Gripex Noc

Leaflet accompanying the packaging: patient information

GRIPEX NOC, coated tablets

Combination product

Read the 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 patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform 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 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 packaging and other information

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

Gripex Noc is a combination medicine with complex analgesic, antipyretic, and anti-cough effects. It reduces swelling of the nasal mucosa and paranasal sinuses, clears nasal passages, and reduces the amount of mucous secretion. The mild sedative effect of chlorpheniramine facilitates falling asleep.

The indication for the use of Gripex Noc is to alleviate symptoms of colds, flu, and flu-like conditions such as fever, runny nose, sneezing, swelling of the nasal mucosa and paranasal sinuses, dry cough, headache, sore throat, muscle and joint pain.

If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

2. Important information before taking Gripex Noc

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

When not to take Gripex Noc:

• if the patient is hypersensitive to the active substances or any of the other ingredients of this medicine (listed in section 6)
• in case of congenital glucose-6-phosphate dehydrogenase deficiency;
• in patients with severe liver failure;
• in case of viral hepatitis;
• in case of very high blood pressure (severe hypertension) or uncontrolled hypertension;
• in case of severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• in case of unstable coronary artery disease;
• in case of alcoholism;
• in case of taking MAO inhibitors (medicines used, among others, in depression) or zidovudine. Do not take during pregnancy and breastfeeding. Do not take in children under 12 years of age.

Warnings and precautions

The medicine contains paracetamol

Due to the risk of overdose, check if other medicines being taken do not contain paracetamol. Before starting to take Gripex Noc, discuss it with your doctor or pharmacist.

Particular caution should be exercised in case of kidney or liver failure, hypertension, heart disease, asthma, lung and bronchial diseases, glaucoma, epilepsy, thyroid diseases, prostatic hyperplasia, diabetes, and before taking the medicine, consult a doctor.

During treatment with Gripex Noc, do not drink alcohol. There is a special risk of liver damage in people who are starving and regularly drink alcohol.

Due to reported cases of dextromethorphan abuse, particular caution should be exercised when using Gripex Noc in adolescents, young adults, and patients who abuse medicines or psychoactive substances.

Particular caution should be exercised in patients with slow metabolism involving the CYP2D6 enzyme or taking substances that inhibit the activity of the CYP2D6 enzyme (listed in the "Gripex Noc and other medicines" section). If you are taking medicines that inhibit the activity of the CYP2D6 enzyme before taking this medicine, consult your doctor.

In the case of necessary concurrent use of CYP2D6 inhibitors and dextromethorphan, 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 concurrently taking CYP2D6 inhibitors, enhanced and/or prolonged effects of dextromethorphan may occur.

Concomitant use of potent CYP2D6 inhibitors 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 (accelerated heart rate, disorientation, excessive sweating, hallucinations, involuntary muscle movements, shivering, tremors).

If the above-mentioned symptoms occur after taking Gripex Noc, stop the treatment and seek medical help immediately.

In case of persistent cough lasting more than 7 days, or fever lasting more than 3 days from the start of treatment, consult a doctor.

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

During treatment with Gripex Noc, immediately inform your doctor if the patient has 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 the patient is 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, nausea, and vomiting.

During treatment with Gripex Noc, sudden abdominal pain or rectal bleeding may occur due to inflammation of the large intestine (ischemic colitis).

If such gastrointestinal symptoms occur, stop taking Gripex Noc and seek medical help immediately.

During treatment with Gripex Noc, a decrease in blood flow in the optic nerve may occur.

If sudden vision loss occurs, stop taking Gripex Noc and contact a doctor or seek medical help immediately.

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.

If symptoms that may be symptoms of PRES or RCVS occur, stop taking Gripex Noc immediately and seek medical help.

If the patient is taking certain antidepressant or antipsychotic medicines, 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, and exaggerated reflexes, muscle stiffness, lack of coordination, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

If the patient develops a fever with generalized redness of the skin and a pustular rash, stop taking Gripex Noc and contact a doctor or seek medical help immediately.

Children

Do not take in children under 12 years of age.

Gripex Noc and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Do not take Gripex Noc with other medicines containing paracetamol, dextromethorphan, pseudoephedrine, or chlorpheniramine, as well as with phenytoin, carbamazepine, rifampicin, and phenobarbital.

In case of taking anticoagulant medicines, blood pressure-lowering medicines, oral anti-diabetic medicines, sedatives, opioid analgesics, or antidepressants, consult your 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 the concentration of dextromethorphan in the blood.

Tell 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).

Pregnancy and breastfeeding

Do not take during pregnancy and breastfeeding.

Driving and using machines

Do not drive or operate machines while taking this medicine.

3. How to take Gripex Noc

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

In case of doubt, consult a doctor or pharmacist.

Recommended dose

Adults and adolescents over 12 years of age:1 or 2 tablets before bedtime (do not take more than 8 tablets per day).

Do not take Gripex Noc for more than 3 days without consulting a doctor.

Method of administration

Oral administration

Taking a higher dose of Gripex Noc than recommended

Immediately consult a doctor or pharmacist. The medicine contains four active substances. Symptoms of overdose may result from the action of one or all of the active substances.

If the patient takes a higher dose of Gripex Noc than recommended, the following symptoms may occur: nausea and vomiting, pallor, excessive sweating, general weakness, abdominal pain, involuntary muscle contractions, agitation, confusion, excessive drowsiness, impaired consciousness, involuntary rapid eye movements (nystagmus), cardiac disorders (rapid heartbeat), coordination disorders, psychosis with visual hallucinations, and increased excitability.

Overdose may cause kidney and liver damage.

Other symptoms of large overdose may include coma, severe respiratory failure, and convulsions.

If any of the above symptoms occur, immediately consult a doctor or go to the hospital.

Treatment of Gripex Noc overdose should be carried out in a hospital.

Missing a dose of Gripex Noc

Gripex Noc is used for the temporary treatment of symptoms of colds, flu, and flu-like conditions.

If a dose is missed and symptoms persist, take the next dose of Gripex Noc. Do 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.

Immediately stop taking Gripex Noc and seek medical help if symptoms occur that may indicate posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), including:

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

Paracetamol: Rare side effects (occurring in 1 to 10 people per 10,000):

Blood and lymphatic system disorders: non-hemolytic anemia, bone marrow suppression, thrombocytopenia;

Cardiovascular disorders: edema;

Gastrointestinal disorders: acute and chronic pancreatitis, bleeding, abdominal pain, diarrhea, nausea, vomiting, liver failure, liver necrosis, jaundice;

Skin and subcutaneous tissue disorders: itching, rash, sweating, urticaria, angioedema;

Kidney and urinary tract disorders: nephropathy and tubulopathy;

Unknown frequency (cannot be estimated from available data): serious disease that can cause acidification of the blood (metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Paracetamol is a commonly used medicine, and reports of side effects are rare and usually related to overdose.

Single cases have been observed: severe skin reactions with the formation of rash, blisters, and skin necrosis (Stevens-Johnson syndrome), and even necrosis and exfoliation of large areas of skin (toxic epidermal necrolysis), laryngeal edema, anaphylactic shock (severe allergic reaction with a drop in blood pressure, pallor, sweating, impaired consciousness, decreased urine output, rapid breathing, and swelling).

Nephrotoxic effects are rare and have not been reported with therapeutic doses, except in cases of chronic use of the medicine.

Pseudoephedrine:

Side effects resulting from the presence of pseudoephedrine in the medicinal product:

Insomnia, gastrointestinal disorders, redness, rash, nausea, vomiting, excessive sweating, dizziness, increased thirst, tachycardia, cardiac arrhythmias, anxiety, involuntary urination, muscle weakness, tremors, anxiety, hallucinations, thrombocytopenia.

Unknown frequency: severe diseases affecting the blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS); ischemic colitis; sudden fever, redness of the skin, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP); decreased blood flow in the optic nerve.

If such symptoms occur, stop taking Gripex Noc and contact a doctor or seek medical help immediately.

Dextromethorphan:

Uncommon side effects (occurring in more than 1 in 1,000 but less than 1 in 100 people):

Nervous system disorders: moderate fatigue, dizziness;

Gastrointestinal disorders: nausea, gastrointestinal problems, vomiting;

Rare side effects (occurring in less than 1 in 10,000 people):

Immune system disorders: hypersensitivity reactions;

Nervous system disorders: drowsiness, hallucinations, development of dependence in case of abuse;

Chlorpheniramine maleate:

Common side effects (occurring in 1 to 10 people per 100):

Nervous system disorders: central nervous system depression in the form of drowsiness, nausea, and muscle weakness, which disappear in some patients after 2-3 days of treatment; dyskinesia in the face, coordination disorders (stiffness), tremors, paresthesia;

Eyes disorders: blurred vision, double vision;

Respiratory, thoracic, and mediastinal disorders: dryness of the nasal mucosa and throat, drying of mucous membranes;

Gastrointestinal disorders: dry mouth, loss of appetite, changes in taste and smell, gastrointestinal disorders (nausea, vomiting, diarrhea, constipation, abdominal pain), which may decrease when taken with food;

Skin and subcutaneous tissue disorders: increased sweating;

Kidney and urinary tract disorders: urinary retention and/or difficulty urinating;

Uncommon side effects (occurring in 1 to 10 people per 1,000) or rare (occurring in 1 to 10 people per 10,000):

Blood and lymphatic system disorders: rare blood morphology disorders (agranulocytosis, leukopenia, aplastic anemia, or thrombocytopenia), with symptoms such as unusual bleeding, sore throat, or fatigue;

Immune system disorders: hypersensitivity reactions, anaphylactic reactions (cough, difficulty swallowing, rapid heartbeat, itching, swelling of the eyelids or eyes, face, tongue, shortness of breath, fatigue, etc.), photosensitivity, cross-sensitivity to similar medicines;

Nervous system disorders: sometimes paradoxical excitement, especially when taking large doses in children or the elderly, characterized by restlessness, insomnia, nervousness, hallucinations, and convulsions;

Cardiac disorders: usually in case of overdose; cardiac arrhythmias, palpitations, tachycardia;

Ear and labyrinth disorders: tinnitus, acute labyrinthitis;

Vascular disorders: hypotension, hypertension, edema;

Respiratory, thoracic, and mediastinal disorders: chest tightness, wheezing;

Hepatobiliary disorders: rare cholestasis, hepatitis, or other liver function disorders (including abdominal pain or dark urine, etc.);

Reproductive system and breast disorders: impotence, intermenstrual bleeding.

Reporting side effects

If you experience any side effects, including any possible side effects 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, 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 Noc

Do not store above 25°C.

Keep the medicine out of the 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 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. Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the packaging and other information

What Gripex Noc contains

One coated tablet contains the active substances:

Paracetamol 500.00 mg

Pseudoephedrine hydrochloride 30.00 mg

Dextromethorphan hydrobromide 15.00 mg

Chlorpheniramine maleate 2.00 mg

Other ingredients are:

tablet core: maize starch, povidone, stearic acid, microcrystalline cellulose, crospovidone, silicon dioxide, 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 inscription "Gripex N" on one side.

Available packs:

6 tablets (3 sachets of 2 tablets each).

6 tablets (1 blister of 6 tablets).

12 tablets (1 blister of 12 tablets).

12 tablets (2 blisters of 6 tablets each).

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 on 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: