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Nerve Agent Pre-Treatment Tablet Set L1a1 (Naps L1a1)

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PACKAGE LEAFLET: INFORMATION FOR THE USER NERVE AGENT PRE-TREATMENT SET L1A1 (NAPS L1A1)

Pyridostigmine Bromide Tablets

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 questions or are in doubt about anything or require further information, please ask your doctor or medical officer.

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

In this leaflet:

1.    What NAPS is and what it is used for

2.    Before you take NAPS

3.    How to take NAPS

4.    Possible side-effects

5.    How to store NAPS

6.    Further information

1. WHAT NAPS IS AND WHAT IT IS USED FOR

NAPS tablets contain pyridostigmine bromide which belongs to a group of medicines known as cholinesterase inhibitors. This medicine reduces the action of proteins in the body called cholinesterases. This helps to counteract the effects of some nerve agents and NAPS is taken as a pre-treatment before a nerve agent attack occurs.

2. BEFORE YOU TAKE NAPS

Do not take NAPS if you:

•    are allergic to pyridostigmine, bromides or any of the other ingredients of NAPS. The other ingredients are listed in Section 6 of this leaflet. If you think you are allergic, ask your doctor or medical officer for advice.

•    are constipated or cannot urinate (gastro-intestinal or urinary obstruction), contact your doctor or medical officer for advice before taking NAPS

•    have been told by your doctor that you have a hereditary intolerance to some sugars, contact your doctor or medical officer before taking NAPS.

NAPS tablets should not be given to children or older people.

Take special care with NAPS if you have:

•    asthma - if you have unstable asthma you should have been medically downgraded in order that you are only deployed within base areas where full medical support is available

•    recently had a coronary thrombosis (heart attack)

•    a slow heart beat

•    vagotonia (a condition where over-activity of the vagus nerve causes symptoms such as constipation, slow heart rate, low blood pressure, sweating and painful muscle spasms)

•    low blood pressure Taking other medicines:

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

The following medicines can prevent your NAPS tablets from working:

•    Antispasmodic medicines e.g. atropine, hyoscine (for motion sickness, gastrointestinal spasm)

•    Some antibiotics (aminoglycosides, clindamycin, polymixins)

•    Propranolol (for hypertension, angina or migraine prophylaxis)

•    Lithium (for manic depression, bipolar disorder)

•    Procainamide, propafenone or quinidine (for irregular heartbeat)

If you are going to have an operation which requires a general anaesthetic, you must tell the medical staff that you have been taking NAPS.

Pregnancy and breast-feeding:

The effects of NAPS in pregnant women are not known, therefore the use of NAPS is not recommended. You are advised not to become pregnant while taking NAPS. If you do become pregnant, you should consult your doctor or medical officer.

It is not known if NAPS passes into breast milk so you should not breast feed if you are taking NAPS.

Driving and using machines:

The recommended dose of NAPS tablets does not affect your ability to drive or use machines.

Important information about some of the ingredients of NAPS

Lactose is an ingredient in NAPS (see Section 6). If you have an intolerance to some sugars, please tell your doctor before taking NAPS.

3. HOW TO TAKE NAPS

You should only begin taking NAPS when ordered to do so in anticipation of a nerve agent attack.

Dosage:

Take one tablet by mouth every 8 hours until the order is given to stop taking the medicine. The length of time for which NAPS is taken will be determined by commanders on medical and intelligence advice.

Do not take more than 2 tablets in an 8 hour period.

NAPS is not recommended for use in children or the elderly.

5. HOW TO STORE NAPS

Keep out of the reach and sight of children

Do not use NAPS tablets after the expiry date which is printed on the packaging after “exp”. The expiry date refers to the last day of the month.

Do not store above 25°C

Keep the plastic sleeve in the outer foil in order to protect from moisture

Return any unused tablets to your Quartermaster's Dept. for disposal.

If you take more NAPS than you should

You may notice that you have stomach or muscle cramps, diarrhoea, nausea and vomiting, increased salivation, sweating, general weakness, a slower heart rate, twitching or lightheadedness.

If you experience any of these symptoms you must seek medical assistance so that you can be treated.

If you forget to take NAPS

If you miss a tablet, you should take the next dose as soon as possible, but do not take more than 2 tablets in an 8 hour period.

4. POSSIBLE SIDE-EFFECTS

Like all medicines, NAPS can cause side-effects, although not everybody gets them.

Common - affecting fewer than 1 in 10 people

•    headache

•    nausea

•    wind

•    diarrhoea

•    stomach cramps

•    more saliva than usual

•    urinating more than usual, or feeling an urgent need to urinate

•    runny nose.

Uncommon - affecting fewer than 1 in 100 people

•    numbness

•    worsening of asthma.

6. FURTHER INFORMATION What NAPS contains

The active substance is pyridostigmine bromide 31.5mg

The other ingredients are starch pregelatinised, maize starch, lactose monohydrate, silica colloidal, anhydrous talc, magnesium stearate.

(see also Section 2: Important information about some of the ingredients of NAPS).

What NAPS looks like and contents of the pack

The NAPS tablets are round, biconvex, white to off-white colour, marked with “L1A1” on one side.

They are packed in a blister pack in a plastic sleeve. Each sleeve contains 21 tablets and is sealed in an aluminium foil sachet. Ten foil sachets are packaged in one cardboard box.

Marketing Authorisation Holder

Secretary of State for Defence Ministry of Defence Main Building Whitehall London SW1 2HB

Manufacturer

Penn Pharmaceutical Services Limited Units 23 & 24

Tafarnaubach Industrial Estate

Tredegar

Gwent

NP23AA

If any of these side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or medical officer.

This leaflet was last approved in August 2012.

41653B