Prontalgin: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 other people, even if their symptoms are the same as yours, because it could be dangerous.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What PRONTALGIN 50 mg effervescent tablets is and what it is used for
Before you take PRONTALGIN 50 mg effervescent tablets
How to take PRONTALGIN 50 mg effervescent tablets
Possible side effects
How to store PRONTALGIN 50 mg effervescent tablets
Further information

1. WHAT PRONTALGIN 50 MG EFFERVESCENT TABLETS IS AND WHAT THEY ARE USED FOR

PURPOSE
Tramadol (tramadol hydrochloride), the active ingredient in PRONTALGIN 50 mg Effervescent Tablets, is a potent analgesic.
PRONTALGIN 50 mg Effervescent Tablets are intended for the treatment of moderate to severe acute or chronic pain, such as pain following surgical procedures, serious injuries, or cancer.

2. BEFORE TAKING PRONTALGIN 50 MG EFFERVESCENT TABLETS

Do not take PRONTALGIN 50 mg Effervescent Tablets

if you are allergic (hypersensitive) to tramadol or any of the excipients in PRONTALGIN 50 mg Effervescent Tablets (see section 6. Further information)
if you are allergic to similar painkillers (opioids)
if you suddenly develop severe intoxication (intense poisoning) from alcohol (alcohol poisoning), sleeping pills, painkillers, or other medicines acting on the central nervous system
if you are taking monoamine oxidase inhibitors (for severe depression) or have taken them within the last two weeks
if you have epilepsy that is not fully controlled
for treating withdrawal symptoms from drugs in drug-dependent patients.

Take special care with PRONTALGIN 50 mg Effervescent Tablets

if you are undergoing general anesthesia
if you have suffered head injuries or have increased intracranial pressure (e.g. following an accident)
if you have 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 medicines that have a central nervous system depressant effect, as tramadol use may worsen your breathing difficulties
if you are prone to seizures
if you are at increased risk of shock (possible symptoms of shock include rapid drop in blood pressure, pallor, anxiety, weak and rapid pulse, cold and clammy skin, reduced level of consciousness)
PRONTALGIN 50 mg Effervescent Tablets may make it more difficult to diagnose certain conditions, 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 in heme production (acute porphyria)
if you have liver or kidney problems
tramadol is metabolized in the liver by an enzyme. Some individuals have a variation in this enzyme, which may lead to different effects in them. Some people may not get sufficient pain relief, while others may experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or malaise, constipation, loss of appetite
use in children (over 12 years of age) with respiratory problems: tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may be worse in these children.

Consult your doctor if any of the above warnings apply to you or have occurred in the past.
Taking PRONTALGIN 50 mg Effervescent Tablets with other medicines
The risk of adverse effects increases

if you are taking medicines that may cause seizures (fits), such as certain 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 advise whether PRONTALGIN 50 mg Effervescent Tablets are suitable for you.
if you are taking certain antidepressants. PRONTALGIN 50 mg Effervescent Tablets may interact with these medicines, and you may experience symptoms such as: involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38°C.
if you are taking PRONTALGIN 50 mg Effervescent Tablets together with sedative medicines such as benzodiazepines or their analogues. This increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, which may be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible. If your doctor prescribes PRONTALGIN 50 mg Effervescent Tablets together with sedative medicines, the dose and duration of treatment must be reduced and determined by your doctor. Inform your doctor if you are taking sedative medicines and always strictly follow your doctor’s advice regarding doses. It may be helpful to inform your family members or caregivers about the signs and symptoms listed 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 without a prescription.

Painkillers or other medicines acting on the central nervous system may increase drowsiness; the central nervous system depressant effect may be enhanced.
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.
Fluoxetine or paroxetine (for treatment of depression), quinidine (for treatment of heart conditions), ritonavir (anti-HIV medicine), and cimetidine (anti-acid) may reduce the effect of tramadol.
Clomipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, and venlafaxine (for treatment of depression), when used together 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 conditions) may, in rare cases, enhance the adverse 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 treatment of nausea and vomiting) may reduce the pain-relieving effect of tramadol.

Taking PRONTALGIN 50 mg Effervescent Tablets with food and drink
You may 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, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Breastfeeding
Tramadol is excreted in breast milk. Therefore, you should not take PRONTALGIN 50 mg Effervescent Tablets more than once while breastfeeding; alternatively, if you take PRONTALGIN 50 mg Effervescent Tablets more than once, you must stop breastfeeding.
Driving and using machines
Avoid driving or operating tools or machinery while taking PRONTALGIN 50 mg Effervescent Tablets. PRONTALGIN 50 mg Effervescent Tablets may impair your reaction time. This effect may be worsened by alcohol or other medicines that affect reaction time.
Important information about some excipients in PRONTALGIN 50 mg Effervescent Tablets

This medicine contains 214 mg of sodium per tablet, which may be harmful for patients on a low-sodium diet.
This medicine contains 10 mg of aspartame per tablet, a source of phenylalanine, which may be harmful for patients with phenylketonuria.
This medicine contains 75 mg of lactose per tablet. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. HOW TO TAKE PRONTALGIN 50 MG EFFERVESCENT TABLETS

Always take PRONTALGIN 50 mg Effervescent Tablets exactly as directed by your
doctor. If you have any doubts, consult your doctor or pharmacist.
The dosage should be adjusted according to the intensity of the pain and your individual sensitivity to
pain. Generally, the lowest effective dose that relieves pain should be used.
The usual dose for adults and children over 12 years of age is 50–100 mg of tramadol (1 or 2 effervescent
tablets), taken 3–4 times daily.
The maximum recommended daily dose of PRONTALGIN 50 mg Effervescent Tablets is generally 400
mg (8 effervescent tablets).
For acute pain, an initial dose of 100 mg is generally required.
If you are taking PRONTALGIN 50 mg Effervescent Tablets for acute pain, you should know that the
onset of effect may be somewhat delayed compared to other analgesic medicines.
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 aged between 12 and 14 years, the lowest dose is recommended.

Elderly patients
In elderly individuals (over 75 years), elimination of tramadol may be delayed. If this applies to you, your
doctor may advise you to increase the interval between doses.

Patients with severe hepatic or renal impairment / dialysis
Patients with severe liver and/or kidney dysfunction must not take PRONTALGIN 50 mg Effervescent
Tablets. In cases of mild to moderate impairment, your doctor may recommend increasing the interval
between doses. If you have liver or kidney problems, discuss this with your doctor, who will likely adjust
your dose or switch you to another analgesic.

Dissolve the effervescent tablets in a glass of water and drink the entire contents.
The tablets may be taken before, during, or after meals.
Your doctor will advise you on how long to continue treatment with PRONTALGIN 50 mg Effervescent
Tablets.
If you feel the effect of PRONTALGIN effervescent tablets is 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 symptoms of overdose may occur: constricted pupils, vomiting, sudden drop in blood
pressure, drowsiness and loss of consciousness, seizures, and breathing difficulties.

If you forget to take PRONTALGIN 50 mg Effervescent Tablets
If you miss a dose, your pain may return. Do not take a double dose to make up for the missed dose. Take
the next dose as scheduled.

If you stop taking PRONTALGIN 50 mg Effervescent Tablets
Do not stop taking this medicine abruptly unless instructed by your doctor. If you intend to discontinue
treatment, especially after prolonged use, discuss this with your doctor first. Your doctor will advise you
on when and how to stop, which may involve gradually reducing the dose to minimize the risk of
unnecessary adverse effects (withdrawal symptoms).
These symptoms may include: anxiety, excessive sweating, insomnia, chills, pain, nausea, tremors,
diarrhea, upper respiratory tract disturbances, piloerection (goosebumps), and, rarely, hallucinations.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, PRONTALGIN 50 mg Effervescent Tablets may cause adverse reactions, although not everyone experiences them.
If any of the following situations occur, contact your doctor immediately:

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

The frequency of adverse reactions is usually classified as follows:

very common (more than 1 in 10 people),
common (more than 1 in 100 people),
uncommon (more than 1 in 1,000 people),
rare (more than 1 in 10,000 people),
very rare (less than 1 in 10,000 people),
not known (frequency cannot be estimated from the available data).

The most common adverse reactions during treatment with PRONTALGIN 50 mg Effervescent Tablets are nausea and dizziness, occurring in more than 1 in 10 patients.

Cardiac and circulatory disorders
Uncommon: effects on the heart and blood circulation (palpitations, rapid heartbeat, sensation of fainting or collapse). These adverse effects may occur particularly in patients who are upright 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, epileptic seizures, muscle spasms, lack of coordination, transient loss of consciousness (syncope).
If recommended doses are exceeded or if other medicines that depress brain function are taken simultaneously, breathing may slow down.
Epileptic seizures have mainly occurred with high doses of tramadol or when tramadol was taken concomitantly with other medicines that may provoke seizures.

Psychiatric disorders
Rare: hallucinations, confusion, sleep disturbances, anxiety, and nightmares. Psychological disturbances may occur after treatment with PRONTALGIN 50 mg Effervescent Tablets and may vary in intensity and nature (depending on the patient's personality and duration of therapy). They may present as mood changes (usually euphoria, occasionally irritability), changes in activity levels (usually slowing down, occasionally increased activity), and reduced awareness and decision-making ability, which may lead to impaired judgment.
Dependence may occur.

Eye disorders
Rare: blurred vision.

Respiratory disorders
Rare: shortness of breath (dyspnea).
Cases of worsening asthma have been reported, although a causal relationship with tramadol has not been established.

Gastrointestinal disorders
Very common: nausea.
Common: vomiting, constipation, dry mouth.
Uncommon: retching, stomach discomfort (feeling of pressure in the stomach, bloating), diarrhoea.

Skin disorders
Common: sweating.
Uncommon: skin reactions (e.g. itching, rash).

Musculoskeletal disorders
Rare: muscle weakness.

Hepatobiliary disorders
Very rare: increased liver enzyme levels.

Urinary disorders
Rare: difficulty urinating or pain, reduced urine output compared to normal.

Systemic disorders
Common: fatigue, tiredness, weakness, lack of energy.
Withdrawal symptoms may occur if treatment is stopped abruptly (see “If you stop taking PRONTALGIN 50 mg Effervescent Tablets”).

Metabolism and nutrition disorders
Not known: decreased blood sugar levels.

Isolated cases of speech disturbances and pupil dilation have been reported.

If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform 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 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. OTHER INFORMATION

What PRONTALGIN 50 mg Effervescent Tablets contains

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

What PRONTALGIN 50 mg Effervescent Tablets looks like and contents of the pack
PRONTALGIN 50 mg Effervescent Tablets are supplied in packs of 10, 20 or 30 effervescent tablets, packed in tablet containers with a cap that acts as a desiccant.
The 10-tablet pack contains 1 container with 10 tablets.
The 20-tablet pack contains 1 container with 20 tablets.
The 30-tablet pack contains 2 containers with 15 tablets each.
It is possible that not all pack sizes will be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15 – 20143 Milan, Italy
Manufacturer:
LOSAN PHARMA GmbH
Otto-Hahn Strasse 13
79395 Neuenburg, GERMANY

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: PRONTALGIN 50 mg Effervescent Tablets
Netherlands: Theradol 50 mg Bruistabletten

This leaflet was last approved in 01/2019

PATIENT LEAFLET: INFORMATION FOR THE USER

PRONTALGIN Capsule, 50 mg hard capsule

Tramadol hydrochloride
Please read this leaflet carefully before taking this medicine.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not give it to others, even if their symptoms are similar to yours, as it could be harmful.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What PRONTALGIN Capsules are and what they are used for
Before taking PRONTALGIN Capsules
How to take PRONTALGIN Capsules
Possible side effects
How to store PRONTALGIN Capsules
Further information

1. WHAT PRONTALGIN CAPSULES ARE AND WHAT THEY ARE USED FOR

Tramadol (tramadol hydrochloride), the active substance in PRONTALGIN Capsules, is a potent
analgesic.
PRONTALGIN Capsules are indicated for the treatment of moderate to severe acute or chronic pain, such as pain following surgery, serious injuries or cancer.

2. BEFORE TAKING PRONTALGIN CAPSULES

Do not take PRONTALGIN Capsules

if you are allergic (hypersensitive) to tramadol or to any of the excipients of PRONTALGIN Capsules (see section 6. Further information)
if you are allergic to similar painkillers (opioids)
in case of sudden intoxication (especially severe) with alcohol (alcohol poisoning), sedatives, painkillers, or other medicines acting on the central nervous system
if you are taking monoamine oxidase inhibitors (for severe depression) or have taken them within the last two weeks
if you have epilepsy that is not fully controlled
for the treatment of withdrawal symptoms from drugs in drug-dependent patients.

Take special care with PRONTALGIN Capsules

if you are due to undergo general anaesthesia
if you have suffered head injuries or have had increased intracranial pressure (e.g. following an accident)
if you have 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 medicines that have a CNS depressant effect, 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 include rapid drop in blood pressure, pallor, anxiety, weak and rapid pulse, cold and clammy skin, reduced level of consciousness)
PRONTALGIN Capsules may make it more difficult to diagnose certain conditions, 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 in heme production (acute porphyria)
if you have liver or kidney problems
tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may lead to different effects in them. Some people may not get sufficient pain relief, while others may experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or malaise, constipation, loss of appetite
use in children (over 12 years of age) with respiratory problems: tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may be more severe in these children.

Consult your doctor if any of the above warnings apply to you or have occurred in the past.
Taking PRONTALGIN Capsules with other medicines
The risk of adverse effects increases

if you are taking medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take PRONTALGIN Capsules at the same time. Your doctor will tell you whether PRONTALGIN Capsules are suitable for you.
if you are taking certain antidepressants. PRONTALGIN Capsules may interact with these medicines and you may experience symptoms such as: involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, body temperature above 38°C.
if you are taking PRONTALGIN Capsules and sedative medicines such as benzodiazepines or similar substances. This increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, which can be life-threatening. Therefore, concomitant use should only be considered when other treatments are not possible. If your doctor prescribes PRONTALGIN Capsules together with sedative medicines, the dose and duration of treatment must be reduced and determined by your doctor. Inform your doctor if you are taking sedative medicines, and always strictly follow your doctor's advice regarding doses. It may be helpful to inform family members and caregivers about the signs and symptoms listed above. Contact your doctor if these symptoms occur.

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

Painkillers or other medicines acting on the central nervous system may increase drowsiness; the CNS depressant effect may be enhanced.
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.
Fluoxetine or paroxetine (for treatment of depression), quinidine (for treatment of heart conditions), ritonavir (anti-HIV drug), and cimetidine (antacid) may reduce the effect of tramadol.
Clomipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, and venlafaxine (for treatment of depression), when used in combination with tramadol, may increase the risk of seizures and serotonin syndrome (symptoms include: confusion, agitation, tremors, fever, and diarrhoea).
Simultaneous use of tramadol and digoxin (for heart conditions) may, in rare cases, enhance the adverse 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 treatment of nausea and vomiting) may reduce the pain-relieving effect of tramadol.

Taking PRONTALGIN Capsules with food and drink
You may take PRONTALGIN Capsules before, during, or after meals.
Alcohol may increase the drowsiness caused by tramadol.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Breast-feeding
Tramadol is excreted in breast milk. Therefore, you must not take PRONTALGIN Capsules more than once during breast-feeding; alternatively, if you take PRONTALGIN Capsules more than once, you must stop breast-feeding.
Driving and using machines
Avoid driving and using tools or machinery while taking PRONTALGIN Capsules.
PRONTALGIN Capsules may reduce reaction times. This effect may be worsened by alcohol or other medicines that affect reaction times.

3. HOW TO TAKE PRONTALGIN CAPSULES

Always take PRONTALGIN Capsules exactly as directed by your doctor. If you have any doubts,
you must consult your doctor or pharmacist.
The dosage should be adjusted according to the intensity of pain and your individual sensitivity to
pain. In general, the lowest effective dose that relieves pain should be used.
The usual dose for adults and children over 12 years of age is 50–100 mg of tramadol (1 or 2 capsules),
taken 3–4 times daily.
The maximum recommended dose of PRONTALGIN Capsules is generally 400 mg (8 capsules) per
day.
For acute pain, an initial dose of 100 mg is generally required.
If you are taking PRONTALGIN Capsules for acute pain, you should be aware that its effect begins
somewhat later compared to other pain-relieving medications.
For chronic pain, an initial dose of 50 mg is recommended.
PRONTALGIN Capsules are not suitable for children under 12 years of age.
For children aged between 12 and 14 years, the lowest recommended dose should be used.

Elderly patients
In elderly individuals (over 75 years of age), elimination of tramadol may be delayed. If this applies to you,
your doctor may advise you to increase the time interval between doses.

Patients with severe hepatic or renal impairment / dialysis
PRONTALGIN Capsules must not be used by patients with severe hepatic and/or renal impairment. In cases
of mild or moderate impairment, your doctor may recommend increasing the interval between doses.
If you have liver or kidney problems, discuss this with your doctor, who will likely adjust your dose or
replace this medicine with another pain reliever.

You may take the capsules with a glass of water. Do not chew them.
The capsules may be taken before, during, or after meals.
Your doctor will tell you how long to continue treatment with PRONTALGIN Capsules.
If you feel the effect of PRONTALGIN Capsules is 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 symptoms of overdose may occur: constricted pupils, vomiting, sudden drop in
blood pressure, drowsiness and loss of consciousness, seizures, and breathing difficulties.

If you forget to take a dose of PRONTALGIN Capsules
If you miss a dose, your pain may return. Do not take a double dose to make up for the missed dose.
Take the next dose at your usual scheduled time.

If you stop taking PRONTALGIN Capsules
Do not stop taking this medicine abruptly, unless instructed by your doctor. If you intend to discontinue
treatment, discuss this first with your doctor, especially if you have been taking the medicine for a long time.
Your doctor will advise you on when and how to stop, which may involve gradually reducing the dose to
minimize the risk of unnecessary adverse effects (withdrawal symptoms). These symptoms may include:
anxiety, excessive sweating, insomnia, chills, pain, nausea, tremors, diarrhea, upper respiratory tract
disturbances, piloerection (goosebumps), and, in rare cases, hallucinations.

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

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, PRONTALGIN Capsules can cause adverse effects, although not everyone experiences them.
If any of the following situations occur, contact your doctor immediately:

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

The frequency of adverse effects is usually classified as follows:

very common (more than 1 in 10 people),
common (more than 1 in 100 people),
uncommon (more than 1 in 1,000 people),
rare (more than 1 in 10,000 people),
very rare (less than 1 in 10,000 people),
not known (frequency cannot be estimated from the available data).

The most common adverse effects during treatment with PRONTALGIN Capsules are nausea and dizziness, occurring in more than 1 in 10 patients.
Cardiac and circulatory disorders
Uncommon: effects on the heart and blood circulation (palpitations, rapid heartbeat, sensation 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, epileptic seizures, muscle spasms, lack of coordination, transient loss of consciousness (syncope).
Slowed breathing may occur if recommended doses are exceeded or if other medicines that depress brain function are taken concomitantly.
Epileptic seizures have mainly occurred with high doses of tramadol or when tramadol was taken concomitantly with other medicines that may provoke seizures.
Psychiatric disorders
Rare: hallucinations, confusion, sleep disturbances, anxiety, and nightmares. Psychiatric disturbances may occur after treatment with PRONTALGIN Capsules and may vary in intensity and nature (depending on the patient's personality and duration of therapy). They may manifest as mood changes (usually euphoria, occasionally irritability), changes in activity levels (usually slowing down, occasionally increased activity), and reduced awareness and decision-making ability, which may lead to impaired judgment.
Dependence may 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 without vomiting, 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 levels.
Urinary disorders
Rare: difficulty urinating or pain, reduced urine output compared to normal.
General disorders
Common: fatigue, tiredness, weakness, lack of energy.
Withdrawal symptoms may occur if treatment is stopped abruptly (see "If you stop taking PRONTALGIN Capsules").
Metabolism and nutrition disorders
Not known: decrease in blood sugar levels.
A few cases of speech disturbances and pupil dilation have been reported.
If any of the adverse effects worsen, or if you notice any adverse effect not listed in this leaflet, inform 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 the original packaging.
Do not use PRONTALGIN Capsules 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 Capsules contain

The active substance is tramadol hydrochloride. Each capsule contains 50 mg of tramadol hydrochloride.
The excipients are: capsule contents: 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 are supplied in packs of 20, 50, 60, 100 or 250 hard capsules in blisters.
The capsules are opaque white 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 European Economic Area countries under the following names:
Italy: PRONTALGIN Capsules
Netherlands: Theradol Capsules
Spain: Tramadol Bexal 50 mg Cápsulas EFG

This leaflet was last approved in 01/2019

PATIENT LEAFLET: INFORMATION FOR THE USER

PRONTALGIN 50 mg/ml solution for injection

Tramadol hydrochloride
Please 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 others, even if their symptoms are the same as yours, as it could be harmful.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What PRONTALGIN Solution for injection is and what it is used for
Before taking PRONTALGIN Solution for injection
How to take PRONTALGIN Solution for injection
Possible side effects
How to store PRONTALGIN Solution for injection
Further information

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

Tramadol (tramadol hydrochloride), the active substance of PRONTALGIN Injectable Solution, is a
potent analgesic.
PRONTALGIN Injectable Solution is intended for the treatment of sudden or prolonged moderate to severe pain, such as pain 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 to any of the excipients of PRONTALGIN Injectable Solution (see section 6. Other information)
if you are allergic to similar painkillers (opioids)
in case of sudden intoxication (severe) by alcohol (alcohol poisoning), sleeping pills, painkillers, or other medicines acting on the central nervous system
if you are taking monoamine oxidase inhibitors (for severe depression) or have taken them within the last two weeks
if you have epilepsy that is not fully controlled
for the treatment of withdrawal symptoms from drugs in drug-dependent individuals.

Take special care with PRONTALGIN Injectable Solution

if you are undergoing general anesthesia
if you have sustained 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 if you are taking tramadol together with medicines that have a central nervous system depressant effect, as in these cases tramadol use may worsen your breathing difficulties
if you are prone to seizures
if you are at increased risk of shock (possible symptoms of shock include rapid drop in blood pressure, paleness, anxiety, weak and rapid pulse, cold and clammy skin, reduced level of consciousness)
PRONTALGIN Injectable Solution may make it more difficult to diagnose certain conditions, 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 in 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 lead to different effects in them. Some people may not achieve sufficient pain relief, while others may experience severe adverse reactions. If you notice any of the following adverse effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or malaise, constipation, loss of appetite
Use in children (above 12 years of age) with respiratory problems: tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may be more severe in these children.

Consult your doctor if any of the above warnings apply to you or have occurred in the past.
Taking PRONTALGIN Injectable Solution with other medicines
The risk of adverse effects increases

if you are taking medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take PRONTALGIN Injectable Solution at the same time. Your doctor will advise you whether PRONTALGIN Injectable Solution is suitable for you.
if you are taking certain antidepressants. PRONTALGIN Injectable Solution may interact with these medicines and you may experience symptoms such as: involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, body temperature above 38°C.
if you are taking PRONTALGIN Injectable Solution and sedative medicines such as benzodiazepines or similar agents. This increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, which may be life-threatening. Therefore, concomitant use should only be considered when other treatments are not possible. If your doctor prescribes PRONTALGIN Injectable Solution together with sedative medicines, the dose and duration of treatment must be reduced and determined by your doctor. Inform your doctor if you are taking sedative medicines, and always strictly follow your doctor's advice regarding dosing. It may be helpful to inform family members or caregivers about the signs and symptoms listed above. Contact your doctor if such symptoms occur. Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.
painkillers or other medicines acting on the central nervous system may increase drowsiness or dizziness; the central nervous system depressant effect may be enhanced.
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.
Fluoxetine or paroxetine (for treatment of depression), quinidine (for treatment of heart conditions), ritonavir (anti-HIV drug), and cimetidine (antacid) may reduce the effect of tramadol.
Clomipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, and venlafaxine (for treatment of depression), when used in combination 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 conditions) may, in rare cases, enhance the adverse 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 treatment of nausea and vomiting) may reduce the pain-relieving effect of tramadol.

Use of PRONTALGIN Injectable Solution with food and drink
Alcohol may increase the drowsiness caused by tramadol.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist 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; alternatively, if you use PRONTALGIN Injectable Solution more than once, you must stop breastfeeding.
Driving and using machines
Avoid driving or operating tools or machinery while using PRONTALGIN Injectable Solution. PRONTALGIN Injectable Solution may impair reaction times. This effect may be worsened by the use of alcohol or other medicines that affect reaction times.

3. HOW TO USE PRONTALGIN INJECTABLE SOLUTION

The vials of PRONTALGIN must be used exactly as directed by the physician. If
you have any doubts, consult your doctor or pharmacist.
The dosage should be adjusted according to the intensity of pain and your individual sensitivity to
pain. Generally, the lowest effective dose that relieves pain should be taken.
The usual dose for adults and children over 12 years of age is 50–100 mg of tramadol, administered 3–4 times daily.
The maximum recommended daily dose of PRONTALGIN Injectable Solution is generally 400 mg (8 ml of
injectable solution).
PRONTALGIN Injectable Solution is not suitable for children under 12 years of age.
For children aged between 12 and 14 years, the lowest recommended dose should be used.

Elderly patients
In elderly individuals (over 75 years), elimination of tramadol may be delayed. If this applies to you, your doctor may advise extending the interval between doses.

Patients with severe hepatic or renal impairment / dialysis
Patients with severe hepatic and/or renal impairment must not take PRONTALGIN Injectable Solution. In cases of mild or moderate impairment, your doctor may recommend increasing the interval between doses. If you have liver or kidney problems, discuss this with your doctor, who will likely adjust your dose or substitute the medication with another analgesic.

PRONTALGIN Injectable Solution can be administered by intramuscular injection, by slow intravenous injection, or, following an initial intramuscular or intravenous injection, by continuous infusion.

Your doctor will advise you on 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 signs of overdose may occur: constricted pupils, vomiting, sudden drop in blood pressure, drowsiness and loss of consciousness, seizures, and respiratory difficulties.

If you forget to use PRONTALGIN Injectable Solution
If you miss a dose, your pain may return. Do not use a double dose to make up for the missed dose. Take the next dose as scheduled.

If you stop treatment with PRONTALGIN Injectable Solution
Do not stop taking this medicine abruptly unless instructed by your doctor. If you intend to discontinue the medicine, discuss this first with your doctor, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to minimize the risk of experiencing unnecessary adverse effects (withdrawal symptoms).
These symptoms may include: anxiety, excessive sweating, insomnia, chills, pain, nausea, tremors, diarrhea, upper respiratory tract disturbances, piloerection (goosebumps), and, in rare cases, hallucinations.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, PRONTALGIN Injectable Solution may cause adverse reactions, although
not everyone experiences them.
If any of the following occur, contact your doctor immediately:

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

The frequency of adverse reactions 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 1,000 people),
rare (affects more than 1 in 10,000 people),
very rare (affects fewer than 1 in 10,000 people),
not known (frequency cannot be estimated from available data).

The most common adverse reactions 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, rapid heartbeat,
sensation 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, epileptic seizures, muscle spasms,
incoordination of movements, transient loss of consciousness (syncope).
If recommended doses are exceeded or if other medicines that depress brain function
are taken simultaneously, slowed breathing may occur.
Epileptic seizures have mainly occurred with high doses of tramadol or when tramadol
was taken concomitantly with other medicines that may provoke seizures.
Psychiatric disorders
Rare: hallucinations, confusion, sleep disturbances, anxiety, and nightmares. Psychological
disorders may occur after treatment with PRONTALGIN Injectable Solution and
may vary in intensity and nature (depending on the patient's personality and duration of therapy).
They may present as mood changes (usually euphoria, occasionally irritability), changes in activity levels (usually slowing down, but occasionally increased activity), and reduced awareness and decision-making ability, which may lead to impaired judgment.
Dependence may 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 without vomiting, 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 levels.
Urinary disorders
Rare: difficulty urinating or pain, reduced urine output compared to normal.
Systemic disorders
Common: fatigue, tiredness, weakness, lack of energy.
Withdrawal symptoms may occur if treatment is stopped abruptly (see "If you stop treatment with PRONTALGIN Injectable Solution").
Metabolism and nutrition disorders
Not known: decreased blood sugar levels.
A few cases of speech disturbances and pupil dilation have been reported.
If any of the adverse reactions worsens, or if you notice any adverse reaction not listed in this
leaflet, inform 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 must not be disposed of via wastewater or household waste. Please 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 substance 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 injectable preparations.

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, colourless 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, Italy
Manufacturer:
DELPHARM TOURS
La Baraudière
37170 Chambray Lès Tours
France

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: PRONTALGIN Injectable Solution
Netherlands: Theradol Injectie
This leaflet was last approved in 01/2019

PACKAGE LEAFLET: INFORMATION FOR THE USER

PRONTALGIN Drops, 100 mg/ml oral drops, solution

Tramadol hydrochloride
Please 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 others, even if their symptoms are the same as yours, as it could be harmful.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What PRONTALGIN Drops is and what it is used for
Before taking PRONTALGIN Drops
How to take PRONTALGIN Drops
Possible side effects
How to store PRONTALGIN Drops
Further information

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

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

2. BEFORE TAKING PRONTALGIN DROPS

Do not take PRONTALGIN Drops

if you are allergic (hypersensitive) to tramadol or to any of the excipients in PRONTALGIN Drops (see section 6. Further information)
if you are allergic to similar painkillers (opioids)
in case of sudden intoxication (severe) with alcohol (alcohol poisoning), sleeping pills, painkillers, or other medicines acting on the central nervous system
if you are taking monoamine oxidase inhibitors (for severe depression) or have taken them within the last two weeks
if you have epilepsy that is not fully controlled
for the treatment of withdrawal symptoms from drugs in drug-dependent patients.

Take special care with PRONTALGIN Drops

if you are due to undergo general anesthesia
if you have suffered head injuries or have increased intracranial pressure (e.g. following an accident)
if you have excessive mucus secretion in the lungs
if you have breathing difficulties or are taking high doses of tramadol, or are taking tramadol together with medicines that have a central nervous system depressant effect, as in these cases tramadol use may worsen your breathing difficulties
if you are prone to seizures
if you are at increased risk of shock (possible symptoms of shock include rapid drop in blood pressure, pallor, anxiety, weak and rapid pulse, cold clammy skin, reduced level of consciousness)
PRONTALGIN Drops may make it more difficult to diagnose certain conditions, 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 in heme production (acute porphyria)
if you suffer from liver or kidney disorders
tramadol is metabolized in the liver by an enzyme. Some individuals have a variation in this enzyme, which may lead to different effects in them. Some people may not achieve sufficient pain relief, while others may experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and contact a doctor immediately: slowed or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or malaise, constipation, loss of appetite
Use in children (over 12 years of age) with respiratory problems: tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may be worse in these children. Consult your doctor if any of the above warnings apply to you or have occurred in the past.

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

if you are taking medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take PRONTALGIN Drops at the same time. Your doctor will advise you whether PRONTALGIN Drops is suitable for you.
if you are taking certain antidepressants. PRONTALGIN Drops may interact with these medicines, and you may experience symptoms such as: involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38°C.
if you are taking PRONTALGIN Drops together with sedative medicines such as benzodiazepines or similar substances. This increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, which may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible. If your doctor prescribes PRONTALGIN Drops together with sedative medicines, the dose and duration of treatment must be reduced and determined by your doctor. Inform your doctor if you are taking sedative medicines, and always follow your doctor’s dosage instructions closely. It may be helpful to inform family members or caregivers about the signs and symptoms listed above. Contact your doctor if these symptoms occur.

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

Painkillers or other medicines acting on the central nervous system may increase drowsiness; the central nervous system depressant effect may be enhanced.
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.
Fluoxetine or paroxetine (for treatment of depression), quinidine (for treatment of heart conditions), ritonavir (anti-HIV drug), and cimetidine (antacid) may reduce the effect of tramadol.
Clomipramine, fluoxetine, fluvoxamine, nefazodone, paroxetine, sertraline, and venlafaxine (for treatment of depression), when used in combination 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 conditions) may, in rare cases, enhance the adverse 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 treatment of nausea and vomiting) may reduce the pain-relieving effect of tramadol.

Taking PRONTALGIN Drops with food and drink
You may take PRONTALGIN Drops before, during, or after meals.
Alcohol may increase the drowsiness caused by tramadol.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding,
consult your doctor or pharmacist 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; alternatively, if you take PRONTALGIN Drops
more than once, you must stop breastfeeding.
Driving and using machines
Avoid driving and operating tools or machinery while taking PRONTALGIN Drops.
PRONTALGIN Drops may impair reaction times. This effect may be worsened by the use
of alcohol or other medicines that affect reaction times.
Important information about some excipients in PRONTALGIN Drops
This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain
sugars, contact him or her before taking this medicine.
PRONTALGIN Drops may be harmful to teeth.

3. HOW TO TAKE PRONTALGIN DROPS

Always take PRONTALGIN Drops exactly as prescribed by your doctor. If you have any doubts, you must consult your doctor or pharmacist.
The dosage should be adjusted according to the intensity of pain and your individual sensitivity to pain. Generally, the lowest effective dose that relieves pain should be used.
The usual dose for adults and children over 12 years of age is 50–100 mg of tramadol (20 or 40 drops), taken 3–4 times daily.
The maximum recommended daily dose of PRONTALGIN Drops is generally 400 mg (160 drops).
For acute pain, an initial dose of 100 mg is generally required.
If you are taking PRONTALGIN Drops for acute pain, you should know that the effect begins somewhat later compared to other pain-relieving medications.
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 aged between 12 and 14 years, the lowest recommended dose should be used.

Elderly patients
In elderly individuals (over 75 years of age), elimination of tramadol may be delayed. If this applies to you, your doctor may advise you to increase the time interval between doses.

Patients with severe liver or kidney disease / dialysis
Patients with severe hepatic and/or renal impairment must not take PRONTALGIN Drops. In cases of mild or moderate impairment, your doctor may recommend increasing the interval between doses. If you have liver or kidney problems, discuss this with your doctor, who will likely adjust your dose or switch you to another pain reliever.

Mix the drops in a glass of water and drink the entire contents.
The medication may be taken before, during, or after meals.
Your doctor will inform you how long you should take PRONTALGIN Drops.
If you feel that the effects of PRONTALGIN Drops are too strong or too weak, consult your doctor or pharmacist.

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

If you forget to take PRONTALGIN Drops
If you miss a dose, your pain may return. Do not take a double dose to make up for the missed dose. Take the next dose as scheduled.

If you stop taking PRONTALGIN Drops
Do not stop taking this medicine abruptly unless instructed by your doctor. If you intend to discontinue treatment, speak 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, which may involve gradually reducing the dose to minimize the risk of unnecessary adverse effects (withdrawal symptoms). These symptoms may include: anxiety, excessive sweating, insomnia, chills, pain, nausea, tremors, diarrhea, upper respiratory tract symptoms, piloerection (hair standing on end), and, in rare cases, hallucinations.

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

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, PRONTALGIN Drops may cause adverse effects, although not everyone experiences them.
If any of the following conditions occur, contact your doctor immediately:

Allergic reactions, such as breathing difficulties, wheezing, skin swelling (rarely observed),
Swelling of the face, tongue and/or throat and/or difficulty swallowing or hives accompanied by breathing difficulties (rarely observed),
Shock/sudden circulatory failure (rarely observed).

The frequency of adverse effects is usually classified as follows:

very common (more than 1 in 10 people),
common (more than 1 in 100 people),
uncommon (more than 1 in 1,000 people),
rare (more than 1 in 10,000 people),
very rare (less than 1 in 10,000 people),
not known (frequency cannot be estimated from the available data).

The most common adverse effects during treatment with PRONTALGIN Drops are nausea and dizziness, occurring in more than 1 in 10 patients.
Cardiac and vascular disorders
Uncommon: effects on the heart and blood circulation (palpitations, rapid heartbeat, sensation 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, epileptic seizures, muscle spasms, lack of coordination of movements, transient loss of consciousness (syncope).
Slowed breathing may occur if recommended doses are exceeded or if other medicines that depress brain function are taken simultaneously.
Epileptic seizures have mainly occurred with high doses of tramadol or when tramadol was taken concomitantly with other medicines that may provoke seizures.
Psychiatric disorders
Rare: hallucinations, confusion, sleep disturbances, anxiety, and nightmares. Psychological disturbances may occur after treatment with PRONTALGIN Drops and may vary in intensity and nature (depending on the patient's personality and duration of therapy). They may manifest as mood changes (usually euphoria, occasionally irritability), changes in activity levels (usually slowing down, but occasionally increased activity), and reduced awareness and decision-making ability, which may lead to impaired judgment.
Dependence may 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, reduced urine output compared to normal.
Systemic disorders
Common: fatigue, tiredness, weakness, lack of energy.
Withdrawal symptoms may occur if treatment is abruptly discontinued (see "If you stop taking PRONTALGIN Drops").
Metabolism and nutrition disorders
Not known: decreased blood sugar levels.
A few cases of speech disturbances and pupil dilation have been reported.
If any of the adverse effects worsens, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

5. HOW TO STORE PRONTALGIN DROPS

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

6. OTHER INFORMATION

What PRONTALGIN Drops contains

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

What PRONTALGIN Drops looks like and contents of the pack

PRONTALGIN Drops is supplied in packages containing a 10 ml amber glass bottle with a dropper 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, Italy

Manufacturer:
DELPHARM Tours
La Baraudière
37170 Chambray Lès Tours, FRANCE

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: PRONTALGIN Drops
Netherlands: THERADOL Drops

This leaflet was last approved in 01/2019