iMedi.co.uk

Normax 50mg/60mg Capsules

Informations for option: Normax 50mg/60mg Capsules, show other option
Document: leaflet MAH BRAND_PL 27827-0008 change

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)

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.

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.

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

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