hard enteric capsules
peppermint oil
Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.
Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse.
- Save this information, you may need to read it again.
- Contact the pharmacy staff if you need more information or advice.
- If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks
In this leaflet:
1. What Colpermin is and what it is used for
2. What you need to know before taking Colpermin
3. How to take Colpermin
4. Possible side effects
5. How to store Colpermin
6. Contents of the packaging and other information
1. What Colpermin is and what it is used for
Colpermin is an herbal medicine intended for the relief of symptoms in mild spasms of the gastrointestinal tract, gas in the stomach, and abdominal pain in patients with IBS (irritable bowel syndrome).
You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks.
2. What you need to know before taking Colpermin
You should only use Colpermin after your doctor has told you that you have IBS (irritable bowel syndrome).
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 liver disease
- if you have inflammation of the bile ducts (cholangitis)
- if you have decreased acid production in the stomach (this condition is called achlorhydria)
- if you have gallstones or another disease of the gallbladder or bile ducts
Colpermin is not recommended for children under 12 years of age.
Colpermin contains peanut oil
If you are allergic to peanuts or soy, do not use this medicine.
Warnings and cautions
Talk to your doctor if any of the following occur (even if you know you have IBS), as this may be a sign of other more serious conditions:
- your symptoms worsen noticeably,
- you are over 40 years old and it has been a long time since you had your last feeling of IBS, or the symptoms are different this time,
- you have recently had blood in your stool,
- you have lost your appetite or lost weight for no known reason.
If you have heartburn or diaphragmatic hernia (a condition in which part of the stomach slides up into the chest) there is a risk that the symptoms will worsen when using Colpermin. If this happens, stop taking Colpermin.
Colpermin enteric capsules should be swallowed whole and should not be shared, chewed, or taken with a meal. This can lead to the peppermint oil being released prematurely from the capsule, which can cause irritation in the mouth and esophagus.
Children and young people
This medicine is only recommended for adults and adolescents from 12 years of age.
Other medicines and Colpermin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant intake of other drugs used to reduce the amount of stomach acid (eg histamine -2 receptor blockers and proton pump inhibitors ) or antacids may result in the premature release of peppermint oil and should be taken at least 2 hours before or after taking this drug.
Colpermin with food and drink
Concomitant food intake can lead to premature release of peppermint oil. Therefore, this medicine should be taken at least 2 hours before or after a meal.
Pregnancy and breastfeeding
When sufficient information is lacking, use during pregnancy and lactation is not recommended for women of childbearing potential not using contraception.
If you are pregnant or breast-feeding, 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 effect on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to take Colpermin
Always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are not sure, talk to your doctor, pharmacist, or nurse.
Use for adults and the elderly
The recommended dose is 1 capsule 3 times daily. If necessary, the dose can be increased to a maximum of 2 capsules 3 times daily.
Use for young people between 12 and 17 years
The recommended dose is 1 capsule 3 times daily.
Children under 12 years of age
This medicine is not recommended for children under 12 years of age.
Special patient groups
There is no evidence to provide dosing instructions for renal impairment.
Colpermin capsules should be swallowed whole with a sufficient amount of liquid for the capsule to be swallowed without difficulty. The capsules must not be chewed, crushed, or divided.
Be careful when removing the capsule from the blister pack.
Colpermin should be taken at least 2 hours before or after a meal.
The treatment usually lasts 1 to 2 weeks. Each round of treatment may last a maximum of 3 months. Consult a doctor if the symptoms do not go away after 2 weeks.
If you take more Colpermin than you should
Symptoms of overdose may include:
- severe gastrointestinal symptoms such as diarrhea, rectal ulcer, and nausea;
- epileptic seizures, loss of consciousness, difficulty breathing;
- heart rhythm disorders;
- difficulty coordinating muscle movements and other symptoms from the central nervous system.
If you forget to take Colpermin
If you forget to take a dose on time, just take the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, 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 the medicine and see a doctor immediately
If you develop severe allergic reactions including anaphylactic shock (sudden severe allergic reaction with symptoms such as low blood pressure and difficulty breathing) requiring urgent medical attention, tremors or tremors, movement disorders with balance difficulties, slow heart rate, and red skin rash. The frequency with which these side effects occur is not known.
The following side effects have been reported with the approximate frequencies listed below:
Common (may affect up to 1 in 10 people):
Headache, heartburn, rectal problems, abnormal odor from the stool, dry mouth, stomach discomfort and vomiting, vomiting.
Uncommon ( may affect up to 1 in 100 people):
Hypersensitivity, itchy skin, stomach bleeding, blurred vision.
Has been reported (occurs in an unknown number of users):
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
5. How to store 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 outer carton and blister after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C. Store in the original package. Sensitive to 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. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is peppermint oil. A hard enteric capsule contains 187 mg (0.2 ml) of Mentha x Piperita L, petroleum (peppermint oil).
- Other ingredients are:
Capsule contents:
- White wax
- Refined peanut oil
- Gelatine
Capsule shell:
- Gelatine
- Indigo Carmine (E132)
- Titanium dioxide (E171)
- Methacrylic acid-methyl methacrylate copolymer
- Methacrylic acid-ethyl acrylate copolymer
- Triethyl citrate
- Glycerol monostearate 40‑55
- Macrogol
- Talc
What the medicine looks like and the contents of the pack
Two-tone opaque capsule with a light blue base and dark blue top separated by a blue ribbon. Capsule size 19.4 mm x 6.8 mm.
Colpermin enteric capsules are supplied in blister strips of ten capsules packaged in 30 enteric capsules per pack (3 blister strips).
Marketing Authorization Holder and Manufacturer
Tillotts Pharma GmbH
Warmbacher Strasse 80
79618 Rheinfelden
Germany
Local representative of the marketing authorization holder:
Tillotts Pharma AB
Gustavslundsvägen 135
167 51 Bromma
