Sominex Sominex

Do not use Sominex if you

: • are allergic to promethazine or any of the other ingredients of this medicine (listed in section 6). • have an allergy to Phenothiazine drugs (used to treat mental illness, severe nausea/vomiting or vertigo, e.g. chlorpromazine, pericyazine). • have concussion, light headedness, drowsiness, dizziness or a recent head injury. • have taken MAOIs (monoamine oxidase inhibitors) for depression within the last two weeks. • use this medicine for short term sleeping problems. It should not be used for more than 7 days without talking to your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sominex if you have: • Asthma. • Breathing problems or bronchitis. • Experienced or are being treated for seizures (e.g. epilepsy). Sominex may affect the risk of seizure. • Difficulty passing urine. • Glaucoma (raised pressure inside the eyeball). • Prostate trouble. • Kidney or liver problems. • Heart problems. • A blocked intestine. Other medicines and Sominex Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. • Other medicines which make you drowsy (e.g.sedatives or relaxants). • MAOIs (monoamine oxidase inhibitors) for depression. • Medicines which may give you a dry mouth or blurred vision (e.g. atropine or antidepressants). • Medicines used to reduce/prevent seizures (e.g. in epilepsy) Sominex may affect the risk of seizure. • Strong pain killers (e.g. codeine, morphine or buprenorphine). • Medicines treating mental illness (e.g. promazine, flupentixol or haloperidol). • Pregnancy tests based on urine samples, as they may give false positive or negative results if used when taking this medicine. • Allergy skin tests, as they may give false negative results. Sominex should not be taken during the 3 days before the test. Sominex with alcohol Do not drink alcohol when taking Sominex.

 Use in children and adolescents Do not give to children under 16 unless your doctor tells you to.

 Pregnant or breast-feeding 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. Sominex should not be taken 2 weeks before birth. You should not take Sominex if you are breast-feeding. This is because small amounts may pass into mothers’ milk. This can be harmful to your baby. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.

 Driving and using machines These tablets will cause drowsiness and you should not drive or operate machinery until the effects have worn off.

Important information about some of the ingredients of Sominex Sominex contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’

Like all medicines, this medicine can cause side effects, although not everybody gets them. Elderly people may be more susceptible to the side effects or confusion when taking this medicine.

Serious side effects If you think you have any of the following side effects or symptoms, stop using this medicine immediately and see a doctor as soon as possible. • Allergic reactions which cause difficulty in breathing, swelling of the mouth or skin, vomiting or stomach pain. • Jaundice (yellowing of the skin and eyes). • Palpitations or abnormal heart rhythm. • Low blood pressure (dizziness and lightheadedness). • Blurred or reduced vision or pain in the eye. • Listlessness and lack of energy. • Reduction of white blood cells and platelets in the blood, causing ulcers in the mouth and throat, high temperature and bruising easily. • Convulsions.

Other possible side effects If you notice these or any other side effect not included below, stop use and tell your doctor or pharmacist. They will tell you what to do. • Drowsiness. • Confusion • Dizziness or headaches. • Clumsiness or disorientation. • Shaking and trembling. • Stomach upsets or dry mouth. • Difficulty in passing urine. • Restlessness or excitation. • Feeling or being sick • Sensitivity to sunlight. • Difficulty sleeping. • Ringing in the ears. • Blocked/stuffy nose. • Rashes

 Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Adults, the elderly and children over 16 • The recommend dose is one tablet at bedtime. • It may be taken up to one hour after going to bed when you can’t go to sleep

. • Do not use this medicine for more than 7 days in a row. If natural sleep does not return within 7 days or you have repeated bouts of sleeplessness talk to your doctor.

 Use in children and adolescents Do not give to children under 16 unless your doctor tells you to.

 If you take more Sominex than you should If you accidentally take too many tablets, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Take the pack with you to show which medicine you have swallowed. Signs of an overdose include: Loss of consciousness, dilated pupils, hot dry skin, feeling sleepy or drowsy, convulsions, involuntary movements, uneven heartbeat, heart failure, increased pressure in the skull causing painful eyes, changes in vision, a bad headache behind the eyes (hypertension), breathing difficulties, feeling or being sick, dry mouth and tongue, uncontrolled eye movements, flushing, fever, visual disturbances, mental disorder including illusions, hallucinations and disorientation, agitation, difficulty passing urine, blocked intestines, lung impairment. Children may also experience excitation, involuntary movement of hands, face and tongue, moving unsteadily or stumbling and hallucinations.

The active substance is: promethazine hydrochloride 20mg.

The other ingredients are: lactose, maize starch, croscarmellose sodium, magnesium stearate.