RELPAX 20MG FILM-COATED TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

RELPAX 20 and 40mg
eletriptan



Film-coated tablets

1. WHAT RELPAX IS AND WHAT IT IS USED FOR
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. 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.

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). 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.

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

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

This medicine contains the dye Sunset Yellow Aluminium Lake (E 110) 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.

Taking Relpax with food and drink
Relpax can be used before or after food and drinks.

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.
YOU WILL FIND OUT MORE ABOUT RELPAX ON THE NEXT PAGE OF THIS LEAFLET

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.

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.

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.

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.

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.

UK

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

If you have any further questions on how to take this product, ask your doctor or pharmacist.

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

4. POSSIBLE SIDE EFFECTS
Like all medicines, Relpax can cause side effects, although not everybody gets them. 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. 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) 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

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.

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.

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. 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.

6. FURTHER INFORMATION
What Relpax contains
The active ingredient is eletriptan (as eletriptan hydrobromide). Each Relpax 20 mg Film-coated tablet contains 20 mg of eletriptan (as eletriptan hydrobromide). Each Relpax 40 mg Film-coated tablet contains 40 mg of eletriptan (as eletriptan hydrobromide). The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, titanium dioxide (E 171), hypromellose, glycerol triacetate and Sunset Yellow Aluminium Lake (E 110).

Marketing Authorisation Holder and Manufacturer
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ

Manufacturer responsible for batch release within the EU:
Pfizer Manufacturing Deutschland GmbH. Heinrich-Mack-Str. 35 D-89257 Illertissen Germany. This medicinal product is authorised in the member states of the EEA under the following names: Relert 20 mg and 40 mg Film Coated Tablets: Belgium, Finland, France, Luxembourg, Portugal, Spain, United Kingdom. Relpax 20 mg and 40 mg Film Coated Tablets: Austria, Denmark, France, Germany, Greece, Iceland, Ireland, Italy, Norway, Spain, Sweden, The Netherlands, United Kingdom. This leaflet was last approved in 04/2011. For further information on this medicine please contact Pfizer Medical Information on 01304 616161

What Relpax looks like and contents of the pack

5. HOW TO STORE RELPAX
Keep out of the reach and sight of children. PVC /Aclar /Aluminium blister packs: There are no special storage instructions. HDPE bottles: Keep the tablets in their original container. Keep the container tightly closed when not in use to protect from moisture. Do not use this medicine after the expiry date which is stamped on the pack or bottle. The expiry date refers to the last day of that month. 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.

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.

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.

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MOCKUP

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Relpax film-coated tablets are orange, round tablets. Relpax 20 mg film-coated tablets are marked PFIZER on one side and REP 20 on the other side. Relpax 40 mg film-coated tablets are marked PFIZER on one side and REP 40 on the other side. Relpax is available in opaque PVC /Aclar/Aluminium blister packs containing 2, 3, 4, 6, 10, 18, 30 and 100 tablets or in HDPE bottles with child-resistant HDPE/PP closures containing 30 and 100 tablets. Not all pack sizes may be marketed.