Nutrizym 22 gastro-resistant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amylase; Lipase; Protease

Available from:

Zentiva Pharma UK Ltd

ATC code:

A09AA02

INN (International Name):

Amylase; Lipase; Protease

Dosage:

19800unit ; 22000unit ; 1100unit

Pharmaceutical form:

Gastro-resistant capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 01090400; GTIN: 5013837106260

Patient Information leaflet

.
April

Summary of Product characteristics

OBJECT 1
NUTRIZYM 22
Summary of Product Characteristics Updated 13-Apr-2018 | Merck
1. Name of the medicinal product
Nutrizym 22
2. Qualitative and quantitative composition
Each capsule contains Pancreatin BP 340mg with not less than the
following activities. Lipase 22,000 BP
Units, Protease 1,100 BP Units and Amylase 19,800 BP Units.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard gelatin red and yellow capsule containing enteric coated
pancreatin minitablets for oral
administration.
4. Clinical particulars
4.1 Therapeutic indications
For the symptomatic relief of pancreatic exocrine insufficiency such
as in fibrocystic disease of the
pancreas and chronic pancreatitis.
4.2 Posology and method of administration
Posology
_Adults (including elderly) and Paediatric population_
1-2 capsules with meals and 1 capsule with snacks.
Since the individual response to pancreatin supplements is variable,
the number of capsules taken may
need to be titrated to the individual according to symptoms and at the
discretion of the physician. Dose
increase, if required should be added slowly with careful monitoring
of response and symptomatology.
Colonic damage has been reported in patients with cystic fibrosis
taking in excess of 10,000 units of
lipase/kg/day. The dose of Nutrizym 22 should usually not exceed this
dose.
Where a patient is already receiving a lower unit dose enteric coated
pancreatic supplement, then
Nutrizym 22 may be substituted at 1/2 of the number of capsules
normally consumed with the previous
preparation.
Method of administration
Capsules should be swallowed whole with water. Where swallowing of
capsules proves to be difficult, the
minitablets may be removed and taken with water or with a small amount
of acidic fluid or soft food, but
without chewing. This could be apple sauce or yoghurt or any fruit
juice with acidic pH (a pH less than
5.5), e.g. apple, orange or pineapple juice. If the minitablets are
mixed with fluid or food, it is important
that they are taken immediately and t