CREADOL+ Tablet

Only for adults and adolescents over 12 years.

This medicine is a combination of two analgesics, which act together to relieve pain.

It is intended for use in the treatment of moderate to severe pain when doctor recommends that a combination of tramadol and paracetamol is needed.

Posology

Usual starting dose is 2 tablets.

If required, further doses may be taken, as recommended by your doctor.

The shortest time between doses must be at least 6 hours.

Do not take more than 8 tablets per day.

Way of administration

Oral route.

Swallow the tablets whole with sufficient liquid. They should not be broken or chewed.

- if you have an allergic reaction (for instance skin rash, swelling of the face, wheezing or difficulty breathing) after taking tramadol or paracetamol or any of the ingredients of this medicine,

- in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions),

- if you are also taking MAO inhibitors (certain medicines used for treatment of depression of Parkinson’s disease) or have taken them in the last 14 days before treatment with CREADOL+,

- if you suffer from a severe liver disorder,

- if you have epilepsy that is not adequately controlled on your current medicine.

Very common: nausea, dizziness, drowsiness.

Common: vomiting, digestion problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth, itching, sweating, headache, shaking, confusion, sleep disorders, mood changes (anxiety, nervousness, a feeling of high spirits).

Uncommon: increase in pulse or blood pressure, heart rate or heart rhythm disorders, difficulty or pain on passing water, skin reactions (for example rashes, hives), tingling, numbness or feeling of pins and needles in the limbs, ringing in the ear, involuntary muscle twitching, depression, nightmares, hallucinations (hearing, seeing or sensing things that are nor really there), memory lapses, difficulty swallowing, blood in the stools, shivering, hot flushes, pain in the chest, difficulty breathing.

Rare: fits, difficulties in carrying out coordinated movements, addiction, blurred vision.

In rare cases, using a medicine of the type of tramadol may make you become dependent on it, making it hard to stop taking it.

On rare occasions, people who have taking tramadol for some time may feel unwell if they stop treatment abruptly.

They may feel agitated, anxious, nervous or shaky. They may be hyperactive, have difficulty sleeping and have stomach or bowel disorders.

Very few people may also get panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and noise in the ears (tinnitus).

In exceptional cases blood tests may reveal certain abnormalities, for instance, low counts of blood platelets, which may result in nose bleeds or bleeding gums.

Use CREADOL+ together with medicines used to thin the blood (example: phenprocoumon, warfarin) may increase the bleeding risk. Any prolonged or unexpected bleeding should be reported to your doctor immediately.

- You must not take this medicine together with monoamine oxidase inhibitors (MAOs).

CREADOL+ is not recommended to be taken with the following:

- Carbamazepine (a medicine commonly used to treat epilepsy or some types of pain such as severe pain attacks in the face called trigeminal neuralgia).

- Buprenorphine, nalbuphine or pentazocine (opioid-type pain relievers). The pain-relieving effect may be reduced.

The risk of side effects increases, if you also take:

- Triptans (for migraine) or selective serotonin re-uptake inhibitors, “SSRIs” (for depression). If you experience confusion, restlessness, fever, sweating, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles or diarrhoea you should call your doctor,

- Tranquillizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), baclofen (a muscle relaxant), medicines used to lower blood pressure, antidepressants or medicines to treat allergies. You may feel drowsy or feel faint. If this happens, tell your doctor,

- Antidepressants, anaesthetics, neuroleptics (medicines that affect the state of mind) or bupropion (to help stop smoking). The risk having a fit may increase. Your doctor will tell you whether CREADOL+ is suitable for you,

- Warfarin or pheprocoumon (for blood thinning). The effectiveness of such medicines may be altered and bleeding may occur. Any prolonged or unexpected bleeding should be reported to your doctor immediately.

The effectiveness of CREADOL+ may be altered if you also take:

- metoclopramide, domperidone or ondansetron (medicines for treatment of nausea and vomiting),

- cholestyramine (medicine to reduce cholesterol in the blood),

- ketoconazole or erythromycin (medicines against infections).

This medicine should not be taken during pregnancy and breast-feeding.

If you become pregnant during treatment. please consult your doctor before taking any further tablets.

Take special care with CREADOL+ if you:

- take other medicines containing paracetamol or tramadol,

- have liver problems or liver disease or if you notice your eyes and skin turning yellow. This may suggest jaundice or problems with your bile ducts,

- have kidney problems,

- have severe difficulties in breathing for example asthma or severe lung problems,

- have epilepsy or have already experienced fits or seizures,

- have recently suffered from a head injury, shock or severe headaches associated with vomiting,

- are dependent on any medicines including those used to relieve pain, for example morphine,

- take other medicines to treat pain that contain buprenorphine, nalbuphine or pentazocine,

- are going to have an anaesthetic.