Preparation Date

Material No.

05 OCT 11

34PO496

Issue No. 1

page 1 of 1

MARKETING

TEXT & DESIGN LAYOUT

34PO496 LEAFLET PROTON TABLETS 20MG

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34PO496

Dimension: 148 X 210 mm

Approved by :

Checked by :

Checked by :

Prepared by :

_________________________ Ahmed El Shaarawy

Position : Marketing Director
Date
: 05 October 11

________________________________ Iyad Eqtefan

Position : Medical & PV Manager
Date
: 05 October 11

_____________________ Mohammed Barhoumi

Position : Creative Manager
Date
: 05 October 11

_____________________ Fahad Al Wohipi

Position : Designer
Date
: 05 October 11

491S426A

MARKETING

TEXT & DESIGN LAYOUT

Material No.

Preparation Date

34PO496

05 OCT 11

page 1 of 1

Issue No. 1

34PO496 LEAFLET PROTON TABLETS 20MG

Proton
Pantoprazole

20

Tablets

COMPOSITION :
Proton 20 tablets are present as Pantoprazole sodium equivalent to 20mg
pantoprazole.
PHARMACOLOGICAL PROPERTIES :
Pantoprazole is selective Proton pump inhibitor, substituted benz-imidazole.
INDICATIONS :
-- Treating mild forms of gastro-oesophageal reflux disease caused by reflux of acid
from the stomach (with or without mild inflammation of the oesophagus).
Prophylaxis of NSAID-associated gastric or duodenal ulcer, in patients with increased
risk.
Short term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adult. It
is classified as a medical product not subjected to medical prescription regarding
this indication.
-- Long-term management of gastro-oesophageal reflux disease (inflammation of the
oesophagus accompanied by the regurgitation of gastric acid) and preventing its
return.
DOSAGE AND ADMINISTRATION :
Mild forms of gastro-oesophageal reflux disease :
One Proton tablet (20 mg) daily in the morning for 4 weeks, followed by further 4
weeks if not fully healed.
Prophylaxis of NSAID - associated gastric or duodenal ulcer in patients with
increased risk of gastroduodenal complications who require continued NSAID
treatment:
One Proton tablet (20 mg) daily.
Short term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in
adult:
The recommended dose is 20 mg per day in case of short term treatment of reflux
symptoms (e.g. heartburn, acid regurgitation) in adult. It is classified as a medical
product not subjected to medical prescription regarding this indication. It might be
necessary to take the tablets for 2-3 consecutive days to achieve improvement of
symptoms. Once complete relief of symptoms has occurred, treatment should be
discontinued. The treatment should not exceed 4 weeks without consulting a doctor.
If no symptom relief is obtained within 2 weeks of continuous treatment, the patient
should be instructed to consult a doctor.
For long-term management and for preventing the return of gastro-oesophageal
reflux disease:
One tablet a day.
If the illness returns, the dose may be doubled, in which case you can use Pantoprazole
40 mg tablets instead, one a day. After healing, you can reduce the dose back again
to one tablet (20 mg) a day.
- Proton gastro-resistant tablets should not be chewed or crushed, and should be
swallowed whole with water 1 hour before breakfast.
- If you have forgotten to take Proton, do not take the dose late, but continue with
the next regular dose on your dosing schedule.Talk to your doctor if you want to
interrupt or prematurely discontinue treatment with Proton.
Specific Populations:
Elderly: No dose adjustment is necessary. However, the daily dose of 40 mg should
not be exceeded. An exception is combination therapy for eradication of H. pylori,
where elderly patients should receive the usual pantoprazole dose (2 x 40 mg/day)
during 1 week treatment.
Children below 12 years of age: Proton is not recommended for use in children
below 12 years of age due to limited data in this age group.
Renal impairment: No dose adjustment is necessary. However, the daily dose of 40mg
should not be exceeded. For this reason, H. pylori triple therapy is not appropriate in
these patients.
Hepatic impairment: A daily dose of 20 mg pantoprazole should not be exceeded in
patients with severe liver impairment. But in case of pantoprazole 40 mg, due to an
increased AUC and a modified metabolism of pantoprazole in patients with hepatic
cirrhosis, the dose regimen should be reduced to one tablet every other day. For this
reason, H. pylori triple therapy is not appropriate in these patients.
GENERAL INSTRUCTIONS FOR USE :
* The suitable dosing and duration of therapy will be prescribed by the Physician.
* As experience with long term administration in human is insufficient, treatment with
Proton should not exceed 8 weeks, except in case of Zollinger-Ellison syndrome
and other pathological hypersecretory conditions.
PRECAUTIONS :
- Proton should be used with caution in patients with severe liver impairment. The
liver enzymes should be monitored during therapy. In case of a rise of the liver
enzymes, Proton should be discontinued.
- Before treatment, the presence of gastric or oesophageal malignancy should be
excluded.
- Increased risk of fractures of the hip, wrist, and spine has been reported in some
studies of people who use Proton pump inhibitors. The greatest increased risk for
these fractures was seen in those who receive high doses of these medications or
use them for a years or longer and who are over 50 years of age.
- Proton pump inhibitor (PPI) drugs may cause low serum magnesium levels
(hypomagnesemia) if taken for longer than one year and can result in serious
adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias)
& convulsions (seizures). Magnesium supplementation alone did not improve low
serum magnesium levels and the PPI had to be discontinued.
pregnancy and lactation :
- As clinical experience in pregnant women is limited, Proton should be used
with caution in pregnancy and breast feeding and should only be used when the
potential benefits outweighs risks.
effect on ability to drive and use machines :
- There are no known effects on the ability to drive and use machines.
CONTRAINDICATIONS :
Known hypersensitivity to one of the constituents of Proton.
Pantoprazole like other PPIs should not be co-administered with atazanavir.
SIDE EFFECTS :
Frequency Common
Uncommon Rare
Very rare
Organ system
Blood and
lymphatic system

Leukopenia;
Thrombocytopenia

Gastrointestinal
Disorders

Upper abdominal Nausea/

pain;
Vomiting
Diarrhoea;
Constipation;
Flatulence

General
disorders
Hepatobiliary
disorders

Immune system
disorders

Dry mouth
-

Peripheral oedema
Severe
hepatocellular
damage leading
to jaundice with
or without hepatic
failure
Anaphylactic
reactions including
anaphylactic shock
Increased
liver enzymes
(transaminases,
g-GT); Elevated
triglycerides;
Increased body
temperature
Myalgia

Investigations
and others

Musculoskeletal,
connective tissue
disorders
Nervous system Headache
disorders

Psychiatric
disorders
Renal and urinary
disorders
Skin and subcutaneous tissue
disorders

Arthralgia

Dizziness;
Disturbances
in vision
(blurred
vision)

Depression.
Hallucination,
Disorientation
and Confusion

Allergic
reactions such
as pruritus and
skin rash

Interstitial nephritis
Urticaria;
Angioedema;
Severe skin
reactions such as
Stevens Johnson
Syndrome,
Erythema
Multi-forme,
Lyell-Syndrome;
Photosensitivity

DRUG INTERACTIONS :
Pantoprazole decreases the systemic concentrations of the HIV protease inhibitor
atazanavir, which is dependent upon the presence of gastric acid for absorption, and
may result in a loss of therapeutic effect of atazanavir and the development of HIV
resistance. Therefore, Pantoprazole, or other Proton pump inhibitors, should not be
co-administered with atazanavir.
Warfarin: There have been reports of increased INR and prothrombin time in patients
receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may
lead to abnormal bleeding and even death. Patients treated with PPIs and warfarin
concomitantly may need to be monitored for increases in INR and prothrombin time.
No clinical significant interactions were observed with carbamazepine, caffeine,
diazepam, diclofenac, ethanol, glibenclamide, metoprolol, nifedipine, phenytoin,
theophylline, naproxen, piroxicam, digoxin, metazolam and oral contraceptives.
No clinical significant interactions were observed with concomitantly administration of
Proton with antacids, clarithromycin, metronidazole and amoxicillin.
Proton may reduce the absorption of drugs whose bioavailability is pH-dependent
(e.g. Ketoconazole, itraconazole and other azole anti-fungals, ampicillin esters and
iron salts).
Pantoprazole, as all acid- blocking medicines, may reduce the absorption of vitamin
B12 (cyano- cobalamin) due to hypo- or achlorhydria. This should be considered if
respective clinical symptoms are observed.
Proton is metabolized in the liver via the cytochrome P450 enzyme system. An
interaction of Proton with other drugs or compounds which are metabolized using the
same enzyme system cannot be excluded.
OVERDOSE :
There are no known symptoms of overdosage, in any case, the doctor must
be consulted. Management of overdose consists essentially of supportive and
symptomatic treatment.
PHARMACEUTICAL PARTICULARS:
List of excipients: Sodium carbonate decahydrate BP, Crospovidone NF (Type XL),
Mannitol BP, Povidone K-90, Calcium stearate USP, Hydroxypropyl methylcellulose,
Povidone K25, Titanium dioxide, Iron oxide yellow, Propylene glycol EP, Methacrylic
acid copolymer (L100-55), Triethyl citrate, Sodium Hydroxide.
STORAGE :
Store below 30C.
PRESENTATIONS :
Proton is available as 20mg gastro-resistant tablets.
This is a medicament
A medicament is a product which affects your health, and its consumption
contrary to instructions is dangerous for you.
Follow strictly the doctors prescription, the method of use and the instructions of
the pharmacists who sold the medicament.
The doctor and the pharmacists are experts in medicine, its benefits and risks.
Do not by yourself interrupt the period of treatment prescribed for you.
Do not repeat the same prescription without consulting your doctor.
Keep medicaments out of the reach of children
Council of Arab Health Ministers
Union of Arab Pharmacists
Manufactured by SPIMACO
Al-Qassim Pharmaceutical Plant,
Saudi Pharmaceutical Industries & Medical Appliances Corporation,
Saudi Arabia.
Proton is a trade mark
Revision date: March 2011.
34PO496

Dimension: 148 X 210 mm

Prepared by :

Checked by :

Checked by :

Approved by :

Fahad Al Wohipi _____________________

Position : Designer
Date
: 05 October 11

Mohammed Barhoumi _____________________

Position : Creative Manager
Date
: 05 October 11

Iyad Eqtefan ________________________________

Position : Medical & PV Manager
Date
: 05 October 11

Ahmed El Shaarawy _________________________

Position : Marketing Director
Date
: 05 October 11

491S426A