Controloc 40 mg
Active ingredient : Pantoprazole sodium sesquihydrate
Active ingredient :
I gastro -resistant tablet contains:
Pantoprazole sodium sesquihydrate 45.1 mg
(conresponding to 40 mg pantoprazole)
Excipients :Sodium carbonate; D-mannitol (conresp. to 0.0036
BU); crospovidone; povidone K 90; povidone K 25; calcium stearate; propylene glycol; methylhydroxypro- pylcellulose; poly( ethyl acrylate -co-methacrylic acid) I: I; polysorbate 80; sodium dodecyl sulfate; triethyl citrate; colours (E 171, E 172); printing ink.
Pharmaceutical form and contents :
Packs with 14 tablets
(Note: possibly not all pack sizes available in each country)
Pharmacotherapeutic / indication group / action mechanism :
Selective proton pump inhibitor, substitut – ed benzi- midazole.
– In combination with two appropriate antibiotics (see Posology”) for the eradication of Helicobacter py- lori in patients with peptic ulcers with the objective of reducing the recunrence of duodenal and gastric
ulcers caused by this microorganism.
– Duodenal ulcer
– Gastric ulcer
– Moderate and severe cases of inflammation of the esophagus (reflux esophagitis).
– Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions
Controloc 40 mg must not be used in combination treatment for eradication of Helicobacter pylori in pa- tients with moderate to severe liver or kidney function disturbances since cunrently no clinical data are available on the efficacy and safety of Controloc 40 mg in combination treatment of these patients.
Controloc 40 mg should generally not be used in cases of known hypersensitivity to one of the constituents of Controloc 40 mg or of the combination partners.
Special warnings and precautions for use :
Controloc 40 mg is not indicated for mild gastrointestinal complaints, e.g. nervous stomach. In the case of combination therapy, the prescribing informations for the respective drugs must be observed.
Prior to treatment with Controloc 40 mg 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 cctcbliahrncnt of the diagnosis.
A diagnosis of refiux esophagitis should be confirmed by endoscopy.
To date there has been no experience with treatment in children.
In patients with Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions requiring longterm treatment, pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B I 2 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered if respective clinical symptoms are observed.
Pregnancy and lactation :
Clinical experience in pregnant women is limited. There is no information on the excretion of pantoprazole into human breast milk Controloc 40 mg tablets should only be used when the benefit to the mother is considered greater than the potential risk to the foetus/baby.Effects on the ability to drive and to use machines or work without a firm foothold
There are no known effects on the ability to drive or to operate machinery or to work without a firm foothold.
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 doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
– The doctor and the pharmacists are the experts in medicines, their benefits and risks.
– Do not by yourself interrupt the period
of treatment prescribed.
– Do not repeat the same prescription without consuiting your doctor.
– Keep all medicaments out of the reach of children.
Controloc 40 mg 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 ave used recently The active ingredient of Controloc 40 mg 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, naproxen,
nifedipine, phenprocoumon, phenytoin, piroxicam, 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, arnoxicillin).
Posology and method of administration :
The following information applies unless Controloc 40 mg has been otherwise prescribed by your doctor. Please follow theseinstructions, as otherwise Controloc 40 mg may not have the desired effect!
In cases of duodenal or gastric ulcer in which infection H licobactet’ l3Y1ori has been confirmed, the microorganism should be eradicated by combination treatment. Depending on the resistance pattem, the
following combinations are recommended:
2 x 1 Controloc 40 mg gastro-resistant tablet / day
+ 2 x 1000 mg amoxicillin / day
+ 2 x 500 mg clarithromycin /day
2 Controloc 40 mg gastro-resistant tablet / day
+ 2 x 500 mg metronidazole / day
+ 2 x 500 mg clarithromycin / day
2 x I Controloc 40 mg gastro-resistant tablet / day
+ 2 x 1000 mg amoxicillin / day
+ 2 x 500 mg metronidazole / day
If combination therapy is not an option, e.g. if the patient has tested negative for Helicobacter pylori, the following dosage guidelines apply for Controloc 40 mg For duodenal ulcer. gastric ulcer. and reflux esophagitis: Generally. I Controloc 40 mg gastro-resistant tablet daily.
In individual cases the dose may be doubl- ed (increase to 2 Controloc 40 mg gastro-resistant tablets 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 I tablet (40 mg pantoprazole) every other day.
Furthermore. in these patients the liver enzymes should be monitored during Controloc 40 mg therapy. In the case of a rise of the liver enzymes. Controloc 40 mg should be discontinued.
The daily dose of 40 mg pantoprazole should not be exceeded in elderly patients or in patients with impaired kidney function. An 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 I-week treatment period.
For the long-term management of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions the recommended daily dose at the beginning of the treatment is 80 mg (2 tablets of Controloc 40 mg). Thereafter. the dosage can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily. the dose should be divided and given twice daily. A temporary increase of the dosage above I 60 mg pan-
toprazole is possible but should not be applied longer than required for adequate acid control.
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 Controloc 40 mg is indicated to ensure that the ulcer 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 duration in Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions is not limited and should be adapted according to clinical needs.
Except for patients with Zollinger-Ellison-Syndrome and other pathological hyperse- cretory conditions. the duration of treatment with the active ingredient pantoprazole should not exceed 8 weeks as experience with long-term-treatment is limited.
Undesirable effects :
Please see table below.
If you experience any side effects not mentioned in this leaflet. please inform your doctor or pharmacist
If you should experience side effects, notifiy your doctor so that he can decide what further measures are necessary.
Instructions for use I handling
Controloc 40 mg gastro-resistant tablets must not be chewed or crushed and must be swallowed whole with water I h before breakfast. In combination therapy for eradication of Helicobacter
pylori infection should be taken before the evening meal
Incorrect use and overdosage :
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 apply.
If you have taken too little Contraloc 40 mg 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 intenrupt or prematurely discontinue treatment with Controloc 40 mg.
Storage conditions and shelf life :
Contraloc 40 mg gastra-resistant tablets stored below 30°C remain unchanged for 3 years.
The expiry date of this pack is printed on the container and on the folding box.
Do not use this pack after the expiry date!
Keep out of the reach of children!
produced by :
Nycomed COUNCIL OF ARAB HEALTH MINISTERS
UNION OF ARAB PHARMACISTS