DOLORTRIPTAN

DOLORTRIPTAN for migraine film-coated tablets

Important notes (mandatory information)

Dolortriptan for Migraine Film-coated Tablets. Active ingredient: Almotriptan. Areas of application: for the acute treatment of headaches in migraine attacks with or without aura.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Dolortriptan for Migraine Film-coated Tablets
Active ingredient: Almotriptan (in the form of almotriptan[(RS)-hydroxysuccinate])

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as your doctor, pharmacist or healthcare professional has told you.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor, pharmacist or healthcare professional. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 1 day, contact your doctor.

What is in this package leaflet

1. WHAT IS DOLORTRIPTAN FOR MIGRAINE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING DOLORTRIPTAN FOR MIGRAINE?
3. HOW TO TAKE DOLORTRIPTAN FOR MIGRAINE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE DOLORTRIPTAN FOR MIGRAINE?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

This medicine is only suitable for patients who know that they have a migraine. If you are not sure whether you have a migraine, talk to your doctor or pharmacist. Typical symptoms of a migraine are: One-sided, throbbing headaches; nausea; sensitivity to light and noise.

1. WHAT IS DOLORTRIPTAN FOR MIGRAINE AND WHAT IS IT USED FOR?

Dolortriptan for Migraine is used for the acute treatment of headaches in migraine attacks with or without aura.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING DOLORTRIPTAN FOR MIGRAINE?

Dolortriptan for Migraine should be used at the first sign of a migraine headache. Migraine symptoms can be caused by a temporary widening of the blood vessels in the head. It is thought that Dolortriptan for Migraine reduces this widening of the blood vessels. This helps to relieve the headache and other symptoms of migraine, such as a general feeling of being unwell (nausea or vomiting), as well as sensitivity to light and noise. The safety and efficacy of Dolortriptan for Migraine in treating the aura symptoms that may occur before the onset of the headache have not yet been demonstrated.

Dolortriptan for Migraine must not be taken:

• to prevent a migraine.
• if you are allergic to almotriptan or any of the other ingredients of this medicine (listed in section 6).
• if you suffer or have suffered from diseases that restrict the blood supply to the heart, such as:
• heart attack
• pain or discomfort in the chest, usually occurring during activity or stress
• heart problems without pain
• chest pain at rest
• severe hypertension (high blood pressure)
• uncontrolled mild or moderate hypertension.
• if you have had a stroke or a restriction of blood flow to the brain.
• if you have had a blockage of the large arteries in the legs or arms (peripheral vascular disease).
• if you are taking other medicines for migraine, including ergotamine, dihydroergotamine and methysergide or other serotonin agonists (e.g. sumatriptan).
• if you have severe liver disease.

Warnings and precautions

Please talk to your doctor, pharmacist or healthcare professional before taking Dolortriptan for Migraine:

• if your migraine type has not been diagnosed by a doctor.
• if you are allergic (hypersensitive) to antibacterial medicines that are mainly used to treat urinary tract infections (sulfonamides). People who are allergic to sulfonamides/antibiotics may also be allergic to triptans. If you know that you are allergic to an antibiotic, but are not sure whether it is a sulfonamide, please ask your doctor or pharmacist.
• if your headache symptoms are different from your usual attacks, i.e. if you have, for example, tinnitus or dizziness, if you have a short-term paralysis of one half of the body or a paralysis of the muscles that control eye movement or if you have any new symptoms.
• if you have risk factors for heart disease such as uncontrolled high blood pressure, high cholesterol, obesity, diabetes, smoking, a strong family history of heart disease; in women past the menopause or men over 40 years of age.
• if you have mild to moderate liver disease.
• if you have severe kidney disease.
• sudden onset of skin rash, in conjunction with severe headaches.
• if the headache lasts for more than 24 hours or occurs more frequently.
• if you have four or more migraine attacks per month.
• if you do not fully recover between migraine attacks.
• if you are over 50 years old and this type of headache occurs for the first time.
• if the migraine attack becomes more severe or occurs more frequently or if the associated signs/symptoms change.
• You smoke heavily (more than 10 cigarettes per day) or use nicotine-containing preparations to quit smoking.
• if you are taking antidepressants such as SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-norepinephrine reuptake inhibitors). See also below under "Taking Dolortriptan for Migraine with other medicines".

As with other medicines for the acute treatment of migraine, excessive use of almotriptan has been reported to cause chronic, daily headaches or worsening of headaches, which may require discontinuation of the medicine.

Children and adolescents

Children under 18 years of age must not take Dolortriptan for Migraine.

Elderly patients (over 65 years of age)

Do not take Dolortriptan for Migraine if you are over 65 years of age.

Taking Dolortriptan for Migraine with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Please inform your doctor:

• if you are taking medicines to treat depression, such as monoamine oxidase inhibitors (e.g. moclobemide) or selective serotonin reuptake inhibitors (e.g. fluoxetine), as these can trigger serotonin syndrome, a potentially life-threatening drug reaction. Symptoms of serotonin syndrome include confusion, restlessness, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle twitching or diarrhea.
• if you are taking the herbal medicine St. John's wort (Hypericum perforatum) at the same time, as this may increase the likelihood of side effects.

Almotriptan must not be taken at the same time as ergotamine-containing medicines, which are also used to treat migraine. However, these medicines can be taken one after the other with the following time differences:

• After taking almotriptan, at least 6 hours should pass before ergotamine is taken.
• After taking ergotamine, almotriptan should not be taken for at least 24 hours.

Oral contraceptives (the pill)

Women with migraine who are also taking oral contraceptives have an increased risk of stroke. If you are taking oral contraceptives and you have only recently developed migraine symptoms (within the last 3 months) or your migraine symptoms have worsened, or if you have migraine with aura (migraine attacks that start with visual disturbances or changes in sensation), you should ask your doctor for advice.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There is only very limited data on pregnant patients for almotriptan. Almotriptan should only be taken during pregnancy if your doctor tells you to and only after they have carefully weighed the benefits and risks. Caution should be exercised when taking this medicine during breast-feeding. You should not breast-feed for 24 hours after taking this medicine.

Driving and using machines

Dolortriptan for Migraine can cause drowsiness. If this is the case for you, do not drive, operate machinery or work without a secure hold.

3. HOW TO TAKE DOLORTRIPTAN FOR MIGRAINE?

Only take Dolortriptan for Migraine to treat an actual migraine attack and not to prevent migraine attacks or headaches. Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor. Check with your doctor or pharmacist if you are not sure. Adults (18-65 years): The recommended dose is one 12.5 mg tablet, to be taken as early as possible after the onset of a migraine attack. If your migraine attack does not subside, do not take more than one tablet for the same attack. If a second migraine attack occurs within 24 hours, a second 12.5 mg tablet may be taken, but at least 2 hours must have passed between your first and second tablet. The maximum daily dose is two (12.5 mg) tablets within 24 hours. Take the tablets with liquid (e.g. water). The tablets can be taken with or without food. Dolortriptan for Migraine should be taken as early as possible after the onset of migraine headache. However, it is also effective if taken at a later stage of the migraine attack. Do not take a second dose for the same attack if the first dose of Dolortriptan for Migraine does not provide relief. This could mean that you do not have a migraine. Contact your doctor. At least 24 hours should have passed after taking Dolortriptan for Migraine before an ergotamine-containing preparation or a 5-HT1 receptor agonist is administered. Conversely, at least 24 hours should pass between the use of an ergotamine-containing preparation and the taking of Dolortriptan for Migraine.

Severe kidney disease

If you have severe kidney disease, you must not take more than one 12.5 mg tablet within 24 hours.

If you have taken more Dolortriptan for Migraine than you should

If you have accidentally taken too many tablets or if someone else or a child has taken this medicine, talk to a doctor or pharmacist immediately.

If you forget to take Dolortriptan for Migraine

Take Dolortriptan for Migraine as recommended in section 3 of this package leaflet as much as possible. Do not take double the amount to make up for a forgotten dose.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (1 to 10 in 100 treated):

• Dizziness
• Drowsiness (somnolence)
• Nausea
• Vomiting
• Fatigue

Uncommon side effects (1 to 10 in 1,000 treated):

• tingling, prickling or numb feeling on the skin (paresthesia)
• Headache
• Tinnitus or ringing in the ears
• Palpitations
• Tightness in the throat
• Diarrhea
• Indigestion (dyspepsia)
• Dry mouth
• Muscle pain (myalgia)
• Bone pain
• Chest pain
• Feeling of weakness (asthenia)

Very rare side effects (less than 1 in 10,000 treated):

• Coronary vasospasms
• Heart attack (myocardial infarction)
• increased heart rate (tachycardia)

Frequency not known (frequency cannot be estimated from the available data):

• allergic reactions (hypersensitivity reactions), including swelling of the mouth, throat or hands (angioedema)
• severe allergic reactions (anaphylactic reactions)
• Seizure (epileptic seizure)
• Visual impairment, blurred vision (visual disturbances can also occur during a migraine attack)
• Intestinal vasospasm, which can lead to damage to the intestine (intestinal ischemia). Abdominal pain and bloody diarrhea may occur.

Inform your doctor immediately during treatment with Dolortriptan for Migraine if you have pain or tightness in the chest or throat or any other symptoms that are reminiscent of a heart attack. Inform your doctor immediately and do not take any more Dolortriptan for Migraine tablets.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW TO STORE DOLORTRIPTAN FOR MIGRAINE?

This medicinal product does not require any special storage conditions. Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton after "use by". The expiry date refers to the last day of the month indicated. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Dolortriptan for Migraine contains

The active substance is: Almotriptan 12.5 mg (in the form of almotriptan[(RS)-hydroxysuccinate]). The other ingredients are: Tablet core: Mannitol (Ph.Eur.); microcrystalline cellulose; povidone K 29-32; poly(O-carboxymethyl)starch, sodium salt; sodium stearyl fumarate (Ph.Eur.). Coating: hypromellose; titanium dioxide; macrogol 400; carnauba wax.

What Dolortriptan for Migraine looks like and contents of the pack

Dolortriptan for Migraine is available in the form of a white, round, biconvex film-coated tablet with an A engraved on one side. Dolortriptan for Migraine is available in blister packs of 2 tablets.

Pharmaceutical entrepreneur and manufacturer

Pharmaceutical entrepreneur

Almirall, S.A.
General Mitre, 151
08022 Barcelona
Spain

Manufacturer

Industrias Farmacéuticas Almirall, S.A.
Ctra. Nacional II, Km. 593
08740 Sant Andreu de la Barca (Barcelona)
Spain

Co-distribution

Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss
Tel.: 00800 260 260 00 (toll-free)

This leaflet was last revised in September 2015.

Active ingredient: Almotriptan. Areas of application: for the acute treatment of headaches in migraine attacks with or without aura.