Tramadol 50mg modified-release capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tramadol hydrochloride

Available from:

Kent Pharma (UK) Ltd

ATC code:

N02AX02

INN (International Name):

Tramadol hydrochloride

Dosage:

50mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

Schedule 3 (CD No Register Exempt Safe Custody)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200

Patient Information leaflet

Colours
CUSTOMER: IS
DESIGNER: DOB
PRODUCT: Tramadol Hydrochloride 50mg Capsules PIL
ITEM CODE:
CP.TDL.50C.IS.V6P1
PROOF NO AND DATE: 1
17/10/2017
REVISION:
ARTWORK FOR SUBMISSION
Supersedes: n/a
DIMENSIONS: 148mm x 450mm
Pantone
280 C WHAT TRAMADOL HYDROCHLORIDE 50MG CAPSULES IS AND WHAT IT IS USED FOR
Tramadol - the active substance in Tramadol
Hydrochloride 50mg Capsules - is a painkiller
belonging to the class of opioids that acts on the
central nervous system. It relieves pain by acting on
specific nerve cells of the spinal cord and brain.
Tramadol Hydrochloride 50mg Capsules is used for
the treatment and prevention of moderate to severe
pain. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL HYDROCHLORIDE 50MG CAPSULES
DO NOT TAKE TRAMADOL HYDROCHLORIDE 50MG
CAPSULES:
- if you are allergic to tramadol or any of the other
ingredients of this medicine (listed in section 6);
- in acute poisoning with alcohol, sleeping pills, pain
relievers or other psychotropic medicines
(medicines that affect mood and emotions);
- if you are also taking MAO inhibitors (certain
medicines used for treatment of depression) or
have taken them in the last 14 days before
treatment with Tramadol Hydrochloride 50mg
Capsules (see “Other medicines and Tramadol
Hydrochloride 50mg Capsules”);
- if you are an epileptic and your fits are not
adequately controlled by treatment;
- are pregnant, planning to become pregnant or are
breast-feeding
- as a substitute in drug withdrawal.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE TAKING TRAMADOL
HYDROCHLORIDE 50MG CAPSULES
- if you think that you are addicted to other pain
relievers (opioids);
- if you suffer from consciousness disorders (if you
feel that you are going to faint);
- if you have experienced dizziness while taking this
medicine as it may increase the risk of falling
- if you are in a state of shock (cold sweat may be a
sign of this);
- if you suffer from increased pressure in the brain
(possibly after a head injury or brain disease);
- if you have difficulty in breathing;
-

Summary of Product characteristics

OBJECT 1
TRAMADOL HYDROCHLORIDE 50MG CAPSULES
Summary of Product Characteristics Updated 01-May-2018 | Kent
Pharmaceuticals Ltd
1. Name of the medicinal product
Tramadol Hydrochloride 50mg Capsules
2. Qualitative and quantitative composition
Each capsule contains 50mg tramadol hydrochloride. Each capsule also
contains the excipient lactose
monohydrate. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard.
_Appearance: _Green and yellow, hard gelatin capsule printed with 'TRA
50'.
4. Clinical particulars
4.1 Therapeutic indications
Management (treatment and prevention) of moderate to severe pain.
4.2 Posology and method of administration
Posology
The dose should be adjusted to the intensity of the pain and the
sensitivity of the individual patient.
Unless otherwise prescribed, Tramadol Hydrochloride Capsules should be
administered as follows:
Adults and adolescents aged 12 years and over
_Acute Pain: _An initial dose of 100mg is usually necessary. This can
be followed by doses of 50 or 100mg
not more frequently than 4 hourly, and duration of therapy should be
matched to clinical need.
_Pain Associated with Chronic Conditions: _Use an initial dose of 50mg
and then titrate dose according to
pain severity.
The need for continued treatment should be assessed at regular
intervals as withdrawal symptoms and
dependence have been reported (See section 4.4).
The lowest analgesically effective dose should generally be selected.
Daily doses of 400 mg active
substance should not be exceeded, except in special clinical
circumstances.
Tramadol Hydrochloride Capsules should under no circumstances be
administered for longer than
absolutely necessary. If long-term pain treatment with Tramadol
Hydrochloride Capsules is necessary in
view of the nature and severity of the illness, then careful and
regular monitoring should be carried out (if
necessary with breaks in treatment) to establish whether and to what
extent further treatment is necessary.
_Children under 12 years_
Tramadol Hydrochloride Capsul