Buscapidol 0,2Ml 24 Gastroresistant Soft Capsules

Buscopan is a herbal medicine that contains peppermint essential oil. It is used for the relief of discomfort and pain associated with mild spasms of the gastrointestinal tract and flatulence (bloating).

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Buscopan 0.2 ml gastro-resistant soft capsules 

Peppermint essential oil

 

1. What is Buscopan, capsules and what is it used for

Buscopan is a herbal medicine that contains peppermint essential oil. It is used for the relief of discomfort and pain associated with mild spasms of the gastrointestinal tract and flatulence (bloating).

 

Buscopan is indicated for adults and adolescents from 12 years of age (with a minimum weight of 40 kg).

 

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 you take Buscopan, capsules

Do not take Buscopan:

 

If you are allergic to peppermint oil, menthol or any of the other ingredients of this medicine (listed in section 6).

 

If you suffer from liver disease (liver disease), bile duct infection, decreased gastric acid production, gallbladder stones or other bile-related conditions.

 

If your body weight is less than 40 kg, for safety reasons.

 

Buscapidol should not be used in children under 12 years of age and adolescents weighing less than 40 kg for safety reasons.

Warnings and cautions

Talk to your doctor or pharmacist before taking Buscopan:

If you suffer from heartburn (heartburn) or hiatal hernia (a condition in which a portion of the stomach protrudes into the chest cavity), symptoms may sometimes worsen after taking Buscopan. In this case, treatment should be stopped.

 

The capsules should be swallowed whole (without breaking or chewing them), as the peppermint oil inside the capsules can cause irritation to the mouth and esophagus (the upper part of the digestive tract).

 

If abdominal pain without apparent persists cause or worsen, or occurs along with symptoms such as fever, yellowing of the skin and mucous membranes (jaundice), vomiting, changes in bowel regularity or blood in the stool, contact the doctor in immediate form .

 

Children and adolescents

Buscapidol should not be used in children under 12 years of age or in adolescents weighing less than 40 kg for safety reasons and due to lack of sufficient clinical information on use in this age group (see section 'Do not take Buscapidol').

 

Other medicines and Buscapidol

No interaction studies have been performed.

 

Tell your doctor or pharmacist if you are taking / using, have recently taken / used or might have to take / use any other medicine.

 

The use of other medications used to decrease gastric acidity, such as h3-antihistamines, proton pump inhibitors, or antacids should be avoided, as they can cause the capsule lining to dissolve prematurely and could lead to inconvenience. Therefore, this and other medications should be separated at least 2 hours before or after taking.

 

Taking Buscopan with food

If you eat food while taking this medicine, the contents of the capsule may be released prematurely. See also section 3: "How to take Buscopan".

 

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you might be pregnant or are planning to become pregnant, consult your doctor before using this medicine.

 

Pregnancy

Safety during pregnancy has not been established. In the absence of sufficient human data, it is not recommended to take Buscapidol during pregnancy.

 

Lactation

It has been shown with clinical data that eucalyptol (1,8-cineole), one of the components of peppermint oil, can be excreted in human milk. It is not recommended to take Buscopan while breastfeeding.

 

Fertility

It is not known whether peppermint oil has an effect on fertility.

 

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

 

Buscopan contains sodium

This medicine contains less than 1 mmol sodium (23 mg) for each individual dose, i.e. it contains practically no sodium.

3. How to take Buscopan, capsules

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

 

The recommended dose is:

One gastro-resistant capsule 3 times a day for Adults and adolescents weighing at least 40 kg.

 

Use in children and adolescents

Buscapidol should not be used in children under 12 years of age or in adolescents weighing less than 40 kg (see section 'Do not take Buscapidol').

 

Form of administration

The capsules should be taken orally without breaking or chewing. In addition, they should be taken 30 minutes before a meal with a sufficient amount of liquid.

 

Duration of use

Buscopan should be taken until symptoms subside, usually between one and two weeks.

 

 

Special population

There are no data available to indicate a dose recommendation in cases of renal function abnormalities.

 

If you take more Buscopan than you should

An overdose can cause

  • severe gastrointestinal symptoms, diarrhea, rectal ulcer, or nausea;
  • epileptic seizures, fainting or shortness of breath (apnea);
  • disturbances in the regularity of the heartbeat (heart rhythm);
  • lack of coordination or other central nervous system problems.

 

If you take more Buscapidol than you should, consult your doctor, who will decide what action should be taken.

 

If you forget to take Buscopan

Do not take a double dose to make up for a forgotten dose. Take the usual dose at the usual 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 everyone gets them.

             

The frequency of these effects is unknown (cannot be estimated from the available data):

- allergic reactions to menthol, such as: anaphylactic shock, abnormal slow heart rate (bradycardia), reddening of the skin (erythematous rash), tremors (muscle tremors), lack of coordination (ataxia) and headache;

- blurry vision;

- gastric acidity (heartburn) or burning in the perianal area;

- nausea and vomiting;

- smell of menthol in feces and urine;

- inflammation of the glans penis;

- pain when urinating (dysuria).

If any of these effects occur, stop treatment and consult your doctor immediately.

 

 

5. How to store Buscapidol, capsules

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

 

Store the blisters in the outer carton in order to protect from light.

 

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

Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines that you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unneeded medicine and containers. This way you will help to protect the environment.

6. Package contents and additional information

What Buscapidol contains

 

The active ingredient is peppermint essential oil.

 

Each gastro-resistant soft capsule contains 0.2 ml (= 181.6 mg) of:

Mentha x piperita L., aetheroleum (peppermint essential oil)

 

The other ingredients are:

 

Capsule shell:

Jelly

Glycerol

Purified water

Yellow iron oxide (E172)

Brilliant Blue FCF (E133)

Medium chain triglycerides

Sunflower lecithin

 

Covering:

Copolymer of methacrylic acid and ethyl acrylate (1: 1) 30% dispersion

Triethyl citrate

Glycerol Monostearate 40-55

Polysorbate 80

Sodium dodecyl sulfate

 

Leaflet Buscapidol 0.2Ml 24 Gastro-resistant Soft Capsules

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