Colpermin 187 mg gastro-resistant hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Colpermin 187 mg gastro-resistant hard capsules
Peppermint essential oil
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use of this medicine contained in this leaflet or as indicated by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 2 weeks.
Contents of the leaflet
- What Colpermin is and what it is used for
- What you need to know before taking Colpermin
- How to take Colpermin
- Possible side effects
- How to store Colpermin
- Contents of the pack and other information
1. What Colpermin is and what it is used for
Colpermin is a herbal medicinal product containing essential oil of peppermint (Mentha piperita).
Colpermin capsules are indicated for the symptomatic relief of mild gastrointestinal spasms, flatulence, and abdominal pain, particularly in patients with irritable bowel syndrome.
2. What you need to know before starting to take Colpermin
Do not take Colpermin
- If you are allergic to peppermint essential oil, menthol, or any of the other components of this medicine (listed in section 6).
- If your doctor has told you that you have liver disease.
- If you have inflammation of the bile duct (cholangitis).
- If you have low production of gastric acids in the stomach (a condition called achlorhydria).
- If you have gallstones or any other biliary disorder.
- In children under 8 years of age.
Colpermin contains oil from Arachis hypogaea L. (peanut oil)
Do not use this medicine if you are allergic to peanuts or soybeans.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Colpermin.
Inform your doctor or pharmacist if you suffer from acid reflux or hiatal hernia (a condition in which part of the stomach protrudes into the chest cavity). In these cases, use of this medicine could worsen symptoms, and treatment should be discontinued.
Colpermin capsules must be swallowed whole, without breaking or chewing them, and should not be taken with food. Doing so may cause premature release of peppermint essential oil and lead to irritation in the mouth and upper digestive tract (esophagus).
Children
This medicine is recommended for use in children aged 8 years and older, and should not be used in children younger than 8 years of age.
Other medicines and Colpermin
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Concomitant administration of other medicines used to reduce gastric acid (such as histamine H2-receptor antagonists and proton pump inhibitors) or antacids may cause premature release of peppermint essential oil; therefore, these should be taken at least 2 hours before or after taking this medicine.
Taking Colpermin with food and drink
Consuming food at the same time may cause premature release of peppermint essential oil. Therefore, this medicine should be taken at least 30 minutes before or after meals.
Pregnancy and breastfeeding
Due to insufficient data, use during pregnancy and breastfeeding is not recommended, nor in women of childbearing age who are not using contraceptive methods.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
The effect of this medicine on your ability to drive and operate machinery is none or negligible.
3. How to take Colpermin
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Use in adults and elderly
The recommended dose is 1 capsule three times a day. The dose may be increased to a maximum of 2 capsules three times a day, if necessary.
Use in adolescents aged 12 to 17 years
The recommended dose is 1 capsule three times a day.
Use in children aged 8 to 11 years
The recommended dose is 1 capsule twice a day.
Children under 8 years
This medicine must not be used in children under 8 years of age.
Special populations
There are no data available on dosage in cases of renal impairment.
The route of administration is oral. Colpermin capsules must be swallowed whole with a sufficient amount of liquid to allow the capsule to pass comfortably. Do not chew, crush, or split the capsules.
Take care when removing the capsules from the blister strip.
Colpermin should be taken at least 30 minutes before or after food.
The usual duration of treatment is 1 or 2 weeks. The maximum duration of treatment is 3 months per course. If symptoms persist, inform your doctor or pharmacist.
If you take more Colpermin than you should
Symptoms of overdose may include:
- Severe gastrointestinal symptoms such as diarrhoea, rectal ulcers, or nausea.
- Epileptic seizures, loss of consciousness, difficulty breathing.
- Changes in heart rhythm.
- Lack of muscular coordination and other central nervous system disorders.
In case of overdose, seek advice from your doctor or pharmacist.
If you forget to take Colpermin
If you forget to take a dose at the correct time, simply take the next dose as usual. Do not take a double dose to make up for forgotten doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
If you stop taking Colpermin
A rebound reaction is not expected.
Take Colpermin for as long as your doctor or pharmacist has instructed. If you have any other questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Stop treatment with this medicine and seek urgent medical assistance
If you develop severe allergic reactions, including anaphylactic shock (a sudden, severe allergic reaction with signs such as low blood pressure and difficulty breathing), which requires immediate medical treatment, mild or severe tremors, movement disorders with balance problems, decreased heart rate, and red skin rash. The frequency of these reactions is unknown.
The following adverse effects have been reported with the approximate frequencies indicated:
Frequent: may affect up to 1 in 10 people
Headache, pyrosis (acid reflux, heartburn), anal discomfort, stools with abnormal odor, dry mouth, feeling of restlessness and stomach discomfort, nausea, and vomiting.
Uncommon: may affect up to 1 in 100 people
Hypersensitivity, skin itching, gastric bleeding, and blurred vision.
Frequency not known: cannot be estimated from available data
Pain around the anus, diarrhea, difficulty and pain when urinating, swelling of the head of the penis (glans), and urine with abnormal odor.
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 may 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 Colpermin
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister strip after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25°C. Keep in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Colpermin
- The active substance is peppermint essential oil. Each gastro-resistant hard capsule contains 187 mg (0.2 ml) of Mentha x piperita L., aetheroleum (peppermint essential oil).
- The other components are:
Contents of the capsule:
- White beeswax
- Refined peanut oil (Arachis hypogaea L. oil)
- Anhydrous colloidal silica
Capsule shell:
- Gelatin
- Indigotine (E132)
- Titanium dioxide (E171)
- Methacrylic acid-methyl methacrylate copolymer (1:2)
- Methacrylic acid-ethyl acrylate copolymer (1:1) – 30% dispersion
- Triethyl citrate
- Glycerol monostearate 40–55
- Macrogol 4000
- Talc
Appearance of the product and contents of the pack
The body of the gastro-resistant hard capsule Colpermin is opaque, light blue in colour; the cap is opaque blue, with a dark blue band between the body and the cap.
Colpermin capsules are packed in blisters of 10 capsules, and each carton may contain 30 or 100 gastro-resistant hard capsules (3 or 10 blister strips). Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Tillotts Pharma GmbH
Warmbacher Strasse 80
79618 Rheinfelden
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
TILLOTTS PHARMA SPAIN, S.L.U.
Travessera de Gràcia 58, 5th floor, office 3
08006 Barcelona
Spain
This medicinal product is authorized in the European Economic Area Member States under the following names:
Denmark, Finland, France, Iceland, Norway, Spain, Sweden: Colpermin
Date of the most recent review of this summary: October 2025
Other sources of information
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/