Disolgas 257.5 mg soft capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
DISOLGAS 257.5 mg soft capsules Simethicone
Read the entire leaflet carefully as it contains important information for you.
This medicine can be purchased without a prescription. However, to achieve the best results, it must be used correctly.
- Keep this leaflet as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If symptoms worsen or persist beyond 10 days, you should consult a doctor.
- If you consider any of the side effects you experience to be severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What DISOLGAS is and what it is used for
- Before taking DISOLGAS
- How to take DISOLGAS
- Possible side effects
- How to store DISOLGAS
- Further information
1. What Disolgas is and what it is used for
Disolgas works by breaking up trapped gas that causes bloating.
Disolgas is indicated for the symptomatic relief of gas in adults and adolescents aged 12 years and older.
2. Before taking Disolgas
Do not take DISOLGAS
If you are allergic to simethicone or to any of the other components of DISOLGAS.
Take special care with DISOLGAS
Consult your doctor if:
- you do not improve after 10 days of treatment
- you have persistent constipation
Use of other medicines
Taking this medicine does not affect the efficacy of other medicines.
Taking DISOLGAS with food and drink
Taking this medicine with food and drink 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 with their doctor.
Driving and operating machinery
Taking this medicine does not affect the ability to drive or operate machinery.
Important information about some of the components of DISOLGAS
This medicine may cause allergic reactions because it contains sunset yellow FCF (E 110) and azorubine (E 122).
It may provoke asthma, especially in patients allergic to acetylsalicylic acid.
3. How to take Disolgas
Follow these instructions unless your doctor has given you different advice.
If in doubt, consult your pharmacist or doctor.
The usual dose is:
Adults and adolescents aged 12 years and over:
1 capsule. Do not take more than 2 capsules per day.
Use in children:
This medicine must not be given to children under 12 years of age.
Method of administration:
DISOLGAS is taken orally. Take the medicine when discomfort occurs. Swallow 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, you must stop taking the medicine 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 at telephone number 915620420, stating the product and the amount ingested.
If you forget to take DISOLGAS
If you forget to take DISOLGAS and symptoms persist, 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 adverse effects
Like all medicines, DISOLGAS may produce adverse effects, although not everyone experiences them.
The following adverse effects have been reported during the use of Simethicone, although their frequency cannot be precisely determined:
- Nausea, constipation
- Allergic reactions such as skin rash, itching, swelling of the face and tongue, or difficulty breathing.
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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater drains 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 unused medicines and their packaging. This will help protect the environment.
6. Additional Information
Composition of DISOLGAS:
Each capsule contains 257.5 mg of simethicone as the active substance.
The other components (excipients) are: gelatin, glycerol (E 422), dimethicone, titanium dioxide (E 171), potassium sorbate (E 202), sunset yellow FCF (E 110), cochineal red A (E 122).
Appearance of the medicinal product and contents of the pack:
Pack of 30 soft capsules, packed in 3 blisters containing 10 capsules each.
Pack of 20 soft capsules, packed in 2 blisters containing 10 capsules each.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder:
ARKOPHARMA LABORATORIOS, S.A.U
C/ Amaltea, 9
28045 MADRID
Manufacturer:
ARKOPHARMA
LABORATOIRES PHARMACEUTIQUES
BP 28 – 06511 CARROS CEDEX – France
This patient information leaflet was approved in: June 2018
“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/”