Dogetic

Package leaflet: Information for the patient

Dogetic 100 microgram tablets for sublingual use, 200 microgram tablets for sublingual use, 300 microgram tablets for sublingual use, 400 microgram tablets for sublingual use, 600 microgram tablets for sublingual use, 800 microgram tablets for sublingual use

Fentanyl
Equivalent medicine
Please read all of 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 give it to other people. Even if their symptoms are the same as yours, it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 Dogetic is and what it is used for

Dogetic is a treatment intended for adults who are already required to take strong
opioid painkillers regularly for persistent cancer-related pain, but who also require treatment for breakthrough pain. If you have any doubts, consult your doctor.
Breakthrough pain is sudden pain that occurs even though you have already taken your usual opioid painkiller.
The active substance in Dogetic sublingual tablets is fentanyl. Fentanyl belongs to a group of strong painkillers called opioids.

2. What you need to know before taking 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 respiratory problems
• if you are not regularly using an opioid medicine prescribed by your doctor (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least one week to manage persistent pain. If you are not using these medicines, you must 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 breakthrough 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 consider these when prescribing your dose:

• head injury, as Dogetic may mask the severity of the injury
• respiratory problems or myasthenia gravis (a condition characterized by muscle weakness)
• heart problems, particularly slow heart rate
• low blood pressure
• kidney or liver disease, as this may require your doctor to more carefully adjust your dose
• brain tumour and/or increased intracranial pressure (increased pressure in the brain causing severe headache, nausea/vomiting and blurred vision)
• mouth sores or mucositis (swelling and redness inside the mouth)
• if you are taking antidepressants or antipsychotics, refer to 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 prescribed medicine.
• you develop 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 lack of sex hormones (androgen deficiency) with the use of opioids. During treatment with Dogetic, if you are about to undergo surgery, inform your doctor or dentist that you are taking this medicine.

For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

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

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

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• carbamazepine, phenytoin or phenobarbital (medicines used to treat seizures/epileptic fits);
• herbal remedies containing St. John’s wort (Hypericum perforatum);
• medicines containing alcohol;
• medicines called monoamine oxidase inhibitors (MAOIs), used for severe depression and Parkinson’s disease; inform your doctor if you have taken this type of medicine within the last two weeks.
• certain types of strong analgesics called partial agonist/antagonists, for example buprenorphine, nalbuphine and pentazocine (medicines used to treat pain). When used together with these medicines, withdrawal symptoms (nausea, vomiting, diarrhoea, anxiety, chills, tremor and sweating) may occur.

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

• other strong painkillers (opioid-type medicines, e.g. for pain and cough)
• general anaesthetics (used to induce sleep during surgery)
• 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 body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Your doctor will advise you whether Dogetic is suitable for you.
The concomitant use of Dogetic and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Dogetic together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendations carefully. It may be helpful to inform and make friends or family aware of the signs and symptoms listed above. Contact your doctor if 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 Dogetic treatment, as it may increase the side effects of Dogetic.

Pregnancy and breastfeeding
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If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Dogetic during pregnancy unless your doctor has specifically instructed you to do so.
Fentanyl can pass into breast milk and cause adverse effects in the breastfed infant.
Do not take Dogetic while breastfeeding. You may resume breastfeeding 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 operating machinery.
If you experience dizziness, drowsiness or blurred vision when taking Dogetic, do not drive or operate machinery.

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 to you how to take it in order to effectively treat your breakthrough pain.
Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
This product is intended for use by YOU ONLY, based on instructions provided by your doctor.
It must not be used by anyone else, as it may pose a SERIOUS risk to their health, especially in children.
Dogetic is different from other medicines you may have used to treat breakthrough pain.
You must always use the dose of Dogetic prescribed by your doctor – this may be a different dose from what you have used with other medicines for breakthrough pain.

Initial treatment – finding the most suitable dose
For Dogetic to work effectively, your doctor must determine the most suitable dose for treating your breakthrough pain. Dogetic is available in a range of strengths. You may need to try different doses of Dogetic during separate episodes of breakthrough pain to find the most suitable dose. Your doctor will help you identify the best dose to use.
If you do not achieve adequate pain relief from a single dose, your doctor may instruct you to take an additional dose to treat an episode of breakthrough pain.
Do not take a second dose unless your doctor has specifically told you to do so, as this may lead to overdose.
Your doctor may advise you to take a dose consisting of more than one tablet at a time. Take such a dose only if specifically prescribed by your doctor.
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Wait at least 2 hours after taking the last dose before treating a new episode of breakthrough pain with Dogetic.

Ongoing treatment – once the most suitable dose has been found
Once you and your doctor have identified a dose of Dogetic that effectively controls your breakthrough pain, you should 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 breakthrough pain with Dogetic.
If you feel that the dose of Dogetic you are currently using does not adequately control your breakthrough pain, inform your doctor, as your dose may need adjustment.
Do not change your dose of Dogetic unless instructed to do so by your doctor.

How to take the medicine
Dogetic must be used sublingually. This means that the tablet must be placed under the tongue, where it dissolves rapidly, allowing fentanyl to be absorbed through the mucous membranes inside the mouth. Once absorbed, fentanyl begins to exert its pain-relieving effect.
When you experience an episode of breakthrough pain, take the dose prescribed 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 use, as follows:
• Separate one blister square from the pack by cutting along the dotted lines (leave the remaining blister squares intact).
• Peel back the edge of the aluminium layer at the location indicated by the arrow and gently remove the tablet. Do not attempt to push the Dogetic sublingual tablets through the aluminium layer, as this may damage them.
• Place the tablet under the 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 analgesic effect. It is therefore important that you do not suck, chew, or swallow the tablet.
• Do not eat or drink anything until the tablet has completely dissolved under the tongue.

If you take more Dogetic than you should

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

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In such a case, seek immediate emergency medical treatment.
If you suspect that someone has accidentally taken Dogetic, seek immediate emergency medical treatment.

If you stop taking Dogetic
If you no longer experience breakthrough pain, you should stop treatment with Dogetic. However, you must continue taking your regular opioid painkiller for persistent cancer pain, as directed by your doctor. If you stop treatment with Dogetic, you may experience 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 a medicine to reduce or eliminate withdrawal symptoms.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you start feeling unusually or extremely drowsy, or if you experience slow or difficult breathing,
you or the person assisting you must immediately contact your doctor or the local hospital for emergency medical treatment (see also section 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 sleepiness
• 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, blurred or disturbed vision, fast or slow heartbeat, low blood pressure, memory loss
• depression, paranoia/unexplained fear, confusion, disorientation, anxiety/unhappiness/restlessness, unusual feeling of happiness/well-being, mood swings
• feeling of fullness in the stomach, stomach ache, indigestion
• mouth ulcers, tongue problems, mouth or throat pain, tightness in the throat, lip or gum ulcers
• loss of appetite, loss or change in 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, tendency to bruise easily
• joint pain or stiffness, muscle stiffness

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• withdrawal symptoms (may occur if any of the following side effects appear: nausea, vomiting, diarrhoea, anxiety, chills, tremors and sweating), accidental overdose, in men inability to achieve and/or maintain an erection, general feeling of malaise

Side effects of unknown frequency: (frequency cannot be estimated from the available data)

• swelling of the tongue, severe breathing problems, falls, flushing, feeling very hot, diarrhoea, seizures (epileptic fits), swelling of the arms or legs, seeing or hearing things that are not there (hallucinations), fever
• drug dependence (addiction)
• drug abuse
• reduced level or loss of consciousness
• itchy rash
• delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not there, sleep disturbances, nightmares)

Prolonged fentanyl treatment during pregnancy may cause withdrawal symptoms in the newborn, which can be fatal (see section 2).

Reporting of side effects
If you experience any side effects, 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 Dogetic

The pain-relieving ingredient in Dogetic is very potent and could be life-threatening if accidentally ingested by a child. Dogetic must be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
It is recommended to store Dogetic in a secure, locked place.
Any unused product should, if possible, be returned to the pharmacist for safe disposal. Do not dispose of any medicines via wastewater or household waste. This will help protect the environment.

6. Package contents and other information

What Dogetic contains

• The active substance 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 components 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, designed to be placed under the tongue. It is available in a range of different strengths and shapes. Your doctor will prescribe the appropriate strength (form) and number of tablets for you.
100 microgram sublingual tablet
White, round-shaped, 6 mm in diameter
200 microgram sublingual tablet
White, oval-shaped, 7 mm long, 4.5 mm wide
300 microgram sublingual tablet
White, triangular-shaped, 6.2 x 6.2 mm
400 microgram sublingual tablet
White, rhomboid-shaped, 8.5 x 6.5 mm
600 microgram sublingual tablet
White, "D"-shaped, 8.5 x 6 mm
800 microgram sublingual tablet
White, capsule-shaped, 10 mm long, 6 mm wide

The sublingual tablets are packaged in PA/aluminum/PVC blisters, thermo-sealed onto an aluminum foil sheet and placed in a box.
Pack sizes:
Dogetic 100, 200, 300 and 400 are available in boxes of 10x1 or 30x1 tablets.
Dogetic 600 and 800 are available in boxes of 30x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Sandoz SpA,
L.go U. Boccioni 1,
21040 Origgio (VA)
Italy

Manufacturer
PRASFARMA S.L.
C. Sant Joan, 11-15
8/10
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 European Economic Area Member States under the following names:

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