Kompensan

KOMPENSAN tablets 340 mg

Important notes (mandatory information)

Kompensan 340 mg tablets. Active ingredient: Carbaldrat. Areas of application: for the treatment of symptoms of heartburn, acid-related stomach complaints, and stomach and duodenal ulcers.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Kompensan 340 mg tablets, for use in adolescents aged 12 years and over and adults
Active ingredient: Carbaldrat

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If your symptoms worsen or do not improve, you must see a doctor in any case.

What this package leaflet contains

1. WHAT IS KOMPENSAN AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING KOMPENSAN?
3. HOW TO TAKE KOMPENSAN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD KOMPENSAN BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS KOMPENSAN AND WHAT IS IT USED FOR?

Kompensan is a gastrointestinal drug and belongs to the antacids (agents that bind stomach acid). Area of application: Kompensan is indicated for the treatment of symptoms of heartburn, acid-related stomach complaints, and stomach and duodenal ulcers.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING KOMPENSAN?

Kompensan must not be taken:

• if you are allergic to carbaldrat, peppermint flavor, or any of the other ingredients of this medicine listed in section 6.
• if you have a significant impairment of kidney function (creatinine clearance less than 30 ml/min),
• if you have low phosphate levels in your blood or
• constipation and narrowing of the intestines (stenoses).

Warnings and precautions

Please talk to your doctor or pharmacist before taking Kompensan:

• if you have kidney problems and are taking high doses for a long period of time. You should then consult your doctor (see also side effects).
• Prolonged and recurring stomach problems can be a sign of a serious illness, such as a stomach or duodenal ulcer. Treatment with Kompensan should therefore not last longer than 14 days without a medical examination.
• If you experience tarry stools, blood in your stools, or vomiting blood, see a doctor immediately.
• With long-term use of Kompensan, regular monitoring of aluminum levels is necessary. These should not exceed 40 pg/l.
• In patients with chronic kidney dysfunction, aluminum levels should also be monitored even with short-term use of Kompensan. These patients should also be examined by a doctor at regular intervals (about every six months) to detect any accumulation of aluminum in the nervous system and bones as early as possible.
• With long-term intake of high doses and a phosphate-poor diet, phosphate depletion can occur, especially in dialysis patients, with the risk of bone softening (osteomalacia).
• In patients with stomach and duodenal ulcers, a test for H. pylori and, if positive, a recognized eradication therapy should be considered.

Children

In children, the absorption of aluminum from the gastrointestinal tract is higher than in adults. Kompensan should not be used to treat children under 12 years of age, as there is insufficient experience in this age group.

Taking Kompensan with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used, or plan to take/use any other medicines. The simultaneous intake of aluminum-containing antacids with other medications can alter their absorption. Clinically significant reductions in absorption have been described for:

• Tetracyclines, quinolones (e.g., ciprofloxacin, norfloxacin, and ofloxacin), and cephalosporins. They can be up to 90% and are a result of the formation of non-absorbable compounds (chelates) of these drugs. Therefore, it is advisable to avoid taking antacids during therapy with these antibiotics and, if necessary, to switch to other stomach acid-inhibiting drugs.
• Lower absorption restrictions are found for chloroquine, allopurinol, non-steroidal anti-inflammatory drugs (e.g., diclofenac, acetylsalicylic acid, penicillamine, naproxen), digoxin, isoniazid, captopril, atenolol or propranolol, dicumarol, levothyroxine, ketoconazole, gabapentin, H2-blockers, diphosphonates, iron compounds and chlorpromazine.

In view of a possible impairment of absorption, a two-hour interval should generally be maintained between taking acid-related antacids and other medications.

Taking Kompensan with food and drink

Aluminum-containing acid-binding antacids increase the absorption of aluminum from the intestine when taken at the same time as acidic drinks (fruit juices, wine, etc.). Effervescent tablets also contain fruit acids, which can increase the absorption of aluminum.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There is insufficient experience with the use of Kompensan in pregnant women. This medicine should not be used during pregnancy unless the potential benefit to the mother outweighs the potential risks to the unborn child.

Breastfeeding

Aluminum passes into breast milk in small amounts. Discuss with your doctor or pharmacist whether you should interrupt treatment with Kompensan or refrain from treatment with Kompensan. The benefit of breastfeeding for the child and the benefit of therapy for the woman should be taken into account.

Driving and operating machinery

No special precautions are required.

This medicine contains sucrose (sugar)

Please only take Kompensan after consulting your doctor if you are known to suffer from an intolerance to certain sugars. Note for diabetics: One Kompensan tablet contains approx. 0.636 g sucrose (sugar) corresponding to approx. 0.05 bread units (BE). If you are on a diabetic diet, you should take this into account. Kompensan can be harmful to your teeth (caries).

3. HOW TO TAKE KOMPENSAN?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is Adolescents aged 12 years and over and adults: Take 1 to 2 Kompensan tablets (300 to 600 mg carbaldrat) between meals, before bedtime, or as needed. Do not take more than 8 tablets (2400 mg carbaldrat) per day (within 24 hours) and not more than 2 tablets (600 mg carbaldrat) per single dose. It is preferable to take Kompensan 1 to 2 hours after meals and at night (sucking). One Kompensan tablet contains 0.636 g sucrose. If the dosage instructions are followed, up to 1.272 g sucrose is administered with each use.

Children

In children, the absorption of aluminum from the gastrointestinal tract is higher than in adults. Kompensan should not be used to treat children under 12 years of age, as there is insufficient experience in this age group.

Method of administration

The tablets should be sucked and not swallowed. Do not dissolve the tablets in water.

Duration of use

Take Kompensan until the desired relief of symptoms occurs. If the symptoms have not subsided during treatment, you should see your doctor no later than after 2 weeks to clarify the possible causes.

Other medicines should generally be taken two hours before or after taking Kompensan. Antacids are not recommended during treatment with antibiotics such as tetracyclines and quinolones (see "Taking Kompensan with other medicines"). Please talk to your doctor or pharmacist if you have the impression that the effect of Kompensan is too strong or too weak.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects

Not known (frequency cannot be estimated from the available data)

Hypersensitivity reactions (e.g., itching, hives, facial edema, tightness in the throat and shortness of breath), throat irritation, constipation, diarrhea, burning tongue, decreased sensitivity of the oral mucosa to touch or pressure, nausea, discomfort in the mouth, swollen tongue, burning of the oral mucosa. In case of impaired kidney function, it is possible that aluminum will accumulate, especially in the nervous and bone tissue, and that phosphate depletion will occur (see also "Special care is required when taking Kompensan").

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW SHOULD KOMPENSAN BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister pack after "Use by". The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. Medicines should be disposed of in accordance with local regulations. Ask your pharmacist how to dispose of the medicine when you are no longer using it. This will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Kompensan contains

The active ingredient is: Carbaldrat. 1 tablet contains 340 mg carbaldrat hydrate, equivalent to 300 mg carbaldrat anhydrous. Acid binding capacity per single dose: 7.79 mVal/tablet. The other ingredients are: sodium alginate, magnesium stearate (Ph. Eur.), sucrose, peppermint flavor, spearmint flavor, gelatin.

What Kompensan looks like and contents of the pack

White to off-white, round tablets with a facet on both sides in blister strips. Pack of 20 tablets, pack of 50 tablets and pack of 100 tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss
Tel.: 00800 260 260 00 (toll-free)

Manufacturer

Janssen Cilag
Domaine de Maigremont
27100 Val de Reuil
France

This leaflet was last revised in August 2014.

Source: Information from the package leaflet
Status: 01/2018
Active ingredient: Carbaldrat. Areas of application: for the treatment of symptoms of heartburn, acid-related stomach complaints, and stomach and duodenal ulcers.