Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Certain symptoms such as dizziness, headache and sleep disturbances may be related to withdrawal symptoms in connection with smoking cessation and may be due to insufficient administration of nicotine. Cold sores may develop in connection with smoking cessation, but any relation with the nicotine treatment is unclear.
Nicotinell gums can cause adverse reactions similar to those associated with nicotine administered by other means (including smoking). These can be attributed to the pharmacological effects of nicotine, which are dose dependant. Non dose-dependent adverse reactions are as follows: 
Jaw muscle ache, erythema, urticaria, hypersensitivity, angioneurotic oedema and anaphylactic reactions.
At recommended doses Nicotinell gum has not been found to cause any serious adverse effects.
Excessive consumption of Nicotinell gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.

Increased frequency of aphthous ulcer may occur after abstinence from smoking.

Most of the side effects which are reported by patients occur generally during the first 3-4 weeks after initiation of therapy.

Nicotine from gums may sometimes cause a slight irritation of the throat and increase salivation at the start of the treatment.

Excessive swallowing of nicotine which is released in the saliva may, at first, cause hiccups. Those who are prone to indigestion may suffer initially from minor degrees of dyspepsia or heartburn; slower chewing will usually overcome this problem.

The gum may stick to and in rare cases damage dentures and dental appliances.

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000),

Nervous system disorders:                            Common: Headache, dizziness Gastrointestinal disorders:                          Common: Salivary hypersecretion, stomatitis, oral pain, pharyngolaryngeal pain, hiccups, nausea, vomiting, dyspepsia and flatulence.
Musculoskeletal, connective and bone                 Common: Jaw muscle ache disorders:
Cardiac disorders:                                  Uncommon: palpitations Rare: Atrial arrhythmia
Skin and subcutaneous tissue disorders:             Uncommon: Erythema, urticaria.
Immune system disorders:                            Rare: Hypersensitivity, angioneurotic oedema and anaphylactic reactions.
The patient may still experience nicotine dependence after smoking cessation.

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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form.
https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.g ov.il