelets).

Frequency unknown (cannot be estimated from available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including any 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 (22) 492 13 01, Fax: +48 (22) 492 13 09
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE THE MEDICINAL PRODUCT Gripex Hot Max

Store the medicinal product at a temperature below 25°C.
Keep the medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging.
Medicinal products must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicinal products no longer required.
This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Gripex Hot Max contains
The active substances in the medicine are: paracetamol 1000 mg, ascorbic acid 100 mg, phenylephrine hydrochloride 12.2 mg.
The excipients are: sucrose, citric acid, disodium citrate dihydrate, acesulfame potassium (E 950), lemon flavour 87A069 (containing citral), lemon flavour 875060 (containing citral and linalool), lemon flavour 501.476/AP0504, lemon flavour 875928, aspartame (E 951), quinoline yellow (E 104).
What Gripex Hot Max looks like and contents of the pack
The medicine is in the form of a powder for oral solution; it is packed in sachets.
Pack sizes: 5, 8, 12 or 20 sachets in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
Ziębicka Street 40
50-507 Wrocław
For further information on this medicine, please contact:
USP Zdrowie Sp. z o.o.
Poleczki Street 35
02-822 Warsaw
Tel. +48 (22) 543 60 00.