Gastrofrenal 100 mg, hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

GASTROFRENAL 100 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, as 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 other people, even if they have the same symptoms as you, because it may 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.

Contents of the leaflet

1. What Gastrofrenal 100 mg hard capsules is and what it is used for.
2. What you need to know before taking Gastrofrenal 100 mg hard capsules.
3. How to take Gastrofrenal 100 mg hard capsules.
4. Possible side effects.
5. How to store Gastrofrenal 100 mg hard capsules.
6. Contents of the pack and other information.

1. What Gastrofrenal 100 mg hard capsules is and what it is used for

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

2. What you need to know before taking Gastrofrenal 100 mg hard capsules

Do not take Gastrofrenal 100 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

Talk to your doctor or pharmacist before taking 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 corticosteroids, consult your doctor before taking this medicine, as your medication dose may need to be adjusted.

Children and adolescents

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

Patients over 65 years

The presence of other 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 100 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 100 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, breast-feeding and fertility

If you are pregnant or breast-feeding, 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, its use during pregnancy should be avoided 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 human milk. Women who are breast-feeding 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 100 mg hard capsules

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

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

1. Treatment of food allergies

• Initial dose:

Adults:

2 capsules of 100 mg (200 mg) 4 times daily, taken before meals.

Adolescents and children weighing ≥ 40 kg:

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

If satisfactory control is not achieved within 2 or 3 weeks, the dose 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 advise you on 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 tolerated well, 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 well tolerated, 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 instructions 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 tolerated well, 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 well tolerated, treatment should continue with the usual dose calculated according to body weight (10 to 15 mg/kg/day), always divided into 4 daily doses.

• Maintenance dose:

Adults:

200 mg (2 capsules of 100 mg) 4 times daily, taken before meals.

Adolescents and children weighing ≥ 40 kg:

10 to 15 mg/kg body weight 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/day in adults and up to 20 mg/kg body weight/day in children, always divided into 4 daily doses.

Method of administration

This medicine is taken orally.

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

If adverse reactions occur or if you do not observe improvement in your symptoms, you should consult your doctor, as a dose adjustment may be necessary.

If you take more Gastrofrenal 100 mg hard capsules than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number (91) 5620420, indicating the medicine and the amount ingested.

If you forget to take Gastrofrenal 100 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 experiences them.

Although this medicine is usually well tolerated, serious allergic reactions have been reported in some cases, especially when administered 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 unknown frequency (cannot be estimated from the available data):

• headache, anxiety, irritability, mood changes, sleep disorders.
• upper abdominal pain, nausea, abdominal cramps, constipation, diarrhea, 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 Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gastrofrenal 100 mg hard capsules

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

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the Sigre collection point at your pharmacy. If you are unsure, 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 Gastrofrenal 100 mg hard capsules

The active substance is sodium cromoglicate. Each capsule contains 100 mg of sodium cromoglicate.

The other components (excipients) are: Gelatin.

Appearance of the product and contents of the container

Gastrofrenal 100 mg hard capsules are presented in amber or clear glass bottles or PVC/PVDC – ALU blisters containing 50 and 100 hard capsules.

Only certain pack sizes may be marketed.

The capsules are size 2, approximately 18 mm in length, 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

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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es