Alimemazine Tartrate 10mg Film Coated Tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Alimemazine is and what it is used for
2. What you need to know before you take Alimemazine
3. How to take Alimemazine
4. Possible side effects
5. How to store Alimemazine
6. Contents of the pack and other information

• To treat itching (pruritus) or an itchy, lumpy rash (urticaria)
• As a sedative for children aged between 3 and 7 years. This is a medicine given to reduce awareness or make the child feel relaxed and at ease before an operation.

• are allergic (hypersensitive) to:
  • alimemazine tartrate or any of the other ingredients of this medicine (listed in section 6).
  • any other similar medicines (phenothiazines) such as chlorpromazine.
  • have signs of an allergic reaction including: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• have liver or kidney problems.
• have epilepsy.
• have Parkinson’s disease.
• have thyroid problems (hypothyroidism).
• have a tumour on the adrenal gland (called phaeochromocytoma).
• have myasthenia gravis (a form of muscle weakness).
• have an enlarged prostate gland.
• have increased pressure in the eye (called narrow angle glaucoma).
• have a history of a blood or bone marrow disorder called agranulocytosis.

Alimemazine should not be used in children less than 3 years old.

For children over 3 years of age, the use of Alimemazine 7.5mg/ml Syrup is recommended.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking alimemazine.

Talk to your doctor or pharmacist before taking alimemazine if you:

• have heart problems.
• have fits (epilepsy).
• are elderly and are dehydrated or have been told you have a low blood volume.
• are elderly and have had constipation for some time.
• are an elderly male and have problems when passing water (urine).
• are elderly and it is very hot or cold.
  Your body may find it harder to control its temperature when taking this medicine.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking alimemazine.

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 can affect the way some medicines work.

Also some medicines can affect the way alimemazine work.

In particular, tell your doctor or pharmacist if you are taking any of the following:

• Medicines to help you sleep or lower your anxiety.
• Lithium - used to treat some types of mental illness.
• Amfetamine - used for Attention Deficit Hyperactivity Disorder (ADHD).
• Phenobarbital - used for epilepsy.
• Adrenaline - used for life threatening allergic reactions.
• Medicines for Parkinson’s disease such as levodopa.
• Medicines for depression.
• Medicines for severe pain (such as codeine or morphine).
• Medicines for diabetes. Your doctor may need to change the dose of your medicine.
• Medicines for high blood pressure such as doxazosin, terazosin, guanethidine or clonidine.
• Medicines for indigestion and heartburn (antacids).
• Anticholinergic medicines - includes some medicines used for irritable bowel syndrome, asthma or incontinence.

Do not drink alcohol or take any medicines containing alcohol while you are taking alimemazine. This is because alcohol can increase the chances of you getting side effects. It can also cause serious breathing difficulties.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take alimemazine 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.

You may feel drowsy or sleepy while taking this medicine. If this happens, do not drive or use any tools or machines.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

• Take this medicine by mouth.
• Do not touch the tablets for any longer than is necessary. This can cause skin redness, swelling and itching (contact skin sensitisation).
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.
• Do not take more than the recommended dose.

The recommended dose for itching or an itchy, lumpy rash is:

Adults

• One tablet (10 mg) two or three times each day.
• Your doctor may increase your dose in some cases.

Elderly

• One tablet (10 mg) once or twice each day.

Children over 3 years of age

• Children will normally be given Alimemazine Tartrate 7.5 mg / 5 ml Syrup. You should check with your doctor or pharmacist.

Children aged between 3 and 7 years

• Children will normally be given Alimemazine Tartrate 7.5 mg / 5 ml Syrup. You should check with your doctor or pharmacist.

Alimemazine can make your skin more sensitive to sunlight. Keep out of direct sunlight while taking this medicine.

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 3 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 heat beats and feeling very cold. You may also feel dizzy, light-headed 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 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.

• An allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• Liver problems that may cause the eyes or skin to go yellow (jaundice).
• High temperature, sweating, stiff muscles, fast heartbeat, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious side effect called ‘neuroleptic malignant syndrome’.
• Very fast, uneven or forceful heartbeat (palpitations). You may also have breathing problems such as wheezing, shortness of breath, tightness in the chest and chest pain.
• Convulsions/fits and movements that you cannot control, mainly of the tongue, mouth, jaw, arms and legs.
• You may get infections more easily than normal such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem.

• Breathing more slowly or less deeply than normal.
• Feeling restless and not being able to keep still.
• Changes in skin or eye colour.
• Problems with your eyesight.
• Rigid or stiff muscles, trembling or shaking or difficulty moving.
• Feeling dizzy, lightheaded or faint when you stand or sit up quickly (due to low blood pressure).
• Unexpected excitement or hyperactivity.
• Problems passing urine.

• Constipation
• Dry mouth
• Stuffy nose
• Difficulty sleeping (insomnia)
• Feeling agitated
• Dizziness
• Headache
• Drowsiness
• Being more sensitive to the sun than usual
• Unusual production of breast milk in men and women
• Breast enlargement in men
• Loss of menstrual periods
• Difficulty in getting or maintaining an erection or in ejaculating (impotence)
• Skin redness, swelling and itching (contact skin sensitisation)
• Skin rashes

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

By reporting side effects, you can help provide more information on the safety of this medicine.

• Each tablet contains 10 mg of the active ingredient, alimemazine tartrate.
• The other ingredients are microcrystalline cellulose, lactose monohydrate (spray dried), colloidal anhydrous silica, magnesium stearate, sodium starch glycollate, hypromellose, polyethylene glycol 300, blue opaspray M-1-4229 (purified water EP, indigo carmine, titanium dioxide, industrial methylated spirits 74).

The tablets are dark blue, circular, biconvex and film coated with a bevelled edge. One side of the tablet is marked V/10 and the other side is plain.

The tablets are available in blister packs of 28.

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