Paracetamol + methocarbamol apap

Package leaflet: Information for the patient

Paracetamol + Methocarbamol APAP, 300 mg + 380 mg, tablets
Paracetamolum + Methocarbamolum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

Paracetamol + Methocarbamol APAP is a combination of an analgesic and antipyretic substance with a muscle relaxant.
Paracetamol + Methocarbamol APAP is used for short-term symptomatic treatment of painful muscle spasms associated with acute musculoskeletal disorders.
Treatment with methocarbamol should be as short as possible. Once painful symptoms subside, the doctor will decide to discontinue the medicine.

2. Important information before using Paracetamol + Methocarbamol APAP

Do not use 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-comatose state,
if the patient suffers from epilepsy or has seizures,
if there is muscle weakness (a condition called myasthenia gravis),
in children and adolescents under 18 years of age.

Warnings and precautions
Before starting treatment, discuss this with your doctor.
Do not exceed the doses recommended in section 3 of the leaflet: How to use Paracetamol +
Methocarbamol APAP. Do not take other medicines containing paracetamol simultaneously
(e.g. cold remedies or other painkillers or antipyretics).

Consult your doctor or pharmacist before taking the medicine:
if the patient frequently consumes alcohol.
if the patient suffers from chronic alcoholism, they should not take more than 2 g
of paracetamol per day (do not take more than 6 tablets per day).
if the patient has impaired liver or kidney function, the doctor may adjust the dosage,
increase the intervals between doses, or avoid prolonged treatment beyond necessity.
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 undergoing treatment with antiepileptic drugs. See below.

During treatment with Paracetamol + Methocarbamol APAP, immediately inform your doctor if:
the patient has serious illnesses, 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 serious condition called metabolic acidosis
(a disturbance in blood and body fluid balance) when taking paracetamol regularly over a long period or when taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Effect on laboratory test results
If the patient is undergoing any diagnostic tests, they should inform the doctor that they are taking Paracetamol + Methocarbamol APAP, as this may affect test results.
Administration of paracetamol may influence the results of certain laboratory tests (e.g. measurement of uric acid or glucose levels).

Paracetamol + Methocarbamol APAP and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Methocarbamol may cause interactions with the following medicines:

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

Paracetamol may cause interactions with the following medicines:

• Oral anticoagulants (used in the treatment of diseases related to excessive blood clotting);
• Antiepileptic drugs (used in epileptic seizures);
• Antibiotics (chloramphenicol);
• Contraceptive agents;
• Diuretics (used to increase urine excretion);
• Isoniazid (used in the treatment of tuberculosis);
• Metoclopramide and domperidone (antiemetic drugs);
• Probenecid (used in the treatment of gout);
• Propranolol (used in the treatment of hypertension, cardiac arrhythmias);
• Rifampicin (used in the treatment of tuberculosis);
• Anticholinergic drugs (used to relieve muscle tension, spasms, gastrointestinal disorders, overactive bladder, and also in locomotor disease);
• Zidovudine (used in the treatment of HIV infection);
• Cholestyramine (used to reduce blood cholesterol levels).

Inform your doctor or pharmacist if the patient is taking:

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

Do not take Paracetamol + Methocarbamol APAP together with other painkillers 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 impact on the central nervous system. Taking paracetamol in patients who regularly consume alcohol may damage the liver.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, or if she plans to become pregnant, she should consult her doctor or pharmacist before starting treatment with Paracetamol + Methocarbamol APAP.

Pregnancy
Use of this medicine is not recommended in women who are pregnant or planning pregnancy. If a patient discovers she is pregnant during treatment, she should contact her doctor immediately to adjust the treatment accordingly.

Breastfeeding
Women who are breastfeeding should consult their doctor before using this medicine. The doctor will decide with the patient whether breastfeeding should be continued. Methocarbamol and/or its metabolites have been detected in dog milk, but it is not known whether methocarbamol or its metabolites pass into human breast milk. Paracetamol passes into breast milk, but not in clinically significant amounts.

Driving and operating machinery
During treatment, the patient may experience drowsiness; therefore, they should not drive or operate machinery until they know how they react to the medicine. This is particularly important if the patient is also taking other medicines that may 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 sodium intake in the adult diet.

3. How to use Paracetamol + Methocarbamol APAP

The medicine should always be taken as directed by the physician. If in doubt, consult your doctor or pharmacist again.
The recommended doses are as follows:
Adults
The recommended dose is 2 tablets every 4–6 hours (four to six times daily), depending on the severity of symptoms. The maximum daily dose is 12 tablets. As soon as pain symptoms begin to subside, treatment should be discontinued.
Elderly patients
Elderly patients may require lower doses to achieve the same analgesic and muscle-relaxant effect. It is recommended to take 1 tablet every 4 hours or 2 tablets every 8 hours.
Patients with hepatic and/or renal impairment
A longer interval between doses may be necessary.
Strict adherence to the physician's instructions is essential (see section 2). Important information before using Paracetamol + Methocarbamol APAP.
Depending on the severity of renal dysfunction, the physician will decide whether the patient should take 1 tablet every 6 or every 8 hours.
In case of liver failure, the total daily dose should not exceed 6 tablets.
Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age due to lack of data on safety and efficacy in this patient group.
This medicine is administered orally.
The tablet should be swallowed whole, without chewing, with an adequate amount of water.
Treatment with Paracetamol + Methocarbamol APAP should last as short a time as possible.
The duration of treatment will be determined by the physician, depending on the intensity of pain or muscle spasm symptoms. As these symptoms subside, the physician may decide to discontinue treatment.
Always remember to take the medicine as prescribed. Do not exceed the recommended dose.
If the patient feels that the effect of Paracetamol + Methocarbamol APAP is too strong or too weak, they should inform their doctor or pharmacist.
Overdose
In case of overdose of Paracetamol + Methocarbamol APAP, contact a doctor or pharmacist immediately or go to the nearest hospital, taking the remaining tablets with you to show to the doctor.
Missed dose
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 regular dosing schedule. Always maintain a 4-hour interval between doses. In case of doubt, consult your doctor or pharmacist.
Discontinuation of treatment
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following reactions occur, treatment must be discontinued immediately and the doctor should be informed without delay:

• Allergic reactions, ranging from skin rash or hives 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 possible liver problems;
• In case of signs of infection such as fever and pain, contact the doctor immediately, as these may indicate disorders in white blood cell or platelet counts, leading to reduced resistance to infections;
• Seizures or fainting.

The following adverse reactions may occur rarely (affecting fewer than 1 in 1,000 people):

• Headache, dizziness, or vertigo;
• Conjunctivitis with rhinitis;
• Drop in blood pressure, metallic taste, increased liver aminotransferase activity;
• Fever, malaise.

The following adverse reactions may occur very rarely (affecting fewer than 1 in 10,000 people):

• Nausea, vomiting;
• Nervousness, anxiety, confusion, tremor, somnolence, blurred vision, nystagmus (rapid, involuntary eye movements);
• Low blood sugar concentration, decreased heart rate, skin flushing (hot flushes);
• Toxic effect on kidneys (cloudy urine);
• Breathing difficulties.

Adverse reactions for which frequency cannot be determined from available data:

• Mild disturbances in muscle coordination, memory loss, labyrinthine dizziness, insomnia, double vision;
• Heartburn, dry mouth, fatigue, diarrhoea;
• Serious condition that may cause blood acidification (so-called metabolic acidosis) in patients with severe disease taking paracetamol (see section 2).

Reporting of adverse reactions to medicinal products
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Paracetamol + Methocarbamol APAP

Keep this medicine out of sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the carton and immediate packaging following “Expiry date (EXP)” and “EXP”, respectively. The expiry date refers to the last day of the stated month.
Blister pack labelling: EXP - expiry date, Lot - batch number.
Medicines must not be disposed of via wastewater or household waste. Empty containers and unused medicines should be returned to designated collection points at pharmacies. If in doubt, ask your pharmacist how to dispose of containers and medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamol + Methocarbamol APAP contains

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

What the medicine looks like and contents of the pack
White, elongated, 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/Aluminium blisters, in a cardboard box.
Pack sizes:
30 tablets – 2 blisters containing 15 tablets each
40 tablets – 4 blisters containing 10 tablets each
45 tablets – 3 blisters containing 15 tablets each
50 tablets – 5 blisters containing 10 tablets each

Marketing Authorisation Holder and Manufacturer
US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław, Poland

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

For further information about this medicine, please contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35, 02-822 Warszawa, Poland
tel.: +48 (22) 543 60 00