DISOLGAS 257.5 mg SOFT CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

DISOLGAS 257.5 mg soft capsulesSimethicone

Read all of this leaflet carefully because it contains important information for you.

This medicine can be obtained without a prescription. Nevertheless, to get the best results, it should be used properly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If your symptoms worsen or persist after 10 days, you should consult a doctor.
• If you think that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What is DISOLGASand what is it used for
2. Before taking DISOLGAS
3. How to take DISOLGAS
4. Possible side effects
5. Storage of DISOLGAS
6. Additional information

1. What is Disolgas and what is it used for

Disolgas acts by breaking up trapped gases that cause bloating.

Disolgas is indicated for the symptomatic relief of gas in adults and adolescents from 12 years of age.

2. Before taking Disolgas

Do not take DISOLGAS

If you are allergic to simethicone or any of the other components of DISOLGAS.

Be careful with DISOLGAS

Consult your doctor if:

• you do not improve after 10 days of treatment
• you have continuous constipation

Use of other medicines

Taking this medicine does not affect the efficacy of other medicines.

Taking DISOLGAS with food and drinks

Taking this medicine with food and drinks does not affect its efficacy.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Since this medicine is not absorbed, pregnant and breastfeeding women may take DISOLGAS after consulting their doctor.

Driving and using machines

Taking this medicine does not affect your ability to drive or use machines.

Important information about some of the components of DISOLGAS

This medicine may cause allergic reactions because it contains orange yellow S (E 110) and azorubine (E 122).

It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Disolgas

Follow these instructions unless your doctor has given you different instructions.

Consult your pharmacist or doctor if you have any doubts.

The normal dose is:

Adults and adolescents from 12 years of age:

1 capsule. Do not take more than 2 capsules per day.

Use in children:

Children under 12 years of age should not take this medicine.

Method of administration:

DISOLGAS is taken orally. Take the medicine when discomfort occurs. Take the capsule whole during or after each main meal (lunch and dinner), with a glass of water.

If your symptoms worsen or persist after 10 consecutive days of treatment, you should stop taking it and consult your doctor.

If you take more DISOLGAS than you should

Consult your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your pharmacist or doctor or call the Toxicology Information Service, phone 915620420, indicating the product and the amount ingested.

If you forget to take DISOLGAS

If you forget to take DISOLGAS and your symptoms continue, do not take a double dose to make up for the missed dose. If necessary, take 1 capsule after the next main meal.

4. Possible side effects

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

During the period of use of Simethicone, the following side effects have occurred, whose frequency could not be determined with precision:

• Nausea, constipation
• Allergic reactions, such as skin rash, itching, swelling of the face and tongue or difficulty breathing.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Disolgas

Keep out of the reach and sight of children.

Do not store above 30°C.

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

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

6. Additional information

Composition of DISOLGAS:

Each capsule contains 257.5 mg of simethicone as the active ingredient.

The other components (excipients) are: gelatin, glycerol (E 422), dimethicone, titanium dioxide (E 171), potassium sorbate (E 202), orange yellow S (E 110), azorubine (E 122).

Appearance of the product and packaging content:

Package of 30 soft capsules, packaged in 3 blisters of 10 capsules each.

Package of 20 soft capsules, packaged in 2 blisters of 10 capsules each.

Marketing authorization holder and manufacturer:

Holder:

ARKOPHARMA LABORATORIOS, S.A.U

C/ Amaltea, 9

28045 MADRID

Manufacturer:

ARKOPHARMA

LABORATOIRES PHARMACEUTIQUES

BP 28 – 06511 CARROS CEDEX – France

This leaflet was approved in: June 2018

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