Pikopil

Leaflet accompanying the packaging: patient information

Pikopil, 7.5 mg, tablets

Sodium picosulfate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult your doctor.

Table of contents of the leaflet

• 1. What is Pikopil and what is it used for
• 2. Important information before taking Pikopil
• 3. How to take Pikopil
• 4. Possible side effects
• 5. How to store Pikopil
• 6. Contents of the pack and other information

1. What is Pikopil and what is it used for

Pikopil contains sodium picosulfate as the active substance. Pikopil belongs to the group of laxative medicines.
Pikopil works by stimulating bowel movements. The medicine also increases the amount of water in the intestines.
Pikopil is used for the short-term relief of symptoms associated with chronic or recurrent constipation in adults and children over 10 years of age.
If after 3 days there is no improvement or you feel worse, consult your doctor.

2. Important information before taking Pikopil

When not to take Pikopil:

• if you are allergic to sodium picosulfate, other triaryl methane derivatives (e.g. bisacodyl) or any of the other ingredients of this medicine (listed in section 6);
• in case of severe dehydration (i.e. loss of too much water from the body);
• if the intestine is blocked (intestinal obstruction);
• in case of serious abdominal disorders such as appendicitis;
• if you have acute inflammatory bowel disease;
• if you have severe abdominal pain that causes nausea or vomiting;
• if you have sudden, severe abdominal pain before taking the medicine;
• in case of a problem called intestinal obstruction, which occurs when the small intestine is blocked.

If any of the above conditions apply to you, do not take Pikopil.
In case of doubt, consult your doctor or pharmacist before taking Pikopil.

Warnings and precautions

If you take Pikopil for a long time or in high doses, it may affect the amount of fluids and electrolytes in your body. This may cause a decrease in potassium levels (hypokalemia), dehydration, or diarrhea.
Dizziness or fainting may occur during bowel movements or due to abdominal pain caused by constipation.
Pikopil should not be taken daily or for a long time. If you notice that you need to take this medicine every day or if your symptoms do not improve, or come back frequently, consult your doctor to diagnose the cause of constipation.
If the above situations apply to you (or if you are not sure), consult your doctor or pharmacist before taking Pikopil.

Children and adolescents

Before giving Pikopil to a child, consult your doctor or pharmacist.
Pikopil should not be used in children under 10 years of age.

Pikopil and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or recently, and about medicines you plan to take. This includes medicines obtained without a prescription and herbal medicines.
This is because Pikopil may affect the action of other medicines. Similarly, other medicines may affect the action of Pikopil.
Particularly, tell your doctor or pharmacist if you are taking any of the following medicines:

• prescription medicines that may affect fluid levels in your body, such as:
• diuretic tablets (e.g. bendroflumethiazide or furosemide),
• corticosteroids (e.g. prednisolone).
• certain heart medicines (e.g. digoxin, digitoxin). Fluid and electrolyte disturbances in your body may increase your sensitivity to these medicines.
• antibiotics (used to treat infections). Taking broad-spectrum antibiotics at the same time may reduce the effectiveness of Pikopil.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pikopil should not be used during pregnancy, unless your doctor decides it is necessary.

Driving and using machines

Dizziness or fainting may occur, usually during bowel movements or due to abdominal pain caused by constipation. If you experience these symptoms, be careful when driving or operating machinery.

Pikopil contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Pikopil

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
It is recommended to start with the lowest dose. To achieve regular bowel movements, the dose can be increased up to the maximum recommended dose.
Do not exceed the maximum recommended daily dose of Pikopil.
Adults
The recommended initial dose is usually one 5 mg tablet per day (treatment should be started with a similar medicine of lower strength).

• If the 5 mg dose is not effective, it can be increased to 7.5 mg per day (which corresponds to 1 tablet of Pikopil 7.5 mg).

Use in children and adolescents

Before giving Pikopil to a child, consult your doctor or pharmacist.
Children from 10 years of age
The usual initial dose is one 5 mg tablet per day (treatment should be started with a similar medicine of lower strength). If the 5 mg dose is not effective, it can be increased to 7.5 mg per day (which corresponds to 1 tablet of Pikopil 7.5 mg).
Children from 4 to 10 years of age
Pikopil should not be used in children under 10 years of age.
If bowel movements return to normal, the dose can be reduced or the medicine can be stopped.

Method of administration

• The tablet should be taken in the evening, before going to bed, with a glass of water.
• The tablet can be divided into equal doses.

As with other bowel-stimulating medicines, Pikopil should not be taken for more than three consecutive days.
If after 3 days there is no improvement or you feel worse, consult your doctor.
While taking this medicine, drink plenty of water during the day to prevent dehydration.

Taking more Pikopil than recommended

If you have taken more Pikopil than you should, contact your doctor or go to the nearest hospital immediately. Take the medicine pack with you. This will help your doctor know what medicine you have taken.
Overdose of Pikopil may cause very severe diarrhea or severe abdominal cramps.
Additionally, in case of significant fluid loss, electrolyte disturbances in the body may occur (mainly low potassium levels). In severe cases of overdose, decreased blood flow to the intestinal mucosa has been reported.
Long-term use of bowel-stimulating medicines (laxatives) may cause chronic diarrhea, abdominal pain, decreased potassium levels in the blood, which in severe cases may cause muscle cramps or weakness, fatigue (due to hypokalemia), impaired kidney function due to increased production of a hormone called aldosterone by the adrenal cortex (secondary aldosteronism), and kidney stone formation.
Due to chronic abuse of laxatives, the following conditions have been reported: kidney damage, increased blood alkalinity (metabolic alkalosis), and muscle weakness caused by low potassium levels.

Missing a dose of Pikopil

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pikopil can cause side effects, although not everybody gets them.
Some side effects may be serious. Stop taking the medicine and contact your doctor or call an emergency immediately if you experience any of the following symptoms:
allergic reactions, including sudden fluid accumulation in the skin and mucous membranes (e.g. in the throat or tongue), difficulty breathing and/or itching and rash, or frequent allergic reactions (angioedema).
After taking Pikopil, the following side effects may also occur:
Very common side effects (may affect more than 1 in 10 people):

• diarrhea;

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

• abdominal cramps;
• abdominal pain;
• unpleasant sensation in the upper abdomen;

Rare side effects (may affect up to 1 in 100 people):

• dizziness*;
• fainting*;
• vomiting;
• nausea;
• skin reactions.

*Dizziness and fainting may occur, especially during bowel movements or abdominal pain caused by constipation.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181 C, 02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pikopil

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: Expiry date (EXP). The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Pikopil contains

• The active substance is sodium picosulfate. Each Pikopil 7.5 mg tablet contains sodium picosulfate monohydrate, equivalent to 7.5 mg of anhydrous sodium picosulfate.
• The other ingredients are: lactose monohydrate, maize starch, maize starch paste, colloidal anhydrous silica, magnesium stearate.

What Pikopil looks like and contents of the pack

Pikopil tablets are white or almost white, round, with beveled edges and a dividing line.
Pikopil is packaged in colorless PVC/Aluminum blisters.
The medicine is available in packs of 10 or 30 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder

Farmak International Sp. z o.o.
Koszykowa 65 Street
00-667 Warsaw

Importer

Symphar Sp. z o.o.
Chełmżyńska 249 Street
04-458 Warsaw

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland:
Pikopil

Date of last revision of the leaflet: ------------------------------------------------------------------------------------------------------------------------------

General information for the user

What is constipation?

The concept of "normal and regular" bowel movements is individual for each person. In some people, bowel movements occur daily, while in others they are less frequent. Regardless of how this is for a given person, it is best if they are regular.

• In some people, constipation is a problem that occurs from time to time. In others, it may occur more frequently.
• Constipation occurs when the normal functioning of the intestinal muscles (large intestine) is slowed down. This can cause the intestinal contents not to be easily eliminated from the body.

Often, the causes of constipation are not known. It may be caused by:

• Sudden changes in diet;
• A diet with insufficient fiber;
• Loss of intestinal muscle tone in older people;
• Pregnancy;
• Medicines such as morphine or codeine;
• A long period of bed rest;
• Lack of physical exercise.

Regardless of the cause, constipation causes discomfort. You may feel bloated or heavy, or be in poor general condition. Constipation can sometimes cause headaches.
The following health tips can help prevent constipation:

• Eat a varied diet, including fresh fruits and vegetables;
• Drink plenty of water to prevent dehydration;
• Exercise regularly and stay fit;
• If your body signals an impending bowel movement, make time for it.