GRIPEXPRO

Package leaflet: Information for the patient

Gripex SinuCaps
(300 mg + 25 mg + 5 mg), hard capsules
(Paracetamolum + Coffeinum + Phenylephrini hydrochloridum)
Please read carefully the entire 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
the physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after a few days or if you feel worse, contact your doctor.

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

1. What Gripex SinuCaps is and what it is used for
Gripex SinuCaps is a combination medicine with antipyretic and analgesic properties.
It relieves symptoms associated with colds, influenza, and influenza-like conditions, such as:
fever, chills, headache, sore throat, muscle pain, joint pain, swelling of the nasal and paranasal sinus mucosa, runny nose, sneezing, and general malaise. If there is no improvement after a few days or if you feel worse, consult your doctor.

2. Important information before taking Gripex SinuCaps

When not to take Gripex SinuCaps:

• if you are allergic to sympathomimetic amines or to any of the active substances or to 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 deficiency or methemoglobin reductase deficiency; severe liver or kidney impairment, viral hepatitis, alcoholic liver disease; narrow-angle glaucoma; hyperthyroidism. The medicine should also not be used during treatment with MAO inhibitors and within 2 weeks after discontinuation of such treatment, in combination with tricyclic antidepressants, during zidovudine treatment, or during pregnancy and breastfeeding.

Warnings and precautions
Gripex SinuCaps contains paracetamol. Do not exceed the recommended dose.
Overdosing on paracetamol may lead to severe liver damage and even death.
Do not take this medicine simultaneously with other medicines containing paracetamol, such as painkillers, antipyretics, or medicines used to treat flu and cold symptoms.
Before starting to use Gripex SinuCaps, discuss this with your doctor or pharmacist.
Using this medicine in patients with liver impairment, alcohol abuse, or malnutrition increases the risk of liver damage. Use with caution in patients with: kidney impairment, bronchial asthma, benign prostatic hyperplasia, Raynaud's syndrome, diabetes, coronary artery disease, or those taking anticoagulant medicines.
Use with caution in patients taking β-adrenergic receptor antagonists.
During treatment with Gripex SinuCaps, immediately inform your doctor if you have severe underlying diseases, including severe kidney function disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In such cases, patients have been reported to develop a serious condition called metabolic acidosis (a disturbance in blood and body fluid balance) when taking paracetamol regularly 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.
Do not drink alcohol while taking this medicine due to the risk of toxic liver damage.

Gripex SinuCaps 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 use.
Do not take this medicine simultaneously with other medicines containing paracetamol, caffeine, or sympathomimetics, and also with: MAO inhibitors (medicines used for hypotension and depression), oral antidiabetic medicines, anticoagulants (warfarin, coumarin), sympathomimetics (medicines used, e.g., in asthma), thyroid hormones, guanethidine, mecamylamine, methyldopa, reserpine (medicines used to treat hypertension), indometacin (an anti-inflammatory and analgesic medicine), β-adrenergic receptor antagonists (used in circulatory failure, hypertension, or ischemic heart disease).
Concomitant use with rifampicin (an antibacterial medicine used, among others, in tuberculosis), antiepileptic medicines, barbiturates (which have sedative and anticonvulsant effects), or other medicines inducing hepatic microsomal enzymes increases the risk of liver damage.
Before using metoclopramide (an antiemetic and gastrointestinal prokinetic agent), cholinolytics (medicines used in bronchial diseases, smooth muscle spasms of the gastrointestinal tract, or for pupil dilation), oral contraceptives, cimetidine (an anti-ulcer medicine), quinolones (antibacterial medicines), methoxsalen (a psoralen used in psoriasis treatment), mexiletine (used in cardiac arrhythmias), verapamil (used in cardiac arrhythmias and hypertension), or tricyclic antidepressants, consult your doctor or pharmacist.
Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disturbances (called metabolic acidosis), which require urgent treatment (see section 2).

Gripex SinuCaps with food, drink, or alcohol
Food does not reduce the absorption of the medicine.

Pregnancy, breastfeeding, and effects on fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.
Do not use during pregnancy and breastfeeding.

Driving and operating machinery
Exercise caution while driving or operating machinery during treatment with this medicine.

3. How to use Gripex SinuCaps

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
Adults and adolescents over 12 years of age: 2 capsules every 4–6 hours (maximum 12 capsules per day). Gripex SinuCaps must not be given to children under 12 years of age.
Taking more Gripex SinuCaps than recommended
If you take more than the recommended dose, seek immediate medical advice, even if you feel well and do not notice any symptoms of poisoning, due to the risk of delayed, severe liver damage, which may result in liver transplantation or death. If a dose of paracetamol equal to or exceeding 5 g has been taken and less than one hour has passed since ingestion, vomiting may be induced. Administer 60–100 g of activated charcoal orally, preferably mixed with water.
Within a few to several hours, symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness may occur. These symptoms may resolve the next day, despite ongoing liver damage, which may then manifest as abdominal discomfort, recurrence of nausea, and jaundice.
Other symptoms may include increased blood pressure, pallor, breathing difficulties, and insomnia.
If you forget to take Gripex SinuCaps
This medicine is intended for temporary relief of symptoms of cold, flu, and flu-like conditions. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.

• Skin and subcutaneous tissue disorders: itching, urticaria, angioedema (swelling of the skin and subcutaneous tissue of the face, sometimes also of the lips, oral cavity, tongue, and larynx); gastrointestinal disorders: nausea, vomiting, diarrhoea, digestive disturbances, epigastric burning, gastric hyperacidity; cardiovascular disorders: tachycardia (increased heart rate), cardiac arrhythmia, pallor; respiratory, thoracic and mediastinal disorders: bronchospasm, bronchial asthma attack, breathing difficulties; renal and urinary disorders: micturition disturbances, renal failure; nervous system disorders: anxiety, restlessness, muscle tremors, difficulty concentrating, insomnia, headache;

psychiatric disorders: anxiety, nervousness, irritability;
blood and lymphatic system disorders: agranulocytosis (lack of a type of white blood cells called neutrophil granulocytes, leading to significantly reduced immunity and development of infections, most commonly oral ulcers and tonsillar infections), anaemia (insufficient number of red blood cells and too low concentration of their pigment, i.e. haemoglobin), leukopenia (reduced number of white blood cells called lymphocytes, leading to decreased resistance to infections).
Frequency unknown (cannot be estimated from available data):
A serious condition that may cause blood acidification (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).
When the medicine is used occasionally, adverse reactions are rare.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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
Phone: +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 collect more information on the safety of the medicine.

5. How to store Gripex SinuCaps

Store the medicine at a temperature below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the carton and on the immediate packaging (month/year).
Blister labelling: EXP – expiry date, Lot – batch number.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.

6. Contents of the pack and other information

What Gripex SinuCaps contains
The active substances are: paracetamol 300 mg, caffeine 25 mg, phenylephrine hydrochloride 5 mg.
The excipients are: starch, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate,
gelatin, titanium dioxide (E 171), iron oxide yellow (E 172), patent blue (E 131), quinoline yellow (E 104).

What Gripex SinuCaps looks like and contents of the pack
Bicolored green/yellow hard capsules intended for oral administration by swallowing, packed in blisters and cardboard boxes with a leaflet.

Pack sizes:
6, 8, 10, 12, 20, 24 capsules in blisters in a cardboard box with a leaflet.
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 regarding this medicinal product, please contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel. +48 (22) 543 60 00.