Home /Pensodin 40 mg Cap

Pensodin 40 mg Cap

Selective proton pump inhibitor/substituted benzimidazole.

Description Wt/Vol
Pensodin 40 mg Cap
Each Capsule Contains:
Pantoprazole ( As Enteric Coated Pellets) 40 mg
In combination with two appropriate antibiotics (See Dosage) for the eradication of Helicobacter in patients with peptic ulcers with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism.
Duodenal ulcer.
Gastric Ulcer.
Moderate and severe cases of inflammation of the esophagus (reflux esophagitis).
Unless otherwise prescribed, the following oral doses apply, Please follow these instructions, as otherwise there is the risk that the drug may not act properly

In cases of duodenal or gastric ulcer in which infection with Helicobacter pylori has been confirmed, the microorganism should be eradicated by combination treatment. Depending on the resistance pattern, the following combinations are recommended:-

- PENSODIN Capsules + amoxicillin 1000 mg + Clarithromycin 500 mg. (all twice daily)
- PENSODIN Capsules + Metronidazole 500 mg + Clarithromycin 500 mg. (all twice daily)
- PENSODIN Capsules + Metronidazole 500 mg + Amoxicillin 1000 mg. (all twice daily

If combination therapy is not an option, e.g. if the patient has tested negative for Helicobacter pylori, the following dosage guidelines apply for PENSODIN mono therapy:

For Duodenal ulcer, Gastric ulcer, and Reflux esophagitis:
Generally, 1 PENSODIN Capsule daily.

In individual cases the dose may be doubled (increase to 2 PENSODIN Capsules per day), particularly when there has been no response to other medicines, in patients with severe liver impairment the dose has to be reduced to 1 capsule (40 mg) every other day.

Furthermore, in these patients the liver enzymes should be monitored during PENSODIN therapy, in the case of arise of the liver enzymes, PENSODIN should be discontinued, the daily dose of 40 mg pantoprazole shout not be exceeded in elderly patients or-in patients with impaired kidney function and exception is combination therapy for eradication of Helicobacter pylori, where also elderly patients should receive the appropriate pantoprazole dose( 2 x 40 mg per day) during the 1 week treatment period.

Type and duration of treatment:
Combination therapy for eradication of Helicobacter pylori infection usually lasts 7 days and can be extended to a maximum of 2 weeks, If after this time further treatment with PENSODIN is indicated to ensure that the ulcers heals completely, the dose recommendations for gastric and duodenal ulcers must be observed.

In the majority of cases, a duodenal ulcer heals completely within 2 weeks, If a two-week treatment period is not sufficient, healing will be achieved in almost all cases within a further 2 weeks, Gastric ulcers and reflux esophagitis usually require a 4 week course of treatment. If this should be inadequate, healing will in most cases be achieved within a further 4 weeks. Treatment should not be exceed 8 weeks as experience with long-term is limited.

Instructions for use/handling
PENSODIN Capsules must not be chewed or crushed and must be swallowed whole with water 1 hour before breakfast

In combination therapy for eradication of Helicobacter pylori infection the second PENSODIN Capsule should be taken before the evening meal.
PENSODIN is not indicated for mild gastrointestinal complaints. e.g. nervous stomach. In the case of combination therapy the prescribing information for the respective drugs must be observed. Prior to treatment with PENSODIN steps must be taken to ensure that the gastric ulcer is not malignant, and that there is no malignant disease in the esophagus, since the treatment would also alleviate the complaints associated with malignant diseases and possibly delay establishment of the diagnosis.
A diagnosis of reflux esophagitis should be confirmed by endoscopy.
To date there has been no experience with treatment in children
Treatment with PENSODIN can occasionally lead to headache, gastrointestinal complaints such as upper abdominal pain. Diarrhea, constipation or flatulence, as well as allergic reactions, such as itching, skin rash and in isolated cases, wheals, mucosa swelling, or anaphylactic reactions including anaphylactic shock with typical symptoms such as dizziness, increased pulse rate or increased perspiration.

There have been rare reports of nausea, dizziness and visual disturbances (blurred vision) in isolated cases, swelling of the lower arms and legs fever, depression and muscular pain were observed which disappeared after discontinuation of PENSODIN.

If you should experience side effects, notify your doctor so that he can decide what further
PENSODIN may reduce the absorption of drugs whose bioavailability is pH-dependent (e.g. ketoconazole). Please note that this Information also applies to drugs, which you might have used recently.
The active ingredient of PENSODIN is metabolized in the liver via the cytochrome P450 enzyme system.

An interaction with other drugs or substances metabolized by the same enzyme system cannot be ruled out. However, in targeted studies involving a range of such drugs and substances no clinically significant interactions were observed; Studies have been carried out on carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, nifedipine, phenprocoumon, phenytoin, theophylline, warfarin, and an oral contraceptive. There were also no interactions with concomitantly administered antacids. No clinically relevant interactions were observed with the respective antibiotics (Clarithromycin, Metronidazole. Amoxicillin).
PENSODIN must not be used in combination treatment for eradication of Helicobacter pylori in patients with moderate to severe liver or kidney functions disturbances since currently no clinical data are available on the efficacy and safety of PENSODIN in combination treatment of these patients.

PENSODIN should generally not be used in case of known hypersensitivity to one of the constituents of PENSODIN or of the combination partners.
If you have taken too little PENSODIN or have forgotten to take it 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 PENSODIN, There are no known symptoms of overdosage in man; in any case, the doctor must be consulted.

In the case of overdosage with clinical signs of intoxication, the usual rules of intoxication
PENSODIN Capsules in blister packing 2x7*s
Clinical experience in pregnant women is limited. There is no information on the excretion of Pantoprazole into human breast milk. PENSODIN Capsules should only be used when the benefit to the mother is considered greater than the potential risk to the fetus/baby.

There are no known effects on the ability to drive or to operate machine or to work without a firm foot hold.