Patient leaflet - Zomig 5 mg nasal spray
1. What Zolmitriptan Grünenthal Nasal Spray is and what it is used for
Zolmitriptan Grünenthal 5 mg Nasal Spray contains zolmitriptan and belongs to a group of medicines called triptans.
Zolmitriptan Grünenthal Nasal Spray is used to treat migraine headache in adults and adolescents aged 12 years and older.
Migraine symptoms may be caused by swollen blood vessels in the head. Zolmitriptan
Grünenthal Nasal Spray is thought to reduce the widening of these blood vessels. This helps to take away the headache and other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and being sensitive to light and sound.
- Zolmitriptan Grünenthal Nasal Spray works only when a migraine attack has started. It will not stop you from getting an attack.
2. What you need to know before you use Zolmitriptan Grünenthal Nasal Spray
Do not use Zolmitriptan Grünenthal Nasal Spray:
- 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.
Warnings and precautions
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.
Children
Zolmitriptan Grünenthal Nasal Spray is not recommended for children aged under 12 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.
Other medicines and Zolmitriptan Grünenthal Nasal Spray
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.
Zolmitriptan Grünenthal Nasal Spray with food and drink
You can use Zolmitriptan Grünenthal Nasal Spray with or without food. It does not affect the way that Zolmitriptan Grünenthal Nasal Spray works.
Pregnancy, breast-feeding and fertility
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.
Driving and using machines
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.
3. How to use Zolmitriptan Grünenthal Nasal Spray
Zolmitriptan Grünenthal Nasal Spray comes in a ready-to-use spray unit. Each unit contains 5 mg of zolmitriptan. Each unit is for single use and gives only one dose.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
You can use Zolmitriptan Grünenthal Nasal Spray as soon as a migraine headache starts. You can also use it once an attack is underway.
- The recommended dose is one spray (5 mg) in one nostril. It does not matter which nostril you use.
You can use another spray if the migraine is still present after two hours or if it returns within
24 hours.
If the nasal spray did not give you enough help with your migraine, tell your doctor. Your doctor may change your treatment.
Do not use more than the dose prescribed for you.
- Do not use more than two spray doses in one day.
- The maximum daily dose is 10 mg.
How to use Zolmitriptan Grünenthal Nasal Spray
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
A
C C B
D 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 use more Zolmitriptan Grünenthal Nasal Spray than you should
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.
If you forget to take Zolmitriptan Grünenthal Nasal Spray
- Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the symptoms below could be part of the migraine attack itself.
Stop using Zolmitriptan Grünenthal Nasal Spray and contact your doctor straight away if you notice any of the following:
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.
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 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.
5. How to store Zolmitriptan Grünenthal Nasal Spray
- Keep this medicine out of the sight and reach of children.
- Keep your medicine in the container it came in.
- Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
- Do not store above 25°C.
- 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 protect the environment.
6. Contents of the pack and other information
What Zolmitriptan Grünenthal 5 mg Nasal Spray contains
The active ingredient is zolmitriptan. Each dose contains 5 mg zolmitriptan. The other ingredients are: citric acid, disodium phosphate and purified water.
What Zolmitriptan Grünenthal 5 mg Nasal Spray looks like and contents of the pack
- 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.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Zolmitriptan Grünenthal 5 mg Nasal Spray is held by Grünenthal Ltd, TOR Building, Saint Cloud Way, Maidenhead, Berkshire, SL6 8BN, United Kingdom. Zolmitriptan Grünenthal 5 mg Nasal Spray is manufactured by Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany or Farmaceutici Formenti S.p.A. Via Di Vittorio 2, 21040 Origgio (VA), Italy.
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Product name Zolmitriptan Grünenthal 5 mg Nasal Spray
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