Toilax 5 mg enteric tablets Toilax 10 mg/5 ml rectal suspension and 5 mg
Toilax 10 mg/5 ml enteric tablets and rectal suspension
bisacodyl
What Toilax is and what it is used for
Toilax exerts its effect through local action on the wall of the large intestine. More intestinal fluid is retained in the intestine and the intestinal contents become looser and pass more quickly. Toilax rectal suspension is injected directly into the rectum and there softens and lubricates the stool. Toilax rectal suspension already works after 15-60 minutes. The effect of the Toilax enteric tablet comes after about 6-12 hours.
Toilax is used for temporary constipation and laxatives before X-ray examinations and before examinations in the rectum and colon.
Bisacodyl contained in Toilax may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
You must talk to a doctor if you do not feel better or if you feel worse after 7 days.
What you need to know before using Toilax
Do not use Toilax
- if you are allergic to bisacodyl or any of the other ingredients of this medicine (listed in section 6)
- if you have irritable bowel syndrome, intestinal obstruction, appendicitis, inflammatory bowel disease, or severe stomach pain with nausea and vomiting
- if you have severe dehydration.
Warnings and precautions
Talk to your doctor or pharmacist before using Toilax.
Long-term use can lead to disturbances in the salt balance in the blood, and reduced potassium content in the blood. If laxatives are used daily for more than a week, a doctor should be consulted.
If you are elderly and/or have reduced kidney function, you should stop treatment with Toilax and consult a doctor if there are signs of dehydration (such as increased thirst and decreased urine output).
Toilax is a motility-stimulating laxative. As it contains bowel-irritating ingredients, Toilax should only be used for temporary constipation. Used for a maximum of one week per treatment session. Not given to children under 10 without a doctor’s prescription.
Dizziness and fainting have been reported in connection with ingestion of Toilax. This has probably been due to straining when emptying the bowels or was an effect of abdominal pain.
The use of rectal suspension can cause local irritation, which is why the preparation should be used with caution in the case of rectal ulcers.
Toilax does not contribute to weight loss.
Ingestion of Toilax with food and drink
If milk products are taken at the same time as Toilax enteric tablet, the tablet’s protective coating can be damaged, which can lead to stomach upset. There should therefore be at least an hour between intake of milk products and Toilax enteric tablet.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. There is a lack of modern studies on pregnant women. Long experience has not shown any harmful or unwanted effects during pregnancy. During pregnancy, however, Toilax, like all medicines, should only be taken on medical advice.
Bisacodyl does not pass into breast milk. Therefore, Toilax is safe to use during breastfeeding.
Driving ability and use of machinery
Dizziness and fainting may occur when using Toilax, most likely due to a reflex that may occur during stomach pain or bowel movements. If you suffer from stomach pain, you should therefore be careful when driving and operating machinery. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. The description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Important information about any ingredient(s) in Toilax
Toilax contains lactose monohydrate
The enteric tablets contain lactose monohydrate. If you cannot tolerate certain sugars, you should contact your doctor before taking the Toilax enteric tablet.
How to use Toilax
Always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. Consult a doctor, pharmacist, or nurse if you are unsure.
Dosage for temporary constipation
Adults
Enteric tablets:
Adults: The recommended dose is 1-2 enteric tablets in the evening. Start with the lower amount and increase if necessary to two enteric tablets per day.
Rectal suspension:
Adults: 1 tube per day.
Children
Children under the age of 10 should not use Toilax except on a doctor’s recommendation. Children under 2 years of age should not be treated with Toilax.
Enteric tablets:
Children over 10 years: The recommended dose is 1-2 enteric tablets in the evening. Start with the longer amount and increase if necessary to two enteric tablets per day.
Children 2-10 years: The recommended dose is 1 enteric tablet in the evening.
Rectal suspension:
Children over 10 years: The recommended dose is 1 tube per day.
Children 2-10 years: The recommended dose is ½ tube per day.
Do not exceed the recommended dose.
Use Toilax for a maximum of one week per treatment session.
Bowel emptying in connection with medical examinations or surgery
Normal dosage (follow this unless you have received other instructions from the clinic)
Adults: 2 enteric tablets in the morning and 2 enteric tablets the evening before the examination, followed by 1 tube on the morning of the examination day.
Children over 10 years: 2 enteric tablets in the morning and 2 enteric tablets the evening before the examination, followed by 1 tube of rectal suspension on the morning of the examination day.
Children 4-10 years: 1 enteric tablet until the evening before the examination followed by ½ tube of rectal suspension of 10 mg on the morning of the examination day.
Instructions for use
Toilax enteric tablets:
It is important that the enteric tablets are swallowed whole with liquid, but not milk because they are coated with a gastro-resistant coating so that they only work when they reach the large intestine. If the tablets are chewed, their properties deteriorate.
The effect is usually achieved after 6–12 hours.
Toilax rectal suspension:
The rectal suspension must be at room temperature before use.
- Twist off the wing on the tube tip.
- Lie down on your side.
- Insert the entire tip of the tube into the rectum. ATTENTION! For children between 2-3 years of age (only after a doctor’s prescription ), the tip of the tube must be inserted halfway and half the tube emptied.
- Squeeze out the contents of the tube.
- Pull out the tube still pinched. The effect is achieved after 15–60 minutes.
If you have used too much Toilax
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Toilax and contact your doctor immediately if you experience any of the following side effects (which may occur in an unknown number of users):
- Severe allergic reaction causing difficulty breathing or dizziness (anaphylactic shock ).
- Swelling of the face, tongue, or throat; difficulty swallowing; hives and breathing difficulties (angioedema).
Common (may affect up to 1 in 10 people ): stomach cramps, stomach pain, nausea, diarrhea.
Uncommon (may affect up to 1 in 100 users ): the rectal suspension may cause local irritation or inflammation of the rectum, gastrointestinal discomfort, vomiting, blood in the stool, and dizziness.
Rare (may affect up to 1 in 1,000 users ): mild transient skin rash, fainting, hypersensitivity.
Has been reported (occurring in an unknown number of users): inflammation of the colon (also with hypoxia in the colon), dehydration.
How Toilax should be stored
Enteric tablets: Store at a maximum of 25 C.
Rectal suspension: Store in a refrigerator.
Enteric tablet er + rectal suspension, combination pack: Store in the refrigerator.
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton after Expiration. dat.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is bisacodyl. 1 enteric tablet contains 5 mg bisacodyl. 1 tube of rectal suspension of 5 ml contains 10 mg bisacodyl.
- Other ingredients are:
1 enteric tablet contains lactose monohydrate, corn starch, Macrogol 6000, glycerol, gelatin, colloidal anhydrous silicon dioxide, magnesium stearate, hypromellose, propylene glycol, hypromellose phthalate, triethyl citrate, quinoline yellow (dye E104).
1 tube of rectal suspension of 5 ml contains Macrogol 400, Macrogol 3000, Macrogol 4000, citric acid monohydrate, anhydrous sodium citrate, and purified water.
Appearance and package sizes of the medicine
The enteric tablets are yellow, round, diameter approx. 6 mm.
The rectal suspension is viscous and gray.
Enteric tablets:
Pressed packs of 25 tablets.
Jar of 25 tablets.
Rectal suspension:
Packages of 1, 5, and 25 tubes.
Enteric tablet er + rectal suspension, combination pack:
Pressure packs of I. 4 enteric tablets + II. 1 tube of rectal suspension: 1 x (I+II).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orion Indie 1
FI-02200 Espoo
Finland
Manufacturer
Enteric tablets:
Orion Corporation Orion Pharma
Orion Indie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
Rectal suspension and combination pack:
Orion Corporation Orion Pharma
Volttikatu 8
FI-70700 Kuopio
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information about this medicine, contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com