Paracetamol + Difenhidramina Hasco Noc

Leaflet attached to the packaging: patient information

PARACETAMOL + DIPHENHYDRAMINE HASCO NOC

500 mg + 25 mg, coated tablets

Paracetamol+ Diphenhydramine hydrochloride

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 this 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 5 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Paracetamol + Difenhydramina Hasco Noc and what is it used for

Paracetamol + Difenhydramina Hasco Noc is a pain reliever and antipyretic, using the combined action of two active substances. The paracetamol in the medicine relieves pain (has an analgesic effect), and diphenhydramine facilitates falling asleep and prevents nighttime awakenings caused by feeling pain. Indications for use: Short-term treatment of pain, including: headache, musculoskeletal pain, muscle pain, toothache, menstrual pain, neuralgia, and pain associated with colds and flu that cause difficulty falling asleep. If after 5 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Paracetamol + Difenhydramina Hasco Noc

When not to take Paracetamol + Difenhydramina Hasco Noc

• if the patient is allergic to the active substances (paracetamol or diphenhydramine) or any of the other ingredients of this medicine listed in section 6;
• if the patient has the following diseases: severe liver or kidney failure, viral hepatitis, glaucoma, prostate enlargement, porphyria, asthma in the acute phase;
• during treatment with so-called MAO inhibitors (drugs used in depression) and within 2 weeks of stopping these medications. Do not use in children under 12 years of age. Do not use during pregnancy and breastfeeding. 1/5

Warnings and precautions

The product contains paracetamol. Due to the risk of overdose, patients should be informed not to take the product at the same time as other medicines containing paracetamol. Before starting treatment with Paracetamol + Difenhydramina Hasco Noc, the patient should discuss it with their doctor or pharmacist if they:

• have liver failure, abuse alcohol, are malnourished, have anorexia, have low body weight;
• have kidney failure, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia, heart rhythm disorders, hypertension, epilepsy, myasthenia gravis, hyperthyroidism, pyloric stenosis, and are elderly;
• have a severe infection that may increase the risk of metabolic acidosis, characterized by deep, rapid, and difficult breathing, nausea, vomiting, loss of appetite, and general malaise; if these occur, the patient should immediately inform their doctor.

During treatment with Paracetamol + Difenhydramina Hasco Noc, the patient should immediately inform their doctor if they experience severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins are present 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 taking paracetamol in regular doses for a longer period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting. The medicine should only be taken before bedtime. Paracetamol may affect laboratory tests: the results of tests assessing uric acid and blood sugar levels may be changed.

Children

Do not use in children under 12 years of age.

Paracetamol + Difenhydramina Hasco Noc and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Paracetamol + Difenhydramina Hasco Noc should not be taken at the same time as other medicines containing paracetamol. The patient should consult their doctor before taking this medicine if they are also taking:

• anti-emetic drugs (e.g., metoclopramide, domperidone);
• drugs used to treat high cholesterol (cholestyramine);
• probenecid (a drug used to treat high uric acid levels in the blood - gout);
• drugs with analgesic or antipyretic effects (aspirin, salicylamide);
• isoniazid (used to treat tuberculosis);
• anticoagulant drugs (warfarin and other coumarin derivatives);
• drugs that depress the central nervous system (such as sleeping pills, sedatives, and opioid analgesics);
• neuroleptic drugs (haloperidol and other butyrophenone derivatives, used in mental illnesses in states of excessive agitation);
• antidepressant drugs (fluoxetine, paroxetine, tricyclic antidepressants), 2/5
• antiepileptic drugs (phenytoin, carbamazepine, phenobarbital);
• rifampicin (an antibiotic used, among other things, to treat tuberculosis);
• drugs that inhibit the activity of cytochrome P450 CYP2D6, i.e., amiodarone (used to treat heart rhythm disorders), ranitidine (used to treat stomach ulcers).

The patient should inform their doctor or pharmacist if they are taking flucloxacillin (an antibiotic) due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be urgently treated (see section 2).

Paracetamol + Difenhydramina Hasco Noc with food, drink, or alcohol

During treatment with the medicine, the patient should not drink alcohol due to the increased risk of liver damage.

Pregnancy and breastfeeding

During pregnancy or if the patient suspects they may be pregnant, as well as during breastfeeding, Paracetamol + Difenhydramina Hasco Noc should not be taken. If the patient plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

While taking the medicine, the patient should not drive vehicles or operate machines.

3. How to take Paracetamol + Difenhydramina Hasco Noc

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist. The medicine is taken orally. It should only be taken before bedtime. The recommended dose is: Adults and adolescents over 16 years old: 1 or 2 tablets 30 minutes before bedtime. Do not take more than 2 tablets before bedtime. Adolescents 12-15 years old: 1 tablet 30 minutes before bedtime. Do not take a dose higher than recommended. Prolonged use without medical supervision may be harmful. The medicine should not be taken for more than 5 days without consulting a doctor. If symptoms persist, the patient should contact their doctor. Do not give to children under 12 years of age.

Taking a higher dose of Paracetamol + Difenhydramina Hasco Noc than recommended

Overdosing on the medicine may cause severe nausea, vomiting, excessive sweating, drowsiness, and a feeling of general weakness. These symptoms may resolve the next day, despite the fact that liver damage is beginning to develop, which later manifests as a feeling of fullness in the upper abdomen and a recurrence of nausea and jaundice. Due to the risk of irreversible liver damage in the event of an overdose, the patient should immediately contact their doctor.

Missing a dose of Paracetamol + Difenhydramina Hasco Noc

Do not take a double dose to make up for a missed dose. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist. 3/5

4. Possible side effects

Like all medicines, Paracetamol + Difenhydramina Hasco Noc can cause side effects, although not everybody gets them. The patient should stop taking the medicine and immediately consult their doctor if they experience any of the following side effects: occurring rarely (in 1 to 10 out of 10,000 patients taking the medicine):

• allergic reactions such as hives, rash, urticaria (including generalized), swelling;

occurring very rarely (less than 1 in 10,000 patients taking the medicine):

• anaphylactic shock (manifested by, among other things, impaired consciousness, reduced urine output, rapid breathing - hyperventilation, and significant weakness);
• bleeding;
• bronchospasm causing breathing difficulties in patients allergic to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs;
• throat swelling, angioedema manifested by swelling of the lips, tongue, throat, or face, difficulty breathing;
• severe skin reaction, such as: acute generalized exanthematous pustulosis, Stevens-Johnson syndrome (pustular multiforme erythema), toxic epidermal necrolysis, manifested as: initially in the form of red spots on the torso, often with blisters in the center, rash with pustules all over the body or erosions in the mouth, eyes, genitals, and skin, or bursting large blisters, peeling off large flakes of epidermis, accompanied by weakness, fever, and joint pain;
• acute liver damage due to paracetamol overdose, liver failure, liver necrosis, jaundice manifested by yellowing of the eyes and skin, abdominal pain, loss of appetite;
• renal papillary necrosis during long-term use, kidney damage (nephropathy or tubulopathy) manifested by fever, pain in the lumbar region, rash on the skin, red urine (hematuria), renal colic, urinary retention.

Other side effects: occurring frequently (more than 1 in 100 patients taking the medicine):

• drowsiness, attention disorders, dizziness;
• dryness of the mucous membranes of the mouth, throat, and nose;

occurring rarely (in 1 to 10 out of 10,000 patients taking the medicine):

• disorientation, anxiety;
• blurred vision;
• rapid heartbeat (tachycardia), heart rhythm disorders (arrhythmia);
• gastrointestinal disorders, nausea, vomiting, diarrhea, abdominal pain, digestive disorders;
• itching, sweating;
• urinary retention;

occurring very rarely (less than 1 in 10,000 patients taking the medicine):

• anemia, bone marrow suppression, thrombocytopenia (reduced platelet count resulting in a tendency to bruise and bleed), agranulocytosis (very significant reduction or absence of white blood cells), leukopenia (reduced white blood cell count), neutropenia (reduced neutrophil count);
• dizziness;
• acute or chronic pancreatitis;
• pigmentary purpura.

occurring with an unknown frequency (cannot be estimated from the available data):

• a serious disease that can cause acidification of the blood (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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: Aleje 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, more information can be collected on the safety of the medicine.

5. How to store Paracetamol + Difenhydramina Hasco Noc

Store the medicine in its original packaging at a temperature below 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 packaging. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Paracetamol + Difenhydramina Hasco Noc contains

• The active substances of the medicine are paracetamol and diphenhydramine (in the form of hydrochloride). Each tablet contains 500 mg of paracetamol and 25 mg of diphenhydramine hydrochloride.
• The other ingredients (excipients) are: cornstarch, povidone K-30, magnesium stearate, and the Opadry II Blue 85F205046 coating, which contains: polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, aluminum lake of brilliant blue FCF (E 133), aluminum lake of indigo carmine (E 132).

What Paracetamol + Difenhydramina Hasco Noc looks like and what the pack contains

Paracetamol + Difenhydramina Hasco Noc are blue, oval, biconvex, coated tablets with "NOC" embossed on one side, packaged in blisters. A cardboard box contains 6, 12, 24, or 48 coated tablets.

Marketing authorization holder and manufacturer

"HASCO-LEK" S.A., 51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

tel.: 22 742 00 22, e-mail: informacjaoleku@hasco-lek.pl

Date of last update of the leaflet:

5/5