Indication
The active ingredients Zaldiar of 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.
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.

Special Precautions
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 Zaldiar.
Pregnancy and lactation:
The use of Zaldiar 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.
Zaldiar should not be administered to children below the age of 12 years.

Drugs interaction:
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").
You should avoid:

• 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.

Missed dose
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.

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

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:

Storage
There are no special storage conditions. Keep out of reach and sight of children. Do not use ZALDIAR after the expiry date indicated on the pack or if the pack is damaged.

Disclaimer
Always read informational leaflet before using medicine! The information can be changed and completed!!

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