50 mg film-coated tablets
What Sumatriptan Sandoz is and what it is used for
Each Sumatriptan Sandoz tablet contains a single dose of sumatriptan, which belongs to a group of medicines called triptans (also called 5-HT 1 – receptor agonists ).
Sumatriptan Sandoz is a medicine used in the treatment of acute migraine , with or without aura (a sensation that usually consists of visual disturbances such as flashes, zigzag lines, stars or waves). Sumatriptan Sandoz should only be used when you have signs or symptoms of a migraine attack. Migraine headaches are usually of moderate to severe intensity , unilateral (but can switch sides between attacks) and have a pulsating character. Symptoms such as nausea, sometimes vomiting, and significant sensitivity to light and sound are common in migraines .
The migraine symptoms are probably caused by a temporary dilation of the blood vessels in the head. Sumatriptan Sandoz is thought to reduce the dilation of these blood vessels. This contributes to the disappearance of the headache as well as other migraine symptoms such as nausea, vomiting and sensitivity to light and sound.
Sumatriptan Sandoz is not intended for the treatment of other types of headache, such as tension headache.
What you need to know before using Sumatriptan Sandoz
Sumatriptan Sandoz should only be used by you who know you have migraines .
You probably have a migraine if you have recurring headaches such as:
- has a pulsating character and is one-sided
- has moderate to strong intensity and lasts for 4-72 hours
- worsens with normal physical activity (eg walking or climbing stairs)
- affects your ability to concentrate and your daily tasks
Migraine can be accompanied by other symptoms such as:
- Nausea, sensitivity to light and sound
- Aura symptoms, for example visual field loss, zigzag patterns or flashes in the visual field , and less often numbness or speech difficulties.
Consult a doctor or pharmacist if you are unsure or need more information.
Do not use Sumatriptan Sandoz
- if you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6)
- if you have heart problems such as narrowing of your arteries (ischemic heart disease), chest pain (angina) or if you have ever had a heart attack.
- if you have problems with blood circulation in your legs that cause cramp-like pain when you walk (so-called peripheral vascular disease)
- if you have had a stroke ( stroke ) or transient circulatory disorder in the brain (so-called Transient Ischemic Attack or TIA )
- if you have high blood pressure . You can use Sumatriptan Sandoz if you have mild high blood pressure and are being treated for it.
- if you have severe liver disease
- if you are treated with other migraine medicines that contain e.g. ergotamine or substances similar to ergotamine such as methysergide or another triptan/5-HT 1 – receptor agonist (such as naratriptan or zolmitriptan)
- if you are being treated with any of the following medicines for e.g. depression or Parkinson’s disease : monoamine oxidase inhibitors ( MAO inhibitors ) or if you have been treated with these medicines (eg moclobemide or selegiline ) in the last two weeks.
If any of the above applies to you: Consult a doctor and do not use Sumatriptan Sandoz tablets.
Sumatriptan Sandoz should only be used for guaranteed migraine . If the headache is not at all similar to your usual headache, you should not use sumatriptan without first consulting a doctor.
Warnings and precautions
Talk to your doctor before using Sumatriptan Sandoz:
If you have additional risk factors
- if you are a heavy smoker or use nicotine replacement products and especially
- if you are a man over 40, or
- if you are a woman and past the age of menstruation.
In very rare cases, serious heart conditions have occurred after taking Sumatriptan Sandoz even though these users had no previous signs of heart disease. If any of the above risk factors apply to you, it may mean that you have a greater risk of developing heart disease:
Therefore, you should tell your doctor about it so that your heart function can be checked before treatment with Sumatriptan Sandoz.
If you have previously had seizures
Or if you have other factors that may increase the risk of seizures, such as brain damage or alcoholism.
Tell your doctor about it so that you can be checked more often.
If you have liver or kidney disease
Tell your doctor about it so that you can be checked more often.
If you are allergic to antibiotics of the sulfonamide type
In that case, you may also be allergic to Sumatriptan Sandoz. If you know you are allergic to antibiotics but if you are not sure if it is sulfonamides: Talk to your doctor or pharmacist before using Sumatriptan Sandoz.
If you use Sumatriptan Sandoz frequently
Using Sumatriptan Sandoz too often can make your headache worse.
Tell your doctor if this applies to you. Your doctor may recommend that you stop using Sumatriptan Sandoz.
If you feel pain or tightness in your chest after using Sumatriptan Sandoz
These symptoms can be intense, but they usually disappear quickly. If they do not go away quickly or if they get worse: Get medical help immediately . In section 4 of this leaflet there is more information about these possible side effects .
Children and young people
Sumatriptan Sandoz tablets are not recommended for use in children or adolescents under 18 years of age because:
- sumatriptan tablets have not been studied in children under 10 years of age.
- the effect of sumatriptan tablets in children and adolescents aged 10 to 17 years has not been demonstrated in clinical studies .
Other medicines and Sumatriptan Sandoz
Tell your doctor or pharmacist if you are using, have recently used or might be using other medicines. This also includes herbal remedies, dietary supplements such as vitamins , iron and calcium and over-the-counter medicines.
Some medicines should not be taken together with Sumatriptan Sandoz and others can cause side effects when used at the same time.
You must tell your doctor if you use:
- Ergotamine which is also used to treat migraines or similar medications such as methysergide. Do not use Sumatriptan Sandoz at the same time as these medicines. You must stop taking these at least 24 hours before using Sumatriptan Sandoz. Do not take any medicine containing ergotamine or substances similar to ergotamine until at least 6 hours after taking Sumatriptan Sandoz.
- Other triptan/5-HT 1 – receptor agonist (such as naratriptan, rizatriptan, zolmitriptan) which is also used to treat migraine (see section “Do not use Sumatriptan Sandoz” above). Do not use Sumatriptan Sandoz at the same time as these medicines. You must stop taking them at least 24 hours before using Sumatriptan Sandoz. Do not take any other medicine containing a triptan/5-HT 1 receptor agonist until at least 24 hours after taking Sumatriptan Sandoz.
- MAO inhibitors ( monoamine oxidase inhibitors ) used in the treatment of depression or Parkinson’s disease . Do not use Sumatriptan Sandoz if you have used these in the last two weeks.
- SSRIs (selective serotonin reuptake inhibitors) or SNRIs ( serotonin and norepinephrine reuptake inhibitors), used to treat depression . Using Sumatriptan Sandoz together with these medicines can cause serotonin syndrome (a collection of symptoms which may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle twitching, tremors, palpitations and tremors). If you get these symptoms, tell your doctor right away.
- St. John’s wort (Hypericum perforatum). When using Sumatriptan Sandoz and herbal medicines containing St. John’s wort at the same time , 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, consult your doctor before using this medicine.
- There is only limited information regarding the safety of Sumatriptan Sandoz when used in pregnant women, although there is no evidence of any increased risk of birth defects to date. Your doctor will discuss with you whether you should use Sumatriptan Sandoz during pregnancy.
- You should not breastfeed your child within 12 hours of using Sumatriptan Sandoz . Breast milk expressed during these 12 hours should not be given to your baby but discarded.
Driving ability and use of machinery
Both the migraine symptoms and your medication can make you drowsy. If you are affected, you should not drive or operate machinery.
You yourself are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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 . Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Sumatriptan Sandoz contains excipients
Sumatriptan Sandoz contains lactose .
If you have an intolerance to certain sugars, you should consult your doctor before using this medication.
This medicine contains the sweetener aspartame which is a source of phenylalanine.
This medicine contains 0.09 mg of aspartame per film-coated tablet.
Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in the body.
This medicine contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e. it is almost ‘sodium-free’.
How to use Sumatriptan Sandoz
Always use this medicine exactly as described in this leaflet or as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
When to use Sumatriptan Sandoz
- It is best to use Sumatriptan Sandoz as soon as you feel a migraine attack is coming, but you can also use Sumatriptan Sandoz later during the attack.
- Do not use Sumatriptan Sandoz to try to avoid an attack. Sumatriptan Sandoz should only be used when the migraine attack has started.
The recommended dose is:
Adults 18-65 years
- The usual dose for people aged 18–65 is one Sumatriptan Sandoz 50 mg tablet. Some patients may need 100 mg. Use Sumatriptan Sandoz as directed by your doctor.
Elderly people (over 65 years old )
- Sumatriptan Sandoz tablets are not recommended for people over 65 years of age.
If your symptoms return
- You can use a dose of Sumatriptan Sandoz on the same day (within 24 hours) if at least 2 hours have passed since the first tablet was taken. Do not use more than two Sumatriptan Sandoz 50 mg tablets (100 mg) in a 24-hour period.
If the first tablet does not work
- Do not use another tablet or any other medicine containing sumatriptan during the same attack. In such cases, the attack can be treated with painkillers such as paracetamol , acetylsalicylic acid or ibuprofen . Sumatriptan Sandoz can be used again at the next attack.
You must contact a doctor if symptoms worsen or do not improve within 3 days.
If you have mild to moderate impaired liver function
- Low doses of 25–50 mg should be considered if you have mild to moderate hepatic impairment. Follow your doctor’s instructions.
If Sumatriptan Sandoz does not relieve your symptoms at all: Consult a doctor or pharmacist.
How to take Sumatriptan Sandoz
The film-coated tablets or tablet halves should be swallowed whole with water.
50 mg tablets can be divided into two equal doses .
If you have used too much Sumatriptan Sandoz
Do not use more than two Sumatriptan Sandoz 50 mg tablets during a 24-hour period (maximum 100 mg per day). If you use too many Sumatriptan Sandoz tablets, you may start to feel unwell.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them. Some symptoms may be caused by a migraine .
Allergic reactions: Seek medical attention immediately
The following side effects have occurred in patients, but no exact frequency of occurrence is known:
- Symptoms of hypersensitivity are rash, hives (itchy rash), wheezing or wheezing, swollen eyelids, face or lips and unconsciousness.
If you get any of the above symptoms soon after taking Sumatriptan Sandoz, you should:
Do not take more of the medicine. Immediately contact a doctor.
Common side effects ( may affect up to 1 in 10 users ):
- Dizziness, sleepiness
- Unusual sensations such as tingling and reduced sensation
- Transient increased blood pressure that occurs soon after treatment
- Hot flashes
- Respiratory distress
- Some patients have experienced nausea or vomiting, but it is unclear whether this is due to sumatriptan or the underlying disease
- Heaviness (usually transient, can be intense and can be felt anywhere in the body, including the chest and neck)
- Pain in one or more muscles
- Pain, feeling hot or cold, pressing or squeezing (usually transient, can be intense and can be felt anywhere in the body, including the chest and neck)
- Feeling of weakness, fatigue (both transient and mild to moderate in intensity ).
Very rare side effects ( may affect up to 1 in 10,000 users ):
- Minor changes in liver function.
Has been reported (occurring in an unknown number of users):
- Hypersensitivity reaction of all degrees of severity from skin hypersensitivity (such as urticaria ) to cases of shortness of breath and drop in blood pressure ( anaphylaxis )
- Seizures, although in some cases these have occurred in patients who have had seizures in the past or in circumstances that may be at risk of triggering seizures. There are also reports of patients without such risk factors.
- Muscle spasms leading to abnormal posture and poor control of movements ( tremor )
- Eye twitching, reduced field of vision , flickering of the eyes, double vision, impaired vision and in some cases loss of vision, even permanent. Visual disturbances can also be caused by the migraine attack itself
- Too slow heartbeats ( bradycardia ), too fast heartbeats ( tachycardia ), palpitations, abnormal heartbeats ( cardiac arrhythmia ), transient disturbances of blood flow in the heart, spasms in the coronary arteries, tightness in the chest, heart attack
- Drop in blood pressure, disturbance of the blood flow in the arms and legs, e.g. in the fingers (Raynaud’s syndrome)
- Inflammation in part of the large intestine due to disturbance in blood flow
- Difficulty swallowing
- Neck stiffness
- Pain in one or more joints
- Abnormal feelings of fear that are often accompanied by physiological signs (eg, sweating, tension, and increased heart rate )
- Profuse sweating
- If you have recently injured yourself or if you have an inflammation (such as rheumatism or inflammation of the colon), you may experience pain or worsening pain at the site of the injury or inflammation .
How to store Sumatriptan Sandoz
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the blister and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
The active substance is sumatriptan (as succinate).
Each film-coated tablet contains 50 mg sumatriptan (as succinate).
Other ingredients are:
Tablet core: lactose monohydrate , microcrystalline cellulose, croscarmellose sodium and magnesium stearate
Film coating: lactose monohydrate, corn starch, soluble starch , mannitol, aspartame, polysorbate 80, tritan dioxide E171, red iron oxide (E172) and talc.
Appearance and package sizes of the medicine
50 mg film-coated tablets:
Pink, capsule-shaped tablets, which are convex on one side and have an angular subscore on the other side.
The film-coated tablets are packed in a PVC/PE/PVDC/ALU blister which is inserted in a cardboard box.
Package size: 2 tablets in blister.
Marketing Authorisation Holder:
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Lek Pharmaceuticals dd, Trimlini 2 D, 9220 Lendava, Slovenia