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CO-DANTHRUSATE CAPSULES 50MG / 60MG CAPSULES

Active substance: DOCUSATE SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Normax 50mg/60mg Capsules
(Dantron/Docusate Sodium)

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. See section 4.
In this leaflet:
1. What Normax 50mg/60mg Capsules are and what they are used for
2. Before you take Normax 50mg/60mg Capsules
3. How to take Normax 50mg/60mg Capsules
4. Possible side effects
5. How to store Normax 50mg/60mg Capsules
6. Further information

1.
WHAT NORMAX 50mg/60mg CAPSULES ARE AND WHAT THEY
ARE USED FOR
Normax 50mg/60mg Capsules (also known as Co-danthrusate) are one of a group of
medicines called laxatives. Each capsule contains a stimulant laxative (dantron) and a
faecal softener (docusate sodium), which help to relieve constipation. Normax
50mg/60mg Capsules should only be used to relieve constipation in patients who are
seriously ill. Normax 50mg/60mg Capsules work by encouraging normal bowel
movements.

2.

BEFORE YOU TAKE NORMAX 50mg/60mg CAPSULES

Do not take Normax 50mg/60mg Capsules
- if you are allergic (hypersensitive) to dantron, docusate sodium or any of the other
ingredients of Normax 50mg/60mg Capsules
- if you are pregnant
- if there is a chance you might become pregnant
- if you are breast-feeding
- if you have severe stomach pains or sickness that is not being treated
- if you have a blocked bowel (intestinal obstruction)
Talk to your doctor if any of the above apply to you.
Take special care with Normax 50mg/60mg Capsules
- if you do not have bladder control (if you are incontinent of urine)
- if you do not have bowel control (if you are incontinent of faeces)
1.3.1 Package Leaflet

If either of the above apply to you, it is important that you tell your doctor or
pharmacist before taking Normax 50mg/60mg Capsules and they will decide what to
do. It may still be safe for you to take Normax 50mg/60mg Capsules.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
medicines containing mineral oil or quinidine, as Normax 50mg/60mg Capsules may
intensify the effect of these medicines.
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Taking Normax 50mg/60mg Capsules with food and drink
Food and drink have no influence.
Pregnancy and breast-feeding
Normax 50mg/60mg Capsules should not be used during pregnancy or while breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine during
pregnancy or while breast-feeding.
Driving and using machines
Normax 50mg/60mg Capsules have no known influence on your ability to drive and
use machines.
Important information about some of the ingredients of Normax 50mg/60mg
Capsules
These capsules contain lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.
This medicinal product contains 9.48mg of sodium per capsule. To be taken into
consideration by patients on a controlled sodium diet.

3.

HOW TO TAKE NORMAX 50mg/60mg CAPSULES

Always take Normax 50mg/60mg Capsules exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
The usual dose for adults is one to three capsules at bedtime. Your doctor will advise
you of the dose you should take. The usual dose for children aged 6-12 years is one
capsule at bedtime. Normax 50mg/60mg Capsules are not recommended for use by
children under 6 years of age.
This product should be taken orally (by mouth). You must swallow the capsules
whole with a drink of water. The capsules must not be crushed or chewed. Normax
50mg/60mg Capsules normally begin to work 8 hours after the dose is taken.

1.3.1 Package Leaflet

If you take more Normax 50mg/60mg Capsules than you should
If you take too many capsules drink plenty of water and contact your nearest casualty
department or tell your doctor or pharmacist immediately. Take this leaflet and any
remaining capsules with you.
If you forget to take Normax 50mg/60mg Capsules
If you forget to take your Normax 50mg/60mg Capsule(s) one night, just take your
normal dose the next night. Do not take a double dose on the next night to make up
for a forgotten dose.
If you stop taking Normax 50mg/60mg Capsules
Your doctor will advise you when to stop taking Normax 50mg/60mg Capsules.
Follow your doctor’s instructions. The prolonged use of laxatives is not normally
recommended.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Normax 50mg/60mg Capsules can cause side effects, although not
everybody gets them.
The following side effects have been reported
- peeling of skin around the back passage (anus)
- skin rash
- skin irritation
- skin discolouration
- orange tint in the urine (this is due to the dantron in the capsules)
Research has shown that in animals, dantron can cause growths in the bowel and liver.
There may be a possible, but very small risk of this happening in humans if the
product is used for a long time. If you have any questions about this, please ask your
doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.

5.

HOW TO STORE NORMAX 50mg/60mg CAPSULES

Keep out of the reach and sight of children.

1.3.1 Package Leaflet

Do not use Normax 50mg/60mg Capsules after the expiry date which is stated on the
carton (or container) and blister foil. The expiry date refers to the last day of that
month.
Do not store your capsules above 25oC. Store in the original packaging to protect the
capsules from moisture.
Do not use Normax 50mg/60mg Capsules if you notice that the pack or any of the
capsules are damaged.
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 Normax 50mg/60mg Capsules contain
The active substances are dantron and docusate sodium. Each Normax 50mg/60mg
Capsule contains 50mg of dantron and 60mg of docusate sodium.
The powder in the capsule shells also contains other ingredients: lactose, sodium
benzoate, magnesium stearate, povidone and colloidal silicon dioxide. The capsule
shells are made of gelatin and contain black iron oxide (E172), red iron oxide (E172),
yellow iron oxide (E172) and titanium dioxide (E171) as colouring agents. The
printing ink on the capsule shells contains titanium dioxide (E171), shellac,
ammonium hydroxide, propylene glycol (E1520) and simeticone.
What Normax 50mg/60mg Capsules look like and the contents of the pack
Normax 50mg/60mg Capsules are hard gelatin capsules which have a brown cap and
a brown body, with ‘Normax’ overprinted in white ink on both the cap and the body.
Normax 50mg/60mg Capsules are available in
- blister packs containing 3 (professional sample pack), 21 or 63 capsules
- aluminium canisters containing 12, 30 or 250 capsules
- securitainers containing 30 or 250 capsules
Not all pack sizes may be marketed. (Delete this section as appropriate.)
Marketing Authorisation Holder
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
UK
Manufacturer
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon
1.3.1 Package Leaflet

BT63 5QD
UK
This leaflet was last revised in 04/2014.
The following date should be inserted below the in-house PX code on the mock-up:
“09/10/14”

1.3.1 Package Leaflet

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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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