Zolmitriptan Grunenthal 5 mg Nasal Spray

• 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.

1. What Zolmitriptan Grünenthal Nasal Spray is and what it is used for
2. What you need to know before you use Zolmitriptan Grünenthal Nasal Spray
3. How to use Zolmitriptan Grünenthal Nasal Spray
4. Possible side effects
5. How to store Zolmitriptan Grünenthal Nasal Spray
6. Contents of the pack and other information

• If you are allergic to zolmitriptan or any of the other ingredients of this medicine (listed in section 6).
• If you have high blood pressure.
• If you 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.
• If you have had a stroke or short-lasting symptoms similar to stroke (transient ischaemic attack or TIA).
• If you are at the same time taking some other medicines for migraine (e.g. ergotamine or ergot-type medicines like dihydroergotamine and methysergide) or other triptan medicines for migraine. See section below: ‘Other medicines and Zolmitriptan Grünenthal Nasal Spray’ for further information.

Do not use Zolmitriptan Grünenthal Nasal Spray if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Zolmitriptan Grünenthal Nasal Spray.

Talk to your doctor or pharmacist before using Zolmitriptan Grünenthal Nasal Spray:

• If you are at risk of getting ischaemic heart disease (poor blood flow in the arteries of the heart). Your risk is greater if you smoke, have high blood pressure, high levels of cholesterol, diabetes or if anyone in your family has ischaemic heart disease.
• If you have been told that you have Wolff-Parkinson-White Syndrome (a type of abnormal heart beat).
• If you have ever had liver problems.
• If you have headaches which are not like your usual migraine headache.
• If you are taking any medicine for treatment of depression (see section below: ‘Other medicines and Zolmitriptan Grünenthal Nasal Spray’ for further information).

If you go into hospital tell the medical staff you are using Zolmitriptan Grünenthal Nasal Spray.

Zolmitriptan Grünenthal Nasal Spray is not recommended for people aged over 65.

Zolmitriptan Grünenthal Nasal Spray is not recommended for children and adolescents aged under 18 years.

As with other migraine treatments, using too much Zolmitriptan Grünenthal Nasal Spray can cause daily headaches or can make your migraine headaches worse. Ask your doctor if you think that this is the case for you. You may need to stop using Zolmitriptan Grünenthal Nasal Spray to correct the problem.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and medicines you buy without prescription.

In particular, tell your doctor if you are taking any of the following medicines:

Medicines for migraine:

• If you take a triptan other than Zolmitriptan Grünenthal Nasal Spray (such as sumatriptan or naratriptan) leave 24 hours before using Zolmitriptan Grünenthal Nasal Spray.
• After using Zolmitriptan Grünenthal Nasal Spray leave 24 hours before taking another triptan.
• If you take medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), leave 24 hours before using Zolmitriptan Grünenthal Nasal Spray.
• After using Zolmitriptan Grünenthal Nasal Spray leave 6 hours before taking ergotamine or ergot-type medicines.

Medicines for depression:

• Mono-Amine Oxidase Inhibitors, also known as MAOIs (such as moclobemide).
• SSRIs (selective serotonin reuptake inhibitors) such as fluoxetine, paroxetine, fluvoxamine or sertraline.
• SNRIs (serotonin norepinephrine reuptake inhibitors) such as venlafaxine or duloxetine. Serotonin syndrome is a rare, life-threatening condition that has been reported in some patients who took Zolmitriptan in combination with so called serotoninergic medicines (e.g. certain medicines for the treatment of depression). Signs of serotonin syndrome may be for example agitation, restlessness, fever, excessive sweating, tremor, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles, twitching and muscle rigidity. Your doctor may advise you on this.

Other medicines:

• Cimetidine (for indigestion or stomach ulcers).
• A quinolone antibiotic (such as ciprofloxacin).

You should not take the herbal remedy St. John’s wort (Hypericum perforatum) at the same time as this medicine. If you already take a St. John’s wort preparation, stop taking the St. John’s wort and mention this to your doctor at your next visit.

You can use Zolmitriptan Grünenthal Nasal Spray with or without food. It does not affect the way that Zolmitriptan Grünenthal Nasal Spray works.

It is not known if using Zolmitriptan Grünenthal Nasal Spray during pregnancy is harmful. 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 using this medicine.

During a migraine attack your reactions may be slower than usual. Bear this in mind when you drive or use any tools or machines.

Zolmitriptan Grünenthal Nasal Spray is unlikely to affect driving or using tools or machines. However, it is best to wait to see how Zolmitriptan Grünenthal Nasal Spray affects you before you try these activities.

Please read these instructions before using Zolmitriptan Grünenthal Nasal Spray.

A. The Protective Cover:

• This covers the nozzle to protect it.
• Remove it before you use the nasal spray.

B. The Nozzle:

• You put this part into your nose.
• The medicine comes out of a tiny hole in the top.

C. The Finger-grip:

• You hold this part when you use the spray.

D. The Plunger:

• You press this part once you have put the nozzle comfortably into your nose.
• The spray contains only one dose and works only once.

Do not press the plunger until you have put the nozzle in your nostril or you will lose the dose.

1

• Blow your nose gently before use.
• Remove the protective cover.

2

• Hold the nasal spray gently with your fingers and thumb as shown in picture 2.
  Do not press the plunger yet!

3

• Block one nostril by pressing a finger on the side of your nose as shown in picture 3.
• Put the nozzle of the nasal spray into the other nostril as far as feels comfortable.
• Tilt your head back slightly and close your mouth as shown in picture 3.
• Breathe in gently through your nose and at the same time press the plunger firmly with your thumb. The plunger may feel stiff and you may hear it click.
• Keep your head slightly tilted back. Remove the nozzle from your nose.
• Breathe gently through your mouth for 5-10 seconds. You may feel liquid inside your nose. This does not mean that the dose is being lost or that the spray has failed. This is normal and will soon pass.

If you have used more Zolmitriptan Grünenthal Nasal Spray than prescribed by your doctor, tell your doctor or go to the nearest hospital straight away. Take this medicine with you.

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

Rare (may affect up to 1 in 1,000 people)

• Allergic reactions including itchy rash (urticaria) and swelling of the face, lips, mouth, tongue and throat.

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

• Angina (pain in the chest, often brought on by exercise), heart attack or spasm of the blood vessels of the heart. The signs include chest pain and shortness of breath.
• Spasm of the blood vessels of the gut, which can cause damage to your gut. The signs include stomach pain or bloody diarrhoea.
• Bleeding in the brain (cerebral bleeding) or stroke.

Other possible side effects include:

Very common (may affect more than 1 in 10 people):

This is usually mild and goes away after a short time.

• Taste disturbance.

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

These are usually mild and go away after a short time.

• Abnormal sensations such as tingling in your fingers and toes or skin that is sensitive to touch.
• Feeling sleepy, dizzy or warm.
• Headache.
• Uneven heart beat.
• Nose bleed, irritation in the nose or the nose being more sensitive than usual.
• Feeling sick (nausea) or being sick (vomiting).
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Feeling weak.
• Heaviness, tightness, pain or pressure in the throat, neck, arms and legs or chest.
• Problems swallowing.

Uncommon (may affect up to 1 in 100 people):

• Very fast heart beat.
• Slightly higher blood pressure.
• An increase in the amount of water you pass (urine) or in how often you need to pass water.

Do not be concerned by this list of possible side effects. You may not get any of them.

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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient is zolmitriptan. Each dose contains 5 mg zolmitriptan. The other ingredients are: citric acid, disodium phosphate and purified water.

• Zolmitriptan Grünenthal 5 mg Nasal Spray is a pre-assembled device.
• Zolmitriptan Grünenthal 5 mg Nasal Spray comes in pack containing 1, 2 or 6 single use nasal spray units. Not all pack sizes may be marketed.
• Each nasal spray unit is ready-to-use and gives only one dose.

Zolmitriptan may also be available as film-coated tablets 2.5 mg and orodispersible tablets 2.5 mg and 5 mg.

The Marketing Authorisation for Zolmitriptan Grünenthal 5 mg Nasal Spray is held by

Zolmitriptan Grünenthal 5 mg Nasal Spray is manufactured by

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