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IMIGRAN RADIS 100 MG TABLETS - patient leaflet, side effects, dosage

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Patient leaflet - IMIGRAN RADIS 100 MG TABLETS

Package Leaflet: Information for the User

The name of your medicine is Imigran Radis 100mg Tablets, but will be referred to as Imigran Radis throughout the remainder of the leaflet.

The 50mg strength is also available for this product.

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.
  • 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 Imigran Radis is and what it is used for

  • 2 What you need to know before you use Imigran Radis

  • 3 How to use Imigran Radis

  • 4 Possible side effects

  • 5 How to store Imigran Radis

  • 6 Contents of the pack and other information

If you have liver or kidney disease

If either of these apply to you:

+ Tell your doctor or pharmacist before using Imigran.

If you are allergic to antibiotics called sulphonamides

If so, you may also be allergic to Imigran. If you know you are allergic to an antibiotic but you are not sure whether it is a sulphonamide:

+ Tell your doctor or pharmacist before using Imigran.

If you are taking anti-depressants called SSRIs

(Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin Noradrenaline Reuptake Inhibitors)

+ Tell your doctor or pharmacist before using Imigran. Also see Other medicines and Imigran, below.

If you use Imigran frequently.

Using Imigran too often may make your headaches worse.

+ Tell your doctor if this applies to you. He or she may recommend you stop using Imigran.

If you feel pain or tightness in your chest after you use Imigran These effects may be intense but they usually pass quickly. If they don’t pass quickly, or they become severe:

+ Get medical help immediately. Section 4 (overleaf) has more information about these possible side effects.

Other medicines and Imigran

Tell your doctor or pharmacist if you’re taking , have recently taken or might take any other medicines. This includes any herbal products or medicines you’ve bought without a prescription.

Some medicines must not be taken with Imigran and others may cause adverse effects if they’re taken with Imigran.

You must tell your doctor if you are taking:

  • ergotamine also used to treat migraine, or similar medicines such as methysergide (see section 2 Don’t use Imigran Radis). Don’t use Imigran at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran. Don’t take any medicines which contain ergotamine or compounds similar to ergotamine again for at least 6 hours after using Imigran.
  • other triptans/5-HT1 receptor agonists (such as naratriptan,

rizatriptan, zolmitriptan), also used to treat migraine , (see section 2 Don’t use Imigran Radis). Don’t use Imigran at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran. Don’t take another triptan/5-HT1 receptor agonist again for at least 24 hours after using Imigran.

  • MAOIs used to treat depression. Don’t use Imigran if you have taken these in the last 2 weeks.
  • SSRIs and SNRIs used to treat depression. Using Imigran with these medicines can cause serotonin syndrome (a collection of symptoms which can include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, shivering, increased heartbeat and shaking). Tell your doctor immediately if you are affected in this way.
  • St John’s Wort (Hypericum perforatum). Taking herbal remedies

containing St John’s Wort together with Imigran may make side effects more likely.

Pregnancy and breast-feeding

  • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. There is only limited information about the safety of Imigran for pregnant women, though up till now there is no evidence of any increased risk of birth defects. Your doctor will discuss with you whether or not you should use Imigran while you are pregnant
  • Don’t breast-feed your baby for 12 hours after using Imigran. If you express any breast milk during this time, discard the milk and don’t give it to your baby.

Driving and using machines

Either the symptoms of migraine or your medicine may make you drowsy. If you are affected, don’t drive or operate machinery.

Imigran Radis contains

  • Sodium: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3 how to use imigran radis

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

When to take Imigran Radis

  • It’s best to take Imigran Radis as soon as you feel a migraine coming on, although you can take it at any time during an attack
  • Don’t use Imigran Radis to try to prevent an attack – only use it after your migraine symptoms start.

How much to take

Adults aged 18 to 65

  • The usual dose for adults aged 18 to 65 is one Imigran Radis 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.
  • If you have problems swallowing tablets, you can disperse a tablet in a small amount of water before you take it – although this may have a bitter taste.
  • Imigran Radis is not recommended for children under 18 years old.
  • Imigran Radis is not recommended for people aged over 65.
  • You can take a second Imigran Radis tablet if at least 2 hours have passed since the first tablet. Don’t take more than 300 mg in total in 24 hours.

If the first tablet has no effect

  • Don’t take a second tablet or any other Imigran preparation for the same attack. Imigran can still be used for your next attack.

If Imigran Radis doesn’t give you any relief:

^ Ask your doctor or pharmacist for advice.

If you take more Imigran than you should

  • Don’t take more than six 50 mg tablets or three 100 mg tablets (that’s 300 mg in total) in any 24 hours.

Taking too much Imigran Radis could make you ill. If you have taken more than 300 mg in 24 hours:

-» Contact your doctor for advice.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4 Possible side effects

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

Some symptoms may be caused by the migraine itself.

Allergic reaction: get doctor’s help straight away

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

  • The signs of allergy include rash, hives (itchy rash); wheezing; swollen eyelids, face or lips; complete collapse.

If you get any of these symptoms soon after using Imigran:

^ Don’t use any more. Contact a doctor straight away.

Common side effects

(affect up to 1 in 10 people)

  • Pain, heaviness, pressure or tightness in the chest, throat or other parts of the body, or unusual sensations, including numbness, tingling and warmth or cold. These effects may be intense but generally pass quickly.

If these effects continue or become severe

(especially the chest pain):

^ Get medical help urgently. In a very small number of people these symptoms can be caused by a heart attack.

Other common side effects include:

  • Feeling sick (nausea) or being sick (vomiting), although this may be due to the migraine itself
  • Tiredness or drowsiness
  • Dizziness, feeling weak, or getting hot flushes
  • Temporary increase in blood pressure
  • Shortness of breath
  • Aching muscles.

Very rare side effects

(affect up to 1 in 10,000 people)

  • Liver function changes. If you have a blood test to check your liver function, tell your doctor or nurse that you are taking Imigran Radis.
  • Seizures/fits, tremors, muscle spasm, neck stiffness
  • Visual disturbances such as flickering, reduced vision, double vision, loss of vision, and in some cases even permanent defects (although these may be due to the migraine attack itself)
  • Heart problems, where your heartbeat may go faster, slower or change rhythm, chest pains (angina) or heart attack
  • Pale, blue-tinged skin and/or pain in your fingers, toes, ears, nose

or jaw in response to cold or stress (Raynaud’s phe­nomenon)

  • Feeling faint (blood pressure may go down)
  • Pain in the lower left side of the stomach and bloody diarrhoea (ischaemic colitis)
  • Diarrhoea
  • If you had a recent injury or if you have inflammation (like rheumatism or inflammation of the colon) you may experience pain or pain worsening at the site of injury or inflammation
  • Pain in the joints
  • Feeling anxious
  • Difficulty swallowing
  • Excessive sweating.

5 how to store imigran radis

Keep out of the sight and reach of children.

Do not use Imigran Radis after the expiry date shown on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6 contents of the pack and other information

Imigran Radis tablets are white, triangular shape with markings ‘GSYE7’ on one side and ‘100’ on the other.

Each film-coated dispersible tablet contains 100 mg sumatriptan (as the succinate).

Also contains calcium hydrogen phosphate, sodium hydrogen carbonate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose (E464), titanium dioxide (E171) and glycerol triacetate.

Imigran Radis is available in a blister pack of 6 and 12 tablets.

Imigran Radis is manufactured by GlaxoSmithKline Pharmaceuticals S.A, Ul. Grunwaldzka 189, 60–322 Poznan, Poland. Procured from within the EU. Quadrant Pharmaceuticals Ltd, Lynstock Hose, Lynstock Way, Lostock Bolton BL6 4SA. Repackaged by Maxearn Ltd, Unit 29, Oakhill Trading Estate, Devonshire Rd, Worsley, Manchester M28 3PT

Imigran Radis 100mg Tablets PL 20774/1191 POM

Imigran Radis is a registered trademark of Glaxo Group Limited.

Date of preparation 25th July 2021

Blind or partially sighted? Is this leaflet hard to see or read? Contact

Quadrant Pharmaceuticals Ltd -Tel 01204 471269

L-03–1191–01