PRONTALGIN 50 mg Effervescent Tablets

Зміст інструкції

1. PRONTALGIN 50 mg effervescent tablets
   1. WHAT IS PRONTALGIN 50 MG EFFERVSCENT TABLETS AND WHAT IT IS USED FOR
   2. BEFORE TAKING PRONTALGIN 50 MG EFFERVSCENT TABLETS
   3. HOW TO TAKE PRONTALGIN 50 MG EFFERVESCENT TABLETS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE PRONTALGIN 50 MG EFFERVESCENT TABLETS
   6. FURTHER INFORMATION
2. PRONTALGIN Capsule, 50 mg hard capsules
   1. WHAT IS PRONTALGIN CAPSULES AND WHAT IT IS USED FOR
   2. BEFORE TAKING PRONTALGIN CAPSULES
   3. HOW TO TAKE PRONTALGIN Capsules
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE PRONTALGIN CAPSULES
   6. OTHER INFORMATION
3. PRONTALGIN 50 mg/ml injectable solution
   1. WHAT IS PRONTALGIN INJECTABLE SOLUTION AND WHAT IT IS USED FOR
   2. BEFORE USING PRONTALGIN INJECTABLE SOLUTION
   3. HOW TO USE PRONTALGIN INJECTABLE SOLUTION
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE PRONTALGIN INJECTABLE SOLUTION
   6. OTHER INFORMATION
4. PRONTALGIN Gocce, 100 mg/ml oral drops, solution
   1. WHAT IS PRONTALGIN DROPS AND WHAT IS IT USED FOR
   2. BEFORE TAKING PRONTALGIN DROPS
   3. HOW TO TAKE PRONTALGIN DROPS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE PRONTALGIN GOCCE
   6. FURTHER INFORMATION

PRONTALGIN 50 mg effervescent tablets

Tramadol hydrochloride
Read this leaflet carefully before taking this medicine.

• 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. Never give it to others, even if they have the same symptoms as you, as it may be harmful.
• If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What PRONTALGIN 50 mg Effervescent Tablets is and what it is used for
• 2. Before taking PRONTALGIN 50 mg Effervescent Tablets
• 3. How to take PRONTALGIN 50 mg Effervescent Tablets
• 4. Possible side effects
• 5. How to store PRONTALGIN 50 mg Effervescent Tablets
• 6. Further information

1. WHAT IS PRONTALGIN 50 MG EFFERVSCENT TABLETS AND WHAT IT IS USED FOR

WHAT IT SERVES FOR
Tramadol (tramadol hydrochloride), the active ingredient of PRONTALGIN 50 mg Effervescent Tablets,
is a powerful pain reliever.
PRONTALGIN 50 mg Effervescent Tablets is intended for the treatment of acute or
prolonged pain of moderate to severe intensity, such as that following surgery, serious injuries or
cancer.

2. BEFORE TAKING PRONTALGIN 50 MG EFFERVSCENT TABLETS

Do not take PRONTALGIN 50 mg Effervescent Tablets

• if you are allergic (hypersensitive) to tramadol or any of the excipients of PRONTALGIN 50 mg Effervescent Tablets (see section 6. Further information)
• if you are allergic to similar pain relievers (opioids)
• if you experience sudden intoxication (intense) from alcohol (alcohol poisoning), sleeping pills, pain relievers or other drugs that act on the central nervous system
• if you are using monoamine oxidase inhibitors (for severe depression) or if you have taken them in the last two weeks
• if you have epilepsy that is not fully controlled
• for the treatment of withdrawal symptoms from drugs in drug addicts.

Take special care with PRONTALGIN 50 mg Effervescent Tablets

• if you are to undergo general anesthesia
• if you have suffered head injuries or have had an increase in intracranial pressure (e.g. following an accident)
• if you suffer from excessive mucus secretion in the lungs
• if you have breathing difficulties or are taking high doses of tramadol or if you are taking tramadol together with drugs that have an inhibitory effect on function

cerebral, as in these cases the use of tramadol may worsen your breathing difficulties

• if you are prone to seizures
• if you are at increased risk of shock (possible symptoms of shock are a rapid drop in blood pressure, pallor, anxiety, weak and rapid pulse, moist skin, decreased state of consciousness)
• PRONTALGIN 50 mg Effervescent Tablets may make it more difficult to diagnose certain disorders, such as acute abdominal disorders
• cases of abuse, drug dependence and withdrawal symptoms have been reported
• if you develop a sudden illness related to a disorder of heme production (acute porphyria)
• if you suffer from liver or kidney disorders
• tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme, which may have different effects on them. Some people may not get enough pain relief, but others may experience serious side effects. If you notice any of the following side effects, you should stop taking this medicine and consult your doctor immediately: slowed or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or sick, constipation, loss of appetite
• use in children (over 12 years of age) with respiratory problems:tramadol is not recommended in children with respiratory problems, because in these children the symptoms of tramadol toxicity may be worse.

Consult your doctor if any of the above warnings apply to your case or if they have occurred in the
past.

Taking PRONTALGIN 50 mg Effervescent Tablets with other medicines
The risk of side effects increases

• If you are taking medicines that can cause seizures (attacks), such as some antidepressants or antipsychotics. The risk of having a seizure may increase if you take PRONTALGIN 50 mg effervescent tablets at the same time. Your doctor will tell you if PRONTALGIN 50 mg Effervescent Tablets is suitable for you.
• If you are taking certain antidepressants. PRONTALGIN 50 mg Effervescent Tablets may interact with these drugs and you may experience symptoms such as: involuntary rhythmic contractions of the muscles, including the muscles that control eye movement, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C.
• If you are taking PRONTALGIN 50 mg Effervescent Tablets and sedatives such as benzodiazepines or analogues. This increases the risk of drowsiness, difficulty breathing (respiratory depression), coma which can be life-threatening. For this reason, concomitant use should only be considered when other treatments are not possible. If your doctor prescribes PRONTALGIN 50 mg Effervescent Tablets in conjunction with sedatives, the dose and duration of treatment must be reduced and decided by your doctor. Tell your doctor if you are taking sedatives, and always strictly follow your doctor's advice regarding dosages. It may be helpful to inform relatives and those who care for you about the signs and symptoms above. Contact your doctor if these symptoms appear.

Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those without a prescription.

• Pain relievers or other drugs that act on the central nervous system can increase drowsiness; the inhibitory effect on the central nervous system may be increased.
• Carbamazepine, a medicine used to treat epilepsy, may reduce or shorten the effect of tramadol.
• Morphine derivatives (buprenorphine, nalbufine, pentazocine) may reduce the analgesic effect of tramadol.
• Fluoxetineor paroxetine(for the treatment of depression), quinidine(for the treatment of heart disease), ritonavir(anti-HIV drug) and cimetidine(antacid) may reduce the effect of tramadol.
• Clomipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertralineand venlafaxine(for the treatment of depression) ,in association with tramadol, may increase the risk of seizures and serotonin syndrome (symptoms include: confusion, agitation, tremors, fever and diarrhea).
• Simultaneous use of tramadol and digoxin(for heart disease) may, in rare cases, amplify the undesirable effects of digoxin.
• Simultaneous use of tramadol and blood-thinning drugs (e.g. anticoagulants such as warfarin) may increase the risk of bleeding.
• Simultaneous use of tramadol and ondansetron(for the treatment of nausea and vomiting) may reduce the pain-relieving effect of tramadol.

Taking PRONTALGIN 50 mg effervescent tablets with food and drink
You can take PRONTALGIN 50 mg Effervescent Tablets before, during or after meals.
Alcohol may increase the drowsiness caused by tramadol.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take PRONTALGIN 50
mg Effervescent Tablets more than once during breastfeeding or, alternatively, if you take
PRONTALGIN 50 mg Effervescent Tablets more than once, you should stop breastfeeding.

Driving and using machines
Avoid driving and using tools or machinery while taking PRONTALGIN 50 mg
Effervescent Tablets. PRONTALGIN 50 mg Effervescent Tablets may reduce reaction times. This effect may be worsened by the use of alcohol or other drugs that alter
reaction times.

Important information about some excipients of PRONTALGIN 50 mg Effervescent Tablets

• This medicine contains 214 mg of sodium per tablet and this may be harmful in subjects on a low-sodium diet.
• This medicine contains 10 mg of aspartame per tablet, a source of phenylalanine and this may be dangerous in subjects with phenylketonuria.
• This medicine contains 75 mg of lactose per tablet. If your doctor has diagnosed you with an intolerance to some sugars, contact him before taking this medicine.

3. HOW TO TAKE PRONTALGIN 50 MG EFFERVESCENT TABLETS

Always take PRONTALGIN 50 mg Effervescent Tablets exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
The dosage should be adjusted according to the intensity of the pain and your personal sensitivity to
pain. Generally, you should take the lowest dose that reduces the pain.
The usual dose for adults and children over 12 years of age is 50-100 mg of tramadol (1 or 2 effervescent
tablets), 3-4 times a day.
The maximum allowed dose of PRONTALGIN 50 mg Effervescent Tablets is generally 400
mg (8 effervescent tablets) per day.
For acute pain, an initial dose of 100 mg is generally necessary.
If you are taking PRONTALGIN 50 mg Effervescent Tablets for acute pain, you should know that
the effect starts with a slight delay compared to other pain relievers.
For chronic pain, an initial dose of 50 mg is recommended.
PRONTALGIN 50 mg Effervescent Tablets are not suitable for children under 12 years of age.
For children between 12 and 14 years of age, the minimum dose is recommended.
Elderly patients
In elderly people (over 75 years of age) the elimination of tramadol may be delayed. If this is the
case, your doctor may advise you to extend the time interval between doses.
Patients with severe liver (insufficiency) or kidney disease / dialysis
Patients with severe hepatic and/or renal insufficiency should not take PRONTALGIN 50 mg
Effervescent Tablets. In case of mild or moderate insufficiency, your doctor may advise you to
extend the time interval between doses. If you have liver or kidney problems, talk to your
doctor, who will probably modify the dose or replace the drug with another
pain reliever.
Dissolve the effervescent tablets in a glass of water and drink the entire contents.
Intake can occur before, during or after meals.
Your doctor will tell you how long to use PRONTALGIN 50 mg Effervescent Tablets.
If you feel that the effects of PRONTALGIN effervescent tablets are too strong or too
weak, consult your doctor or pharmacist.

If you take more PRONTALGIN 50 mg Effervescent Tablets than you should
Contact your doctor or pharmacist immediately.
The following overdose effects may occur: constricted pupils, vomiting, a sudden drop in
blood pressure, drowsiness and loss of consciousness, convulsions and difficulty breathing.

If you forget to take PRONTALGIN 50 mg Effervescent Tablets
If you have forgotten to take a dose, the pain is likely to return. Do not take a double
dose to make up for a missed dose. Take the next dose as usual.

If you stop taking PRONTALGIN 50 mg Effervescent Tablets
You should not suddenly stop taking this medicine unless your doctor tells you to. If you intend to stop taking the medicine, talk to your doctor first,
especially if you have been taking it for a long time. Your doctor will advise you when and how to stop it, which
may involve gradually reducing the dose to reduce the likelihood of developing unnecessary side
effects (withdrawal symptoms).
These symptoms may include: anxiety, excessive sweating, insomnia, chills, pain, nausea, tremors,
diarrhea, upper respiratory tract disorders, piloerection (hair standing on end), and, in rare cases,
hallucinations.

If you have any doubts about the use of PRONTALGIN, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, PRONTALGIN 50 mg Effervescent Tablets can cause side effects, although not everybody gets them.

If any of the following occur, seek medical attention immediately:

• Allergic reactions, such as difficulty breathing, wheezing, skin swelling(occurs rarely),
• Swelling of the face, tongue and/or throat and/or difficulty swallowing or hivesassociated with difficulty breathing (occurs rarely),
• Shock/sudden circulatory failure (occurs rarely).

Usually the frequency of side effects is classified as follows:

• very common (in more than 1 in 10 people),
• common (in more than 1 in 100 people),
• uncommon (in more than 1 in 1000 people),
• rare (in more than 1 in 10000 people),
• very rare (in less than 1 in 10000 people),
• not known (frequency cannot be estimated from the available data).

The most common side effects during treatment with PRONTALGIN 50 mg Effervescent Tablets are nausea and dizziness, which occur in more than 1 in 10 patients.
Cardiac and circulatory disorders
Uncommon: effects on the heart and blood circulation (palpitations, accelerated heartbeat, feeling of fainting or collapse). These adverse effects may
occur particularly in patients in an upright position or during physical exertion.
Rare: slowed heartbeat, increased blood pressure.
Very rare: hot flushes.
Nervous system disorders
Very common: dizziness.
Common: headache, drowsiness.
Rare: changes in appetite, abnormal sensations (such as itching, tingling, numbness), tremor, slowed breathing, seizures, muscle spasms,
loss of coordination, transient loss of consciousness
(syncope).
If you exceed the recommended doses or if you take other
medicines that depress brain function at the same time, slowed
breathing may occur.
Seizures have occurred mainly with high doses of tramadol or
when tramadol was taken in conjunction with other medicines that can
cause seizures.
Psychiatric disorders
Rare: hallucinations, confusion, sleep disturbances, anxiety and nightmares. Psychiatric
disorders may appear after treatment with PRONTALGIN 50 mg Effervescent Tablets
and may vary in intensity and nature (depending on the patient's personality and the duration of therapy). They may manifest as changes in
mood (generally exaltation, occasionally irritability), variations in active life (generally slowing down but occasionally increased activity) and
reduced awareness and decision-making ability, which may
lead to errors in judgement.
Dependence can occur.
Eye disorders
Rare: blurred vision.
Respiratory disorders
Rare: shortness of breath (dyspnea).
Cases of worsening asthma have been reported, although it has not been established
whether they were caused by tramadol.
Gastrointestinal disorders
Very common: nausea.
Common: vomiting, constipation, dry mouth.
Uncommon: retching, stomach discomfort (feeling of pressure in the stomach, bloating), diarrhea.
Skin disorders
Common: sweating.
Uncommon: skin reactions (e.g. itching, rash).
Musculoskeletal disorders
Rare: muscle weakness.
Hepatobiliary disorders
Very rare: increased liver enzyme values.
Urinary disorders
Rare: difficulty urinating or pain, decreased amount of urine.
Systemic disorders
Common: fatigue, tiredness, weakness, lack of energy.
Abruptly stopping therapy may cause withdrawal symptoms
(see “If you stop taking PRONTALGIN 50 mg Effervescent Tablets”).
Metabolism and nutrition disorders
Not known: decreased blood sugar level.
Some cases of speech disorders and dilated pupils have been reported.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE PRONTALGIN 50 MG EFFERVESCENT TABLETS

Keep PRONTALGIN 50 mg Effervescent Tablets out of the reach and sight of children.
Do not store at a temperature above 30°C.
Store the product in its original packaging. Keep the tablet container tightly
closed.
Do not use PRONTALGIN 50 mg Effervescent Tablets after the expiry date stated on the
packaging after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. FURTHER INFORMATION

What PRONTALGIN 50 mg Effervescent Tablets contain

• The active ingredient is tramadol hydrochloride. Each effervescent tablet contains 50 mg of tramadol hydrochloride.
• The excipients are: anhydrous citric acid, sodium hydrogen carbonate, anhydrous sodium sulfate, lactose monohydrate, macrogol, anhydrous sodium carbonate, sodium cyclamate, povidone, aspartame, orange flavour (containing orange essence, orange essential oil free of terpenes, citric acid monohydrate, butylated hydroxyanisole, dextrin, acacia), simeticone emulsion (containing dimethicone, anhydrous colloidal silica, methylcellulose and sorbic acid).

Description of the appearance of PRONTALGIN 50 mg Effervescent Tablets and contents of the
pack
PRONTALGIN 50 mg Effervescent Tablets is supplied in packs of 10, 20 or 30 effervescent
tablets packaged in a tablet container with a cap with a desiccant function.
The pack of 10 effervescent tablets contains 1 container of 10 tablets.
The pack of 20 effervescent tablets contains 1 container of 20 tablets.
The pack of 30 effervescent tablets contains 2 containers of 15 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15 – 20143 Milano

Manufacturer:
LOSAN PHARMA GmbH
Otto-Hahn Strasse 13
79395 Neuenburg
GERMANY

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy: PRONTALGIN 50 mg Effervescent Tablets
Netherlands: Theradol 50 mg Bruistabletten

This leaflet was last revised in 01/2019

PRONTALGIN Capsule, 50 mg hard capsules

Tramadol hydrochloride
Read this leaflet carefully before taking this medicine.

• 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. Do not give it to other people even if their symptoms are the same as yours, as it could be dangerous.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What PRONTALGIN Capsule is and what it is used for
• 2. Before taking PRONTALGIN Capsule
• 3. How to take PRONTALGIN Capsule
• 4. Possible side effects
• 5. How to store PRONTALGIN Capsule
• 6. Further information

1. WHAT IS PRONTALGIN CAPSULES AND WHAT IT IS USED FOR

Tramadol (tramadol hydrochloride), the active ingredient of PRONTALGIN Capsules, is a potent
painkiller.
PRONTALGIN Capsules is intended for the treatment of acute or prolonged moderate to
severe pain, such as that following surgery, serious injuries or cancer.

2. BEFORE TAKING PRONTALGIN CAPSULES

Do not take PRONTALGIN Capsules

• if you are allergic (hypersensitive) to tramadol or any of the excipients of PRONTALGIN Capsules (see section 6. Further information)
• if you are allergic to similar painkillers (opioids)
• if you experience sudden intoxication (intense) from alcohol (alcohol poisoning), sleeping pills, painkillers or other drugs that act on the central nervous system
• if you are using monoamine oxidase inhibitors (for severe depression) or if you have taken them in the last two weeks
• if you have epilepsy that is not fully controlled
• for the treatment of withdrawal symptoms from drugs in drug addicts.

Take special care with PRONTALGIN Capsules

• if you are to undergo general anesthesia
• if you have suffered head injuries or have an increase in intracranial pressure (e.g. following an accident)
• if you suffer from excessive mucus secretion in the lungs
• if you have breathing difficulties or are taking high doses of tramadol or if you are taking tramadol together with drugs that have an inhibitory effect on the function

cerebral, as in these cases the use of tramadol may worsen your breathing difficulties

• if you are predisposed to seizures
• if you are at increased risk of shock (possible symptoms of shock are a rapid drop in blood pressure, pallor, anxiety, weak and rapid pulse, damp skin, decreased state of consciousness)
• PRONTALGIN Capsules may make it more difficult to diagnose certain disorders, such as acute abdominal disorders
• cases of abuse, drug dependence and withdrawal symptoms have been reported
• if you develop a sudden illness related to a disorder of heme production (acute porphyria)
• if you suffer from liver or kidney disorders
• tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme, which may have different effects on them. Some people may not get enough pain relief, but others may experience serious side effects. If you notice any of the following side effects, you should stop taking this medicine and consult a doctor immediately: slowed or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or sick, constipation, loss of appetite
• use in children (over 12 years of age) with respiratory problems:tramadol is not recommended in children with respiratory problems, because in these children the symptoms of tramadol toxicity may be worse.

Consult your doctor if any of the above warnings apply to your case or if it has occurred in the
past.

Taking PRONTALGIN Capsules with other medicines
The risk of side effects increases

• If you are taking medicines that can cause seizures (attacks), such as some antidepressants or antipsychotics. The risk of having a seizure may increase if you take PRONTALGIN Capsules at the same time. The doctor will tell you if PRONTALGIN Capsules is suitable for you.
• If you are taking some antidepressants. PRONTALGIN Capsules can interact with these drugs and you may experience symptoms such as: involuntary rhythmic contractions of the muscles, including the muscles that control eye movement, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C.
• If you are taking PRONTALGIN Capsules and sedatives such as benzodiazepines or similar. This increases the risk of drowsiness, difficulty breathing (respiratory depression), coma which may be life-threatening. For this reason, concomitant use should only be considered when other treatments are not possible. If your doctor prescribes PRONTALGIN Capsules in conjunction with sedatives, the dose and duration of treatment must be reduced and decided by your doctor. Tell your doctor if you are taking sedatives, and always strictly follow your doctor's advice regarding doses. It may be helpful to inform relatives and caregivers of the signs and symptoms above. Contact your doctor if these symptoms appear.

Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.

• Painkillers or other drugs that act on the central nervous system can increase drowsiness; the inhibitory effect on the central nervous system may be increased.
• Carbamazepine, a medicine used to treat epilepsy, can reduce or shorten the effect of tramadol.
• Morphine derivatives (buprenorphine, nalbufine, pentazocine) can reduce the analgesic effect of tramadol.
• Fluoxetineor paroxetine(for the treatment of depression), quinidine(for the treatment of heart disease), ritonavir(anti-HIV drug) and cimetidine(antacid) can reduce the effect of tramadol.
• Clomipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertralineand venlafaxine(for the treatment of depression), in association with tramadol, can increase the risk of seizures and serotonin syndrome (symptoms include: confusion, agitation, tremors, fever and diarrhea).
• Simultaneous use of tramadol and digoxin(for heart disease) may, in rare cases, amplify the undesirable effects of digoxin.
• Simultaneous use of tramadol and blood-thinning drugs (e.g. anticoagulants such as warfarin) may increase the risk of bleeding.
• Simultaneous use of tramadol and ondansetron(for the treatment of nausea and vomiting) may reduce the analgesic effect of tramadol.

Taking PRONTALGIN Capsules with food and drink
You can take PRONTALGIN Capsules before, during or after meals.
Alcohol can increase the drowsiness caused by tramadol.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take PRONTALGIN
Capsules more than once during breastfeeding or, alternatively, if you take PRONTALGIN Capsules
more than once, you should stop breastfeeding.

Driving and using machines
Avoid driving and using tools or machinery while taking PRONTALGIN Capsules.
PRONTALGIN Capsules can reduce reaction times. This effect may be worsened
by the use of alcohol or other drugs that alter reaction times.

3. HOW TO TAKE PRONTALGIN Capsules

Always take PRONTALGIN Capsules exactly as your doctor has instructed. If you have any doubts,
you should consult your doctor or pharmacist.
The dosage must be adjusted according to the intensity of the pain and your personal sensitivity to
pain. Generally, you should take the lowest dose that reduces the pain.
The usual dose for adults and children over 12 years of age is 50-100 mg of tramadol (1 or 2 capsules),
3-4 times a day.
The maximum allowed dose of PRONTALGIN Capsules is generally 400 mg (8 capsules) per
day.
For acute pain, a starting dose of 100 mg is generally necessary.
If you are taking PRONTALGIN Capsules for acute pain, you should know that the effect starts with a
slight delay compared to other pain relievers.
For chronic pain, a starting dose of 50 mg is recommended.
PRONTALGIN Capsules are not suitable for children under 12 years of age.
For children between 12 and 14 years of age, the minimum dose is recommended.
Elderly patients
In elderly people (over 75 years of age), the elimination of tramadol may be delayed. If this is the
case, your doctor may advise you to extend the time interval between doses.
Patients with severe liver (hepatic) or kidney (renal) disease / dialysis
Patients with severe hepatic and/or renal insufficiency should not take PRONTALGIN Capsules. In
cases of mild or moderate insufficiency, your doctor may advise you to extend the time interval
between doses. If you have liver or kidney problems, talk to your doctor, who will probably modify the dose or replace the medicine with another pain reliever.
You can take the capsules by swallowing them with a little water. Do not chew them.
Taking can occur before, during or after meals.
Your doctor will tell you how long to use PRONTALGIN Capsules.
If you feel that the effects of PRONTALGIN Capsules are too strong or too weak, consult
your doctor or pharmacist.

If you take more PRONTALGIN Capsules than you should
Contact your doctor or pharmacist immediately.
The following effects from an overdose may occur: constricted pupils, vomiting, a sudden drop in
blood pressure, drowsiness and loss of consciousness, convulsions and difficulty breathing.

If you forget to take PRONTALGIN Capsules
If you have forgotten to take a dose, the pain is likely to return. Do not take a double
dose to make up for a missed dose. Take the next dose as usual.

If you stop taking PRONTALGIN Capsules
You should not suddenly stop taking this medicine unless your doctor tells you to.
If you intend to stop taking the medicine, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop it, which
may involve gradually decreasing the dose to reduce the likelihood of developing unnecessary side
effects (withdrawal symptoms). These symptoms may include: anxiety, excessive sweating, insomnia, chills, pain, nausea, tremors, diarrhea, upper respiratory tract disorders,
piloerection (hair standing on end) and, in rare cases, hallucinations.

If you have any questions about the use of PRONTALGIN, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, PRONTALGIN Capsules can cause side effects, although not everybody gets them.

If any of the following occur, seek medical attention immediately:

• Allergic reactions, such as difficulty breathing, wheezing, skin swelling(occurs rarely),
• Swelling of the face, tongue and/or throat and/or difficulty swallowing or hivesassociated with difficulty breathing (occurs rarely),
• Shock/sudden circulatory failure (occurs rarely).

The frequency of side effects is usually classified as follows:

• very common (affects more than 1 in 10 people),
• common (affects more than 1 in 100 people),
• uncommon (affects more than 1 in 1000 people),
• rare (affects more than 1 in 10000 people),
• very rare (affects less than 1 in 10000 people),
• not known (frequency cannot be estimated from the available data).

The most common side effects during treatment with PRONTALGIN Capsules are nausea and
dizziness, which occur in more than 1 in 10 patients.
Cardiac and circulatory disorders
Uncommon: effects on the heart and blood circulation (palpitations, fast heartbeat,
feeling of fainting or collapse). These adverse effects may
occur particularly in patients in an upright position or under physical exertion.
Rare: slow heartbeat, increased blood pressure.
Very rare: hot flushes.
Nervous system disorders
Very common: dizziness.
Common: headache, drowsiness.
Rare: changes in appetite, abnormal sensations (such as itching, tingling,
numbness), tremor, slowed breathing, seizures, muscle spasms,
loss of coordination, transient loss of consciousness
(syncope).
If you exceed the recommended doses or if you take other
medicines that depress brain function at the same time, slowed
breathing may occur.
Seizures have occurred mainly with high doses of tramadol or
when tramadol was taken in combination with other medicines that can
cause seizures.
Psychiatric disorders
Rare: hallucinations, confusion, sleep disturbances, anxiety and nightmares. Psychiatric
disorders may appear after treatment with PRONTALGIN Capsules and may
vary in intensity and nature (depending on the patient's personality and the duration of
therapy). They may manifest as mood changes (usually
exaltation, occasionally irritability), changes in active life (usually
slowing down but occasionally increased activity) and reduced
awareness and decision-making ability, which can lead to errors in
judgement.
Dependence can occur.
Eye disorders
Rare: blurred vision.
Respiratory disorders
Rare: shortness of breath (dyspnea).
Cases of worsening asthma have been reported, although it has not been established
whether they were caused by tramadol.
Gastrointestinal disorders
Very common: nausea.
Common: vomiting, constipation, dry mouth.
Uncommon: retching, stomach discomfort (feeling of pressure in the stomach,
bloating), diarrhea.
Skin disorders
Common: sweating.
Uncommon: skin reactions (e.g. itching, rash).
Musculoskeletal disorders
Rare: muscle weakness.
Hepatobiliary disorders
Very rare: increased liver enzyme values.
Urinary disorders
Rare: difficulty urinating or pain, decreased amount of urine.
Systemic disorders
Common: fatigue, tiredness, weakness, lack of energy.
Abruptly stopping therapy may cause withdrawal symptoms
(see “If you stop taking PRONTALGIN Capsules”).
Metabolism and nutrition disorders
Not known: decreased blood sugar level.
Some cases of speech disorders and dilated pupils have been reported.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE PRONTALGIN CAPSULES

Keep PRONTALGIN Capsules out of the reach and sight of children.
Store the product in its original packaging.
Do not use PRONTALGIN Capsules after the expiry date stated on the packaging after SCAD. The
expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What PRONTALGIN Capsules contains

• The active ingredient is tramadol hydrochloride. Each capsule contains 50 mg of tramadol hydrochloride.
• The excipients are: capsule content: calcium hydrogen phosphate dihydrate, magnesium stearate, anhydrous colloidal silica; capsule shell: gelatin, titanium dioxide (E171).

Description of the appearance of PRONTALGIN Capsules and contents of the pack
PRONTALGIN Capsules is supplied in packs of 20, 50, 60, 100 or 250 hard capsules in blisters.
The capsules are opaque white in colour and contain a white powder.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15 – 20143 Milano

Manufacturer:
Therabel Industries s.a.s.
Zone d’Enterprise Les Playes
Jean Monnet
274, Avenue de Bruxelles
F 83500 La Seyne Sur Mer

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy: PRONTALGIN Capsules
Netherlands: Theradol Capsules
Spain: Tramadol Bexal 50 mg Capsules EFG

This leaflet was last approved in 01/2019

PRONTALGIN 50 mg/ml injectable solution

Tramadol hydrochloride
Read this leaflet carefully before using this medicine.

• 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. Do not give it to other people even if their symptoms are the same as yours, as it could be dangerous.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 7. What PRONTALGIN Injectable Solution is and what it is used for
• 8. Before you take PRONTALGIN Injectable Solution
• 9. How to take PRONTALGIN Injectable Solution
• 10. Possible side effects
• 11. How to store PRONTALGIN Injectable Solution
• 12. Further information

1. WHAT IS PRONTALGIN INJECTABLE SOLUTION AND WHAT IT IS USED FOR

Tramadol (tramadol hydrochloride), the active ingredient of PRONTALGIN Injectable Solution, is a
potent pain reliever.
PRONTALGIN Injectable Solution is intended for the treatment of acute or prolonged pain of
moderate to severe intensity, such as that following surgery, serious injuries or cancer.

2. BEFORE USING PRONTALGIN INJECTABLE SOLUTION

Do not use PRONTALGIN Injectable Solution

• if you are allergic (hypersensitive) to tramadol or any of the excipients of PRONTALGIN Injectable Solution (see section 6. Further information)
• if you are allergic to similar pain relievers (opioids)
• if you experience sudden alcohol intoxication (severe poisoning) from alcohol, sleeping pills, pain relievers or other drugs that act on the central nervous system
• if you are using monoamine oxidase inhibitors (for severe depression) or have taken them in the last two weeks
• if you have epilepsy that is not fully controlled
• for the treatment of withdrawal symptoms from drugs in drug addicts.

Take special care with PRONTALGIN Injectable Solution

• if you are going to undergo general anesthesia
• if you have suffered head injuries or have increased intracranial pressure (e.g. following an accident)
• if you suffer from excessive mucus secretion in the lungs
• if you have breathing difficulties or are taking high doses of tramadol or are still taking tramadol together with drugs that have an inhibitory effect on brain function, as in these cases the use of tramadol may worsen your breathing difficulties
• if you are predisposed to seizures
• if you are at increased risk of shock (possible symptoms of shock are a rapid drop in blood pressure, paleness, anxiety, weak and rapid pulse, moist skin, decreased level of consciousness)
• PRONTALGIN Injectable Solution may make it more difficult to diagnose certain disorders, such as acute abdominal disorders
• cases of abuse, drug dependence and withdrawal symptoms have been reported
• if you develop a sudden illness related to a disorder of heme production (acute porphyria)
• if you suffer from liver or kidney disorders
• the first injection of tramadol must be administered under strict medical supervision
• tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may have different effects on them. Some people may not get sufficient pain relief, but others may experience serious side effects. If you notice any of the following side effects, you should stop taking this medicine and consult a doctor immediately: slowed or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or sick, constipation, loss of appetite
• Use in children (over 12 years of age) with respiratory problems:tramadol is not recommended in children with respiratory problems, because the symptoms of tramadol toxicity may be worse in these children.

Consult your doctor if any of the above warnings apply to your case or have occurred in the
past.

Taking PRONTALGIN Injectable Solution with other medicines
The risk of side effects increases

• If you are taking medicines that can cause seizures (fits), such as some antidepressants or antipsychotics. The risk of having a fit may increase if you take PRONTALGIN Injectable Solution at the same time. Your doctor will tell you if PRONTALGIN Injectable Solution is suitable for you.
• If you are taking certain antidepressants. PRONTALGIN Injectable Solution can interact with these drugs and you may experience symptoms such as: involuntary rhythmic contractions of the muscles, including the muscles that control eye movement, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38°C.
• If you are taking PRONTALGIN Injectable Solution and sedating medicines such as benzodiazepines or similar. This increases the risk of drowsiness, difficulty breathing (respiratory depression), coma which can be life-threatening. For this reason, concomitant use should only be considered when other treatments are not possible. If your doctor prescribes PRONTALGIN Injectable Solution in conjunction with sedating medicines, the dose and duration of treatment must be reduced and decided by your doctor. Tell your doctor if you are taking sedating medicines, and always follow your doctor's advice regarding doses. It may be helpful to inform relatives and caregivers of the signs and symptoms above. Contact your doctor if these symptoms appear. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.
• Pain relievers or other drugs that act on the central nervous system can increase drowsiness or dizziness; the inhibitory effect on the central nervous system may be increased.
• Carbamazepine, a medicine used to treat epilepsy, can reduce or shorten the effect of tramadol.
• Morphine derivatives (buprenorphine, nalbufine, pentazocine) can reduce the analgesic effect of tramadol.
• Fluoxetineor paroxetine(for the treatment of depression), quinidine(for the treatment of heart disease), ritonavir(anti-HIV drug) and cimetidine(antacid) can reduce the effect of tramadol.
• Clomipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertralineand venlafaxine(for the treatment of depression), in association with tramadol, can increase the risk of seizures and serotonin syndrome (symptoms include: confusion, agitation, tremors, fever and diarrhea).
• Simultaneous use of tramadol and digoxin(for heart disease) may, in rare cases, amplify the undesirable effects of digoxin.
• Simultaneous use of tramadol and blood-thinning medicines (e.g. anticoagulants such as warfarin) may increase the risk of bleeding.
• Simultaneous use of tramadol and ondansetron(for the treatment of nausea and vomiting) may reduce the pain-relieving effect of tramadol.

Use of PRONTALGIN Injectable Solution with food and drink
Alcohol can increase the drowsiness caused by tramadol.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not use PRONTALGIN
Injectable Solution more than once during breastfeeding or, alternatively, if you use
PRONTALGIN Injectable Solution more than once, you should stop breastfeeding.

Driving and using machines
Avoid driving and using tools or machines while using PRONTALGIN Injectable
Solution. PRONTALGIN Injectable Solution can reduce reaction times. This effect may
be worsened by the use of alcohol or other drugs that alter reaction times.

3. HOW TO USE PRONTALGIN INJECTABLE SOLUTION

The vials of PRONTALGIN must be used exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The dosage must be adjusted according to the intensity of the pain and your personal sensitivity to pain. Generally, the lowest dose that reduces the pain should be taken.
The usual dose for adults and children over 12 years of age is 50-100 mg of tramadol, 3-4 times a day.
The maximum allowed dose of PRONTALGIN Injectable Solution is generally 400 mg (8 ml of injectable solution) per day.
PRONTALGIN Injectable Solution is not suitable for children under 12 years of age.
For children between 12 and 14 years of age, the minimum dose is recommended.
Elderly patients
In elderly people (over 75 years of age), the elimination of tramadol may be delayed. If this is the case, your doctor may advise you to lengthen the time interval between doses.
Patients with severe liver (hepatic) or kidney failure / dialysis
Patients with severe hepatic and/or renal failure should not take PRONTALGIN Injectable Solution. In case of mild or moderate failure, your doctor may advise you to lengthen the time interval between doses. If you have liver or kidney problems, talk to your doctor, who will probably modify the dose or replace the medicine with another pain reliever.
PRONTALGIN Injectable Solution can be administered by intramuscular injection, by slow intravenous injection or, after an initial intramuscular or intravenous injection, can be continued by infusion.
Your doctor will tell you how long to use PRONTALGIN Injectable Solution.
If you feel that the effects of PRONTALGIN vials are too strong or too weak, consult your doctor or pharmacist.

If you use more PRONTALGIN Injectable Solution than you should
Contact your doctor or pharmacist immediately.
The following overdose effects may occur: constricted pupils, vomiting, a sudden drop in blood pressure, drowsiness and loss of consciousness, convulsions and breathing difficulties.

If you forget to use PRONTALGIN Injectable Solution
If you have forgotten to administer a dose, the pain is likely to return. Do not use a double dose to make up for a missed dose. Use the next dose as usual.

If you stop using PRONTALGIN Injectable Solution
You should not suddenly stop taking this medicine unless your doctor tells you to. If you intend to stop taking the medicine, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop it, which may involve gradually decreasing the dose to reduce the likelihood of developing unnecessary side effects (withdrawal symptoms).
These symptoms may include: anxiety, excessive sweating, insomnia, chills, pain, nausea, tremors, diarrhea, upper respiratory tract disorders, piloerection (hair standing on end) and, in rare cases, hallucinations.

If you have any doubts about the use of PRONTALGIN, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, PRONTALGIN Injectable Solution can cause side effects, although
not everyone will experience them.

If any of the following situations occur, seek medical attention immediately:

• Allergic reactions, such as difficulty breathing, wheezing, skin swelling(occurs rarely),
• Swelling of the face, tongue and/or throat and/or difficulty swallowing or hivesassociated with difficulty breathing (occurs rarely),
• Shock/sudden circulatory failure (occurs rarely).

Usually the frequency of side effects is classified as follows:

• very common (in more than 1 in 10 people),
• common (in more than 1 in 100 people),
• uncommon (in more than 1 in 1000 people),
• rare (in more than 1 in 10000 people),
• very rare (in less than 1 in 10000 people),
• not known (the frequency cannot be estimated based on available data).

The most common side effects during treatment with PRONTALGIN Injectable Solution
are nausea and dizziness, which occur in more than 1 in 10 patients.
Cardiac and circulatory disorders
Uncommon: effects on the heart and blood circulation (palpitations, fast
heartbeat, feeling of fainting or collapse). These adverse effects may
occur particularly in patients in an upright position or under physical exertion.
Rare: slowed heartbeat, increased blood pressure.
Very rare: hot flushes.
Nervous system disorders
Very common: dizziness.
Common: headache, drowsiness.
Rare: changes in appetite, abnormal sensations (such as itching, tingling,
numbness), tremor, slowed breathing, seizures, muscle spasms,
incoordination of movements, transient loss of consciousness
(syncope).
If you exceed the recommended doses or if you take other
medicines that depress brain function at the same time, a slowing
of breathing may occur.
Seizures have occurred mainly with high doses of tramadol or
when tramadol was taken in conjunction with other medicines that can
cause seizures.
Psychiatric disorders
Rare: hallucinations, confusion, sleep disturbances, anxiety and nightmares. Psychiatric
disorders may appear after treatment with PRONTALGIN Injectable Solution and
may vary in intensity and nature (depending on the patient's personality and the
duration of therapy). They may manifest as mood changes
(generally exaltation, occasionally irritability), changes in active life
(generally slowing down but occasionally increased activity) and reduced
awareness and ability to make decisions, which can lead to
judgment errors.
Dependence can occur.
Eye disorders
Rare: blurred vision.
Respiratory disorders
Rare: shortness of breath (dyspnea).
Cases of worsening asthma have been reported, although it has not been established
whether they were caused by tramadol.
Gastrointestinal disorders
Very common: nausea.
Common: vomiting, constipation, dry mouth.
Uncommon: retching, stomach discomfort (feeling of pressure in the stomach,
bloating), diarrhea.
Skin disorders
Common: sweating.
Uncommon: skin reactions (e.g. itching, rash).
Musculoskeletal disorders
Rare: muscle weakness.
Hepatobiliary disorders
Very rare: increased liver enzyme values.
Urinary disorders
Rare: difficulty urinating or pain, decreased amount of urine compared to normal.
Systemic disorders
Common: fatigue, tiredness, weakness, lack of energy.
Abruptly stopping therapy may cause withdrawal symptoms
(see “If you stop taking PRONTALGIN Injectable Solution”).
Metabolism and nutrition disorders
Not known: decreased blood sugar level.
Some cases of speech disorders and pupil dilation have been reported.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE PRONTALGIN INJECTABLE SOLUTION

Keep PRONTALGIN Injectable Solution out of the reach and sight of children.
Store the product in its original packaging.
Do not use PRONTALGIN Injectable Solution after the expiry date stated on the packaging after
EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What PRONTALGIN Injectable Solution contains

• The active ingredient is tramadol hydrochloride. Each vial contains 100 mg of tramadol hydrochloride in 2 ml of injectable solution.
• The excipients are sodium acetate and water for injections.

Description of the appearance of PRONTALGIN Injectable Solution and contents of the pack
PRONTALGIN Injectable Solution is supplied in packs of 5 or 10 vials.
The vials are made of colorless glass and contain a clear and colorless solution.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15 – 20143 Milano

Manufacturer:
DELPHARM TOURS
La Baraudière
37170 Chambray Lès Tours
France

This medicinal product is authorised in the Member States of the European Economic Area under the following denominations:
Italy: PRONTALGIN Soluzione iniettabile
Netherlands: Theradol Injectie

This leaflet was last approved in 01/2019

PRONTALGIN Gocce, 100 mg/ml oral drops, solution

Tramadol hydrochloride
Read this leaflet carefully before taking this medicine.

• 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. Do not give it to other people even if their symptoms are the same as yours, as it could be dangerous.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 13. What PRONTALGIN Gocce is and what it is used for
• 14. Before you take PRONTALGIN Gocce
• 15. How to take PRONTALGIN Gocce
• 16. Possible side effects
• 17. How to store PRONTALGIN Gocce
• 18. Further information

1. WHAT IS PRONTALGIN DROPS AND WHAT IS IT USED FOR

Tramadol (tramadol hydrochloride), the active ingredient of PRONTALGIN Drops, is a potent
pain reliever.
PRONTALGIN Drops is intended for the treatment of acute or prolonged moderate to severe
pain, such as that following surgery, serious injuries or cancer.

2. BEFORE TAKING PRONTALGIN DROPS

Do not take PRONTALGIN Drops

• if you are allergic (hypersensitive) to tramadol or any of the excipients of PRONTALGIN Drops (see section 6. Further information)
• if you are allergic to similar pain relievers (opioids)
• if you experience sudden alcohol intoxication (severe alcohol poisoning), sleeping pills, pain relievers or other drugs that act on the central nervous system
• if you are using monoamine oxidase inhibitors (for severe depression) or have taken them in the last two weeks
• if you have epilepsy that is not fully controlled
• for the treatment of withdrawal symptoms from drugs in drug addicts.

Take particular care with PRONTALGIN Drops

• if you are to undergo general anesthesia
• if you have suffered head injuries or have increased intracranial pressure (e.g. following an accident)
• if you suffer from excessive mucus secretion in the lungs
• if you have breathing difficulties or are taking high doses of tramadol or are still taking tramadol together with drugs that have an inhibitory effect on brain function, as in these cases the use of tramadol may worsen your breathing difficulties
• if you are prone to convulsions
• if you are at increased risk of shock (possible symptoms of shock are a rapid drop in blood pressure, paleness, anxiety, weak and rapid pulse, clammy skin, decreased state of consciousness)
• PRONTALGIN Drops may make it more difficult to diagnose certain disorders, such as acute abdominal disorders
• cases of abuse, drug addiction and withdrawal symptoms have been reported
• if you develop a sudden illness related to a disorder of heme production (acute porphyria)
• if you suffer from liver or kidney disorders
• tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may have different effects on them. Some people may not get enough pain relief, but others may experience serious side effects. If you notice any of the following side effects, you should stop taking this medicine and consult your doctor immediately: slowed or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or sick, constipation, loss of appetite
• Use in children (over 12 years of age) with respiratory problems:tramadol is not recommended in children with respiratory problems, because the symptoms of tramadol toxicity may be worse in these children. Consult your doctor if any of the above warnings apply to your case or have occurred in the past.

Taking PRONTALGIN Drops with other medicines
The risk of side effects increases

• If you are taking medicines that can cause convulsions (seizures), such as some antidepressants or antipsychotics. The risk of having a seizure may increase if you take PRONTALGIN Drops at the same time. Your doctor will tell you if PRONTALGIN Drops is suitable for you.
• If you are taking certain antidepressants. PRONTALGIN Drops can interact with these drugs and you may experience symptoms such as: involuntary rhythmic contractions of the muscles, including the muscles that control eye movement, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38°C.
• If you are taking PRONTALGIN Drops and sedatives such as benzodiazepines or similar. This increases the risk of drowsiness, difficulty breathing (respiratory depression), coma which can be life-threatening. For this reason, concomitant use should only be considered when other treatments are not possible. If your doctor prescribes PRONTALGIN Drops in conjunction with sedatives, the dose and duration of treatment must be reduced and decided by your doctor. Tell your doctor if you are taking sedatives, and always follow your doctor's advice regarding doses. It may be helpful to inform relatives and caregivers of the signs and symptoms above. Contact your doctor if these symptoms occur.

Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.

• Pain relievers or other drugs that act on the central nervous system can increase drowsiness; the inhibitory effect on the central nervous system may be increased.
• Carbamazepine, a medicine used to treat epilepsy, may reduce or shorten the effect of tramadol.
• Morphine derivatives (buprenorphine, nalbuphine, pentazocine) may reduce the analgesic effect of tramadol.
• Fluoxetineor paroxetine(for the treatment of depression), quinidine(for the treatment of heart disease), ritonavir(anti-HIV drug) and cimetidine(antacid) may reduce the effect of tramadol.
• Clomipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertralineand venlafaxine(for the treatment of depression), in association with tramadol, may increase the risk of seizures and serotonin syndrome (symptoms include: confusion, agitation, tremors, fever and diarrhea).
• Simultaneous use of tramadol and digoxin(for heart disease) may, in rare cases, amplify the undesirable effects of digoxin.
• Simultaneous use of tramadol and blood-thinning medications (e.g. anticoagulants such as warfarin) may increase the risk of bleeding.
• Simultaneous use of tramadol and ondansetron(for the treatment of nausea and vomiting) may reduce the pain-relieving effect of tramadol.

Taking PRONTALGIN Drops with food and drink
You can take PRONTALGIN Drops before, during or after meals.
Alcohol may increase the drowsiness caused by tramadol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take PRONTALGIN
Drops more than once during breastfeeding or, alternatively, if you take PRONTALGIN Drops more than
once, you should stop breastfeeding.

Driving and using machines
Avoid driving and using tools or machines while taking PRONTALGIN Drops.
PRONTALGIN Drops may reduce reaction times. This effect may be worsened by the use
of alcohol or other drugs that alter reaction times.

Important information about some excipients of PRONTALGIN Drops
This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to some
sugars, contact him before taking this medicine.
PRONTALGIN Drops is potentially harmful to teeth.

3. HOW TO TAKE PRONTALGIN DROPS

Always take PRONTALGIN Drops exactly as your doctor has instructed. If you have any doubts, you should
consult your doctor or pharmacist.
The dosage must be adjusted according to the intensity of the pain and your personal sensitivity to
pain. Generally, you should take the lowest dose that reduces the pain.
The usual dose for adults and children over 12 years of age is 50-100 mg of tramadol (20 or 40 drops),
3-4 times a day.
The maximum allowed dose of PRONTALGIN Drops is generally 400 mg (160 drops) per day.
For acute pain, an initial dose of 100 mg is generally necessary.
If you are taking PRONTALGIN Drops for acute pain, you should know that the effect starts with a slight
delay compared to other pain relievers.
For chronic pain, an initial dose of 50 mg is recommended.
PRONTALGIN Drops are not suitable for children under 12 years of age.
For children between 12 and 14 years of age, the minimum dose is recommended.
Elderly patients
In elderly people (over 75 years of age), the elimination of tramadol may be delayed. If this is the
case, your doctor may advise you to lengthen the time interval between doses.
Patients with severe liver (hepatic) or kidney (renal) disease / dialysis
Patients with severe hepatic and/or renal insufficiency should not take PRONTALGIN Drops. In
cases of mild or moderate insufficiency, your doctor may advise you to lengthen the time interval
between doses. If you have liver or kidney problems, talk to your doctor, who will probably modify the
dose or replace the medicine with another pain reliever.
Mix the drops in a glass of water and drink the entire contents.
Taking can occur before, during or after meals.
Your doctor will tell you how long to use PRONTALGIN Drops.
If you feel that the effects of PRONTALGIN drops are too strong or too weak, contact your
doctor or pharmacist.

If you take more PRONTALGIN Drops than you should
Contact your doctor or pharmacist immediately.
The following overdose effects may occur: constricted pupils, vomiting, a sudden drop in
blood pressure, drowsiness and loss of consciousness, convulsions and difficulty breathing.

If you forget to take PRONTALGIN Drops
If you have forgotten to take a dose, the pain is likely to return. Do not take a double
dose to make up for a missed dose. Take the next dose as usual.

If you stop taking PRONTALGIN Drops
You should not suddenly stop taking this medicine unless your doctor tells you to. If you intend to stop
taking the medicine, talk to your doctor first, especially if you have been taking it for a long time. The
doctor will advise you when and how to stop it, which may involve gradually reducing the dose to reduce
the likelihood of developing unnecessary side effects (withdrawal symptoms). These symptoms may be: anxiety, excessive sweating, insomnia, chills, pain, nausea, tremors, diarrhea, upper respiratory tract disorders,
piloerection (hair standing on end) and, in rare cases, hallucinations.

If you have any questions about the use of PRONTALGIN, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, PRONTALGIN Gocce may cause side effects, although not everybody gets them.

If any of the following occurs, seek immediate medical attention:

• Allergic reactions, such as difficulty breathing, wheezing, skin swelling(occurs rarely),
• Swelling of the face, tongue and/or throat and/or difficulty swallowing or hivesassociated with difficulty breathing (occurs rarely),
• Shock/sudden circulatory failure (occurs rarely).

Usually the frequency of side effects is classified as follows:

• very common (in more than 1 in 10 people),
• common (in more than 1 in 100 people),
• uncommon (in more than 1 in 1000 people),
• rare (in more than 1 in 10000 people),
• very rare (in less than 1 in 10000 people),
• not known (the frequency cannot be estimated from the available data).

The most common side effects during treatment with PRONTALGIN Gocce are nausea and
dizziness, which occur in more than 1 in 10 patients.
Cardiac and vascular disorders
Uncommon: effects on the heart and blood circulation (palpitations, fast heartbeat, feeling of fainting or collapse). These adverse effects may
occur particularly in patients in an upright position or under physical exertion.
Rare: slow heartbeat, increased blood pressure.
Very rare: flushing.
Nervous system disorders
Very common: dizziness.
Common: headache, drowsiness.
Rare: changes in appetite, abnormal sensations (such as itching, tingling,
numbness), tremor, slowed breathing, seizures, muscle spasms,
incoordination of movements, transient loss of consciousness
(syncope).
If you exceed the recommended doses or if you take other
medicines that depress brain function at the same time, slowed
breathing may occur.
Seizures have occurred mainly with high doses of tramadol or
when tramadol was taken in combination with other medicines that can
cause seizures.
Psychiatric disorders
Rare: hallucinations, confusion, sleep disturbances, anxiety and nightmares. Psychiatric
disorders may appear after treatment with PRONTALGIN Gocce and may
vary in intensity and nature (depending on the patient's personality and the duration of
therapy). They may manifest as mood changes (generally
exaltation, occasionally irritability), changes in active life (generally
slowing down but occasionally increased activity) and reduced
awareness and decision-making ability, which can lead to errors in
judgment.
Dependence can occur.
Eye disorders
Rare: blurred vision.
Respiratory disorders
Rare: shortness of breath (dyspnea).
Cases of worsening asthma have been reported, although it has not been established
whether they were caused by tramadol.
Gastrointestinal disorders
Very common: nausea.
Common: vomiting, constipation, dry mouth.
Uncommon: nausea, stomach discomfort (feeling of pressure in the stomach,
bloating), diarrhea.
Skin disorders
Common: sweating.
Uncommon: skin reactions (e.g. itching, rash).
Musculoskeletal disorders
Rare: muscle weakness.
Hepatobiliary disorders
Very rare: increased liver enzyme values.
Urinary disorders
Rare: difficulty urinating or pain, decreased amount of urine.
Systemic disorders
Common: fatigue, tiredness, weakness, lack of energy.
Abruptly stopping therapy may cause withdrawal symptoms
(see “If you stop taking PRONTALGIN Gocce”).
Metabolism and nutrition disorders
Not known: decreased blood sugar level.
Some cases of speech disorders and pupil dilation have been reported.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE PRONTALGIN GOCCE

Keep PRONTALGIN Gocce out of the reach and sight of children.
Keep the dropper bottle tightly closed.
Do not use PRONTALGIN Gocce after the expiry date stated on the packaging after SCAD. The
expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. FURTHER INFORMATION

What PRONTALGIN Gocce contains

• The active ingredient is tramadol hydrochloride. Each bottle contains 100 mg/ml of tramadol hydrochloride.
• The excipients are: potassium sorbate, sodium saccharinate, polysorbate 20, peppermint essential oil, anethole, sucrose, purified water.

Description of the appearance of PRONTALGIN Gocce and contents of the pack
PRONTALGIN Gocce is supplied in packs containing an amber glass bottle of 10 ml, with
the dropper inserted and sealed with a screw cap.
The solution is clear, colourless or slightly yellowish.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15 – 20143 Milano

Manufacturer:
DELPHARM Tours
La Baraudière
37170 Chambray Lès Tours
FRANCE

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy: PRONTALGIN Gocce
Netherlands: THERADOL Druppels

This leaflet was last approved in 01/2019