Pico-Salax 10 mg tabletten

Pico-Salax contains a medicine called sodium picosulfate. This belongs to a group of medicines called laxatives.

Pico-Salax is used for short term relief of constipation. It is used in adults and children aged from 10 years old.

Pico-Salax works by stimulating your bowel movements. It also increases the amount of water in your bowel. Pico-Salax usually takes 6 to 12 hours to work.

• if you are allergic (hypersensitive) to sodium picosulfate or any of the other ingredients of Pico-Salax (listed in Section 6)
• if you have liver failure
• if you have severe dehydration
• if you have ulcers in your stomach or intestines
• if you have perforation of your stomach or intestines
• if you have a blocked bowel (intestinal obstruction)

• if you have a serious abdominal problem such as appendicitis
• if you have acute inflammatory bowel disease
• if you have severe abdominal pain which makes you feel or be sick
• if you have sudden, severe abdominal pain just before intake
• if you have bleeding from your back passage and the cause is not known
• if you have a bowel problem called “ileus” where your small intestine is blocked.

Do not take Pico-Salax if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Pico-Salax.

Take special care with Pico-Salax

• if you have heart problems
• if you have kidney problems
• if you have been diagnosed with inflammatory bowel disease
• if you have recently had an operation on your stomach or intestines
• if you are taking any medicine that may affect the amounts of fluids and salts in your body (see “Taking other medicines”)
• if you are taking regularly prescribed oral medication (see “Taking other medicines”).

If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Pico-Salax.

If you take Pico-Salax for a long time, it may affect the amounts of fluids and salts in your body. In particular, you may get low levels of potassium (hypokalaemia).

Long term use could weaken the motility of your colon (cathartic colon).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Pico-Salax can affect the way some other medicines work. Also some other medicines can affect the way Pico-Salax works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• prescribed medicine that may affect the amounts of fluids and salts in your body e.g.:
  • water tablets (diuretics) such as bendrofluazide or furosemide (frusemide)
  • steroid medicines such as prednisolone
  • lithium
  • NSAIDs
  • antidepressants
  • anti-psychotics
  • carbamazepine.
• prescribed oral medicine, especially if it is regularly prescribed as the effect may be modified e.g.:
  • antibiotics – used for infections
  • contraceptives

• • anti-epileptics
  • anti-diabetics.
• antibiotics – used for infections – may reduce the effect of Pico-Salax.

If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Pico-Salax.

Pregnancy and breast-feeding

You should not use Pico-Salax during pregnancy or breast-feeding unless your doctor decides it is necessary. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

Pico-Salax will not affect you being able to drive or use any tools or machines.

Always take Pico-Salax exactly as described in this leaflet or as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Do not take Pico-Salax every day for more than five days. See your doctor:

• if you need laxatives every day for more than five days
• if you have abdominal pain which does not go away.

Taking this medicine

• Swallow the tablet whole with a drink of water at bedtime.
• While you are taking this medicine, drink plenty of water through the day. This is to stop you getting dehydrated.

How much to take

• The usual starting dose is one 5 mg tablet a day.
• Your dose can be increased to 10 mg a day if 5 mg is not effective.
• When your bowel movements have returned to normal, the dose can be lowered or stopped.

Use in children

• Ask your doctor or pharmacist for advice before giving them Pico-Salax.
• Do not give Pico-Salax to children under 10 years old. This is because it is not known if it is safe to use Pico-Salax in children under 10 years old.

If you take more Pico-Salax than you should

If you take more of this medicine than you should, talk to your doctor or contact a hospital immediately. Take the medicine pack with you. This is so the doctor knows what you have taken. You may experience excessive diarrhoea or severe abdominal cramps.

Drink plenty of water so that you do not get dehydrated.

If you forget to take Pico-Salax

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Pico-Salax can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Rare (affects less than 1 in 1000 people):

• Allergic reactions - If you have an allergic reaction, stop taking this medicine and see a doctor immediately. The signs may include:
  • Rash
  • Swelling of your skin, mouth and face
  • Swallowing or breathing problems.

Stop taking Pico-Salax and see a doctor immediately, if you notice any of the signs above.

Uncommon (affects less than 1 in 100 people):

•

•

Feeling sick (nausea) Being sick (vomiting).

Common (affects less than 1 in 10 people):

•

•

Diarrhoea

Discomfort, cramps or pain in your abdomen.

It is not known how often the following side effects happen:

•

•

•

•

Headache Feeling dizzy Wind (flatulence) Fainting.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not take Pico-Salax after the expiry date which is printed on the carton label and blister foil after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

• The active substance is sodium picosulfate. Each Pico-Salax 5 mg tablet contains 5 mg sodium picosulfate. Each Pico-Salax 10 mg tablet contains 10 mg sodium picosulfate.
• The other ingredients are microcrystalline cellulose, maize starch, colloidal anhydrous silica and magnesium stearate.

What Pico-Salax looks like and contents of the pack

• Pico-Salax tablets are white to off-white and round. They are 6 mm in diameter and debossed with the number 5 or 10.
• Pico-Salax is available in packs which contain 2 or 10 tablets. However, not all pack sizes may be marketed.

Marketing Authorisation Holder

Ferring B.V

Polarisavenue 130

2132 JX Hoofddorp

Manufacturer

Ferring GmbH

Wittland 11, D-24109 Kiel, Germany.

RVG nummer

Pico-Salax 5 mg tabletten, RVG 108032

Pico-Salax 10 mg tabletten, RVG 108033

This medicinal product is authorised in the Member States of the EEA under the

following names:
Austria, Sweden:	Picosalax
Belgium, Luxembourg, Netherlands:	Pico-Salax
Bulgaria, Cyprus, Estonia, Germany, Greece, Hungary, Latvia,
Lithuania, Malta, Slovakia:	PICO-SALAX
Denmark, Finland, France, Iceland, Norway, Romania,
Spain:	PICOSALAX

Czech Republic:	ANTOCILE
Portugal:	LAXIFER
Ireland, Italy, United Kingdom:	To be completed nationally
This leaflet was last revised in September 2011