PATIENT INFORMATION LEAFLET

DANTRIUM® CAPSULES

(Dantrolene Sodium)

What is this leaflet about?

This leaflet is a summary of information about Dantrium capsules. Read it carefully and keep it in case you need to refer to it again. If you have any questions about your medicine or your illness, ask your pharmacist (chemist) or doctor.

What is in Dantrium Capsules?

Dantrium capsules are available in two strengths, containing either 25mg or 100mg of the active ingredient dantrolene sodium. They are supplied in containers of 100 capsules.

Each capsule also contains: lactose, starch, talc and magnesium stearate. The capsule shell contains gelatin and colourings (E110, E171, E172).

What are Dantrium Capsules used for?

Dantrolene sodium is a muscle relaxant. It affects muscle directly rather than the nerves controlling muscle. This is helpful when the muscle is too tense, as in spasticity where it is used to treat symptoms.

Are Dantrium Capsules right for you?

Do not take Dantrium capsules without talking to your doctor first, if:

• you have liver, heart or lung problems
• your muscles have suddenly gone rigid (acute skeletal muscle spasm)
• you need extra tension in your muscles to stand up, walk and cope with daily activities
• you drive a car or take part in hazardous activities, as Dantrium capsules may cause drowsiness or dizziness
• you are breast feeding, pregnant, trying to become pregnant
• you are taking other medicines listed in the next section or are allergic to any of the ingredients stated above

Can you use Dantrium Capsules while you are taking other medicines?

Do not take Dantrium capsules without talking to your doctor or pharmacist first if you are taking:

• Oestrogen (found in most oral contraceptive pills and hormone replacement therapy) or other drugs which might affect the liver.
• Tranquillisers (for example, diazepam, lorazepam or temazepam).
• It is also best to avoid alcohol while taking Dantrium capsules as it may increase drowsiness. If affected, do not drive or operate machinery.
• Products containing verapamil (normally used for treating abnormal heart rhythms, angina or high blood pressure).

How to take Dantrium Capsules

Swallow the capsules with a glass of water.

 

Children should not take Dantrium Capsules

What should you do if you take your medicine incorrectly?

If you take too much medicine contact your doctor or your nearest casualty department. If you miss a dose do not double up, just continue as normal with the next dose at the correct time.

Medical checks

Your doctor will want to make sure that the Dantrium capsules are not affecting your liver. This will mean having blood tests before you start and while you are taking your medicine.

Do Dantrium Capsules have side effects?

Minor side effects are sometimes seen for the first weeks as your body gets used to the effect of Dantrium capsules. The most frequently reported side effects are drowsiness, dizziness, weakness, feeling generally unwell, tiredness and diarrhoea.

If severe diarrhoea occurs, your doctor may suggest you stop taking your capsules for a short while. If you start taking the capsules again and the diarrhoea comes back, Dantrium is usually stopped permanently.

Other effects have also been noticed by patients taking Dantrium capsules. Because they only happen occasionally, it is less clear whether Dantrium capsules actually causes the effects. They are grouped together under the part of the body affected:

The digestive system: Constipation, loss of appetite, difficulty in swallowing, feeling sick.

The liver: Very rarely, Dantrium capsules affect the liver. Jaundice (yellowing of the skin), pale stools, dark urine, generalised pruritis (itching), anorexia, nausea and vomiting may be warning signs of liver dysfunction and should they occur seek a medical opinion urgently. The reaction is more common in patients taking high doses, or those taking other drugs affecting the liver. Your doctor will check for these effects (see the section on medical checks).

The nervous system: Difficulty in speaking, seizures (fits), headache, visual disturbances, or difficulty sleeping (insomnia).

The heart, blood vessels and lungs: Fast heartbeat, unstable blood pressure, difficulties breathing, or inflammation of the membrane around the heart (pericarditis) sometimes accompanied by fluid in the lungs (pleural effusion).

The mind: Feelings of depression, confusion or nervousness.

The urinary and reproductive system: A need to pass urine (go to the toilet) frequently, tiny crystals or traces of blood in the urine, difficulty in controlling the bladder (incontinence), being unable to pass urine easily.

The skin: Various types of skin rashes.

The whole body: Chills or fever.

Tell your doctor or pharmacist immediately if you notice these or any other effects.

Storing Dantrium Capsules

Do not take the capsules after the expiry “exp” date which is printed on the pack. Store the capsules below 30° C in a safe place where children cannot reach them.