Gripex Sinucaps

Package Leaflet: Information for the Patient

Gripex SinuCaps

(300 mg + 25 mg + 5 mg), hard capsules
(Paracetamol + Caffeine + Phenylephrine hydrochloride)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after a few days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Leaflet:

1. What is Gripex SinuCaps and what is it 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 is Gripex SinuCaps and what is it used for

Gripex SinuCaps is a multi-component medicine with antipyretic and analgesic effects.
It alleviates symptoms that occur during colds, flu, and flu-like conditions, such as:
fever, chills, headaches, sore throats, muscle aches, bone and joint pain, swelling of the nasal mucosa and paranasal sinuses, runny nose, sneezing, feeling of general malaise. If after a few days there is no improvement or you feel worse, consult a doctor.

2. Important information before taking Gripex SinuCaps

When not to take Gripex SinuCaps:

Warnings and precautions

Gripex SinuCaps contains paracetamol. Do not take a dose higher than recommended.
Overdose of paracetamol can lead to severe liver damage and even death.
Do not take this medicine simultaneously with other medicines containing paracetamol, such as painkillers, antipyretics, used to treat flu and cold symptoms.
Before starting treatment with Gripex SinuCaps, discuss it with your doctor or pharmacist.
Taking this medicine by people with liver failure, alcohol abuse, or starvation poses a risk of liver damage. Be cautious when taking this medicine if you have: kidney failure, asthma, prostate enlargement, Raynaud's syndrome, diabetes, coronary artery disease, and are taking anticoagulant medications. This medicine should be taken with caution in patients taking beta-adrenergic receptor antagonist medications.
During treatment with Gripex SinuCaps, immediately inform your doctor if you have 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 been reported to develop a severe disease called metabolic acidosis (a blood and body fluid disorder), when they took paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.
Do not drink alcohol while taking this medicine due to the risk of toxic liver damage.

Gripex SinuCaps with food, drink, or alcohol

Food does not reduce the absorption of the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy and breastfeeding.

Driving and using machines

While taking this medicine, be cautious when driving a car and operating machinery.

3. How to take Gripex SinuCaps

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.
In case of doubt, consult a doctor or pharmacist.
Take the medicine orally.
Adults and adolescents over 12 years of age:2 capsules every 4-6 hours (maximum 12 capsules per day). Do not give this medicine to children under 12 years of age.

Taking a higher dose of Gripex SinuCaps than recommended

In any case of taking a higher dose than recommended, immediately seek medical advice, even if you feel well and have not observed any symptoms of poisoning, due to the risk of delayed, severe liver damage, which may result in liver transplantation or death.
In any case of taking paracetamol in a single dose of 5 g or more and if no more than an hour has passed since ingestion, vomiting can be induced.
Administer 60-100 g of activated charcoal orally, preferably mixed with water.
Within several to several dozen hours, the following may occur: nausea, vomiting, excessive sweating, drowsiness, and general weakness.
These symptoms may subside the next day, despite the developing liver damage, which will then manifest as abdominal distension, return of nausea, and jaundice.
The following symptoms may also occur: increased blood pressure, pallor, breathing difficulties, insomnia.

Missing a dose of Gripex SinuCaps

This medicine is intended for temporary relief of cold, flu, and flu-like symptoms.
Do not take a double dose to make up for a missed dose.

4. Possible side effects

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

• skin and subcutaneous tissue disorders: itching, hives, angioedema (swelling of the skin and subcutaneous tissue of the face, sometimes also the lips, mouth, and tongue, as well as the larynx); gastrointestinal disorders: nausea, vomiting, diarrhea, digestive disorders, heartburn, acid reflux; cardiovascular disorders: tachycardia (rapid heart rate), arrhythmias, pallor; respiratory, thoracic, and mediastinal disorders: bronchospasm, asthma attack, breathing difficulties; renal and urinary disorders: urinary disorders, kidney failure; nervous system disorders: anxiety, restlessness, muscle tremors, inability to concentrate, insomnia, headache;

psychiatric disorders: anxiety, nervousness, irritability;
blood and lymphatic system disorders: agranulocytosis (a lack of a type of white blood cell called neutrophils, which causes a significant decrease in immunity and the development of infections, most often oral and tonsil ulcers), anemia (a lack of sufficient red blood cells and too low a concentration of their pigment, i.e., hemoglobin), leukopenia (a decreased number of white blood cells called lymphocytes, which causes a decrease in immunity to infections).
Frequency not known (cannot be estimated from available data):
A serious disease that can cause blood acidification (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).
In the case of occasional use of the medicine, side effects are rare.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, 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 181C
02-222 Warsaw
tel.: +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 allow for more information to be collected 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 blister pack (month/year).
The applied labeling for the blister is: 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 that are no longer needed.
This will help protect the environment.

6. Contents of the pack and other information

What Gripex SinuCaps contains

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

What Gripex SinuCaps looks like and contents of the pack

Two-color green/yellow hard capsules, intended for oral use, packaged in blisters and a cardboard box with a leaflet.

Packaging:

6, 8, 10, 12, 20, 24 capsules in blisters in a cardboard box with a leaflet.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

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

Date of last revision of the leaflet: