If you forget to take Remedeine or Rmedeine Forte tablets If you miss a dose you should take it as soon as you remember and then carry on as before. Do not take a double dose to make 151 for a forgotten tablet

If you stop taking Remedeine or Remedeine Forte tablets You should not stop taking these tablets unless your doctor tells you to. If you want to slop taking your tablets, discuss this with your doctor first

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

Taking a painkiller for headaches too often or for too long can make your headaches worse.

Common side effects (Probably affecting more than 1 in 100 people taking these tablets)

Most people will have constipation when they take these tablets.

Your doctor can prescribe a laxative to overcome this problem.

You may feel sick or vomit (be sick) when you take your tablets, this should normally wear off after a few days however your doctor can prescribe an anti-vomiting medicine if it continues to be a problem.

You may find that you feel more sleepy than normal when you start taking your tablets or when your dose is increased. This should wear offafterafewdays.

The following side effects have also been commonly reported in patients treated with these tablets:

•    Headache.

•    Rash or itchy skin.

Uncommon side effects (Probably affecting fewer than 1 in 100 people taking these tablets)

•    An unpleasant or uncomfortable mood.

•    Hallucinations.

•    A feeling of dizziness or ‘ spinning’.

•    Difficulty in passing urine.

•    Aneed to take increasingly higher doses to obtain the same level of pain relief (tolerance).

•    Withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping taking the tablets.

Rare side effects (Probably affecting fewer than 1 in 1,000 people taking these tablets)

•    Inflammation ofthe pancreas (which causes severe pain in the abdomen and back).

•    Abnormal cells in the blood (blood dyscrasias).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possibile 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.

4. Possible side effects

5. How to store Remedeme and Remedeine Forte tablets

Like all medicines, this medicine can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.

As with all strong painkillers, there is a risk you may become addicted or reliant on these tablets.

Keep this medicine out of the sight and reach of children.

Do not use any tablets afler the expiry date which is stated on the carton EXP 08 2010 means that you should not take the tablets after the last day of that month Le. August 2010.

Do not store your tablets above 30°C. Keep the bottle tightly closed to protect the tablets fiom moisture.

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

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•    have prostate problems; • atypeofmedicineknownasamonoamineoxidaseinhibitar medicines,theeffectoflhesetabletsortheothermedicmemaybe

^{r r} chaneed.

•    are addicted to alcohol; (examples include tranylcypromide, phenelzine, isocaiboxazid, °

•    areorhaveeverbeenaddictedtodrugs. moclobemide and linezolid), or you have taken this type of Other special warnings:

medicine in the last two weeks; * Do not take for longer than directed by your prescriber.

Taking other medicines j . _medicines to treat depression or anxiety; j * Taking dihydrocodeine regularly for a long time can lead to | Tell your doctor or pharmacist if you are taking: j . _{metoclopraini(]e OT} domperidone _to stop you feefing or being sick; | addiction, which might cause you to feel restless and irritable

•    any ota medicines containing paracetamol (you should not take j . colestyraminetotreathighbloodpressureordiarrhoea; when you stop taking the tablets.

tee tablets ifyou are already taking anote medicine containing | . medici^^asw^topreventyo^biooddotangorto j * Taking* parntaller for headaches too often or for too long can

5“*“* ! help thin your blood. !

•    medicines to help you sleep (for example tranquillisers, hypnotics _n1 i1T , _A , . ._r t. , Taking Remedeme or RemedemeForte with alcohol

^{rv r} ' Please tell your doctor or pharmacist if you are taking or have

or sedatives); recently taken any other medicines, including medicines obtained Drinking alcohol during your treatment with these tablets may make

•    medicines to treat psychiatric or mental disorders; without a prescription. If you take these tablets with some other you sleepy. If you are affected you should avoid drinking alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding do not take these tablets until you have spoken to your doctor.

Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines

You may feel sleepy when taking these tablets. If you are affected you should not drive or use machinery. This medicine can affect your ability to drive. Do not drive whilst taking this medicine until you know how this medicine affects you. It may be an offence to drive if your ability to drive safely is affected There is forte information for patients who are intending to drive in Great Britain - go to https://www.gov.uk/drug-driving-law

The usual starting dose for adults and children over 12 years of age is one or two tablets every 4 to 6 hours. If you are elderly your doctor may suggest a lower starting dose. Your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking these tablets discuss this with your doctor.

Do not take more than eight tablets in 24 hours.

Do not take these tablets if you are already taking another medicine containing paracetamol.

If you take more Remedeme or Remedeme Forte tablets than you should or if someone accidentally swallows your tablets

Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy and sick, and have abdominal pain. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. 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 fiver damage. When seeking medical attention make sure that you take this Met and any remaining tablets with you to show the doctor.

3. How to take Remedeme and Remedeme Forte tablets

Two different strengths of tablets are available. Your doctor will decide which strength of tablet will suit you best Always take these tablets exactly as your doctor has told you. The label on your medicine will tell you how many tablets to take and how often. Do not take for longer than directed by your doctor. You should check with your doctor or pharmacist if you are not sure. Swallow your tablets whole with a glass of water.

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If you forget to take Remedeine or Remedeine Forte tablets If you miss a dose you should take it as soon as you remember and then carry on as before. Do not take a double dose to make up for a forgotten tablet

If you stop taking Remedeine or Remedeine Forte tablets You should not stop taking these tablets unless your doctor tells you to. If you want to stop taking your tablets, discuss this with your doctor first

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

Taking a painkiller for headaches too often or for too long can make your headaches worse.

Common side effects (Probably affecting mcme than 1 in 100 people taking these tablets)

Most people wib have constipation when they take these tablets.

Your doctor can prescribe a laxative to overcome this problem.

You may feel sick or vomit (be sick) when you take your tablets, this should normaby wear off after a few days however your doctor can prescribe an anti-vomiting medicine if it continues to be a problem.

You may find that you feel more sleepy than normal when you start taking your tablets or when your dose is increased. This should wear offafterafewdays.

The fobowing side effects have also been commonly reported in patients treated with these tablets:

•    Headache.

•    Rash or itchy skin.

Uncommon side effects (Probably affecting fewer than 1 in 100 people taking these tablets)

•    An unpleasant or uncomfortable mood.

•    Habucinations.

•    A feeling of dizziness or ‘ spinning’.

•    Difficulty in passing urine.

•    Aneed to take increasingly higher doses to obtain the same level of pain relief (tolerance).

•    Withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping taking the tablets.

Rare side effects (Probably affecting fewer than 1 in 1,000 people taking these tablets)

•    Inflammation ofthe pancreas (which causes severe pain in the abdomen and back).

•    Abnormal cells in the blood (blood dyscrasias).

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/yebowcard. By reporting side effects you can help provide more information on the safety of this medicine.

4. Possible side effects

5. How to store Remedeine and Remedeine Forte tablets

Like all medicines, this medicine can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or bps, rash or itching especiaby those covering your whole body.

As with ah strong painkillers, there is a risk you may become addicted or reliant on these tablets.

Keep this medicine out of the sight and reach of chbdren Do not use any tablets after the expiry date which is stated on the carton EXP 08 2010 means that you should not take the tablets after the last day of that month Le. August 2010.

Do not store your tablets above 30°C. Keep the bottie tightly closed to protect the tablets fiom moisture.

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

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Read all of this leaflet carefully before you start taking this

medicine.

•    KeepthisleafletYoumayneedtoreaditagam.

•    If you have any further questions, ask your doctor or pharmacist

•    Thismedicinehasbeenprescribedforyou.Donotpassitonto others. It may harm them, even if their symptoms are die same as yours.

•    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet:

1.    What/iemafemcandfianaiancfortetabletsareandwhatthey are used for

2.    Before you take Remedeine or Remedeme Forte tablets

3.    How to take Remedeme and Remedeme Forte tablets

4.    Possible side effects

5.    How to store Remedeine and Remedeme Forte tablets

6.    Further information

Take special care with Remedeme and Remedeme Forte tablets Before treatment with these tablets tell your doctor or pharmacist if you:

•    have asthma or any allergies;

•    have an under-active thyroid gland (hypothyroidism);

•    have kidney or long-term liver problems;

•    have a severe headache or feel sick due to a head injury or increased pressure in your skull (for instance due to brain disease). This is because the tablets may make these symptoms worse or hide the extent of a head injury;

•    have prostate problems;

•    are addicted to alcohol;

•    are or have ever been addicted to drugs.

Taking other medicines

Tell your doctor or pharmacist if you are taking:

•    anyothermedicinescontainingparacetamol these tablets if you are already taking another paracetamol);

•    medicines to help you sleep (for example ton or sedatives);

•    medicines to treat psychiatric or mental dison

Package Leaflet: Information for the user

Remedeind® and Remedeine Forte* tablets Paracetamol and Dihydrocodeine tartrate

1. What Remedeme and Remedeme Forte tablets are and what they are used for

These tablets have been prescribed for you to relieve severe pain over a period of 4 to 6 hours. They contain the active ingredients dihydrocodeine and paracetamol which belong to a group of medicines called strong analgesics or ‘painkillers’. The other ingredients are listed in section 6 of this leaflet

2. Before you take Remedeme or Remedeine Forte tablets Do not take Remedeme or Remedeme Forte tablets if you:

•    are allergic (hypersensitive) to dihydrocodeine, paracetamol or any of the other ingredients of the tablets (see section 6 ‘Further Information’);

•    have breathing problems, such as breathing more slowly or weakly than expected, or obstructive airways disease;

■ are having an asthma attack

Children under 12 years of age should not take these tablets.

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