FORTEX ELAXA PICO / 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, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 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 exerts its therapeutic effect on the large intestine, ELAXA pico specifically stimulates the natural process of emptying the lower 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:
- use in patients with constipation (difficulty defecating);
- preparation for diagnostic procedures, before and after surgical treatment and in conditions where facilitating defecation is required.
- 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 any of the other ingredients of this medicine (listed in section 6);
- you have a bowel obstruction or intestinal obstruction;
- you have severe abdominal pain and/or are in a state 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 determine the cause of constipation, as prolonged use of high doses can lead to a disruption of water and electrolyte balance and a decrease in the level of potassium in the blood (hypokalemia).
There have been reports of dizziness and nausea in patients taking sodium picosulfate. These events may be related to constipation (contractions during bowel movements, abdominal pain), but not necessarily to the administration of sodium picosulfate itself.
Children and adolescents
ELAXA pico should not be used in children under the age of 4. 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 (water tablets) or steroids may increase the risk of electrolyte imbalance. Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides (a group of medicinal products used in heart failure and irregular heart rhythm, e.g. digoxin).
Concomitant administration with antibiotics (medicines to treat bacterial infections) may reduce the laxative effect of ELAXA pico.
Pregnancy, breastfeeding 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 informed that due to a reaction of the autonomic nervous system (e.g. abdominal spasm), they may experience dizziness or nausea. If patients experience abdominal spasm, 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 may 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 may 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 postoperative treatment and in conditions where defecation is required, the administration of ELAXA pico should be carried out under medical supervision.
Method of administration
ELAXA pico should be taken in the evening with enough water to induce defecation the next morning. The effect usually occurs after 6-12 hours.
If you take more ELAXA pico than you should
If you take more ELAXA pico than you should, 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 has been 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, low blood potassium, secondary hyperaldosteronism (increased production of the hormone aldosterone, which controls the levels of sodium and potassium in the blood) and kidney stones. Cases of renal tubular damage (a type of kidney disorder), metabolic alkalosis (a disorder of acid-base balance) and muscle weakness due to low blood potassium have been described 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 stop taking ELAXA pico
The medicinal product should be taken only when needed, and, if necessary, the intake may be discontinued.
If you have any further questions on 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;
- abdominal pain;
- stomach discomfort.
Uncommon (may affect up to 1 in 100 people):
- vomiting;
- nausea;
- dizziness.
Not known (frequency cannot be estimated from the available data ):
- skin reactions such as:
- rapid swelling of the skin or mucous membranes, which may cause difficulty in breathing (angioedema);
- drug rash (a rash or skin reaction caused by a medicine);
- rash;
- itching;
- fainting.
Dizziness and fainting occurring after taking sodium picosulfate may be due to constipation (pain during defecation, abdominal pain).
Reporting side effects
If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Bulgarian Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia, tel.: +359 2 8903417, website: www.bda.bg. By reporting side effects, you can help to obtain more information on 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 expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of product deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.- Package contents and additional information
What does ELAXA pico contain?
- The active substance is: sodium picosulfate monohydrate 5.19 mg, equivalent to 5 mg sodium picosulfate.
- Excipients are: lactose, corn starch, pregelatinized corn starch, magnesium stearate, colloidal anhydrous silica.
What ELAXA pico looks like and what the pack contains
ELAXA pico is a white to off-white, round, biconvex tablet.
Each pack contains 20 tablets (2 blisters of 10 tablets each) and a patient information leaflet.
Marketing Authorisation Holder and Manufacturer
Fortex Nutraceuticals Ltd.,
10 Prohladen Kat Street,
1362 Sofia, BulgariaDate the leaflet was last revised
March 2019
