Keral 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dexketoprofen trometamol

Available from:

A. Menarini Farmaceutica Internazionale SRL

ATC code:

M01AE17

INN (International Name):

Dexketoprofen trometamol

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5038227000027 5038227000041

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KERAL 25 MG FILM-COATED TABLETS
_ _
Dexketoprofen
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 Keral is and what it is used for
2.
What you need to know before you take Keral
3.
How to take Keral
4.
Possible side effects
5.
How to store Keral
6.
Contents of the pack and other information
1.
WHAT KERAL IS AND WHAT IT IS USED FOR
Keral is a pain killer from the group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
It is used to treat mild to moderate pain, such as muscular pain,
painful periods (dysmenorrhoea), toothache.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KERAL
DO NOT TAKE KERAL:

If you are allergic to dexketoprofen or any of the other ingredients
of this medicine (listed in section 6);

If you are allergic to acetylsalicylic acid or to other non-steroidal
anti-inflammatory medicines;

If you have asthma or have suffered attacks of asthma, acute allergic
rhinitis (a short period of inflamed
lining of the nose), nasal polyps (lumps within the nose due to
allergy), urticaria (skin rash), angioedema
(swollen face, eyes, lips, or tongue, or respiratory distress) or
wheezing in the chest after taking
acetylsalicylic acid or other non-steroidal anti-inflammatory
medicines;

If you have suffered from photoallergic or phototoxic reactions (a
particular form of reddening and/or
blistering of the skin exposed to sunlight) while taking ketoprofen (a
non-steroidal anti-inflammatory
drug) or fibrates (drugs used to

Summary of Product characteristics

OBJECT 1
KERAL
Summary of Product Characteristics Updated 03-May-2018 | A. Menarini
Farmaceutica Internazionale
SRL
1. Name of the medicinal product
Keral 25 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains: dexketoprofen 25 mg as dexketoprofen trometamol.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablet.
Keral 25 mg: white, round, scored film-coated tablet. The tablets can
be divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Symptomatic treatment of pain of mild to moderate intensity, such as
musculo-skeletal pain,
dysmenorrhoea, dental pain.
4.2 Posology and method of administration
Posology
_Adults_
According to the nature and severity of pain, the recommended dosage
is generally 12.5 mg every 4-6
hours or 25 mg every 8 hours. The total daily dose should not exceed
75 mg.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
Keral tablets are not intended for long term use and the treatment
must be limited to the symptomatic
period.
_Elderly_
In elderly patients it is recommended to start the therapy at the
lower end of the dosage range (50 mg total
daily dose). The dosage may be increased to that recommended for the
general population only after good
general tolerance has been ascertained.
_Hepatic impairment_
Patients with mild to moderate hepatic dysfunction should start
therapy at reduced doses (50 mg total
daily dose) and be closely monitored. Keral tablets should not be used
in patients with severe hepatic
dysfunction.
_Renal impairment_
The initial dosage should be reduced to 50 mg total daily dose in
patients with mildly impaired renal
function (creatinine clearance 60 - 89 ml / min) (see section 4.4).
KERAL tablets should not be used in
patients with moderate to severe renal dysfunction (creatinine
clearance ≤59 ml / min) (see section 4.3).
_Paediatric Population _
Keral has not been studied in child