Tiblelan

Package leaflet: Information for the user

Tiblelan 1.3 mg film-coated tablets, 2.6 mg film-coated tablets

hydrochloride hydromorphone
This medicinal product contains hydromorphone, an opioid that may cause dependence.
Abrupt discontinuation of treatment may cause withdrawal symptoms.
Read this leaflet carefully before taking 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Tiblelan is and what it is used for

This medicine has been prescribed for you to treat severe pain.
The active substance in Tiblelan is hydromorphone hydrochloride, which belongs to a group of medicines
called opioids, known as "analgesics". The effect of the medicine lasts approximately 4 hours.

2. What you need to know before taking Tiblelan

Do not take Tiblelan

• if you are allergic to hydromorphone or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from respiratory problems, such as severe chronic obstructive pulmonary disease, respiratory depression, or severe asthma. Symptoms may include shortness of breath, coughing, or slower and weaker breathing than normal
• if you have severe abdominal pain
• if you have lost consciousness (coma)
• if you have a condition in which the small intestine does not function properly (paralytic ileus)
• if you are taking, or have taken within the last two weeks, a type of medicine known as a monoamine oxidase inhibitor (for example, tranylcypromine, phenelzine, isocarboxazid, moclobemide, or linezolid)

Warnings and precautions
Talk to your doctor or pharmacist before taking Tiblelan.
Special caution is needed during treatment with this medicine if:

• you are elderly or frail
• you have previously experienced withdrawal symptoms such as restlessness, anxiety, tremors, or sweating when stopping alcohol or drugs
• you are taking this medicine together with tranquilizers or sleeping pills (sedative medicines)
• you have respiratory problems, such as severe impairment of lung function, chronic obstructive pulmonary disease, or reduced respiratory reserve. Your doctor will have informed you if you have any of these conditions. Symptoms may include breathlessness and cough
• you experience breathing pauses during sleep (sleep apnoea)
• you have a severe headache or feel unwell due to head trauma or increased pressure inside the skull (e.g., due to a brain disorder). This is because the tablets may worsen symptoms or mask the severity of head trauma
• you have reduced level of consciousness
• you have biliary problems (e.g., biliary colic) or renal colic
• you suffer from seizures, fits, or attacks
• you have a mental disorder caused by infection (toxic psychosis)
• you have inflammation of the pancreas (causing severe abdominal and back pain)
• you have an underactive thyroid gland (hypothyroidism)
• you have low blood pressure with dehydration (hypotension with hypovolemia)
• you have severe kidney or liver problems
• you are alcohol-dependent or have a severe reaction to alcohol withdrawal (delirium tremens)
• you have poor adrenal gland function (adrenal insufficiency, which may cause symptoms such as weakness, weight loss, dizziness, nausea, or vomiting)
• you have prostate problems
• you are in shock (this may make you suddenly feel very weak, faint, cold, sweaty, and appear pale)
• you have intestinal problems such as intestinal inflammation or obstruction
• you suffer from constipation

Respiratory depression
The main risk in case of opioid overdose is slowed and weakened breathing (respiratory depression).
Sleep-related breathing disorders
This medicine may cause sleep-related breathing disorders, such as sleep apnoea (breathing pauses during sleep) and nocturnal hypoxaemia (low oxygen levels in the blood). Symptoms may include breathing pauses during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.
Tolerance, dependence, and addiction
This medicine contains hydromorphone, which is an opioid substance. It may cause dependence and/or addiction.
This medicine contains hydromorphone, which is an opioid medicine. Repeated use of opioid analgesics may make the medicine less effective (you become accustomed to it, a phenomenon known as drug tolerance). Repeated use of Tiblelan may also lead to dependence, abuse, and addiction, which may result in potentially fatal overdose.
The risk of these adverse effects may increase with higher doses and prolonged duration of use.
Dependence or addiction may make you feel that you no longer have control over how much medicine you take or how often you take it.
The risk of developing dependence or addiction varies from person to person. You may have a higher risk of becoming dependent on or addicted to Tiblelan if:

• you or a family member has previously suffered from alcohol, prescription medicine, or illegal substance abuse or dependence ("addiction");
• you are a smoker;
• you have previously had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while taking Tiblelan, it may be a sign of dependence or addiction:

• you feel the need to take the medicine for longer than prescribed by your doctor
• you feel the need to take a higher dose than recommended
• you feel compelled to continue taking the medicine even if it does not relieve pain
• you use the medicine for reasons other than prescribed, e.g., “to stay calm” or “to help sleep”
• you have repeatedly tried to stop or control use of this medicine without success
• when you stop taking the medicine, you feel unwell, and when you restart it, you feel better (“withdrawal effects”).

If you notice any of these symptoms, talk to your doctor to discuss the best treatment approach for you, including when it may be appropriate to stop treatment and how to do so safely (see section 3, If you stop taking Tiblelan).
Hyperalgesia
Rarely, increasing the dose of this medicine may make you more sensitive to pain (hyperalgesia). If this occurs, you should talk to your doctor about treatment.
Dependence may cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms may include restlessness, difficulty sleeping, irritability, agitation, anxiety, awareness of heartbeat (palpitations), increased blood pressure, nausea or vomiting, diarrhoea, loss of appetite, tremors, chills, or sweating. Your doctor will discuss with you how to gradually reduce the dose before stopping treatment. It is important not to stop taking the medicine suddenly, as this would increase the risk of withdrawal symptoms.
Paralytic ileus
This medicine must not be used if there is a possibility of absent intestinal motility (paralytic ileus). If paralytic ileus is suspected or occurs during treatment, hydromorphone therapy must be stopped immediately.
Surgery and other pain-relieving procedures
Tiblelan must be used with caution before and during the first 24 hours after surgery.
After this period, this medicine should be used with caution, particularly after abdominal surgery.
In patients undergoing surgical procedures for pain relief (e.g., cordotomy), treatment with this medicine must be stopped 4 hours before the procedure. If treatment with this medicine is continued, the dose must be readjusted after the procedure.
Opioids must only be taken by the person to whom they have been prescribed. Do not give this
medicine to anyone else. Taking higher or more frequent doses of opioids may increase the risk of
dependence. Abuse and misuse may lead to overdose and/or death.
Hormonal changes may occur during treatment with these tablets. Your doctor may wish to monitor such changes.
Children
Children under 12 years of age must not take this medicine.
Other medicines and Tiblelan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. If you take these tablets together with other medicines, the effect of the tablets or the other medicine may change.
These tablets must not be used together with a type of medicine known as monoamine oxidase inhibitors. Inform your doctor if you have taken such medicines within the last two weeks (see section 2).
Inform your doctor or pharmacist if you are taking:

• medicines that help you sleep or stay calm (e.g., benzodiazepines, tranquillisers, hypnotics, or sedatives)
• medicines known as barbiturates for treating seizures or helping you sleep
• medicines to prevent nausea or vomiting (antiemetics)
• medicines for treating allergies (antihistamines)
• medicines for treating depression (antidepressants)
• medicines for treating psychiatric or mental disorders (such as neuroleptics)
• other strong analgesics or "painkillers"

Also, inform your doctor if you have recently been given an anaesthetic.
Concomitant use of this medicine with 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. Concomitant use of opioids and medicines used to treat epilepsy, nerve pain, or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression, and may be life-threatening.
However, if your doctor prescribes this medicine 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 strictly the dosing instructions provided by your doctor. It may be helpful to inform friends or family members to be aware of the signs and symptoms described above. Contact your doctor if you experience such symptoms.
Concomitant use of this medicine with certain muscle relaxants may increase breathing difficulties (respiratory depression).
Tiblelan and alcohol
Drinking alcohol while taking this medicine may increase drowsiness or increase the risk of serious side effects such as shallow breathing with risk of respiratory arrest and loss of consciousness. You are advised not to drink alcohol during treatment with this medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The use of Tiblelan during pregnancy is not recommended.
If this medicine is administered during pregnancy or labour, uterine contractility may be impaired and the newborn may experience breathing problems (respiratory depression).
Newborns whose mothers have taken hydromorphone for a prolonged period during pregnancy may experience withdrawal symptoms (such as high-pitched crying, agitation, seizures, feeding difficulties, and diarrhoea).
Breastfeeding
Do not take this medicine during breastfeeding, as hydromorphone passes into breast milk and may affect the newborn. If it is necessary to take this medicine, breastfeeding must be discontinued.
Fertility
Studies in rats have not shown adverse effects of hydromorphone on fertility in males or females.
Driving and using machines
This medicine may cause side effects such as drowsiness, which may impair your ability to drive or operate machinery (see section 4 for a complete list of undesirable effects). These effects are generally more noticeable when you first start taking the tablets or when you switch to a higher dose. They are also more likely to occur if you take Tiblelan together with alcohol or other medicines that depress the central nervous system.
If you experience these effects, you must not drive or operate machinery.
This medicine may affect your ability to drive because it may cause drowsiness or dizziness.

• Do not drive while taking this medicine until you know how it affects you.

Talk to your doctor or pharmacist if you are unsure whether you can drive while taking this medicine.
Tiblelan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., essentially “sodium-free”.

3. How to take Tiblelan

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist. The medicine label indicates how many tablets you should take and how often.

Adults and adolescents over 12 years of age
The usual starting dose is one film-coated tablet every 4 hours. However, your doctor will determine the dose needed to treat your pain. If you still experience pain while taking these tablets, discuss it with your doctor.

Use in children under 12 years of age
Children under 12 years of age must not take this medicine.

Elderly patients
Elderly patients may require a lower dose to achieve adequate pain relief.

Patients with hepatic or renal impairment
If you have reduced liver or kidney function, you may need lower doses than other patients to achieve adequate pain relief. Therefore, the dose of this medicine must be adjusted with particular care.

Do not exceed the dose recommended by your doctor. If you have any doubts, consult your doctor or pharmacist.

Your doctor should have explained to you how long your treatment with Tiblelan will last. They will establish a plan for stopping the treatment. This plan will indicate how to gradually reduce the dose and discontinue the medicine.

Oral use.

Swallow the tablets with a glass of water and do not chew or crush the tablet.
You must take the tablets only by oral route. Other routes of administration may lead to serious, potentially fatal consequences.

Take the tablets every 4 hours. For example, if you take a tablet at 4 a.m., take the next tablet at 8 a.m.

The 2.6 mg film-coated tablets may be divided into equal doses.

If you take more Tiblelan than you should
Contact your doctor immediately or go to hospital, as you may require emergency treatment. People who have taken an overdose may experience constricted pupils (miosis), slowed heart rate (bradycardia), a brain disorder (known as toxic leukoencephalopathy), and low blood pressure (hypotension). They may also feel very drowsy, nauseous, dizzy, or develop pneumonia due to inhalation of vomit or foreign substances (symptoms may include breathing difficulties, cough, and fever). They may also experience breathing difficulties leading to loss of consciousness or even death.

When seeking medical help, make sure to bring this leaflet and any remaining tablets with you to show the doctor.

If you forget to take Tiblelan
Do not take a double dose to make up for a forgotten tablet. If you miss a dose, take it as soon as you remember, and then take the next dose 4 hours after that. Do not take two doses within 4 hours.

If you stop taking Tiblelan
Your pain may return. Do not stop taking this medicine without consulting your doctor. If you stop taking this medicine after prolonged use, withdrawal symptoms may occur (such as increased excitability, anxiety, nervousness, insomnia, involuntary movements, tremors, and gastrointestinal disturbances). If treatment is no longer required, your doctor may decide to discontinue it gradually.

If you have any questions about how to use 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.
This medicine may cause allergic reactions. The frequency of severe allergic reactions is unknown.
Inform your doctor immediately if you experience sudden breathlessness, difficulty breathing,
swelling of the eyelids, face or lips, mouth or throat, or skin rashes or itching, especially if widespread
throughout the body.
The most serious side effect is a condition in which breathing becomes slower or weaker than normal
(respiratory depression).

Withdrawal
When you stop taking this medicine, you may experience withdrawal symptoms, including restlessness,
difficulty sleeping, irritability, agitation, anxiety, awareness of heartbeat (palpitations), increased
blood pressure, feeling nauseous or vomiting, diarrhoea, tremors, chills or sweating.

How can I tell if I have developed dependence?
If you notice any of the signs (see section 2) while taking this medicine, this could be a sign of
dependence.

Constipation is common in most people using this medicine. Increasing your intake of fibre (fruit,
vegetables, wholemeal bread, pasta, brown rice) and fluids may help reduce the problem, but if needed,
your doctor may prescribe a laxative.

You may feel sick or vomit while taking this medicine. This effect usually resolves after a few days;
however, if the problem persists, your doctor may prescribe an antiemetic medicine.

Very common (may affect more than 1 in 10 people)
Dizziness, constipation, nausea, sedation
Drowsiness (this effect is more likely at the beginning of treatment or when the dose is increased, but
should disappear after a few days)

Common (may affect up to 1 in 10 people)
Loss of appetite
Confusion, anxiety, difficulty sleeping
Headache
Vomiting, abdominal pain, dry mouth
Unusual weakness
Itching of the skin, sweating
Sudden need to urinate

Uncommon (may affect up to 1 in 100 people)
Agitation, depression, hallucinations, nightmares
Feeling of euphoria
Muscle spasms, tremors, tingling in hands or feet
Blurred vision
Low blood pressure
Shortness of breath
Diarrhoea, altered taste, indigestion
Worsening of liver function test results (observed via blood tests)
Skin rash
Difficulty urinating
Impotence, decreased sex drive
Withdrawal symptoms (see section “Withdrawal”)
Tiredness, general malaise
Swelling of hands, ankles or feet

Rare (may affect up to 1 in 1,000 people)

• Aggression
• Lack of energy
• Fast or slow heartbeat, palpitations
• Condition in which breathing is slower and weaker than normal (respiratory depression)
• Chest tightness with cough (bronchospasm)
• Increased pancreatic enzymes
• Dull pain in the central or upper right part of the abdomen (caused by a gallstone blocking the bile duct)

Not known (frequency cannot be estimated from the available data)

• Allergic reactions
• Dependence and tolerance (see “How can I tell if I have developed dependence?”)
• Drug tolerance
• Unpleasant or dysphoric mood, feeling of disorientation or abnormal sensation
• Fainting
• Constriction of the pupils
• Double vision
• Nystagmus
• Increased sensitivity to pain (hyperalgesia; see “Warnings and precautions” in section 2)
• Seizures, epileptic fits or convulsions
• Involuntary muscle movements
• Facial flushing
• Increased blood pressure
• Condition in which the small intestine (part of the bowel) does not function properly (paralytic ileus)
• Itchy skin rash (urticaria)
• Withdrawal symptoms in newborns born to mothers who have taken hydromorphone (see “Pregnancy and breastfeeding” in section 2)
• Sleep apnoea (breathing pauses during sleep)
• Muscle rigidity
• Spasm of the vocal cords causing temporary difficulty speaking or breathing
• Chills
• Increased intracranial pressure

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

5. How to store Tiblelan

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 blister after "Exp.".
This medicine does not require any special storage conditions.
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. Package contents and other information

What Tiblelan contains
The active substance is hydrochloride hydromorphone.
Each 1.3 mg film-coated tablet of Tiblelan contains 1.3 mg of hydromorphone hydrochloride,
equivalent to 1.16 mg of hydromorphone.
Each 2.6 mg film-coated tablet of Tiblelan contains 2.6 mg of hydromorphone hydrochloride,
equivalent to 2.32 mg of hydromorphone.
The excipients of the tablet core are:
Microcrystalline cellulose (E 460)
Calcium hydrogen phosphate (E 341)
Sodium croscarmellose (E 468)
Silicon dioxide, anhydrous colloidal (E 551)
Magnesium stearate (E 470b)
The excipients of the tablet coating are:
Hypromellose 15 mPas (E 464)
Polydextrose (E 1200)
Titanium dioxide (E 171)
Maltodextrin
Medium-chain triglycerides
Iron oxide red (E 172)
Iron oxide yellow (E 172) [for the 1.3 mg strength]
Ferrous ferric oxide/Iron oxide black (E 172) [for the 2.6 mg strength]

Description of the appearance of Tiblelan and pack contents
Tiblelan 1.3 mg film-coated tablets are yellowish to brownish in colour, round and biconvex, with a diameter of 6.1 mm ± 0.2 mm and without a breakline.
Tiblelan 2.6 mg film-coated tablets are red in colour, oblong and biconvex, with a diameter of 10.7 mm ± 0.2 mm and a breakline on one side. The tablet may be divided into equal doses.
Tiblelan is available in blisters containing 10, 20, 28, 30, 50, 60 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH
Industriestrasse 1,
8502 Lannach
Austria

This medicinal product is authorised in the Member States of the European Economic Area under the
following names:
Austria Hydagelan 1.3 mg, 2.6 mg Film Tablets
Germany Dolomorphon akut 1.3 mg, 2.6 mg Film Tablets
Italy Tiblelan

The following information is intended for healthcare professionals only:

Overdose management
First and foremost, attention must be paid to ensuring airway patency and initiating assisted or controlled ventilation.
Immediate medical emergency measures must be implemented, or, if necessary, intensive care therapy (e.g., intubation and ventilation). Specific opioid antagonists (e.g., naloxone) may be used to treat intoxication symptoms. The dosage of individual opioid antagonists varies (refer to the respective SmPCs).
Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to hydromorphone overdose. Naloxone must be administered with caution in patients with known or suspected physical dependence on hydromorphone. In such cases, a sudden or complete reversal of opioid effects may precipitate an acute withdrawal syndrome.
Gastric lavage may be indicated to remove unabsorbed drug. If necessary, artificial respiration must be provided. Fluid and electrolyte balance should be maintained.
Other supportive measures should also be considered, depending on the patient’s clinical course and condition.