FORTEX ELAXA PICO 5mg x 20 tabl
Read all of this leaflet carefully before you start taking 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 you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
- If you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
- What is ELAXA pico and what is it used for
- What you need to know before you take ELAXA pico
- How to take ELAXA pico
- Possible side effects
- How to store ELAXA pico
- Package contents and additional information
- What is ELAXA pico and what is it used for
ELAXA pico is a locally acting laxative that stimulates intestinal peristalsis and softens stools.
As a laxative that exhibits its therapeutic effect on the large intestine, ELAXA pico stimulates in a specific way the natural process of emptying the lower part of the gastrointestinal tract. Therefore, ELAXA pico does not affect digestion, nor does it lead to the accumulation of calories or other nutrients in the small intestine.
ELAXA pico is used for:
- application in patients with constipation (difficult defecation);
- preparation for diagnostic procedures, pre- and post-operative treatment and for conditions requiring bowel facilitation.
- What you need to know before you take ELAXA pico
Do not take ELAXA pico if :
- you are allergic to the active substance (sodium picosulfate) or to any of the other ingredients of this medicine (listed in point 6);
- you have a bowel obstruction or bowel obstruction;
- you have severe abdominal pain and/or are in conditions of acute abdominal pain accompanied by fever (e.g. appendicitis), potentially associated with nausea and vomiting;
- you have acute inflammatory bowel disease;
- you are severely dehydrated.
Warnings and precautions
Talk to your doctor or pharmacist before taking ELAXA pico:
- if you need laxatives every day or for a long period of time - you should contact your doctor to find out the cause of the constipation, since the long-term use of high doses can lead to a violation of the water and electrolyte balance and a decrease in the level of potassium in the blood (hypokalaemia).
There have been reports of dizziness and malaise in patients who have taken sodium picosulfate. These events may be related to constipation (faecal contractions, abdominal pain), but not necessarily to the administration of sodium picosulfate itself.
Children and adolescents
ELAXA pico should not be used in children under 4 years of age. In older children, laxatives should only be used after consulting a doctor.
Other medicines and ELAXA pico
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
When taking high doses of ELAXA pico, the simultaneous use of diuretics (drainage agents) or steroids may increase the risk of electrolyte imbalance. Electrolyte imbalance can lead to increased sensitivity to cardiac glycosides (a group of drugs used in heart failure and irregular heart rhythm, eg digoxin).
Simultaneous administration with antibiotics (medicines to treat bacterial infections) may reduce the laxative effect of ELAXA pico.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
No studies have been conducted on the effect of ELAXA pico on the ability to drive and use machines. However, patients should be advised that due to an autonomic nervous system reaction (eg, abdominal cramping), they may experience dizziness or nausea. If patients experience abdominal cramping, they should avoid potentially hazardous activities such as driving and operating machinery.
ELAXA pico contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
- How to take ELAXA pico
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Adults: 1-2 tablets (5-10 mg sodium picosulfate) daily. Start with 1 tablet. The dose can be increased to a maximum of 2 tablets. Do not exceed the maximum daily dose of 2 tablets.
Use in children and adolescents
Children over 10 years : 1-2 tablets (5-10 mg sodium picosulfate) daily. Start with 1 tablet. The dose can be increased to a maximum of 2 tablets. Do not exceed the maximum daily dose of 2 tablets.
Children aged 4 to 10 years : 1 tablet (5 mg sodium picosulfate) daily.
Use in preparation for diagnostic procedures and before surgery
In preparation for diagnostic procedures, in pre- and post-operative treatment and in conditions that require the facilitation of defecation, the application of ELAXA pico should be carried out under medical supervision.
Application method
ELAXA pico should be taken in the evening with enough water to cause a bowel movement the next morning. The effect usually occurs after 6-12 hours.
If you have taken more than the required dose of ELAXA pico
If you take more than the required dose of ELAXA pico, you should seek advice from your doctor or pharmacist.
If high doses are taken, watery stools (diarrhea), abdominal cramps and loss of fluids, potassium and other electrolytes may occur.
In addition, cases of damage to the inner lining of the colon have been reported when the medicinal product was taken in doses significantly higher than those recommended for the treatment of constipation.
Chronic overdose with ELAXA pico, as with all laxatives, can cause chronic diarrhea, abdominal pain, decreased potassium in the blood, secondary hyperaldosteronism (increased production of the hormone aldosterone, which controls sodium and potassium levels in the blood), and kidney stones. disease. Cases of renal tubule damage (a type of kidney failure), metabolic alkalosis (acid-base imbalance) and muscle weakness due to low blood potassium have been reported as a result of chronic laxative abuse.If you forget to take ELAXA pico
Do not take a double dose to make up for a missed tablet.
If you have stopped taking ELAXA pico
The medicinal product should be taken only as needed, and if necessary, the intake can be discontinued.
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.- Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):
- diarrhea.
Common (may affect up to 1 in 10 people):
- abdominal cramps;
- stomach ache;
- stomach discomfort.
Uncommon (may affect up to 1 in 100 people):
- vomiting;
- nausea;
- dizziness.
With an unknown frequency (an estimate cannot be made from the available data ):
- skin reactions such as:
- rapid swelling of the skin or mucous membrane, which may cause difficulty in breathing (angioedema);
- drug rash (a rash or skin reaction caused by a drug);
- rash;
- itching;
- seizure.
Dizziness and fainting occurring after taking sodium picosulfate may be due to constipation (pain during defecation, abdominal pain).
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the Executive Medicines Agency, 8 Damyan Gruev St., 1303 Sofia, phone: +359 2 8903417, website: www.bda.bg. By reporting side effects, you can contribute to getting more information about the safety of this medicine.
- How to store ELAXA pico
No special storage conditions.
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiration date corresponds to the last day of the specified month.
Do not use this medicine if you notice visible signs of product deterioration.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.- Package contents and additional information
What ELAXA pico contains
- The active substance is: sodium picosulfate monohydrate 5.19 mg, equivalent to 5 mg of sodium picosulfate.
- Excipients are: lactose, corn starch, pregelatinized corn starch, magnesium stearate, colloidal anhydrous silica.
What ELAXA pico looks like and what it contains
ELAXA pico is white to off-white, round, biconvex tablets.
Each pack contains 20 tablets (2 blisters of 10 tablets each) and a patient leaflet.
Marketing Authorization Holder and Manufacturer
Fortex Nutraceuticals Ltd.,
10 Prohladen kat St.,
1362 Sofia, BulgariaDate of last revision of leaflet
March 2019
