Bemolan 2000 mg oral gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Bemolan 2000 mg oral gel
Magaldrate
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.
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Keep this leaflet, as you may need to read it again.
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If you need advice or more information, consult your doctor or pharmacist.
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If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
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You must consult a doctor if you worsen or do not improve after 7 days of treatment.
Contents of the leaflet:
- What Bemolan is and what it is used for.
- What you need to know before taking Bemolan.
- How to take Bemolan.
- Possible adverse effects.
- Storage of Bemolan.
- Contents of the pack and other information.
1. What Bemolan is and what it is used for
Bemolan belongs to a group of medicines called antacids. The active substance, magaldrate, is converted into aluminum and magnesium salts in the stomach, helping to regulate stomach acidity.
It is indicated for the symptomatic relief of occasional gastric discomfort associated with hyperacidity, acid indigestion, and heartburn in adults.
2. What you need to know before taking Bemolan
Do not take Bemolan:
- if you are allergic (hypersensitive) to magaldrate or to any of the other ingredients of this medicine (listed in section 6).
- if you have intestinal obstruction.
- if you have severe renal insufficiency or low levels of phosphate in the blood (hypophosphatemia).
- if you have high levels of magnesium in the blood (hypermagnesemia).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Bemolan.
Before beginning treatment with Bemolan, you must inform your doctor if you currently have or have previously had any of the following conditions:
- Impaired kidney function: with very prolonged treatment and high doses, signs of chronic aluminium and/or magnesium intoxication may occur.
- Osteoporosis (loss of bone density) and osteomalacia (softening of the bones): prolonged use and high doses of aluminium-containing antacids may worsen certain bone diseases due to decreased absorption of phosphate and calcium from food.
- Dementia (progressive deterioration of brain function): prolonged use and high doses of aluminium-containing antacids may worsen dementia in patients with this condition, as aluminium may accumulate in brain tissue.
Taking Bemolan with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
You should avoid taking Bemolan at the same time as the following medicines, as Bemolan may reduce the absorption of these medicines:
- Tetracyclines and quinolone derivatives such as ciprofloxacin, ofloxacin and norfloxacin (a group of antibiotics)
- Digoxin (used to treat heart problems)
- Benzodiazepines (used as sedatives and for sleep disorders)
- Coumarin derivatives such as acenocoumarol, warfarin (oral anticoagulants)
- Indomethacin (anti-inflammatory)
- Cimetidine (antacid)
- Chenodeoxycholic and ursodeoxycholic acid (used for liver disorders)
- Iron supplements (used for anemia)
- Isoniazid (antitubercular)
- Chlorpromazine (neuroleptic)
For this reason, administration of the above-mentioned medicines should be scheduled at least 2–3 hours before or after taking Bemolan.
Taking Bemolan with food and drink:
Take this medicine 1 to 2 hours after main meals.
Concomitant use of aluminium-containing antacids with acidic drinks (fruit juices, wine, etc.) may increase intestinal absorption of aluminium. The same applies to effervescent tablets containing citric or tartaric acid.
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines:
Bemolan has no or negligible influence on the ability to drive and use machines.
Bemolan contains sodium:
This medicine contains less than 23 mg of sodium (1 mmol) per sachet; therefore, it is essentially “sodium-free”.
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3. How to take Bemolan
Follow exactly the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 800 mg to 2000 mg of gel (1 sachet of 800 mg or 1 sachet of 2000 mg) orally, depending on the intensity of symptoms, taken one to two hours after main meals. In certain cases, an additional sachet may be taken before going to bed.
Before ingestion, it is important to properly squeeze the Bemolan sachet by pressing in different directions before opening it.
Refer to the following illustration for handling the sachet:
If symptoms worsen or persist beyond 7 days, you should consult your doctor.
If you take more Bemolan than you should:
It is recommended not to exceed the total daily amount of 8 grams of magaldrate.
Excessive doses or habitual doses in patients on a phosphate-poor diet may lead to phosphorus loss, resulting in bone loss and calcium excretion in urine, with risk of osteomalacia (softening of the bones).
Cases of overdose have not been reported. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the quantity ingested.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The side effects of Bemolan are generally mild and transient. Especially at high doses, it may cause constipation and diarrhea. However, at the recommended dose, such manifestations are very rare.
Inform your doctor as soon as possible if you notice any of the following symptoms:
Very common side effects (may affect more than 1 in 10 patients):
- Soft stools
Very rare side effects (may affect up to 1 in 10,000 patients):
- Diarrhea and hypermagnesemia
Frequency not known (cannot be estimated from available data):
- Neurotoxicity, encephalopathy, constipation, nausea, vomiting, abdominal pain, and hypophosphatemia.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Bemolan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Do not use Bemolan if you notice any signs of damage to the container or its contents.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bemolan
The active substance is: magaldrate. One 12.5 ml sachet contains 2000 mg of magaldrate.
The other components are: arabic gum, hypromellose, sodium cyclamate, calcium hypochlorite, simethicone, methylcellulose, sorbic acid, silver sulfate, chlorhexidine digluconate (20% aqueous solution), peppermint flavor, purified water.
Appearance of the product and contents of the pack
Each sachet contains 12.5 ml of white or creamy-colored gel with a slight peppermint taste.
Pack sizes: 30 sachets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Takeda Farmacéutica España, S.A.
Calle Albacete, 5, planta 9ª,
Edificio Los Cubos
28027 Madrid
Spain
Tel: +34 91 790 42 22
Manufacturer:
TAKEDA GMBH,
Robert Bosch Strasse, 8.
Singen, Germany
Date of the most recent review of this leaflet: July 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/