Paracetamol + Methocarbamol Apap

Leaflet: Patient Information

Paracetamol + Methocarbamol APAP, 300 mg + 380 mg, tablets

Paracetamol + Methocarbamol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Paracetamol + Methocarbamol APAP and what is it used for

Paracetamol + Methocarbamol APAP is a combination of a pain-relieving and antipyretic substance and a muscle relaxant.
Paracetamol + Methocarbamol APAP is used for the short-term symptomatic treatment of painful muscle spasms associated with acute musculoskeletal disorders.
Treatment with methocarbamol should be as short as possible. After the painful symptoms have subsided, the doctor will decide to stop taking the medicine.

2. Important information before taking Paracetamol + Methocarbamol APAP

Do not take Paracetamol + Methocarbamol APAP

if the patient is allergic to paracetamol or methocarbamol or any of the other ingredients of this medicine (listed in section 6),
if the patient has brain damage,
if the patient is in a coma or pre-coma state,
if the patient has epilepsy or seizures,
if the patient has muscle weakness (a disease called myasthenia gravis),
in children and adolescents under 18 years of age.

Warnings and precautions

Before starting treatment, discuss it with your doctor.
Do not exceed the recommended doses in section 3 of the leaflet: How to take Paracetamol + Methocarbamol APAP. Do not take other medicines containing paracetamol at the same time (e.g. cold medicines or other pain-relieving or antipyretic medicines).

Before taking the medicine, consult a doctor or pharmacist:

if the patient frequently consumes alcohol.
if the patient has chronic alcoholism, they should not take more than 2 g of paracetamol per day (do not take a dose larger than 6 tablets per day).
if the patient has liver or kidney disorders, the doctor may adjust the dosage, increase the intervals between doses, or not prolong treatment more than necessary.
if the patient has anemia or heart or lung disease.
if the patient has asthma and is allergic to acetylsalicylic acid.
if the patient is being treated with antiepileptic drugs. See below.
While taking Paracetamol + Methocarbamol APAP, immediately inform your doctor if:
the patient has severe diseases, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition,
chronic alcoholism or when 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, feeling of nausea (nausea) and vomiting.
Effect on laboratory test results
If the patient is undergoing any diagnostic tests, they should inform their doctor that they are taking Paracetamol + Methocarbamol APAP, as it may affect the test results.
Paracetamol may affect the results of some laboratory tests (e.g. determination of uric acid or glucose levels).

Paracetamol + Methocarbamol APAP and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
Methocarbamol may interact with the following medicines:

• Barbiturates (medicines used in epilepsy or as sleeping pills);
• Appetite suppressants (used to reduce body weight);
• Anticholinergic medicines (used to relieve muscle tension, muscle spasms, gastrointestinal disorders, overactive bladder, and motion sickness);
• Psychotropic medicines (used to treat anxiety, depression, or other mental illnesses);
• Anesthetics (before receiving anesthesia for any reason, the patient should inform their doctor or dentist that they are taking Paracetamol + Methocarbamol APAP);
• Cholinesterase inhibitors (used to treat myasthenia gravis).

Paracetamol may interact with the following medicines:

• Oral anticoagulants (used to treat blood clotting disorders);
• Antiepileptic medicines (used to treat epileptic seizures);
• Antibiotics (chloramphenicol);
• Contraceptives;
• Diuretics (used to increase urine production);
• Isoniazid (used to treat tuberculosis);
• Metoclopramide and domperidone (anti-emetic medicines);
• Probenecid (used to treat gout);
• Propranolol (used to treat hypertension, heart arrhythmia);
• Rifampicin (used to treat tuberculosis);
• Anticholinergic medicines (used to relieve muscle tension, muscle spasms, gastrointestinal disorders, overactive bladder, and motion sickness);
• Zidovudine (used to treat HIV infections);
• Cholestyramine (used to reduce blood cholesterol levels).

Tell your doctor or pharmacist if the patient is taking:

• flucloxacillin (an antibiotic) due to the risk of serious blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).
• 2).

Paracetamol + Methocarbamol APAP should not be taken with other pain-relieving medicines without consulting a doctor.

Taking Paracetamol + Methocarbamol APAP with food, drink, and alcohol

Do not drink alcohol while taking this medicine. Alcohol may enhance the sedative effect of methocarbamol and its effect on the central nervous system. Taking paracetamol by patients who regularly drink alcohol may damage the liver.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or plans to become pregnant, they should consult their doctor or pharmacist before taking Paracetamol + Methocarbamol APAP.
Pregnancy
It is not recommended to take this medicine in pregnant women or women planning to become pregnant. If the patient becomes pregnant during treatment, they should immediately contact their doctor to adjust the treatment to their condition.
Breastfeeding
Women who are breastfeeding should consult their doctor before taking this medicine. The doctor will discuss with the patient whether to breastfeed. Methocarbamol and (or) its metabolites have been detected in dog milk, but it is not known whether methocarbamol or its metabolites pass into human milk. Paracetamol passes into breast milk, but these are not clinically significant amounts.

Driving and using machines

While taking the medicine, the patient may feel drowsy, so they should not drive a car or operate machines until it is known how they react to the medicine. This is especially important if the patient is taking other medicines that can also cause drowsiness.

Paracetamol + Methocarbamol APAP contains sodium.

The medicine contains 4.2 mg of sodium (the main component of table salt) in each tablet. This corresponds to 0.2% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Paracetamol + Methocarbamol APAP

Take the medicine always as directed by your doctor. In case of doubts, consult your doctor or pharmacist again.
The recommended doses are as follows:
Adults
The recommended dose is 2 tablets every 4-6 hours (4 to 6 times a day), depending on the severity of symptoms. The maximum daily dose is 12 tablets. As soon as the painful symptoms subside, treatment should be stopped.
Elderly patients
Elderly patients may require lower doses of the medicine to achieve the same pain-relieving and muscle-relaxing effect. It is recommended to take 1 tablet every 4 hours or 2 tablets every 8 hours.
Patients with liver and (or) kidney disorders
A longer interval between doses may be necessary.
Always follow the doctor's instructions (see section 2). Important information before taking Paracetamol + Methocarbamol APAP.
Depending on the severity of kidney function disorders, the doctor will decide whether the patient should take 1 tablet every 6 or 8 hours.
If there is liver failure, the daily dose should not exceed 6 tablets.

Children and adolescents

Do not take the medicine in children and adolescents under 18 years of age, due to the lack of data on safety and efficacy in this patient group.
The medicine is administered orally.
Swallow the tablet without chewing, washing it down with a sufficient amount of water.
Treatment with Paracetamol + Methocarbamol APAP should be as short as possible.
The doctor will determine the duration of treatment, which will depend on the severity of pain or muscle spasms. As the symptoms subside, the doctor may decide to stop treatment.
Remember to take the medicine. Do not exceed the recommended dose.
If the patient thinks that the effect of Paracetamol + Methocarbamol APAP is too strong or too weak, they should tell their doctor or pharmacist.

Taking a higher dose of the medicine than recommended

In case of overdose of Paracetamol + Methocarbamol APAP, immediately contact a doctor or pharmacist or go to the nearest hospital, taking the remaining tablets with you to show them to the doctor.

Missing a dose of Paracetamol + Methocarbamol APAP

Do not take a double dose to make up for a missed dose. If a dose is missed, take the next dose as soon as possible and return to the usual dosing schedule.
Always maintain a 4-hour interval between doses. In case of doubts, consult a doctor or pharmacist.

Stopping treatment with Paracetamol + Methocarbamol APAP

In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following reactions occur, stop treatment and immediately inform your doctor:

• Allergic reactions, from skin rash or urticaria to more severe reactions, such as anaphylactic reaction or angioedema (rash, itching, swelling of limbs, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing) or severe skin reactions;
• Jaundice (yellowing of the skin and whites of the eyes), indicating liver problems;
• In case of symptoms of infection, such as fever and pain, immediately contact a doctor, as they may indicate disorders of white blood cell or platelet count, leading to reduced immunity to infections;
• Seizures or fainting.

The following side effects may occur rarely (may affect less than 1 in 1,000 people):

• headache, dizziness or drowsiness;
• conjunctivitis with rhinitis;
• low blood pressure, metallic taste, increased liver transaminase activity;
• fever, malaise.

The following side effects may occur very rarely (may affect less than 1 in 10,000 people):

• nausea, vomiting;
• nervousness, anxiety, confusion, tremors, drowsiness, blurred vision, nystagmus (rapid and involuntary eye movements);
• low blood sugar, decreased heart rate, flushing (hot flashes);
• toxic effect on the kidneys (cloudy urine);
• breathing difficulties.

Side effects for which the frequency cannot be estimated from the available data:

• mild coordination disorders, memory loss, vertigo of labyrinthine origin, insomnia, double vision;
• heartburn, dry mouth, fatigue, diarrhea;
• a serious disease that can cause blood acidification (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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://smz2.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Paracetamol + Methocarbamol APAP

Keep the medicine out of the sight and reach of children.
Store in a temperature below 30°C.
Do not take this medicine after the expiry date stated on the carton after "EXP" and on the blister pack after "EXP". The expiry date refers to the last day of the month.
The applied labeling for the blister is: EXP - expiry date, Lot - batch number.
Medicines should not be disposed of via wastewater or household waste. Packaging and unused medicines should be disposed of in special collection points in pharmacies. In case of doubts, ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamol + Methocarbamol APAP contains

• The active substances of the medicine are paracetamol (Paracetamolum) and methocarbamol (Methocarbamolum). Each tablet contains 300 mg of paracetamol and 380 mg of methocarbamol.
• The other ingredients are: maize starch, cornstarch, sodium carboxymethylcellulose (Type A), croscarmellose sodium, povidone K 30, stearic acid, glycerol distearate (Type I), silica colloidal anhydrous, talc, magnesium stearate.

What Paracetamol + Methocarbamol APAP looks like and contents of the pack

White, oblong, biconvex tablets, smooth on both sides, with dimensions: height 6.0-7.0 mm, width 8.0 ± 0.2 mm, length 19.0 ± 0.2 mm.
PVC/Aluminum blister pack, in a cardboard box.
Pack sizes:
30 tablets – 2 blisters of 15 tablets
40 tablets – 4 blisters of 10 tablets
45 tablets – 3 blisters of 15 tablets
50 tablets – 5 blisters of 10 tablets

Marketing authorization holder and manufacturer

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław

Manufacturer

Meditop Pharmaceutical Ltd.
Ady Endre u. 1, Pilisborosjenő, 2097, Hungary
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: