Zolmitriptan Sandoz tablet 5 mg, filmomhulde tabletten

[Nationally completed name] contains zolmitriptan and belongs to a group of medicines called triptans.

[Nationally completed name] is used to treat migraine headache.

• Migraine symptoms may be caused by the widening of blood vessels in the head. [Nationally completed name] is thought to reduce the widening of these blood vessels. This helps to take away the headache.
• [Nationally completed name] works only when a migraine attack has started. It will not stop you from getting an attack.

Do not take [nationally completed name] if you:

Sandoz GmbH	Page 2
Zolmitriptan 2.5 mg / 5 mg film-coated tablet	7218910_7218911-1313-967-02
1.3.1.3 Package Leaflet	6 May 2011

• are allergic (hypersensitive) to zolmitriptan or any of the other ingredients of [nationally completed name] (see Section 6 and end of Section 2)
• have severely impaired kidney function
• have had a previous stroke (cerebrovascular accident or CVA) or symptoms similar to a stroke which wear off after a day or two (transient ischaemic attack or TIA)
• have moderate or severe high blood pressure, or mild high blood pressure that is NOT controlled by medication
• have ever suffered from heart disease (poor blood flow in the arteries of the heart), heart attack or a particular type of chest pain known as Prinzmetal’s angina
• have had problems with the blood supply to your legs (peripheral vascular disease)
• have a particular problem with the way your heart beats (Wolff-Parkinson-White Syndrome)
• are taking any other medicine for your migraine such as ergotamine, ergotamine-type medicines (dihidroergotamine, methysergide), or another medicine in the same class (i.e. 5-HT1B/1D receptor agonists, such as sumatriptan, naratriptan or rizatriptan) (see section ‘Taking other medicines’)

Take special care with [nationally completed name]

Before taking [nationally completed name] tell your doctor, if you have:

• any of the following risk factors for heart disease: -high blood pressure or diabetes -high blood levels of cholesterol -you smoke or are using a nicotine substitution -a family history of heart disease -you are a man over 40 years, or a postmenopausal woman
• kidney or liver problems
• a headache associated with dizziness, difficulty in walking, lack of coordination or weakness in the leg and arm
• had short-lived symptoms including chest pain and tightness

Please tell your doctor if you are taking any medicine for treatment of depression (see Section ‘Taking other medicines’ for further information).

Nationally completed name] can lead to an increase in blood pressure. If your blood pressure rises too high you may experience symptoms such as headache, dizziness or ringing in the ears. If this applies to you you should contact your doctor.

If you take [nationally completed name] too often you may get a chronic headache. If this happens, you should contact your doctor as you may have to stop taking these tablets.

It is not recommended to take [nationally completed name] during the aura phase (period that precedes the head pain) to prevent migraine headaches from developing. You should take your medicine during the headache phase of the migraine.

Sandoz GmbH	Page 3
Zolmitriptan 2.5 mg / 5 mg film-coated tablet	7218910_7218911-1313-967-02
1.3.1.3 Package Leaflet	6 May 2011

Please tell your doctor or pharmacist about your symptoms. Your doctor will decide if you have migraine. You should only take [nationally completed name] for a migraine attack. [nationally completed name] should not be used to treat headaches that might be caused by other, more serious conditions.

[Nationally completed name] should only be used for patients over the age of 18 years. If you are older than 65 years, your doctor will advise whether you can take these tablets.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do NOT take [nationally completed name] with certain other migraine medicines i.e.

• other medicines in the same class as zolmitriptan, for example sumatriptan, naratriptan or rizatriptan.
• ergotamine-type medicines such as ergotamine, dihydroergotamine or methysergide. You should wait at least 6 hours before taking these medicines after taking ,[nationally completed name] and you should allow at least 24 hours between stopping ergotamine- type medicines and starting [nationally completed name].

Ask your doctor for instructions and the risks about taking these tablets if you are also taking

• Mono-Amine Oxidase Inhibitors, also known as MAOIs (such as moclobemide)
• antidepressant such as sertraline, escitalopram, fluoxetine, fluvoxamine, venlafaxine, and duloxetine
• cimetidine (for indigestion or stomach ulcers)
• a quinolone antibiotic (such as ciprofloxacin)
• the herbal remedy St. John’s Wort (Hypericum perforatum). Taking this together with [nationally completed name] may increase the likelihood of side effects. It is recommended that you do not take [nationally completed name] and St. John’s Wort at the same time.

Taking [nationally completed name] with food

You can take [nationally completed name] with or without food. It does not affect the way that [nationally completed name] works.

Pregnancy and breast-feeding

You must tell your doctor if you are pregnant or intend to become pregnant. If you are pregnant you may take [nationally completed name] only if your doctor decides it is clearly needed.

If you are breast-feeding, or planning to breast-feed, consult your doctor before taking the medicine. You should avoid breast-feeding for 24 hours following treatment with [nationally completed name].

Sandoz GmbH	Page 4
Zolmitriptan 2.5 mg / 5 mg film-coated tablet	7218910_7218911-1313-967-02
1.3.1.3 Package Leaflet	6 May 2011

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Migraine itself or treatment with [nationally completed name] may cause sleepiness in some patients. Dizziness has also been reported in some patients receiving this medicine. If you experience these effects you should check your ability to drive or to operate machinery.

Important information about some of the ingredients of [nationally completed name]

[Nationally completed name] 2.5 mg and 5 mg tablets contain 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 take [nationally completed name] exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

[Nationally completed name] is not intended for prevention of migraine. It will only work once an attack has started.

The usual dose for adults over 18 years is one tablet (2.5 mg) at the first signs of a migraine attack. You can also take the tablet once an attack is underway. Your doctor will have decided which dose is appropriate for you and it is important you take your medicine as your doctor has instructed.

Swallow your tablet with a drink of water.

Most migraine attacks are relieved with one dose (one tablet) of [nationally completed name], but if your migraine is not relieved after a single tablet, DO NOT take a second tablet to treat the same migraine attack, as it is unlikely to be of benefit.

Speak to your doctor if the tablets do not provide sufficient effect against migraine Your doctor may choose to increase the dose to 5 mg or change your treatment. If you take a higher dose (5 mg) you are more likely to suffer side effects.

If you have ANOTHER migraine attack within 24 hours of the first attack, you can take one further tablet of [nationally completed name], but do not take more than two tablets in a 24 hour period. If you have been prescribed the 2.5 mg tablet, the maximum daily dose is 5 mg. If you have been prescribed the 5 mg tablet, the maximum daily dose is 10 mg. Always leave at least 2 hours between doses.

If you take more [nationally completed name] than you should

It is important to keep to the dose the doctor has prescribed. If you do take more tablets than the doctor has advised, you should seek medical attention immediately as too many tablets can make you ill.

Sandoz GmbH	Page 5
Zolmitriptan 2.5 mg / 5 mg film-coated tablet	7218910_7218911-1313-967-02
1.3.1.3 Package Leaflet	6 May 2011

The effects of taking too many tablets will include similar effects to those detailed in Section 4, especially: dizziness, sleepiness, tiredness and pressure in the throat, neck, arms and legs. You may also experience raised blood pressure and side effects affecting your heart and circulation.

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

Like all medicines, [nationally completed name] can cause side effects, although not everybody gets them.

If any of the following happen, contact your doctor immediately.

These are rare serious side effects (affects 1 to 10 users in 10,000):

• allergic reactions sometimes very severe, including swelling of the face, lips, tongue and throat which may cause difficulty in breathing, speaking or swallowing

These are very rare serious side effects (affects less than 1 user in 10,000):

• chest pain, tightness in the chest or throat or other symptoms consistent with heart attack
• weakness or paralysis of limbs or face, difficulty speaking which may indicate a stroke (see the end of this section)
• spasm of the blood vessels of the gut, which can cause damage to your gut. You may notice stomach pain or bloody diarrhea
• a syndrome called “serotonin syndrome” characterised by coma, unstable blood pressure, extremely high body temperature, lack of muscle coordination, agitation, and hallucinations

Other possible side effects

Common (affects 1 to 10 users in 100):

• headache, sensations of pins and needles, increased skin sensitivity
• feeling sleepy, dizzy or warm
• sensations of irregular and rapid heartbeat
• nausea (feeling sick), dry mouth, vomiting, stomach pain
• muscle weakness or muscle pain
• feeling weak
• feelings of heaviness, tightness, pain or pressure in parts of the body

Uncommon (affects 1 to 10 users in 1000):

• rapid heart beat
• high blood pressure

Sandoz GmbH	Page 6
Zolmitriptan 2.5 mg / 5 mg film-coated tablet	7218910_7218911-1313-967-02
1.3.1.3 Package Leaflet	6 May 2011

• increase in the amount of water you pass (urine) or in how often you need to pass water

Rare (affects 1 to 10 users in 10,000):

• itchy rash (urticaria)

Very rare (affects less than 1 user in 10,000):

• sudden, compelling urge to urinate

As with other medicines in this class, there have been very rare reports of heart attack and stroke and most of these events have occurred in patients with risk factors for heart and blood vessel disease (high blood pressure, diabetes, smoking, family history of heart disease or stroke).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use [nationally completed name] after the expiry date which is stated on the after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

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

What [nationally completed name] contains

• The active substance is Zolmitriptan. Each film-coated tablet contains 2.5 mg zolmitriptan or 5 mg zolmitriptan.
• The other ingredients are:

1. Tablet core: Anhydrous lactose – see end of section 2 for further information, colloidal anhydrous silica, microcrystalline cellulose, crospovidone and magnesium stearate.

1. Tablet coating: Hypromellose, hydroxypropylcellulose, macrogol, iron oxide yellow E172, iron oxide red E172 (5 mg tablet only), titanium dioxide E171 and talc.

Sandoz GmbH	Page 7
Zolmitriptan 2.5 mg / 5 mg film-coated tablet	7218910_7218911-1313-967-02
1.3.1.3 Package Leaflet	6 May 2011

What [nationally completed name] looks like and contents of the pack

[Nationally completed name, 2.5 mg, film-coated tablet] are yellow, round, biconvex, film- coated tablets with ‘ZMT 2.5’ debossed on one side.

[Nationally completed name, 5 mg, film-coated tablet] are pink, round, biconvex, film-coated tablets with ‘ZMT 5’ debossed on one side.

Zolmitriptan Sandoz tablet 2,5 mg, filmomhulde tabletten: The film-coated tablets are packed in an aluminium blister containing 2, 3, 6, 12 or 18 tablets.

Zolmitriptan Sandoz tablet 5 mg, filmomhulde tabletten: The film-coated tablets are packed in an aluminium blister containing 3, 6, 12 or 18 tablets.

Marketing Authorisation Holder and Manufacturer

The marketing authorization holder is:

Sandoz B.V.

Veluwezoom 22

Almere

Nederland

The manufacturer is:

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Telephone: +49 392 03/ 71 - 28 20

Telefax: +49 392 03/ 71 - 29 50

Salutas Pharma GmbH

Administrative site

Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Telephone: +49 392 03/ 71 - 28 20

Telefax: +49 392 03/ 71 - 29 50

Manufacturing site

Dieselstrasse 5, 70839 Gerlingen, Germany

Telephone: +49-(0) 7156 943 110

Telefax: +49-(0) 7156 943 200

Lek Pharmaceuticals d.d.

Verovškova 57, 1526 Ljubljana, Slovenia

Telephone: +386 1 580 21 11

Telefax: +386 1 568 35 17

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220 Lendava, Slovenia

Telephone: + 386 2 577 3333

Telefax: + 386 2 578 1331

Sandoz GmbH	Page 8
Zolmitriptan 2.5 mg / 5 mg film-coated tablet	7218910_7218911-1313-967-02
1.3.1.3 Package Leaflet	6 May 2011

LEK S.A.

Administrative site

ul. Podlipie 16, 95-010 Stryków, Poland Telephone: +48 42 7 106 120 Telefax: +48 42 7 106 170

Manufacturing site

ul. Domaniewska 50 C, 02-672 Warszawa, Poland Telephone: +48/22/549 15 00

Telefax: +48/22/549 15 46

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania

Telephone: +4 0265 208 140 (direct)

Telefax: +4 0265 254 767

In het register ingeschreven onder

RVG 106557

RVG 106558

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

<To be completed nationally>

This leaflet was last approved in mei 2011