Leaflet: information for the user

Bemolan 800 mg oral gel

magaldrate

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4
• You should consult a doctor if your symptoms worsen or do not improve after 7 days of treatment.

1.What Bemolan is and what it is used for.

2.What you need to know before starting to take Bemolan.

3.How to take Bemolan.

4.Possible side effects.

1. Storage of Bemolan.
2. Contents of the pack and additional information.

Bemolan belongs to a group of medications known as antacids. The active ingredient, magaldrate, is converted into aluminum and magnesium salts in the stomach, regulating stomach acidity.

It is indicated for the symptomatic relief of occasional gastrointestinal discomfort related to hyperacidity, stomach acid, and heartburn in adults.

Do not takeBemolan:

• if you are allergic (hypersensitive) to magaldrate or any of the other components of this medication (listed in section 6).
• if you have intestinal obstruction.
• if you have severe kidney failure or low levels of phosphate in the blood (hypophosphatemia).
• if you have high levels of magnesium in the blood (hypermagnesemia).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeBemolan.

Before starting treatment with Bemolan, you must inform your doctor if you suffer or have suffered from any of the following conditions:

TakingBemolanwith other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication:

You should avoid administering Bemolan simultaneously with the following medications, as Bemolan may reduce the absorption of the following medications:

• 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 problems)
• Coumarin derivatives such as acenocoumarol, warfarin (oral anticoagulants)
• Indomethacin (anti-inflammatory)
• Cimetidine (antacid)
• Quenac and ursodeoxycholic acid (used in liver problems)
• Iron supplements (used in anemia)
• Isoniazid (antitubercular)
• Chlorpromazine (neuroleptic)

For this reason, the intake of the mentioned medications should be taken at least 2-3 hours before or after the administration of Bemolan.

TakingBemolan with food and drinks:

Take this medication 1 to 2 hours after main meals.

The concomitant use of aluminum-containing antacids with acidic beverages (fruit juices, wine, etc.) may increase the intestinal absorption of aluminum. The same occurs with effervescent tablets containing citric or tartaric acid.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery:

The influence ofBemolanon the ability to drive and operate machinery is negligible or insignificant.

Follow the administration instructions exactly as stated in this prospectus or as indicated by your doctor or pharmacist. If in doubt, ask 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) taken orally, depending on the severity of symptoms one to two hours after main meals. In certain cases, another sachet may be taken before bedtime.

Before ingestion, it is essential to remove the Bemolan sachet correctly, pressing in different directions before opening it.

Observe the following diagram for sachet manipulation:

If symptoms worsen or persist after 7 days, consult your doctor.

If you take moreBemolan than you should:

It is recommended not to exceed the total daily dose of 8 grams of magaldrate.

Excessive doses or regular doses in patients with a low-phosphate diet may lead to phosphate loss, resulting in bone and calcium loss in urine, with a risk of osteomalacia (bone softening).

No cases of overdose have been described. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The adverse effects of Bemolan are generally mild and transient. Especially at high doses, it may produce constipation and diarrhea. However, at the recommended dose, such manifestations are very rare.

Inform your doctoras soon as possible,if you notice any of the following symptoms:

Very frequent 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

Unknown frequency (cannot be estimated from available data):

•Neurotoxicity, encephalopathy, constipation, nausea, vomiting, abdominal pain, and hypophosphatemia.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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No special storage conditions are required.

Do not use Bemolan if you observe signs of deterioration of the packaging or its contents.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Bemolan

The active ingredient is: magaldrate. A 10 ml sachet contains 800 mg of magaldrate.

The other components are: gum arabic, hypromellose, maltol, sodium cyclamate, simethicone,

methylcellulose, sorbic acid, silver sulfate, chlorhexidine digluconate (20% aqueous solution),

cream flavor, caramel flavor, purified water.

Appearance of the product and contents of the packaging

Each sachet contains 10 ml of white or creamy gel, with a caramel odor and taste.

Presentations: 30 sachets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and manufacturer

Holder of the marketing authorization:

TAKEDA FARMACÉUTICA ESPAÑA, S.A.

Paseo de la Castellana 95, 22nd floor

Edificio Torre Europa

28046 Madrid

Spain

Tel: +34 91 790 42 22

Manufacturer:

TAKEDA GMBH,

Robert Bosch Strasse, 8.

Singen, Germany

Last review date of this leaflet:December 2019

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/