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Package Leaflet: Information for the user

Sumatriptan Bluefish 50 mg tablets

Sumatriptan Bluefish 100 mg tablets

sumatriptan

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

What is in this leaflet:

Sumatriptan Bluefish belongs to a group of medicines called triptanes, which are used to treat migraine headache.

Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Sumatriptan Bluefish is believed to reduce the widening of these blood vessels. This in turn helps to take away the headache and relieve other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and sensitivity to light and sound.

Sumatriptan Bluefish works only when a migraine attack has started. It will not stop you from getting an attack.

You must not use sumatriptan to prevent a migraine attack.

Do not take Sumatriptan Bluefish

• if you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6).

• if you have or have ever had heart problems, including a heart attack, angina (chest pain caused by exercise or effort), Prinzmetal’s angina (chest pain which happens at rest) or have experienced heart related symptoms such as shortness of breath or pressure over the chest or if you have problems with the blood circulation to your hands and feet (peripheral vascular disease).

• if you have had a stroke/cerebral infarction, also described as an “attack” or cerebral haemorrhage (CVA; cerebrovascular accident).

• if you have had a temporary disturbance of the blood supply to the brain that left little or no residual symptoms (TIA).

• if you have severe liver function impairment.

• if you have high blood pressure.

• if you are taking drugs containing ergotamine or ergotamine derivatives (migraine drugs such as methysergide) or other triptans (5 hydroxytryptamine (5HT₁) receptor agonists, such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan or zolmitriptan etc). These must not be taken at the same time as Sumatriptan Bluefish (see also “Taking other medicines”).

• if you are currently taking MAO inhibitors (e.g. moclobemide for depression or selegiline for Parkinson's disease). Sumatriptan must not be used with in two weeks of discontinuation of therapy with MAO inhibitors. See also ´Taking other medicines´ below.

Warnings and precautions

Talk to your doctor before you start using Sumatriptan Bluefish, if:

• you are a heavy user of tobacco or products containing nicotine (patches or chewing gum), especially if you are a woman past the menopause or a man over 40 years. The doctor should examine you first.

• you have liver or kidney impairment. The doctor might adjust the dose.

• you have ever suffered seizures/fits (convulsions) or have a predisposition to seizures/fits (convulsions); sumatriptan can cause seizures/fits. Sumatriptan Bluefish might increase the risk of seizures.

• you are hypersensitive to certain antibiotics (sulphonamides). You may experience an allergic reaction after taking sumatriptan. Caution is advisable.

• you use herbal products containing St John’s Wort (Hypericum perforatum). Side effects may occur with greater frequency.

• you are diabetic, especially if you are a woman past the menopause or a man over 40 years. The doctor should examine you first.

Sumatriptan Bluefish must only be used if a diagnosis of “migraine” has been clearly established in your case and other factors have been excluded. Certain forms of migraine cannot be treated with sumatriptan.

After taking Sumatriptan Bluefish you may feel pain in your chest and a feeling of pressure for a short time. This can be quite intensive and may radiate up towards your throat. In very rare cases this may be caused by effects on your heart. Therefore, if the symptoms do not disappear, contact your doctor.

Overuse of Sumatriptan Bluefish may cause chronic, daily headache or worsened headache. Ask your doctor if you think that this is the case for you. It may be necessary to discontinue the treatment with Sumatriptan Bluefish in order to correct the problem.

Other medicines and Sumatriptan Bluefish

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

An interaction means that medicines used at the same time can influence the effect(s) and/or side effect(s) of each other. The following comments may also apply to medicines that you have used any time in the past or are to use in the near future.

Please note that the above medicines may be known to you by other names, often the brand names. In this section only the active ingredient or therapeutic group of the medicine is given, and not the brand name. Always thoroughly check the pack and information leaflet of the medicines you are already using for the active ingredient or therapeutic group of that medicine.

Pregnancy and Breast-feeding

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.

Pregnancy

During pregnancy, sumatriptan must only be taken following consultation with your doctor. Sumatriptan should be used during the pregnancy only if the potential benefit to the mother is greater than any possible risk to the foetus and no other appropriate treatment option is available.

Breast-feeding

Sumatriptan passes into breast milk. You are advised not to breastfeed within 12 hours after taking Sumatriptan Bluefish. Do not feed your child with milk expressed during this period.

Driving and using machines

Drowsiness may occur as a result of migraine or its treatment with Sumatriptan and this may influence the ability to drive and to operate machinery.

3. How totake Sumatriptan Bluefish

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage:

Adults:

• The usual dose for adults is oneSumatriptan Bluefish 50 mg tablet, swallowed whole with water (do not crush or chew it).

Some patients may need a 100 mg dose – you should follow your doctor’s advice.

Use in children and adolescents:

• SumatripatnBluefish is not recommended for children under 18 years old.

Elderly (above 65 years of age)

Sumatriptan Bluefish is not recommended for this age group.

Method of administration

• It’s best to take Sumatriptan Bluefish as soon as possible after onset of the migraine attack, although you can take it at any time during an attack

• Don’t use Sumatriptan Bluefish to try to prevent an attack.

The tablet should be swallowed whole with water, preferably as soon as possible after onset of the migraine attack.

Duration of treatment:

If symptoms are not reduced after the first dose, you must not take a second dose for the same attack. In the event of a subsequent attack, Sumatriptan Bluefish can be taken again.

If, after the first dose, your symptoms are reduced, but then return, you may take a second dose within 24 hours, provided that you wait at least two hours between doses.

You must not take more than 300 mg of Sumatriptan Bluefish in any 24-hour period.

The recommended dose must not be exceeded.

If you take more Sumatriptan Bluefish than you should

When you take too much of Sumatriptan Bluefish, immediately contact your doctor or pharmacist. Side effects such as those mentioned under “Possible side effects” may occur.

If you forget to take Sumatriptan Bluefish

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects are listed by the following frequency-

Most Serious side effects: Seek medical care immediately.

The following side effects have occurred but their exact frequency is not known.

• Allergic/hypersensitivity reactions, varying from skin reactions to rare cases of anaphylaxis (sharp fall in blood pressure, pallor, agitation, weak and rapid pulse, clammy skin, impaired consciousness).

• Angina (pain in the chest, often brought on by exercise), heart attack or spasm of the blood vessels of the heart, transient ischaemic ECG changes. Chest pain or shortness of breath after taking Sumatriptan Bluefish.

• Spasm of the blood vessels of the gut, which can cause damage to your gut. You may notice stomach pain or bloody diarrhoea.

If you get any of these symptoms soon after using Sumatriptan Bluefish. Do not take more of the medication. Contact a doctor immediately.

Other side effects:

Common (may affect up to 1 in 10 people):

• Feeling dizzy, drowsy or warm, sensory disturbance

• Transient increase in blood pressure soon after treatment. Flushing

• Breathlessness

• Feeling sick. Vomiting

• Feeling of heaviness, tightness, pain or pressure in any part of the body including throat or chest. Myalgia.

• Feeling pain, sensation of heat or cold;

• feeling of weak and fatigue

Very rare (may affect up to 1 in 10,000 people):

Has been reported (occurs in an unknown number of users):

• Fits/seizures

• Tremor

• Dystonia

• Impaired vision, e.g. double vision, flickering and sometimes loss of vision with permanent impairment. Visual disturbances can also occur as a result of the migraine attack itself.

• Slow heart beat, fast heart beat, irregular heart beat, palpitations

• Reduced blood flow to the arms and legs and consequent pallor or blur tinge to the fingers and toes.

• Diarrhoea

• Fall in blood pressure

• Stiff neck

• Joint pain

• Anxiety

• Increased perspiration

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Sumatriptan Bluefish

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 box and blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not use Sumatriptan Bluefish if you notice any visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Sumatriptan Bluefish contains

Each tablet contains 50 mg sumatriptan (assumatriptan succinate).

Each tablet contains 100 mg sumatriptan (as sumatriptan succinate).

What Sumatriptan Bluefish looks like and contents of the pack

Tablets.

Sumatriptan Bluefish 50 mg tablets are white to off-white, capsule shaped, biconvex, uncoated tablets, debossed with ‘C’ on one side and ‘33’ on the other side.

Sumatriptan Bluefish 100 mg tablets are white to off-white, capsule, shaped, biconvex, uncoated tablets, debossed with ‘C’ on one side and ‘34’ on the other side.

Sumatriptan Bluefish 50 mg/ Sumatriptan Bluefish 100 mg tablets are available in packs of 2, 3, 4, 6, 8, 12, 18, 20, 30, 50 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

To be completed nationally

This medicinal product is authorised in the Member States of the EEA under the following names:

50 mg tablet

100 mg tablet

Name of the Member State	Name of the medicinal product
DK	Sumatriptan Bluefish
FI	Sumatriptan Bluefish Pharmaceuticals 100 mg tabletti Sumatriptan Bluefish Pharmaceuticals 100 mg tabletter
DE	Sumatriptan Bluefish 100 mg Tabletten
NL	Sumatriptan Bluefish 100 mg tabletten
NO	Sumatriptan Bluefish 100 mg tabletter
ES	Sumatriptan Bluefish 100 mg comprimidos
SE	Sumatriptan Bluefish 100 mg tabletter

This leaflet was last revised in 2013-09-10