Gastopret

Patient Information Leaflet

Gastopret gastro-resistant soft capsules

Peppermint oil
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 2 weeks.

Contents of this leaflet

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

1. What Gastopret is and what it is used for

A herbal medicinal product indicated for the symptomatic relief of mild spasms of the gastrointestinal tract, flatulence, and abdominal pain, particularly in patients with irritable bowel syndrome.
Gastopret is indicated for adults, adolescents, and children aged 8 years and older.

2. What you need to know before taking Gastopret

Do not take Gastopret

• if you are allergic to peppermint oil or menthol or to any of the other ingredients of this medicine (listed in section 6).
• if you have liver disorders, inflammation of the bile duct (cholangitis), low gastric acid production (achlorhydria), gallstones, or any other biliary disorder.
• in children under 8 years of age and in children weighing less than 19 kg.

Warnings and precautions
Talk to your doctor or pharmacist before taking Gastopret:

• if you already suffer from heartburn (acid regurgitation) or hiatal hernia (protrusion of the upper part of the stomach), symptoms may sometimes worsen after taking Gastopret. Discontinue use of Gastopret in these cases.
• avoid taking Gastopret together with any other product containing peppermint oil.

The gastro-resistant soft capsules (referred to as capsules) must be swallowed whole, without breaking or chewing them, as doing so would cause premature release of peppermint oil, possibly leading to local irritation of the mouth and esophagus.
Children
Gastopret is contraindicated in children under 8 years of age and in children weighing less than 19 kg.
Other medicines and Gastopret
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Other medicines used to reduce gastric acidity, such as H2-receptor antagonists, proton pump inhibitors, and drugs used to neutralize gastric acid (antacids), may potentially cause premature release of the capsule contents and should therefore be avoided.
No interaction studies have been conducted.
Gastopret with food
Concomitant intake of food may potentially cause premature dissolution of the gastro-resistant capsule's contents. For this reason, it is recommended to take Gastopret 30 minutes before meals.
Pregnancy and breastfeeding
Due to insufficient data, the use of Gastopret is not recommended during pregnancy, breastfeeding, and in women of childbearing age who do not use contraception.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
No studies on the effects on the ability to drive vehicles and operate machinery have been conducted.
Gastopret contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.

3. How to take Gastopret

Take this medicine exactly as stated in this instruction leaflet,
or as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

Administration method
For oral use.
Gastopret should be taken 30 minutes before meals with a sufficient amount of cold liquid (preferably a glass of cold water).
The capsules must be swallowed whole, without breaking or chewing them.
Duration of treatment
Gastopret should be taken until symptoms resolve (signs of disease), usually within one or two weeks. In case of more persistent symptoms, capsule intake may continue for periods not exceeding 3 months per treatment cycle.
If you take more Gastopret than you should
If you take a higher dose than recommended, consult your doctor or pharmacist and bring this leaflet with you.
Overdose may possibly cause severe symptoms affecting the stomach and small and large intestine, diarrhea, rectal lesions, epileptic seizures, loss of consciousness, apnea (cessation of breathing), nausea (stomach discomfort), disturbances in heart rhythm, lack of muscular coordination, and other nervous system problems, possibly due to the presence of menthol.
If you forget to take Gastopret
Continue taking the usual dose at the regular time. It does not matter if you missed a dose.
Do not take a double dose to make up for the forgotten dose.
Consult your doctor or pharmacist if you have any further questions about how to take this medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported.

Common side effects (may affect up to 1 in 10 people)

• Acid regurgitation (heartburn), perianal burning, blurred vision, dry mouth, nausea and vomiting

Side effects with unknown frequency (cannot be estimated from the available data):

• Urine and faeces with a menthol odour;
• Painful urination (dysuria) and inflammation of the glans penis;
• Allergic reactions to menthol with headache, abnormally slow heart rate (bradycardia), tremors (muscular tremor), lack of muscular coordination (ataxia), anaphylactic shock (sudden and severe allergic reaction with symptoms of low blood pressure and breathing difficulties), and red skin rashes (erythematous skin eruption).

Stop taking the medicine and consult a doctor urgently if you experience severe allergic reactions, including anaphylactic shock, which requires immediate medical treatment.
If you experience any side effect, contact your doctor or pharmacist. This includes any side effect not listed in this leaflet.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gastopret

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
Exp./EXP. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you
no longer use. This will help protect the environment.

6. Package contents and other information

What Gastopret contains

• The active substance is Mentha × piperita L., aetheroleum (peppermint oil). Each capsule contains 182 mg (0.2 ml) of Mentha × piperita L., aetheroleum (peppermint oil).
• The other components are: Capsule shell: gelatin, glycerol (E 422), purified water
  Gastro-resistant coating: sodium alginate, stearic acid, ethylcellulose, medium-chain triglycerides, oleic acid

Description of the appearance of Gastopret and contents of the pack
The capsules are oval-shaped, opaque-transparent, and contain a slightly viscous, clear liquid.
The capsule is approximately 10 mm long and about 7 mm wide.
Gastopret is available in blister packs of 15 and 45 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
BIONORICA SE
Kerschensteinerstrasse 11-15
92318 Neumarkt
Germany
Tel. +49 (0)9181 / 231-90
Fax +49 (0)9181 / 231-265
E-mail: [email protected]

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Intestipret magensaftresistente Weichkapseln
Belgium, France
Bulgaria Интестипрет, 182 mg стомашно-устойчиви капсули, меки
Croatia Intestipret meke želučanootporne kapsule
Germany, Greece, Netherlands, Spain Digestopret
Italy Gastopret
Poland, Slovenia, Sweden Gastropret
Czech Republic, Slovakia Digelib
Hungary
Romania Digestopret 182 mg capsule moi gastroresistente