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MINVOSO 5 MG TABLETS

Active substance(s): SODIUM PICOSULFATE

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The PL includes alternative texts for different legal status in different countries as follows:
-Boxed texts are only applicable for OTC versions.
-Grey-shaded texts are only applicable for prescription versions.
For OTC use in Sweden, please refer to the approved Swedish package leaflet published on
MPA’s web site.

PACKAGE LEAFLET: INFORMATION FOR THE USER
MINVOSO 5 mg tablets
MINVOSO 10 mg tablets
Sodium picosulfate
Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.

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.
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take MINVOSO
carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do not improve within five days.

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.

In this leaflet:
1. What MINVOSO is and what it is used for
2. Before you take MINVOSO
3. How to take MINVOSO
4. Possible side effects
5. How to store MINVOSO
6. Further information

1. WHAT MINVOSO IS AND WHAT IT IS USED FOR
MINVOSO contains a medicine called sodium picosulfate. This belongs to a group of
medicines called laxatives.
MINVOSO is used for short term relief of constipation. It is used in adults and children aged
from 10 years old.

RMS (SE) will nationally change the age limit to 12 years in the OTC leaflet.

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

2. BEFORE YOU TAKE MINVOSO
Do not take MINVOSO

if you are allergic (hypersensitive) to sodium picosulfate or any of the other ingredients of
MINVOSO (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 MINVOSO if any of the above applies to you. If you are not sure, talk to your
doctor or pharmacist before taking MINVOSO.
Take special care with MINVOSO
• 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 MINVOSO.
If you take MINVOSO 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 MINVOSO can affect the way some other medicines work. Also some other
medicines can affect the way MINVOSO 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 MINVOSO.
If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist
before taking MINVOSO.


Pregnancy and breast-feeding
You should not use MINVOSO 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
MINVOSO will not affect you being able to drive or use any tools or machines.

3. HOW TO TAKE MINVOSO
Always take MINVOSO 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 MINVOSO 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 MINVOSO.
 Do not give MINVOSO to children under 10 years old. This is because it is not known if
it is safe to use MINVOSO in children under 10 years old.
If you take more MINVOSO 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 MINVOSO
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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, MINVOSO 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 MINVOSO 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.

5. HOW TO STORE MINVOSO
Keep out of the reach and sight of children.
Do not take MINVOSO 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.

6. FURTHER INFORMATION
What MINVOSO contains

The active substance is sodium picosulfate. Each MINVOSO 5 mg tablet contains 5 mg
sodium picosulfate. Each MINVOSO 10 mg tablet contains 10 mg sodium picosulfate.

The other ingredients are microcrystalline cellulose, maize starch, colloidal anhydrous
silica and magnesium stearate.
What MINVOSO looks like and contents of the pack

MINVOSO tablets are white to off-white and round. They are 6 mm in diameter and
debossed with the number 5 or 10.

MINVOSO is available in packs which contain 2 or 10 tablets. However, not all pack
sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
PL03194/0110 (5mg)
PL03194/0111 (10mg)
Ferring GmbH
Wittland 11, D-24109 Kiel, Germany.

This medicinal product is authorised in the Member States of the EEA under the
following names:
Austria, Sweden:
MINVOSO
Belgium, Luxembourg, Netherlands:
Pico-Salax
Bulgaria, Cyprus, Estonia, Germany, Greece, Hungary, Latvia,
Lithuania, Malta, Slovakia:
PICO-SALAX
Denmark, Finland, France, Iceland, Norway, Romania,
Spain:
MINVOSO
Czech Republic:
ANTOCILE
Portugal:
LAXIFER
Ireland, Italy, United Kingdom:
MINVOSO
This leaflet was last revised on 27 July 2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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