The distribution of this drug over the Internet is strictly prohibited and regulated by the laws of the Republic of Serbia, while its presentation on the Internet is allowed, solely for the purpose of informing the general and professional public about its purpose and better familiarization with the basic characteristics of the drug itself.
YOU CAN VIEW THE REGULATION ON THE METHOD OF ADVERTISING MEDICINE, REGARDING MEDICINE ("Sl. Gl. RS", no. 79/2010) HERE.
Read this manual carefully because it contains information that is important to you.
You can buy this medicine without a doctor's prescription, for the treatment of mild diseases without the help of your doctor. In addition, you need to use this medicine carefully to get the best results from it.
Save the instructions. You might want to read it again.
If you need any additional information or advice, contact your doctor or pharmacist.
If your symptoms worsen or you do not feel better after 7 days, be sure to visit your doctor!
Proprietary drug name, drug strength, pharmaceutical form: RUPURUT®, 500 mg chewable tablets
Unprotected, generic name: hydrotalcite
Content of active substances: Each Rupurut® chewable tablet contains 500 mg of hydrotalcite.
Content of auxiliary substances: Auxiliary substances are: mannitol, corn starch, magnesium stearate, sodium saccharin, banana flavor, peppermint flavor.
Name and address of the marketing authorization holder: Bayer doo, Omladinskih brigada 88b, 11070 Belgrade
Manufacturer's name and address: Bayer Bitterfeld GmbH, OT Greppin, Salegaster Chaussee 1, Bitterfeld-Wolfen, Germany
COMPOSITION:
One Rupurut® chewable tablet contains 500 mg of hydrotalcite, which corresponds to a neutralization capacity of at least 13 mEq of hydrochloric acid.
Pharmaceutical form and content: chewable tablets, hydrotaicit 500 mg
PACKAGING:
Rupurut® chewable tablets are available in a box of 20 tablets.
20 chewable tablets - decision number and date: 484/2007/12 from 07.02.2007.
HOW DOES RUPURUT® WORK?
Rupurut® is a drug that reduces the acidity of gastric juice by neutralizing hydrochloric acid. It is a modern antacid containing hydrotalcite.
WHEN IS RUPURUT® USED?
Rupurut® chewable tablets are used to relieve complaints in disorders that require a reduction in stomach acidity:
– Ulcers on the stomach and duodenum
– Heartburn and stomach disorders caused by acid
WHEN YOU MUST NOT TAKE THE MEDICINE:
Rupurut® chewable tablets must not be used:
- If you are hypersensitive to hydrotalcite or any other ingredient of the medicine.
- Patients with impaired kidney function (creatinine clearance <30ml/min) can use Rupurut® chewable tablets only on condition that the level of magnesium and aluminum in the serum is regularly checked.
- Patients with reduced phosphate concentration in the blood (hypophosphatemia) must not use Rupurut® chewable tablets without prior consultation with a doctor.
WARNINGS AND PRECAUTIONS:
If stomach disturbances are persistent and constantly present, it may be a sign of a serious condition, such as a stomach ulcer or duodenal ulcer. Treatment with Rupurut® chewable tablets should therefore not last longer than 14 days without a medical examination.
Please consult a doctor immediately if tarry stools, blood in the stool or vomiting occur.
Long-term use of Rupurut® chewable tablets requires regular monitoring of aluminum levels in patients. The aluminum level should not exceed 40 pg/l.
In patients with impaired renal function, including patients on hemodialysis, and chronic use of higher doses, the level of magnesium and aluminum in the body may increase.
For this reason, patients with impaired kidney function should avoid long-term use and higher doses. Long-term use of large doses, malabsorption of nutrients in the intestines and diets with low phosphate content (for example, poor nutrition or malnutrition) can cause a drop in phosphate with the risk of bone breakdown due to insufficient mineral incorporation (osteomalacia).
Rupurut® chewable tablets should not be used in children under 14 years of age as there is insufficient experience for this age group.
TAKING RUPURUT WITH FOOD OR DRINKS:
- Concomitant use of Rupurut® chewable tablets and acidic beverages (for example fruit juices, wine) lead to an unwanted increase in the absorption of aluminum from the intestine.
- Effervescent tablets also contain fruit acids that can increase the absorption of aluminum.
APPLICATION IN PREGNANCY AND BREASTFEEDING:
Before you start taking any medicine, consult your doctor or pharmacist.
During pregnancy and breastfeeding, hydrotalcite should only be used for short periods of time in order to avoid the appearance of increased amounts of aluminum in children.
Aluminum and magnesium components pass into the fetus and are also found in milk, so the possibility that prolonged use can lead to the accumulation of aluminum and magnesium in the tissues of the fetus and newborn is not excluded. Risk to the newborn is unlikely because only small amounts are resorbed.
There are no published reports of adverse effects of hydrotalcite during pregnancy or breastfeeding. However, there are no specific studies on the children of those mothers who used hydrotalcite during pregnancy or breastfeeding, which could rule out adverse effects.
INFLUENCE ON PSYCHO-PHYSICAL ABILITIES WHEN DRIVING A MOTOR VEHICLE AND MACHINERY:
Rupurut® has no effect on psychophysical abilities when driving a motor vehicle and machines.
WHAT SHOULD YOU BE CAREFUL ABOUT IF YOU ARE TAKING OTHER MEDICINES?
Please note that this information may also apply to medicines you are no longer taking, as well as medicines you plan to take in the future. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Rupurut® chewable tablets can affect the resorption and thus the effectiveness of other substances. The rate of resorption of dicoumarol increases. A significant decrease in resorption has been described with certain antibiotics (for example tetracycline and quinolone derivatives such as ciprofloxacin, ofloxacin and norfloxacin), substances used to improve cardiac function (cardiotonic glycosides), as well as ketoconazole, chloroquine, chlorpromazine, rifampicin, isoniazid. Also, the resorption of indomethacin, iron salts, vitamins, captopril, phenytoin, thyroid hormones, etc. is disturbed.
You should also be careful about the possible influence of Rupurut® chewable tablets on the solubility of drugs that are excreted in the urine, e.g. salicylates or quinidine.
Therefore, other preparations should always be taken 2-3 hours before or after Rupurut® chewable tablets.
3.HOW IS RUPURUT® USED?
If you think that Rupuruf is acting too weakly or strongly on your body, contact your doctor or pharmacist.
The medicine must be taken as prescribed in this instruction (unless your doctor has prescribed otherwise). If you do not follow the instructions, the medicine will not work properly.
Adults and children over 14 years:
One to two tablets (500 mg - 1000 mg of hydrotalcite), three to four times a day one to two hours after eating, before going to bed or when stomach problems occur.
The daily dose must not exceed 12 chewable tablets, which is equivalent to 6000 mg of hydrotalcite.
Other preparations should always be taken 2-3 hours before or after Rupurut® chewable tablets.
The duration of treatment depends on the type, severity and course of the disorder.
If the symptoms last longer than 2 weeks of treatment, you should consult a doctor.
IF YOU TAKE MORE MEDICINE THAN YOU SHOULD:
If you have taken a larger dose of Rupurut® than you should, talk to your doctor or pharmacist immediately! Poisoning with Rupurut® chewable tablets is unlikely due to poor absorption of aluminum and magnesium. Excessive doses may cause changes in stool characteristics such as soft stools or increased frequency. Therapeutic measures in such cases are generally not required.
IF YOU FORGET TO TAKE RUPURUT:
Never take a double dose to make up for a missed dose
WHAT HAPPENS IF YOU SUDDENLY STOP TAKING RUPURUT®?
You should always consult a doctor first before deciding to stop treatment or stop taking Rupurut® chewable tablets, for example because of side effects.
4. ADVERSE EFFECTS OF THE MEDICINE:
Large doses may cause soft or more frequent stools. However, these signs are unlikely at recommended doses. In patients with severe kidney function disorders, including hemodialysis patients, the use of products containing magnesium and aluminum, such as Rupurut® chewable tablets, can cause an increase in the level of magnesium and aluminum in the blood. Patients with kidney dysfunction who take large doses for a long period of time may be susceptible to aluminum deposition, especially in nervous tissue with brain dysfunction (encephalopathy and dementia), and in bones with softening of bones (osteomalacia) and consequent formation of kidney stones. Accumulation of magnesium leads to toxicity with lowering of pressure, slowing of the heart with arrhythmia, mental depression and breathing disorder.
For this reason, patients with kidney dysfunction who use Rupurut® chewable tablets for a long period of time should regularly check their aluminum levels.
Due to the reaction of the components of the drug in the intestine with phosphates from food, in the case of long-term administration of larger doses, reduced intake of phosphates through food or their impaired resorption in the intestines, there may be a decrease in the amount of phosphate in the body when there is a risk of bone breakdown (osteomalacia) and increased resorption of calcium.
If you notice any symptoms that could be an adverse reaction to the drug Rupurut®, and are not mentioned in this instruction, immediately inform your doctor or pharmacist.
Consult a doctor if diarrhea occurs during treatment with Rupurut® chewable tablets. Lowering the dose will generally lead to improvement.
5. STORAGE AND EXPIRY DATE STORAGE:
Keep the drug Rupuruf out of the reach of the decel There are no special storage conditions.
EXPIRATION DATE:
5 years.
The expiration date is marked on the packaging.
The drug must not be used after the expiration date marked on the package!
METHOD OF DISPENSING THE MEDICINE:
The drug can also be dispensed without a prescription.
SPECIAL MEASURES FOR DISPOSAL OF UNUSED MEDICINE OR REMAINS OF MEDICINE:
In accordance with current regulations.
DATE OF LAST REVISION OF THE TEXT OF THE INSTRUCTIONS:
April 2010
ADDITIONAL INFORMATION:
Dear patients,
The following is information related to stomach problems:
What are the symptoms of gastric (eg acid-induced) disorders?
The following symptoms may occur:
– Heartburn, sour belching
– Pressure in the stomach
- Pain in my stomach
What causes these symptoms?
I can cause them, for example:
- Stress
– Bad eating habits
- Excessive consumption of nicotine, caffeine and/or alcoholic beverages
- And some medicines
How do Rupurut® chewable tablets work?
Rupurut® chewable tablets work quickly and lead to relief:
– Rupurut® chewable tablets quickly neutralize stomach acid
– Rupurut® chewable tablets provide long-term binding of pepsin and bile acids that can damage the stomach
– Rupurut® chewable tablets strengthen the protective factors of the stomach lining
Before use, read the instructions in detail! Consult your doctor or pharmacist about indications, precautions and adverse drug reactions!
Note: We strive to be as accurate as possible in the description of all products, but we cannot guarantee that all descriptions are complete and error-free. Thank you for your understanding.
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