Sumatriptan Doc Generici

Package leaflet: Information for the patient

SUMATRIPTAN DOC 6 mg solution for injection in pre-filled pen

Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What SUMATRIPTAN DOC is and what it is used for
2. What you need to know before using SUMATRIPTAN DOC
3. How to use SUMATRIPTAN DOC
4. Possible side effects
5. How to store SUMATRIPTAN DOC
6. Contents of the pack and other information
7. Instructions for use

1. What SUMATRIPTAN DOC is and what it is used for

SUMATRIPTAN DOC contains the active substance sumatriptan, which belongs to a group of
medicines called triptans (5-HT receptor agonists).
SUMATRIPTAN DOC is used to treat migraine and a rare condition called cluster headache.
The symptoms of migraine and cluster headache may be caused by a temporary
dilation of the blood vessels in the head. Sumatriptan is thought to reduce this dilation of the blood vessels.
This in turn helps relieve headache pain and alleviates other symptoms such as nausea or vomiting, and sensitivity to light and sound.

2. What you need to know before using SUMATRIPTAN DOC

Do not use SUMATRIPTAN DOC

• if you are allergic to sumatriptan or to any of the other ingredients of this medicine (listed in section 6);
• if you have heart problems such as narrowing of the arteries (ischaemic heart disease) or chest pain (angina), or if you have previously had a heart attack;
• if you have circulation problems in your arms or legs causing cramp-like pain when walking (peripheral vascular disease);
• if you have had a stroke (also called cerebrovascular accident or CVA) or a transient ischaemic attack (also called TIA);
• if you have slightly uncontrolled or high blood pressure. You may use SUMATRIPTAN DOC if your blood pressure is slightly elevated and is being treated;
• if you have severe liver disease;
• together with other medicines for migraine treatment, including those containing ergotamine, or similar medicines such as methysergide maleate, or any triptan/5-HT receptor agonist (such as naratriptan, rizatriptan or zolmitriptan; see section “Other medicines and SUMATRIPTAN DOC”);
• together with the following antidepressants:
  • MAOIs (monoamine oxidase inhibitors) or if you have taken an MAOI within the last two weeks; see section “Other medicines and SUMATRIPTAN DOC”.

If any of these apply to you, inform your doctor and do not use SUMATRIPTAN DOC.
Warnings and precautions
Talk to your doctor or pharmacist before using SUMATRIPTAN DOC.
Additional risk factors

• If you are a heavy smoker or are using nicotine replacement therapy, and particularly
• if you are a man over 40 years of age or
• if you are a woman who has gone through menopause

Very rarely, some people have developed serious heart conditions after using sumatriptan, even though they had never previously shown signs of heart disease. If any of the above points apply to you, this may mean you have a higher risk of developing heart disease; therefore:

• Inform your doctor so they can check your heart function before prescribing SUMATRIPTAN DOC.

If you have a history of seizures (epileptic fits)
or if you have other conditions that may make seizures more likely, such as head injury or alcoholism:

• Inform your doctor so they can monitor you more closely.

If you have had high blood pressure
SUMATRIPTAN DOC may not be suitable for you.

• Inform your doctor or pharmacist before using SUMATRIPTAN DOC.

If you have liver or kidney disease
If either of these applies to you:

• Inform your doctor or pharmacist before using SUMATRIPTAN DOC.

If you are allergic to antibiotics called sulphonamides
If so, you may also be allergic to sumatriptan. If you know you are allergic to an antibiotic but are unsure whether it is a sulphonamide:

• Inform your doctor or pharmacist before using SUMATRIPTAN DOC.

If you are taking antidepressants called SSRIs
(selective serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors):

• Inform your doctor or pharmacist before using SUMATRIPTAN DOC. See also “Other medicines and SUMATRIPTAN DOC” below.

The SUMATRIPTAN DOC pen may contain latex
The transparent needle guard cap of the pen may contain latex.

• Inform your doctor if you are allergic to latex.

If you use SUMATRIPTAN DOC frequently
Using SUMATRIPTAN DOC too often may worsen your headaches.

• Inform your doctor if this applies to you. Your doctor may recommend you stop using SUMATRIPTAN DOC.

If you experience pain or tightness in the chest after using SUMATRIPTAN DOC
These effects can be intense but usually disappear quickly. If they do not disappear quickly or worsen, seek immediate medical attention. Section 4 (below) contains further information about these possible side effects.
Children and adolescents
SUMATRIPTAN DOC is not recommended for children and adolescents under 18 years of age.
No data are available.
Elderly (over 65 years of age)
SUMATRIPTAN DOC is not recommended for elderly patients over 65 years of age.
Other medicines and SUMATRIPTAN DOC
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines must not be taken with SUMATRIPTAN DOC and others may cause adverse effects if taken with SUMATRIPTAN DOC. You must inform your doctor if you are taking:

• ergotamine, also used to treat migraine, or similar medicines such as methysergide maleate (see section 2 “Do not use SUMATRIPTAN DOC”). Do not use SUMATRIPTAN DOC at the same time as these medicines. Stop taking these medicines at least 24 hours before using SUMATRIPTAN DOC. Do not take any medicine containing ergotamine or ergotamine-like compounds for at least 6 hours after using SUMATRIPTAN DOC.
• other triptans/5-HT receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), also used to treat migraine (see section 2 “Do not use SUMATRIPTAN DOC”). Do not use SUMATRIPTAN DOC at the same time as these medicines. Stop taking these medicines at least 24 hours before using SUMATRIPTAN DOC. Do not take any other triptan/5-HT receptor agonist for at least 24 hours after using SUMATRIPTAN DOC.
• MAOIs used to treat depression. If you have taken them within the last 2 weeks, do not use SUMATRIPTAN DOC. See section 2 “Do not use SUMATRIPTAN DOC”.
• SSRIs and SNRIs used to treat depression. Using SUMATRIPTAN DOC with these medicines may cause serotonin syndrome (a group of symptoms which may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, shivering, increased heart rate and tremor). Inform your doctor immediately if you experience these symptoms.
• St John’s wort or Hypericum (Hypericum perforatum). Taking herbal remedies containing Hypericum together with SUMATRIPTAN DOC may increase the likelihood of side effects.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
There is only limited data on the safety of sumatriptan in pregnant women, although to date there is no evidence of an increased risk of birth defects. Your doctor will discuss with you whether or not to use SUMATRIPTAN DOC during pregnancy.
Do not breastfeed your baby for 12 hours after using SUMATRIPTAN DOC. If you express breast milk during this time, discard the milk and do not give it to your baby.
Driving and using machines
Both migraine symptoms and this medicine may cause drowsiness. If affected, do not drive or operate machinery.
SUMATRIPTAN DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 0.5 mL, i.e. it is essentially ‘sodium-free’.

3. How to use SUMATRIPTAN DOC

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
SUMATRIPTAN DOC is for subcutaneous use and is usually injected into the upper arm or thigh.
DETAILED INSTRUCTIONS for using the pen are described at the end of this leaflet
(see section 7 “Instructions for use”).

When to use SUMATRIPTAN DOC

• It is best to use SUMATRIPTAN DOC as soon as you feel a migraine or cluster headache starting, although you may use it at any time during an attack.
• Do not use SUMATRIPTAN DOC to try to prevent an attack; use it only after symptoms have begun.

How much SUMATRIPTAN DOC to use
Adults aged 18 to 65

• The recommended dose for adults aged 18 to 65 with migraine or cluster headache is one 6 mg injection.
• If symptoms return, you may use a second injection of SUMATRIPTAN DOC, provided at least 1 hour has passed since the first injection.
• If the first injection has no effect, do not use another injection or any other injectable sumatriptan preparation for the same attack.
• If SUMATRIPTAN DOC does not relieve your symptoms, consult your doctor or pharmacist.

If you use more SUMATRIPTAN DOC than you should
If you use too much SUMATRIPTAN DOC, you may feel unwell. If you have used more than two injections within 24 hours:

• consult your doctor.

If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Some symptoms may be caused by migraine itself.

Allergic reactions: seek immediate medical help
The following side effects have occurred, but their exact frequency is unknown.

• Signs of allergy include skin rash, urticaria (itchy rash); wheezing; swelling of the eyelids, face or lips; collapse.

If any of these symptoms occur immediately after using SUMATRIPTAN DOC:
Stop using it immediately and contact a doctor without delay.

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

• Transient pain at the injection site
• Pricking pain or burning sensation, redness, swelling, bruising, and bleeding at the injection site

Common (may affect up to 1 in 10 people)

• Pain, tightness, pressure, or heaviness in the chest, throat, or other parts of the body, or unusual sensations including numbness, tingling, warmth, or cold. These effects may be intense but usually resolve quickly.

If these effects persist or worsen (especially chest pain):
Seek urgent medical attention. In a very small number of people, these symptoms may be due to a heart attack.

Other common side effects (may affect up to 1 in 10 people)

• Feeling unwell (nausea) or sickness (vomiting), although these may also be due to migraine itself
• Tiredness or drowsiness
• Dizziness, feeling weak or hot flushes
• Temporary increase in blood pressure
• Shortness of breath
• Muscle pain

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

• Changes in liver function. If you are due to have a blood test to check your liver function, inform your doctor or nurse that you are taking SUMATRIPTAN DOC.

Not known: frequency cannot be estimated from the available data

• Seizures/convulsions, tremors, muscle spasms, neck stiffness
• Vision disturbances such as flickering vision, reduced vision, double vision, loss of vision, and in some cases even permanent defects (although these may also occur due to the migraine attack itself)
• Heart problems, irregular heartbeat (which may be fast, slow, or irregular), chest pain (angina), or heart attack
• Pale or bluish skin and/or pain in fingers, toes, ears, nose, or jaw in response to cold or stress (Raynaud's phenomenon)
• Feeling faint (blood pressure may drop)
• Pain in the lower left part of the stomach and bloody diarrhoea (ischaemic colitis)
• Diarrhoea
• Joint pain
• Feeling anxious
• Excessive sweating
• If you have recently had an injury or have an inflammation (such as rheumatism or inflammation of the colon), you may experience pain or worsening of pain at the site of injury or inflammation
• Difficulty swallowing

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SUMATRIPTAN DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the pen. The expiry date refers to the last day of that month.
Do not store this medicine above 25°C. Keep it in the original packaging to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What SUMATRIPTAN DOC contains

• The active substance is sumatriptan. Each pre-filled pen contains 6 mg of sumatriptan (as sumatriptan succinate).
• The other components are sodium chloride and water for injections.

Description of the appearance of SUMATRIPTAN DOC and pack contents
SUMATRIPTAN DOC is a clear, colourless to pale yellow solution.
The pre-filled pen consists of a 1 mL transparent type I glass syringe barrel with cut flange and a pre-attached needle (29 Gauge, ½ inch length, 5 bevel tip) sealed with a transparent rigid needle protective cap, and a sterile black chlorobutyl rubber plunger stopper, packed in a cardboard carton.
Each pack contains 1, 2, 6 or 12 pre-filled pens.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan, Italy.
Manufacturer
Hormosan Pharma GmbH, Hanauer Landstrasse 139-143, 60314 Frankfurt am Main, Germany.

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany Sumatriptan Hormosan 6 mg Injektionslösung im Fertigpen
Denmark Sumatriptan "Advanz Pharma"
Finland Sumatriptan Advanz Pharma 12 mg/ml injektioneste, liuos, esitäytetty kynä
Italy SUMATRIPTAN DOC
Netherlands Sumatriptan Advanz Pharma 6 mg/0.5 ml oplossing voor injectie in een voorgevulde pen
Norway Sumatriptan Advanz Pharma 12 mg/ml injeksjonsvæske, oppløsning i ferdigfylt penn
Spain Sumatriptan CFOURHEALTH 6mg/0.5ml solución inyectable en pluma precargada
Sweden Sumatriptan Advanz Pharma 12 mg/ml, injektionsvätska, lösning i förfylld injektionspenna

7. Instructions for Use

HOW TO USE THE PRE-FILLED PEN Figure 1
(front view of the
pre-filled pen)
SUMATRIPTAN DOC
This section explains how to use the sumatriptan pre-filled pen.
Please read it TWICE before proceeding to the first step. For any doubts, consult your
physician or pharmacist.
Use only for patients who have been prescribed a 6 mg dose.

PRECAUTIONS:

• Check the appearance of sumatriptan through the viewing window (Fig. 1). The solution should be clear, colorless to pale yellow. Do not inject the solution if it shows discoloration, appears cloudy, or contains clumps, flakes, or particulate matter.
• Do not remove the transparent needle protective cap from the pre-filled pen until ready for injection.
• NEVER reinsert the transparent needle protective cap onto the pre-filled pen.
• NEVER touch or press the grey needle shield with your thumb, fingers, or hand.

How to use the pre-filled pen
a. Wash hands thoroughly.
b. Choose a comfortable, well-lit area and prepare all necessary items within easy reach (pre-filled pen, alcohol or sterile swabs).
c. Select an injection site with an adequate layer of subcutaneous fat, such as the upper arm or thigh (Fig. 2).
Do not administer the injection at sites where the skin is tender, bruised, red, or hardened.
d. Clean the injection site with alcohol or a new sterile swab and allow it to dry. Do not touch the area again before injection.
e. Remove the pre-filled pen from its carton packaging.
f. Hold the pre-filled pen in one hand and, with the other, gently remove the transparent needle protective cap by pulling it straight off. Do not twist the cap or reattach it to the pen, to avoid damaging the internal needle (Fig. 3).

How to administer the injection:

1. Place the open end of the pre-filled pen perpendicularly (at a 90º angle) onto the injection site and firmly press the safety needle shield against the skin to unlock it. Once the safety needle shield is fully depressed, the needle is inserted into the subcutaneous tissue.

2. An audible "click" indicates the start of the injection. Keep the pre-filled pen steady at the injection site. Figure 4 Continue to press the pen firmly against the skin until a second "click" is heard, indicating the injection is complete. Hold the pen in place against the skin for an additional 5 seconds to ensure the full dose is delivered (Fig. 4).

3. Remove the pen while keeping it perpendicular to the tissue Figure 5 (Fig. 5).

4. At the end of the injection, the grey plunger will be fully visible in the viewing window.
   Even if the viewing window does not appear grey, DO NOT attempt to reuse the pre-filled pen.
   NEVER ATTEMPT TO USE THE PRE-FILLED PEN A SECOND TIME

5. The safety needle shield on the pre-filled pen will automatically cover the needle and lock into place. The needle will no longer be visible (Fig. 6).

Do not repeat the injection with a new pre-filled pen if there is any doubt that the full dose was not administered.

6. Clean any blood at the injection site with a cotton ball or tissues. Do not rub the injection site. If necessary, cover the injection site with a plaster.

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6