Temgesic

Package leaflet: Information for the patient

TEMGESIC

0.2 mg sublingual tablets
buprenorphine hydrochloride
Please read all of 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Temgesic is and what it is used for
Temgesic sublingual tablets contain buprenorphine, which belongs to a group of medicines called analgesics, used for the treatment of moderate to severe acute and chronic pain of various origin and type.

2. What you need to know before taking Temgesic

Do not take Temgesic

• if you are allergic to buprenorphine or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from severe respiratory problems (respiratory failure);
• if you suffer from severe liver problems (hepatic failure);
• if you suffer from severe kidney problems (renal failure), if you have alcohol intoxication, or if you suffer from tremors and delirium due to alcohol withdrawal (delirium tremens);
• during concomitant treatment with antidepressant medicines (MAO inhibitors);
• if you have increased intracranial pressure (endocranial hypertension);
• in children under 12 years of age;
• during breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Temgesic if:

• you have depression or other conditions treated with antidepressants. Using these medicines together with Temgesic may lead to serotonin syndrome, a condition that can be fatal (see "Other medicines and Temgesic").

Take Temgesic with caution:

• if you have respiratory problems (e.g. chronic obstructive pulmonary disease, asthma, cor pulmonale (enlargement of part of the heart due to lung disease), reduced respiratory reserve (reduced air volume in the lungs), hypoxia (lack of oxygen), hypercapnia (increased concentration of carbon dioxide in the blood), pre-existing respiratory depression, spinal deformities that may lead to dyspnea (difficulty breathing);
• if you have reduced normal liver function;
• if you have reduced normal kidney function;
• if you have dysfunction of part of the liver (biliary tract);
• if you have head trauma, intracranial injuries, or other brain diseases in which the pressure of the fluid surrounding the brain (cerebrospinal fluid) may be increased, or if you have a history of seizures. Temgesic may cause pupil constriction (miosis) and changes in level of consciousness or perception of painful symptoms, which could complicate diagnosis or mask the progression of certain conditions;
• in cases of acute abdominal conditions.

Special caution is advised if you are currently undergoing treatment or have recently taken medicines with
central nervous system/respiratory depressant effects (see "Other medicines and Temgesic").
Central nervous system depression
Buprenorphine may increase central nervous system depression when taken concomitantly with:

• other medicines used to treat pain (opioid analgesics);
• general anesthetics;
• medicines used to treat allergy symptoms (antihistamines);
• other central nervous system depressants (such as alcohol, benzodiazepines, phenothiazines, tranquilizers, sedatives, or hypnotics).

Sleep-related respiratory disorders
Temgesic may cause sleep-related respiratory disorders such as nocturnal apnea (breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.
Tolerance, dependence, and addiction
This medicine contains buprenorphine, which is an opioid medicine. Repeated use of opioids may lead to reduced effectiveness of the medicine (you become accustomed to the medicine, known as tolerance). Repeated use of Temgesic may also lead to dependence, abuse, and addiction, with a risk of potentially fatal overdose. The risk of these side effects may increase with higher doses and longer duration of use.
Dependence or addiction may make you feel unable to control how much medicine you take or how often. The risk of dependence or addiction varies from person to person. You may have a higher risk of developing dependence or addiction to Temgesic if:

• you or a family member has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction");
• you are a smoker;
• you have ever had mood disorders (depression, anxiety, or personality disorders) or have been treated by a psychiatrist for other mental illnesses.

Signs of dependence or addiction may include one or more of the following while taking Temgesic:

• You need to use the medicine for longer than recommended by your doctor;
• You need to take a higher dose than recommended;
• You feel you need to keep using the medicine even though it no longer helps relieve your pain;
• You are using the medicine for reasons other than those prescribed, e.g., to "stay calm" or "help sleep";
• You have made repeated unsuccessful attempts to stop or control your use of the medicine;
• You feel unwell when you stop taking the medicine and feel better once you restart it ("withdrawal effects").

If you notice any of these signs, consult your doctor to discuss the best treatment approach for you, including when and how to safely discontinue treatment (see section 3, "If you stop taking Temgesic"). After prolonged use, abrupt discontinuation of treatment is not recommended, as it may cause a withdrawal syndrome that may appear later.

Use in opioid-dependent patients
Buprenorphine may cause withdrawal symptoms in opioid-dependent patients using heroin or undergoing treatment with medicines for addiction such as methadone.
Heart conditions
Like other opioids, buprenorphine may cause a sudden drop in blood pressure when standing up from a sitting or lying position (orthostatic hypotension).
Other warnings for the opioid class
Take buprenorphine with caution if:

• in elderly or debilitated patients;
• thyroid gland problems (myxedema) or hypothyroidism (reduced thyroid function);
• adrenal gland disorders (e.g. Addison's disease);
• central nervous system depression or coma;
• psychosis due to drug intoxication or hallucinogens;
• urinary tract problems, especially if related to prostate enlargement (prostatic hypertrophy) or urethral narrowing (urethral stenosis);
• biliary tract disorders.

For athletes: Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
Do not administer Temgesic to children under 12 years of age.
Other medicines and Temgesic
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may increase the side effects of Temgesic and sometimes cause very serious reactions. Do not take other medicines during treatment with Temgesic without first consulting your doctor, especially:

• antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, or trimipramine. These medicines may interact with Temgesic and cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, and fever above 38°C. Contact your doctor if you experience such symptoms.

Take Temgesic with caution with the following medicines:

• Benzodiazepines: (used to treat anxiety or sleep disorders) or related medicines: concomitant use of Temgesic and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes Temgesic 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 dosage recommendations carefully. It may be helpful to inform friends or family members to watch for the symptoms listed above. Contact your doctor if such symptoms occur. Self-administration of non-prescribed benzodiazepines while taking this medicine is extremely dangerous.
• Other medicines that may cause drowsiness and are used to treat anxiety, difficulty falling asleep, seizures, or pain: because these medicines reduce alertness, making driving and operating machinery dangerous. They may also cause central nervous system depression, a serious condition. The following is an illustrative list of such medicines:
  • Other opioid-derived medicines (e.g.: methadone, analgesics)
  • Some anesthetics
  • Some tranquilizers
  • Sedative hypnotics
  • Some cough suppressants
  • Some antidepressants
  • Sedative H1 histamine receptor antagonists (used to treat allergic reactions)
  • Barbiturates (used to promote sleep or sedation)
  • Anxiolytics (used for anxiety states) other than benzodiazepines
  • Neuroleptics (medicines used to treat psychosis)
  • Medicines used to treat allergies, motion sickness, or nausea (antihistamines or antiemetics)
  • Muscle relaxants
  • Medicines for Parkinson's disease
  • Clonidine (a medicine used for blood pressure) and similar substances
• Naltrexone (a medicine used for opioid dependence): because it may block the effects of buprenorphine. When used together with naltrexone, pain treatment with buprenorphine may be inadequate. Moreover, in patients who have developed physical dependence on buprenorphine, naltrexone may trigger sudden onset of opioid withdrawal symptoms.
• Other painkillers (opioid analgesics): The pain-relieving effect of these medicines may decrease in patients treated with buprenorphine.

In opioid-dependent patients, treatment with buprenorphine may trigger withdrawal symptoms
(see also “Warnings and precautions”).

• Antiretrovirals (used to treat AIDS), antibiotics (macrolides), antifungals (azoles: used to treat fungal infections), gestodene (used as a contraceptive), OAT (oral anticoagulant therapy, used to prevent or slow blood clotting) because they may increase the effects of Temgesic.
• Phenobarbital, carbamazepine, phenytoin, gabapentin or pregabalin (medicines for treating epilepsy or nerve-related pain/neuropathic pain) and rifampicin (medicines for treating tuberculosis): because they may reduce the effect of buprenorphine.
• Antidepressants: Monoamine oxidase inhibitors (MAOIs) because they may increase the effects of other opioids. Avoid taking Temgesic simultaneously and within two weeks after stopping treatment with antidepressants (MAOIs).
• Halothane (a general anesthetic) and other medicines that reduce the elimination of buprenorphine through the liver: because they may increase the effects of Temgesic.

Temgesic and alcohol
Temgesic must not be taken with alcoholic beverages and should be used cautiously with medicines containing alcohol because alcohol increases the sedative effect of buprenorphine (see "Driving and using machines").
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Towards the end of pregnancy, high doses of buprenorphine may cause breathing problems (respiratory depression) in the newborn, even after short-term administration. Prolonged administration of buprenorphine during the last three months of pregnancy may cause withdrawal syndrome in the newborn. This syndrome usually appears from several hours to several days after birth.
Breastfeeding
Buprenorphine and its metabolites are excreted in breast milk: buprenorphine must not be used in breastfeeding women (see “Do not take Temgesic”).
Driving and using machines
Caution is advised when driving or operating machinery (see “Other medicines and Temgesic”).
Low doses of buprenorphine may cause drowsiness. This effect may increase when buprenorphine is taken together with alcohol or medicines acting on the central nervous system (see “Other medicines and Temgesic”).
Temgesic sublingual tablets contain lactose and sodium.
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take Temgesic

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you
what you should expect from using Temgesic, when and for how long you should take it,
when to contact your doctor, and when you should stop taking it (see also If you stop taking Temgesic).

Sublingual tablets
The recommended dose is 1–2 tablets (0.2–0.4 mg of buprenorphine) to be dissolved
under the tongue every 6–8 hours, or as needed.
Do not chew or swallow the tablets.

If you take more Temgesic than you should
Symptoms
If you have taken excessive doses of Temgesic, this may cause:

• constriction of the pupils (miosis)
• sedation
• low blood pressure (hypotension)
• sudden drop in blood pressure (cardiovascular collapse)
• severe breathing problems (respiratory depression) which may progress to cessation of breathing (respiratory arrest), with risk of death
• nausea
• vomiting

The main symptoms requiring intervention are respiratory depression, which may progress to respiratory arrest and death, and vomiting.

Treatment
In case of overdose, your doctor may administer naloxone (a substance used to counteract the effects of opioid overdose), if necessary.

If you stop taking Temgesic
You are advised not to stop treatment abruptly, as this may cause a withdrawal syndrome that may appear later.
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.
Below is a summary of the side effects:

Very common side effects (may affect more than 1 in 10 people) include:

• Sedation
• Dizziness
• Nausea

Common side effects (may affect more than 1 in 100 people) include:

• Headache (cephalalgia)
• Constriction of the pupil (miosis)
• Low blood pressure (hypotension)
• Reduced volume of air circulating in the lungs (hypoventilation)
• Vomiting
• Confusion
• Drug dependence
• Hallucinations
• Drowsiness
• Dizziness
• Severe breathing problem (respiratory depression)
• Itching
• Skin rash
• Excessive sweating (hyperhidrosis)
• Loss of drug effectiveness
• Interactions with other medicines
• Fatigue

Uncommon side effects (may affect more than 1 in 1,000 people) include:

• Euphoria
• Nervousness
• Depression
• Psychotic disorders
• Feeling detached from one's body (depersonalization)
• Speech articulation disorder (dysarthria)
• Altered sensation in limbs (paresthesia)
• Coma
• Tremor
• Blurred vision, double vision (diplopia), visual impairment, inflammation of the conjunctiva (conjunctivitis)
• Ringing in the ears (tinnitus)
• Increased heart rate (tachycardia), reduced heart rate (bradycardia)
• Bluish discoloration of the skin due to inadequate oxygenation of the blood (cyanosis)
• Heart problems (Wenckebach block, second-degree atrioventricular block)
• High blood pressure (hypertension)
• Pallor
• Breathing difficulties (dyspnea), cessation of breathing (apnea)
• Dry mouth (xerostomia), constipation, gastric discomfort (dyspepsia), accumulation of gas in the intestine (flatulence)
• Inability of the bladder to empty (urinary retention)
• Weakness (asthenia)
• Malaise

Rare side effects (may affect more than 1 in 10,000 people) include:

• Allergic reaction (hypersensitivity)
• Loss or reduced appetite
• Mood disturbance (dysphoria), agitation
• Seizures
• Abnormal coordination
• Difficulty falling asleep (insomnia)
• Diarrhea
• Hives (urticaria)
• Fainting

Side effects with unknown frequency include:

• Severe allergic reaction occurring rapidly (anaphylactic shock)
• Constriction of the bronchi (bronchospasm)
• Sudden swelling of the skin (angioneurotic edema)
• Dental caries

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

5. How to store Temgesic

Sublingual tablets in PVC/PVDC/Al blisters: Do not store above 25°C.
Keep in the original packaging.
Sublingual tablets in Nylon/Al/PVC blisters: Do not store above 30°C.
Keep in the original packaging.
Keep this medicine out of the sight and reach of children.
Store this medicine in a safe and secure place, inaccessible to others.
This medicine may cause serious harm or be fatal to individuals who take it accidentally or intentionally when it has not been prescribed for them.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Temgesic contains
Temgesic 0.2 mg sublingual tablets
The active substance is: buprenorphine hydrochloride. One sublingual tablet contains 0.216 mg of
buprenorphine hydrochloride (equivalent to 0.2 mg buprenorphine base).
The other components are: lactose, maize starch, mannitol, povidone, anhydrous citric acid, sodium
citrate anhydrous, magnesium stearate.

Description of the appearance of Temgesic and pack contents
Temgesic 0.2 mg sublingual tablets
10 sublingual tablets packaged in PVC/PVDC/Al blisters
10 sublingual tablets packaged in Nylon/Al/PVC blisters

Marketing Authorization Holder
EUMEDICA Pharmaceuticals GmbH
Basler Straße 126
79540 Lörrach
Germany

Manufacturer
Medinfar Manufacturing S.A.
Parque Industrial Armando Martins Tavares
Rua Outeiro Da Armada No. 5
Condeixa-a-Nova
3150-194 Sebal
Portugal
EUMEDICA S.A.
Chemin de Nauwelette 1
7170 Manage
Belgium