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VOKE is a brand name for Nicotine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Voke relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them. Voke is…
Verbatim from this product's MHRA label. Tap a section to expand.
Voke is for oral inhalation use only.
Posology Adults over 18 years of age:
Voke should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur. Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the Inhaler and as soon as they are able, reduce the number of charges used until they have stopped completely.
Smokers aiming to reduce cigarettes should use the Inhaler, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. As soon as they are ready, smokers should aim to quit smoking completely.
Maximum daily dose: 2 refill canisters When making a quit attempt, behavioural therapy, advice and support will normally improve the success rate. Those who have quit smoking, but are having difficulty discontinuing their Inhaler are recommended to contact their pharmacist or doctor for advice.
Each refill canister lasts for 20 charges. Each charge apart from the first one (see Section 2) provides a comparable number of inhalations to a conventional cigarette, although frequency, puffing/inhalation time and technique vary between individuals.
3). Method of administration Step 1.
Filling Voke:
Check the expiry date of the refill canister and the inhaler and refill canister for any damage. If you have a new inhaler that has not been used before or you have not used the inhaler for more than 2 days, repeat the filling process again - steps (a) to (d) before using to ensure it works properly and gives you the correct dose.
You should only fill the inhaler immediately before you intend to use it. (a) Hold the inhaler and the refill canister in separate hands. (b) Hold the refill canister vertically above the inhaler, with the refill canister valve pointing downwards, above the inhaler.
(c) To start the filling process, insert the white end of the inhaler into the refill canister firmly and hold it in place for 5 seconds to initiate the filling process. You may hear a short hissing sound as you insert it. (d) Remove the inhaler from the refill canister as it is now filled.
Effects of smoking Cessation Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include: irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance and decreased heart rate.
Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear. Adverse Drug Reactions Voke may cause adverse reactions similar to those associated with nicotine given by other means, including smoking, and these are mainly dose- dependent.
At recommended doses, nicotine has not been found to cause any serious adverse effects. Excessive use of nicotine by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.
Most of the undesirable effects reported by the patient occur during the first weeks after starting treatment. About 40% of users experience mild local reactions such as cough and irritation in the mouth and throat. Allergic reactions (including symptoms of anaphylaxis) occur rarely during use of this product.
The adverse reactions below are listed by system organ class (SOC).
Frequencies are defined in accordance with current guidance, as:
Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1 000, <1/100); rare (≥1/10 000, <1/1 000); very rare (<1/10 000), Not known - cannot be estimated from the available data.
Reported adverse events associated with inhaled nicotine include:
System Organ Class Incidence Reported Adverse Event Immune System Disorders Common Not known Hypersensitivitya Anaphylactic reactiona Psychiatric disorders Uncommon Abnormal dreamsc Nervous System Disorders Very Common Common Common Common Common Not known Headachea# Burning sensationb Dizziness Dysgeusia Paraesthesiaa Seizures Eye Disorders Not known Not known Blurred Vision Lacrimation increased Cardiac Disorders Uncommon Uncommon Very Rare Palpitationsa Tachycardiaa Reversible atrial fibrillation Vascular Disorders Uncommon Uncommon Flushinga Hypertensiona Respiratory, Thoracic and Mediastinal Disorders Very Common Very Common Common Uncommon Uncommon Uncommon Uncommon Uncommon Cough* Throat irritation Nasal Congestion Bronchospasm Dysphonia Dyspnoeaa Sneezing Throat tightness Gastrointestinal Disorders Very Common Very Common Very Common Common Common Common Common Common Common Common Uncommon Uncommon Uncommon Uncommon Rare Rare Rare Not known Nauseaa Stomatitis Hiccups Abdominal pain Diarrhoea** Dry mouth Dyspepsia Flatulence Salivary hypersecretion Vomitinga Eructation Glossitis Oral mucosal blistering and exfoliation Paraesthesia oral** Dysphagia Hypoaesthesia oral** Retching System Organ Class Incidence Reported Adverse Event Not known Not known Dry throat Gastrointestinal discomforta Lip pain Skin and Subcutaneous Tissue Disorders Uncommon Uncommon Uncommon Uncommon Not known Not known Hyperhidrosisa Pruritusa Rasha Urticariaa Angioedemaa Erythemaa General Disorders and Administration Site Conditions Common Uncommon Uncommon Uncommon Fatiguea Astheniaa Chest discomfort and paina Malaisea a Systemic effects; b At the application site c Identified if formulation was used at night *Higher frequency observed in clinical studies with inhaler formulation.
Any risks that may be associated with the use of nicotine are substantially outweighed by the well-established dangers of continued smoking.
Underlying cardiovascular disease:
In stable cardiovascular disease, Voke presents a lesser hazard than continuing to smoke. However, dependent smokers currently hospitalised as a result of myocardial infarction, unstable or worsening angina including Prinzmetal’s angina, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable and/or who have uncontrolled hypertension should be encouraged to stop smoking with non-pharmacological interventions.
If this fails, Voke may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision.
Diabetes mellitus:
Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when nicotine replacement therapy (NRT) is initiated, as catecholamines released by nicotine can affect carbohydrate metabolism.
GI disease:
Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.
Renal or hepatic impairment:
Use with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.
Danger in children:
Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. If a child chews or sucks on Voke that contains any nicotine, there is a risk of poisoning in the child.
Hypersensitivity to any component of Voke. Voke is contraindicated in children and adolescents under the age of 18 years
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Nicotine in United Kingdom.
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(e) If this is a new inhaler, repeat steps (a) to (d). If spray comes into contact with skin or eyes, rinse gently with water. Step 2. Using Voke: (f) Hold the inhaler away from your mouth with the Voke logo facing upwards. (g) Breathe out as far as is comfortable, away from the device (h) Hold the inhaler horizontally and place the grey mouthpiece between your lips and close your lips firmly around the mouthpiece to form a good seal.
(i) Inhale forcibly through your mouth until you feel the spray from the inhaler release into your mouth. Take as much or as little aerosol spray to your mouth as you like or feel comfortable with. At first, it might take you a few attempts to get the inhaler to release the aerosol spray.
Don’t worry, it isn’t broken, it just needs a stronger sharp puff to open the pressure sensitive valve inside the inhaler. You will quickly get used to controlling the strength of puff and the amount of aerosol spray released. (j) Gently remove the inhaler from your mouth whilst continuing to breathe in to inhale the aerosol spray from your mouth into your lungs.
(k) Breathe out slowly You may see some spray escape as you breathe out, but this can occasionally happen so don’t worry. (l) Repeat steps (f) to (k) several times until you no longer feel spray coming from the inhaler. You have now completed taking 1 full charge.
When you no longer feel spray coming from the inhaler it means it is empty and you will need to refill it from the refill canister before using it again. The maximum daily dose is 2 full refill canisters As with most inhaled medications, the therapeutic effect of this medication may decrease when the pack is cold.
Step 3. Refilling Voke: (m) To refill the inhaler, use the refill canister supplied, following the relevant instructions in Step 1. (n) Wipe the mouthpiece of the inhaler gently with a dry tissue after each refill canister. Do not clean the inhaler with any chemicals or cleaning agents.
Do not immerse the inhaler in any liquids. (o) Dispose of the refill canister with household rubbish or at an appropriate recycling facility. Each refill canister contains 20 charges and each inhaler can be used with up to 30 refill canisters.
**Reported the same or less frequently than placebo # Although the frequency in the active group is less than that of the placebo group, the frequency in the specific formulation in which the preferred term was identified as a systemic ADR was greater in the active group than the placebo group.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard), or to search for MHRA Yellow Card in the Google Play or Apple App Store.
Phaeochromocytoma and uncontrolled hyperthyroidism:
As nicotine causes release of catecholamines, Voke should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.
Seizures:
Potential risks and benefits of nicotine should be carefully evaluated before use in subjects taking anticonvulsant therapy or with a history of epilepsy, as cases of convulsions have been reported in association with nicotine.
Transferred dependence:
Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.
Stopping smoking:
Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs.
g. theophylline, clozapine and ropinirole.
Lung Disease:
Patients with obstructive lung disease may find use of the inhaler difficult. Nicotine gum, patches, nasal spray, or sublingual tablets may be preferred in such patients. Voke should be used with caution in patients with chronic throat disease and bronchospastic disease.
Allergic Reactions:
Susceptibility to angioedema and urticaria.
Potential choking hazard:
When not in use, the stick should be kept in the pack. This reduces the potential for contamination with dirt or fluff which, if inhaled, may cause choking.
Excipients:
This medicinal product contains small amounts of ethanol (alcohol), less than 10 mg per charged inhaler. The amount in one charge of Voke is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in Voke will not have any noticeable effects.
7mg in each full charge of the stick.