Ramipril 2.5mg/5ml oral solution

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Ramipril

Dostupné z:

Special Order

ATC kód:

C09AA05

INN (Medzinárodný Name):

Ramipril

Dávkovanie:

500microgram/1ml

Forma lieku:

Oral solution

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 02050501

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JOB INFORMATION
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JOB SPECIFICATION
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THIRD PARTY APPROVAL REQUIRED
Name:
Name:
Signature:
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AUTHORITY APPROVAL SUPPLIED
REGULATORY SIGN-OFF
YES
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NO
N/A
TICK APPLICABLE BOX
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Univers Roman
UNIVERS BOLD
2.5mg/5ml
BLACK
PANTONE
PANTONE
KEYLINE
UKL411
592
300 x 330mm
N/A
150 x 37mm
1
1 of 2
9pt
NO
150ml
150ml
N/A
D7SD1RBJ4
D7SD1RBJ3
N/A
1187785
Ramipril 2.5mg/5ml Oral Solution
31/03/20
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NH
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2
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n
Sweating more than usual
n
Loss or decrease of appetite (anorexia)
n
Increased or irregular heart beats
n
Swollen arms and legs. This may be a sign of your body holding onto
more water than usual
n
Flushing
n
Blurred vision
n
Pain in your joints
n
Fever
n
Sexual inability in men, reduced sexual desire in men or women
n
An increased number of certain white blood cells (eosinophilia) found
during a blood test
n
Blood tests showing changes in the way your liver, pancreas or kidneys
are working.
RARE (affects less than 1 in 1,000 people):
n
Feeling shaky or confused
n
Red and swollen tongue
n
Severe flaking or peeling skin, itchy, lumpy rash
n
Nail problems (e.g. loosening or separation of a nail
from its bed)
n
Skin rash or bruising
n
Blotches on your skin and cold extremities
n
Red, itchy, swollen or watery eyes
n
Disturbed hearing or ringing in your ears
n
Feeling weak
n
Blood tests showing a decrease in the number of red
blood cells, white blood cells or platelets or in the
amount of haemoglobin.
VERY RARE (affects less than 1 in 10,000 people):
n
Being more sensitive to the sun than usual.
OTHER SIDE EFFECTS REPORTED:
Please tell your doctor if any of the following gets ser

Súhrn charakteristických

OBJECT 1
RAMIPRIL 2.5MG/5ML ORAL SOLUTION
Summary of Product Characteristics Updated 30-Apr-2020 | Rosemont
Pharmaceuticals Limited
•
1. Name of the medicinal product
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2. Qualitative and quantitative composition
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3. Pharmaceutical form
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4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
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4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Pregnancy and lactation
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4.7 Effects on ability to drive and use machines
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4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
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10. Date of revision of the text
1. Name of the medicinal product
Ramipril 2.5mg/5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml of solution contains 2.5mg Ramipril.
Excipients with known effect:
Ethyl Hydroxybenzoate (E214) 3mg/5ml
Butyl Hydroxybenzoate 0.25mg/5ml
Propylene Glycol (E1520) 250mg/5ml
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Oral Solution
A clear colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
• Treatment of hypertension.
• Cardiovascular prevention: reduction of cardiovascular morbidity
and mortality in patients with:
- manifest atherothrombotic cardiovascular disease (history of
coronary heart disease or stroke, or
peripheral vascular disease) or
- diabetes with at least one cardiovascular risk factor (see section
5.1).
• Treatment of renal disease:
- Incipient glomerul