Promethazine Theoclate

Promethazine Theoclate Tablets are an anti-emetic (anti-sickness drug) which helps to prevent, and treat nausea and vomiting, including travel sickness, and vertigo. Promethazine Theoclate contains promethazine which belongs to a group of medicines called phenothiazines. Your doctor may prescribe this medicine for giddiness or light-headedness (vertigo), or for sickness after an operation, and in such cases the tablets should be taken as instructed by your doctor.

Anti-emetic drugs, Miscellaneous sedatives & hypnotics, Sedating Anti-histamine

Promethazine Theoclate works by stopping histamine from binding to its receptors in an area in the brain known as the vomiting centre. The vomiting centre is responsible for causing feelings of sickness and for the vomiting reflex. It is activated when it receives nerve messages from the vestibular apparatus in the middle ear.

The vestibular apparatus provides constant feedback to the brain about the position of our body. When something disturbs the vestibular apparatus, such as movements of the head when travelling by boat or car, nerve signals are sent from the vestibular apparatus to the vomiting centre. This can cause the symptoms of motion sickness, such as nausea, dizziness or spinning sensations (vertigo) and vomiting.

By blocking the histamine receptors in the vomiting centre, Promethazine Theoclate prevents disturbances in the middle ear from activating the vomiting centre.

To prevent travel sickness on short journeys: Promethazine Theoclate should be taken at least one or two hours before travelling. Adults and children aged over 10 years should take one tablet. Children aged 5 to 10 years should be given half a tablet.

To prevent travel sickness on long journeys: Promethazine Theoclate should be taken at bedtime each night during the journey, starting the night before you travel. Adults and children aged over 10 years should take one tablet. Children aged 5 to 10 years should be given half a tablet.

To treat travel sickness: Adults and children over 10 years should take one tablet as soon as you feel sick, followed by a second tablet the same evening. Take a third tablet the following evening if necessary. Children aged 5 to 10 years should treated in the same way, but with half a tablet each time.

For sickness and vomiting due to other causes, and for treating vertigo: Adults and children aged over 10 years should take one tablet up to three times a day. Children aged 5 to 10 years should be given half a tablet up to three times a day. Alternatively you should follow the instructions given by your doctor.

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start taking Promethazine Theoclate. Similarly, check with your doctor or pharmacist before taking any new medicines while taking Promethazine Theoclate, to make sure that the combination is safe.

Promethazine Theoclate should not be taken by anyone who has taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), eg phenelzine, tranylcypromine, isocarboxazid, in the previous 14 days.

You are more likely to feel drowsy if you take Promethazine Theoclate with any of the following (which can also cause drowsiness):

• alcohol
• antipsychotic medicines, eg chlorpromazine
• barbiturates, eg phenobarbital
• benzodiazepines, eg diazepam, temazepam
• sedating antihistamines, eg chlorphenamine, brompheniramine, hydroxyzine
• sleeping tablets, eg zopiclone
• strong opioid painkillers, eg morphine, codeine, dihydrocodeine, tramadol
• tricyclic antidepressants, eg amitriptyline.

• Children under five years of age.
• People with reduced awareness, slow reactions or extreme drowsiness caused by medicines or illnesses that reduce activity in the central nervous system.
• People who have taken a type of medicine called a monoamine-oxidase inhibitor antidepressant (MAOI) in the past 14 days.
• Children and adolescents who have signs and symptoms suggestive of Reye's syndrome.
• People who are allergic to any ingredients of the tablets.
• Promethazine Theoclate tablets contain lactose and should not be taken by people with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with promethazine. Just because a side effect is stated here does not mean that all people using Promethazine Theoclate will experience that or any side effect.

• Drowsiness or feeling tired.
• Dizziness.
• Restlessness.
• Headache.
• Nightmares.
• Blurred vision.
• Difficulty passing urine.
• Dry mouth.
• Confusion.
• Feeling disorientated.
• Unexpected increase in excitability in children.
• Increased sensitivity of the skin to sunlight (photosensitivity). If affected you should avoid sun lamps and direct sunlight while you are taking this medicine.
• Loss of appetite.
• Awareness of your heartbeat (palpitations).
• Abnormal heartbeats (arrhythmias).
• Low blood pressure (hypotension).
• Abnormal movements of the hands, legs, face, neck and tongue, eg tremor, twitching, rigidity (extrapyramidal effects).
• Blood disorders.

If you are pregnant you should not take Promethazine Theoclate without consulting your doctor first. Promethazine Theoclate should only be used during pregnancy if essential, and only if the expected benefit to the mother outweighs any potential risks to the developing baby. It should not be used during the last two weeks of pregnancy, because if taken during this time it may cause irritability or excitement in the baby after birth. Seek further medical advice from your doctor.

Small amounts of Promethazine Theoclate may pass into breast milk. This is not expected to be harmful to a nursing infant with occasional short-term use of Promethazine Theoclate, but there is a risk that it may cause drowsiness, irritability or excitement in a newborn baby. If you are breastfeeding you should not take Promethazine Theoclate without getting medical advice from your doctor first.

Symptoms of severe overdosage are variable. They are characterised in children by various combinations of excitation, ataxia, inco-ordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsion may occur in both adults and children; coma or excitement may precede their occurrence. Cardiorespiratory depression is uncommon. If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the anti-emetic effect of promethazine; alternatively, gastric lavage may be used. Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anticonvulsant.

Store between 15-30° C. Protect from light.

Safe

Promethazine Theoclate 25 mg