Pantoloc Control 20mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pantoprazole sodium sesquihydrate

Available from:

GlaxoSmithKline Consumer Healthcare

ATC code:

A02BC02

INN (International Name):

Pantoprazole sodium sesquihydrate

Dosage:

20mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030500; GTIN: 5051562018014 5051562018113

Patient Information leaflet

Recto
Pharma code 2388
Pharma code 2388
Pharma code 2388
Pharma code 2388
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
20 mg gastro-resistant tablets
Pantoprazole
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
Always take this medicine exactly as described in this
leaflet or as your doctor or pharmacist have told you.
–
Keep this leaflet. You may need to read it again.
–
Ask your pharmacist if you need more information or
advice.
–
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
–
You must talk to a doctor if you do not feel better or if
you feel worse after 2 weeks.
–
You should not take PANTOLOC Control tablets for
more than 4 weeks without consulting a doctor.
What is in this leaflet:
1.
What PANTOLOC Control is and what it is used for
2.
What you need to know before you take PANTOLOC
Control
3.
How to take PANTOLOC Control
4.
Possible side effects
5.
How to store PANTOLOC Control
6.
Contents of the pack and other information
1. What PANTOLOC Control is and what
it is used for
PANTOLOC Control contains the active substance pantopra-
zole, which blocks the ‘pump’ that produces stomach acid.
Hence it reduces the amount of acid in your stomach.
PANTOLOC Control is used for the short-term treatment
of reflux symptoms (for example heartburn, acid
regurgitation) in adults.
Reflux is the backflow of acid from the stomach into the
gullet (“foodpipe”), which may become inflamed and painful.
This may cause you symptoms such as a painful burning
sensation in the chest rising up to the throat (heartburn)
and a sour taste in the mouth (acid regurgitation).
You may experience relief from your acid reflux and
heartburn symptoms after just one day of treatment with
PANTOLOC Control, but this medicine is not meant to
bring immediate relief. It may be necessary to take the
tablets for 2–3 consecutive days to relieve the symptoms.
You m

Summary of Product characteristics

OBJECT 1
PANTOLOC CONTROL 20MG GASTRO-RESISTANT TABLETS
Summary of Product Characteristics Updated 13-Apr-2017 |
GlaxoSmithKline Consumer Healthcare
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
PANTOLOC Control 20 mg gastro-resistant tablets
2. Qualitative and quantitative composition
Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium
sesquihydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant tablet.
Yellow, oval biconvex film-coated tablets imprinted with “P20” in
brown ink on one side.
4. Clinical particulars
4.1 Therapeutic indications
PANTOLOC Control is indicated for short-term treatment of reflux
symptoms (e.g. heartburn, acid
regurgitation) in adults.
4.2 Posology and method of administration
Posology
The recommended dose is 20 mg pantoprazole (one tablet) per day.
It might be necessary to take the tablets for 2-3 consecutive days to
achieve improvement of symptoms.
Once complete relief of symp