2.5 mg film-coated tablets
naratriptan
What Naramig is and what it is used for
Naramig tablets contain naratriptan (hydrochloride) which belongs to a group of medicines called triptans (also called 5-HT1 receptor agonists ).
Naramig tablets are used to treat the headache phase during a migraine attack.
The migraine symptoms are probably caused by a temporary dilation of the blood vessels in the head. Naramig tablets are considered to reduce the dilation of these blood vessels. This helps the headache to disappear and relieves other migraine symptoms such as nausea, vomiting, and sensitivity to light and sound.
What you need to know before you take Naramig
Do not take Naramig:
- if you are allergic to naratriptan or any of the other ingredients of this medicine (listed in section 6)
- if you have heart problems such as narrowed blood vessels (ischemic heart disease) or chest pain (angina) or if you have had a heart attack
- if you have problems with blood circulation in the legs that cause cramp-like pain when you walk (so-called peripheral vascular disease)
- if you have had a stroke or TIA (transient circulatory disorder in the brain)
- if you have high blood pressure . You can use Naramig if you have a mild increase in blood pressure for which you are receiving treatment
- if you have severe kidney or liver disease
- if you are being treated with other migraine medicines that contain ergotamine or ergotamine-like substances such as methysergide, or another triptan / 5-HT1 receptor agonist .
- If any of the above applies to you, consult your doctor and do not use Naramig.
Warnings and cautions
Talk to your doctor or pharmacist before taking Naramig.
If you have any additional risk factors
- if you are a heavy smoker or use nicotine replacement therapy and especially
- if you are a man over 40 years
- if you are a woman and have passed menopause
In very rare cases, severe heart conditions have occurred after taking Naramig even though no signs of previous heart disease have been detected.
If any of the above points apply to you, it may involve a greater risk of developing heart problems. Therefore you should:
- Tell your doctor so that your heart function can be checked before Naramig is prescribed to you.
If you are allergic to sulfonamides
If so, you may also be allergic to Naramig. If you know you are allergic to antibiotics but are not sure if they are sulphonamides:
- Tell your doctor or pharmacist before taking Naramig.
If you use Naramig often
Using Naramig too often can make your headaches worse.
- Tell your doctor if this is the case for you. He or she may recommend that you stop using Naramig.
If you experience pain or tightness in the chest after taking Naramig
These symptoms can be intense but usually, go away quickly. If symptoms persist or worsen:
- Seek help immediately. Section 4 of this leaflet provides more information about these possible side effects .
If you are being treated with antidepressants such as SSRIs (selective serotonin reuptake inhibitors) or SNRIs ( serotonin noradrenaline reuptake inhibitors)
- Tell your doctor or pharmacist before using Naramig.
Other drugs and Naramig
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This also includes natural remedies and over-the-counter medications.
Some medicines should not be taken with Naramig and others may cause side effects when used concomitantly. Tell your doctor if you use the following:
- any other triptan / 5-HT1 receptor agonist used to treat migraines . Do not take Naramig while taking these medicines. Do not use them again until at least 24 hours after taking Naramig.
- ergotamine which is also used to treat migraines or medicines similar to ergotamine such as methysergide. Do not take Naramig while taking these medicines. You must stop taking them at least 24 hours before taking Naramig. Do not start taking them again until at least 24 hours after taking Naramig.
- SSRIs (selective serotonin reuptake inhibitors) or SNRIs ( serotonin noradrenaline reuptake inhibitors) used in depression . If you use Naramig with these medicines, it may cause confusion, weakness and / or coordination disorders. Contact a doctor immediately if you experience such symptoms.
- St. John’s wort (Hypericum perforatum). With concomitant use of Naramig and herbal remedies containing St. John’s wort , side effects may occur to an increased extent.
Pregnancy and breastfeeding
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby , ask your doctor or pharmacist for advice before taking this medicine. There is only limited information on the safety of Naramig in pregnant women. To date, these data do not indicate an increased risk of malformations. Your doctor may recommend that you do not take Naramig during your pregnancy.
- You should not breast-feed your baby for 24 hours after taking Naramig. Breast milk pumped out during this time should be discarded and not given to your baby
Driving and using machines
- Both the migraine symptoms and your medication can make you drowsy. If you are affected, do not drive or operate machinery. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Naramig contains lactose
Naramig tablets contain a small amount of milk sugar ( lactose ). If your doctor tells you that you do not tolerate certain sugars:
- consult your doctor before taking Naramig.
Naramig contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Naramig
Naramig should only be taken when the migraine attack has started.
| Do not take Naramig to try to avoid an attack. Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. | ||
| DoseUsual dose for adults (18 – 65 years)is a Naramig 2.5 mg tablet that is swallowed whole with water. | ||
| Naramig is not recommended for children under 18 or adults over 65 years. | ||
| When to take NaramigPreferably to take Naramig as soon as you feel the migraine attack is on its way, but you can take Naramig at any time during an attack. | ||
| If your symptoms start to come back you can take a second tablet after 4 hours if you have no kidney or liver damage. If you have kidney or liver damage, do not take more than one tablet in one day. Do not take more than two tablets in one day. | ||
| If the first tablet has no effect not take a second tablet for the same attack. If you do not get the effect of Naramig: contact a doctor or pharmacist for advice. | ||
If you take more Naramig than you should
- Do not take more than two Naramig tablets in one day.
Taking too much Naramig can cause side effects.
If you have ingested too much medicine (more than 2 tablets in one day) or if, for example, a child has accidentally ingested the medicine, always contact a doctor or hospital for risk assessment and advice…
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reaction: Get medical attention immediately.
(may affect up to 1 in 1,000 people):
- Signs of allergy include rash, wheezing, swollen eyelids, face or lips, unconsciousness.
If you get any of these symptoms immediately after taking Naramig:
- Do not take more of this medicine. Contact a doctor immediately.
Common side effects are
(may affect up to 1 in 10 users):
- Nausea or vomiting. These symptoms may be part of the migraine attack itself.
- Fatigue, drowsiness or general malaise.
- Dizziness, tingling, feeling hot and redness ( flush ).
If you get any of these side effects:
- talk to a doctor or pharmacist.
Uncommon side effects are
(may affect up to 1 in 100 people):
- Feeling of heaviness, feeling of pressure or tightness or pain in the chest, pharynx or other parts of the body. These symptoms can be intense but are usually transient.
If these side effects persist or get worse (especially chest pain):
- Seek emergency medical help. In a small number of patients, these symptoms can be caused by a heart attack.
Other less common side effects:
- Visual disturbances (these can occur as part of the migraine attack).
- Unusually slow or fast heartbeat (palpitations), changes in heart rhythm.
- Slight increase in blood pressure that can last up to 12 hours after taking Naramig.
If you get any of these side effects:
- talk to a doctor or pharmacist.
Rare side effects
(may affect up to 1 in 1,000 people):
- Sleepiness ( somnolence ).
- Pain in the lower left part of the abdomen and bloody diarrhea (ischemic colitis ).
If you get any of these symptoms:
- talk to a doctor or pharmacist.
Very rare side effects
(may affect up to 1 in 10,000 users):
- Heart problems such as chest pain (angina) and heart attack.
- Poor blood circulation in the arms and legs that causes pain and discomfort.
If you get any of these side effects:
- talk to a doctor or pharmacist.
How to store Naramig
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
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.
Contents of the pack and other information
Content declaration
The active substance is naratriptan 2.5 mg (as hydrochloride).
The other ingredients in the tablet core are microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, and magnesium stearate. Ingredients in the tablet case are hypromellose, titanium dioxide (E171), triacetin, yellow iron oxide (E172), indigo carmine (E132).
What the medicine looks like and contents of the pack
Naramig tablets are green, film-coated, D-shaped, marked GX CE5 on one side.
They are available in child-resistant blister packs of 2, 3, 4, 6, 12, and 18 tablets, but not all packs may be marketed.
Marketing Authorization Holder / Information provided by:
GlaxoSmithKline AB, Box 516, 169 29 Solna
Tel: 08-638 93 00
Email: info.produkt@gsk.com
This medicinal product is authorized under the European Economic Area under the names:
| Belgium | Naramig |
| Finland | Naramig |
| France | Naramig |
| Germany | Naramig |
| Greece | Naramig |
| Luxembourg | Naramig |
| Holland | Naramig |
| Portugal | Naramig |
| Spain | Naramig |
| Sweden | Naramig |