Co-Diovan 160 mg/25 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Valsartan; Hydrochlorothiazide

Available from:

Lexon Pharmaceuticals (Ireland) Limited

ATC code:

C09DA; C09DA03

INN (International Name):

Valsartan; Hydrochlorothiazide

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Angiotensin II antagonists and diuretics; valsartan and diuretics

Authorization date:

2022-06-24

Patient Information leaflet

_Very rare (may affect up to 1 in 10,000 people):_
_ _
•
inflammation of blood vessels with symptoms
such as rash, purplish-red spots, fever
(vasculitis)
•
rash, itching, hives, difficulty breathing or
swallowing, dizziness (hypersensitivity reactions)
•
facial rash, joint pain, muscle disorder, fever
(lupus erythematosus)
•
severe upper stomach pain (pancreatitis)
•
difficulty breathing with fever, coughing,
wheezing, breathlessness (respiratory distress
including pneumonitis and pulmonary oedema)
•
pale skin, tiredness, breathlessness, dark urine
(haemolytic anaemia)
•
fever, sore throat or mouth ulcers due to
infections (leucopenia)
•
confusion, tiredness, muscle twitching and
spasm, rapid breathing (hypochloraemic
alkalosis)
_ _
_Not known (frequency cannot be estimated from _
_the available data): _
•
weakness, bruising and frequent infections
(aplastic anemia)
•
severely decreased urine output (possible signs
of renal disorder or renal failure)
•
rash, red skin, blistering of the lips, eyes or
mouth, skin peeling, fever (possible signs of
erythema multiforme)
•
muscle spasm
•
fever (pyrexia)
•
weakness (asthenia)
•
skin and lip cancer (non-melanoma skin cancer)
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via HPRA Pharmacovigilance,
Website: www.hpra.ie. By reporting side effects
you can help provide more information on the
safety of this medicine.
5. HOW TO STORE CO-DIOVAN
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the carton and blister after EXP.
The expiry date refers to the last day of that
month.
Do not store above 30°C. Store in the original
package in order to protect from moisture.
Do not use this medicine if you notice that the
pack is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater
or household was

Summary of Product characteristics

Health Products Regulatory Authority
24 June 2022
CRN00CVZ0
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-Diovan 160 mg/25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 160 mg of valsartan and 25 mg of
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
_Product imported from Italy:_
Brown, ovaloid tablet imprinted with HXH on one side and NVR on the
other side.
4 CLINICAL PARTICULARS
As per PA0896/007/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0896/007/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Microcrystalline cellulose
Silica, Colloidal anhydrous
Crospovidone
Magnesium stearate
Coating:
Hypromellose
Macrogol 4000
Talc
Titanium dioxide (E171)
Red iron oxide (E172)
Yellow iron oxide (E172)
Black iron oxide (E172).
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Health Products Regulatory Authority
24 June 2022
CRN00CVZ0
Page 2 of 2
Do not store above 30° C.
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
28 film-coated tablets contained in blisters marked with the days of
the week in an outer carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon Pharmaceuticals (Ireland) Limited
Block 3, Harcourt Centre,
Harcourt Road,
Dublin 2,
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23176/046/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 24
th
June 2022
10 DATE OF REVISION OF THE TEXT