ACENOL 300 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. ACENOL
3. 300 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains
   2. Table of contents of the leaflet
4. What is Acenol and what is it used for
5. Important information before taking Acenol
   1. When not to take Acenol:
   2. Warnings and precautions
   3. Children
   4. Acenol and other medicines
   5. Acenol with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
6. How to take Acenol
   1. Recommended dose
   2. Method of administration
   3. Taking a higher dose of Acenol than recommended
   4. Missing a dose of Acenol
   5. Stopping Acenol treatment
7. Possible side effects
   1. A doctor should be contacted immediately if any of the following side effects occur:
   2. Reporting side effects
8. How to store Acenol
9. Contents of the packaging and other information
   1. What Acenol contains
   2. What Acenol looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer

Leaflet attached to the packaging: patient information

ACENOL

300 mg, tablets

Paracetamol

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 advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• 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 after 3 days in the case of fever and 5 days in the case of pain, no improvement occurs or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Acenol and what is it used for

Acenol contains paracetamol, used for pains of various origins (headaches, toothaches, joint pains, menstrual pains, neuralgias, and others). It can be one of the medicines used to combat pain. It has an antipyretic effect.

2. Important information before taking Acenol

When not to take Acenol:

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has an alcoholic disease,
• if the patient has severe liver or kidney failure.

Warnings and precautions

Particular caution should be exercised when taking Acenol because:

• the medicine contains paracetamol,
• paracetamol overdose is life-threatening, and during the use of this medicine, it is necessary to control whether other medicines taken simultaneously contain paracetamol,
• the medicine should be used with caution in patients with kidney and/or liver function disorders,
• caution should be exercised when taking paracetamol in the case of a deficiency of glucose-6-phosphate dehydrogenase,
• the medicine should not be taken for longer than 3 days in the case of fever and 5 days in the case of pain without consulting a doctor,
• if the pain does not subside or worsens, or if the fever does not decrease or worsens, a doctor should be contacted immediately,
• during paracetamol treatment, alcohol should not be consumed due to the increased risk of toxic liver damage.

A doctor should be consulted, even if the above warnings concern situations that occurred in the past.

Children

Due to the strength of the medicine (i.e., 300 mg), its use is possible in children over 6 years old.

Acenol and other medicines

The doctor or pharmacist should be informed about all medicines currently taken by the patient or recently taken, as well as about medicines that the patient plans to take.
Before taking Acenol, the doctor should be informed about the use of:

• oral anticoagulant medicines from the coumarin group, e.g., warfarin, as paracetamol may enhance their effect;
• rifampicin (a medicine used to treat tuberculosis) and some sedatives or antiepileptic medicines, e.g., phenobarbital, phenytoin, carbamazepine, as they inhibit paracetamol metabolism, which may increase the risk of liver damage;
• MAO inhibitor medicines (medicines used to treat depression), as stimulation or high fever may occur;
• antiemetic medicines, e.g., metoclopramide, domperidone, as they accelerate paracetamol absorption from the gastrointestinal tract;
• cholestyramine (a medicine that reduces blood cholesterol levels), as it delays paracetamol absorption from the gastrointestinal tract;
• nonsteroidal anti-inflammatory medicines (medicines with analgesic, antipyretic, and anti-inflammatory effects, e.g., acetylsalicylic acid), as they increase the risk of kidney function disorders;
• salicylamide, as it prolongs paracetamol excretion time.

Caffeine enhances the analgesic effect of paracetamol.
Blood sugar test results may be altered.

Acenol with food, drink, and alcohol

The presence of food in the stomach reduces paracetamol absorption, so taking the medicine after eating reduces its effectiveness.
Alcohol enhances the toxic effect of paracetamol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Acenol can be used during pregnancy if necessary. The smallest recommended dose that reduces pain and/or fever should be taken for the shortest possible time and as infrequently as possible.
A doctor should be consulted if the pain and/or fever do not decrease or if the patient needs to take the medicine more frequently.

Driving and using machines

The medicine does not affect the ability to drive vehicles and operate machines.

3. How to take Acenol

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubts, a doctor or pharmacist should be consulted.
The medicine is dosed similarly in both indications, i.e., as a pain reliever and as an antipyretic.

Recommended dose

Adults and children over 12 years old
One to three tablets three or four times a day at intervals of not less than 4 hours, a maximum of thirteen (13) tablets per day (24 hours).
The maximum daily dose of paracetamol is 4 g and proportionally less in people for whom doses have been reduced and/or the interval between doses has been extended for various reasons.
In case of doubts, a doctor should be consulted.
If the pain persists for more than 5 days or the fever lasts longer than 3 days, worsens, or other symptoms appear, the treatment should be discontinued, and a doctor's advice should be sought.
Children from 6 to 12 years old
Maximum daily dose of paracetamol: 60 mg/kg body weight/24 hours administered in divided doses of 10-15 mg/kg body weight.
If, considering the above dosing, it is possible to use Acenol tablets with a strength of 300 mg, one tablet can be taken three or four times a day (24 hours) at intervals of not less than 6 hours. In other cases, to precisely dose paracetamol in children, another medicine approved for sale in the form of a syrup should be used.
Elderly patients
There is no need to modify the dose for elderly patients.
Patients with kidney and/or liver function disorders
In the case of kidney failure, the dose of the medicine should be reduced or the time interval between doses extended from 4 to 6 hours (adults).
In the case of liver diseases, paracetamol is used in the same dose in chronic stable conditions. Due to the lack of information on the toxicity of the medicine in acute liver diseases or diseases with a poor prognosis, the use of the medicine should be discontinued.

Method of administration

Oral administration.

Taking a higher dose of Acenol than recommended

Accidental or intentional overdose of the medicine may cause symptoms such as nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few or several hours. These symptoms may subside the next day, despite the fact that liver damage is developing, which then manifests as abdominal distension, return of nausea, and jaundice. In every case of taking paracetamol in a dose of 5 g or more, vomiting should be induced if it has not been more than an hour since ingestion, and a doctor should be contacted immediately. It is worth administering 60-100 g of activated carbon orally, preferably mixed with water.
A reliable assessment of the severity of poisoning is provided by determining the paracetamol level in the blood. The level of paracetamol in relation to the time elapsed since its ingestion is a valuable indicator of whether and how intensive treatment with antidotes should be conducted. If such a test is not possible, and the probable dose of paracetamol was high, very intensive treatment with antidotes should be initiated. At least 2.5 g of methionine should be administered and continued (already in the hospital) with acetylcysteine or (and) methionine treatment, which is very effective in the first 10-12 hours after poisoning but is probably also beneficial after 24 hours. Treatment of paracetamol poisoning must take place in a hospital under intensive therapy conditions.

Missing a dose of Acenol

A double dose should not be taken to make up for a missed dose.

Stopping Acenol treatment

In case of any further doubts regarding the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

A doctor should be contacted immediately if any of the following side effects occur:

• fainting or dizziness and disorientation - these may be symptoms of a life-threatening anaphylactic shock (insufficient blood flow in organs due to circulatory failure). The frequency of these side effects is unknown.
• sudden wheezing, breathing difficulties, swelling of the eyelids, face, or lips;
• rash, urticaria, or itching. These side effects occur rarely.
• severe skin reactions, such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. These side effects occur very rarely.
• methemoglobinemia - the loss of hemoglobin's ability to transport oxygen, manifested as cyanosis, fatigue, shortness of breath during exertion, increased heart rate, pain, and dizziness, drowsiness, or coma, occurs very rarely.
• thrombocytopenia - a decrease in the number of platelets in the blood, manifested as bleeding, hemorrhages, easily occurring bruises, and petechiae, occurs very rarely.

Other possible side effects of Acenol:
Very rare(occur less frequently than in 1 in 10,000 patients):

• leukopenia (decrease in the number of white blood cells), pancytopenia (decrease in the number of all types of blood cells), agranulocytosis (decrease in the number of neutrophils in the blood);
• nausea, vomiting, digestive disorders.

Frequency not known(frequency cannot be estimated from the available data):

• hemolysis occurring occasionally in people with glucose-6-phosphate dehydrogenase deficiency, mainly in Mediterranean and black populations;
• liver damage occurring with therapeutic doses of paracetamol, manifested as an increase in serum aminotransferase activity, concerned either patients with alcoholic disease or people taking the medicine daily for several years;
• kidney and urinary tract disorders - it has not been confirmed whether this side effect is caused by paracetamol. The basis for this suspicion was clinical-control studies with an unclear temporal relationship between taking paracetamol in large doses and kidney failure.
• hypothermia (body temperature below 35.5°C) is an extremely rare side effect, so far detected only in children.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, a doctor or pharmacist should be informed. 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
Poland
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Acenol

There are no special precautions for storing the medicine.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Acenol contains

• The active substance of the medicine is paracetamol. One tablet contains 300 mg of paracetamol.
• The other ingredients are: gelatin starch, povidone, sodium croscarmellose, stearic acid.

What Acenol looks like and what the packaging contains

Acenol is available in the form of tablets. The tablet is white, round, and slightly convex on both sides.
Packaging:
6 tablets,
20 tablets.
Blisters of PVC/Al foil in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Pharmaceutical Cooperative "GALENA"
ul. Krucza 62
53-411 Wrocław
Poland
Date of last revision of the leaflet:04.06.2019