Elaxa pico

• Short description
• How to use

• CONTENT
  What ELAXA pico looks like and contents of the pack ELAXA pico are white to off white, round, biconvex tablets Each pack contains 2 or 3 blisters of 10 tablets each placed in a carton box with a patient leaflet. Not all pack sizes may be marketed.

  Method of use

  The recommended dose is: Adults: 1- 2 tablets (5-10 mg sodium picosulfate) a day. You start with one tablet a day. It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum 2 tablets. Do not exceed the maximum daily dose of 2 tablets. Use in children and adolescents: Children over 10 years of age: 1-2 tablets a day (5- 10 mg sodium picosulfate) a day. You start with one tablet a day. It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum 2 tablets. Do not exceed the maximum daily dose of 2 tablets. Children from 4 to less than 10 years of age: 1 tablet a day (5 mg sodium picosulfate) a day.

• General information
• Ingredients
• Video

• Package leaflet: Information for the patient

  ELAXA pico 5 mg tablets

  Sodium picosulfate

   

  Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  This medicine is available without prescription. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist 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 or pharmacist. 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 ELAXA pico is and what it is used for  

  2. What you need to know before you take ELAXA pico  

  3. How to take ELAXA pico

  4. Possible side effects  

  5. How to store ELAXA pico

  6. Contents of the pack and other information

   

  1. What ELAXA pico is and what it is used for

  ELAXA pico belongs to a group of laxatives containing sodium picosulfate and are used to relieve constipation (difficulty with bowel movements). It is a stimulant laxative, which induces a stool production and emptying the bowel.  

  ELAXA pico also acts locally, increases the amount of water in the bowel and softens stools. These effects do not harm the natural process of digestion and nutrients absorption. The use of ELAXA pico does not lead to accumulation of calories and nutrients in the small intestine.  

  ELAXA pico is used for:

  • use in patients with constipation (difficulty with bowel movements);

  • preparation of diagnostic procedures, preoperatively and postoperatively treatment and in situations where it is necessary to facilitate defecation.

   

  2. What you need to know before you take ELAXA pico

  Do not take ELAXA pico, if:

  • you are allergic to active substance sodium picosulfate or any of the other ingredients of this medicine (listed in section 6).
  • you have a blocked bowel (ileus) or intestinal obstruction;
  • you have severe abdominal pain, accompanied with high   temperature (for example appendicitis).
  • you have acute inflammatory bowel disease;
  • you have severe dehydration.

   

  Warnings and precautions  

  Talk to your doctor or pharmacist before taking ELAXA pico. If you need laxatives every day or for an extended period of time - you should contact your doctor to identify the cause of constipation as prolonged use of high doses may lead to a water and electrolyte balance and low levels of potassium (hypokalaemia).

  There are reports of dizziness and fainting in patients who have taken sodium picosulfate. These events may be associated with constipation (basal contraction, abdominal pain), but not necessarily with the use of sodium picosulfate itself.

   Children and adolescents  

  Do not give ELAXA pico to children under 4 years old. For older children, laxatives should only be used after consultation with 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, co-administration of diuretics (drainage agents) 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 for heart failure and impaired cardiac rhythm, eg digoxin).

  Concurrent administration of broad-spectrum antibiotics may reduce the effect of ELAXA pico.

  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.

  Driving and using machines

  Dizziness and fainting may occur, usually in conjunction with faeces or abdominal pain due to constipation (constipation). If you are affected by these reactions, use caution when you are driving a car or using machines.

   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.

   3. How to take ELAXA pico

   Always take use 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:

  Adults: 1- 2 tablets (5-10 mg sodium picosulfate) a day. You start with one tablet a day. It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum 2 tablets. Do not exceed the maximum daily dose of 2 tablets.

   Use in children and adolescents

  Children over 10 years of age: 1-2 tablets a day (5- 10 mg sodium picosulfate) a day. You start with one tablet a day. It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum 2 tablets. Do not exceed the maximum daily dose of 2 tablets.

  Children from 4 to less than 10 years of age: 1 tablet a day (5 mg sodium picosulfate) a day.

  For preparation of diagnostic procedures and preoperatively

  For preparation of diagnostic procedures, in pre- and postoperative treatment and in medical

  conditions which require defecation to be facilitated, ELAXA pico should be used under

  medical supervision.

   

  Method of administration

  ELLAXA pico should be taken in the evening with enough water to cause 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 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 fluid loss, potassium and other electrolytes may occur.

  In addition, cases of colorectal injury were reported when the medicinal product was taken at doses significantly higher than those recommended for the treatment of constipation.

  In severe overdoses, there are reported cases of reduced blood flow to the intestinal mucosa. Long term overuse of resources that promote bowel movements (laxatives) can cause chronic diarrhea, abdominal pain, too little potassium in the blood, which in severe form can be recognized by muscle spasms or muscle weakness and fatigue (hypokalemia), poor kidney function as a result of increased production of the hormone aldosterone by the adrenal cortex (secondary aldosteronism), and the formation of kidney stones. The following conditions are also described in association with chronic laxative abuse: damage of the kidneys, increasing acidity of the blood (metabolic alkalosis) and muscle weakness by a low potassium content.

   

  If you forget to take ELAXA pico

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

   

  If you stop taking ELAXA pico

  ELAXA pico should be taken only if it is necessary. In other cases using of the medicine should be stopped.

  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.

  A very common side effect (may affect more than 1 user in 10) can be:

  • diarrhea.

  Common side effects (may affect up to 1 in 10 users ):

  • abdominal cramping;

  • abdominal pain;

  • an uncomfortable feeling in the stomach.

  Uncommon side effects (may affect up to 1 in 100 users):

  • vomiting;

  • nausea;

  • dizziness.

  With unknown frequency (the available data cannot be evaluated):

  • skin reaction such as:

  - fast swelling of the skin or mucous membrane, which may cause breathing difficulties (angioedema);

  - drug rash (rash or skin reaction caused by a medicine);

  - rash;

  - itching;

  - fainting.

  Dizziness and fainting may occur, usually in conjunction with stools or abdominal pain due to constipation

   

  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

  BULGARIAN DRUG AGENCY

  8 Damyan Gruev Str., Sofia 1303, BULGARIA

  Phone: +359 2 890 3417;  

  Website: www.bda.bg

  By reporting side еffects you can help provide more information on the safety of this medicine.

   

   5. How to store ELAXA pico

  This medicinal product does not require any special storage conditions.  

  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 blister and the carton after “Exp”.  The expiry date refers to the last day of that month.

  Do not use this medicine if you notice the visible signs of deterioration.

  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 ELAXA pico contains  

  - The active substance in 1 tablet is sodium picosulfate monohydrate 5,19 mg equivalent to 5 mg sodium picosulfate.

  - The excipients are lactose, corn starch, pregelatinized maize starch, magnesium stearate and colloidal anhydrous silica.  

   

  What ELAXA pico looks like and contents of the pack

  ELAXA pico are white to off white, round, biconvex tablets

  Each pack contains 2 or 3 blisters of 10 tablets each placed in a carton box with a patient leaflet.

  Not all pack sizes may be marketed.

   

  Marketing Authorisation Holder and manufacturer

  Fortex Nutraceutical Ltd.

  10, Prohladen kat str.,  

  Sofia 1362, Bulgaria

   

  Date of last revision of the leaflet

  April 2024

   

   

   

   

• What ELAXA pico contains  

  - The active substance is sodium picosulfate monohydrate 5,19 mg equivalent to 5 mg sodium picosulfate.

  - The excipients are lactose, corn starch, pregelatinized maize starch, magnesium stearate, colloidal anhydrous silica.  

   

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