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GUTTALAX GTT 7.5MG/ML 15ML

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-28
GUTTALAX-drug/medicine aproximate price on "GUTTALAX GTT 7.5MG/ML 15ML" in Riga city, Latvia is:
  • 4.53€  4.9$  3.89£  523Rub  52.1SEK  20PLN  17.93₪ 

GUTTALAX GTT 7.5MG/ML 15ML


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine  GUTTALAX GTT 7.5MG/ML 15ML     Recheck

Reģ. Nr.: 96-0168

ATC codeA06AB08 

Active substances: Natrii Picosulfas

 


Vendor, principal: Boehringer Ingelheim Intern. G
No prescription needed/Patient care products, dressings, gloves, medical devices,...

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GUTTALAX 7,5 mg/ml pilieni, 15 ml

 .

GUTTALAX 7.5MG/1ML 15ML

Package leaflet: Information for the user

GUTTALAX, 7.5 mg/mL oral drops, solution Sodium picosulfate

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, pharmacist or nurse have told 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

1.   What GUTTALAX is and what it is used for
2.   What you need to know before you take GUTTALAX
3.   How to take GUTTALAX
4.   Possible side effects
5.   How to store GUTTALAX
6.   Contents of the pack and other information

1. What GUTTALAX is and what it is used for

The active substance of GUTTALAX, sodium picosulphate is a locally effective laxative belonging to triarylmethane group, which after bacterial degradation in colon stimulates the large intestine mucosa causing more intensive peristalsis of colon.
As a laxative effective in colon, GUTTALAX specifically stimulates natural defecation process in the lower part of gastrointestinal tract. Thus GUTTALAX does not change digestion or the absorption of calories or important nutrients in the small intestine.
GUTTALAX is used for the treatment of constipation not correctable with diet.

2. What you need to know before you take GUTTALAX

Do not take GUTTALAX:

-   if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
-   if you have ileus or stenosis of intestine;
-   if you have acute disease of abdominal cavity accompanied by severe pain and/or fever (e.g. appendicitis) and with possible nausea and vomiting;
-   if you have acute inflammation of intestines;
-   if you have severe dehydration;
-   if you have hereditary fructose intolerance (see section “GUTTALAX contains sorbitol”).

Warnings and precautions

Talk to your doctor or pharmacist before taking GUTTALAX.
If you need laxatives every day or during longer periods, you have to visit your doctor for the
investigation of the cause of constipation, as prolonged excessive use of the medicine may
cause liquid and electrolyte balance disorder and low levels of potassium in blood (hypokalaemia).

Children and adolescents

GUTTALAX may be given to children under 10 years of age only with the doctor’s prescription.

Other medicines and GUTTALAX

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
When high doses of GUTTALAX are administered with diuretic medicines or adrenal cortex preparations (adrenocorticosteroids), the risk of electrolyte balance disorders increases. Electrolyte balance disorders may increase susceptibility to cardiac glucosides.
Simultaneous use with antibiotics (used for the treatment of certain bacterial infections) may reduce the laxative effect of GUTTALAX.

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 using this medicine.
Pregnancy
GUTTALAX, as all medicines, should be used during pregnancy only with doctor’s recommendation.
Breast-feeding
GUTTALAX can be used safely during breast-feeding.

Driving and using machines

No studies on the effect of the medicine on the ability to drive and use machines have been performed.
Nonetheless you may experience dizziness and/or fainting in association with constipation (e.g. as a result of abdominal spasm). Therefore, if you experience abdominal spasm, you should avoid potentially hazardous activities like driving and using machines.

GUTTALAX contains sorbitol

1 mL of drops contains 0.45 g of sorbitol, therefore the maximum recommended daily dose for adults and children over 10 years old contains 0.6 g of sorbitol. If you have been told by your doctor that you have intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take GUTTALAX

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Drops 7.5 mL/1 mL (= 15 drops)
Adults take 10-20 drops (5-10 mg) in the evening. Start with taking 10 drops. The dose may be adjusted to the maximum dose of 20 drops. Do not exceed the maximum daily dose of 20 drops.
Use in children and adolescents
Children over 10 years old take 10-20 drops (5-10 mg) in the evening. Start with taking 10 drops. The dose may be adjusted to the maximum dose of 20 drops. Do not exceed the maximum daily dose of 20 drops.
For children 4-10 years old the dose is 5-10 drops (2.5-5 mg) in the evening. Start with giving 5 drops. The dose may be adjusted to the maximum dose of 10 drops. Do not exceed the maximum daily dose of 10 drops.
For children 2-4 years old the recommended dose is 0.25 mg/kg of body weight, i.e. 1 drop per 2 kilograms of body weight in the evening.
Method of administration
GUTTALAX should be administered in the evening so that the emptying of the bowel would take place in the morning. The effect of the medicine becomes usually evident during 6-12 hours after administration.
If you have the impression that the effect of GUTTALAX is too strong or too weak, talk to your doctor or pharmacist.

If you take more GUTTALAX than you should

If you have taken more GUTTALAX than you should, contact your doctor or pharmacist. Symptoms
In case of high doses liquid faeces (diarrhoea), abdominal cramps and clinically significant loss of liquid, potassium and other electrolytes may occur.
Cases of oxygen lack (ischaemia) of colon mucosa have been observed which have been associated with administration of much higher GUTTALAX doses than recommended for the treatment of constipation.
Repeated overdose of GUTTALAX, like all other laxatives, may cause chronic diarrhoea, abdominal pain, potassium deficiency, secondary hypersecretion of aldosterone (adrenocortical hormone) and kidney stones. Also damage of renal tubule, metabolic alkalosis of tissues and muscle weakness due to potassium deficiency have been described with abuse of laxatives.
Treatment of overdose
After ingestion of excessive dose of GUTTALAX the absorption of the medicine may be reduced or avoided with inducing vomiting or performing gastric lavage. Replacement of fluid and correction of electrolyte balance disorder if required is especially important in children and elderly patients. Administration of smooth muscle relaxing agents may also help.

If you forget to take GUTTALAX

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Below are listed side effects that may be caused by the administration of GUTTALAX:
Very common (occurs in more than 1 patient out of 10):
diarrhoea.
Common (occurs in up to 1 patient out of 10): abdominal spasms, abdominal pain, abdominal discomfort.
Uncommon (occurs in up to 10patients out of 100):
vomiting, nausea, dizziness.
Not known (frequency cannot be estimated_from the available data):
skin reactions, including:
-   rapid swelling of skin or mucosal membranes that may cause respiratory obstruction (angioedema)
-   medicinal rash (skin rash or damage caused by the medicine)
-   skin rash
-   pruritus
Dizziness and fainting occurring after taking sodium picosulfate, are probably associated with constipation (effort during defecation, abdominal pain).

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 www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GUTTALAX

Keep this medicine out of the sight and reach of children.
Do not store above 30 °C.
After first opening of the bottle use within 12 months.
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.

6. Contents of the pack and other information What GUTTALAX contains

-   The active substance is sodium picosulfate. 1 mL (= 15 drops) contains 7.5 mg of sodium picosulfate.
-   The other excipients are: sodium bensoate; sorbitol solution (non-crystallizing); sodium citrate dihydrate; citric acid monohydrate; purified water.
What GUTTALAX looks like and contents of the pack Oral drops in 15 mL and 30 mL HDPE bottles.
Clear, colourless to yellowish or slightly yellowish-brown, slightly viscous solution.

Marketing Authorisation Holder

sanofi-aventis Estonia OÜ Pämu mnt. 139 E/2 11317 Tallinn Estonia

Manufacturer

Istituto de Angeli S.r.l
Localito Prulli 103/C - 50066 Regello (FI)
Italy
For any information about this medicine, please contact the the Marketing Authorisation Holder:
sanofi-aventis Estonia OÜ Pämu mnt. 139 E/2 11317 Tallinn Tel 627 3488

This leaflet was last revised in April 2017.

The following information is for healthcare professionals only:
Treatment of overdose
After the administration of oral forms of GUTTALAX the absorption can be minimised or avoided by inducing vomiting or performing gastric lavage. Replacement of fluids and correction of electrolyte balance disorder may be required. This is especially important in elderly and young patients.
Administration of spasmolytic agents may help.





  Instruction, annotation source for medicine: State Agency of Medicines, Estonia





• Medicaments images are for illustrative purposes only and may differ from the actual product.


[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health


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