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Dantrium® 25mg Capsules

(dantrolene sodium)

Patient Information Leaflet

This medicine is available using the above name but will be referred to as Dantrium throughout this leaflet. Please note that the leaflet also contains information about other strengths of the medicine, Dantrium 100mg Capsules.

In this leaflet:

1)    What Dantrium is and what it is used for

2)    Before you take Dantrium

3)    How to take Dantrium

4)    Possible side effects

5)    How to store Dantrium

6)    Further information

Dantrium Capsules contain the active substance dantrolene sodium - this is a muscle relaxant which is used to treat severe, long term muscle stiffness (spasticity) in adults.

2) BEFORE YOU TAKE DANTRIUM

DO NOT take Dantrium if you:

•    are allergic to any ingredients in the product (see Section 6 and end of Section 2)

•    have a known liver function impairment

•    have acute skeletal muscle spasms (your muscles go rigid suddenly)

•    need spasticity to stand up, walk or cope with daily activities.

DO NOT give Dantrium Capsules to children.

Take special care with Dantrium if you:

•    have heart or lung function impairment

•    have liver disorders or notice signs or symptoms of liver toxicity (e.g. discoloured faeces, intense itching, jaundice, anorexia, nausea, vomiting during therapy) -contact your doctor immediately

•    are elderly.

Liver function tests should be performed frequently before start and during Dantrium therapy as the risk of liver toxicity appears to be greater in

•    females

•    patients over 30 years old

•    patients taking other medication

•    females using oral oestrogen contraception.

Taking other medicines:

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Talk to your doctor before taking Dantrium if you are already taking:

•    Oestrogen (found in most oral contraceptive pills and hormone replacement therapy) or other drugs which might affect the liver.

•    Tranquillisers (e.g, diazepam, lorazepam or temazepam).

•    Medicines used to treat abnormal heartbeat, angina or high blood pressure (e.g.products containing verapamil)

•    Products normally used to help doctors anaesthetise patients (e.g.products containing vecuronium).

Taking Dantrium with food and drink

Avoid taking alcohol with this medicine as it may make you feel dizzy or drowsy.

Pregnancy and breast-feeding

Do not take the capsules if pregnant or breast-feeding unless advised otherwise by your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Dantrium may cause drowsiness or dizziness. These symptoms may be intensified if you have consumed alcohol.

Do not take the capsules without talking to your doctor if you drive or are involved in hazardous activities.

Important information about some of the ingredients of Dantrium

Lactose - if you know you have an intolerance to some sugars, speak to your doctor before taking this medicine.

Sunset yellow colouring (E110) - may cause allergic reactions. (Dantrium 25mg Capsules only).

Always take Dantrium exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will want to make sure that the capsules do not affect your liver. This will mean having blood tests before you start and while you are taking them.

Adults and Elderly:

Dantrium are to be taken by mouth. Swallow the capsule with a glass of water.

The dose will vary from person to person.

•    The starting dose is usually one 25mg capsule a day.

•    If there is no improvement, your doctor may increase your dose every week until the right dose for you is reached.

•    The normal maximum dose is one 100mg capsule four times a day. It is important to take the lowest dose which works for you.

•    If there is no improvement after about 6-8 weeks, your medication will be stopped by your doctor.

Children should NOT be given Dantrium.

If you take more Dantrium than you should

Do not exceed the recommended dose. If you take too much medicine, tell your doctor immediately or go to your nearest Accident & Emergency Department (take the pack with you if possible).

If you forget to take Dantrium

If you miss a dose, do not take a double dose to make up for a forgotten capsule; continue taking your medicine as normal at the correct time.

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

Like all medicines, Dantrium Capsules can cause side effects, although not everybody gets them.

You may suffer an allergic reaction, symptoms of which include: rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue. If this happens to you, stop taking the capsules immediately and seek urgent medical attention.

The following side effects have also been reported:

Most common side effects

•    dizziness, drowsiness

•    weakness, tiredness

•    feeling generally unwell

•    diarrhoea - if severe diarrhoea occurs, your doctor may stop the capsules for a short while. If you start taking them again and the diarrhoea returns, Dantrium is usually stopped permanently.

Less common side effects

•    loss of appetite (anorexia)

•    seizures

•    speech or visual disturbance

•    headache

•    inflammation of the membrane around the heart, sometimes accompanied by fluid in the lungs

•    feeling sick (nausea, vomiting)

•    abdominal pain

•    liver toxicity (characterised by inflammation of the liver), problems with liver function.

•    skin rash, acne

•    fever, chills.

Rare side effects

•    confusion, nervousness

•    depression

•    difficulty sleeping (insomnia)

•    fast heartbeat

•    worsening of heart problems

•    unstable blood pressure

•    difficulty in breathing

•    difficulty in swallowing

•    constipation (which may on rare occasions lead to a blockage in bowel movement)

•    sweating

•    increased urinary frequency

•    tiny crystals or traces of blood in the urine, difficulty in controlling the bladder (incontinence), being unable to pass urine easily.

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

Product: Dantrium 25mg Capsules	PLPI: 17211/0837	Dimensions: 210mm x 400mm
Colours: Black	Item Code: DAN2001F/H	Proof: 3

•    Keep out of the sight and reach of children.

•    Store Dantrium Capsules below 30°C.

•    Do not take the capsules after the expiry “exp” date printed on the label.

•    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.

What Dantrium contains

Each capsule contains 25mg of the active ingredient dantrolene sodium.

They also contain the following inactive ingredients: lactose, magnesium stearate, wheat starch, titanium dioxide (E171), erythrosine (E127), iron oxide (E172), talc and gelatin.

What Dantrium looks like and contents of the pack

Each capsule has a dark orange cap and a pale orange body, with no markings.

The capsules are available in blister packs containing 50 capsules.

Manufacturer

This product is manufactured by Merck, S.L., Poligono Merck, 08100 Mollet Del Valles (Barcelona), Spain and procured from within the EU by the Product Licence Holder Polyfarma Ltd and repackaged by Kent Pharmaceuticals Ltd both at Repton Road, Measham, DE12 7DT, UK.

Dantrium 25mg Tablets PL No: 17211/0837

Dantrium® is a registered Trademark of Proctor & Gamble Pharmaceuticals, Inc. USA.

Leaflet revision and issue date: 27.09.2012