Leaflet: information for the user

GASTROFRENAL 200 mg hard capsules

Sodium cromoglicate

Read this leaflet carefully before you start taking this medicine, as 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Gastrofrenal 200 mg hard capsules are and what they are used for

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

3. How to take Gastrofrenal 200 mg hard capsules

4. Possible side effects

5. Storage of Gastrofrenal 200 mg hard capsules

6. Contents of the pack and additional information

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

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 corticosteroids, consult your doctor before taking this medicine, as you will need to adjust the dose of your medication.

Children and adolescents

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

People over 65 years

Consider the presence of any concomitant diseases. If there are any renal or hepatic function impairments, your doctor may adjust the dose of this medicine.

If you suffer an allergic reaction, you must stop taking the medicine definitively.

If you suffer any other adverse reaction, stop taking the medicine and see your doctor. Your doctor will tell you how to resume taking Gastrofrenal.

Patients with renal or hepatic insufficiency

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

Taking Gastrofrenal 200 mg hard capsules with other medicines

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

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

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

This medicine should be taken on an empty stomach. No solid foods should be ingested in the 30 minutes before or in the 2 hours after taking the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend 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 it 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. Women who are breastfeeding should consult their doctor before taking this medicine.

Driving and operating machinery

This medicine is unlikely to affect your ability to drive and use machines.

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

Your doctor will inform you of the recommended dose for you, as follows:

1. Allergic food treatment

-Initial dose:

Adults:

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

Adolescents and children with a weight of ≥ 40 kg:

10 to 15 mg/kg of body weight per day divided into 4 doses, 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 to20 mg/kg/day in children.

-Maintenance dose:

Once therapeutic response is achieved, the dose should be reduced to the minimum necessary to maintain the patient free of symptoms.

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 inform you of the dose and how to take this medication. However, the usual dose is as follows:

-Initial dose:

Adults:

For the first 2 days of treatment, only 200 mg will be administered per day, at night. 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 is good, treatment will continue with the usual dose of 200 mg 4 times a day.

Adolescents and children with a weight of ≥ 40 kg:

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

The most suitable regimen would be: for the first 2 days, only 100 mg per day, at night. Iftolerance 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 will continue with the usual dose calculated based on weight (10 to 15 mg/kg of body weight per day) divided into 4 daily doses.

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

-Maintenance dose:

Adults:

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

Adolescents and children with a weight of ≥ 40 kg:

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

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

Administration form

This medication is taken orally.

You should take the capsules with a glass of water and an empty stomach. Do not ingest solid foods within 30 minutes before or 2 hours after taking the medication.

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

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 medication and the amount ingested.

If you forgot to take Gastrofrenal 200 mg hard capsules

Do not take a double dose to compensate for the missed doses.

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

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

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

The following adverse reactions have been reported, of unknown frequency (cannot be estimated from available data).

• Headache, anxiety, irritability, mood changes, sleep disturbances.

• Upper abdominal pain, nausea, abdominal cramps, constipation, diarrhea, indigestion.

• Rash, itching.

• Muscle pain, joint pain, and moderate fatigue.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use www.notificaRAM.es . By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date that appears on the packaging after “CAD”. The expiry date is the last day of the month indicated.

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

Composition of Gastrofrenal 200 mg hard capsules

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

The other components (excipients) are: Gelatin.

Appearance of the product and contents of the packaging

Gastrofrenal 200 mg hard capsules are presented in amber glass bottles or in PVC/PVDC – ALU blister packs with 50 and 20 hard capsules.

Only some packaging sizes may be marketed.

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

Holder of the marketing authorization and responsible for manufacturing:

Holder:

Alfasigma España S.L.

Av. Diagonal, 490

08006 Barcelona

Spain

Responsible for manufacturing:

Pharmaloop, S.L.

Polígono Industrial Azque

28806, Alcalá de Henares – Madrid

or

ITC Production S.R.L.

Via Pontina, Km 29

00071 Pomezia. ITALY

Last review date of this leaflet: November 2023

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