Leaflet: information for the patient

Colpermin 187 mg hard gastro-resistant capsules

Piperine mint essential oil

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You must consult a doctor if you get worse or do not improve after 2 weeks.

1. What isColperminand what it is used for

2. What you need to know before starting to takeColpermin

3. How to takeColpermin

4. Possible side effects

5. Storage ofColpermin

6. Contents of the pack and additional information

Colpermin is a plant-based medication containing peppermint essential oil.

Colpermin capsules are indicated for the symptomatic relief of mild gastrointestinal spasms, flatulence, and abdominal pain, particularly in patients with irritable bowel syndrome.

Do not take Colpermin

• If you are allergic to peppermint essential oil, menthol, or any of the other components of this medication (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 stomach acid production (a condition known as achlorhydria).
• If you have gallstones or any other bile disorder.
• In children under 8 years old.

Colpermin contains oil ofArachis hypogaeaL. (peanut oil)

Do not use this medication if you are allergic to peanuts or soy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Colpermin.

Inform your doctor or pharmacist if you have heartburn or hiatal hernia (a condition in which a portion of the stomach protrudes into the thoracic cavity). In these cases, the use of this medication may worsen symptoms and treatment may need to be discontinued.

Colpermin capsules should be swallowed whole, without breaking or chewing, and should not be taken with meals. This may cause premature release of peppermint essential oil and cause irritation in the mouth and upper part of the digestive tube (esophagus).

Children

This medication is recommended for use in children from 8 years old and should not be used in children under this age (8 years).

Other medications and Colpermin

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The simultaneous administration of other medications used to reduce stomach acid (such as H2 receptor antagonists and proton pump inhibitors) or antacids may cause premature release of peppermint essential oil, therefore they should be taken at least 2 hours before or after taking this medication.

Use of Colpermin with food and drinks

The simultaneous consumption of food may cause premature release of peppermint essential oil. Therefore, this medication should be taken at least 30 minutes before or after meals.

Pregnancy and breastfeeding

Lack of sufficient data, this medication is not recommended for use during pregnancy and breastfeeding, or in women of childbearing age who are not using contraceptive methods.

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

The influence of this medication on your ability to drive and operate machines is negligible or insignificant.

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

Use in adults and elderly people

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 12 to 17 years old

The recommended dose is 1 capsule 3 times a day.

Use in children 8 to 11 years old

The recommended dose is 1 capsule 2 times a day.

Children under 8 years old

This medication should not be used in children under 8 years old.

Special populations

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

The administration route 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 pack.

Colpermin should be taken at least 30 minutes before or after a meal.

The usual duration of treatment is 1 or 2 weeks. The maximum duration of treatment is 3 months per course of treatment. If symptoms persist, inform your doctor or pharmacist.

If you take more Colpermin than you should

The symptoms of an overdose may be:

• Important gastrointestinal symptoms, such as diarrhea, rectal ulcers, or nausea.
• Seizures, loss of consciousness, difficulty breathing.
• Arrhythmias
• 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 forgot to take Colpermin

If you forget to take a dose at the right time, simply take the next dose in the usual way. Do not take a double dose to make up for the missed doses.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

If you interrupt the treatment with Colpermin

No rebound effect is expected.

Take Colpermin for the time your doctor or pharmacist has indicated. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Stop treatment with this medication and seek urgent medical assistance

If you develop severe allergic reactions, including anaphylactic shock (a severe, sudden allergic reaction with symptoms such as a drop in blood pressure and difficulty breathing), which requires immediate medical treatment, mild or intense 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 described with the approximate frequencies indicated:

Frequent:may affect up to 1 in 10 people

Headache, heartburn (acid reflux, burning), anal discomfort, abnormal-smelling stools, dry mouth, feeling of unease, and stomach discomfort and nausea, and vomiting.

Rare:may affect up to 1 in 100 people

Allergic hypersensitivity, skin itching, gastric hemorrhage, and blurred vision.

Unknown frequency: cannot be estimated from available data

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Colpermin

• The active ingredient is peppermint essential oil. Each gastro-resistant hard capsule contains 187mg (0.2ml) ofMentha x piperitaL., aetheroleum (peppermint essential oil).
• The other components are:

Content of the capsule:

• White beeswax
• Refined peanut oil (arachis hypogaea L)
• Anhydrous colloidal silica

Capsule shell:

• Gelatin
• Indigotin (E132)
• Titanium dioxide (E171)
• Acrylate-methacrylate copolymer (1:2)
• Acrylate-ethylacrylate copolymer (1:1) – 30% dispersion
• Triethyl citrate
• Monoestearate of glycerol 40‑55
• Macrogol 4000
• Talc.

Appearance of the product and contents of the package

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

Colpermin capsules are packaged in blister strips of 10 capsules and each box may contain 30 or 100 hard gastro-resistant capsules (3 or 10 blister strips). Some package sizes may only be marketed.

Marketing Authorization Holder

Tillotts Pharma GmbH

Warmbacher Strasse 80

79618 Rheinfelden, Germany

Responsible for manufacturing

Tillotts Pharma GmbH

Warmbacher Strasse 80

79618 Rheinfelden,

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

TILLOTTS PHARMA SPAIN, S.L.U.

Gran Via de les Corts Catalanes 680,1st 1st

08010 Barcelona

Spain

This medicinal product is authorized in the Member States of the EEA with the following names:

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

Austria: Pfefferminzöl Tillotts 187 mg gastro-resistant hard capsules

Last review date of this leaflet:September 2022

Other sources of information

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/