Document: leaflet BOOTS_PL 20417-0063 change

• leaflet BOOTS_PL 20417-0063
• leaflet MAH GENERIC_PL 20417-0063

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200 mm

fhfdrmatroh for the user

Paracetamol Extra Effervescent Tablets 500 mg/65 mg

(Paracetamol, Caffeine)

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.

•    You must talk to a doctor if you do not feel better or if you feel worse

What this medicine is for

This medicine contains paracetamol which belongs to a group of medicines called analgesics and antipyretics that relieve mild to moderate pain and reduce fever. Caffeine helps to increase the pain relief.

It can be used to relieve headache, migraine, toothache, period pain, backache, rheumatic aches and pains, sore throats and the symptoms of colds and flu.

Before you take this medicine

This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

XDo not take:

•    If you are allergic to any of the ingredients in this medicine (see "What is in this medicine")

•    If you are pregnant or breastfeeding

f Talk to your pharmacist or doctor:

•    If you have kidney or liver problems (including a disease caused by drinking alcohol)

•    If you have phenylketonuria (this medicine contains aspartame, a source of phenylalanine, which may be harmful to you)

•    If you are on a low salt (sodium) diet (each tablet contains 409 mg of sodium, which may be harmful to you)

Other important information

This medicine contains caffeine, which is also found in tea, coffee, chocolate and some fizzy drinks such as cola. Taking too much caffeine can cause difficulty sleeping, shaking or a thumping sensation in the chest (palpitations).

You must not drink tea, coffee, chocolate or fizzy drinks containing caffeine if you need to take this medicine.

Do not drink alcohol (e.g. wine, beer, spirits) whilst taking this medicine.

If you take other medicines

f This medicine contains paracetamol.

Do not take anything else containing paracetamol while taking this medicine.

Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

•    Domperidone or metoclopramide for feeling sick or being sick (may increase the pain relief effect of paracetamol)

•    Colestyramine for reducing blood fat levels (may reduce the pain relief effect of paracetamol)

•    Warfarin or other blood thinners - if you take warfarin you can take occasional amounts of this medicine, but talk to your doctor first before you take it on a regular basis

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

Do not give to children under 12 years.

Do not take more than the amount recommended above.

If you do not get better, or your headache becomes persistent, talk to your doctor.

f If you take too many tablets: Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

f If you get any of these serious side effects, stop taking the tablets.

See a doctor at once:

•    Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

•    Allergic skin reactions (which can sometimes be severe and include peeling, blistering and lesions of the skin)

•    Signs of caffeine sensitivity including

-    Difficulty sleeping, dizziness, nervousness, restlessness, irritability, anxiety, palpitations

-    Headache, stomach upset Breathing problems are more likely if you have asthma and have experienced them before when you have taken other medicines such as aspirin or ibuprofen (non-steroidal anti-inflammatory medicines).

If you get any of the following side effects see your doctor or pharmacist:

•    Other allergic reactions (e.g. skin rash)

•    Unusual bruising, or infections such as sore throats - this may be a sign of very rare changes in the blood

•    Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be signs of liver problemsj

Information for the user

Paracetamol Extra Effervescent Tablets 500 mg/65 mg

(Paracetamol, Caffeine)

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.

•    You must talk to a doctor if you do not feel better or if you feel worse

What this medicine is for

This medicine contains paracetamol which belongs to a group of medicines called analgesics and antipyretics that relieve mild to moderate pain and reduce fever. Caffeine helps to increase the pain relief.

It can be used to relieve headache, migraine, toothache, period pain, backache, rheumatic aches and pains, sore throats and the symptoms of colds and flu.

Before you take this medicine

This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

XDo not take:

•    If you are allergic to any of the ingredients in this medicine (see "What is in this medicine")

•    If you are pregnant or breastfeeding

f Talk to your pharmacist or doctor:

•    If you have kidney or liver problems (including a disease caused by drinking alcohol)

•    If you have phenylketonuria (this medicine contains aspartame, a source of phenylalanine, which may be harmful to you)

•    If you are on a low salt (sodium) diet (each tablet contains 409 mg of sodium, which may be harmful to you)

Other important information

This medicine contains caffeine, which is also found in tea, coffee, chocolate and some fizzy drinks such as cola. Taking too much caffeine can cause difficulty sleeping, shaking or a thumping sensation in the chest (palpitations).

You must not drink tea, coffee, chocolate or fizzy drinks containing caffeine if you need to take this medicine.

Do not drink alcohol (e.g. wine, beer, spirits) whilst taking this medicine.

If you take other medicines

f This medicine contains paracetamol.

Do not take anything else containing paracetamol while taking this medicine.

Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

•    Domperidone or metoclopramide for feeling sick or being sick (may increase the pain relief effect of paracetamol)

•    Colestyramine for reducing blood fat levels (may reduce the pain relief effect of paracetamol)

•    Warfarin or other blood thinners - if you take warfarin you can take occasional amounts of this medicine, but talk to your doctor first before you take it on a regular basis

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

Do not give to children under 12 years.

Do not take more than the amount recommended above.

If you do not get better, or your headache becomes persistent, talk to your doctor.

f If you take too many tablets: Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

f If you get any of these serious side effects, stop taking the tablets.

See a doctor at once:

•    Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

•    Allergic skin reactions (which can sometimes be severe and include peeling, blistering and lesions of the skin)

•    Signs of caffeine sensitivity including

-    Difficulty sleeping, dizziness, nervousness, restlessness, irritability, anxiety, palpitations

-    Headache, stomach upset Breathing problems are more likely if you have asthma and have experienced them before when you have taken other medicines such as aspirin or ibuprofen (non-steroidal anti-inflammatory medicines).

If you get any of the following side effects see your doctor or pharmacist:

•    Other allergic reactions (e.g. skin rash)

•    Unusual bruising, or infections such as sore throats - this may be a sign of very rare changes in the blood

•    Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be signs of liver problemsj