COLPERMIN 187 mg GASTRO-RESISTANT HARD CAPSULES

Introduction

Patient Information Leaflet

Colpermin 187 mg hard gastro-resistant capsules

Peppermint oil

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 2 weeks.

Contents of the pack

1. What is Colpermin and what is it used for
2. What you need to know before you take Colpermin
3. How to take Colpermin
4. Possible side effects
5. Storing Colpermin
6. Package contents and further information

1. What is Colpermin and what is it used for

Colpermin is a herbal medicine that contains peppermint oil.

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 you take Colpermin

Do not take Colpermin

• If you are allergic to peppermint oil, menthol, or any of the other ingredients of this medicine (listed in section 6).
• If your doctor has told you that you have a liver disease.
• If you have inflammation of the bile duct (cholangitis).
• If you have a low production of stomach acid (a condition called achlorhydria).
• If you have gallstones or any other biliary disorder.
• In children under 8 years of age.

Colpermin contains peanut oil

Do not use this medicine if you are allergic to peanuts or soya.

Warnings and precautions

Consult your doctor or pharmacist before taking Colpermin.

Tell your doctor or pharmacist if you have heartburn or a hiatus hernia (a condition where part of the stomach protrudes into the chest cavity). In these cases, taking this medicine could worsen symptoms and treatment should be discontinued.

Colpermin capsules should be swallowed whole, without being broken or chewed, and should not be taken with food. This could cause the premature release of peppermint oil and irritation of the mouth and upper digestive tract (esophagus).

Children

The use of this medicine is recommended for children from 8 years of age and should not be used in children under this age (8 years).

Other medicines and Colpermin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking other medicines that reduce stomach acid (such as H2 receptor antagonists and proton pump inhibitors) or antacids at the same time as this medicine could cause the premature release of peppermint oil. Therefore, they should be taken at least 2 hours before or after taking this medicine.

Using Colpermin with food and drinks

Eating food at the same time as taking this medicine could cause the premature release of peppermint oil. Therefore, this medicine should be taken at least 30 minutes before or after food.

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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines.

3. How to take Colpermin

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use in adults and the elderly

The recommended dose is 1 capsule 3 times a day. The dose may be increased to a maximum of 2 capsules 3 times a day if necessary.

Use in adolescents from 12 to 17 years of age

The recommended dose is 1 capsule 3 times a day.

Use in children from 8 to 11 years of age

The recommended dose is 1 capsule 2 times a day.

Children under 8 years of age

This medicine should not be used in children under 8 years of age.

Special populations

No data are available on the dosage in case of renal insufficiency.

The route of administration is oral. Colpermin capsules should be swallowed whole with a sufficient amount of liquid to allow the capsule to pass comfortably. Do not chew, crush, or break the capsules.

Be careful 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 treatment course. If symptoms persist, inform your doctor or pharmacist.

If you take more Colpermin than you should

Symptoms of an overdose may be:

• Severe gastrointestinal symptoms, such as diarrhea, rectal ulcers, or nausea.
• Epileptic seizures, loss of consciousness, difficulty breathing.
• Cardiac rhythm disturbances
• Lack of coordination of muscle movements and other central nervous system problems.

In case of overdose, seek advice from your doctor or pharmacist.

If you forget to take Colpermin

If you miss a dose at the right 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 on the use of this medicine, ask your doctor or pharmacist.

If you stop taking Colpermin

No rebound effect is expected.

Take Colpermin for the time your doctor or pharmacist has indicated. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and seek urgent medical attention

If you develop severe allergic reactions, including anaphylactic shock (a severe, sudden 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 side effects have been reported with the approximate frequencies indicated:

Common:may affect up to 1 in 10 people

Headache, heartburn (acidity), anal discomfort, abnormal-smelling stools, dry mouth, feeling of unease, and stomach discomfort and 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 the available data

Pain around the anus, diarrhea, difficulty and pain when urinating, inflammation of the head of the penis (glans), and abnormal-smelling urine.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Colpermin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister strip after EXP. The expiry date is the last day of the month stated.

Do not store above 25°C. Store in the original package to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and further information

Colpermin composition

• The active substance is peppermint oil. Each hard gastro-resistant capsule contains 187 mg (0.2 ml) of Mentha x piperitaL., aetheroleum (peppermint oil).
• The other ingredients are:

Contents of the capsule:

• White beeswax
• Peanut oil (refined Arachis hypogaeaL. oil)
• Colloidal anhydrous 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 and package contents

The body of the Colpermin hard gastro-resistant capsule is opaque, light blue; the cap is opaque, blue, with a dark blue stripe between the body and the cap.

Colpermin capsules are packaged in blister strips of 10 capsules and each carton may contain 30 or 100 hard gastro-resistant capsules (3 or 10 blister strips). Not all pack sizes may be marketed.

Marketing authorisation holder

Tillotts Pharma GmbH

Warmbacher Strasse 80

79618 Rheinfelden, Germany

Manufacturer

Tillotts Pharma GmbH

Warmbacher Strasse 80

79618 Rheinfelden,

Germany

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

TILLOTTS PHARMA SPAIN, S.L.U.

Travessera de Gràcia 58, 5º 3ª

08006 Barcelona

Spain

This medicine is authorised in the Member States of the EEA under the following names:

Belgium, Denmark, Finland, France, Germany, Iceland, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden: Colpermin

Austria: Pfefferminzöl Tillotts 187 mg magensaftresistente Hartkapseln

Date of last revision of this leaflet:September 2022

Other sources of information

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