Gripex

Package Leaflet: Information for the Patient

GRIPEX, 325 mg + 30 mg + 10 mg, coated tablets

Paracetamol + Pseudoephedrine hydrochloride + Dextromethorphan hydrobromide

You should carefully read the contents of the leaflet before using 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Gripex and what is it used for

Gripex is a multi-component medicine intended for short-term, occasional treatment of symptoms of colds and flu. It contains three active substances: paracetamol, pseudoephedrine, and dextromethorphan.
It acts as an analgesic, antipyretic, anti-cough, decongestant, reduces the amount of mucous secretion, and reduces congestion and swelling of the nasal mucosa. Gripex is a medicine intended for the treatment of adults and adolescents, as well as children over 6 years old.
The indication for the use of Gripex is the occasional treatment of symptoms of colds, flu, flu-like conditions, sinusitis (fever, runny nose, cough, headache, sore throat, muscle and joint pain).

2. Important information before taking Gripex

Taking this medicine can lead to addiction. Therefore, treatment should be short-term.

When not to take Gripex:

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during pregnancy and breastfeeding;
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Warnings and precautions

Before starting to take Gripex, you should discuss it with your doctor or pharmacist.
Gripex contains paracetamol.You should not take a dose higher than recommended.
Overdosing on paracetamol can lead to severe liver damage and even death.
The medicine should not be taken at the same time as other medicines containing paracetamol, such as painkillers, antipyretics, or medicines used to treat flu and cold symptoms.
Taking the medicine by people with liver failure, alcohol abusers, and fasting individuals poses a risk of liver damage.
You should not drink alcohol while taking the medicine.
The medicine should not be taken for chronic cough with expectoration.
While taking Gripex, you should immediately inform your doctor if you experience severe diseases, including severe kidney dysfunction 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 these situations, patients have reported the occurrence of a severe disease called metabolic acidosis (blood and body fluid disorder), when they took paracetamol in standard 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, nausea (nausea) and vomiting.
Caution should be exercised in patients with kidney failure, hypertension, heart rhythm disorders, chronic obstructive pulmonary disease (COPD), increased intraocular pressure, prostatic hyperplasia, hyperthyroidism, diabetes, respiratory failure, asthma, and in patients at risk of respiratory failure, taking anxiolytics, tricyclic antidepressants, other sympathomimetic medicines, i.e., decongestants, appetite suppressants, and psychostimulants similar to amphetamine.
Due to reported cases of dextromethorphan abuse, particular caution should be exercised when using Gripex in adolescents, young adults, and patients who abuse drugs or psychoactive substances.
Particular caution should be exercised in patients with slow metabolism involving the CYP2D6 enzyme or those taking substances that inhibit the activity of the CYP2D6 enzyme (listed in the "Gripex and other medicines" section). If you are taking medicines that inhibit the activity of the CYP2D6 enzyme before taking this medicine, you should consult your doctor. In the event of a need to take medicines that inhibit CYP2D6 activity and dextromethorphan at the same time, the patient must be under close medical supervision. It may be necessary to reduce the dose of dextromethorphan.
In patients with poor metabolism of this enzyme and in patients who are also taking medicines that inhibit CYP2D6 activity, increased and/or prolonged effects of dextromethorphan may occur. Concurrent use of medicines that strongly inhibit this enzyme increases the risk of dextromethorphan poisoning, manifested by stimulation, disorientation, tremors, insomnia, diarrhea, and respiratory depression. It can also lead to the development of life-threatening serotonin syndrome (rapid heartbeat, disorientation, excessive sweating, hallucinations, involuntary muscle movements, chills, tremors). If the above symptoms occur after taking Gripex, you should stop the treatment with this medicine and seek medical attention immediately.
If the patient experiences fever with generalized redness of the skin and pustular rash, they should stop taking Gripex and contact their doctor or seek medical attention immediately. See section 4.
If the patient is taking such medicines as certain antidepressants or antipsychotics, Gripex may interact with them, causing changes in mental state (e.g., stimulation, hallucinations, coma) and other symptoms, such as body temperature above 38°C, increased heart rate, unstable blood pressure, and excessive reflexes, muscle stiffness, lack of coordination, and (or) symptoms related to the digestive system (e.g., nausea, vomiting, diarrhea).
During the use of Gripex, sudden abdominal pain or rectal bleeding may occur due to inflammation of the colon (ischemic colitis). If such gastrointestinal symptoms occur, you should stop taking Gripex and seek medical attention immediately. See section 4.
During the use of Gripex, a decrease in blood flow in the optic nerve may occur. If sudden vision loss occurs, you should stop taking Gripex and seek medical attention immediately. See section 4.
After taking medicines containing pseudoephedrine, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported.
PRES and RCVS are rare diseases that may be associated with reduced blood flow to the brain.
In the event of symptoms that may be symptoms of PRES or RCVS, you should immediately stop taking Gripex and seek medical attention (symptoms, see section 4 "Possible side effects").
You should consult your doctor even if the above warnings concern situations that have occurred in the past.
If the symptoms worsen or do not improve after 3 days, you should contact your doctor.

Children

The medicine should not be taken by children under 6 years old.

Gripex and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking, or have recently taken, and about medicines you plan to take.
The interaction of Gripex with other medicines results from the interaction of the active substances that make up the medicine:
Paracetamol

• The medicine should not be taken at the same time as other medicines containing paracetamol.
• Medicines that accelerate gastric emptying (e.g., metoclopramide) accelerate the absorption of paracetamol.
• Medicines that delay gastric emptying (e.g., propanteline) may delay the absorption of paracetamol.
• Taking paracetamol at the same time as MAO inhibitors (used in the treatment of depression) and within 2 weeks after stopping treatment with these medicines may cause a state of stimulation and fever.

Dextromethorphan

• The medicine should not be taken with MAO inhibitors (medicines used in the treatment of depression).
• Concurrent use with medicines that inhibit the CYP2D6 enzyme, such as fluoxetine, paroxetine, quinidine, terbinafine, amiodarone, flecainide, propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine, and thioridazine, may increase the concentration of dextromethorphan in the blood.

Gripex with food, drink, or alcohol

Food does not significantly affect the absorption of the medicine.
You should not drink alcohol during the use of the medicine.

Pregnancy and breastfeeding

Taking Gripex during pregnancy and breastfeeding is contraindicated.

Driving and using machines

When taking Gripex, you should be cautious while driving vehicles and operating machines.

Gripex contains orange yellow S (E 110) and Allura red AC (E 129)

The medicine may cause allergic reactions.

3. How to take Gripex

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Gripex should be taken orally.
Recommended dose
Adults and adolescents over 12 years old:1 to 2 tablets, 3-4 times a day.
You should not take more than 8 tablets per day.
Children 6 to 12 years old:1 tablet, 3-4 times a day. You should not take a dose higher than 4 tablets per day.

Taking a higher dose of Gripex than recommended

In the event of an overdose in children, severe side effects may occur, including neurological disorders. Caregivers should not give the child a higher dose than recommended.

You should immediately consult a doctor or pharmacist. The medicine contains three active substances.

Symptoms of overdose may result from the action of one or all of the active substances.

In any case of taking a higher dose than recommended, you should immediately seek medical attention, even if the patient's condition is good and no symptoms of poisoning have been observed, due to the risk of delayed, severe liver damage, which may result in liver transplantation or death.
Accidental or intentional overdose of the medicine may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, general weakness, anxiety, tremors, involuntary muscle contractions, stimulation, confusion, impaired consciousness, coordination disorders, psychosis with visual hallucinations, and increased excitability.
There may be oculogyric crisis, cardiac disorders (rapid heartbeat), increased blood pressure, difficulty urinating.
Symptoms of a large overdose may include coma, severe respiratory disorders, and convulsions.
These symptoms may resolve the next day, despite the fact that liver damage is beginning to develop, which will then manifest as abdominal distension, return of nausea, and jaundice.
If any of the above symptoms occur, you should immediately consult a doctor or go to the hospital.
Treatment should be carried out in a hospital. It involves accelerating the elimination of the medicine's components from the body and maintaining vital functions. In the event of paracetamol overdose, it may be necessary to administer an antidote: N-acetylcysteine and/or methionine. The elimination of pseudoephedrine can be accelerated by forced diuresis or dialysis therapy.
To counteract the toxic effect of dextromethorphan on the central nervous system, the doctor may administer naloxone.

Missing a dose of Gripex

Gripex is intended for the occasional treatment of symptoms of colds, flu, and flu-like conditions.
If a dose of the medicine is missed and the symptoms persist, you should take the next dose of Gripex. You should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediately stop taking Gripex and seek medical attention if you experience symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache with a sudden onset,
• nausea,
• vomiting,
• confusion,
• seizures,
• vision changes.

Uncommon side effects (occurring in 1 to 10 in 1,000 patients taking the medicine):

• fatigue, dizziness;
• nausea and vomiting.

Rare side effects (occurring in 1 to 10 in 10,000 patients taking the medicine):

• allergic reactions type I: allergic edema (i.e., edema of the skin and soft tissues, often on the face, e.g., lips, tongue, eyelids), anaphylactic reaction (i.e., shortness of breath, sweating, decreased blood pressure up to symptoms of shock);
• skin allergic reactions, redness, rash.

Very rare side effects (occurring less frequently than 1 in 10,000 patients taking the medicine):

• disorders of blood cell production: granulocytopenia (decreased number of granulocytes in the blood), agranulocytosis (lack of granulocytes in the blood), thrombocytopenia (decreased platelet count);
• asthma attack;
• liver damage, most often due to overdose;
• renal colic, renal papillary necrosis, acute renal failure, urolithiasis;
• hallucinations.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• severe diseases affecting the blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS);
• drowsiness;
• rapid heartbeat (tachycardia);
• slight increase in blood pressure; urinary disorders, urinary retention, especially in patients with prostatic hyperplasia;
• ischemic colitis (inflammation of the colon due to insufficient blood supply);
• sudden fever, redness of the skin, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of taking Gripex. See section 2. If such symptoms occur, you should stop taking Gripex and contact your doctor or seek medical attention immediately;
• decreased blood flow in the optic nerve (ischemic optic neuropathy);
• a serious disease that can cause acidification of the blood (metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl/
Side effects can also be reported to the marketing authorization holder.

• By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Gripex

Do not store above 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack (month/year). The expiry date refers to the last day of the month.
The labeling used for the blister is: EXP - expiry date, Lot - batch number.
Medicines should not be disposed of via wastewater or household waste. You should 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 contains:

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The active substances of the medicine are: paracetamol, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide. Each coated tablet contains: 325 mg of paracetamol, 30 mg of pseudoephedrine hydrochloride, and 10 mg of dextromethorphan hydrobromide.
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The other ingredients are:
Core:
microcrystalline cellulose, pregelatinized starch, colloidal silica, stearic acid, povidone, crospovidone.
Coating:
(Opadry II Orange Y-22-13204): hypromellose, titanium dioxide (E 171), macrogol, polydextrose, triacetin, orange yellow S (E 110), Allura red AC (E 129).
Ink for printing:
(Opacode Black S-1-17823): shellac, iron oxide black (E 172), n-butyl alcohol, isopropyl alcohol, ammonium hydroxide, propylene glycol.

What Gripex looks like and what the pack contains

Orange-colored, round, coated tablets with black printing "Gripex" on one side.

Pack sizes:

Blisters of PVC/PVDC/Aluminum in a cardboard box.
10 tablets (1 blister of 10 tablets)
12 tablets (1 blister of 12 tablets)
24 tablets (2 blisters of 12 tablets)
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
Ziębicka 40
50-507 Wrocław

• For more detailed information on this medicine, you should contact:
  USP Zdrowie Sp. z o.o.
  Poleczki 35
  02-822 Warsaw, tel.: +48 (22) 543 60 00

Date of last revision of the leaflet: