Naratriptan 2.5mg Film-Coated Tablets
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 foryou. Do not pass it on to others. It may harm them, even iftheirsymptoms 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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Naratriptan 2.5 mg Film-coated tablets
(Naratriptan)
In this leaflet:
1. What Naratriptan is and what it is used for
2. Before you take Naratriptan
3. How to take Naratriptan
4. Possible side effects
5. How to store Naratriptan
6. Further information
1. WHAT NARATRIPTAN IS AND WHAT IT IS USED FOR
This medicinal product contains naratriptan which belongs to a group of medicines called triptans (also known as 5 HT1 receptor agonists).
Naratriptan is used to treat migraine headache with or without distortions, such as seeing light-flashes, zigzag lines, stars, or waves (known as aura).
Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Naratriptan is believed to reduce the widening of these blood vessels. This in turn helps to relieve the headache and other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and sensitivity to light and sound.
2. BEFORE YOU TAKE NARATRIPTAN
Do not take Naratriptan:
- If you are allergic (hypersensitive) to Naratriptan, or any of the other ingredients of this medicine (see section 6)
- If you have or have ever had heart problems, including a heart attack (myocardial infarction), narrowing of arteries (ischaemic heart disease), chest pain which happens while resting (Prinzmetal's angina) or have experienced heart-related symptoms such as shortness of breath or chest pressure
- If you have problems with the blood circulation to your hands and feet (peripheral vascular disease)
- If you have ever had a stroke or a mini-stroke (also called a transient ischaemic attack)
- If you have high blood pressure. You may be able to take Naratriptan if your high blood pressure is mild and is being treated
- If you have serious kidney or serious liver problems
- If you are taking other migraine medicines, including those which contain ergotamine or with similar medicines such as methysergide, or with any other 5-HT1 receptor agonists, such as sumatriptan.
- If you are elderly and over 65 years of age
- If you are under 18 years of age
Take special care with Naratriptan if you
- are at a higher risk of heart disease. This applies if you are a
• heavy smoker or are using nicotine replacement therapy
• woman past the menopause
• man over 40 years of age.
Tell your doctor who will check your heart function before Naratriptan is prescribed to you.In very rare cases, people have developed serious heart conditions after taking Naratriptan, even though they had no signs of heart disease before. Contact your doctor for advice if you have any concerns.
- feel pain or tightness in your chest. This can be quite intensive and may radiate towards your throat. If the symptoms do not disappear or if they become severe, your doctor may recommend you to stop taking Naratriptan.
- are allergic to antibiotics called sulphonamides. If so,
you may also be allergic to Naratriptan.
- are taking medicines for treating your depression or other mental disorders such as selective serotonin reuptake inhibitors (SSRIs)/serotonin nor-epinephrine reuptake inhibitors (SNRIs).
Naratriptan must only be used if a diagnosis of migraine has been clearly established in your case. Certain types of migraines cannot be treated with Naratriptan. You should not take more than the usual dose of Naratriptan.
Taking Naratriptan or any other pain killer too often for a long time may make your headache worse. Tell your doctor if you experience frequent or daily headaches even though you are regularly using medications to treat your headache. Your doctor may recommend you to stop taking Naratriptan.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines must not be taken with Naratriptan and others may cause adverse effects if they're taken with Naratriptan. You must tell your doctor if you are taking:
• any medicines for your migraine which contain any triptan/5HT1 agonist (such as sumatriptan or zolmitriptan). Do not take Naratriptan at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Naratriptan.
• ergotamine also used to treat migraine, or similar medicines such as methysergide. Do not take Naratriptan at the same time as these medicines. Stop taking these medicines at least 24 hours before taking Naratriptan.
• any antidepressants classed as selective serotonin reuptake inhibitors (SSRIs), such as citalopram, fluoxetine or paroxetine, or serotonin noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine. If you are not sure, talk to your doctor or pharmacist.
• St John’s Wort (Hypericum perforatum). Using herbal remedies that contain St John's Wort while you are taking Naratriptan may make side effects more likely.
Taking Naratriptan with food and drink
Naratriptan can be taken with or without food.
Fertility, pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Before starting treatment, you must tell your doctor if you are pregnant or if you intend to become pregnant. There are no studies on the use of Naratriptan in pregnant women and it is not known if Naratriptan may harm your unborn baby. Your doctor may recommend that you do not take Naratriptan while you are pregnant.
Breast-feeding
Mothers who wish to breast-feed should discuss with their doctor. It is not known whether Naratriptan passes in to mother's milk. You are advised not to breastfeed for 24 hours after taking Naratriptan. Do not feed your child with milk produced during this period.
Driving and using machines
There is currently no information available about the effect of Naratriptan on the ability to drive and use machines. However, this medicine might cause drowsiness in some people (see section 4). Do not drive or operate machinery if you are affected.
Important information about some of the ingredients of Naratriptan
This medicinal product contains lactose.
Ifyou have been told byyourdoctor thatyou have intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE NARATRIPTAN
Dosage
Always take Naratriptan exactly as your doctor has told you. Your doctor will prescribe the dose of Naratriptan that is right for you. Do not change your dose of Naratriptan without talking to your doctor.
Naratriptan should be taken as soon as you feel a migraine coming on, although it can be taken at any time during an attack.
You must not use Naratriptan to prevent a migraine attack.
The usual dose is:
Adults (18 to 65 years of age)
The usual dose for adults is one Naratriptan 2.5 mg tablet.
If the first tablet relieves your migraine but if your symptoms start to come back, you can take a second Naratriptan tablet 4 hours after your first dose.
The total daily dose should not exceed more than two Naratriptan 2.5 mg tablets.
If the first tablet has no effect on your migraine , do not take the second tablet for the same migraine. Ask your doctor or pharmacist for advice.
Elderly (over 65 years of age)
Naratriptan is not recommended for use in elderly patients.
Adolescents (12 to 17 years of age) and Children (under 12 years of age)
Naratriptan is not recommended for use in children and adolescents
Patients with kidney problems
In patients with mild or moderate kidney problems, the daily dose of Naratriptan should not exceed one Naratriptan 2.5 mg tablet. Do not take Naratriptan if you have severe kidney problems.
Patients with liver problems
In patients with mild or moderate liver problems, the daily dose of Naratriptan should not exceed one Naratriptan 2.5 mg tablet. Do not take Naratriptan ifyou have severe liver problems.
Method of administration
Naratriptan tablet should be swallowed whole with water.
How frequently you should take Naratriptan
Naratriptan is usually taken once a day.
Duration of treatment
Your doctor will advise you on how long your treatment should last. The duration of treatment will depend on how severe your condition is, and how well you are responding to the treatment.
If you take more Naratriptan than you should
If you take too many tablets, or if a child takes a tablet or someone you know has received too much medicine, please tell your doctor or nurse immediately or contact the nearest hospital emergency department.
The following symptoms have been seen when very high doses of Naratriptan have been swallowed: high blood pressure, dizziness, tension in the neck, tiredness and loss ofcoordination.
There is no specific treatment for Naratriptan overdose. The treatment would be based on the symptoms.
If you stop taking Naratriptan
You must take your medicine exactly as directed. Do not stop your therapy on your own for any reason because your condition could worsen. Do not change your dosage schedule without talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
- irregular heartbeat
- heaviness, pressure, tightness or pain in the chest, throat or other parts of the body
- slightly increase in blood pressure which may last for up to 12 hours after taking Naratriptan
Rare side effects (affects 1 to 10 users in 10,000) include:
- pain in the lower left side of the stomach and bloody diarrhoea
- rash
- hives
- itching
- swelling of the face
Very rare side effects (affects less than 1 user in 10,000) include:
- narrowing of the artery that supplies blood to the heart
- chest pain
- heart attack
- poor blood circulation to the arms and legs, causing pain and discomfort
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 NARATRIPTAN
Keep out of the reach and sight of children.
Do not take Naratriptan after the expiry date which is stated on the blister and carton after “EXP”.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 Naratriptan contains
The active substance is Naratriptan. Each Film-coated tablet contains 2.78 mg of Naratriptan hydrochloride equivalent to 2.5 mg of Naratriptan.
The other ingredients are: tablet core: Cellulose microcrystalline, lactose anhydrous, croscarmellose sodium, magnesium stearate, film-coating: hypromellose 6 cp (E464), titanium Dioxide (E 171), triacetin, Iron oxide yellow (E172) and FD&C blue #2/indigo carmine aluminium lake (E132).
What Naratriptan looks like and contents of the pack
Green colored, capsule shaped, film coated tablets debossed with “N” on one side and plain on the other side.
The film-coated tablets are available in:
- PVC/ PVdC/Aluminium blisters orAlu/Alu blisters
Pack size: 12 film-coated tablets
4. POSSIBLE SIDE EFFECTS
Like all medicines, Naratriptan can cause side effects, although not everybody gets them.
Stop taking Naratriptan and see your doctor immediately if the following symptoms occur
Rare side effects (affects 1 to 10 users in 10,000) include:
- a sudden allergic reaction includes shortness of breath, rash, wheezing, swelling of eyelids, face, lips or throat and complete collapse
The following side effects have also been reported:
Common side effects (affects 1 to10 users in 100) include:
- tingling sensation
- dizziness
- drowsiness
- feeling sick
- being sick
- hot flashes
- tiredness
- generally feeling unwell
Uncommon side effects (affects 1 to 10 users in 1,000) include:
- visual disturbances
- slow or fast heartbeat
MarketingAuthorisation Holder and Manufacturer
Orchid Europe Ltd.
Building 3, Chiswick Park,
566 Chiswick High Road,
Chiswick, London, W4 5YA United Kingdom.
This medicinal product is authorised in the Member states of the EEA under the following names:
Belgium - Naratriptan Orchid Europe Ltd 2.5mg
Filmomhulde tabletten Naratriptan Orchid Europe Ltd 2.5 mg comprimes pellicules Naratriptan Orchid Europe Ltd 2.5 mg Filmtabletten
France - Naratriptan Orchid Europe Ltd 2.5 mg
comprimes pellicules
Germany - Naratriptan Orchid Europe Ltd 2.5 mg
Filmtabletten
Spain - Naratriptan Orchid Europe Ltd 2.5 mg
Comprimidos recubiertos con pelicula The Netherlands - Naratriptan Orchid Europe Ltd 2.5mg Filmomhulde tabletten
United Kingdom - Naratriptan 2.5 mg Film-coated tablets This leaflet was last approved in {MM/YYYY}
02/2011