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ROBAXIN-750

Active substance(s): METHOCARBAMOL

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Robaxin -750

Marked trade name:

®

Tablets for oral use
Methocarbamol

1

P Robaxin 750mg tabs UK Mock up
POM

Regulatory text number:

WARNING:
May cause drowsiness.
If affected, do not drive
or operate machinery.
Avoid alcoholic drink.

uk-package-leaflet-robaxin-tracked

PL Holder:
Almirall, S.A.
Ronda General Mitre,151
08022 Barcelona, Spain.

PMS
PROCESS BLACK

PMS
30% 2718

BRAILLE

00000000

Name:

Version number:
Date:

08/07/2013

Exp:

100 Tablets

Item Number:

DRAWING

BN:

Dosage: 2 tablets to be swallowed 4
times a day or as directed by your doctor.
Please read the enclosed leaflet
Each tablet contains methocarbamol
750mg.
Also contains: maize starch, sodium
lauryl sulphate, hypromellose and
propylene glycol.
KEEP OUT OF THE REACH
AND SIGHT OF CHILDREN

PROOF:

01

00000000

robaxin

Base Label

Robaxin -750
®

Patient Information Leaflet

Tablets for oral use
Methocarbamol
Dosage: 2 tablets to be swallowed 4 times
a day or as directed by your doctor.
Please read the enclosed leaflet
Each tablet contains methocarbamol 750mg.
Also contains: maize starch, sodium lauryl
sulphate, hypromellose and propylene glycol.
KEEP OUT OF THE REACH
AND SIGHT OF CHILDREN

Robaxin -750
®

POM

WARNING:
May cause drowsiness.
If affected, do not drive
or operate machinery.
Avoid alcoholic drink.
PL Holder:
Almirall, S.A.
Ronda General Mitre,151
08022 Barcelona, Spain.

PL 16973/0015

100 Tablets

Tablets for oral use
Methocarbamol

Please read all of this leaflet carefully before you start taking this
medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.

If you are worried by any of the side effects, of if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

2. BEFORE YOU TAKE ROBAXIN-750 TABLETS

In this leaflet:
1.
2.
3.
4.
5.
6.

What Robaxin-750 tablets are and what they are used for
Before you take Robaxin-750 tablets
How to take Robaxin-750 tablets
Side effects
How to store Robaxin-750 tablets
Further information

1. WHAT Robaxin-750 TABLETS ARE AND WHAT THEY
ARE USED FOR
Robaxin-750 contains the active ingredient methocarbamol (750mg) which
belongs to a group of medicines called muscle relaxants.
Robaxin-750 is used for the short-term treatment of pain and muscle spasm
caused by injuries such as sprains and strains.

Do not take Robaxin-750 if you:
• are allergic to, or have had any problems in the past with, medicines
containing methocarbamol
• are allergic to any of the other ingredients in Robaxin-750
(see Section 6 Further Information)
• have ever suffered any brain damage or coma
• suffer from epilepsy or convulsions
• suffer from muscle weakness (a disease called myasthenia gravis)
Take special care with Robaxin-750:
Tell your doctor or pharmacist before taking Robaxin-750 if you:
• are pregnant or thinking of becoming pregnant
• are breastfeeding
• have, or have had, any kidney or liver problems
• are having any medical investigations or tests as Robaxin-750 could
interfere with the results. Tell your doctor that you are taking
Robaxin-750 before you have the test.

Taking other medicines:
If you are taking any of the following medicines, you should tell your doctor
or pharmacist as Robaxin-750 may interact with them:
• Barbiturates which can be taken for epilepsy or to help you sleep.
• Appetite suppressants to help you lose weight.
• Medicines for stomach upsets or sea-sickness (anti-cholinergics).
• Psychotropic drugs for the treatment of anxiety, depression or other
mental illnesses.
• If you are due to have anaesthetic for any reason, tell your doctor or
dentist that you are taking Robaxin-750.
Taking Robaxin-750 with food and drink:
You should avoid drinking alcohol while taking Robaxin-750.
Driving and using machines:
The tablets may make you feel sleepy. Do not drive or operate machinery
until you are sure you are not affected.

Front side

3. HOW TO TAKE ROBAXIN-750 TABLETS
Adults: Take TWO tablets with a little water, FOUR times a day. Sometimes
a lower dose may be sufficient. You should spread the doses
as evenly as possible over a 24-hour period.
Elderly: older patients may only need half the usual dose to give the same
relief from the pain and muscle spasms.
Children: These tablets should not be given to children.
Liver impairment: you may need a longer interval between taking
the tablets if you have liver disease. You should always follow your doctor's
instructions carefully.
These tablets are for short-term treatment. Take them for as long as your
doctor has recommended, or until you no longer need them to ease the
pain. Return any unused tablets to your pharmacist.

Back side

If you take more Robaxin-750 tablets than you should:
Contact your doctor immediately, go or take the person to the Accident
and Emergency Department of your local hospital. Always take the bottle of
Robaxin-750 with you, even if it is empty.
If you forget to take Robaxin-750 tablets:
Take your normal dose when you remember. Always leave at least 4 hours
before taking any more tablets. DO NOT TAKE A DOUBLE DOSE OF TABLETS
TO MAKE UP FOR A MISSED DOSE.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Robaxin-750 may cause unwanted effects in some people.
If you notice any of the following rare symptoms, you should STOP taking
your tablets and tell your doctor immediately:
• confusion, convulsions, fits, and rash or swelling of the face or neck and
shortness of breath which may be a sign of an allergy.
If you notice any of these symptoms, you should contact your doctor:
• yellowing of the skin and/or whites of the eyes.

The levels of your white blood cells may also be reduced which can lead to recurrent:
• infections
• mouth ulcers.
If any of the following side effects are troublesome, you should tell your doctor:
• drowsiness, difficulty in sleeping,
• restlessness, anxiety or worry,
• dizziness,
• memory loss,
• blurred or double vision, rapid or unusual eye movements,
• reddening of the eyes together with nasal stuffiness,
• feeling sick or vomiting,
• heartburn,
• taste disturbance,
• tremor or shakiness, mild muscle incoordination,
• headache,
• flushing,
• fever,
• fainting or feeling faint,
• itching,
• low blood pressure.
• a slow heartbeat,

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme, Website:
http://www.mhra.gov.uk/yellowcard. By reporting side effects you can also
provide more information on the safety of this medicine.
5. HOW TO STORE ROBAXIN-750 TABLETS
Keep out of the reach and sight of children. Do not take Robaxin-750 after
the 'expiry date' (EXP) that is shown on the label of the container. Take any
unused medicine to your pharmacist to be disposed of.
6. FURTHER INFORMATION
What Robaxin-750 tablets contain
Each tablet contains the active ingredient methocarbamol (750mg).

Other ingredients are: maize starch, alginic acid, povidone, sodium lauryl sulphate, magnesium
stearate, talc, and gelatine.
The tablet coating contains hypromellose (E464), microcrystalline cellulose (E460), polyoxyl
8 stearate, propylene glycol and titanium dioxide (E171).
What Robaxin-750 tablets look like and contents of the pack.
Robaxin-750 tablets are white, capsule-shaped tablets and are supplied in bottles of 100 tablets.
Marketing authorisation holder and manufacturer:
Marketing Authorisation Holder:
Almirall, S.A.; Ronda General Mitre, 151; 08022 Barcelona; Spain
Manufacturer:
Industrias Farmacéuticas Almirall, S.A.
Ctra. Nacional II, km 593
08740 Sant Andreu de la Barca, Barcelona - Spain
Date of Preparation: July 2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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