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Sumatriptan Actavis

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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.


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


What Sumatriptan Actavis is and what it is used for


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).


What you need to know before you use Sumatriptan Actavis


Do not use Sumatriptan Actavis

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


Warnings and precautions

Talk to your doctor or pharmacist before using Sumatriptan Actavis


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


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.


How to use Sumatriptan Actavis


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.


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

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


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



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


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