Timolol 10mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Timolol maleate

Beschikbaar vanaf:

Viatris UK Healthcare Ltd

ATC-code:

C07AA06

INN (Algemene Internationale Benaming):

Timolol maleate

Dosering:

10mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 02040000; GTIN: 5060035248308

Bijsluiter

123/L/a/6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TIMOLOL/AMILORIDE/HYDROCHLOROTHIAZIDE 10 MG/2.5 MG/25 MG TABLETS
Timolol maleate/Amiloride hydrochloride/Hydrochlorothiazide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 any of the 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 TIMOLOL/AMILORIDE/HYDROCHLOROTHIAZIDE TABLETS IS AND WHAT IT IS
USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TIMOLOL/AMILORIDE/HYDROCHLOROTHIAZIDE TABLETS
3.
HOW TO TAKE TIMOLOL/AMILORIDE/HYDROCHLOROTHIAZIDE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE TIMOLOL/AMILORIDE/HYDROCHLOROTHIAZIDE TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT TIMOLOL/AMILORIDE/HYDROCHLOROTHIAZIDE TABLETS IS AND WHAT IT IS
USED FOR
These tablets contain three active ingredients: timolol, amiloride and
hydrochlorothiazide.

Timolol is a beta-blocker to help lower your blood pressure.

Amiloride is a potassium-sparing diuretic that acts by increasing the
amount of urine you
produce.

Hydrochlorothiazide is a thiazide diuretic that acts by increasing the
amount of urine you
produce.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TIMOLOL/AMILORIDE/HYDROCHLOROTHIAZIDE TABLETS
DO NOT TAKE THESE TABLETS IF YOU:

are allergic to timolol, amiloride, hydrochlorothiazide, or any of the
other ingredients (see
section 6)

are allergic to sulphonamides with include co-trimoxazole (an
antibiotic) and acetazolamide
(for glaucoma, heart problems, epilepsy)

are pregnant or planning to become pregnant

are breast-feeding

have high levels of potassium in your blood
�

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Timolol/Amiloride/Hydrochlorothiazide 10 mg/2.5 mg/25 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg hydrochlorothiazide, 2.5 mg amiloride
hydrochloride and
10 mg timolol maleate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Light-blue coloured, square, compressed tablets with rounded corners;
one
side flat with bevelled edges and scored, the other side convex and
imprinted
‘17’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of mild to moderate hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
1 to 2 tablets once a day, taken orally.
_Use in the elderly_: Timolol/amiloride/hydrochlorothiazide has been
shown to
be as well tolerated in the elderly as in younger patients. The
recommended
starting dose is 1 tablet daily.
_Children_: Because the safety and efficacy has not been established
in children,
it is not recommended for paediatric use.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
•
Patients with bronchial asthma or with a history of bronchial asthma,
severe
chronic obstructive pulmonary disease, sinus bradycardia, second- or
third-
degree AV block, overt cardiac failure, right ventricular failure
secondary to
pulmonary hypertension, significant cardiomegaly and cardiogenic
shock.
•
Hyperkalaemia (plasma potassium over 5.5 mmol/l).
•
Anuria, acute and chronic renal insufficiency, severe progressive
renal disease,
and diabetic nephropathy.
•
Patients with blood urea over 10 mmol/l or serum creatinine over 130
µmol/l
or diabetes mellitus should not receive
Timolol/Amiloride/Hydrochlorothiazide without careful and frequent
serum
urea and serum electrolyte monitoring.
•
Anaesthetic agents causing myocardial depression, hypersensitivity to
any
component of the medicinal product or other sulphonamide-derived
drugs.
•
Use with other potassium-conserving agents. Use with potassium-ric