ACENOL 500 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. ACENOL FORTE
3. 500 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 forte and what is it used for
5. Important information before taking Acenol forte
   1. When not to take Acenol forte:
   2. Warnings and precautions
   3. Children
   4. Acenol forte and other medicines
   5. Acenol forte with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
6. How to take Acenol forte
   1. Recommended dose
   2. Method of administration
   3. Taking a higher dose of Acenol forte than recommended
   4. Missing a dose of Acenol forte
   5. Stopping Acenol forte 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 forte
9. Contents of the packaging and other information
   1. What Acenol forte contains
   2. What Acenol forte looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer

Leaflet attached to the packaging: patient information

ACENOL FORTE

500 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, there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

1. What is Acenol forte and what is it used for

Acenol forte 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 forte

When not to take Acenol forte:

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

Warnings and precautions

Particular caution should be exercised when taking Acenol forte 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 at the same time 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 have occurred in the past.

Children

Due to the strength of the medicine (i.e., 500 mg), its use is possible in children over 12 years of age.

Acenol forte and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken by the patient or recently taken, as well as any medicines that the patient plans to take.
Before taking Acenol forte, 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;
• monoamine oxidase inhibitors (medicines used to treat depression), as they may cause agitation or high fever;
• antiemetic medicines, e.g., metoclopramide, domperidone, as they accelerate paracetamol absorption from the gastrointestinal tract;
• cholestyramine (a medicine that lowers blood cholesterol levels), as it delays paracetamol absorption from the gastrointestinal tract;
• non-steroidal 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 forte 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 forte 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 subside 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 or operate machines.

3. How to take Acenol forte

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubt, 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 of age
One to two tablets three or four times a day at intervals of not less than 4 hours, a maximum of eight tablets (4 g of paracetamol) per day (24 hours).
The maximum daily dose of paracetamol is 4 g, and less for people for whom the doses have been reduced and/or the time between doses has been extended for various reasons.
In case of doubt, a doctor should be consulted.
If the pain persists for more than 5 days or the fever lasts for more than 3 days, worsens, or other symptoms appear, the treatment should be discontinued and a doctor consulted.

Method of administration

Oral administration.

Taking a higher dose of Acenol forte 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 will then manifest 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 no more than an hour has passed 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 treatment with acetylcysteine or methionine should be continued (already in the hospital), which are very effective in the first 10-12 hours after poisoning, but are probably also useful after 24 hours. Treatment of paracetamol poisoning must take place in a hospital under intensive therapy conditions.

Missing a dose of Acenol forte

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

Stopping Acenol forte 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 (inadequate blood flow in organs due to circulatory failure). The frequency of these side effects is unknown.
• sudden onset of 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 - loss of hemoglobin's ability to transport oxygen, manifesting as cyanosis, fatigue, shortness of breath during exertion, increased heart rate, pain, and dizziness, drowsiness, or coma, occurs very rarely;
• thrombocytopenia - decreased platelet count in the blood, manifesting as bleeding, hemorrhages, easily occurring bruises, and petechiae, occurs very rarely.

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

• leukopenia (decreased white blood cell count), pancytopenia (decreased count of all blood cell types), agranulocytosis (decreased count of neutrophilic granulocytes in the blood);
• nausea, vomiting, digestive disorders.

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

• hemolysis occurring sporadically in people with glucose-6-phosphate dehydrogenase deficiency, mainly in Mediterranean and black populations;
• liver damage occurring with therapeutic doses of paracetamol, manifesting as increased 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 assumption was clinical-control studies with an unclear temporal relationship between taking paracetamol in high 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
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 allow for the collection of more information on the safety of the medicine.

5. How to store Acenol forte

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

6. Contents of the packaging and other information

What Acenol forte contains

• The active substance of the medicine is paracetamol. One tablet contains 500 mg of paracetamol.
• The other ingredients are: gelatin starch, povidone, sodium croscarmellose, stearic acid.

What Acenol forte looks like and what the packaging contains

Acenol forte is available in tablet form. The tablet is white, round, and slightly convex on both sides.
Available packaging:
20 tablets
PVC/Aluminum blisters in a cardboard box.

Marketing authorization holder and manufacturer

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