GASTROFRENAL 200 mg HARD CAPSULES

2. What you need to know before taking Gastrofrenal 200 mg hard capsules

Do not take Gastrofrenal 200 mg hard capsules:

• If you are allergic to sodium cromoglicate or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

In the treatment of food allergies, any reintroduction of an allergenic food into the diet should only be done under strict medical supervision.

If you are taking oral corticosteroid medications, consult your doctor before taking this medicine, as you may need to adjust the dose of your medication.

Children and adolescents

Treatment of mastocytosis with cromoglicate in children should only be done in cases where the doctor considers it necessary, such as when severe symptoms require intensive treatment.

Over 65 years

The presence of other concomitant diseases should be taken into account. In case of renal or hepatic function alterations, your doctor may adjust the dose of this medicine.

If you experience an allergic reaction, you should permanently discontinue treatment.

If you experience any other adverse reaction, discontinue treatment and consult your doctor. Your doctor will indicate how to resume treatment with Gastrofrenal.

Patients with renal or hepatic insufficiency

If you have renal or hepatic insufficiency, consult your doctor to adjust the dose of the medicine.

Taking Gastrofrenal 200 mg hard capsules with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicines.

Although no interactions with other medicines have been described, it is still recommended to space out the administration of cromoglicate and other medicines.

Taking Gastrofrenal 200 mg hard capsules with food, drinks, and alcohol

This medicine should be administered on an empty stomach. You can eat food 30 minutes after taking the medicine or 2 hours before administration.

Pregnancy, breastfeeding, and fertility

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.

There are no data on the treatment with this medicine in pregnant women, so its use should be avoided during pregnancy unless your doctor considers it strictly necessary. Women who wish to become pregnant should consult their doctor.

There are no data on the excretion of sodium cromoglicate in breast milk. Breastfeeding women should consult their doctor before taking this medicine.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive and use machines.

3. How to take Gastrofrenal 200 mg hard capsules

Treatment with this medicine can only be initiated and supervised by an experienced doctor in the management of these diseases.

Your doctor will indicate the recommended dose for you, as a recommendation:

1. Treatment of food allergies

-Initial dose:

Adults:

1 capsule of 200 mg 4 times a day, before meals.

Adolescents and children with weight ≥ 40 kg:

10 to 15 mg/kg body weight per day, divided into 4 doses, before meals.

If satisfactory control is not achieved after 2 or 3 weeks, the dosage may be increased to 1500 mg/day in adults and up to 20 mg/kg/day in children, always divided into 4 doses.

-Maintenance dose:

Once the therapeutic response is achieved, the dose should be reduced to the minimum necessary to keep the patient symptom-free.

1. Symptoms associated with the release of mast cell mediators (mastocytosis and mast cell activation syndromes)

Treatment should be individualized and adapted to each patient. Your doctor will indicate the dose and how to take this medicine. However, the usual dose is as follows:

-Initial dose:

Adults:

For the first 2 days of treatment, only 200 mg per day will be administered, at night. If tolerance is good, during days 3 and 4 of treatment, the dose can be increased to 400 mg, divided into 2 doses (200 mg at bedtime and 200 mg in the morning). If tolerance is good, treatment will continue with the usual dose of 200 mg 4 times a day.

Adolescents and children with weight ≥ 40 kg:

During the first days of treatment, the same instructions given for adults should be followed.

The most suitable regimen would be: for the first 2 days, administer only 100 mg per day, at night. If tolerance is good, during days 3 and 4 of treatment, the dose can be increased to 200 mg, divided into 2 doses (100 mg at bedtime and 100 mg in the morning). If tolerance is good, treatment will continue with the usual dose calculated based on weight (10 to 15 mg/kg body weight per day), always divided into 4 daily doses.

For this population, the other presentation of this medicine, Gastrofrenal 100 mg hard capsules, with a lower dose, may be more suitable.

-Maintenance dose:

Adults:

200 mg (1 capsule) 4 times a day, before meals.

Adolescents and children with weight ≥ 40 kg:

10 to 15 mg/kg body weight per day, divided into 4 doses.

If satisfactory control of symptoms is not achieved after 2 or 3 weeks, your doctor may increase the dose to 1500 mg per day in adults and up to 20 mg/kg body weight per day in children, always divided into 4 doses.

Method of administration

This medicine is taken orally.

You should take the capsules with a glass of water and on an empty stomach. Take the medicine 30 minutes before eating or 2 hours after eating.

In case of adverse reactions or if you do not observe improvement in the symptoms of the disease, you should consult your doctor, as a dose adjustment may be necessary.

If you take more Gastrofrenal 200 mg hard capsules than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Gastrofrenal 200 mg hard capsules

Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Although this medicine is generally well tolerated, serious allergic reactions have been described in some cases, especially when used by inhalation. If you experience symptoms of anaphylaxis (swelling of the face, tongue, eyes, difficulty breathing), stop taking the medicine immediately.

The following adverse reactions have been reported, with a frequency that is not known (cannot be estimated from the available data).

• headache, anxiety, irritability, mood changes, sleep disorders.

• pain in the upper abdominal area, nausea, abdominal cramps, constipation, diarrhea, dyspepsia.

• rash, itching.

• muscle pain, joint pain, and moderate fatigue.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gastrofrenal 200 mg hard capsules

Keep out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

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

6. Package contents and additional information

Composition of Angileptol mint flavor

Each tablet contains:

• The active ingredients:

Chlorhexidine dihydrochloride, 5 mg

Benzocaine, 4 mg

Enoxolone, 3 mg

• The other ingredients (excipients) are: sorbitol (E420), acesulfame potassium (E950), magnesium stearate, and mint flavor

Appearance of the product and package contents

Angileptol are sucking tablets, white, round, and with the Greek letter σ on one face.

They are presented in packages containing 15 and 30 sucking tablets.

Other presentations

Angileptol Mint-eucalyptus flavor

Angileptol Honey-lemon flavor

Marketing authorization holder

Alfasigma Spain S.L.

C/ Aribau 195, 4th floor

08021 Barcelona, Spain

Manufacturer

Pharmaloop, S.L.

Polígono Industrial Azque C/Bolivia, 15

28806 Alcalá de Henares (Madrid), Spain

or

Alfasigma, S.p.A.

Via Pontina, Km 30,400

00071 Pomezia (Rome), Italy

Date of the last revision of this leaflet:September 2021

Other sources of information

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