The active ingredients per tablet are 37,5 milligrams of tramadol hydrochloride and 325 milligrams of paracetamol.

The other ingredients (excipients) are: powdered cellulose, pregelatinised starch, sodium starch glycolate, maize starch and magnesium stearate. Film-coating: hypromellose, titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172), polysorbate 80 and carnauba wax.

WHAT IS ZALDIAR

ZALDIAR comes in the form of film-coated tablets. Each pack contains 20 tablets. ZALDIAR is indicated for the symptomatic treatment of moderate to severe pain in adults and children over 12 years of age.

BEFORE TAKING ZALDIAR

Do not take ZALDIAR if you:

• Have had allergic reactions (skin rash, swelling of the face, wheezing or difficulty breathing) after taking tramadol or paracetamol or any of the other ingredients in this medication.
• Have drunk alcohol.
• Have taken any medication for the treatment of insomnia, potent analgesics (opioids), or psychotropic drugs (medications that may alter the level of consciousness).
  
• Are taking certain antidepressants (monoamine oxidase inhibitors, MAOIs), or have taken any within the last two weeks.
• Suffer from severe hepatic impairment.
• Suffer epilepsy not controlled by treatment.

Take special care with ZALDIAR:

• If you are epileptic or have experienced fits or seizures.
• If you have suffered from a head injury, severe headaches associated with vomiting and / or difficulty breathing.
• If you are dependent on any other medication used to relieve moderate to severe pain, for example, morphine.
• If you have had an allergic reaction when using other medications used to relieve moderate to severe pain.
• If you have kidney or liver problems.
• If you have important respiratory problems.
• If you are taking other medications used to treat pain, such as nalbuphine, buprenorphine or pentazocine (see section: "Taking other medications").

If you develop any of these symptoms while you are taking ZALDIAR, please tell your doctor. He/she can then decide whether you should continue to use this medication.

Taking ZALDIAR with food and drink:

You should not drink alcohol while taking this medication.

Pregnancy and lactation:

The use of this medication during pregnancy and lactation is not recommended. If it is necessary to take ZALDIAR, your doctor will determine the convenience of using it or not.

Children:

ZALDIAR should not be administered to children below the age of 12 years.

Elderly:

In patients over 75 years old, it is recommended that the minimum interval between doses should be more than 6 hours.

Driving and using machinery:

ZALDIAR may cause drowsiness and dizziness; therefore patients should not drive or operate machinery when taking this medication.

Taking other medications:

It is important that you tell your doctor or pharmacist if you are taking or have recently taken any other medications, including any you have bought without a prescription. Certain medications may interact with ZALDIAR, in some cases it may be necessary to adjust the dose or discontinue treatment with one of the medications. The administration of ZALDIAR is contraindicated with:

• - medications used to treat depression, known as monoamine oxidase inhibitors (MAOIs), for example, iproniazide, moclobemide and toloxatone (see section: "Do not take ZALDIAR if").

The concomitant treatment of ZALDIAR should be avoided with:

• alcohol, because it may increase drowsiness;
  
• a medication called carbamazepine, because it may reduce the effect of ZALDIAR;
  
• medications known as opioids (buprenorphine, nalbuphine and pentazocine), because it can increase the risk of respiratory disorders.

Caution should be exercised when taking ZALDIAR with some of the following medications:

• Certain morphine-like medications, sedatives (for example, benzodiazepines), sleeping pills, (for example, barbiturates), some medications used to lower blood pressure, thalidomide and baclofen (a muscle relaxant), because of the risk of decreasing the level of consciousness.
• Bupropion (a medication used to help people to stop smoking), serotonin re-uptake inhibitors (SRIs), tricyclic antidepressants and tranquillisers, because they may increase the risk of convulsions.
• Warfarin (a medication used to prevent blood clots), due to the increased anticoagulant effect of warfarin with risk of bleeding.
• CYP3A4 inhibitors (such as, ketoconazole and erythromycin), because they might inhibit the metabolism of tramadol and increase its plasma concentration and therefore, its adverse effects.

Your doctor will know which medications are safe to take with ZALDIAR.

HOW TO TAKE ZALDIAR

Follow these instructions unless otherwise specified by your doctor.
Remember to take your medication.
ZALDIAR is administered orally. The tablets must be swallowed with some liquid. They should not be broken or chewed.
The usual starting dose in adults is two tablets. Additional doses can be taken, as recommended by your doctor, not exceeding 8 tablets per day. Do not take ZALDIAR more often than your doctor has told you to. The shortest time between doses must be at least 6 hours.
If you have been using this medication for a long period of time, you may become dependent on it, making it difficult to stop taking it, or your body may get used to it, reducing its efficacy. Never take more of this medication than recommended by your doctor, because it may cause liver problems.
Your doctor will indicate the duration of your treatment with ZALDIAR. The tablets should be taken for as short a time as possible.
If you are aged over 75 years or have kidney problems, your doctor may increase the time between doses.
If you think that the effect of ZALDIAR is too strong or too weak, contact your doctor or pharmacist.

If you forget to take ZALDIAR:

If you forget to take a dose of ZALDIAR, take your next tablet as usual; do not take a double dose to make up for forgotten individual doses.

Effects that may appear when the treatment with ZALDIAR is stopped:

If you have been using ZALDIAR for some time, you should talk to your doctor if you want to discontinue treatment. If you suddenly stop using ZALDIAR you may experience anxiety, agitation, somnolence, tremors and gastrointestinal symptoms.

If you take more ZALDIAR than you should:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Go to the nearest hospital Accident and Emergency Department and tell them what you have taken.

POSSIBLE SIDE EFFECTS

As with any medication, ZALDIAR may cause some unwanted effects. If you are worried about the side effects, talk to your doctor. The most serious adverse effects reported are: hypertension, tachycardia, arrhythmia, convulsion, dyspnoea and bleeding in the intestine (melaena). The most commonly reported adverse effects are:

• nausea
• dizziness
• somnolence

These effects were observed in more than 10% of the patients treated with ZALDIAR. Most were usually mild and not troublesome. 1 - 10% of patients may experience:

Vomiting, constipation, flatulence, diarrhoea, stomach pain, digestion problems, a dry mouth, headache, agitation, confusion, sleep disorders, mood changes, anxiety, nervousness, euphoria (a sense of feeling 'high' all the time), increased sweating, itching. 0,1 - 1% of patients may develop:

Heart rhythm and heart rate disorders, changes in blood pressure, difficulty or pain on passing urine/ protein in the urine, skin reactions/ urticaria, ringing in the ear, depression, nightmares, hallucinations (hearing, seeing or sensing things that are not really there), loss of memory, difficulty swallowing, blood in the stools, shivers, hot flushes, pains in the chest, uncoordinated movement, muscle cramps, unusual tingling feeling, convulsions, drug dependence, blurred vision, shortness of breath, raised liver enzymes. Do not be alarmed by the above lists - you may not experience any of these effects. However, if you do notice any of these effects, or any other unusual symptoms, please tell your doctor or pharmacist as soon as possible. The following are recognized side effects, which have been reported by people using medications that contain only tramadol or only paracetamol. However, if you experience any of these while taking ZALDIAR, you should tell your doctor:

Tramadol:

• Feeling faint when getting up from a lying or sitting position
• Slow heart rate
• Fainting
• Mood changes, changes in activity
• Allergic reactions, such as itching, swollen face or lips, or shortness of breath,
• Changes in appetite, weakness, difficulty breathing,
• Agitation, anxiety, nervousness, sleep disorders, hyperactivity, tremors and gastrointestinal symptoms.
• Worsening of existing asthma.

Paracetamol:

• Allergic reactions with rash
• Thrombocytopenia, where the number of platelets in the blood is reduced or agranulocytosis which is characterized by the decrease or absence of leukocytes
• A deficiency of prothrombin in the blood

If you notice any other reaction not mentioned in this leaflet, consult your doctor or pharmacist.

STORAGE OF ZALDIAR

There are no special storage conditions. Keep out of reach and sight of children.

Expiry:

Do not use ZALDIAR after the expiry date indicated on the pack or if the pack is damaged.