DOGETIC 100 MICROGRAMS Sublingual tablet

Зміст інструкції

1. Dogetic 100 micrograms sublingual tablets, 200 micrograms sublingual tablets, 300 micrograms sublingual tablets, 400 micrograms sublingual tablets, 600 micrograms sublingual tablets, 800 micrograms sublingual tablets
   1. What is Dogetic and what is it used for
   2. What you need to know before you take Dogetic
   3. How to take Dogetic
   4. Possible side effects
   5. How to store Dogetic
   6. Package contents and other information

Dogetic 100 micrograms sublingual tablets, 200 micrograms sublingual tablets, 300 micrograms sublingual tablets, 400 micrograms sublingual tablets, 600 micrograms sublingual tablets, 800 micrograms sublingual tablets

Fentanil
Equivalent medicinal product

Read this leaflet carefully before taking this medicine as 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 pass it on to others. Even if they have the same symptoms as you, it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Dogetic is and what it is used for
• 2. What you need to know before you take Dogetic
• 3. How to take Dogetic
• 4. Possible side effects
• 5. How to store Dogetic
• 6. Contents of the pack and other information

1. What is Dogetic and what is it used for

Dogetic is a treatment intended for adults who already need to regularly take potent
painkillers (opioids)for persistent cancer pain, but who require
treatment for intense episodic pain. If you have any doubts, consult your doctor.
Intense episodic pain is pain that occurs suddenly, even if you have already taken
your usual opioid painkiller.
The active substance in Dogetic sublingual tablets is fentanyl. Fentanyl
belongs to a group of potent painkillers called opioids.

2. What you need to know before you take Dogetic

Do not take Dogetic

• if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6)
• if you have severe breathing problems
• if you do not regularly use an opioid medicine prescribed by your doctor (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day according to a regular schedule, for at least one week, for the control of persistent pain. If you are not using these medicines, you should not use Dogetic because it may increase the

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risk that your breathing may become slow and/or difficult in a dangerous way, or
even stop.

• if you suffer from short-term pain other than intense episodic pain.

Warnings and precautions
Talk to your doctor or pharmacist before taking Dogetic if you have or have recently had any of the
following conditions, as your doctor will need to take these into account when prescribing the dose:

• a head injury, as Dogetic may mask the extent of the injury
• breathing problems or myasthenia gravis (a condition characterized by muscle weakness)
• if you have heart problems, especially slow heartbeat
• low blood pressure
• kidney or liver disease, as this may require your doctor to make a more careful dose adjustment
• brain tumor and/or increased intracranial pressure (increased pressure in the brain causing severe headache, nausea/vomiting and blurred vision)
• sores in the mouth or mucositis (swelling and redness inside the mouth)
• if you are taking antidepressants or antipsychotics, refer to the section “Other medicines and Dogetic”.

Talk to your doctor WHILE taking Dogetic if:

• you experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of the medicine prescribed by your doctor.
• you experience a combination of the following symptoms: nausea, vomiting, loss of appetite, fatigue, weakness, dizziness and low blood pressure. Together, these symptoms may be a sign of a potentially life-threatening condition called adrenal insufficiency, a condition in which the adrenal glands do not produce enough hormones.
• you have ever developed adrenal insufficiency or a lack of sex hormones (androgen deficiency) with the use of opioids. During treatment with Dogetic, if you are about to undergo surgery, tell your doctor or dentist that you are taking this medicine.

For those who play sports: the use of the drug without a therapeutic need constitutes doping and
may still result in a positive doping test.

Other medicines and Dogetic
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines (other than your usual opioid painkiller).
Some medicines can increase or decrease the effects of Dogetic. Therefore, if you start or
stop taking the following medicines, or change their dose, tell your doctor because
they may need to adjust the dose of Dogetic:

• some types of antifungal agents containing e.g. ketoconazole or itraconazole (used to treat fungal infections);
• some types of antibiotic medicines used to treat infections (called macrolides, containing e.g. erythromycin);
• some types of antiviral medicines called protease inhibitors containing e.g. ritonavir (used to treat infections caused by viruses);
• rifampicin or rifabutin (medicines used to treat bacterial infections);

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• carbamazepine or phenytoin or phenobarbital (medicines used to treat seizures/epileptic seizures);
• herbal remedies based on St. John's wort ( Hypericum perforatum);
• medicines containing alcohol;
• medicines called monoamine oxidase inhibitors (MAOIs), which are used for severe depression and Parkinson's disease; tell your doctor if you have taken this type of medicine in the last two weeks.
• some types of potent painkillers, called partial agonists/antagonists, for example buprenorphine, nalbuphine and pentazocine (medicines for the treatment of pain). In combination with the use of these medicines, withdrawal symptoms (nausea, vomiting, diarrhea, anxiety, chills, tremors and sweating) may occur.

Dogetic can intensify the effect of medicines that cause drowsiness, such as:

• other potent painkillers(opioid-type medicines, e.g. for pain and cough)
• general anesthetics (used to put you to sleep during operations)
• muscle relaxants
• sleeping pills
• medicines used to treat depression, allergies, anxiety and psychosis
• medicines containing clonidine (used to treat high blood pressure).

The risk of side effects increases if you are taking certain antidepressants or antipsychotics.
Dogetic may interact with these medicines and you may experience changes in mental status
(e.g. agitation, hallucinations, coma) and other effects such as a body temperature above 38
°C, increased heart rate, unstable blood pressure and exaggeration of
reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea,
vomiting, diarrhea). Your doctor will tell you if Dogetic is suitable for you.
The concomitant use of Dogetic and sedatives such as benzodiazepines or related drugs
increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can
be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Dogetic together with sedatives, the dose and duration of
concomitant treatment must be limited by the doctor.
Tell your doctor about all the sedatives you are taking and carefully follow
your doctor's recommendations on dosage. It may be helpful to inform and make aware
friends or family members of the signs and symptoms above. Contact your doctor when
these symptoms occur.

Dogetic with food, drinks and alcohol
In some people, Dogetic may cause drowsiness. Do not drink alcohol without consulting your doctor,
as it may cause you to feel more drowsy than usual.
Do not drink grapefruit juice if you have been prescribed treatment with Dogetic, as it may
increase the side effects of Dogetic.

Pregnancy and breastfeeding
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If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Dogetic during pregnancy unless explicitly told to do so by
your doctor.
Fentanyl can pass into breast milk and cause unwanted effects in the breastfed baby.
Do not take Dogetic while breastfeeding. You can start breastfeeding your
baby only at least 5 days after taking the last dose of Dogetic.

Driving and using machines
Dogetic may affect your physical or mental ability to perform potentially dangerous activities, such as driving or using machines.
If you experience dizziness, drowsiness or blurred vision when taking Dogetic, do not drive or use
machines.

Dogetic contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per sublingual tablet, i.e.
essentially “sodium-free”.

3. How to take Dogetic

Before taking Dogetic for the first time, your doctor will explain how to take it to effectively treat
acute episodic pain.
Take this medicine following your doctor's instructions exactly. If you have any doubts
consult your doctor or pharmacist.
This product must be used ONLY by you, based on the instructions provided by your doctor.
It must not be used by anyone else as it may pose a SERIOUS risk to
your health, especially for children.
Dogetic is different from other medicines you may have used to treat acute episodic pain.

You must always use the dose of Dogetic prescribed by your doctor–this may be a dose
different from the one you have used with other medicines for acute episodic pain.

Initial treatment – finding the most suitable dose
For Dogetic to work, your doctor must identify the most suitable dose for treating your
acute episodic pain. Dogetic is available in a range of dosages. You may need to
try different dosages of Dogetic over several episodes of acute episodic pain
to find the most suitable dose. Your doctor will help you find the best dose to use.
If you do not get adequate pain relief from a dose, your doctor may ask you to take a
supplementary dose to treat an episode of acute episodic pain.
Do not take a second dose unless your doctor has told you to do so, as this may
cause an overdose.
It may happen that your doctor advises you to take a dose consisting of more than one
tablet
at a time. Take this dose only if prescribed by your doctor.
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Wait at least 2 hours after taking the last dose before treating a new episode of
acute episodic pain with Dogetic.

Continuing treatment – once the most suitable dose has been found
Once you and your doctor have found a dose of Dogetic that can control your
acute episodic pain, you must take this dose no more than four times a day. A dose of
Dogetic may consist of more than one tablet.
Wait at least 2 hours after taking the last dose before treating a new episode of
acute episodic pain with Dogetic.
If you think that the dose of Dogetic you are using does not adequately control your
acute episodic pain, tell your doctor, as they may need to adjust your dose.
You must not change the dose of Dogetic unless you have been told to do so by your doctor.

Taking the medicine
Dogetic must be used sublingually. This means that the tablet must be placed
under the tongue, where it dissolves quickly, so that fentanyl can be absorbed
through the lining of the mouth. Once absorbed, fentanyl begins to work to
exert its pain-relieving effect.
When you have an episode of acute episodic pain, take the dose indicated by your doctor, as follows:

• if your mouth is dry, take a sip of water to moisten it. Spit out or swallow the water.
• remove one or more tablets from the blister pack immediately before taking them, as follows:
• separate one of the squares of the blister pack from the pack by cutting along the dotted lines (leaving the remaining squares of the blister pack intact).
• peel off the edge of the aluminum layer where the arrow is indicated and gently remove the tablet. Do not try to push the Dogetic sublingual tablets through the top layer of aluminum, as this would damage them.
• place the tablet under your tongue as far back as possible and allow it to dissolve completely.
• Dogetic will dissolve rapidly under the tongue and be absorbed to exert its pain-relieving effect. Therefore, it is important that you do not suck, chew or swallow the tablet.
• do not drink or eat anything until the tablet has completely dissolved under your tongue.

If you take more Dogetic than you should

• Remove any tablets from your mouth
• Inform the person assisting you or anyone else about what has happened
• You or the person assisting you must immediately contact your doctor, pharmacist or local hospital and discuss what action to take
• While awaiting the doctor, the person should be kept awake by talking to them or shaking them continuously. Symptoms of an overdose include:
• extreme drowsiness
• slowed and difficult breathing
• coma

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In such an event, seek immediate emergency medical treatment.
If you think that someone has taken Dogetic accidentally, seek immediate
emergency medical treatment.

If you stop taking Dogetic
If you no longer experience acute episodic pain, you should stop taking Dogetic. However,
you should continue to take your usual opioid pain medicine for the treatment of
persistent cancer pain, following your doctor's instructions. If you stop
taking Dogetic, you may experience drug withdrawal symptoms similar to
the possible side effects of Dogetic.
Contact your doctor if you develop withdrawal symptoms or have concerns about
pain relief. Your doctor will assess whether to prescribe you medicine to reduce
or eliminate withdrawal symptoms.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you begin to feel unusually or extremely sleepy, or in case of slow or difficult breathing, you or the person assisting you must immediately contact your doctor or local hospital for emergency medical attention (see also paragraph 3 “If you take more Dogetic than you should”).
Very common side effects(may affect more than 1 in 10 people) include:
nausea

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

• dizziness, headache, excessive drowsiness
• shortness of breath
• inflammation of the oral mucosa, vomiting, constipation, dry mouth
• sweating, fatigue/tiredness/lack of energy

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

• allergic reaction, tremor/shaking, blurred or disturbed vision, fast or slow heartbeat, low blood pressure, memory loss
• depression, paranoia/unfounded fear, feeling of confusion, disorientation, anxiety/unhappiness/restlessness, unusual feeling of happiness/well-being, mood swings
• feeling of having a full stomach, stomach pain, indigestion
• mouth ulcers, tongue problems, pain in the mouth or throat, tightness in the throat, lip or gum ulcers
• loss of appetite, loss or alteration of taste/smell
• difficulty sleeping or disturbed sleep, attention disorders/distractibility, lack of energy/weakness/loss of strength
• skin abnormalities, skin rashes, itching, night sweats, reduced sensitivity to touch, easy bruising
• joint pain or stiffness, muscle stiffness

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• drug withdrawal symptoms (may occur if the following side effects appear: nausea, vomiting, diarrhea, anxiety, chills, tremors and sweating), accidental overdose, in men inability to achieve and/or maintain an erection, general feeling of discomfort Side effects of unknown frequency:(frequency cannot be estimated on the basis of available data)
• swelling of the tongue, severe breathing problems, falls, flushing, feeling very hot, diarrhea, seizures (fits), swelling of arms or legs, seeing or hearing things that do not exist (hallucinations), fever.
• drug dependence (addiction)
• drug abuse
• reduced level of consciousness or loss of consciousness
• itchy rash
• delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that do not exist, sleep disturbances, nightmares)

Prolonged treatment with fentanyl during pregnancy can cause withdrawal symptoms in the
newborn, which can have fatal consequences (see paragraph 2)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through 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 Dogetic

The analgesic active ingredient present in Dogetic is very strong and could be dangerous to life if accidentally taken by a child. Dogetic must be kept out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
It is recommended to store Dogetic in a protected and locked storage place.
Any unused product should be delivered, if possible, to the pharmacist for safe disposal. Do not dispose of any medicine in the wastewater and household waste. This will help to protect the environment.

6. Package contents and other information

What Dogetic contains

• The active ingredient is fentanyl.

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Each sublingual tablet contains 100 micrograms of fentanyl (as citrate)
Each sublingual tablet contains 200 micrograms of fentanyl (as citrate)
Each sublingual tablet contains 300 micrograms of fentanyl (as citrate)
Each sublingual tablet contains 400 micrograms of fentanyl (as citrate)
Each sublingual tablet contains 600 micrograms of fentanyl (as citrate)
Each sublingual tablet contains 800 micrograms of fentanyl (as citrate)

• The other ingredients are mannitol (E421), silicified microcrystalline cellulose, sodium croscarmellose and magnesium stearate.

Description of the appearance of Dogetic and contents of the pack
Dogetic is a small, white sublingual tablet, to be placed under the tongue. It is provided in
a range of different dosages and shapes. Your doctor will prescribe the dosage (the shape) and the number
of tablets suitable for you.

100 micrograms sublingual tableti
White color, round shape with a diameter of 6 mm

200 micrograms sublingual tablet
White color, oval shape, 7 mm in length, 4.5 mm in width

300 micrograms sublingual tablet
White color, triangular shape, 6.2 x 6.2 mm

400 micrograms sublingual tablet
White color, rhomboid shape, 8.5 x 6.5 mm

600 micrograms sublingual tablet
White color, “D” shape, 8.5 x 6 mm

800 micrograms sublingual tablet
White color, capsule shape, 10 mm in length, 6 mm in width
The sublingual tablets are packaged in PA/aluminum/PVC blisters, heat-sealed to an
aluminum foil and placed in a carton.
Packs:
Dogetic 100, 200, 300 and 400 is available in boxes of 10x1 or 30x1 tablets.
Dogetic 600 and 800 is available in boxes of 30x1 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:
Marketing authorization holder
Sandoz SpA,
L.go U. Boccioni 1,
21040 Origgio (VA)
Italy

Manufacturer
PRASFARMA S.L.

• C. Sant Joan, 11-15

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08560 Manlleu (Barcelona)
Spain
KERN PHARMA, S.L.
Polígono Ind. Colón II
Venus, 72
08228 Terrassa - (Barcelona),
Spain
Lek Pharmaceuticals d.d.,
Verovškova ulica 57,
1526 Ljubljana, Slovenia

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:

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