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CHLORPHENAMINE MALEATE 4 MG - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - CHLORPHENAMINE MALEATE 4 MG

What is in your medicine?

The active ingredient in this medicine is Chlorphenamine Maleate. This is the new name for Chlorpheaniramine Maleate. The ingredient itself has not changed.

This medicine contains Chlorphenamine Maleate, available in tablets of 4 mg and the excipients lactose, maize starch, povidone, E104, magnesium stearate and sodium starch glycollate. Chlorphenamine Maleate is available in containers of 100, 500 and 1,000 tablets, and in blister packs of 10 and 30 tablets.

How does Chlorphenamine work?

Chlorphenamine is a phenothiazine derivative with antihistamine action and is useful in controlling allergic conditions.

The Manufacturer is:

DDSA Manufacturing Ltd., Chatfield Road, off York Road, London SW11 3SE.

The Product Licence Holder is:

Chelonia Healthcare Limited, 11 Boumpoulinas, 3rd Floor, 1060 Nicosia, Cy­prus

What are Chlorphenamine tablets for?

Chlorphenamine is used to control the symptoms of allergic conditions which include urticaria, hayfever, food allergy, drug and serum reactions, insect bites, nasal inflammation with running nose and fluid build-up in the tissues below the skin.

Check before you take Chlorphenamine Maleate tablets

Before taking this medicine, tell your doctor if you have ever had any unusual or allergic reactions to Chlorphenamine or any other ingredients of Chlorphenamine Maleate tablets, or other antihistamine medicines, or medicines of the phenothiazine grou­p.

Also tell your doctor or pharmacist if you are allergic to any other substances such as foods, preservatives or dyes.

You should not take this medicine if you have taken monoamine oxidase inhibitor medicines during the previous 14 days.

It is important that you tell your doctor if you are pregnant, or likely to become pregnant, or if you are breast feeding.

The presence of other medical problems may affect the use of this medicine. Make sure, therefore, to tell your doctor or pharmacist if you have any other medical problems, especially: epilepsy, glaucoma, enlargement of the prostate gland, difficulty passing urine, blockage between the stomach and intestines, liver disease or any bronchial conditions, thyrotoxicosis, blood pressure, heart disease or bronchial asthma. The effects of alcohol may be increased by this medicine.

Use in pregnancy

Safety for use during pregnancy has not been established, and Chlorphenamine should only be used when it is clearly needed, and when the potential benefit outweighs the potential unknown risks to the unborn baby when taken during the last 3 months of pregnancy. Chlorphenamine Maleate may result in reactions in the newborn or premature babies. Small amounts of Chlorphenamine Maleate are excreted in breast milk. Use by nursing mothers is not recommended because of the risk of adverse effects in the infant. Chlorphenamine may stop lactation.

Can you take Chlorphenamine Maleate with other medicines?

You can take these tablets with other medicines, but there are some medicines that can interfere with Chlorphenamine. It is very important to tell your doctor or pharmacist about all the medicines that you are taking, whether or not any medicines were prescribed by your doctor or bought without a prescription from the pharmacy or elsewhere. This includes monoamine oxidase inhibitors which should not be taken within 14 days of using Chlorphenamine Maleate, medicines that have been prescribed for sleep such as nitrazepam; for anxiety such as chlordiazepoxide and carbamazepine or phenytoin.

When and how to take Chlorphenamine Maleate tablets

The tablets should be taken by mouth.

Adults: 4 mg (1 tablet) three or four times daily.

Children: Below 6 years: Not recommended.

6–12 years: 2 mg (% tablet) three or four times daily.

Elderly: The dosage as in adults but the elderly are prone to confusional and other nervous system effects.

CURRENT

What to do if too many tablets are taken at the same time

If you accidentally take more tablets than recommended, contact your doctor or hospital casualty department at once.

What to do if you miss a dose

If you miss a dose, skip the missed dose and go back to your regular dosage schedule. Do not double the dose. If you feel that this medicine is not working as well after you have taken it for a short time (1–2 weeks) do not increase the dose, instead check with your doctor.

What side effects can Chlorphenamine Maleate tablets have?

Because Chlorphenamine causes drowsiness, dizziness, blurred vision and difficulty in co-ordination, which can hamper the ability to drive and to use machines, you should not drive or operate machinery while taking Chlorphenamine Maleate tablets. The tablets produce sedation varying from slight drowsiness to deep sleep. Other side-effects include: Inability to concentrate, a feeling of weakness (lassitude), blurred vision, stomach upset such as nausea, vomiting, diarrhoea, heart burn, abdominal pain, dryness of the mouth, headache, dizziness, difficulty in passing water, difficulty in producing tears, constipation, twitching, tremor, changes in heartbeat, low blood pressure, loss of appetite, hepatitis (including jaundice), different forms of anaemia.

Allergic reactions are rare but include scaling and flaking of the skin, nettle rash (urticaria), sensitivity to sunlight, spasm of the windpipe, fluid under the skin and around certain organs, and anaphylaxis which may cause tightness of the chest resulting in difficulty breathing, with swelling of the face, neck and skin around the eyes. Muscular weakness, incoordination, convulsions, buzzing in the ears, irritability, confusion, depression and nightmares may also occur on rare occasions. Children may become unusually excitable and the elderly are prone to confusion.

Storing your medicine

You must keep the medicine in a safe place where children cannot get it. Your medicine could harm them.

Keep your medicine in a dry place below 25°C and protect it from light.

Keep the tablets in the container in which they were given to you.

On the label you will find the words „Expiry Date“ followed by numbers indicating the day, month and year. This is the date when the medicine is no longer fit for use. Do not use the medicine after this date.

A reminder

This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.

PL 33414/0022

This leaflet was revised in November 2004

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is chlorphenamine maleate used for?

Chlorphenamine maleate is an antihistamine medication primarily used to relieve symptoms of allergies, hay fever, and the common cold, such as sneezing, runny nose, and itchy or watery eyes.

Can chlorphenamine maleate be used for a cold?

Yes, chlorphenamine maleate can help alleviate symptoms of a cold, including nasal congestion and sneezing. However, it does not cure the cold itself.

Is chlorphenamine maleate safe for children?

Chlorphenamine maleate is generally considered safe for children over the age of 2. Always consult your healthcare provider for appropriate dosing and to ensure it's suitable for your child.

Are there any side effects of taking chlorphenamine maleate?

Common side effects may include drowsiness, dizziness, dry mouth, and gastrointestinal disturbances. If you experience severe side effects or allergic reactions, seek medical attention immediately.

Can I drive after taking chlorphenamine maleate?

It’s advisable to avoid driving or operating heavy machinery after taking chlorphenamine maleate since it can cause drowsiness.

How long does it take for chlorphenamine maleate to start working?

Chlorphenamine maleate typically starts working within 30 minutes to an hour after ingestion.

Can I take chlorphenamine maleate with other medications?

Before taking chlorphenamine maleate with other medications, consult your healthcare provider as it may interact with certain drugs such as sedatives and alcohol.

What should I do if I miss a dose of chlorphenamine maleate?

If you miss a dose of chlorphenamine maleate, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double up on doses.

Is there a specific time when I should take chlorphenamine maleate?

Chlorphenamine maleate can be taken at any time of day; however, taking it before bed may help mitigate drowsiness during the day.

Can pregnant or breastfeeding women take chlorphenamine maleate?

Consult your healthcare provider before using chlorphenamine maleate during pregnancy or while breastfeeding to discuss potential risks and benefits.

Can you build up a tolerance to chlorphenamine maleate?

With regular use over time, some individuals may develop tolerance to the sedative effects of chlorphenamine maleate. However, tolerance levels vary by individual.

Does chlorphenamine maleate cause weight gain?

Weight gain is not commonly reported with chlorphenamine maleate; however, some individuals may experience increased appetite or changes in metabolism. Monitor any significant changes with your doctor.

What are the signs of an overdose of chlorphenamine maleate?

Signs of an overdose may include extreme drowsiness, confusion, hallucinations, seizures, or difficulty breathing. Seek emergency medical help if these symptoms occur.

Can I drink alcohol while taking chlorphenamine maleate?

It is strongly advised to avoid alcohol while taking chlorphenamine maleate as it can increase sedation and other side effects.

Is there anyone who should avoid taking chlorphenamine maleate?

Individuals with certain health conditions like glaucoma or prostate enlargement should avoid using chlorphenamine maleate unless advised by a healthcare professional.

How is chlorphenamine maleate typically dosed for adults?

For adults, the typical dose is 4 mg every 4 to 6 hours as needed, but do not exceed 24 mg in one day without consulting your doctor.

Are there any natural alternatives to chlorphenamine maleate I can try for allergies?

Some natural alternatives include nasal saline rinses, quercetin supplements, and local honey; however, consult your healthcare provider before trying these alternatives.

What happens if I stop taking chlorphenamine maleate suddenly after long-term use?

While discontinuing chlorphenamine maleate suddenly doesn’t usually cause withdrawal symptoms, it’s always best to consult with a healthcare professional before stopping any medication suddenly.

Is it safe to use expired chlorphenamine maleate medication?

Using expired medications is not recommended as they may lose potency over time and could potentially be harmful. Always check expiration dates before use!