Pikopil

Package leaflet: Information for the user

Pikopil, 7.5 mg, tablets
Sodium picosulfate
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet

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

1. What Pikopil is and what it is used for

Pikopil contains sodium picosulfate as the active substance. Pikopil belongs to a group of medicines called laxatives.
Pikopil works by stimulating intestinal 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 there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before taking Pikopil

When not to take Pikopil:

• if the patient is allergic to sodium picosulfate, other substances belonging to the group of triarylmethane 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 excessive amount of fluid from the body);
• if the intestine is blocked (intestinal obstruction);
• in case of serious abdominal disorders such as appendicitis;
• in case of acute inflammatory bowel disease;
• if there is severe abdominal pain accompanied by nausea or vomiting;
• if sudden, acute abdominal pain occurred shortly before taking the medicine;
• in case of a condition called intestinal obstruction, which occurs when the small intestine is blocked.

If any of the above situations apply to the patient, Pikopil must not be taken.
If in doubt, consult a doctor or pharmacist before taking Pikopil.

Warnings and precautions

If the patient takes Pikopil for a long time or in high doses, it may affect the amount of fluids and electrolytes in the body. This may especially lead to decreased potassium levels (hypokalaemia), loss of body fluids (dehydration), or diarrhoea.

Dizziness or fainting may occur during bowel movements or due to abdominal pain caused by constipation.

Pikopil must not be taken daily or for prolonged periods. If the patient notices the need to take this medicine every day, or if symptoms do not improve or recur frequently, consult a doctor to diagnose the underlying cause of constipation.

If any of the above situations apply to the patient (or if the patient is unsure), discuss this with a doctor or pharmacist before starting Pikopil.

Children and adolescents

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

Pikopil and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes also medicines available without prescription and herbal medicines.

Do this because Pikopil may affect the action of other medicines. Likewise, other medicines may affect the action of Pikopil.

Especially inform the doctor or pharmacist if the patient is taking any of the following medicines:

• prescription medicines that may affect body fluid levels, such as:
• diuretics (water pills) like bendroflumethiazide or furosemide,
• steroid medicines, such as prednisolone.
• certain medicines used for heart conditions (e.g. digoxin, digitoxin). Fluid and electrolyte imbalances in the body may increase the patient's sensitivity to these medicines.
• antibiotics (used to treat infections). Concomitant use of broad-spectrum antibiotics may reduce the effectiveness of Pikopil.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pikopil must not be used during pregnancy unless a doctor decides it is necessary.

Driving and operating machinery

Dizziness or fainting may occur, usually during bowel movements or due to abdominal pain associated with constipation. If the patient experiences such symptoms, caution should be exercised when driving or operating machinery.

Pikopil contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to take Pikopil

This medicine should always be taken according to the instructions provided by the doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
It is recommended to start treatment with the lowest dose. The dose may be increased up to the maximum recommended dose
in order to achieve regular bowel movements.
Do not exceed the maximum recommended daily dose of the medicine.
Adults
The usual initial dose is generally one 5 mg tablet per day (treatment should begin with a similar, less potent medicine).

• If the 5 mg dose is ineffective, it may be increased to 7.5 mg per day (equivalent to one 7.5 mg Pikopil tablet).

Use in children and adolescents
Before administering Pikopil to a child, consult a doctor or pharmacist.
Children aged 10 years and older
The usual initial dose is generally one 5 mg tablet per day (treatment should begin with a similar, less potent medicine). If the 5 mg dose is ineffective, it may be increased to 7.5 mg per day (equivalent to one 7.5 mg Pikopil tablet).
Children aged 4 to 10 years
Pikopil should not be used in children under 10 years of age.
If bowel movements return to normal, the dose may be reduced or treatment discontinued.
Administration instructions

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

As with other medicines that stimulate intestinal motility, Pikopil should not be taken for more than
three consecutive days.
If there is no improvement after 3 days, or if the patient feels worse, medical advice should be sought.
During treatment with this medicine, it is important to drink plenty of water throughout the day. This will help prevent dehydration.
Accidental overdose of Pikopil

If a patient has taken more medicine than recommended, seek immediate medical advice or go to the nearest hospital.
Bring the medicine packaging along. This will allow the doctor to identify which medicine has been taken.
In case of overdose, severe diarrhoea or intense abdominal cramps may occur.
Additionally, with significant fluid loss, disturbances in electrolyte concentrations in the body may develop (mainly low potassium levels). In cases of severe overdose, reduced blood flow to the intestinal mucosa has been reported.
Prolonged use of medicines that stimulate intestinal motility (laxatives) may lead to chronic diarrhoea, abdominal pain, decreased blood potassium levels, which in severe cases may cause muscle cramps or weakness, and fatigue (due to hypokalaemia), impaired kidney function due to increased production of the hormone aldosterone by the adrenal cortex (secondary hyperaldosteronism), 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 decreased potassium levels.
Missed dose of Pikopil
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Some adverse reactions may be serious. You must stop taking the medicine immediately
and contact your doctor or call an ambulance if any of the following symptoms occur:
hypersensitivity reactions including sudden fluid accumulation in the skin and mucous membranes
(e.g. in the throat or tongue), difficulty in breathing and/or itching and rash, or frequent allergic reactions
(angioedema).

The following adverse reactions may also occur after taking this medicine:

Very common adverse reactions (may occur in more than 1 in 10 people):

• diarrhoea;

Common adverse reactions (may occur in less than 1 in 10 people):

• abdominal cramps;
• abdominal pain;
• discomfort in the upper part of the abdomen;

Rare adverse reactions (may occur in less than 1 in 100 people):

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

*Dizziness and fainting may occur especially during defecation or abdominal pain caused by constipation.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C, 02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Pikopil

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following: EXP. The expiry date refers to the last day of the specified month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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: monohydrate lactose, corn starch, pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate.

What Pikopil looks like and contents of the pack
Pikopil tablets are white or almost white, round, with bevelled edges and a score line.
Pikopil is packed in clear PVC/Aluminum blisters.
The medicine is available in packs containing 10 or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
Importer
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Pikopil

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 it
occurs in a given individual, it is best if they are regular.

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

Often, the causes of constipation are unknown. It may be caused by:

• A sudden change in diet;
• A diet low in fiber;
• Loss of intestinal muscle tone in elderly people;
• Pregnancy;
• Medications such as morphine or codeine;
• Prolonged bed rest;
• Lack of physical exercise.

Regardless of the cause, constipation causes discomfort. The patient may feel bloated and heavy
or generally unwell. Constipation can sometimes cause headaches.
The following health recommendations may help prevent constipation:

• Eat a varied diet, including fresh fruits and vegetables;
• Drink enough water to prevent dehydration;
• Perform physical exercises and maintain fitness;
• If the body signals an upcoming bowel movement, allow sufficient time for it.