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PACKAGE LEAFLET

Package leaflet: Information for the user

Sumatriptan Actavis 50 mg coated tablets

Sumatriptan Actavis 100 mg coated tablets

Sumatriptan

Read all of this leaflet carefully before you start using 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.

• 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.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Sumatriptan Actavis is and what it is used for

2. What you need to know before you use Sumatriptan Actavis

3. How to use Sumatriptan Actavis

4. Possible side effects

5. How to store Sumatriptan Actavis

6. Contents of the pack and other information

Sumatriptan Actavis belongs to a group of medicines called triptans.

Migraine headaches are thought to result from the dilatation of blood vessels. Sumatriptan Actavis constricts these blood vessels, thus relieving the migraine headache.

Sumatriptan Actavis is used to treat migraine attacks with or without aura (a warning sensation that usually involves distortions, such as light-flashes, zigzag lines, stars, or waves).

Do not use Sumatriptan Actavis

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

• if you have had a heart attack.

• if you have any heart disease.

• if you have symptoms that might indicate heart disease, such as temporary chest pain or a sensation of pressure in your chest.

• if you have a history of stroke or transient ischaemic attack (TIA, a minor form of stroke that lasts less than 24 hrs).

• if you have blood circulation problems in your legs that cause cramps like pains when you walk (called peripheral vascular disease).

- if you have significantly high blood pressure, or if your blood pressure is high despite medication.

• if you have severely reduced liver function.

• if you use, or have recently used, other migraine medicines, including those which contain ergotamine, or similar medicines such as methysergide; or any triptans (such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan or zolmitriptan).

• if you use, or have recently used, MAO inhibitors (for instance moclobemide for depression or selegiline for Parkinson's disease).

Warnings and precautions

Talk to your doctor or pharmacist before using Sumatriptan Actavis

• if you have symptoms of heart disease, such as transient chest pain or a feeling of pressure in your chest, which may also radiate towards your throat

• if you use medicines to control high blood pressure

• if you use medicines which belong to the group of selective serotonin re-uptake inhibitors (for depression or other mental disorders)

• if you have reduced liver or kidney function

• if you have epilepsy or any other disease which reduces your seizure threshold

• if you are hypersensitive to sulphonamides

• if you are considered to be at risk of developing heart disease (e.g. diabetic, heavy smoker or undergoing nicotine replacement therapy), and particularly if you are a post-menopausal woman or a man over 40 years with these risk factors, your doctor should check your heart function before prescribing Sumatriptan Actavis. In very rare cases serious heart conditions have occurred after taking Sumatriptan Actavis, even if no signs of any heart disease were found. Contact your doctor for advice if you have any concerns.

Sumatriptan Actavis should only be used if your headache is definitely migraine. If the headache is different from your usual headaches, you should not take Sumatriptan Actavis without first contacting your doctor.

After taking Sumatriptan Actavis 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 Actavis 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 Actavis in order to correct the problem.

Children and adolescents

Sumatriptan Actavis is not recommended for children and adolescents under 18 years of age.

Other medicines and Sumatriptan Actavis

Some medicines may influence the effect of Sumatriptan Actavis, and Sumatriptan Actavis may influence the effects of other medicines. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal remedies and natural products.

This is especially important when using medicines that contain

• ergotamine (for migraine) or other triptans. These must not be taken at the same time as Sumatriptan Actavis (see “Do not use Sumatriptan Actavis”). After taking medicines containing ergotamine or another triptan, you are advised to wait at least 24 hours before taking Sumatriptan Actavis. After taking Sumatriptan Actavis you are advised to wait at least 6 hours before taking medicines containing ergotamine and at least 24 hours before taking medicines containing other triptans.

• MAO inhibitors (e.g. moclobemide for depression or selegiline for Parkinson's disease),

• lithium (for manic/depressive (bipolar) disorders),

• selective serotonin re-uptake inhibitors (SSRI's for depression and other mental conditions)

• or herbal remedies containing St. Johns wort (Hypericum perforatum).

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.

Experienceof useduringpregnancyislimited.

Sumatriptan Actavis passesinto breastmilk. Therefore, breast-feedingshould be avoided for12 hoursaftertakingsumatriptan. Do not feed your child with milk expressed during this period.

Driving and using machines

A migraine patient may feel sleepy due to the migraine attack or to the treatment with Sumatriptan Actavis. This should be taken into consideration when increased attention is required, for instance while driving. See also Possible side effects.

Sumatriptan Actavis 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.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide on a dose which suits you personally. The recommended dose should not be exceeded.

• The tablets should be swallowed whole with a ½ glass of water. The 50 mg tablets may be divided into two equal doses. The tablets can be crushed and mixed with water.

• Sumatriptan Actavis should be taken at the first sign of a migraine attack, but may also be taken during an ongoing attack.

• Sumatriptan Actavis should not be used as a preventative (prophylactically).

Dosage:

The recommended dose for adults is one 50 mg tablet for a migraine attack. Some patients may require 100 mg. The maximum dose per day is 300 mg.

If migraine symptoms are relieved after the first dose of the medicine but later return, the dose may be repeated once during 24 hours provided that there is a minimum interval of 2 hours between the doses.

A daily dose of 300 mg must not be exceeded.

If migraine symptoms are NOT relieved after the first dose and the medicine has no effect, you should not take further doses during the same migraine attack.

Next time you get migraine, you can try Sumatriptan Actavis again.

If you experience that the effect of Sumatriptan Actavis is too strong or too weak, talk to your doctor or pharmacist.

If you use more Sumatriptan Actavis than you should:

Overdose symptoms are the same as those listed in section 4 ´Possible side effects´. If you have taken too many tablets, contact a doctor or hospital.

Ifyou haveany furtherquestionson theuseof thismedicine, askyour doctoror pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the symptoms given below can be caused by a migraine attack itself.

If you get any of the following side effects, you should stop taking Sumatriptan Actavis and contact your doctor immediately:

• Sudden wheeziness, fluttering or tightness in the chest, swelling of eyelids, face or lips, skin rash - red spots or hives (skin lumps), which may be signs of an allergic reaction

• Fits (usually in people with a history of epilepsy)

• Angina (pain in the chest, often brought on by exercise) or heart attack

The above side effects are very rare: may affect up to 1 in 10,000 people.

Common: may affect up to 1 in 10 people

• Flushing (redness of the face lasting a few minutes), dizziness, feelings of weakness, tiredness and drowsiness

• Short lasting increases in blood pressure soon after taking the medicine

• Feeling sick (nausea) or being sick (vomiting)

• Pain, ^{feeling of} heat, or cold, heaviness, pressure or tightness in any part of the body including chest and throat

• unusual sensations, including numbness and tingling

• Shortness of breath

• Muscle pain

If these effects continue or are particularly severe, especially chest or heart pain which spreads to the arms, tell your doctor immediately

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

• Visual disturbances including flickering, double vision and reduced vision. There have been cases where permanent vision defects have occurred

• Lowering of blood pressure that can lead to a feeling of faintness especially on standing up

• Transient ischaemic ECG changes. Slowing or quickening in the speed of your heart beat, palpitations (feeling of fast heart beat), changes in heart rhythm

• Shaking, tremors or uncontrolled movements

• Stiffness in the neck

• ^{Liver function changes. If you have a blood test to check your liver function, tell your doctor or nurse that you are taking} Sumatriptan Actavis

• Inflammation of the colon (part of the intestine), which may present as lower left-sided tummy pain and/or bloody diarrhoea

• Raynaud’s phenomenon, which might appear as paleness or a blue tinge to the skin and/or pain of the fingers, toes, ears, nose or jaw in response to cold or stress

Not known: frequency cannot be estimated from the available data

• Diarrhoea

• Joint pain

• Anxiety

• Excessive sweating

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sumatriptan Actavis

Keepthis medicineoutofthesightandreach ofchildren

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.

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

6. Contents of the pack and other information

What Sumatriptan Actavis contains

• The active substance is sumatriptan. One tablet contains 50 mg or 100 mg sumatriptan (as sumatriptan succinate).

• The other ingredients are: Core: Lactose monohydrate, anhydrous lactose, croscarmellose sodium, microcrystalline cellulose, magnesium stearate. Coating: Lactose monohydrate, mannitol, triacetin, talc, and titanium dioxide (E 171).

What Sumatriptan Actavis looks like and contents of the pack

Coated tablet (tablet).

50 mg: white, oval, biconvex tablets with scoring on both sides and on the edges, imprinted with "SN" on one side and "50" on the other.

100 mg: white, oval, biconvex tablets, imprinted with "SN" on one side and "100" on the other.

Pack sizes:

Blister packs: 2, 3, 4, 6, 12, 18 and 24 tablets.

Plastic tablet jars: 2, 3, 4, 6, 12, 18 and 24 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Market authorisation holder:

<[To be completed nationally]>

Manufacturer:

Actavis hf., Reykjavikurvegur 76-78, IS-220 Hafnarfjördur, Iceland

Or

Balkanpharma – Dupnitsa AD, 3, Samokovsko Shosse Str., 2600 Dupnitsa, Bulgaria

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

Sweden Sumatriptan Actavis 50 mg coated tablets

Sumatriptan Actavis 100 mg coated tablets

Denmark Sumatriptan Actavis

Finland Sumatriptan Actavis

Italy Sumatriptan Aurobindo

The Netherlands Sumatriptan AB 50 mg

Sumatriptan AB 100 mg

This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.2016-04-21