Gastrofrenal 200 mg, hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

GASTROFRENAL 200 mg hard capsules

Sodium cromoglicate

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

• Keep this leaflet; you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What GASTROFRENAL 200 mg hard capsules is and what it is used for
2. What you need to know before taking GASTROFRENAL 200 mg hard capsules
3. How to take GASTROFRENAL 200 mg hard capsules
4. Possible side effects
5. How to store GASTROFRENAL 200 mg hard capsules
6. Contents of the pack and other information

1. What Gastrofrenal 200 mg hard capsules is and what it is used for

Gastrofrenal is indicated in food allergies and in the treatment of symptoms associated with mastocyte mediator release (mastocytosis and mastocyte activation syndromes) in adults, adolescents, and children weighing 40 kg or more.

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

Do not take Gastrofrenal 200 mg hard capsules:

• If you are allergic to sodium cromoglicate or to any of the other ingredients 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 must only be carried out under strict medical supervision.

If you are taking oral corticosteroid medicines, consult your doctor before taking this medicine, as your medication dose may need to be adjusted.

Children and adolescents

Treatment of mastocytosis with sodium cromoglicate in children should only be carried out when the doctor considers it necessary, such as in cases with severe symptoms requiring intensive treatment.

Patients over 65 years of age

Concomitant diseases should be taken into account. In case of impaired renal or hepatic function, your doctor may adjust the dose of this medicine.

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

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

Patients with renal or hepatic impairment

If you have renal or hepatic impairment, consult your doctor so that your dose of the medicine can be adjusted.

Taking Gastrofrenal 200 mg hard capsules with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Although no interactions with other medicines have been reported, it is still recommended to separate the administration times of sodium cromoglicate and other medicines.

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

This medicine should be taken on an empty stomach. You may consume food 30 minutes after taking the medicine or 2 hours before administration of this medicine.

Pregnancy, breastfeeding and fertility

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.

There are no data on the use of this medicine in pregnant women; therefore, it should be avoided during pregnancy unless your doctor considers it strictly necessary. Women planning to become pregnant should consult their doctor.

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

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or operate machinery.

3. How to take Gastrofrenal 200 mg hard capsules

Treatment with this medicine must be initiated and supervised only by a physician experienced in managing these conditions.

Your doctor will indicate the recommended dose for you. As a general guideline:

1. Treatment of food allergies

-Initial dose:

Adults:

1 capsule of 200 mg 4 times daily, taken before meals.

Adolescents and children weighing ≥ 40 kg:

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

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

-Maintenance dose:

Once the therapeutic response has been achieved, the dose should be reduced to the lowest necessary to keep the patient symptom-free.

1. Symptoms associated with mast cell mediator release (mastocytosis and mast cell activation syndromes)

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

-Initial dose:

Adults:

During the first 2 days of treatment, only 200 mg should be administered daily, at bedtime. If tolerance is good, during days 3 and 4 of treatment, the dose may be increased to 400 mg divided into 2 doses (200 mg at bedtime and 200 mg in the morning). If tolerance remains good, treatment should continue with the usual dose of 200 mg 4 times daily.

Adolescents and children weighing ≥ 40 kg:

During the first days of treatment, the same recommendations as for adults should be followed.

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

For this population, another 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 daily, before meals.

Adolescents and children weighing ≥ 40 kg:

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

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

Method of administration

This medicine is taken orally.

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

If adverse reactions occur or if you do not observe improvement in disease symptoms, you should consult your doctor, as a dosage 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 Toxicology Information Service at 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 missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

The following adverse reactions have been reported, with frequency 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, diarrhoea, dyspepsia.

• rash, itching.

• muscle pain, joint pain, and moderate fatigue.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gastrofrenal 200 mg hard capsules

Keep out of the sight and reach of children.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre collection point at your pharmacy. If in doubt, ask your pharmacist how to properly 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 Gastrofrenal 200 mg hard capsules

The active substance is sodium cromoglicate. Each capsule contains 200 mg of sodium cromoglicate.

The other components (excipients) are: Gelatin.

Appearance of the product and contents of the pack

Gastrofrenal 200 mg hard capsules are available in amber glass bottles or in PVC/PVDC – ALU blisters containing 50 or 20 hard capsules.

Only certain pack sizes may be marketed.

The capsules are size number 1, approximately 19.2 mm long, transparent, and contain white powder.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Alfasigma España S.L.
C/ Aribau 195, 4º
08021 Barcelona. Spain

Manufacturer:

Pharmaloop, S.L.
Polígono Industrial Azque
28806, Alcalá de Henares – Madrid
Spain

or

ITC Production S.R.L.
Via Pontina, Km 29
00071 Pomezia. ITALY

Date of the most recent revision of this leaflet: November 2023

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.gob.es