Package leaflet: Information for the patient

Gripex Hot
(650 mg + 50 mg + 10 mg)/sachet, effervescent powder for oral solution
(Paracetamolum + Acidum ascorbicum + Phenylephrini hydrochloridum)
Please read the entire 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 directed by a doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 to 5 days, or if you feel worse, consult your doctor.

Table of contents
1. What Gripex Hot is and what it is 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 pack and other information

1. WHAT IS Gripex Hot AND WHAT IS IT USED FOR?
Gripex Hot, effervescent powder for oral solution, is a combination medicine with antipyretic, analgesic and nasal decongestant properties. It helps relieve symptoms of colds, influenza and influenza-like illnesses.
It is indicated for the relief of symptoms associated with colds, flu and influenza-like infections, such as fever, headache, sore throat, muscle and joint pain, and nasal congestion due to rhinitis occurring in colds and flu.
If there is no improvement after 3 to 5 days, or if you feel worse, consult your doctor.

2. IMPORTANT INFORMATION BEFORE TAKING Gripex Hot

When not to take Gripex Hot

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

Warnings and precautions
Before starting Gripex Hot, discuss it with your doctor or pharmacist.

Consult your doctor if:
- you have: liver or kidney failure, bronchial asthma, benign prostatic hyperplasia, hyperthyroidism, Raynaud's syndrome (pallor followed by cyanosis of fingers, toes, earlobes and nasal tip, often triggered by cold or emotional stress), coronary heart disease, hypertension, diabetes;
- you are taking anticoagulant medicines.
Due to the risk of overdose, check whether other medicines you are taking contain paracetamol.
Do not take other cold, flu or nasal decongestant medicines at the same time.
Use of this product in patients with liver impairment, alcohol abuse, or fasting increases the risk of liver damage.

During treatment with Gripex Hot, immediately inform your doctor if you have severe conditions, including severe kidney dysfunction, 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 developed a serious condition called metabolic acidosis (a disturbance in blood and body fluid balance) while taking paracetamol at standard doses over 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.

Children and adolescents
This medicine must not be used in children under 12 years of age.

Gripex Hot 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 Gripex Hot at the same time as medicines containing:

paracetamol (an active ingredient found in many cold and flu preparations);
phenylephrine or pseudoephedrine (used in symptomatic treatment of nasal mucosal inflammation, 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 infections).

Consult your doctor or pharmacist before taking simultaneously with:

anticoagulants (warfarin, coumarin);
antiepileptic medicines;
barbiturates (medicines with sedative and hypnotic effects);
other medicines inducing hepatic microsomal enzymes (e.g. isoniazid, rifampicin – antituberculosis medicines);
metoclopramide (an antiemetic medicine);
anticholinergics (used in bronchial asthma, treatment of gastric ulcers and reflux, as antiemetics, in gastrointestinal spastic conditions, and symptomatic treatment of Parkinson's disease);
flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disturbances (called metabolic acidosis) which require urgent treatment (see section 2);
antihypertensive medicines (guanethidine, mecamylamine, methyldopa, reserpine);
indomethacin (an analgesic and anti-inflammatory medicine, used e.g. in rheumatoid arthritis);
β-adrenergic receptor antagonists (medicines used in hypertension and cardiovascular diseases);
tricyclic antidepressants.

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

aluminium (found in antacids);
iron.

Gripex Hot with food, drink or alcohol
This medicine can be taken independently of meals.
Do not drink alcohol during treatment 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 operating machinery
This medicine may reduce the ability to concentrate and impair reaction time. Therefore, caution is advised when driving or operating machinery during treatment.

This medicine contains sucrose. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this 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.
This medicine contains 20 mg of aspartame per sachet, equivalent to 120 mg in six 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 impaired excretion.
This medicine contains 78.13 mg of sodium (the main component of table salt) per sachet. This corresponds to 3.9% of the maximum recommended daily sodium intake in the adult diet.

3. HOW TO USE THE MEDICINAL PRODUCT Gripex Hot

This medicine should always be used exactly as described in this patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a physician or pharmacist.
Adults and children over 12 years of age: 1 sachet every 4–6 hours (maximum 6 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 for longer than 3 to 5 days without consulting a physician.
Use of a higher than recommended dose of Gripex Hot
In any case of overdose, contact a physician immediately, even if the patient feels well. Specialized treatment under hospital conditions may be necessary. Paracetamol overdose may lead to life-threatening liver damage.
If less than 1 hour has passed since the overdose, vomiting should be induced.
Symptoms may include nausea, vomiting, excessive sweating, drowsiness, and general weakness. These symptoms may resolve spontaneously, but this does not exclude the development of liver damage. Additional symptoms may include tremor, restlessness, insomnia, increased blood pressure, marked tachycardia, pallor, and urinary retention. In later stages, abdominal pain and jaundice may occur.
Missed dose of Gripex Hot
Do not take a double dose to make up for a missed dose.
Discontinuation of Gripex Hot
Gripex Hot is intended for short-term relief of cold, flu, and flu-like symptoms. If you have any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

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

Skin and subcutaneous tissue disorders: allergic reactions (itching, urticaria);
Immune system disorders: hypersensitivity reactions up to anaphylactic shock symptoms (manifested by disturbances in 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 blood pressure, tachycardia (rapid heartbeat), 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: anxiety, 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):

severe condition that may lead to blood acidification (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 of 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 Gripex Hot

Keep this medicine below 25°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Medicines must not be disposed of in the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Gripex Hot contains
The active substances in the medicine are:
paracetamol 650 mg, ascorbic acid 50 mg, phenylephrine hydrochloride 10 mg.
The other ingredients are: aspartame (E 951), sucrose, citric acid, disodium citrate dihydrate,
lemon flavour 87A069 (containing citral), lemon flavour 875060 (containing citral and linalool), lemon flavour
501.476/AP0504, lemon flavour 875928, acesulfame potassium (E 950), quinoline yellow (E 104).

What Gripex Hot looks like and contents of the pack
The medicine is a powder for oral solution, packed in sachets.
Pack sizes: 5, 7, 8, 10, 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.
ul. Ziębicka 40
50-507 Wrocław
For further information about this medicine, please contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel. +48 (22) 543 60 00.