Tempocol Will Pharma
Gastro resistant capsules NL/H/2376/001/DC
Module 1.3.1 PIL
Package Leaflet: Information for the User
Tempocol
Gastro-resistant soft capsules
Peppermint Oil
Read all of this leaflet carefully before you start using 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 to you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
You must talk to a doctor if you do not feel better or if you feel worse
within 14 days.
What is in this leaflet
1. What Tempocol, capsules is and what it is used for
2. What you need to know before you take Tempocol, capsules
3. How to take Tempocol, capsules
4. Possible side-effects
5. How to store Tempocol, capsules
6. Contents of the pack and other information
1. What Tempocol, capsules is and what it is used for
Tempocol, capsules is a Herbal Medicinal Product which is used to relieve the
symptoms of minor spasms (light cramps) of the gastrointestinal tract,
flatulence and abdominal pain.
You must talk to a doctor if you do not feel better or if you feel worse within 14
days.
2. What you need to know before you take Tempocol, capsules
Do not take Tempocol, capsules:
- if you are allergic to peppermint oil or menthol or any of the other
ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before taking Tempocol, capsules
- if you already suffer from heartburn (acid ingestion) or hiatal hernia
(protrusion of the upper part of the stomach) symptoms sometimes worsen
after taking Tempocol, capsules. You must stop using Tempocol, capsules
in these cases.
- The use of Tempocol, capsules is not recommended in children under 8
years of age, as there is no sufficient experience available.
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Tempocol Will Pharma
Gastro resistant capsules NL/H/2376/001/DC
Module 1.3.1 PIL
- The capsules should be swallowed whole, i.e. not broken or chewed,
because this would release the peppermint oil prematurely possibly
causing local irritation of the mouth and gullet (oesophagus).
- If you suffer from liver disease
- If you have inflammation of the bile duct (cholangitis),
- If you suffer from a low production of gastric acid in the
stomach(achlorhydria)
- If you suffer from gallstones and any other biliary disorders.
Other medicines and Tempocol, capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including medicines obtained without a prescription.
Other medicinal products used to decrease stomach acid, like histamine-2
blockers and proton pump inhibitors or antacids may cause premature
dissolution of the enteric coating and should be avoided.
Tempocol, capsules with food, drink and alcohol
Use of food or antacids (medication to neutralize stomach acidity) administered
at the same time could cause early release of capsule content.
Pregnancy, breast-feeding and fertility
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.
Studies in animals have shown no effects disturbing the growth and
development of an embryo or fetus (teratogenic effects) for Menthol
It is unknown if peppermint constituents are excreted in human breast milk. In
the absence of sufficient data, you should not take Tempocol, capsules during
pregnancy and lactation.
It is unknown if peppermint oil affects fertility.
Driving and using machines
No data on the effects on the ability to drive and use machines are available.
Make sure you know how it affects you before you drive. If affected do not
drive.
3. How to take Tempocol, capsules
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adolescents over 12 years of age, adults and the elderly
The starting dose is 1 capsule taken 1-3 times daily. The dosage may be
increased as necessary up to a maximum dose of 2 capsules 3 times daily.
Children between 8 to 12 years of age
1 capsule up to three times daily
Not for use in children under 8 years of age
Special groups of patients:
There is no information available regarding a dosing recommendation for
patients with reduced kidney or liver function.
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Tempocol Will Pharma
Gastro resistant capsules NL/H/2376/001/DC
Module 1.3.1 PIL
The capsules should be swallowed whole, i.e. not broken or chewed,
Do not exceed the stated dose
The capsule(s) must be taken on an empty stomach before meals with a
sufficient amount of cold liquid (preferably a glass of cold water).
Duration of treatment
The gastro-resistant capsules should be taken until symptoms (signs of illness)
resolve, usually within two or four weeks. At times when the symptoms are
more persistent, the intake of gastro-resistant capsules can be continued for
periods of no longer than 3 months per course. Inform your doctor if symptoms
persist.
If you take more Tempocol, capsules than you should
If you take more than the recommended dose speak to a doctor, pharmacist or
healthcare practitioner and take this leaflet with you.
Overdose may cause:
severe symptoms in stomach and small and large intestine,
diarrhoea, injuries of the rectum nausea (wamble),
epileptic convulsions, loss of consciousness, apnoea (cessation of
breathing),
disturbances in rhythms of heartbeat,
lack of coordination of muscle movement and other problems with
the nervous system
In the event of overdose, the stomach should be emptied by astic lavage.
Observation should be carried out with symptomatic treatment, if necessary.
If you forget to take Tempocol, capsules
Continue to take your usual dose at the usual time, it does not matter if you
have missed a dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Tempocol, capsules
The use of this product can be stopped at any time.
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.
The following adverse reactions were reported:
- Urine and stools with an odour of menthol were observed. The frequency is
not known.
- Painful urination (dysuria) and inflammation of the glans of the penis have
been reported. The frequency is not known.
- Allergic reactions to menthol were reported, with headache, too low heart
beat frequency (bradycardia), trembling (muscle tremor), lack of coordination of
muscle movement (ataxia), anaphylactic shock and red skin eruptions
(erythematous skin rash). The frequency is not known.
- Acid ingestion (heartburn), perianal burning, blurred vision, nausea (wamble)
and vomiting were reported. The frequency is not known.
Discontiue use if the side effects are troubling.
If you get any side effects, talk to your doctor or pharmacist. This includes any
side effects not listed in this leaflet.
Reporting of side effects
If you get 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 national reporting system listed in Appendix V*. By reporting
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Tempocol Will Pharma
Gastro resistant capsules NL/H/2376/001/DC
Module 1.3.1 PIL
side effects you can help provide more information on the safety of this medi-
cine.
5. How to store Tempocol, capsules
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
the blister pack. The expiry date refers to the last day of that month.
This product does not require any special storage conditions
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
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Tempocol Will Pharma
Gastro resistant capsules NL/H/2376/001/DC
Module 1.3.1 PIL
6. Content of the pack and other informations
What Tempocol, capsules contains
The active substance is peppermint oil.
Each gastro-resistant soft capsule contains 182 mg of peppermint oil
(Mentha piperita aetheroleum)
The other ingredients are:
Gelatin, Glycerol, Ethylcellulose, Sodiumalginate (E401), Medium-chain
triglycerides, Stearic acid, Oleic acid.
What Tempocol, capsules looks like and contents of the pack
Tempocol, capsules are oval shaped, transparent-opaque soft capsule
containing a clear liquid.
Each pack contains 10, 15, 30, 60, 90 or 120 capsules
Marketing Authorisation Holder and Manufacturer
To be completed nationally
Manufacturer of the finished product and batch release site:
C.P.M. Contract Pharma GmbH & Co KG
Frühlingstr. 7
D-86320 Feldkirchen-Westerham
Germany
Wievelhove GmbH
Dörnebrink 19
D-49479 Ibbenbüren
Germany
Telephone: +49 5451 9401 0
Telefax: +49 5451 9401 90
This medicinal product is authorised in the Member States of the EEA
under the following names:
Belgium: Tempocol
Gastro-resistant soft capsule for oral use
…….
Luxemburg: Tempocol
Gastro-resistant soft capsule for oral use
…..
Netherlands: Tempocol
Gastro-resistant soft capsule for oral use
……
This leaflet was last revised …
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