Promethazine Hydrochloride 25mg Tablets

Document: leaflet MAH BRAND_PLPI 18799-2345 change

PACKAGE LEAFLET:

INFORMATION FOR THE USER

PACKAGE LEAFLET:

INFORMATION FOR THE USER

Phenergan 25mg Tablets

(promethazine hydrochloride)

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

• Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again

• Ask your pharmacist if you need more information or advice

• 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.

• You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

The name of your medicine is Phenergan 25mg Tablets but will be referred as Phenergan throughout this leaflet.

What is in this leaflet:

1. What Phenergan is and what it is used for

2. What you need to know before you take Phenergan

3. How to take Phenergan

4. Possible side effects

5. How to store Phenergan

6. Contents of the pack and other Information

1. What Phenergan is and what it is used for

Phenergan contain a medicine called promethazine hydrochloride. This 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 Phenergan is used for

Phenergan are used to treat the following conditions:

• For short-term use: to treat adults with difficulty sleeping (insomnia)

• To treat allergic conditions such as hay fever or rashes (like nettle rash or hives)

• To treat or stop you feeling sick (nausea) or being sick (vomiting) such as travel sickness

• For short-term use: as a sedative for children aged 5 years and above

2. What you need to know before you take Phenergan

Do not take this medicine if:

x The person taking the medicine is under 5 years of age

x You are allergic (hypersensitive) to promethazine hydrochloride or any of the other ingredients of Phenergan (listed in Section 6 overleaf). The signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

x You are taking a medicine for depression called a monoamine oxidase inhibitor (MAOI). Also do not take Phenergan if you have stopped taking one of these MAOI medicines within the last 14 days. If you are not sure ask your doctor or pharmacist (see Taking other medicines’ section overleaf) x The person is unconscious (in a coma) or suffers from severe dizziness, drowsiness or headache

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 Phenergan.

Warnings and precautions Check with your doctor or pharmacist before taking your medicine if

▲ You have difficulty breathing, wheezing, tightness in the chest (asthma) or an infection in your lungs (bronchitis)

▲ You have epilepsy

▲ You have any serious heart problems

▲ You have liver or kidney problems

▲ You have a stomach blockage or difficulty passing water

▲ You have hearing problems

▲ You have increased pressure in the eye (narrow angle glaucoma)

▲ You have had something called Reye’s Syndrome or possible Reye’s Syndrome - signs include being sick and confused following a viral illness

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

You may get high fever, muscle cramps or stiffness, dizziness, very bad headache, fast heart beat, confusion, agitation, hallucinations, or are sweating a lot. This may be signs of a very serious and sometimes deadly health problem called neuroleptic malignant syndrome. Stop taking your medicine and tell your doctor immediately.

There have been some cases of abuse with this medicine. The risk of abuse is greater in those with a history of drug abuse.

Other medicines and Phenergan

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you can buy without prescription, including herbal medicines. This is because Phenergan can affect the way some medicines work. Also some medicines can affect the way Phenergan work.

Do not take this medicine, and tell your doctor, if you are taking or have taken the following in the last 2 weeks:

• Some medicines for depression called monoamine oxidase inhibitors (MAOIs). If you are not sure ask your doctor or pharmacist

Tell your doctor or pharmacist if you are taking any of the following:

• Anticholinergic medicines - includes some medicines used for irritable bowel syndrome, asthma or weak bladder.

• These can increase the risk of dizziness, dry mouth and blurred eyesight

• Medicines for depression (such as amitriptyline)

• Medicines to help you to sleep or feel more relaxed (such as diazepam or zolpidem)

• Medicines such as aspirin (for arthritis and pain in your joints). Phenergan may hide the side effects of these medicines

Phenergan with food and drink

Do not drink alcohol while you are taking Phenergan. This is because it can affect the way the medicine works

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

Phenergan should not be taken 2 weeks before birth.

You should not take Phenergan 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 breastfeed, talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Phenergan contains lactose:

• This is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine

3. How to take Phenergan

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The amount you need to take depends on the reason you are taking Phenergan. The following information will help you to decide how much you need to take.

Taking this medicine

• Take this medicine by mouth

• Do not take for longer than 7 days.

• If your symptoms worsen or do not improve after 7 days talk to your doctor or pharmacist

• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

How much to take

The recommended dose is:

For allergies (such as hay fever, rashes and hives)

Children 2-5 years:

• Phenergan Elixir should be given in this age group

Children 5-10 years:

• A single tablet (25mg) given at night

• DO NOT give more than 25mg each day

Children over 10 years and adults (including the elderly):

• Start with one tablet (25mg) taken at night

• This may be increased to a maximum of one tablet (25mg) twice a day if necessary

For treatment and prevention of feeling sick or being sick (such as travel sickness)

Children 2-5 years:

• Phenergan Elixir should be given in this age group

Children 5-10 years:

• Phenergan Elixir or Phenergan 10mg Tablets should be given in this age group

Children over 10 years and adults (including the elderly):

• A single tablet (25mg) to be taken the night before the journey

• This may be repeated after 6-8 hours if necessary

As a short-term paediatric sedative and for short term treatment of insomnia in adults Children 2-5 years:

• Phenergan Elixir should be given in this age group

Children 5-10 years:

• A single tablet (25mg) given at night

Children over 10 years and adults (including the elderly):

• One or two tablets (25mg-50mg) taken at night

Use this medicine only as recommended. Do not exceed the recommended dose.

Exposure to sunlight

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

If you take more Phenergan than you should

If you or your child takes more Phenergan 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 or your child has taken.

The following effects may happen:

In children: Excitation, moving unsteadily or stumbling, uncontrolled writhing movements especially of the hands or feet, hallucinations, fits (seizures), loss of consciousness, uneven heart beat and breathing difficulties.

In adults: Feeling sleepy or drowsy, fits, loss of consciousness, uneven heart beat and breathing difficulties.

If you forget to take Phenergan

Do not take a double dose to make up for a forgotten dose

• If you are taking Phenergan for an allergic condition - take your medicine as soon as you remember, then carry on as before

• If you are taking Phenergan for sedation or sleeping problems - miss that dose and take the next evening’s dose as usual

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Tests

Taking Phenergan may affect the results of certain tests. These include some pregnancy tests and skin tests. Phenergan should not be taken at least 3 days before the start of a skin test.

4. Possible side effects

Like all medicines, Phenergan can cause side effects, although not everybody gets them. Stop taking Phenergan 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)

• Muscle stiffness or shaking

• Being unable to control some muscles in your head or face

• You notice unusual movements of the tongue, facial muscle spasms, rolling eyes and trembling

• Very fast, uneven or forceful heart beat (palpitations)

• Irregular heart beat

• Tiredness which lasts for a long time. This may be due to a blood problem called anaemia

• Over-active behaviour in children

Not known: frequency cannot be estimated from the available data

• You have high fever, muscle cramps or stiffness, dizziness, very bad headache, fast heart beat, confusion, agitation, hallucinations, or are sweating a lot. This may be signs of a very serious and sometimes deadly health problem called neuroleptic malignant syndrome

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet.

• Dry mouth, blurred vision or you cannot pass water (urine)

• Feeling drowsy or sleepy, tiredness, disorientation, having nightmares, headaches, feeling restless

• Loss of appetite (anorexia), indigestion

• Feeling dizzy, light-headed, faint (hypotension)

• Feeling confused, especially in elderly people

• Being more sensitive to the sun than usual. If this happens keep out of direct sunlight and do not use sun lamps

Reporting of Side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Phenergan

Keep out of the sight and reach of children Do not take your tablet after the expiry date which is stated on the carton/blister after ‘Exp’. The expiry date refers to the last day of that month.

Do not store above 30°C. Store in the original package in order to protect from light.

If the tablets become discoloured or show any visible signs of deterioration, seek the advice of your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Phenergan contains

Each film-coated tablet contains 25mg promethazine hydrochloride. The other ingredients are lactose monohydrate, maize starch, povidone K30, magnesium stearate, macrogol 200, indigo carmine (E132), titanium dioxide (E171) and hypromellose.

What Phenergan looks like and contents of the pack

Phenergan are pale blue, film-coated, circular biconvex marked ‘PN 25’ on one side and plain on the other.

Phenergan is available in blister pack of 56 tablets.

Manufactured by: Famar Healthcare Services Madrid, S.A.U., Avenida de Leganes 62, 28923 Alcoron, Spain.

Procured from within the EU and repackaged by the Product Licence holder:

B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Phenergan 25mg Tablets, r-p-i

PL 18799/2345 ¹-¹

Leaflet date: 14.03.2016

Phenergan is a registered trademark of Sanofi.

• For short-term use: as a sedative for children aged 5 years and above

Promethazine

hydrochloride 25mg Tablets

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

• Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again

• Ask your pharmacist if you need more information or advice

• 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.

• You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

The name of your medicine is Promethazine hydrochloride 25mg Tablets but will be referred as Promethazine throughout this leaflet.

What is in this leaflet:

1. What Promethazine is and what it is used for

2. What you need to know before you take Promethazine

3. How to take Promethazine

4. Possible side effects

5. How to store Promethazine

6. Contents of the pack and other Information

1. What Promethazine is and what I • it is used for I l

Promethazine contain a medicine called promethazine hydrochloride. This 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 Promethazine is used for

Promethazine are used to treat the following conditions:

• For short-term use: to treat adults with difficulty sleeping (insomnia)

• To treat allergic conditions such as hay fever or rashes (like nettle rash or hives)

• To treat or stop you feeling sick (nausea) or being sick (vomiting) such as travel sickness

2. What you need to know before you take Promethazine

Do not take this medicine if:

x The person taking the medicine is under 5 years of age

x You are allergic (hypersensitive) to promethazine hydrochloride or any of the other ingredients of Promethazine (listed in Section 6 overleaf). The signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

x You are taking a medicine for depression called a monoamine oxidase inhibitor (MAOI). Also do not take Promethazine if you have stopped taking one of these MAOI medicines within the last 14 days. If you are not sure ask your doctor or pharmacist (see Taking other medicines’ section overleaf) x The person is unconscious (in a coma) or suffers from severe dizziness, drowsiness or headache

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 Promethazine.

Warnings and precautions Check with your doctor or pharmacist before taking your medicine if

▲ You have difficulty breathing, wheezing, tightness in the chest (asthma) or an infection in your lungs (bronchitis)

▲ You have epilepsy

▲ You have any serious heart problems

▲ You have liver or kidney problems

▲ You have a stomach blockage or difficulty passing water

▲ You have hearing problems

▲ You have increased pressure in the eye (narrow angle glaucoma)

▲ You have had something called Reye’s Syndrome or possible Reye’s Syndrome - signs include being sick and confused following a viral illness

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

There have been some cases of abuse with this medicine. The risk of abuse is greater in those with a history of drug abuse.

Other medicines and Promethazine

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you can buy without prescription, including herbal medicines. This is because Promethazine can affect the way some medicines work. Also some medicines can affect the way Promethazine work.

Do not take this medicine, and tell your doctor, if you are taking or have taken the following in the last 2 weeks:

• Some medicines for depression called monoamine oxidase inhibitors (MAOIs). If you are not sure ask your doctor or pharmacist

Tell your doctor or pharmacist if you are taking any of the following:

• Anticholinergic medicines - includes some medicines used for irritable bowel syndrome, asthma or weak bladder.

• These can increase the risk of dizziness, dry mouth and blurred eyesight

• Medicines for depression (such as amitriptyline)

• Medicines to help you to sleep or feel more relaxed (such as diazepam or zolpidem)

• Medicines such as aspirin (for arthritis and pain in your joints). Promethazine may hide the side effects of these medicines

Promethazine with food and drink

Do not drink alcohol while you are taking Promethazine. This is because it can affect the way the medicine works

Promethazine should not be taken 2 weeks before birth.

You should not take Promethazine 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 breastfeed, talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Promethazine contains lactose:

• This is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine

3. How to take Promethazine

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The amount you need to take depends on the reason you are taking Promethazine. The following information will help you to decide how much you need to take.

Taking this medicine

• Take this medicine by mouth

• Do not take for longer than 7 days.

• If your symptoms worsen or do not improve after 7 days talk to your doctor or pharmacist

• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

How much to take

The recommended dose is:

For allergies (such as hay fever, rashes and hives)

Children 2-5 years:

• Promethazine Elixir should be given in this age group

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

Children 5-10 years:

• A single tablet (25mg) given at night

• DO NOT give more than 25mg each day

Children over 10 years and adults (including the elderly):

• Start with one tablet (25mg) taken at night

• This may be increased to a maximum of one tablet (25mg) twice a day if necessary

For treatment and prevention of feeling sick or being sick (such as travel sickness)

Children 2-5 years:

• Promethazine Elixir should be given in this age group

Children 5-10 years:

• Promethazine Elixir or Promethazine 10mg Tablets should be given in this age group

Children over 10 years and adults (including the elderly):

• A single tablet (25mg) to be taken the night before the journey

• This may be repeated after 6-8 hours if necessary

As a short-term paediatric sedative and for short term treatment of insomnia in adults Children 2-5 years:

• Promethazine Elixir should be given in this age group

Children 5-10 years:

• A single tablet (25mg) given at night.

Children over 10 years and adults (including the elderly):

• One or two tablets (25mg-50mg) taken at night

Use this medicine only as recommended. Do not exceed the recommended dose.

Exposure to sunlight

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

If you take more Promethazine than you should

If you or your child takes more Promethazine 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 or your child has taken.

The following effects may happen:

In adults: Feeling sleepy or drowsy, fits, loss of consciousness, uneven heart beat and breathing difficulties.

If you forget to take Promethazine

Do not take a double dose to make up for a forgotten dose

• If you are taking Promethazine for an allergic condition - take your medicine as soon as you remember, then carry on as before

• If you are taking Promethazine for sedation or sleeping problems - miss that dose and take the next evening’s dose as usual

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Tests

Taking Promethazine may affect the results of certain tests. These include some pregnancy tests and skin tests. Promethazine should not be taken at least 3 days before the start of a skin test.

4. Possible side effects

Like all medicines, Promethazine can cause

side effects, although not everybody gets them.

Stop taking Promethazine 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)

• Muscle stiffness or shaking

• Being unable to control some muscles in your head or face

• You notice unusual movements of the tongue, facial muscle spasms, rolling eyes and trembling

• Very fast, uneven or forceful heart beat (palpitations)

• Irregular heart beat

• Tiredness which lasts for a long time. This may be due to a blood problem called anaemia

• Over-active behaviour in children

Not known: frequency cannot be estimated from the available data

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet.

• Dry mouth, blurred vision or you cannot pass water (urine)

• Feeling drowsy or sleepy, tiredness, disorientation, having nightmares, headaches, feeling restless

• Loss of appetite (anorexia), indigestion

• Feeling dizzy, light-headed, faint (hypotension)

• Feeling confused, especially in elderly people

• Being more sensitive to the sun than usual. If this happens keep out of direct sunlight and do not use sun lamps

Reporting of Side effects

6. Contents of the pack and other information

What Promethazine contains

What Promethazine looks like and contents of the pack

Promethazine are pale blue, film-coated, circular biconvex marked ‘PN 25’ on one side and plain on the other.

Promethazine is available in blister pack of 56 tablets.

Manufactured by: Famar Healthcare Services Madrid, S.A.U., Avenida de Leganes 62, 28923 Alcoron, Spain.

Procured from within the EU and repackaged by the Product Licence holder:

B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Promethazine hydrochloride 25mg Tablets, PL 18799/2345

Leaflet date: 14.03.2016 ^

5. How to store Promethazine

Keep out of the sight and reach of children Do not take your tablet after the expiry date which is stated on the carton/blister after ‘Exp’. The expiry date refers to the last day of that month.

Do not store above 30°C. Store in the original package in order to protect from light.

If the tablets become discoloured or show any visible signs of deterioration, seek the advice of your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.