Tramadol Krka 50mg hard capsules

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Tramadol hydrochloride

Dostupno od:

KRKA, d.d., Novo mesto

ATC koda:

N02AX; N02AX02

INN (International ime):

Tramadol hydrochloride

Doziranje:

50 milligram(s)

Farmaceutski oblik:

Capsule, hard

Tip recepta:

Product subject to prescription which may not be renewed (A)

Područje terapije:

Other opioids; tramadol

Status autorizacije:

Marketed

Datum autorizacije:

2018-03-16

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRAMADOL KRKA 50 MG HARD CAPSULES
tramadol hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tramadol Krka is and what it is used for
2.
What you need to know before you take Tramadol Krka
3.
How to take Tramadol Krka
4.
Possible side effects
5.
How to store Tramadol Krka
6.
Contents of the pack and other information
1.
WHAT TRAMADOL KRKA IS AND WHAT IT IS USED FOR
Tramadol – the active substance in Tramadol Krka – 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 Krka capsules are used for the treatment of moderate to
severe pain in adults and children
aged 12 years and over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL KRKA
DO NOT TAKE TRAMADOL KRKA
-
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 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
Krka (see "Other medicines
and Tramadol Krka");
-
if you suffer from epilepsy and your fits are not adequately
controlled by treatment;
-
as a substitute in drug withdrawal.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Tramadol Krka:
-
if you think t

Svojstava lijeka

Health Products Regulatory Authority
11 July 2022
CRN00CTQZ
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tramadol Krka 50mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 50 mg tramadol hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule (capsule)
The body of the capsule is white and the cap is blue. Capsules are
filled with white or almost white powder. The size of the
capsule is No: 4. The length of filled capsules is 14-15 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate to severe pain in adults and adolescents aged 12
years and over.
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. The lowest effective dose
for analgesia should generally be selected. The total daily dose of
400 mg active substance should not be exceeded, except in
special circumstances.
Unless otherwise prescribed, Tramadol Krka should be administered as
follows:
_Adults and adolescents aged 12 years and over_
Dosage form
Single dose
Total daily dose
Tramadol Krka
50-100 mg
Every 4 to 6 hours
(1 to 2 hard capsules)
(see section 5.1)
400 mg
(Up to 8 hard capsules)
If there is no sufficient pain relief after administration of a single
dose of 50 mg tramadol hydrochloride within 30 to 60
minutes, a second single dose of 50 mg can be administered.
If in severe pain the demand is likely to be higher, the higher single
dose of Tramadol Krka (100 mg tramadol hydrochloride)
may be given as the initial dose.
ACUTE PAIN: An initial dose of 100 mg is usually necessary. This can
be followed by doses of 50 or 100 mg at 4 - 6 hourly
intervals, and duration of treatment should be matched to clinical
need.
PAIN ASSOCIATED WITH CHRONIC CONDITIONS: An initial dose of 50 mg is
advised and then titration according to pain severity.
The need for continued treatment should be assessed at regular
intervals as withdr