Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Alimemazine tartrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for The name of your medicine is Alimemazine oral solution, Sugar-Free (called Alimemazine oral solution throughout this leaflet). Alimemazine oral solution contains the active ingredient alimemazine tartrate and belongs to a group of medicines called phenothiazines and works by blocking a natural substance (histamine) that your body makes during an allergic reaction. It also works directly on the brain to help you feel more relaxed. This medicine is used:
e Alimemazine oral solution Do not take Alimemazine oral solution if:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you can buy without prescription, including herbal medicines. This is because Alimemazine oral solution can affect the way some medicines work. Also some medicines can affect the way Alimemazine oral solution works. In particular, tell your doctor or pharmacist if you are taking any of the following:
Alimemazine oral solution Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Taking this medicine
Method of administration For oral administration. A 5 ml graduated oral syringe with intermediate graduations of 0.1 ml and a "Press-In" Bottle Adapter (PIBA) are provided with the product. 1. Open the bottle and at first use insert the "Press-In" Bottle Adapter (PIBA) (see pictures A-B). 2. Insert the syringe into the PIBA and draw out the required volume from the inverted bottle (see pictures C-D). 3. Remove the filled syringe from the bottle in the upright position (see picture E). 4. Discharge the syringe contents into the mouth. Repeat steps 2 to 4 as needed to achieve the required dose. 5. Rinse the syringe and replace the cap on the bottle (PIBA remains in place).
(impotence)
not listed in this leaflet:
What Alimemazine oral solution contains The active substance is alimemazine tartrate.
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Alimemazine oral solution Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month. Store in the original package in order to protect from light. After first opening use within 1 month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
If you take more Alimemazine oral solution than you should If you take more of this medicine than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. Also do this if a child under 2 years of age swallows some of this medicine. The following effects may happen: feeling drowsy, loss of consciousness, increased or rapid heartbeat, changes in heartbeat, uneven heartbeats and feeling very cold. You may also feel dizzy, lightheaded or faint (due to low blood pressure) and you may notice that you cannot control your movements (for example of the eyes, neck, arms and legs). If you forget to take Alimemazine oral solution If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Alimemazine oral solution and see a doctor or go to a hospital straight away if you notice any of the following side effects:
Itzenal 30 mg/ 5ml Oral Solution, Sugar-Free comes as oral solution containing 30mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Itzenal 30 mg/ 5ml Oral Solution, Sugar-Free is alimemazine tartrate.
Medicines with the same active substance, strength and form include: Alfresed 30mg/5ml Syrup, Alimemazine Tartrate 30 mg/ 5 ml Oral Solution, Alimemazine Tartrate 30mg/5mL Oral Solution, Sugar-Free. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Itzenal 30 mg/ 5ml Oral Solution, Sugar-Free, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Itzenal/Alimemazine tartrate 30 mg/ 5ml Oral Solution, Sugar-Free (referred to as Itzenal/Alimemazine oral solution) has a central sedative effect comparable to that of chlorpromazine but largely devoid of the latter's anti adrenaline action. It has powerful antihistamine and anti-emetic actions. In the management of urticaria and pruritus.
In pre-medication as a sedative before anaesthesia in children aged between 2 to 7 years.
Posology
Not recommended for infants less than 2 years old.
DO NOT exceed the recommended dose (see also section 4.9).
Urticaria and pruritus
Adults: 10 mg (approx. 1.6 ml) two or three times daily; up to 100 mg per day have been used in intractable cases.
Elderly: Dose should be reduced to 10 mg (approx. 1.6 ml) once or twice daily.
Children over 2 years of age: The use of Itzenal 7.5 mg/ 5 ml oral solution is recommended.
As a sedative before anaesthesia
Children aged 2 – 7 years: The maximum dosage recommended is 2 mg (approx. 0.33 ml) per kg bodyweight 1 – 2 hours before the operation.
When the use of small volumes is required, Itzenal/Alimemazine 7.5 mg/ 5 ml oral solution is recommended.
Method of administration
For oral administration.
A 5 ml graduated oral syringe with intermediate graduations of 0.1 ml and a “press-in” syringe/bottle adapter are provided with the product.
Alimemazine is contraindicated in patients with:
• Known hypersensitivity to phenothiazines or to any of the excipients listed in section 6.1.
• Hepatic or renal dysfunction
• Epilepsy
• Parkinson's disease
• Hypothyroidism
• Phaeochromocytoma
• Myasthenia gravis
• History of narrow angle glaucoma
• History of agranulocytosis
• Prostatic hypertrophy
Alimemazine is contraindicated for use in children less than 2 years of age (see section 4.4).
Patients are strongly advised not to consume alcoholic beverages or medicines containing alcohol throughout treatment (see section 4.5).
Exposure to sunlight should be avoided during treatment (see section 4.8).
Alimemazine should be used with caution in:
• Elderly or volume depleted patients who are more susceptible to orthostatic hypotension (see section 4.8).
• Elderly patients presenting chronic constipation (risk of paralytic ileus).
• Elderly patients with possible prostatic hypertrophy (see section 4.3).
• Elderly patients in hot and cold weather (risk of hyper/hypothermia) (see section 4.8).
• Patients with certain cardiovascular diseases: alimemazine may cause arrhythmias due to the tachycardia-inducing and hypotensive effects of phenothiazines (see section 4.8).
• Patients with seizures (see section 4.8).
Paediatric population
Alimemazine is contraindicated for use in children less than 2 years of age due to the risk of marked sedation and respiratory depression.
There is a risk of post-operative restlessness especially if the child is in pain.
Itzenal /Alimemazine 30 mg/ 5ml oral solution contains sodium methyl parahydroxybenzoate.
This medicine contains sodium methyl parahydroxybenzoate and may cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol sodium (23 mg) per 8.5 ml dose, that is to say essentially 'sodium-free'.
The sedative effects of phenothiazines may be intensified (additively) by alcohol (see section 4.4), anxiolytics & hypnotics, opiates, barbiturates and other sedatives. There may be increased antimuscarinic and sedative effects of phenothiazines with tricyclic antidepressants and MAOIs (including moclobemide). Respiratory depression may occur.
The hypotensive effect of most antihypertensive drugs especially alpha-adrenoreceptor blocking agents may be exaggerated by phenothiazines.
The use of antimuscarinics will increase the risk of antimuscarinic side effects when used in conjunction with antihistamines.
The action of some drugs may be opposed by phenothiazines: these include amphetamine, levodopa, clonidine, guanethidine and adrenaline.
The mild anticholinergic effect of phenothiazines may be enhanced by other anticholinergic drugs possibly leading to constipation, heat stroke etc. Anticholinergic agents may reduce the antipsychotic effect of phenothiazines.
Some drugs interfere with absorption of phenothiazines: antacids, anti- Parkinson and lithium. Increases or decreases in the plasma concentrations of a number of drugs, e.g. propranolol, phenobarbital have been observed but were not of clinical significance.
High doses of phenothiazines reduce the response to hypoglycaemic agents, the dosage of which may have to be raised. Adrenaline must not be used in patients overdosed with phenothiazines.
Pregnancy
There are limited data from the use of alimemazine in pregnant women, but it has been widely used for many years without apparent ill consequence. Some phenothiazines have shown evidence of harmful effects in animals. Alimemazine, like other drugs, should be avoided in pregnancy unless the physician considers it essential. Neuroleptics may occasionally prolong labour and at such a time should be withheld until the cervix is dilated 3 – 4 cm. Possible adverse effects on the neonate include lethargy or paradoxical hyperexcitability, tremor and low Apgar score.
Breast-feeding
Phenothiazines may be excreted in human milk. Breast-feeding should be discontinued during treatment with alimemazine tartrate.
Fertility
There are no fertility data available.
Patients should be warned about drowsiness during the early days of treatment, and advised not to drive or operate machinery.
Blood and lymphatic system disorders:
• Mild leukopenia occurs in up to 30% of patients on prolonged high dosage.
• Agranulocytosis may occur rarely; it is not dose related.
The occurrence of unexplained infections or fever requires immediate haematological investigation.
Endocrine disorders:
• Hyperprolactinaemia which may result in galactorrhoea, gynaecomastia, amenorrhoea and impotence.
• Neuroleptic malignant syndrome (hyperthermia, rigidity, autonomic dysfunction and altered consciousness) may occur (see section 4.9).
Psychiatric disorders:
• Insomnia
• Agitation
Nervous system disorders:
• Extrapyramidal effects, such as:
- Acute dystonias or dyskinesias, usually transitory are commoner in children and young adults and usually occur within the first 4 days of treatment or after dosage increases.
- Akathisia characteristically occurs after large doses.
- Parkinsonism is commoner in adults and the elderly. It usually develops after weeks or months of treatment. One or more of the following may be seen: tremor, rigidity, akinesia or other features of Parkinsonism (commonly just tremor).
- Tardive dyskinesia: If this occurs it is usually, but not necessarily, after prolonged or high dosage. It can even occur after treatment has been stopped. Dosage should therefore be kept low whenever possible.
• Convulsions have been reported in some patients.
• Dizziness
• Headache
• Drowsiness
Eye disorders:
• Accommodation disorders
Cardiac disorders:
Cardiac arrhythmias including atrial arrhythmia, atrio-ventricular (A-V) block, ventricular tachycardia and ventricular fibrillation have been reported during therapy, possibly related to dosage (see section 4.4). Pre-existing cardiac disease, old age, hypokalaemia and concurrent tricyclic antidepressants may predispose.
Vascular disorders:
• Hypotension or pallor may occur in children.
• Elderly or volume depleted subjects are particularly susceptible to postural hypotension (see section 4.4).
Respiratory, thoracic and mediastinal disorders:
• Nasal congestion
• Respiratory depression is possible in susceptible patients.
Gastrointestinal disorders:
• Constipation
• Dry mouth
Hepatobiliary disorders:
Jaundice, usually transient, occurs in a very small percentage of patients. A premonitory sign may be a sudden onset of fever after one to three weeks of treatment followed by the development of jaundice. Neuroleptic jaundice has the biochemical and other characteristics of obstructive jaundice and is associated with obstructions of the canaliculi by bile thrombi; the frequent presence of an accompanying eosinophilia indicates the allergic nature of this phenomenon. Treatment should be withheld on the development of jaundice.
Skin and subcutaneous tissue disorders:
• Contact skin sensitisation is a serious but rare complication in those frequently handling preparations of phenothiazines. Care must be taken to avoid contact of the drug with the skin.
• Skin rashes of various kinds may also be seen in patients treated with the drug.
• Patients on high dosage may develop photosensitivity in sunny weather and should avoid exposure to direct sunlight (see section 4.4). Ocular changes and the development of a metallic greyish-mauve colouration of exposed skin have been noted in some individuals, mainly females, who have received chlorpromazine continuously for long periods (four to eight years).
Renal and urinary disorders:
• Retention of urine
General disorders and administration site conditions:
• Paradoxical excitement has been noted.
Investigations:
Electrocardiogram changes, usually benign, including:
• QT interval prolongation
• U-wave abnormality
• T-wave abnormality
• ST segment depression
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. Healthcare professionals are asked to report any suspected adverse reactions 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.
Symptoms of phenothiazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias and hypothermia. Severe extra-pyramidal dyskinesias may occur.
If the patient is seen sufficiently soon (up to 6 hours) after ingestion of a toxic dose, gastric lavage may be attempted. Pharmacological induction of emesis is unlikely to be of any use. Activated charcoal should be given. There is no specific antidote. Treatment is supportive.
Generalised vasodilatation may result in circulatory collapse; Raising the patient's legs may suffice, in severe cases, volume expansion by intravenous fluids may be needed; infusion fluids should be warmed before administration in order not to aggravate hypothermia.
Positive inotropic agents such as dopamine may be tried if fluid replacement is insufficient to correct the circulatory collapse. Peripheral vasoconstrictor agents are not generally recommended; avoid the use of adrenaline.
Ventricular or supraventricular tachy-arrhythmias usually respond to restoration of normal body temperature and correction of circulatory or metabolic disturbances. If persistent or life-threatening, appropriate antiarrhythmic therapy may be considered. Avoid lidocaine and, as far as possible, long acting anti-arrhythmic drugs.
Pronounced central nervous system depression requires airway maintenance or, in extreme circumstances, assisted respiration. Severe dystonic reactions, usually respond to procyclidine (5-10mg) or orphenadrine (20-40mg) administered intramuscularly or intravenously. Convulsions should be treated with intravenous diazepam.
Neuroleptic malignant syndrome (NMS) has been reported in the context of alimemazine overdose. Symptoms of NMS include a combination of hyperthermia, muscle rigidity, altered mental status and autonomic instability. Since this syndrome is potentially fatal, alimemazine must be discontinued immediately, and intensive clinical monitoring and symptomatic treatment must be initiated.
Strict adherence to the recommended dose is critical (see also section 4.2).
Neuroleptic malignant syndrome should be treated with cooling. Dantrolene sodium may be tried.
Ask anything about Itzenal 30 mg/ 5ml Oral Solution, Sugar-Free. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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