Methocarbamol Espefa

Leaflet attached to the packaging: patient information

Methocarbamol Espefa, 500 mg, tablets

Methocarbamol
Read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 Methocarbamol Espefa and what is it used for
• 2. Important information before using Methocarbamol Espefa
• 3. How to use Methocarbamol Espefa
• 4. Possible side effects
• 5. How to store Methocarbamol Espefa
• 6. Package contents and other information

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

Methocarbamol Espefa reduces muscle tone by acting on the central nervous system. It does not directly affect muscles, motor nerves, or nerve-muscle connections. The medicine is quickly absorbed when taken orally. The effect occurs after about 30 minutes and lasts 4 to 6 hours. Methocarbamol is metabolized in the liver and excreted mainly in the urine.

Indications for use:

Symptomatic treatment of musculoskeletal disorders with pain due to increased muscle tension (myositis, arthritis, tendinitis, disc syndrome, after injuries and surgical procedures). Facilitating rehabilitation procedures or allowing them to start earlier.

2. Important information before using Methocarbamol Espefa

When not to use Methocarbamol Espefa:

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

Warnings and precautions

Before starting to use Methocarbamol Espefa, discuss it with your doctor.
Using Methocarbamol Espefa in patients with kidney and/or liver function disorders
In patients with liver or kidney failure, the duration of methocarbamol action is prolonged and its excretion from the body is impaired. Particular caution should be exercised and the smallest effective doses should be used.

Children and adolescents

The use of Methocarbamol Espefa is not recommended in children, as the safety of methocarbamol in children under 12 years of age has not been sufficiently determined.

Methocarbamol Espefa and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The sedative effect of the medicine is enhanced by alcohol and drugs that depress the central nervous system (some antihistamines, sedatives, antidepressants, neuroleptics, and opioid analgesics), which can lead to increased drowsiness or coma.
Methocarbamol Espefa may enhance the effect of appetite suppressants and anticholinergic drugs.

Using Methocarbamol Espefa with food, drink, and alcohol

Do not drink alcohol during treatment, as it increases the undesirable effects of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Due to the lack of studies documenting the safety of use, Methocarbamol Espefa is not recommended in pregnant and breastfeeding women.

Driving and operating machines

Methocarbamol Espefa may cause drowsiness or dizziness. During treatment, do not drive vehicles or operate machines .

3. How to use Methocarbamol Espefa

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Recommended dose:
In acute conditions, adults take 3 tablets every 6 hours (6 g / day) orally, after 2-3 days the dose is reduced to 2 tablets every 6 hours (4 g / day).
The effectiveness of the medicine has also been observed after taking 5 tablets per day (2.5 g).
In elderly patients, use the smallest effective dose.
The use of this medicine is not recommended in children under 12 years of age.
If you feel that the effect of Methocarbamol Espefa is too strong or too weak, consult your doctor.

Using a higher dose of Methocarbamol Espefa than recommended

There have been single cases of overdose, mainly manifested by nausea, drowsiness, vision disturbances, hypotension, convulsions, and coma.
In such a case, it is recommended to perform gastric lavage and supportive treatment for 24 hours after the overdose.
If you have taken more than the recommended dose of the medicine, consult your doctor or pharmacist immediately.

Missing a dose of Methocarbamol Espefa

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Methocarbamol Espefa can cause side effects, although not everybody gets them.
Tell your doctor if you experience any of the following symptoms:
fever, headache, dizziness, tachycardia, hypotension, fainting, nausea, vomiting, anxiety, fear, tremors, disorientation, vision disturbances, drowsiness or insomnia, allergic reactions (rash, itching, hives), yellowing of the skin or whites of the eyes, metallic taste, conjunctivitis, and nasal congestion.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. 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 Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Methocarbamol Espefa

Keep the medicine out of sight and reach of children.
Store in a temperature below 25°C.
Store 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 specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Methocarbamol Espefa contains

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

What Methocarbamol Espefa looks like and what the pack contains

Methocarbamol Espefa is available in packs 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 authorization holder and manufacturer

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

Information for the blind and visually impaired: 800-007-777

Date of last update of the leaflet:

• 19.04.2023