Gripex noc

Patient Information Leaflet

Gripex Noc, coated tablets
Combination product
Please read the entire leaflet carefully before using this 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 a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if your condition worsens, consult your doctor.

Contents of the leaflet

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

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

Gripex Noc is a multi-component medicine with comprehensive analgesic, antipyretic, and antitussive effects. It reduces swelling of the nasal and paranasal sinus mucosa, clears nasal passages, and decreases mucus secretion. The mild sedative and hypnotic effect of chlorpheniramine facilitates falling asleep.
Gripex Noc is indicated for the relief of symptoms of cold, influenza, and influenza-like conditions such as fever, nasal congestion, sneezing, swelling of the nasal and paranasal sinus mucosa, dry cough, headache, sore throat, and muscle and joint pain.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Gripex Noc

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

When not to use Gripex Noc:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6)
• in patients with congenital glucose-6-phosphate dehydrogenase deficiency;
• in patients with severe liver impairment;
• in cases of viral hepatitis;
• in cases of very high blood pressure (severe hypertension) or hypertension that cannot be controlled with medication;
• in cases of severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• in cases of unstable coronary artery disease;
• in cases of alcoholic liver disease;
• during treatment with MAO inhibitors (medicines used, among others, for depression) or zidovudine. Do not use during pregnancy and while breastfeeding. Do not use in children under 12 years of age.

Warnings and precautions

The medicine contains paracetamol
Due to the risk of overdose, check whether other medicines being used contain paracetamol. Paracetamol overdose may lead to life-threatening liver damage.
Before starting treatment with Gripex Noc, discuss this with your doctor or pharmacist.
Special caution is required in patients with kidney or liver impairment, high blood pressure, heart disease, asthma, lung or bronchial disorders, glaucoma, epilepsy, thyroid disorders, benign prostatic hyperplasia, or diabetes. Consult a doctor before taking the medicine. Alcohol must not be consumed during treatment. The risk of liver damage is particularly high in fasting individuals and in regular alcohol drinkers.

Due to reported cases of abuse of dextromethorphan, special caution should be exercised when using Gripex Noc in adolescents, young adults, and patients with a history of drug or psychoactive substance abuse.

Special caution is required in patients who are poor metabolizers via the CYP2D6 enzyme or who are taking substances that inhibit CYP2D6 enzyme activity (listed in section "Gripex Noc and other medicines"). If taking medicines that inhibit CYP2D6 enzyme activity, consult a doctor before using this medicine. If it is necessary to use CYP2D6-inhibiting medicines together with dextromethorphan, the patient must be under strict medical supervision. A reduced dose of dextromethorphan may be required.

In patients who are poor metabolizers of this enzyme and in patients taking other medicines that inhibit CYP2D6 activity, enhanced and/or prolonged effects of dextromethorphan may occur. Concurrent use of strong inhibitors of this enzyme increases the risk of dextromethorphan toxicity, manifesting as agitation, disorientation, tremor, insomnia, diarrhea, and respiratory depression. It may also lead to the development of life-threatening serotonin syndrome (rapid heartbeat, disorientation, profuse sweating, hallucinations, involuntary muscle movements, chills, tremors). If any of the above symptoms occur after taking Gripex Noc, discontinue treatment immediately and seek medical advice without delay.

If cough persists for more than 7 days or fever for more than 3 days from the start of treatment, contact your doctor.

The chlorpheniramine contained in the medicine causes drowsiness; therefore, Gripex Noc should be taken only before bedtime.

During treatment with Gripex Noc, immediately inform your doctor if the patient has severe illnesses, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In such cases, patients have been reported to develop a serious condition called metabolic acidosis (abnormality in blood and body fluids) when taking paracetamol regularly for 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.

During treatment with Gripex Noc, sudden abdominal pain or rectal bleeding due to inflammation of the large intestine (ischemic colitis) may occur. If such gastrointestinal symptoms occur, discontinue use of Gripex Noc immediately and seek medical advice or medical help without delay. See section 4.

During treatment with Gripex Noc, reduced blood flow to the optic nerve may occur. If sudden vision loss occurs, discontinue use of Gripex Noc immediately and contact a doctor or seek medical help without delay. See section 4.

Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine. PRES and RCVS are rare conditions that may involve reduced blood flow to the brain.

If symptoms suggestive of PRES or RCVS occur, immediately discontinue use of Gripex Noc and seek immediate medical help (symptoms, see section 4 "Possible side effects").

If the patient is taking medicines such as certain antidepressants or antipsychotics, Gripex Noc may interact with them, causing changes in mental state (e.g., agitation, hallucinations, coma) and other symptoms such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

If the patient develops fever with generalized skin redness and blistering rash, stop taking Gripex Noc and contact a doctor or seek immediate medical help. See section 4.

Children
Use of the medicine in children under 12 years of age is contraindicated (see section When not to use Gripex Noc).

Gripex Noc and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Do not use Gripex Noc simultaneously with other medicines containing paracetamol, dextromethorphan, pseudoephedrine, or chlorpheniramine, or with phenytoin, carbamazepine, rifampicin, and phenobarbital. If the patient is taking anticoagulants, blood pressure-lowering medicines, oral antidiabetic medicines, sedatives, opioid painkillers, or antidepressants, consult a doctor before starting treatment.

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 blood levels of dextromethorphan.

Inform your doctor or pharmacist if the patient is taking flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).

Pregnancy and breastfeeding
Use of this medicine during pregnancy and while breastfeeding is contraindicated (see section When not to use Gripex Noc).

Driving and operating machinery
During treatment with this medicine, do not drive or operate machinery.

3. How to use Gripex Noc

This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
Adults and adolescents aged 12 years and over: 1 or 2 tablets immediately before bedtime (do not use more than 8 tablets per day). A 4-6 hour interval must be maintained between doses.
Do not use Gripex Noc for longer than 3 days without medical advice.
Method of administration
Oral administration.
Use of a higher than recommended dose of Gripex Noc
If more than the recommended dose has been taken, seek medical advice immediately, even if the patient feels well.
Gripex Noc contains four active substances. Symptoms of overdose may result from the effects of one or all of these active substances.
The consequences of overdose with the medicinal product Gripex Noc are primarily related to the hepatotoxicity of paracetamol. Accidental or intentional overdose of Gripex Noc may cause symptoms within a few to several hours such as nausea, vomiting, excessive sweating, drowsiness and general weakness. These symptoms may subside the next day, despite the onset of potentially life-threatening liver damage, which subsequently manifests as upper abdominal discomfort, recurrence of nausea and jaundice. Paracetamol overdose can lead to liver failure, which may require liver transplantation or result in death.
If any of the above symptoms occur, immediate hospitalization is required.
Missed dose of Gripex Noc
Gripex Noc is intended for temporary relief of symptoms of cold, flu and flu-like conditions. If a dose is missed and symptoms persist, take the next dose of Gripex Noc as scheduled. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must immediately stop taking Gripex Noc and seek immediate medical help if you experience symptoms indicating:

• posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), including:
• sudden, severe headache,
• nausea,
• vomiting,
• confusion,
• seizures,
• visual disturbances.
• a serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2);
• severe skin reactions characterized by erythematous-swelling lesions (erythema multiforme), blistering and epidermal necrosis (Stevens-Johnson syndrome), or even necrosis and shedding of large areas of skin (toxic epidermal necrolysis);
• laryngeal edema, anaphylactic shock (a severe allergic reaction characterized by low blood pressure, pale skin, sweating, disturbances of consciousness, reduced urine output, rapid breathing, swelling) and dizziness;

Adverse reactions occurring frequently (may affect less than 1 in 10 patients):

• central nervous system depression manifesting as drowsiness, nausea and muscle weakness, which may resolve after 2–3 days of treatment in some patients; facial dyskinesias, coordination disorders (stiffness), tremors, paresthesias;
• dizziness;
• blurred vision, double vision;
• dryness of nasal and pharyngeal mucous membranes, drying of mucous membranes;
• dry mouth, loss of appetite, disturbances in taste and smell perception;
• gastrointestinal complaints (nausea, vomiting, diarrhea, constipation, epigastric pain), which may be reduced when taken with food;
• excessive sweating;
• urinary retention and (or) difficulty urinating;

Adverse reactions occurring not frequently (may affect less than 1 in 100 patients):

• anaphylactic reactions (cough, difficulty swallowing, rapid heartbeat, itching, eyelid or periorbital, facial, tongue swelling, shortness of breath, fatigue, etc.);
• hypersensitivity reactions, photosensitivity, cross-sensitivity to similar medicines;
• moderate fatigue;
• tinnitus, acute labyrinthitis;
• impotence, intermenstrual bleeding;
• chest tightness, dyspnea;
• hypotension, hypertension, edema; cardiac arrhythmias, palpitations, tachycardia (usually in cases of overdose);

Adverse reactions occurring rarely (may affect less than 1 in 1000 patients):

• non-hemolytic anemia (not related to red blood cell destruction), bone marrow suppression, thrombocytopenia;
• laryngeal edema, anaphylactic shock (a severe allergic reaction characterized by low blood pressure, pale skin, sweating, disturbances of consciousness, reduced urine output, rapid breathing, swelling);
• edema;
• acute and chronic pancreatitis, hemorrhage, abdominal pain;
• liver failure, hepatic necrosis, jaundice, cholestasis (bile stasis), hepatitis or other liver function disorders (including epigastric or abdominal pain, dark urine color, etc.);
• itching, rash, sweating, purpura, angioedema, urticaria;
• nephropathies (kidney diseases) and tubulopathies (diseases causing renal tubular dysfunction), kidney damage associated with overdose, nephrotoxic effects (not observed at therapeutic doses except in cases of chronic use), uncontrolled urination;
• blood morphology disorders (agranulocytosis - significant decrease in certain types of white blood cells, leukopenia - reduced white blood cell count, aplastic anemia - resulting from impaired bone marrow function, or thrombocytopenia - reduced platelet count), with symptoms such as unusual bleeding, sore throat or fatigue;
• paradoxical excitation, especially when high doses are used in children or elderly patients, characterized by restlessness, anxiety, insomnia, nervousness, hallucinations, palpitations, and seizures;

Adverse reactions occurring very rarely (may affect less than 1 in 10,000 patients):

• drowsiness, hallucinations; development of dependence in case of abuse;

Adverse reactions with unknown frequency (cannot be estimated from available data):

• serious conditions affecting cerebral blood vessels known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS); colitis of the large intestine due to insufficient blood supply (ischemic colitis); sudden fever, skin redness or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of using Gripex Noc. See section 2; reduced blood flow in the optic nerve (ischemic optic neuropathy). If such symptoms occur, discontinue use of Gripex Noc and contact a doctor or seek immediate medical help.
• a serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2);
• severe skin reactions characterized by erythematous-swelling lesions (erythema multiforme); blistering and epidermal necrosis (Stevens-Johnson syndrome), or even necrosis and shedding of large areas of skin (toxic epidermal necrolysis);
• increased thirst, excessive sweating;
• rashes;
• muscle weakness;
• gastrointestinal dysfunction, dyspepsia;
• restlessness, anxiety, insomnia;

Paracetamol is a widely used medicine, and reports of adverse reactions are rare and usually associated with overdose.
Reporting of adverse reactions
If any adverse symptoms occur, including any 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 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Gripex Noc

Do not store above 25 °C.
Keep the medicine in a place invisible and out of reach of children.
Do not use this medicine after the expiry date stated on the carton and immediate packaging (month/year). The expiry date refers to the last day of the stated month.
Blister labelling: EXP - expiry date, Lot - batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Gripex Noc contains
One coated tablet contains the active substances:
500 mg paracetamol
30 mg pseudoephedrine hydrochloride
15 mg dextromethorphan hydrobromide
2 mg chlorpheniramine maleate
The other ingredients are:
tablet core: pregelatinized starch, povidone, stearic acid, microcrystalline cellulose,
crospovidone, colloidal anhydrous silica, brilliant blue (E 133), indigo carmine, lake (E 132);
coating: polydextrose, titanium dioxide (E 171), hypromellose, brilliant blue, lake (E 133),
triacetin, Macrogol 8000, Macrogol 400;
printing ink: Opacode Black S-1-17823 (shellac, iron oxide black (E 172), n-butyl alcohol,
isopropyl alcohol, ammonium hydroxide, propylene glycol).

What Gripex Noc looks like and contents of the pack
Blue, round coated tablets with a black "Gripex N" imprint on one side.

Available pack sizes:
6 tablets (3 sachets containing 2 tablets each).
6 tablets (1 blister containing 6 tablets).
12 tablets (1 blister containing 12 tablets).
12 tablets (2 blisters containing 6 tablets each).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
ul. Ziębicka 40,
50-507 Wrocław, Poland
For further information about this medicinal product, please contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw, Poland
tel.: +48 (22) 543 60 00