Niconex 1 mg/spray to help quit smoking

Niconex is used to help you give up smoking, if you want to stop smoking, or to help you reduce your cigarette consumption (smoke reduction) to help you quit smoking completely.
This is a type of treatment called nicotine replacement therapy.

Niconex relieves nicotine withdrawal symptoms including cravings, which are the symptoms you get when you stop smoking. If you suddenly stop providing your body with nicotine through smoking tobacco, you may experience various types of unpleasant sensations called withdrawal symptoms. By using Niconex you can prevent or reduce these unpleasant sensations and the desire to smoke. This is because you continue to provide your body with a small amount of nicotine over a short period of time. Niconex does not contain tar, carbon monoxide or other toxins found in cigarette smoke.

If possible, seek additional advice and support to increase your chances of quitting smoking.

Contraindications

Niconex must NOT be used

• if you are allergic to nicotine or any of the other ingredients of this medicine listed in section 6.
• if you are under 18 years old.
• if you have never smoked.

Interactions

Using Niconex with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important if you are taking medicines that contain the following active ingredients:

• Theophylline for the treatment of asthma
• Tacrine for the treatment of Alzheimer's disease
• Clozapine for the treatment of schizophrenia
• Ropinirole for the treatment of Parkinson's disease

Using Niconex with food and drink
Do not eat or drink while using the spray.

Pregnancy, breast-feeding and fertility
It is very important to stop smoking during pregnancy as it can lead to reduced growth of your baby. It can also lead to premature birth or stillbirth. It is best if you can quit smoking without using medicines that contain nicotine. If you are unable to do this, only use Niconex after consulting the healthcare professional managing your pregnancy, your family doctor or a doctor at a center that specializes in helping people give up smoking.

The use of Niconex should be avoided if you are breastfeeding, as nicotine passes into breast milk and may affect your child. If your doctor has recommended that you use Niconex, use the spray immediately after breastfeeding and not in the last 2 hours before breastfeeding.

Smoking increases the risk of infertility in women and men. The effects of nicotine on fertility are unknown.

Application

Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist tells you. Check with your doctor or pharmacist if you are unsure.

People under 18 must not use Niconex.
Consult your doctor if you have not been able to reduce the number of sprays you use or reduce your cigarette consumption after 6 weeks, or if you need to use Niconex for more than 6 months. Normally Niconex should be used for 3 months, but not longer than 6 months.

The instructions for using Niconex depend on whether you stop smoking immediately or reduce the number of cigarettes you smoke step by step before you stop smoking completely.

Smoking Cessation with Immediate Quit Smoking
The goal is to stop smoking immediately and use Niconex to reduce the urge to smoke.
Do not use more than 2 sprays at the same time or 4 sprays per hour for 16 hours. Over a period of 24 hours, the maximum dose is 64 sprays within 16 hours.

The following overview shows the recommended step-by-step procedure when using Niconex.

Step 1: Weeks 1 to 6
Use 1 or 2 puffs when you would normally smoke a cigarette or when you have the desire to smoke. Use one spray first and if your cravings don't go away within a few minutes, use a second spray. If 2 sprays are required, 2 sprays can be used in a row for the following applications. Most smokers require 1 or 2 puffs
every 30 to 60 minutes. For example, if you smoke an average of 15 cigarettes per day, then use 1 or 2 puffs at least 15 times throughout the day.

Step 2: Weeks 7 to 9
Begin reducing the number of sprays per day.
At the end of Week 9, use only HALF the average number of sprays per day used in Step 1.

Step 3: Weeks 10 to 12
Continue to reduce the number of sprays per day so that in week 12 you are using no more than 4 sprays per day. Stop using Niconex when you have reduced your use to 2 to 4 sprays per day.

Smoking reduction followed by smoking cessation
The aim is to gradually replace some of your cigarettes with Niconex. If this is successful, you can then use the spray to give up your cigarettes completely. Finally, stop using the spray.

If you have a strong urge to smoke, use 1 to 2 puffs of the spray instead of a cigarette to satisfy your craving. The spray is intended to replace the cigarette, so do not smoke shortly after using the spray. Using the spray without reducing the number of cigarettes smoked will cause nausea (see section “If you use more Niconex than you should”). Reduce the number of cigarettes you smoke per day as much as possible and replace them with a puff. If after 6 weeks you have not been able to reduce the number of cigarettes you smoke per day, talk to a doctor. You should stop smoking completely as soon as you feel able, but no later than 12 weeks after starting treatment. Once you have stopped smoking, gradually reduce the number of puffs you use each day. Once you only need 2 to 4 sprays per day, stop using Niconex completely.

Do not use more than 2 sprays in a row or 4 sprays per hour for 16 hours. Over a period of 24 hours, the maximum dose is 64 sprays within 16 hours.

After treatment ends, you may be tempted to smoke again. Therefore, keep unused spray as the urge to smoke can occur suddenly. If you feel the need to smoke, use one or two puffs if one puff does not work within a few minutes.

Follow the instructions to make sure you use Niconex correctly.

How to load the dispenser
If you are using Niconex for the first time, you must first load the spray pump. Keep the spray pump a safe distance from yourself or other adults, children or pets around you. Use your index finger to press the top of the pump three times until a fine spray comes out.
If you do not use the spray for more than 2 days, you must repeat this charging process.

How to use the dispenser

• After getting the dispenser ready for use, point the spray nozzle as close to your open mouth as possible.
• Squeeze the top of the dispenser and release a spray into your mouth. Avoid wetting your lips.
• Aim the spray tube between the cheek and the lower gums/teeth to target the inside of the cheek and avoid wetting the lips.

Do not inhale while spraying to prevent the spray from entering your throat.
For best results, do not swallow for a few seconds after spraying.
Be careful not to spray in your eyes when using the mouth spray. If you get spray in your eyes, rinse them carefully with water. Do not eat or drink while using the spray.

Side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Niconex can cause the same side effects as other forms of nicotine. Side effects generally depend on the dose you use.

Effects associated with stopping smoking (nicotine withdrawal)
Some of the side effects you experience when you stop smoking may be withdrawal symptoms due to the decrease in nicotine intake.

These side effects include:

• Irritability, aggression, impatience or frustration
• Anxiety, restlessness or difficulty concentrating
• Nighttime awakenings or difficulty sleeping
• Increased appetite or weight gain
• Gloomy mood
• Strong desire to smoke
• Slow heartbeat
• Bleeding gums or mouth ulcers
• Dizziness or lightheadedness
• Cough, sore throat, stuffy or runny nose
• constipation

Stop using Niconex and contact a doctor immediately if you notice any of the following serious rare side effects (signs of angioedema):

• Swelling of the face, tongue or throat
• Difficulty swallowing
• hives and difficulty breathing

Other possible side effects:

Very common (may affect more than 1 in 10 people):

• Hiccups (are particularly common)
• Headache, nausea (feeling sick)
• Irritation in the throat

Common (may affect up to 1 in 10 people):

• Local complaints such as burning, inflammation in the mouth, changes in the sense of taste
• Dry mouth or increased salivation
• Digestive problems (dyspepsia)
• Pain or discomfort in the abdomen
• Vomiting, flatulence or diarrhea
• fatigue
• Hypersensitivity (allergy)
• Tingle
• Cough

Uncommon (may affect up to 1 in 100 people):

• Effects on the nose such as stuffy or runny nose, sneezing
• Wheezing (bronchospasm) or feeling that breathing is more labored than usual (dyspnoea), tightness in the throat
• Redness of the skin (flushing) or increased sweating
• Effects in the mouth such as tingling in the mouth, inflammation of the tongue, mouth ulcers, damage to the lining of the mouth or changes in the sound of your voice, pain in the mouth and throat, belching, bleeding gums
• Heartbeat (palpitations), increased heart rate, high blood pressure
• Rash and/or itching of the skin (pruritus, urticaria)
• Unusual dreams
• Discomfort and pain in the chest area
• Weakness, malaise

Rare (may affect up to 1 in 1,000 people):

• Difficulty swallowing, reduced sensitivity to pain in the mouth
• Strangle

Not known (frequency cannot be estimated from available data):

• Blurred vision, increased tear formation (tear secretion)
• Dry throat, gastrointestinal problems, sore lips
• Irregular heartbeat
• Redness of the skin
• Allergic reactions including swelling of the face and mouth (angioedema or anaphylaxis)

composition

The active ingredient is nicotine.
Each spray releases 1 mg of nicotine in 0.07 ml of solution.
1 ml solution contains 13.6 mg nicotine.

The other ingredients are:
propylene glycol (E1520), glycerol (E422), ethanol anhydrous, poloxamer 407, glycine (E640), sodium bicarbonate (E500(ii)), levomenthol, mint flavor (contains benzyl alcohol, propylene glycol (E1520), pulegone) , Freshness flavor (contains menthol, menthol carboxamide, essential oil, propylene glycol (E1520)), sucralose (E955), acesulfame potassium (E950), sodium hydroxide (E524), purified water.

Usually ships out within 3-4 business days