Caution

What you need to know before you use Jext

Jext can always be used during an allergic emergency. If you are allergic (hypersensitive) to sodium metabisulphite or to any of the other ingredients of Jext, your doctor will need to instruct you under which circumstances Jext should be used. For further information on hypersensitivity to sulphites please look in the section: Jext contains sodium metabisulphite and sodium chloride. Warnings and precautions Talk to your doctor when you are prescribed Jext • if you have heart disease • if you have an overactive thyroid • if you have high blood pressure • if you have diabetes • if you have a tumour on the adrenal gland (phaeochromocytoma) • if you have increased pressure in the eye (glaucoma) • if you have renal or prostate disease • if you have low potassium levels or high calcium levels in your blood • and/or if you are elderly, pregnant or the child weighs less than 15 kg as there is a greater risk of getting side effects. If you have asthma you may be at increased risk of a severe allergic reaction. Anyone who has an episode of anaphylaxis should see their doctor about testing for substances they may be allergic to, so these can be strictly avoided in future. It is important to be aware that an allergy to one substance can lead to allergies to a number of related substances. If you have food allergies it is important to check the ingredients in everything you ingest (including medicines) as even small amounts can cause severe reactions. You should have been carefully instructed by your doctor or nurse when and how to correctly use Jext. The instructions for use must be carefully followed in order to avoid accidental injection. Jext should only be injected intramuscularly into the outer thigh. It should not be injected into the buttock due to the risk of accidental injection into a vein. Warning Accidental injection into the hands or feet may result in reduced blood supply to these areas. If there is an accidental injection into these areas, you should go immediately to the nearest hospital emergency department for treatment. If you have a thick sub-cutaneous fat layer, there is a risk that a single dose of Jext may not be sufficient. A second injection may be needed. Carefully follow the instructions for use given in section 3. Laceration may occur if the injection is given by someone other than the patient and the patient’s leg is not immobilised during injection. To prevent injuries, the instructions for use given in section 3 must be carefully followed. Other medicines and Jext Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important if you take any of the following medicines: • Antidepressants such as tricyclic antidepressants or monoamine oxidase inhibitors (MAO inhibitors). • Medicines for treatment of Parkinsons disease such as catechol-O-methyl transferase inhibitors (COMT inhibitors) and levodopa. • Medicines that may make the heart sensitive to uneven beats (arrhythmias), such as digitalis and quinidine.

• Medicines for thyroid disease (levothyroxine). • Medicines that make you breathe more easily; used for asthma (theophylline). • Medicines used in labour (e.g. oxytocin). • Medicines used to treat allergies such as diphenhydramine, chlorpheniramine (first generation antihistamines). • Alpha and beta blocking medicines for heart disease. • Medicines that act on the parasympathetic nervous system which regulates the body´s unconscious functions such as heartbeat and lung function (parasympatholytics, parasympathomimetics). Diabetic patients should carefully monitor their glucose levels after use of Jext as adrenaline can increase the blood glucose level. Jext with alcohol Alcohol can increase the effect of adrenaline. Pregnancy, breast-feeding and fertility If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There is limited experience of the use of adrenaline during pregnancy. If you are pregnant, do not hesitate to use Jext in an emergency, since you and your baby’s life may be in danger. Jext would not be expected to have any effect on the nursing infant. Driving and using machines The ability to drive and use machines is unlikely to be affected by the administration of an adrenaline injection, but may be affected by an anaphylactic reaction. If affected, do not drive. Jext contains sodium metabisulphite and sodium chloride Jext contains sodium metabisulphite, which may rarely cause severe allergic reactions (hypersensitivity) or breathing difficulty (bronchospasm). Your doctor must instruct you under which circumstances Jext should be used. Jext contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium free.