Patient leaflet - ALIMEMAZINE TARTRATE 10 MG FILM-COATED TABLETS, VALLERGAN 10 MG FILM-COATED TABLETS
1. WHAT VALLERGAN ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Vallergan Tartrate 10mg Film Coated Tablets (called Vallergan 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.
What Vallergan tablets are used for
- 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
2. what you need to know before you take vallergan
Do not take Vallergan tablets if:
- 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.
- You have liver or kidney problems.
- You have epilepsy.
- You have Parkinson’s disease.
- You have thyroid problems (hypothyroidism).
- You have a tumour on the adrenal gland (called phaeochromocytoma).
- You have myasthenia gravis (a form of muscle weakness).
- You have an enlarged prostate gland.
- You have increased pressure in the eye (called narrow angle glaucoma).
- You have a history of a blood or bone marrow disorder called agranulocytosis.
Children
Vallergan should not be used in children less than 3 years old.
For children over 3 years of age, the use of Vallergan 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 Vallergan tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Vallergan 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 Vallergan tablets.
Other medicines and Vallergan 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 Vallergan tablets can affect the way some medicines work. Also some medicines can affect the way Vallergan 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.
Vallergan tablets with alcohol
Do not drink alcohol or take any medicines containing alcohol while you are taking Vallergan 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 Vallergan 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.
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.
Vallergan tablets contain lactose
If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking Vallergan tablets.
3. how to take vallergan
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 (10mg) two or three times each day
- Your doctor may increase your dose in some cases
Elderly
- One tablet (10mg) once or twice each day
Children over 3 years of age
- Children will normally be given Vallergan 7.5mg/5ml 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 Vallergan 7.5mg/5ml Syrup.
You should check with your doctor or pharmacist
Exposure to sunlight
Vallergan tablets can make your skin more sensitive to sunlight.
Keep out of direct sunlight while taking this medicine.
If you take more Vallergan tablets than you should
If you take more Vallergan 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 heart 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 Vallergan 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
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 Vallergan 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.
- 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.
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days or if you notice any side effects not listed in this leaflet:
- 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
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed on this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.
5. HOW TO STORE VALLERGAN
- Keep out of the sight and reach of children.
- Do not use Vallergan 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
- Do not store above 25°C.
- Protect from light
6. contents of the pack and other information
What Vallergan contains
- 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, indigotin (E132), titanium dioxide (E171).
What Vallergan looks like and contents of the pack
Vallergan 10 mg Tablets are dark blue circular tablets with „V10“ embossed on one side and plain on the other.
Available in blister packs containing 25 Tablets.
Manufactured by Farmar Health Care Services Madrid, S.A.U., Alcorcon, Madrid, Spain and procured from within the EU and repackaged in the UK by the Product Licence holder: CD Pharma Ltd, 4 Cairn Court, East Kilbride, G74 4NB.
Vallergan 10 mg Film Coated Tablets PL: 20492/0537
POM
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Vallergan is a registered trademark.
Date of preparation: 12th November 2020