Package leaflet: Information for the patient

Methocarbamol Espefa, 500 mg, tablets
Methocarbamolum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms of illness are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Methocarbamol Espefa is and what it is used for
Important information before taking Methocarbamol Espefa
How to take Methocarbamol Espefa
Possible side effects
How to store Methocarbamol Espefa
Contents of the pack and other information

1. What Methocarbamol Espefa is and what it is used for

Methocarbamol Espefa reduces skeletal muscle tension through action on the central nervous system. It does not act directly on muscles, motor nerves, or neuromuscular junctions. When administered orally, the drug is rapidly absorbed. Its effect begins approximately 30 minutes after administration and lasts for 4 to 6 hours. Methocarbamol is metabolized in the liver and primarily excreted in urine.
Indications:
Symptomatic treatment of musculoskeletal disorders associated with pain due to increased muscle tension (myositis, arthritis, tendinitis, disc-root syndrome, following trauma and surgical procedures). Facilitation of rehabilitation procedures or enabling their earlier initiation.

2. Important information before using Methocarbamol Espefa

When not to use Methocarbamol Espefa:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if the patient is in a coma or a pre-coma state;
if the patient has brain damage;
if the patient has myasthenia gravis (a disease characterized by significant muscle weakness);
if the patient has epilepsy.

Warnings and precautions
Before starting treatment with Methocarbamol Espefa, discuss it with your doctor.
Use of Methocarbamol Espefa in patients with impaired kidney and/or liver function
In patients with liver or kidney impairment, the duration of action of methocarbamol is prolonged and elimination from the body is reduced. Particular caution is required and the lowest effective doses should be used.
Children and adolescents
Use in children is not recommended, as the safety of methocarbamol has not been sufficiently established in children under 12 years of age.
Methocarbamol Espefa and other medicines
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take.
The sedative effect of the medicine is enhanced by alcohol and drugs that depress the central nervous system (certain antihistamines, sedatives, antidepressants, neuroleptics, and opioid analgesics), which may lead to increased drowsiness or coma.
Methocarbamol Espefa may enhance the effects of appetite suppressants and anticholinergic drugs.
Use of Methocarbamol Espefa with food, drink and alcohol
Alcohol should not be consumed during treatment, as it intensifies the undesirable effects of the medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Due to lack of studies documenting safety, use of Methocarbamol Espefa is not recommended in women during pregnancy and breastfeeding.
Driving and operating machinery
Methocarbamol Espefa may cause drowsiness or dizziness. During treatment, patients should not drive or operate machinery.

3. How to use Methocarbamol Espefa

This medicine should always be used according to the doctor's instructions. In case of doubts, consult
your doctor.
Recommended dose:
For acute conditions, adults should initially take orally 3 tablets every 6 hours (6 g/day); after 2–3 days,
the dose should be reduced to 2 tablets every 6 hours (4 g/day).
Effectiveness of the drug has also been observed with a dose of 5 tablets per day (2.5 g).
In elderly patients, the lowest effective doses should be used.
This medicine is not recommended for children under 12 years of age.
If you feel that the effect of Methocarbamol Espefa is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Methocarbamol Espefa
There have been isolated cases of overdose, manifesting mainly as nausea,
drowsiness, visual disturbances, hypotension, convulsions, and coma.
In such cases, gastric lavage is recommended, along with supportive treatment maintaining vital functions for 24 hours following overdose.
If you have taken more than the recommended dose of this medicine, seek immediate medical advice from a doctor or pharmacist.
Missed dose of Methocarbamol Espefa
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everybody experiences them.
You should inform your doctor if any of the following symptoms occur:
fever, headache, dizziness, bradycardia, hypotension, fainting, dyspepsia,
nausea, vomiting, restlessness, anxiety, tremor, disorientation, visual disturbances, drowsiness or
insomnia, allergic reactions (rash, itching, urticaria), yellowish discoloration of the skin or sclera,
metallic taste, conjunctivitis, and nasal mucosa congestion.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Reactions of Medicinal Products
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://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Methocarbamol Espefa

Keep the medicine out of sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Methocarbamol Espefa contains

The active substance is methocarbamol. One tablet contains 500 mg of methocarbamol.
The other ingredients (excipients) are: maize starch, povidone, microcrystalline cellulose, talc, magnesium stearate.

What Methocarbamol Espefa looks like and contents of the pack
Methocarbamol Espefa is available in packages containing:
30 tablets (2 blisters of 15 tablets)
50 tablets (5 blisters of 10 tablets or 2 blisters of 25 tablets)
60 tablets (4 blisters of 15 tablets)
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
ul. J. Lea 208,
30-133 Kraków
Tel.: 12 639 27 27

Information for blind and partially sighted people: 800-007-777
19.04.2023