PATIENT INFORMATION LEAFLET

DISOLGAS 257.5 mg Soft CapsulesSimeticona

Read this leaflet carefully before you start taking this medicine.

This medicine can be obtained without a prescription. However, for the best results, it should be used properly.

• Keep this leaflet, as you may need to read it again.
• For advice or further information, consult your pharmacist.
• If symptoms worsen or persist after 10 days, consult a doctor.
• If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Disolgas works by breaking down trapped gases that cause bloating.

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

Do not take DISOLGAS

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

Be extra careful with DISOLGAS

Consult your doctor if:

• You do not improve after 10 days of treatment
• You have persistent constipation

Use of other medications

The taking of this medication does not affect the efficacy of other medications.

Taking DISOLGAS with food and drinks

The taking of this medication with food and drinks does not affect its efficacy.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machines

The taking of this medication does not affect the ability to drive or operate machines.

Important information about some of the components of DISOLGAS

This medication may cause allergic reactions because it contains Yellow B (E 110) and azorubine (E 122).

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

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 12 years of age and older:

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

Use in children:

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

Form of use:

DISOLGAS is taken orally. Take the medication when symptoms occur. Take the capsule whole during or after each of the main meals (lunch and dinner), with a glass of water.

If symptoms worsen or persist after 10 consecutive days of treatment, discontinue 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 Toxicological Information Service, phone 915620420, indicating the product and the amount ingested.

If you forgot to take DISOLGAS

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

Like all medications, DISOLGAS may cause adverse effects, although not everyone will experience them.

During the period of use of Simeticona, the following adverse effects have occurred, whose frequency has not been determined with exactness:

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

Reporting Adverse Effects

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

Keep out of reach and sight of children.

Do not store at a temperature above 30°C.

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

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

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), yellow-orange S (E 110), azorubine (E 122).

Appearance of the product and contents of the package:

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

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

Holder of the marketing authorization and responsible for manufacturing:

Holder:

ARKOPHARMA LABORATORIOS, S.A.U

C/ Amaltea, 9

28045 MADRID

Responsible for manufacturing:

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 Medical Devices(AEMPS) <http://www.aemps.gob.es/>”