Material No. Preparation Date
34PO496 05 OCT 11page 1 of 1 Issue No. 1
MARKETINGTEXT & DESIGN LAYOUT
491S426A
Prepared by :
Fahad Al Wohipi _____________________Position : DesignerDate :
05 October 11
Checked by :
Iyad Eqtefan ________________________________Position : Medical
& PV ManagerDate : 05 October 11
Approved by :
Ahmed El Shaarawy _________________________Position : Marketing
DirectorDate : 05 October 11
Checked by :
Mohammed Barhoumi _____________________Position : Creative
ManagerDate : 05 October 11
Dimension: 148 X 210 mm
GastrointestinalDisorders
Upper abdominal pain;Diarrhoea;Constipation;Flatulence
Nausea/Vomiting
Dry mouth
-
General disorders - - -
Peripheral oedema
Hepatobiliary disorders
- - -
Severe hepatocellular damage leading to jaundice with or without
hepatic failure
Immune system disorders - - -
Anaphylactic reactions including anaphylactic shock
Investigationsand others
- - -
Increased liver enzymes (transaminases, g-GT); Elevated
triglycerides;Increased body temperature
Musculoskeletal, connective tissue disorders
- -Arthralgia Myalgia
Nervous system disorders
Headache Dizziness;Disturbances in vision (blurred vision)
- -
Psychiatric disorders - -
Depression. Hallucination, Disorientation and Confusion
-
Renal and urinary disorders - - -
Interstitial nephritis
Skin and sub-cutaneous tissue disorders
- -
Allergic reactions such as pruritus and skin rash
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.
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
Organ system
Common Uncommon Rare Very rare
Blood and lymphatic system - - -
Leukopenia;Thrombocytopenia
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 childrenCouncil of Arab
Health MinistersUnion of Arab Pharmacists
Manufactured by SPIMACOAl-Qassim Pharmaceutical Plant,Saudi
Pharmaceutical Industries & Medical Appliances
Corporation,Saudi Arabia.
Revision date: March 2011.Proton is a trade mark
34PO496
Proton 20 TabletsPantoprazole
34PO496 LEAFLET PROTON TABLETS 20MG
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