Gripex Hot

Leaflet attached to the packaging: patient information

Gripex Hot

(650 mg + 50 mg + 10 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 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 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 and what is it used for

2. Important information before taking Gripex Hot

3. How to take Gripex Hot

4. Possible side effects

5. How to store Gripex Hot

6. Contents of the packaging and other information

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

Gripex Hot, a powder for oral solution preparation, is a multi-component medicine with antipyretic, analgesic, and nasal decongestant effects. It alleviates the symptoms of colds, flu, and flu-like illnesses.
The indication for use is to alleviate the symptoms of colds, flu, and flu-like infections such as: fever, headaches, throat pain, muscle and bone pain, as well as symptoms of rhinitis occurring in colds and flu.
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

When not to take Gripex Hot

• 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,
• anatomically narrow angle of filtration.
• During the use of MAO inhibitor drugs and for up to 2 weeks after stopping these medications.
• During the administration of zidovudine (a drug used to treat HIV infection).
• In children under 12 years of age.

Warnings and precautions

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

• The patient should contact their doctor if:
• they have: liver or kidney failure, asthma, prostate enlargement, hyperthyroidism, 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, high blood pressure, diabetes;
• they are taking anticoagulant medications.
• Due to the risk of overdose, the patient should check if other medications they are taking contain paracetamol.
• The patient should not take other flu, cold, or nasal decongestant medications at the same time.
• Taking this product by people with liver failure, alcohol abuse, and starvation poses a risk of liver damage.

During the use of Gripex Hot, the patient should immediately inform their doctor if they 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 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 emergency treatment (see section 2). The 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 and other medicines

The patient should tell their doctor or pharmacist about all the 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., a cold);
• other sympathomimetics or MAO inhibitors (used in the treatment of low blood pressure or depression);
• zidovudine (an antiviral drug used to treat HIV infections).

The patient should consult their doctor or pharmacist before taking the following medications at the same time:

• anticoagulant medications (warfarin, coumarin);
• antiepileptic medications;
• barbiturates (sedative and hypnotic medications);
• other medications that induce liver microsomal enzymes (e.g., isoniazid, rifampicin, anti-tuberculosis medications);
• metoclopramide (an antiemetic medication);
• cholinolytics (used in asthma, gastric ulcer treatment, and reflux, as antiemetic medications, in spastic conditions of the digestive tract, and in the symptomatic treatment of Parkinson's disease);
• 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);
• medications that lower blood pressure (guanethidine, mecamylamine, methyldopa, reserpine);
• indomethacin (a pain reliever and anti-inflammatory medication, used in rheumatoid arthritis);
• beta-adrenergic receptor antagonists (medications used in high blood pressure and cardiovascular diseases);
• tricyclic antidepressant medications.

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

• aluminum (found in antacids);
• iron.

Gripex Hot with food, drink, or alcohol

The medicine can be taken regardless of meals.
Alcohol should not be consumed during the use of 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 operating machinery

The medicine may reduce concentration and impair reaction time. Therefore, during the use of the medicine, the patient should be cautious while driving and operating mechanical devices.
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. One sachet contains 1.981 g of sucrose, and the daily dose (six sachets) contains 11.89 g of sucrose. This should be taken into account in patients with diabetes.
The medicine contains 20 mg of aspartame in each sachet, which corresponds to 120 mg in six sachets (the maximum daily dose). Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
The medicine contains 78.13 mg of sodium (the main component of table salt) in each sachet, which corresponds to 3.9% of the maximum recommended daily dose of sodium in the diet for adults.

3. HOW TO TAKE GRIPex Hot

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

Taking a higher dose of Gripex Hot than recommended

In any case of taking a higher dose of the medicine than recommended, the patient should immediately contact their doctor, even if they feel well. Specialized treatment in a hospital setting may be necessary. Overdosing on paracetamol can lead to life-threatening liver damage.
If the overdose occurred no more than 1 hour ago, the patient should induce vomiting.
Symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness may occur. These symptoms may resolve on their own, but this does not rule out the development of liver damage. Other symptoms such as tremors, anxiety, insomnia, increased blood pressure, significant acceleration of heart rate, pallor, and urinary retention may also occur. Later, abdominal pain and jaundice may appear.

Missing a dose of Gripex Hot

A double dose should not be taken to make up for a missed dose.

Stopping the use of Gripex Hot

Gripex Hot is intended for short-term relief of cold, flu, and flu-like symptoms. If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Gripex Hot 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 by impaired consciousness, pallor, decreased blood pressure, sweating, decreased urine output, accelerated breathing, and edema);
• gastrointestinal disorders:nausea, vomiting, digestive disorders, heartburn, dry mouth;
• cardiovascular disorders:increased blood pressure, tachycardia (rapid heart rate), heart rhythm disorders, pallor;
• respiratory, thoracic, and mediastinal disorders:breathing difficulties, 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 (decreased number of one type of white blood cell), agranulocytosis (absence of one type of white blood cell), thrombocytopenia (decreased platelet count).

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

• a serious disease that can cause acidification of the blood (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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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

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 expiration 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 unused medicines. This will help protect the environment.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What Gripex Hot contains

The active substances of the medicine are :
paracetamol 650 mg, ascorbic acid 50 mg, phenylephrine hydrochloride 10 mg,
The excipients are: aspartame (E 951), sucrose, citric acid, sodium citrate, lemon flavor 87A069 (including citral), lemon flavor 875060 (including citral and linalol), lemon flavor 501.476/AP0504, lemon flavor 875928, acesulfame potassium (E 950), quinoline yellow (E 104).

What Gripex Hot looks like and what the packaging contains

The medicine is a powder for oral solution preparation, packaged in sachets.
Packaging:5, 7, 8, 10, 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.
Ziębicka Street 40
50-507 Wrocław
To obtain more detailed information about this medicine, the patient should contact:
USP Zdrowie Sp. z o.o.
Poleczki Street 35
02-822 Warsaw
phone: +48 (22) 543 60 00.

Date of the last update of the leaflet: