Syprol Oral Solution 5mg/5ml

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

PROPRANOLOL HYDROCHLORIDE

Mevcut itibaren:

Cherubino Limited DELF Building, Sliema Road, Gzira, GZR 1637, Malta

ATC kodu:

C07AA05

INN (International Adı):

PROPRANOLOL HYDROCHLORIDE 5 mg/ml

Farmasötik formu:

ORAL SOLUTION

Kompozisyon:

PROPRANOLOL HYDROCHLORIDE 5 mg/ml

Reçete türü:

POM

Terapötik alanı:

BETA BLOCKING AGENTS

Ürün özeti:

Licence number in the source country: UNITED KINGDOM - PL00427/0122

Yetkilendirme durumu:

Withdrawn

Yetkilendirme tarihi:

2014-07-22

Bilgilendirme broşürü

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Univers Roman
UNIVERS BOLD
5mg/5ml
BLACK
PANTONE
PANTONE
KEYLINE
UKL412
564
210 x 300mm
N/A
30 x 150mm
1
1 of 2
8.6pt
NO
150ml
150ml
N/A
F4QD1RBJ4
F4QD1RBJ3
N/A
1153205
Propranolol Rosemont 5mg/5ml Oral Solution
24/03/20
-
NH
-
3
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NOT KNOWN (FREQUENCY CANNOT BE ESTIMATED FROM THE AVAILABLE DATA)
n
low levels of blood sugar (hypoglycaemia) may occur in diabetic and
non diabetic patients including the
newborn, toddlers and children, elderly patients, patients on
artificial kidneys (haemodialysis) or patients
on medication for diabetes. It may also occur in patients who are
fasting or have been fasting recently or
who have a long-term liver disease (signs include weakness, headache,
feeling hungry, visual disturbances
and mood changes)
n
seizure linked to low levels of sugar in the blood.
TELL YOUR DOCTOR IF YOU GET ANY OF THESE SIDE EFFECTS:
COMMON (AFFECTS LESS THAN 1 IN 10 PEOPLE)
n
cold fingers and toes
n
numbness and spasm in the fingers which is followed
by warmth and pain (Raynaud’s phenomenon)
n
nightmares, tiredness or difficulty sleeping.
UNCOMMON (AFFECTS LESS THAN 1 IN 100 PEOPLE)
n
feeling or being sick
n
stomach ache
n
diarrhoea.
RARE (AFFECTS LESS THAN 1 IN 1000 PEOPLE)
n
feeling confused
n
changes in your mood
n
memory loss
n
mental illness where a person loses touch with reality (psychoses)
n
strange sounds and visions (hallucinations)
n
thinning of the hair
n
skin rash, worsen

Ürün özellikleri

Propranolol Rosemont 5mg/5ml Oral Solution
Summary of Product Characteristics Updated 06-Apr-2020 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Propranolol Rosemont 5mg/5ml Oral Solution
2. Qualitative and quantitative composition
Propranolol Hydrochloride 5mg/5ml
Excipients with known effect:
Methyl parahydroxybenzoate (E218) 6mg/5ml
Propyl parahydroxybenzoate (E216) 1.5mg/5ml
Liquid maltitol (E965) 3000mg/5ml
Propylene glycol (E1520) 100mg/5ml
Ethanol 4.7mg/5ml
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Oral Solution
Clear colourless liquid with odour of orange/tangerine.
4. Clinical particulars
4.1 Therapeutic indications
Propranolol is indicated in:
- the control of hypertension
- the management of angina pectoris
- the long term prophylaxis against reinfarction after recovery from
acute myocardial infarction
- the control of most forms of cardiac arrhythmia
- the prophylaxis of migraine
- the management of essential tremor
- relief of situational anxiety and generalised anxiety symptoms,
particularly those of the somatic type
- prophylaxis of upper gastro-intestinal bleeding in patients with
portal hypertension and oesophageal varices
- the adjunctive management of thyrotoxicosis and thyrotoxic crisis
- management of hypertrophic obstructive cardiomyopathy
- management of phaeochromocytoma perioperatively (with an
alpha-adrenoceptor blocking drug).
4.2 Posology and method of administration
Posology
Adults:
Hypertension – A starting dose of 80mg twice a day may be increased
at weekly intervals according to response. The
usual dose range is 160–320mg per day. With concurrent diuretic or
other antihypertensive drugs a further reduction of
blood pressure is obtained.
Angina, migraine and essential tremor – A starting dose of 40mg two
or three times daily may be increased by the same
amount at weekly intervals according to patient response. An adequate
response in migraine and essential tremor is
usually seen in the range 80–160mg/day and in angina in th