PATIENT INFORMATION LEAFLET

SECONAL SODIUM CAPSULES

What you should know about Seconal Sodium capsules

Please read Ihis lcaflei carefully before you start to take your medicine. It does not contain all the information about your medicine that you may need to know, so please ask your doctor or pharmacist if you have any questions. This leaflet only applies to Seconal Sodium capsules.

What is in your medicine?    ______________

The active ingredient is called secobarbital sodium. Thisis the new name for quinalbarbitone sodium. The ingredient itself has not changed. _

The capsules arc orange and marked F40 or B42.

Each capsule marked F42 has 50 milligrams of secobarbital sodium, and each capsule marked F40 has 100 milligrams of secobarbital sodium. They also contain the inactive ingredients starch and silicone. The capsules are made with gelatin and are coloured with El27 and HI04. Each pack contains 100 capsules, however, your pharmacist may dispense a smaller number and this will be clearly shown on the label.

Seconal Sodium is a sedative (sleeping pill). It is one of a group of medicines called barbiturates which cause drowsiness and sleep.

Seconal Sodium is made by Clonmel Healthcare Limited. Waterford Road. Clonmel. Co. Tipperary. Ireland. The product licences are held by Flynn Pharma 1 .td.. Alton House. 4 Herbert Street. Dublin 2, Republic of Ireland. The product licence numbers are 13621/0002 (50mg) and 13621/0003 (lOOmg).

Why do I need Seconal Sodium?

Seconal Sodium is used for short term treatment of severe sleeping problems which have been difficult to cure in other ways. Patients who have never used any form of barbiturates should not take this medication.

Before you take your medicine

Make sure it is safe for you to take Seconal Sodium. It should not normally be taken by children, young adults, elderly people or people In poor health.

If you answer YES to any of the following questions, or you are not sure, tell your doctor or pharmacist.

•    Have you ever had an allergic reaction to a barbiturate medicine? An allergic reaction may include

rash, swelling, breathing difficulties or flaking skin. (Barbiturates may have names like butobarbital.

Phcnobarbital or quinalbarbilal.)

•    Have you ever had porphyria?

•    Do you have liver or kidney trouble or breathing difficulties?

•    Are you often in pain?

•    Have you ever had a drink or drug problem?

•    Are you taking other sleeping pills, tranquilliscrstsuch as kirazcpara or diarcpanOor antihistamines?

You may become dangerously sleepy if you take Seconal Sodium capsules at the same lime.

•    Are you pregnant or could you be? Do not take Seconal Sodium during pregnancy or labour.

•    Are you breast feeding? Do not take Seconal Sodium while breast-feeding.

Are you suffering from depression?

•    Are you being treated for adrenal gland trouble?

•    Are you laking any olhcr medicines. It is important to tell your doctor if you are taking any of the following- other sedatives, ’blood-thinner’ medicines (such as warfarin), corticosteroids, gnscofulvtn or doxycycline (for infections), phenytom or other medicines for epilepsy, MAOI antidepressants (such as phcnylzinc or tranylcypromine) or oral contraceptives.

•    Barbiturates can affect your judgement or co-ordination. You should not drive or use machinery unless you are sure lhai you are not affected.

•    Do not drink alcohol while taking Seconal Sodium capsules. It can be veiy dangerous.

•    Barbiturates can be addictive, If you take them for a long time, or if you take high doses, they have less efTect and you may become dependent on them. You must not take more than your doctor tells you to.

. If vou have been taking barbiturates for a long time, or high doses of them, you should stop taking them gradually. Stopping them suddenly can cause serious withdrawal problems (such as nightmares, mood swings, sleeplessness, or even serious tits in rare cases).

Taking your medicine

• hollow your doctor’s advice. Check die label for how many capsules you should take. They arc not meant to be taken for a long period of time.

The usual dose is one capsule (50 or 100 milligrams) at bedtime.

If you arc not sure how many capsules to take, ask your doctor or pharmacist.

•    Swallow the capsules with water.

•    They should start to work 10 to 15 minutes after you have taken them.

NEVER take more capsules than your doetor tells you to. If you ever lake too many, ask someone to take you to the nearest hospital casualty department or tell your doctor immediately. An overdose can be very dangerous and could kill you.

While laking your medicine

These capsules may cause side-effects, the most common side effect is feeling sleepy in Ihc day. Some patients taking barbiturates may:- feel nervous: feel confused or have abnormal thoughts, reel hyperactive or have jerky movements, have nightmares, disturbed sleep or hallunicalions; feel toy or faint, have headaches; have a slow heartbeat or low blood pressure; have a rash or other allergic reactions; feel sick or be sick: become constipated or have liver trouble.

•    If you sian to have breathing problems, stop taking your capsules and contact your doctor straight away.

. If you have these or any other ill-effects, tell your doctor. He or she has more informauon about Seconal Sodium and will tell you what to do.

How to store your medicine

•    Do not take the capsules after the ‘Use before’ date.

•    Keep your capsules in the tightly closed container and store them in a dry, safe place bekiw 25°C and where children cannot sec or reach them. Your capsules could kill them.

•    If your doctor tells you to stop taking the capsules, please lake them back to Ihc pharmacist so they can get rid of Ihem safely. Only keep the capsules if your doctor tells you to.

Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them, even if their symptoms are the same as yours.

Seconal Sodium is a registered trademark.    INLF308

Dale this leaflet was revised: September 2004.