Methocarbamol 750mg tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Methocarbamol

Dostupno od:

Aristo Pharma Ltd

ATC koda:

M03BA03

INN (International ime):

Methocarbamol

Doziranje:

750mg

Farmaceutski oblik:

Oral tablet

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 10020200; GTIN: 4251575902725

Uputa o lijeku

Dimensions:
140 X 331.5 MM
Created By:
DTAWDE
Artwork Code:
A0000/O/PIL/A
Final Preparation Date For Submission:
28/08/2019
Packing Site Technical Approval:
00/00/0000
Authority Approval Date:
00/00/0000
Latest Implementation Deadline:
00/00/0000
Print Proof Approval:
00/00/0000
CHILDREN: These tablets should not be given to
children and adolescents under 18 years old.
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.
The score line is only there to help you break
the tablet if you have difficulty swallowing it
whole.
DURATION OF TREATMENT
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.
IF YOU TAKE MORE METHOCARBAMOL THAN YOU
SHOULD
It is important to stick to your prescribed dose.
If you or someone else takes too much
medicine, contact your doctor or nearest
hospital emergency department immediately.
Always take any medicine left over with you
and also the pack, as this will allow easier
identification of the medicine.
IF YOU FORGET TO TAKE METHOCARBAMOL
If you forget to take a dose, simply take the
next dose when it is due. Do not take a double
dose of tablets to make up for a missed dose.
IF YOU STOP TAKING METHOCARBAMOL
Keep taking Methocarbamol until your doctor
tells you to stop or until you no longer need
them to ease the pain.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
STOP TAKING THIS MEDICINE AND TELL YOUR
DOCTOR IMMEDIATELY IF YOU EXPERIENCE ANY OF
THE FOLLOWING RARE SYMPTOMS:
•
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:
•
y

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Methocarbamol 750mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 750mg of methocarbamol.
Excipients with known effect:
Lactose monohydrate: each tablet contains 5.5mg.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white slightly curved oblong film coated tablets with
double-sided
scoring. The dimensions of the tablets are: length 19mm, width 8mm and
thickness
6.60±0.4mm.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As a short-term adjunct to the symptomatic treatment of acute
musculoskeletal
disorders associated with painful muscle spasms.
Methocarbamol 750mg film-coated tablets is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage:
Adults: The usual dose is 2 tablets four times daily but therapeutic
response has been
achieved with doses as low as 1 tablet three times daily.
Elderly: Half the maximum dose or less may be sufficient to produce a
therapeutic
response.
_Paediatric population _
The safety and efficacy of Methocarbamol 750mg film-coated tablets in
children and
adolescents have not been established. No data are available.
Hepatically impaired: In patients with chronic hepatic disease the
elimination half-life
may be prolonged. Therefore, consideration should be given to
increasing the dose
interval.
Duration of Treatment: The duration of administration depends on the
symptoms
induced by increased muscle tone, but should not exceed 30 days.
Route of administration
For oral use.
4.3
CONTRAINDICATIONS
Hypersensitivity to methocarbamol or any of the other excipients
listed in section 6.1.
Coma or pre-coma states.
Known brain damage or epilepsy.
Myasthenia gravis.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Methocarbamol should be used with caution in patients with renal and
hepatic
insufficiency. Since met