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ALIMEMAZINE TARTRATE 10 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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Patient leaflet - ALIMEMAZINE TARTRATE 10 MG FILM-COATED TABLETS

5. HOW TO STORE ALIMEMAZINE TABLETS

  • Keep out of the sight and reach of children.
  • Do not use Alimemazine tablets after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.
  • Protect from light
  • Do not store above 25 °C.
  • 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 this medicine becomes discoloured or shows any other sign of deterioration, please contact your pharmacist who will advise you on what to do.

6. contents of the pack and other information

What Alimemazine tablets contain

  • Each tablet contains 10mg of the active ingredient, alimemazine tartrate.
  • The other ingredients are lactose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, sodium starch glycollate, hypromellose, macrogol 200, indigotine (E 132) and titanium dioxide (E 171).

What Alimemazine tablets look like and contents of the pack

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 25.

Product License Holder and Manufacturer

Procured from within the EU by the Product Licence holder OrifarmA/S, Energivej 15, 5260 Odense S, Denmark

Repacked by Orifarm Supply s.r.o., Palouky 1366, 253 01 Hostivice, Czech Republic

Manufactured by Famar Health Care Services Madrid, S.A.U., Alcorcon, Madrid, Spain

Alimemazine Tartrate 10 mg film-coated tablets _____

PL 46927/0021 | pom |

Leaflet revision date: 08/09/2020

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Alimemazine Tartrate 10 mg film-coated tablets

What Alimemazine tablets are used for

or make the child feel relaxed and at ease B before an operation

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • 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 tablets are and what they are used for

  • 2. What you need to know before you take Alimemazine tablets

  • 3. Howto take Alimemazine tablets

  • 4. Possible side effects

  • 5. How to store Alimemazine tablets

  • 6. Contents of the pack and other information

  • 1. WHAT ALIMEMAZINE TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Alimemazine Tartrate 10 mg film-coated tablets (called Alimemazine tablets throughout this leaflet). It contains the active ingredient alimemazine tartrate and belongs to a group of medicines called phenothiazines. It 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.

2. what you need to know before you take alimemazine tablets

Do not take Alimemazine tablets if:

x You 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. The signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

x You have liver or kidney problems.

x You have epilepsy.

x You have Parkinson’s di­sease.

x You have thyroid problems (hypothyroidism).

x You have a tumour on the adrenal gland (called phaeochromocytoma).

x You have myasthenia gravis (a form of muscle weakness).

x You have an enlarged prostate gland.

x You have increased pressure in the eye (called narrow angle glaucoma).

x You have a history of a blood or bone marrow disorder called agranulocytosis.

Children

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

For children over 3 years of age, the use of Alimemazine 7.5 mg/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 tablets.

S——' Warnings and precautions

Talk to your doctor or pharmacist before taking Alimemazine tablets if:

  • ▲ You have heart problems.

  • ▲ You have fits (epilepsy).

  • ▲ You are elderly and are dehydrated or have been told you have a low blood volume.

  • ▲ You are elderly and have had constipation for some time.

  • ▲ You are an elderly male and have problems when passing water (urine).

  • ▲ You 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 tablets.

Other medicines and Alimemazine tablets

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 tablets can affect the way some medicines work. Also some medicines can affect the way Alimemazine tablets 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.
  • Amphetamine – 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.

Alimemazine tablets with alcohol

Do not drink alcohol or take any medicines containing alcohol while you are taking Alimemazine tablets.

This is because alcohol can increase the chances of you getting side effects. It can also cause serious breathing difficulties.

Pregnancy and breast-feeding

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 tablets 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.

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Driving and using machines

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

Alimemazine tablets contain lactose

If you have been told by your doctorthat you cannot tolerate some sugars, talk to your doctor before taking Alimemazine tablets.

3. how to take alimemazine tablets

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

  • 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.

How much to take

The usual dose is:

For itching or an itchy, lumpy rash 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.

As a sedative before general anaesthesia

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.

Exposure to sunlight

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

If you take more Alimemazine tablets than you should

If you take more Alimemazine tablets 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 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 to take Alimemazine tablets 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

Elf 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 tablets and see a doctor or go to a hospital straight away if you notice any of the following side effects:

  • 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.

Tell a pharmacist or doctor as soon as possible if you have any of the following side effects:

  • 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.