BEMOLAN 800 mg ORAL GEL

Introduction

Package Leaflet: Information for the User

Bemolan 800 mg Oral Gel

Magaldrate

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

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

Contents of the Package Leaflet:

1. What Bemolan is and what it is used for.
2. What you need to know before taking Bemolan.
3. How to take Bemolan.
4. Possible side effects.
1. Storage of Bemolan.
2. Package Contents and Additional Information.

1. What Bemolan is and what it is used for

Bemolan belongs to a group of medicines called antacids. The active ingredient, magaldrate, is transformed into aluminum and magnesium salts in the stomach, regulating stomach acidity.

It is indicated for the symptomatic relief of occasional gastric discomfort related to hyperacidity, stomach acid, 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 any of the other components of this medicine (listed in section 6).
• if you have intestinal obstruction.
• if you have severe kidney failure or low phosphate levels in the blood (hypophosphatemia).
• if you have high magnesium levels in the blood (hypermagnesemia).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Bemolan.

Before starting treatment with Bemolan, you should inform your doctor if you have or have had any of the following disorders:

• Kidney function impairment: in very prolonged treatments and at high doses, there may be signs of chronic aluminum and/or magnesium poisoning.
• Osteoporosis (bone density loss) and osteomalacia (bone softening): prolonged use and high doses of antacids containing aluminum can worsen some bone diseases due to decreased absorption of phosphorus and calcium from food.
• Dementia (progressive brain function impairment): prolonged use and high doses of antacids containing aluminum can aggravate dementia in patients with this disease, as aluminum can accumulate in brain tissue.

Taking Bemolan with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine:

You should avoid taking Bemolan simultaneously with the following medicines, as Bemolan may reduce their absorption:

• 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 and warfarin (oral anticoagulants)
• Indomethacin (anti-inflammatory)
• Cimetidine (antacid)
• Chenodeoxycholic and ursodeoxycholic acid (used in liver problems)
• Iron supplements (used in anemia problems)
• Isoniazid (antitubercular)
• Chlorpromazine (neuroleptic)

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

Taking Bemolan with food and drinks:

Take this medicine 1 to 2 hours after main meals.

The concomitant use of antacids containing aluminum 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, think you may be pregnant, or plan 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.

3. How to take Bemolan

Follow exactly the administration instructions of this medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of 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) orally, depending on the intensity of the symptoms, 1 to 2 hours after main meals. In certain cases, another sachet can be taken before bedtime.

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

Observe the following diagram for handling the sachet:

If symptoms worsen or persist after 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 usual doses in patients with a phosphate-poor diet may lead to phosphorus loss, resulting in bone and calcium loss in the urine, with a risk of osteomalacia (bone softening).

No cases of overdose have been reported. 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 medicine and the amount ingested.

4. Possible side effects

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

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

Tell your doctor as soon as possibleif 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 the available data):

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

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side 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 expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not use Bemolan if you notice signs of deterioration of the package or its contents.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Bemolan Composition

The active ingredient is: magaldrate. One 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.

Product Appearance and Package Contents

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

Presentation: 30 sachets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Takeda Farmacéutica España, S.A.

Calle Albacete, 5, 9th floor, Edificio Los Cubos, 28027 Madrid, Spain. Phone: +34 91 790 42 22

Manufacturer:

TAKEDA GMBH, Robert Bosch Strasse, 8, Singen, Germany.

Date of the last revision of this package leaflet:December 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS): http://www.aemps.es/