Pikopil

Leaflet attached to the packaging: patient information

Pikopil, 7.5 mg/ml, oral drops, solution
Sodium picosulfate

You should carefully read the contents of the leaflet 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.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact 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 packaging 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 short-term relief of symptoms associated with chronic or recurrent constipation.
If after 3 days there is no improvement or you feel worse, you should 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., excessive loss of 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 symptoms do not improve, or frequently recur, consult your doctor to diagnose the cause of constipation.
If bowel movements do not increase after taking Pikopil, discontinue use of the medicine.
If the above situations apply to you (or if you are unsure), consult your doctor or pharmacist before starting Pikopil.

Children and adolescents

Before giving Pikopil to a child, consult a doctor or pharmacist. Pikopil is less effective in children under 4 years of age.

Pikopil and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those 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 the body, such as diuretics (e.g., bendroflumethiazide or furosemide), or steroid medicines (e.g., prednisolone).
• certain heart medicines (e.g., digoxin, digitoxin). Fluid and electrolyte disturbances may increase sensitivity to these medicines.
• antibiotics (used to treat infections). Concurrent use of broad-spectrum antibiotics 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.
Do not use Pikopil 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 cautious when driving or operating machinery.

Pikopil contains sorbitol

If you have been told that you have an intolerance to some sugars, consult 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.

Dosage for adults

The recommended dose is 8 to 12 drops at a time.
You can take fewer or more drops of the medicine to determine the optimal dose.

Use in children and adolescents

Before giving Pikopil to a child, consult a doctor or pharmacist. Pikopil is less effective in children under 4 years of age.
The recommended daily dose for children is:

• Children over 6 years: 8 to 12 drops at a time;
• Children from 4 to 6 years: 6 drops at a time.

Method of administration

• To administer the oral solution, count the number of drops onto a spoon;
• Holding the bottle upside down with the dropper vertical, gently squeeze the bottle;
• The drop rate should not exceed 2 drops per second;
• If a drop contains an air bubble, do not count it and add another drop.

Pikopil should be taken in the evening, before bedtime, with or without a drink. The action of the medicine usually occurs after about 6 to 12 hours, so sleep will not be disturbed.
While taking this medicine, drink plenty of water during the day to prevent dehydration.

Duration of treatment

Do not take Pikopil for more than 3 consecutive days. If after 3 days there is no improvement or you feel worse, consult your doctor.

Taking more than the recommended dose of Pikopil

If you have taken more medicine than you should, contact your doctor or go to the nearest hospital immediately. Take the medicine packaging with you. This will help your doctor know what medicine you have taken. Drink plenty of water.
In this case, very severe diarrhea or severe abdominal cramps may occur. Additionally, in case of significant fluid loss, there may be disturbances in electrolyte levels in the body (mainly low potassium levels). In cases of severe overdose, there have been reports of reduced blood flow to the intestinal mucosa.
Laxatives can cause chronic diarrhea, abdominal pain, decreased potassium levels in the blood, which in severe cases can cause muscle cramps or weakness, fatigue, impaired kidney function, and kidney stone formation.

Missing a dose of Pikopil

Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult 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. You should stop taking the medicine immediately and contact your doctor or call an emergency numberif you experience any of the following symptoms:

• Allergic reaction. Symptoms may include itching, rash, swelling of the lips, mouth, tongue, throat, or difficulty breathing.

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 any possible side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +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.
Reporting side effects will help gather 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 label and carton after: Expiry date (EXP). The expiry date refers to the last day of the month.
There are no special precautions for storage.
Shelf life after first opening the container: 12 months.
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 packaging and other information

What Pikopil contains

• The active substance is sodium picosulfate. 1 ml contains sodium picosulfate equivalent to 7.5 mg anhydrous sodium picosulfate (1 ml = 15 drops).
• The other ingredients are: sodium benzoate, sorbitol, citric acid monohydrate, sodium citrate, water for injections.

What Pikopil looks like and contents of the pack

Pikopil, 7.5 mg, oral drops, solution, is a colorless or yellowish solution.
Pikopil is packaged in white, opaque polyethylene containers with a dropper and green cap, secured with a tamper-evident ring, containing 15 ml or 30 ml oral drops in solution form.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder

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

Importer

Symphar Sp. z o.o.
ul. Chełmżyńska 249
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 sporadically. 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 unknown. 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 recommendations can help prevent constipation:

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