The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: methocarbamolOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

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Methocarbamol Aristo 750 mg Tablets

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Methocarbamol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Methocarbamol

Equivalent medicines (same active substance, strength and form)

→ Robaxin-750, 750 mg Film-coated Tablets brand

→ Methocarbamol 750 mg film coated-Tablet

→ Methocarbamol 750 mg film-coated tablets

→ Methocarbamol 750 mg tablets

→ Methocarbamol neuraxpharm 750 mg film-coated tablets

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

for Methocarbamol tablets contain the active substance methocarbamol. Methocarbamol belongs to a group of medications described as muscle relaxants. Methocarbamol is used for the symptomatic treatment of painful muscle spasms, especially in the lower back (lumbago). Methocarbamol is used in adults.

What you need to know before you take it

e Methocarbamol Do not take Methocarbamol

if you are allergic to methocarbamol or any of the other ingredients of this medicine (listed in section 6).
if you have ever suffered from a coma or reduced consciousness.
if you suffer from any disorders of the central nervous system.
if you suffer from abnormal muscle weakness (known as 'Myasthenia gravis')
if you suffer from epileptic seizures Warnings and precautions Talk to your doctor or pharmacist before taking Methocarbamol
if you suffer from kidney and/or liver problems. Interactions with laboratory tests Methocarbamol may cause colour interference in certain screening tests (for hydroxindolacetic acid [5-HIAA] and for vanilylmandelic acid [VMA].The urine of some patients receiving methocarbamol has been reported to turn brown, black, blue or green when stored. Use in children and adolescents This medicine is not recommended for use in children aged to 12 years and adolescents due to a lack of data. 1

Other medicines and Methocarbamol Tell your doctor or pharmacist if you are taking, have recently taken/used or might take/use any other medicines including medicines obtained without prescription. Taking Methocarbamol at the same time as certain medicines such as barbiturates, opioids or appetite suppressants may increase the effect of these medicines. The effects of anticholinergics, e.g. atropine and other psychotropic drugs may be increased by Methocarbamol. Methocarbamol may decrease the effect of pyridostigmine bromide. Therefore methocarbamol must not be used in patients with abnormal muscle weakness (myasthenia gravis), especially those being treated with pyridostigmine. Methocarbamol with alcohol Alcohol may increase the effects of methocarbamol. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy If you are pregnant you should not take this medicine since the safe use of Methocarbamol has not been established. Breast-feeding It is not known whether methocarbamol and/or its metabolites are passed into human milk. Therefore, you should not use this medicine if you are breast-feeding. Fertility No data are available about the effects of Methocarbamol on human fertility. Driving and using machines Methocarbamol may affect your ability to drive and use machines. Before driving or using machines, you should consider your general health and the possible side effects of Methocarbamol (see section 4) and you should not drive or use machines if you experience any side effects such as dizziness or sleepiness. Methocarbamol tablets contain sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodiumfree'. 3. How to take Methocarbamol Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The recommended dose Adults Unless otherwise prescribed, the recommended dosage is 2 tablets taken three times a day. At the start of treatment, it is recommended to take 2 tablets four times a day. In severe cases, up to 7500 mg Methocarbamol (10 tablets) daily may be taken. Elderly patients 2

Elderly patients may only need half the usual dose to give the same relief from the pain and muscle spasms. Liver problems You may need a longer interval between taking the tablets if you have liver disease. You should always follow your doctor's instructions carefully.

How to take it

the tablets Methocarbamol is for oral use. The tablets should be taken with a glass of water (approx. 200 ml). How long should you take the tablets The duration of treatment depends on your symptoms but should not exceed 30 days. If you take more Methocarbamol than you should Please contact your doctor immediately. He-she will decide what to do. If you forget to take Methocarbamol Do not take a double dose to make up for a forgotten dose. Please take the next dose at the usual time. If you stop taking Methocarbamol Please tell your doctor if you wish to stop your treatment with Methocarbamol. There are unlikely to be any unwanted effects on stopping your treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Rare side effects (may affect up to 1 in 1,000 people)

conjunctivitis
headache
dizziness
metallic taste
decrease in blood pressure
swelling of the nasal mucosa
angioedema (a serious allergic reaction which causes swelling of the face or throat)
rash
itching
urticaria (itchy skin)
fever. Very rare side effects (may affect up to 1 in 10,000 people)
anaphylactic reactions (allergic hypersensitivity reactions)
loss of appetite
restlessness
anxiety
confusion
fainting
nystagmus (rapid, uncontrollable eye movements)
drowsiness
tremor
convulsions 3

• • • • • •

blurred vision double vision slowed heartbeat hot flush feeling sick vomiting.

Possible side effects

with unknown frequency (frequency cannot be estimated from the available data)

sleepiness.
loss of coordination
local temporary sensory disorders (predominantly in the area of the face, scalp, lips, hands, fingers or feet),
nausea
diarrhoea
fatigue Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

Methocarbamol Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Contents of the pack and other information

What Methocarbamol tablets contain The active substance is methocarbamol. Each tablet contains 750 mg methocarbamol. The other ingredients are sodium starch glycolate (type A), magnesium stearate and povidone K25. What Methocarbamol looks like and contents of the pack Methocarbamol 750 mg tablets are white, slightly convex, oblong tablets. Methocarbamol is available in packs containing 20, 50 and 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Germany 4

This leaflet was last revised in 11/2024.

Frequently asked questions about Methocarbamol Aristo 750 mg Tablets

How do I take Methocarbamol Aristo 750 mg Tablets?

Methocarbamol Aristo 750 mg Tablets comes as tablet containing 750mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Methocarbamol Aristo 750 mg Tablets?

The active substance in Methocarbamol Aristo 750 mg Tablets is methocarbamol.

Are there equivalent medicines to Methocarbamol Aristo 750 mg Tablets?

Medicines with the same active substance, strength and form include: Robaxin-750, 750 mg Film-coated Tablets, Methocarbamol 750 mg film coated-Tablet, Methocarbamol 750 mg film-coated tablets. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Methocarbamol Aristo 750 mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Methocarbamol Aristo 750 mg Tablets without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Active substance: methocarbamol
Official document: view the original leaflet on emc →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Methocarbamol (9 medicines)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Symptomatic treatment of painful muscle tone, especially in the low back region (lumbago).

Methocarbamol is used in adults.

4.2. Posology and method of administration

Posology

The dosage for adults is 1500 mg methocarbamol three times a day.

For the start of treatment, intake of 1500 mg methocarbamol four times a day is recommended. In the case of severe complaints, patients may take up to 7500 mg methocarbamol per day.

Duration of administration

Methocarbamol should be taken for as long as the symptoms induced by increased muscle tone persist, but should not exceed 30 days.

Elderly patients

Half the maximum dose or less may be sufficient to produce a therapeutic response.

Patients with hepatic impairment

In patients with chronic hepatic disease the elimination half-life may be prolonged. Therefore, consideration should be given to increasing the dose interval.

Paediatric population

The safety and efficacy of Methocarbamol Aristo in children and adolescents have not been established.

Method of administration

Methocarbamol Aristo is for oral use.

The tablets should be taken with a sufficient amount of water.

4.3. Contraindications

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1,

- comatose or pre-comatose states,

- diseases of the central nervous system,

- Myasthenia gravis,

- Patients with a predisposition to epileptic seizures

4.4. Special warnings and precautions for use

Methocarbamol should be used with special care in patients with impaired renal function and/or impaired liver function.

Interference with laboratory tests

The urine of some patients receiving methocarbamol has been reported to turn brown, black, blue or green when stored. Methocarbamol may cause colour interference in certain screening tests for hydroxyindolacetic acid (5-HIAA) and for vanillylmandelic acid (VMA).

Methocarbamol Aristo contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

4.5. Interaction with other medicinal products and other forms of interaction

In the case of the concomitant use of methocarbamol and centrally acting medicinal products such as barbiturates, opioids or appetite suppressants pharmacological effects may mutually be enhanced.

If alcohol is taken during treatment with methocarbamol, an increase in effect may occur.

The effects of anticholinergics, e.g. atropine and some other psychotropic drugs may be potentiated by methocarbamol. Methocarbamol may decrease the effect of pyridostigmine bromide. Therefore, methocarbamol must not be taken by patients with myasthenia gravis, particularly those being treated with pyridostigmine.

4.6. Fertility, pregnancy and lactation

Pregnancy

There is no experience concerning the use of methocarbamol during pregnancy. Animal studies have not established the safe use of methocarbamol with regard to effects on pregnancy, embryonic/fetal development, parturition and postnatal development (see section 5.3). The potential risk for humans is not known.

Therefore, methocarbamol should not be used during pregnancy.

Breast-feeding

It is not known whether methocarbamol and/or its metabolites pass into human milk. Methocarbamol and/or its metabolites are excreted into the milk of lactating dogs. Therefore, methocarbamol should not be used by breast-feeding women.

Fertility

No data are available about the influence of Methocarbamol on the human fertility.

4.7. Effects on ability to drive and use machines

Methocarbamol may have an influence on the ability to drive and use machines since methocarbamol can cause dizziness and sleepiness, especially in concomitant use with other medications which also can cause sleepiness.

Patients should be advised not to carry out these activities in case dizziness or sleepiness occur.

4.8. Undesirable effects

The following groups have been used for frequency of undesirable effects:

very common

(≥ 1/10)

common

(≥ 1/100, < 1/10)

uncommon

(≥ 1/1000, < 1/100)

rare

(≥ 1/10 000, < 1/1000)

very rare

(< 1/10 000)

not known

(frequency cannot be estimated from the available data)

Immune system disorders

Very rare: anaphylactic reaction

Metabolism and nutrition disorders

Very rare: decreased appetite

Psychiatric disorders

Very rare: restlessness, anxiety, confusion

Nervous system disorders

Rare: headache, dizziness, metallic taste

Very rare: syncope, nystagmus, drowsiness, tremor, convulsions

Not known: sleepiness, loss of coordination, hypoesthesia*, paraesthesia*

Eye disorders

Rare: conjunctivitis

Very rare: visual impairment, double vision

Cardiac disorders

Very rare: bradycardia

Vascular disorders

Rare: hypotonia

Very rare: hot flash

Respiratory, thoracic and mediastinal disorders

Rare: swelling of the nasal mucosa

Gastrointestinal disorders

Very rare: feeling sick, vomiting

Not known: nausea, diarrhoea

Skin and subcutaneous tissue disorders

Rare: angioedema, skin rash, pruritus, urticaria

General disorders and administration site conditions

Rare: fever

Not known: fatigue

*Localised,temporary sensory disorders predominantly affecting the head (e.g. face, scalp), the mouth region (e.g. lips and tongue) or the limbs (hands, fingers, feet).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the yellow card scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures and coma.

Following oral use of methocarbamol in doses of 22.5 g to 50 g by patients who intended to commit suicide, sleepiness was observed in two patients. Both patients recovered completely within 24 hours. There are 3 reported death cases in the literature, which involved the concomitant use of large quantities of alcohol (2x) and opiates (1x) alongside methocarbamol with suicidal intent.

Treatment of intoxication comprises symptomatic therapy and monitoring of vital functions.

The benefit of hemodialysis in the treatment of a methocarbamol overdose is not known.

💬 Ask about this leaflet

Ask anything about Methocarbamol Aristo 750 mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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