RELPAX 40MG TABLETS

Active substance: ELETRIPTAN HYDROBROMIDE

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1. What Relpax is and what it is used for
Relpax is one of a group of medicines called serotonin receptor agonists.
Serotonin is a natural substance found in the brain that helps to narrow the blood vessels.
Relpax can be used to treat migraine headache with or without aura.
Before the start of a migraine headache, you may experience a phase called an aura, which can involve
vision disorders, numbness and speech disorders.
2. Before you take Relpax
Do not take Relpax:
• If you are allergic (hypersensitive) to eletriptan, or any of the other ingredients of Relpax. For a full
list of ingredients, see Section 6 ‘Further Information’.
• If you have severe liver or kidney disease.
• If you have moderate to severe high blood pressure or untreated mild high blood pressure.
• If you have ever had heart problems, (e.g. heart attack, angina, heart failure or significant abnormal
heart rhythm (arrhythmia)).
• If you have poor circulation (peripheral vascular disease).
• If you have ever had a stroke (even a mild one that lasted for only a few minutes or hours).
• If you have taken ergotamine or medicines like ergotamine (including methysergide) within 24 hours
before or after taking Relpax.
• If you are taking any other medicines that end in ‘triptan’ (for example sumatriptan, rizatriptan,
naratriptan, zolmitriptan, almotriptan and frovatriptan).

Take special care with Relpax
Medicines are not always suitable for everyone. Your doctor needs to know before you take Relpax if any of
the following apply to you, so tell your doctor if:
• you have diabetes.
• you smoke or use nicotine replacement therapy.
• you are male and over 40 years.
• you are female and post-menopausal.
• you or anybody in your family have coronary artery disease.
• you have ever been told that you may have an increased risk of heart disease, discuss this with
your doctor before using Relpax.

DATE:

CUSTOMER
APPROVED:

Please consult your doctor and do not take Relpax, if these statements apply to you now or have applied to
you at any time in the past.

Repeat use of migraine medicines
If you repeatedly use Relpax or any medicines for the treatment of migraine over several days or weeks, this
can cause daily long-term headaches. Tell your doctor if you experience this as you might need to stop
treatment for a while.

DATE:
15/03/13
DATE OF PROOF:

Taking Relpax together with some medicines may cause serious side effects. Do not use Relpax if:
• you have taken ergotamine or medicines like ergotamine (including methysergide) within 24 hours
before or after taking Relpax
• you are taking any other medicines that end in ‘triptan’ (for example sumatriptan, rizatriptan,
naratriptan, zolmitriptan, almotriptan and frovatriptan).
Some medicines can affect the way Relpax works, or Relpax itself can reduce the effectiveness of other
medicines taken at the same time.
These include:
• Drugs used to treat fungal infections (e.g. ketoconazole and itraconazole).
• Drugs used to treat bacterial infections (e.g. erythromycin, clarithromycin and josamycin).
• Drugs used to treat AIDS and HIV (e.g. ritonavir, indinavir and nelfinavir).

UK PIL DATED APRIL 2011

64641660B

The herbal preparation St John’s wort (Hypericum perforatum) should not be taken at the same time as this
medicine. If you already take St John’s wort, consult your doctor before stopping the St John’s wort
preparation.

CODE:

Q.A.
APPROVED:
DT

PRE-PRESS NO.:

04-1957

PRODUCT:

CUSTOMER: Waymade

Relpax 40mg tabs

ARTWORKER:

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.

Tell your doctor before starting treatment with eletriptan, if you are taking some medicines (commonly
referred to as SSRIs* or SNRIs**) for depression and other mental disorders. These medicines may increase
the risk of developing serotonin syndrome during combined use with certain migraine medications. See
Section 4 ‘Possible Side Effects’ for more information on the symptoms of serotonin syndrome.
*SSRIs – Selective serotonin re-uptake inhibitors
**SNRIs – Serotonin norepinephrine reuptake inhibitors
Taking Relpax with food and drink
Relpax can be used before or after food and drinks.
Pregnancy and Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you think you might be pregnant, or are planning to get pregnant, tell your doctor before you take Relpax
as it may not be suitable.
Tell your doctor if you are breast-feeding. It is recommended to avoid breast-feeding for 24 hours after taking
this medicine.
Driving and using machines
Relpax or the migraine itself may make you sleepy. This medicine may also make you feel dizzy. Therefore
avoid driving and using machines during the migraine attack or after taking your medicine.
Important information about some of the ingredients of Relpax
Relpax contains lactose, a type of sugar. If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.
This medicine contains the dye Sunset Yellow Aluminium Lake (E110) which may cause allergic reactions.
3. How to take Relpax
Always take Relpax exactly as your doctor tells you. You should check with your doctor or pharmacist if you
are still not sure.
Adults
Your medicine can be taken at any time after the start of the migraine headache, but it is best to take it
as soon as possible. However you should only take Relpax during the headache phase of the
migraine. You should not take this medicine to prevent a migraine attack.
• The usual starting dose is one 40 mg tablet
• Swallow each tablet whole with a drink of water.
• If the first tablet does not relieve your migraine, do not take a second tablet for the same attack.
• If after a first tablet your migraine is relieved and then comes back, you may take a second tablet.
However, after taking the first tablet you must wait at least 2 hours before taking the second tablet.
• You should not take more than 80 mg (2 x 40 mg tablets) within 24 hours.
• If you find that a dose of one 40 mg tablet does not relieve your migraines, tell your doctor – he or
she may decide to increase the dose to two 40 mg tablets for future attacks.

WARNING!

ARIAL REGULAR FONT SIZE 8
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CRESTOR 6464/2069 2070

In this leaflet:
1. What Relpax is and what it is used for
2. Before you take Relpax
3. How to take Relpax
4. Possible side effects
5. How to store Relpax
6. Further information

PROOF HISTORY:
v.2 - waymade - 15/03/13

Leaflet Flat Size = 148 x 432

Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

This product is available as the above names but will be referred to as Relpax throughout this leaflet.

WARNING!

27mm

RELPAX® 40 mg TABLETS/
ELETRIPTAN 40 mg TABLETS
(eletriptan hydrobromide)
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000B

If you take more Relpax than you should
If you accidentally take too much Relpax contact your doctor at once or go to the nearest hospital casualty
department. Always take the labelled medicine package with you, whether there is any medicine left or not.
Side effects from taking too much Relpax include high blood pressure and heart problems.

Leaflet Flat Size = 148 x 432

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

If you forget to take Relpax
If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take
a double dose to make up for a missed dose.
If you have any further questions on how to take this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Relpax can cause side effects, although not everybody gets them.

Other side-effects that may occur are:
Common side effects
(affects 1 to 10 users in 100)
• Chest pain or tightness or pressure, Heart palpitations, Increased heart rate,
• Dizziness, Sensation of spinning or whirling (Vertigo), Headache, Feeling sleepy, Reduced sense
of touch or pain
• Sore throat, Throat tightness, Dry mouth
• Abdominal and stomach pain, Indigestion (upset stomach), Nausea (sensation of unease and
discomfort in stomach or abdomen with an urge to vomit)
• Stiffness (Increased muscle tone ), Muscle weakness, Back pain, Muscle pain
• Generally feeling weak, Feeling hot, Chills, Runny nose, Sweating, Tingling or abnormal sensation,
Flushing
Uncommon side effects
(affects 1 to 10 users in 1000)
• Difficulty breathing, Yawning.
• Swelling of the face or hands and feet, Inflammation or infection of the tongue, Skin rash, Itching
• Increased sense of touch or pain (Hyperaesthesia), Loss of co-ordination, Slow or reduced
movement, Tremor, Slurred speech
• Not feeling oneself (Depersonalisation), Depression, Thinking strangely, Feeling agitated, Feeling
confused, Mood swings (Euphoria), Periods of unresponsiveness (Stupor), General feeling of
discomfort, illness or lack of wellbeing (Malaise), Sleeplessness (Insomnia)
• Loss of appetite and weight loss (Anorexia), Taste disturbance, Thirst
• Degeneration of the joints (Arthrosis), Bone pain, Joint pain
• Increased need to pass water (urinate), Problems with urinating, Passing excessive quantity of
urine, Diarrhoea
• Abnormal vision, Eye pain, Intolerance to light, Dry or watery eyes
• Ear pain, Ringing in the ears (Tinnitus)
• Poor circulation (Peripheral vascular disorder)

DATE:

DT

15/03/13

ARTWORKER:

DATE OF PROOF:

DATE:

Q.A.
APPROVED:
04-1957
PRE-PRESS NO.:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.2 - waymade - 15/03/13

Tell your doctor immediately if you experience any of the following symptoms after taking this medicine.
• Sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching
(especially affecting the whole body) as this may be a sign of a hypersensitivity reaction.
• Chest pain and tightness, which may be intense and involve the throat. These may be symptoms of
problems of the blood circulation of the heart (Ischaemic heart disease).
• Signs and symptoms of serotonin syndrome which may include restlessness, hallucinations, loss of
co-ordination, fast heart beat, increase body temperature, fast changes in blood pressure and
overactive reflexes.

Rare side effects
(affects 1 to 10 users in 10,000)
• Shock, Asthma, Hives (Urticaria), Skin disorder, Swollen tongue
• Throat or chest infection, Swollen lymph glands
• Slow heart rate
• Emotionally fragile (mood swings)
• Degeneration of joints (Arthritis), Muscle disorder, Twitching
• Constipation, Inflamed gullet, Belching
• Breast Pain, Heavy or prolonged menstrual periods
• Eye infection (Conjunctivitis)
• Changes to voice
Other side effects reported include fainting, high blood pressure, inflammation of the large intestine and
vomiting.

64641660B
CODE:

UK PIL DATED APRIL 2011

Relpax 40mg tabs
PRODUCT:

CUSTOMER: Waymade

Your doctor may also take regular blood samples to test for raised liver enzymes or any blood problems.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.







5. How to store Relpax
Relpax should not be stored above 30°C.
Keep out of sight and reach of children.
Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to
the last day of that month.
If the tablets become discoloured or show any other signs of deterioration, seek the advice of your
pharmacist.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
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. Further information
What Relpax contains
Relpax contains the following inactive ingredients:
lactose monohydrate, hypromellose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate,
glycerol triacetate, Sunset Yellow Aluminium Lake (E110) and titanium dioxide (E171).
What Relpax looks like and contents of the pack
Each Relpax 40 mg tablet/Eletriptan 40 mg tablet contains 40 mg of the active ingredient, eletriptan (as
eletriptan hydrobromide) in an orange, round, film-coated tablet marked ‘Pfizer’ on one side and ‘REP 40’ on
the other side.
Relpax 40 mg tablets/Eletriptan 40 mg tablets are available as blister packs of 6 tablets.
POM

PL No: 6464/1660

This product is manufactured by Pfizer Manufacturing Deutschland GmbH, Illertissen, Germany and is
procured from within the EU and repackaged by the Product Licence holder who is:
Waymade plc Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 14.03.2013
Relpax is a registered trademark of Pfizer Products Inc.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Liver Impairment
This medicine can be used in patients with mild or moderate liver problems. No dose adjustment is required
for mild or moderate liver impairment.

WARNING!

Kidney Impairment
This medicine can be used in patients with mild or moderate kidney problems. In these patients a starting
dose of 20 mg is recommended, and the total daily dose should not be more than 40 mg. Your doctor will tell
you what dose to take.

WARNING!

Elderly
Relpax tablets are not recommended for patients over 65 years of age.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Children and adolescents under 18 years
Relpax tablets are not recommended for children and adolescents under 18 years of age.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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