2.5 mg film-coated tablets
naratriptan
What Naratriptan Orifarm is and what it is used for
Naratriptan Orifarm contains naratriptan (hydrochloride) which belongs to a group of medicines called triptans (also called 5-HT 1 – receptor agonists ).
Naratriptan Orifarm is 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. Naratriptan Orifarm is 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.
Naratriptan contained in Naratriptan Orifarm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you take Naratriptan Orifarm
Do not take Naratriptan Orifarm
- 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 Naratriptan Orifarm 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 substances similar to ergotamine such as methysergide, or another triptan / 5-HT 1 receptor agonist .
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Naratriptan Orifarm.
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 naratriptan, although no evidence of previous heart disease has been identified.
If any of the above points apply to you, it may involve a greater risk of developing heart problems.
If you are allergic to sulfonamides antibiotics If
this is the case then you may also be allergic to Naratriptan Orifarm. If you know that you are allergic to antibiotics, but if you are not sure if it is a sulphonamide: Tell your doctor or pharmacist before taking Naratriptan Orifarm.
If you use Naratriptan Orifarm often
If you use Naratriptan Orifarm too often, it may make your headache worse.
Tell your doctor if this is the case for you. Doctors may advise you to stop using Naratriptan Orifarm.
If you experience pain or tightness in the chest after taking Naratriptan Orifarm
These symptoms may 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
Tell your doctor or pharmacist before using Naratriptan Orifarm if you are being treated with antidepressants. See also “Other medicines and Naratriptan Orifarm” below.
Other medicines and Naratriptan Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines must not be taken with Naratriptan Orifarm and others may cause side effects when used concomitantly. Tell your doctor if you use the following:
- any other triptan / 5-HT 1 receptor agonist used to treat migraines . Do not take Naratriptan Orifarm while taking these medicines. Do not use them again until at least 24 hours after taking Naratriptan Orifarm.
- ergotamine which is also used to treat migraines or medicines similar to ergotamine such as methysergide. Do not take Naratriptan Orifarm while taking these medicines. You must stop taking them at least 24 hours before taking Naratriptan Orifarm. Do not start taking them again until at least 24 hours after taking Naratriptan Orifarm.
- SSRIs ( selective serotonin reuptake inhibitors ) or SNRIs ( serotonin noradrenaline reuptake inhibitors ) used in depression. If you use Naratriptan Orifarm 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 the concomitant use of Naratriptan Orifarm and herbal remedies containing St. John’s wort , side effects may occur to an increased extent.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 naratriptan in pregnant women. To date, these data do not indicate an increased risk of malformations. Doctors may recommend that you do not take Naratriptan Orifarm during your pregnancy.
You should not breastfeed your baby for 24 hours after taking Naratriptan Orifarm. 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 attention. 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.
Naratriptan Orifarm contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Naratriptan Orifarm
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Naratriptan Orifarm should only be taken when the migraine attack has started. Do not take Naratriptan Orifarm to try to avoid an attack.
The recommended dose is:
Adults (18 – 65 years)
The recommended dose is one tablet (2.5 mg) that is swallowed whole with a glass of water.
Use for children
Naratriptan Orifarm is not recommended for use in children below 18 years.
Use for the elderly
Naratriptan Orifarm is not recommended for adults over 65 years of age.
When to take Naratriptan Orifarm
Preferably take Naratriptan Orifarm as soon as you feel the migraine attack is on its way, but you can take Naratriptan Orifarm 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
Do not take a second tablet for the same attack.
Contact your doctor or pharmacist for advice if you are not taking Naratriptan Orifarm.
If you take more Naratriptan Orifarm than you should
Do not take more than two tablets of Naratriptan Orifarm in one day.
Taking too much Naratriptan Orifarm can cause side effects.
Signs of overdose may include high blood pressure, “strange feeling in the head”, the tension in the neck, fatigue, and lack of coordination.
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, 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, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Naratriptan Orifarm and contact your doctor immediately if the following serious side effects occur:
Allergic reaction (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 Naratriptan Orifarm, do not take more of this medicine. Contact a doctor immediately.
Other side effects ar
Common side effects ( may affect up to 1 in 10 people):
- 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 ).
Uncommon side effects ( 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): Get urgent medical attention. In a small number of patients, these symptoms can be caused by a heart attack.
- 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 may last up to 12 hours after taking Naratriptan Orifarm.
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 ). Seek medical help.
Very rare side effects ( may affect up to 1 in 10,000 people):
- Poor blood circulation in the arms and legs that causes pain and discomfort.
- Heart problems such as chest pain (angina) and heart attack. Seek medical help.
How to store Naratriptan Orifarm
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 after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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 naratriptan hydrochloride.
- Other ingredients are:Tablet core: anhydrous lactose; microcrystalline cellulose; croscarmellose sodium; magnesium stearate.Film coating: Macrogol; titanium dioxide (E171); poly (vinyl alcohol); talc; indigo carmine (E132); yellow iron oxide (E172).
What the medicine looks like and contents of the pack
Naratriptan Orifarm is green, film-coated, oblong tablets approximately 12x5x4 mm.
Naratriptan Orifarm is available in blister packs of 2, 3, 4, 6, 12, and 18 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Orifarm Generics A / S
Energizer 15
5260 Odense S
Denmark
Local representative:
Orifarm Generics AB,
Box 56048
102 17 Stockholm
info@orifarm.com
Manufacturer
Chanelle Medical
Loughrea
Co. Galway
Ireland
or
Orifarm Generics A / S
Energivej 15
5260 Odense S
Denmark