Document: Sumatriptan Amneal tablet ENG PL change

• Sumatriptan Amneal tablet PL
• Sumatriptan Amneal tablet ENG PL

---

Package leaflet: Information for the user

Sumatriptan Amneal 50 mg tablets

Sumatriptan Amneal 100 mg tablets

sumatriptan

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:

Sumatriptan Amneal belongs to a group of medicines called triptanes, which are used to treat migraine headache.

Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Sumatriptan Amneal is believed to reduce the widening of these blood vessels. This in turn helps to take away the headache and relieve other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and sensitivity to light and sound.

Sumatriptan Amneal works only when a migraine attack has started. It will not stop you from getting an attack.

You must not use sumatriptan to prevent a migraine attack.

Do not take Sumatriptan Amneal

• if you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6).

• if you have or 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 problems with the blood circulation to your hands and feet (peripheral vascular disease).

• if you have had a stroke/cerebral infarction, also described as an “attack” or cerebral haemorrhage (CVA; cerebrovascular accident).

• if you have had a temporary disturbance of the blood supply to the brain that left little or no residual symptoms (TIA).

• if you have severe liver function impairment.

• if you have high blood pressure.

• if you are taking drugs containing ergotamine or ergotamine derivatives (migraine drugs such as methysergide) or other triptans (5 hydroxytriptamine (5HT₁) receptor agonists, such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan or zolmitriptan etc.). These must not be taken at the same time as Sumatriptan Amneal (see also “Other medicines and Sumatriptan Amneal”).

• if you are currently taking MAO inhibitors (e.g. moclobemide for depression or selegiline for Parkinson's disease). Sumatriptan must not be used with in two weeks of discontinuation of therapy with MAO inhibitors. See also “Other medicines and Sumatriptan Amneal” below.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sumatriptan Amneal if:

• you are diabetic, especially if you are a woman past the menopause or a man over 40 years. The doctor should examine you first.

• you are a heavy user of tobacco or products containing nicotine (patches or chewing gum), especially if you are a woman past the menopause or a man over 40 years. The doctor should examine you first.

• you have liver or kidney impairment. The doctor might adjust the dose.

• you have ever suffered seizures/fits (convulsions) or have a predisposition to seizures/fits (convulsions); sumatriptan can cause seizures/fits. Sumatriptan Amneal might increase the risk of seizures.

• you are hypersensitive to certain antibiotics (sulphonamides). You may experience an allergic reaction after taking sumatriptan. Caution is advisable.

• you use herbal products containing St John’s Wort (Hypericum perforatum). Side effects may occur with greater frequency.

Sumatriptan Amneal must only be used if a diagnosis of “migraine” has been clearly established in your case and other factors have been excluded. Certain forms of migraine cannot be treated with sumatriptan.

After taking Sumatriptan Amneal you may feel pain in your chest and a feeling of pressure for a short time. This can be quite intensive and may radiate up towards your throat. In very rare cases this may be caused by effects on your heart. Therefore, if the symptoms do not disappear, contact your doctor.

Overuse of Sumatriptan Amneal may cause chronic, daily headache or worsened headache. Ask your doctor if you think that this is the case for you. It may be necessary to discontinue the treatment with Sumatriptan Amneal in order to correct the problem.

Children and adolescents

Sumatriptan Amneal is not recommended in children and adolescents under 18 years of age.

Other medicines and Sumatriptan Amneal

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

An interaction means that medicines used at the same time can influence the effect(s) and/or side effect(s) of each other. The following comments may also apply to medicines that you have used any time in the past or are to use in the near future.

• medicines containing ergotamine (migraine drugs) or other triptans. These must not be taken at the same time as Sumatriptan Amneal (see “Do not take Sumatriptan Amneal”).
  After taking medicines containing ergotamine, you are advised to wait at least 24 hours before taking Sumatriptan Amneal. After taking Sumatriptan Amneal you are advised to wait at least 6 hours before taking medicines containing ergotamine and atleast 24 hours before taking medicines containing other triptans.

• MAO inhibitors (e.g. moclobemide for depression or selegiline for Parkinson's disease). Sumatriptan Amneal must not be taken within two weeks after stopping use of MAO inhibitors.

• Use of triptans with antidepressant drugs like Selective serotonin reuptake inhibitors (SSRI) and Serotonin – nor epinephrine reuptake inhibitors (SNRI) may cause serotonin syndrome (a combination of symptoms that may include confusion, hallucination, restlessness, sweating, muscle spasms, and tremors). If you experience these symptoms please tell your doctor.

• There is a risk that concomitant use of sumatriptan and lithium (for manic/depressive (bipolar) disorders) may cause serotonin syndrome.

Please note that the above medicines may be known to you by other names, often the brand names. In this section only the active ingredient or therapeutic group of the medicine is given, and not the brand name. Always thoroughly check the pack and information leaflet of the medicines you are already using for the active ingredient or therapeutic group of that medicine.

Pregnancy and breast-feeding

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 taking this medicine.

Pregnancy

During pregnancy, sumatriptan must only be taken following consultation with your doctor. Sumatriptan should be used during the pregnancy only if the potential benefit to the mother outweighs the potential risk to the unborn child and no other appropriate treatment option is available.

Breast-feeding

Sumatriptan Amneal passes into breast milk. You are advised not to breastfeed within 12 hours after taking Sumatriptan Amneal. Do not feed your child with milk expressed during this period.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Drowsiness may occur as a result of migraine or its treatment with Sumatriptan and this may influence the ability to drive and to operate machinery.

3. How to take Sumatriptan Amneal

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

Dosage:

Adults:

The recommended dose is 50 mg Sumatriptan Amneal. Some patients may need to take a dose of 100 mg Sumatriptan Amneal.

Elderly (patients above 65 years of age)

Sumatriptan Amneal is not recommended for this age group.

Method of administration:

Take the tablet with water, preferably as soon as possible after onset of the migraine attack. Do not chew or crush the tablets.

Duration of treatment:

If symptoms are not reduced after the first dose, you must not take a second dose for the same attack. In the event of a subsequent attack, Sumatriptan Amneal can be taken again.

If, after the first dose, your symptoms are reduced, but then return, you may take a second dose within 24 hours, provided you wait at least 2 hours between doses.

You must not take more than 300 mg of Sumatriptan Amneal in any 24-hour period.

The recommended dose must not be exceeded.

If you take more Sumatriptan Amneal than you should

When you take too much of Sumatriptan Amneal, immediately contact your doctor or pharmacist. Side effects such as those mentioned under “Possible side effects” may occur.

If you forget to take Sumatriptan Amneal

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 given below can be caused by a migraine attack itself.

If you get any of the following side effects, you should stop taking Sumatriptan Amneal and contact your doctor immediately:

• Allergic/hypersensitivity reactions, with symptoms like swelling of the lips-, face, or throat, rash and difficulty breathing or anaphylaxis with symptoms like sharp fall in blood pressure, pallor, agitation, weak and rapid pulse, clammy skin, impaired consciousness.

• Angina (pain in the chest, often brought on by exercise), heart attack or spasm of the blood vessels of the heart. Symptoms may be chest pain or shortness of breath.

• Spasm of the blood vessels of the gut, which can cause damage to your gut. You may notice stomach pain or bloody diarrhoea.

The frequency of the above side effects is not known (cannot be estimated from the available data).Other side effects are:

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

• Feeling dizzy, drowsy or warm, sensory disturbance

• Transient increase in blood pressure soon after treatment, Flushing

• Breathlessness

• Feeling sick, Vomiting

• Feeling of heaviness, tightness, pain or pressure in any part of the body including throat or chest, Myalgia

• Feeling pain, sensation of heat or cold

• Feeling of weak and fatigue

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

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

Not Known(frequency cannot be estimated from the available data):

• Fits/seizures

• Tremor

• Dystonia

• Impaired vision, e.g. double vision, flickering and sometimes loss of vision with permanent impairment. Visual disturbances can also occur as a result of the migraine attack itself

• Slow heart beat, fast heart beat, irregular heartbeat, palpitations

• Reduced blood flow to the arms and legs and consequent pallor or blur tinge to the fingers and toes

• Diarrhoea

• Fall in blood pressure

• Stiff neck

• Joint pain

• Anxiety

• Increased perspiration

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 national reporting system listed in Appendix V*.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sumatriptan Amneal

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Sumatriptan Amneal contains

Each tablet contains 50 mg sumatriptan (as sumatriptan succinate).

Each tablet contains 100 mg sumatriptan (as sumatriptan succinate).

What Sumatriptan Amneal looks like and contents of the pack

Sumatriptan Amneal 50 mg tablets are white to off-white, capsule shaped, biconvex, uncoated tablets, debossed with ‘C’ on one side and ‘33’ on the other side. The size is 11 X 5 mm.

Sumatriptan Amneal 100 mg tablets are white to off-white, capsule, shaped, biconvex, uncoated tablets, debossed with ‘C’ on one side and ‘34’ on the other side. The size is 12 X 6.5 mm.

Sumatriptan Amneal 50 mg/ Sumatriptan Amneal 100 mgtablets are available in packs of 2, 3, 4, 6, 8, 12, 18, 20, 30, 50 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

[To be completed nationally]

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

Denmark	Sumatriptan Amneal
Spain	Sumatriptán Amneal 50 mg & 100 mg Comprimidos
Norway	Sumatriptan Amneal
Sweden	Sumatriptan Amneal

This leaflet was last revised in 10 April 2015