Gripex Forte

Leaflet attached to the packaging: patient information

Gripex FORTE, 500 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 you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

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

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

Gripex Forte is a combination medicine. It contains three active substances: paracetamol, pseudoephedrine
hydrochloride, and dextromethorphan hydrobromide. Paracetamol acts as an antipyretic and analgesic,
dextromethorphan acts as an antitussive, and pseudoephedrine restores nasal patency.
Gripex Forte is a medicine intended for the treatment of adults and adolescents over 12 years of age.
The indication for using Gripex Forte is the short-term treatment of severe symptoms of
the common cold, flu, and flu-like conditions: fever, runny nose, dry cough, headache, sore throat,
muscle and joint pains.
Without consulting a doctor, the medicine should not be used for more than 3 days.

2. Important information before using Gripex Forte

When not to use Gripex Forte:

• if you are allergic to paracetamol, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, or any of the other ingredients of this medicine (listed in section 6);
• if you are taking other medicines containing paracetamol, pseudoephedrine, or dextromethorphan;
• if you are taking monoamine oxidase inhibitors (MAOIs) (medicines used, among others, in depression), as well as within 2 weeks of stopping their use;
• if you have hemolytic anemia or a congenital deficiency of glucose-6-phosphate dehydrogenase;
• if you have severe liver failure;
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension;
• if you have severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• if you have ischemic heart disease;
• in patients with alcoholism;
• in patients with asthma;
• if you have respiratory failure or are at risk of respiratory failure;
• during pregnancy and breastfeeding;
• in children under 12 years of age.

Warnings and precautions

Before starting to use Gripex Forte, you should discuss it with your doctor or pharmacist.
Taking this medicine may lead to dependence. Therefore, treatment should be short-term.
The medicine contains paracetamol. Do not take it at the same time as other medicines containing paracetamol. In case of overdose, contact your doctor immediately, even if no symptoms have occurred, as it may lead to life-threatening liver damage.
Do not take it at the same time as other medicines containing dextromethorphan and pseudoephedrine.
Taking the medicine by people with liver failure, alcohol abusers, and fasting individuals carries a risk of liver damage. Cases of liver failure have been reported in patients taking paracetamol in states of reduced glutathione levels, especially in severely malnourished patients, those suffering from anorexia, having a low body mass index (BMI), and regularly drinking alcohol or suffering from sepsis.
During the use of Gripex Forte, you should immediately inform your doctor if you have 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 taking paracetamol in standard doses for a longer period or taking paracetamol with flucloxacillin have been reported to develop a severe condition called metabolic acidosis (a blood and body fluid disorder), which can be life-threatening. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea (nausea) and vomiting.
Be cautious when using the medicine in patients with kidney failure, pheochromocytoma, hypertension, heart rhythm disorders, chronic obstructive pulmonary disease (COPD), increased intraocular pressure, prostatic hyperplasia, hyperthyroidism, diabetes, patients with methemoglobin reductase deficiency, and those taking anxiolytics, tricyclic antidepressants, other sympathomimetic medicines, e.g., decongestants, appetite suppressants, and psychostimulants similar to amphetamine.
The medicine should not be used in chronic cough with expectoration, e.g., accompanying smoking, bronchitis.
The medicine should not be used in patients with respiratory failure, asthma, or those at risk of respiratory failure.
The medicine should be used with caution in patients taking anticoagulant medicines.
Due to reported cases of dextromethorphan and pseudoephedrine abuse, particular caution should be exercised when using Gripex Forte in adolescents, young adults, and patients abusing medicines or psychoactive substances.
Particular caution should be exercised in patients with poor metabolism of this enzyme and in patients also taking medicines that inhibit CYP2D6 activity (see "Gripex Forte and other medicines"), as increased and/or prolonged effects of dextromethorphan may occur.
Concomitant use of medicines that strongly inhibit this enzyme increases the risk of dextromethorphan poisoning, manifested by agitation, disorientation, tremors, insomnia, diarrhea, and respiratory depression. It can also lead to the development of life-threatening serotonin syndrome (involuntary, rhythmic muscle contractions, including those controlling eye movement, agitation, excessive sweating, tremors, increased reflexes, muscle tension, body temperature above 38°C). If the above symptoms occur after using Gripex Forte, treatment should be discontinued, and medical advice should be sought immediately. If the patient knows that they quickly metabolize this type of medicine or have experienced the above symptoms in the past when taking this type of medicine, they should not use Gripex Forte without consulting a doctor.
The medicinal product should be discontinued if neurological symptoms such as nervousness, dizziness, and insomnia occur during treatment.
The medicine should be avoided in patients with atopic dermatitis, as dextromethorphan may exacerbate allergic reactions.
During the use of Gripex Forte, sudden abdominal pain or rectal bleeding may occur due to inflammation of the colon (ischemic colitis). If such gastrointestinal symptoms occur, the use of Gripex Forte should be discontinued, and medical advice or assistance should be sought immediately. See section 4.
If the patient develops a fever with generalized redness of the skin and a pustular rash, they should discontinue taking Gripex Forte and contact their doctor or seek medical assistance immediately. See section 4.
During the use of Gripex Forte, a decrease in blood flow in the optic nerve may occur. If sudden vision loss occurs, the use of Gripex Forte should be discontinued, and medical advice or assistance should be sought immediately. See section 4.
After using 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 that may be symptoms of PRES or RCVS occur, the use of Gripex Forte should be discontinued immediately, and medical assistance should be sought immediately (symptoms, see section 4 "Possible side effects").
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 Forte 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 Forte with other medicines results from the interaction of the active substances contained in the medicine:
Paracetamol

• The medicine should not be used 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, pethidine, pentazocine, diamorphine) may delay the absorption of paracetamol.
• Taking paracetamol at the same time as monoamine oxidase inhibitors (MAOIs) (used in the treatment of, among others, depression) and within 2 weeks after stopping treatment with these medicines may cause a state of agitation and fever.
• Concomitant 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, such as warfarin, acenocoumarol, or dicoumarol).
• Concomitant 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 and isoniazid (used in the treatment of, among others, tuberculosis), may lead to liver damage, even when paracetamol is used in recommended doses.
• Paracetamol accelerates the elimination of lamotrigine from the body.
• Certain medicines acting on beta-adrenergic receptors may decrease (salbutamol) or increase (propranolol) the absorption of paracetamol.
• Concomitant administration of an antihistamine (nizatidine) with paracetamol increases the paracetamol concentration in blood serum.
• Caffeine enhances the analgesic effect of paracetamol.
• Concomitant administration with chloramphenicol (a broad-spectrum antibiotic) may increase the chloramphenicol concentration in blood serum.
• 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 (metabolic acidosis), which must be treated urgently (see section 2).

Pseudoephedrine

• The medicine should not be used at the same time as other medicines containing pseudoephedrine.
• Concomitant use with albuterol (used, among others, in the treatment of asthma) may enhance the vasoconstrictive effect.
• The medicine should not be used at the same time as amitriptyline (used, among others, in depression) and sympathomimetics (used in the treatment of bronchospasm, e.g., in asthma).
• Concomitant use with other sympathomimetics, such as decongestants, appetite suppressants, or substances with psychostimulant effects 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 (e.g., aluminum hydroxide, used to relieve heartburn and indigestion) may increase the absorption of pseudoephedrine.
• Monoamine oxidase inhibitors (MAOIs) (used in the treatment of 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).
• The medicine should not be used at the same time as furazolidone (an antibacterial medicine).

Dextromethorphan

• The medicine should not be used at the same time as other medicines containing dextromethorphan.
• The medicine should not be used with monoamine oxidase inhibitors (MAOIs) (medicines used in the treatment of depression).
• Dextromethorphan may enhance the effect of alcohol, antihistamines, and psychotropic medicines on the central nervous system.
• Concomitant administration of dextromethorphan with nonsteroidal anti-inflammatory medicines, such as ketorolac and tenoxicam, may increase their analgesic effect.
• The dose and duration of the product should be limited when concomitantly taking opioid and sedative medicines, due to the risk of excessive sedation, respiratory depression, coma, or death.
• 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 dextromethorphan concentration in the blood (see "Warnings and precautions").

Gripex Forte with food, drink, or alcohol

During the use of the medicine, you should not drink alcohol. Drinking alcohol during paracetamol treatment leads to the formation of a toxic metabolite that causes liver cell necrosis, which can lead to liver failure.

Pregnancy and breastfeeding

Gripex Forte should not be used during pregnancy and breastfeeding.

Driving and using machines

During the use of the medicine, you should be cautious when driving vehicles and operating machines due to the possibility of dizziness and drowsiness.

Gripex Forte contains tartrazine, lake (E 102).

The medicine may cause allergic reactions.

3. How to use Gripex Forte

This medicine should always be used exactly as described in the patient leaflet or as directed by
your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
Gripex Forte should be used orally.
Recommended dose
Adults and adolescents over 12 years of age:1 or 2 tablets, which can be repeated
3 to 4 times a day if necessary.
Do not take more than 8 tablets per day.
You should consult your doctor if symptoms worsen or do not improve after 3 days.
Do not take a higher dose than recommended. You should use the lowest effective dose of the medicine for the shortest possible time.

Using a higher than recommended dose of Gripex Forte

You should immediately contact your doctor. The medicine contains three active substances. Overdose symptoms may result from the action of one or all of the active substances.
Overdose of the medicine may cause symptoms such as nausea, vomiting, dilated pupils, excessive sweating, drowsiness, general weakness, anxiety, tremors within a few or several hours. Oculogyric crisis, increased blood pressure, rapid heart rate, seizures, difficulty urinating, and shortness of breath may also occur. These symptoms may resolve the next day, despite the fact that life-threatening liver damage is beginning to develop, which will then become apparent with abdominal pain, return of nausea, and jaundice. In case of overdose, you should immediately contact your doctor. Overdose treatment should be carried out in a hospital and 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 Forte

Gripex Forte is used for the temporary treatment of symptoms of the common cold, flu, and flu-like conditions. If a dose is missed and symptoms persist, the next dose of Gripex Forte should be taken. 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.
You should immediately discontinue the use of Gripex Forte and seek medical assistance if symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) occur. These include:

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

If the following side effects occur, you should immediately contact your doctor or seek medical assistance:

• type I hypersensitivity reactions: 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) (rare);
• skin allergic reactions, redness, rash (rare):
• severe skin reactions (very rare in the case of paracetamol), including sudden fever, redness of the skin, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP, unknown frequency in the case of pseudoephedrine) may occur within the first 2 days of using Gripex Forte. See "Warnings and precautions" in section 2.
• asthma attack (very rare);
• liver damage, most often due to overdose (very rare);
• kidney colic, renal papillary necrosis, acute kidney failure (very rare);
• urination disorders, urinary retention, especially in patients with prostatic hyperplasia (very rare);
• ischemic colitis (see also "Warnings and precautions").

Other side effects:

Uncommon side effects (less frequent than 1 in 100 patients using the medicine):

• fatigue.

Rare side effects (less frequent than 1 in 1000 patients using the medicine):

• nausea and vomiting.

Very rare side effects (less frequent than 1 in 10,000 patients using the medicine):

• blood cell production disorders: granulocytopenia (decreased granulocyte count in the blood), agranulocytosis (lack of granulocytes in the blood), thrombocytopenia (decreased platelet count);
• kidney stones.

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

• severe conditions affecting the blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS);
• dizziness;
• drowsiness;
• hallucinations (especially in children);
• rapid heart rate (tachycardia);
• mild increase in blood pressure;
• decreased blood flow in the optic nerve (ischemic optic neuropathy);
• a serious condition that can cause blood acidification (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 this 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.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Gripex Forte

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.
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 packaging and other information

What Gripex Forte 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 10 mg of dextromethorphan hydrobromide.
• Other ingredients are: Tablet core:povidone K30, cornstarch, crospovidone (type A), microcrystalline cellulose, stearic acid 50, anhydrous colloidal silica. Coating:hypromellose type 2910, 6 mPas, titanium dioxide (E 171), tartrazine, aluminum lake (E 102), macrogol 400. Printing ink: shellac, iron oxide black (E 172), n-butyl alcohol, isopropyl alcohol, ammonium hydroxide, propylene glycol.

What Gripex Forte looks like and what the packaging contains

Coated tablets are yellow, round, with black printing Gripex F on one side.
The dimensions of each tablet are approximately 12 mm x 8 mm.

Available packaging:

10 tablets (1 blister of 10 tablets);
20 tablets (2 blisters of 10 tablets).
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, you should contact the representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
tel.: +48 (22) 543 60 00

Date of last revision of the leaflet: