Gripex Max

Leaflet attached to the packaging: patient information

GRIPEX MAX, 500 mg + 30 mg + 15 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 advised by
the 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 there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Gripex Max is a combination medicine. It contains three active substances: paracetamol, pseudoephedrine,
and dextromethorphan. Paracetamol acts as an antipyretic and analgesic, dextromethorphan acts as an
antitussive, and pseudoephedrine restores nasal patency. Gripex Max is a medicine intended for the
treatment of adults and adolescents over 12 years of age. The indication for the use of Gripex Max is
the short-term treatment of severe symptoms of colds, flu, and flu-like conditions, such as: fever, headache,
sore throat, muscle and joint pain, runny nose, dry cough.

2. Important information before taking Gripex Max

Taking this medicine may lead to dependence. Therefore, treatment should be short-term.

When not to take Gripex Max:

• if the patient is hypersensitive to paracetamol, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking other medicines containing paracetamol;
• if the patient is taking MAO inhibitor medicines (used in depression), as well as within 2 weeks of stopping their use;
• if there is a congenital deficiency of glucose-6-phosphate dehydrogenase;
• if there is severe liver failure;
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension;
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• if there is coronary heart disease;
• in patients with alcoholism;
• in patients with asthma;
• during pregnancy and breastfeeding;
• in children under 12 years of age.

Warnings and precautions

Before starting treatment with Gripex Max, you should discuss it with your doctor or pharmacist.
The medicine contains paracetamol.You should not take other medicines containing paracetamol (e.g., some medicines used to relieve cold and flu symptoms) due to the risk of overdose and potentially life-threatening liver damage. It is not recommended to use the medicine for a long time or frequently.
You should not take a higher daily dose than recommended. In case of overdose, you should immediately contact your doctor, even if you feel well.
See also section 3 "Taking a higher dose of Gripex Max than recommended".
Taking the medicine by people with liver failure, alcohol abuse, and starvation carries a risk of liver damage. You should use it with caution in patients with kidney failure, hypertension, heart rhythm disorders, chronic obstructive pulmonary disease, increased intraocular pressure, prostatic hyperplasia, hyperthyroidism, diabetes, and in patients taking anxiolytic, tricyclic antidepressant, and other sympathomimetic medicines, i.e., decongestants, appetite suppressants, or psychostimulants similar to amphetamine.
The medicine should not be used in chronic cough with expectoration. The medicine should not be used in patients with respiratory failure, asthma, or patients at risk of respiratory failure.
The medicine should be used with caution in patients taking anticoagulant medicines. You should not drink alcohol while taking the medicine.
Due to reported cases of dextromethorphan abuse, you should be particularly cautious when using Gripex Max in adolescents, young adults, and patients who abuse medicines or psychoactive substances.
You should be particularly cautious in patients with slow metabolism involving the CYP2D6 enzyme or taking substances that inhibit the activity of the CYP2D6 enzyme (listed in the "Gripex Max 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. If it is necessary 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 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 Max, you should stop the treatment and seek medical attention immediately.
If the patient develops a fever with generalized redness of the skin and a pustular rash, they should stop taking Gripex Max and contact their doctor or seek medical attention immediately. See section 4.
While taking Gripex Max, you should immediately inform your doctor if you experience severe 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 these situations, patients have developed a severe condition called metabolic acidosis (a blood and body fluid disorder), when they took paracetamol in regular doses for a longer period or took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
While taking Gripex Max, 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 Max and seek medical attention immediately. See section 4.
While taking Gripex Max, a decrease in blood flow in the optic nerve may occur. If you experience sudden vision loss, you should stop taking Gripex Max and contact your doctor or seek medical attention immediately. See section 4.
After taking pseudoephedrine-containing medicines, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported.
PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain.
If symptoms occur that may be symptoms of PRES or RCVS, you should immediately stop taking Gripex Max and seek medical attention (symptoms, see section 4 "Possible side effects").
If you are taking certain antidepressant or antipsychotic medicines, Gripex Max 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 exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
If the symptoms worsen or do not improve after 3 days, you should contact your doctor.
You should consult your doctor, even if the above warnings refer to situations that have occurred in the past.

Children

The medicine should not be used in children under 12 years of age.

Gripex Max and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The interaction of Gripex Max with other medicines results from the interaction of the active substances contained in the medicine:
Paracetamol

• The medicine should not be used concurrently with 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 concurrently with MAO inhibitor medicines (used in depression) and within 2 weeks after stopping their use may cause stimulation and fever.
• Concurrent use of paracetamol with zidovudine (AZT, a medicine used in HIV infection) may enhance the toxic effect of zidovudine on the bone marrow.
• Paracetamol may enhance the effect of anticoagulant medicines (coumarin derivatives).
• Concurrent use of paracetamol and medicines that increase liver metabolism, such as certain sedatives or antiepileptic medicines (e.g., phenobarbital, phenytoin, carbamazepine), as well as rifampicin (used in tuberculosis), may lead to liver damage, even when taking the recommended doses of paracetamol.
• Drinking alcohol during paracetamol treatment leads to the formation of a toxic metabolite that causes liver cell necrosis, which can lead to liver failure.
• Concomitant use with chloramphenicol (a broad-spectrum antibacterial antibiotic) may increase the concentration of chloramphenicol in the blood.
• You should inform your doctor or pharmacist if you are taking 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).

Pseudoephedrine

• Concurrent use with albuterol (used in asthma) may enhance the vasoconstrictive effect.
• Do not use concurrently with amitriptyline (used in depression) and sympathomimetics (used in bronchial spasm, e.g., in asthma).
• Concurrent use with other sympathomimetics, such as decongestants, appetite suppressants, or substances with psychostimulant activity similar to amphetamine, may cause increased blood pressure.
• Ammonium chloride, by alkalizing the urine, increases the reabsorption of pseudoephedrine metabolites in the kidneys and prolongs its duration of action.
• Antacids (used to relieve heartburn and indigestion) may increase the absorption of pseudoephedrine.
• MAO inhibitors (used in depression) cause slower elimination of pseudoephedrine from the body and increase its bioavailability.
• Pseudoephedrine reduces the effect of antihypertensive medicines and may modify the effect of digitalis glycosides (used in heart failure).
• Do not use concurrently with furazolidone (an antibacterial medicine).

Dextromethorphan

• Do not use with MAO inhibitors (medicines used in depression).
• Medicines that reduce the activity of 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 Max with food, drink, or alcohol

Food does not significantly affect the absorption of the medicine.
You should not drink alcohol while taking the medicine.

Pregnancy and breastfeeding

Taking Gripex Max during pregnancy and breastfeeding is contraindicated.

Driving and using machines

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

Gripex Max contains tartrazine, lake (E 102).

The medicine may cause allergic reactions.

3. How to take Gripex Max

This medicine should always be used exactly as described in the patient leaflet or as advised by
the doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
Gripex Max should be taken orally.
Recommended dose
Adults and adolescents over 12 years of age:1 to 2 tablets, 3-4 times a day.
You should not take more than 8 tablets per day.

Taking a higher dose of Gripex Max than recommended

You should immediately contact your 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.

If you take a higher dose of Gripex Max than you should, within a few, dozen hours, the following symptoms may occur: nausea, vomiting, involuntary muscle contractions, excessive sweating, stimulation, increased excitability, confusion, drowsiness, general weakness, anxiety, tremors, disturbances of consciousness, involuntary rapid eye movements, nystagmus, increased blood pressure, cardiac disorders (rapid heartbeat), coordination disorders, psychosis with visual hallucinations, difficulty urinating, and shortness of breath.
Other symptoms of a large overdose may include: coma, severe respiratory disorders, and convulsions.
These symptoms may resolve the next day, despite the fact that life-threatening liver damage is developing, which will then manifest as abdominal distension, return of nausea, and jaundice.
In case of overdose or occurrence of any of the above symptoms, you should immediately contact your doctor or go to the hospital.
Treatment of Gripex Max overdose 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 case of paracetamol overdose, it may be necessary to administer an antidote: N-acetylcysteine and/or methionine.

Missing a dose of Gripex Max

Gripex Max is used for the temporary treatment of cold and flu symptoms and flu-like conditions.
If you miss a dose of the medicine and the symptoms persist, you should take the next dose of Gripex Max. 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 Max 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 out of 1,000 patients taking the medicine):

• fatigue, dizziness;
• nausea and vomiting.

Rare side effects (occurring in 1 to 10 out of 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):

• blood cell production disorders: 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;
• kidney colic, renal papillary necrosis, acute kidney failure, kidney stones;
• hallucinations.

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

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severe conditions affecting the blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS);
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drowsiness;
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rapid heartbeat (tachycardia);
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mild increase in blood pressure;
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urination disorders, urinary retention, especially in patients with prostatic hyperplasia;
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inflammation of the colon due to insufficient blood supply (ischemic colitis);
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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 Max. See section 2.
If such symptoms occur, you should stop taking Gripex Max and contact your doctor or seek medical attention immediately;

• decreased blood flow in the optic nerve (ischemic optic neuropathy);
• a serious condition that can cause blood acidification (called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should 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 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 Max

Medicine packaged in a container or in sachets in a cardboard box: no special storage precautions.
Medicine packaged in blisters in a cardboard box: 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 packaging (month/year). The expiry date refers to the last day of the stated month.
Labeling used for blisters: 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 packaging and other information

What Gripex Max contains:

• The active substances of the medicine are paracetamol, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide. Each coated tablet contains 500 mg of paracetamol, 30 mg of pseudoephedrine hydrochloride, and 15 mg of dextromethorphan hydrobromide. The other ingredients are:

Core:
powdered cellulose, microcrystalline cellulose, pregelatinized starch, crospovidone, colloidal anhydrous silica, stearic acid.
Coating:
(yellow coating system): hypromellose, titanium dioxide (E 171), tartrazine, lake (E 102), macrogol 400.
Printing ink:
(Opacode Black S-1-17823): shellac, iron oxide black (E 172), n-butyl alcohol, isopropyl alcohol, ammonium hydroxide, propylene glycol.
Carnauba wax.

What Gripex Max looks like and what the pack contains

Yellow, round, coated tablets with a black print Gripex M on one side.

Available packs:

Blisters of PVC/PVDC/Aluminum in a cardboard box:
6 pieces (1 blister of 6 pieces);
10 pieces (1 blister of 10 pieces);
12 pieces (1 blister of 12 pieces);
20 pieces (2 blisters of 10 pieces).
Sachets of paper/PE/Aluminum/PE in a cardboard box:
6 pieces (3 sachets of 2 pieces).
HDPE container with an HDPE cap in a cardboard box:
20 pieces (1 container of 20 pieces).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
Ziębicka 40
50-507 Wrocław
To obtain more detailed information, 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: