Tramadol HCl/Paracetamol CF 37,5 mg / 325 mg, filmomhulde tabletten

Tramadol/Paracetamol CF is a combination of two analgesics tramadol hydrochloride and paracetamol. Tramadol/Paracetamol CF is used for the treatment of moderate to severe pain. Your doctor will prescribe you this medicine if he decides that a combination of tramadol hydrochloride and paracetamol is recommended.

Tramadol/Paracetamol CF should only be taken by adults and adolescents over 12 years.

Do not take Tramadol/Paracetamol CF

• If you are allergic (hypersensitive) to tramadol, paracetamol or any of the other ingredients in this medicine (see list of ingredients in Section 6).
• In case of acute alcohol poisoning.
• If you are taking sleeping pills, pain relievers or medicines that affect mood and emotions.
• If you are also taking medicines called monoamine oxidase inhibitors (MAOIs) or within two weeks after you have stopped the treatment. MAOIs are used in the treatment of depression or Parkinson’s disease.
• If you suffer from severe liver disease.
• If you suffer from epilepsy that is not adequately controlled by your current medicine.

Take special care with Tramadol/Paracetamol CF Tell your doctor:

• If you take other medicines containing paracetamol or tramadol
• If you have severe kidney problems. In this case the use of Tramadol/Paracetamol CF is not recommended. In cases of moderate kidney problems, the interval between doses should be increased to 12 hours.
• If you have liver problems or disease as your eyes and skin may turn yellow, which may suggest jaundice.
• If you have severe difficulties in breathing, for example asthma or severe lung problems.
• If you are dependent on any medicine (for example morphine).
• If you have recently suffered from a head injury, shock or severe headaches associated with vomiting (being sick).
• If you have epilepsy or have already experienced fits or seizures.
• If you are in a reduced consciousness for unknown reasons.
• If you are going to have an anaesthetic. Tell your doctor or dentist that you are taking Tramadol/Paracetamol CF

In all cases described above, this medicine should only be used with caution.

Tramadol must not be taken as a substitute therapy in opioid-dependent patients, since it does not suppress morphine withdrawal symptoms.

Tramadol can cause convulsions even at the recommended doses. Epileptic patients controlled by a treatment, or those susceptible to fits or seizures should therefore not be treated with Tramadol/Paracetamol CF unless absolutely necessary.

Children

Treatment with Tramadol/Paracetamol CF is not recommended in children under the age of 12 years. The efficacy and safety of use in children has not been established.

Abuse

At therapeutic doses, tramadol may cause withdrawal symptoms. Rarely, cases of dependence and abuse have been reported.

Taking other medicines

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

Important: This medicine contains paracetamol and tramadol. Tell your doctor if you are taking any other medicine containing paracetamol or tramadol, so that you do not exceed the maximum daily doses.

Tramadol/Paracetamol CF must not be taken in combination with: MAO inhibitors (used in the treatment of depression or Parkinson’s disease), since there is a risk of getting serotoninergic syndrome. Symptoms of serotoninergic syndrome include diarrhoea, increased heartbeat, sweating, tremor, confusion and even coma. In case of recent treatment with MAO inhibitors, you have to maintain a delay of two weeks before you start the treatment with tramadol.

Tramadol/Paracetamol CF should not be taken in combination with:

• Carbamazepine (a medicine used to treat epilepsy or some types of pain). If you take these medicines simultaneously the efficacy and the duration of effect of tramadol will be reduced.
• Painkillers (buprenorphine, nalbuphine, pentazocine). If you take these medicines simultaneously the painrelieving effect of Tramadol/Paracetamol CF is reduced, with the risk of occurrence of withdrawal syndrome.

Furthermore Tramadol/Paracetamol CF should not be taken in combination with:

• Certain antidepressants and triptans used for migraine. Tramadol/Paracetamol CF may interact with these medicines and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38 °C
• Other opioid derivatives (including cough medicines and substitutive treatments), barbiturates and benzodiazepines (sedatives). If you take these medicines simultaneously the risk of respiratory depression can increase, which can be fatal in cases of overdose.
• Other central nervous system depressants, anxiolytics (used to lower fear), hypnotics, sedative antidepressants, sedative anti-histamines (used to treat allergies), neuroleptics (used to treat pyschosis), centrallyacting antihypertensive medicines (used to lower blood pressure), thalidomide (a sedative) and baclofen (a muscle relaxant). These medicines may cause worsening of central depression. The effect on alertness may make driving vehicles and using machines dangerous.
• Warfarin-like medicines (used for blood thinning). Your doctor might have to evaluate prothrombin time regularly.
• Other medicines known to inhibit the liver enzyme “CYP3A4”, such as ketoconazole and erythromycin.
• Medicines which reduce the seizure threshold, such as bupropion, serotonin reuptake inhibitor antidepressants, tricyclic antidepressants and neuroleptics. If you take tramadol together with these medicinal products the risk of convulsions may increase.
• Metoclopramide or domperidone (medicines used to treat nausea and vomiting/being sick). The absorption of paracetamol may be increased if you take these medicines simultaneously.
• Cholestyramine (medicine used to reduce cholesterol in the blood), since the absorption of Tramadol/Paracetamol CF may be reduced.

If you have taken ondansetron (used to treat nausea) the effectiveness of Tramadol/Paracetamol CF may be altered.

Taking Tramadol/Paracetamol CF with food and drink

Tramadol/Paracetamol CF can be taken with or without food. You should not drink any alcohol during the treatment, since alcohol increases the sedative effect of Tramadol/Paracetamol CF.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not use this medicine during pregnancy.

The long-term treatment during pregnancy may result in withdrawal symptoms in the newborn, as a consequence of habituation.

Breast-feeding

This medicine is excreted into human breast milk. You should not take this medicine while you are breast-feeding, as small amounts of tramadol may pass into the breast-milk.

Driving and using machines

This medicine may cause drowsiness or dizziness, which may be enhanced by alcohol or other depressants, which react with the central nervous system. If you feel drowsy or dizzy you should not drive or use machines.

Always take Tramadol/Paracetamol CF exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is:

Adults and adolescents (aged 12 years or over):

• Your doctor will adjust the dose individually according to the severity of your pain and your response. In general the lowest pain-relieving dose should be taken.
• A starting dose of 1 tablet in the morning and 1 tablet in the evening is recommended. The interval between two administrations should not be less than 6 hours.
• If necessary, you can take more tablets per day, but you should not exceed the maximum daily dose of 8 tablets (equivalent to 300 mg of tramadol and 2600 mg of paracetamol) and you should not take other medicines containing paracetamol or tramadol hydrochloride in order to avoid overdose.

Elderly Patients (over 65 years):

• The usual doses as recommended for adults and adolescents may be used.
• In patients over 75 years of age, it is recommended that the interval between the doses is not less than 6 hours, owing to the presence of tramadol.

Severe liver or kidney disease (insufficiency)/dialysis patients:

Patients with severe liver and/or kidney insufficiency should not take Tramadol/Paracetamol CF. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.”

Method of administration

• You have to take the tablets orally.
• You should swallow the tablets whole, with a sufficient quantity of liquid (e.g. a 200 ml glass of water). The tablets should not be broken or chewed.

Duration of treatment

You should not take this medicine for longer than strictly necessary.

If repeated or prolonged treatment with this medicine is required (owing to the nature and severity of the disorder), careful, regular monitoring should be carried out to assess whether the treatment needs to be continued. Whenever possible, breaks in the treatment should be included during long-term treatment.

If you take more Tramadol/Paracetamol CF than you should

• If you have taken more tablets than you should, you must contact your doctor or the nearest emergency department immediately.
• In case of an overdose, you may experience nausea (feeling sick), miosis (pupil constriction), vomiting (being sick), anorexia (less appetite), abdominal pain, cardiovascular collapse, consciousness disorders including coma, convulsions and respiratory depression which can cause respiratory arrest.
• Liver damage may appear 12 or 48 hours after ingestion. In severe poisoning, liver failure may lead to severe brain disease (encephalopathy), coma and death. Acute kidney failure with tubular necrosis (cell destruction) may develop, even in the absence of severe liver damage. Cardiac arrhythmias (irregular heartbeat) and pancreatitis (inflammation of the pancreas) have also been reported.

If you forget to take Tramadol/Paracetamol CF

If you forget to take this medicine you can skip the missed dose and continue the treatment as normal, or you can take the missed tablet but have to keep a 6 hour interval to the next intake. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Tramadol/Paracetamol CF

Do not stop taking this medicine without consulting your doctor.

If therapy is no longer necessary the treatment should be stopped by gradually reducing the dose to prevent withdrawal symptoms.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side-effects are very common (affects more than 1 user in 10):

• dizziness, somnolence,
• feeling sick.

The following side-effects are common (affects 1 to 10 users in 100):

• confusion, mood changes (anxiety, nervousness, elation), sleep disorders,
• headache, shiver,
• vomiting (being sick), constipation, dry mouth, diarrhoea, abdominal pain, indigestion, flatulence,
• sweating, itching.

The following side-effects are uncommon (affects 1 to 10 user in 1,000):

• depression, hallucinations, nightmares, memory loss,
• involuntary muscular contractions, tingling or numbness, ringing in the ears,
• high blood pressure, palpitations, fast heartbeat, irregular heartbeat,
• laboured breathing,
• difficulty in swallowing, blood stained stools,
• elevated transaminase (a liver enzyme) levels,
• skin reactions (e.g. rash, urticaria),

• albuminuria (albumin (a protein) in the urine), urination disorders (dysuria, urinary retention),
• shivers, hot flushes, chest pain.

The following side-effects are rare (affects 1 to 10 users in 10,000):

• drug dependence,
• lack of coordination, fits (seizures),
• blurred vision.

The following side-effects are very rare (affects less than 1 user in 10,000):

• abuse.

The following are recognised side effects which have been reported by people using medicines that contain only tramadol or only paracetamol. However, if you experience any of these while taking Tramadol/Paracetamol CF , you should tell your doctor:

• worsening of asthma.
• feeling faint when getting up from a lying or sitting position, slow heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, changes in perception, worsening of existing asthma.
• In some rare cases a skin rash, indicating an allergic reaction, may develop with sudden swelling of the face and neck, difficulties breathing or drop of blood pressure and fainting. If this happens to you, stop treatment and see a doctor immediately. You must not

take the medicine again.

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 been 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).

If you experience any of these complaints after stopping Tramadol/Paracetamol CF , please consult your doctor.

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 of Tramadol/Paracetamol CF together with medicines used to thin the blood (e.g. phenprocoumon, warfarin) may increase the bleeding risk. Any prolonged or unexpected bleeding should be reported to your doctor immediately.

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

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the blister pack and on the carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Tramadol/Paracetamol CF contains

• The active substances are: 37.5 mg tramadol hydrochloride and 325 mg paracetamol.
• The other ingredients are:Film-coated tablet core: Pre-gelatinised Starch Maize Starch Sodium Starch Glycolate (Type A) Microcrystalline cellulose (Avicel PH 102) Magnesium stearate Film-coating: Opadry yellow 03K82345 (Hypromellose 6 cPs (E464), Titanium dioxide (E171), Triacetin, Iron oxide yellow (E172))

What Tramadol/Paracetamol CF looks like and contents of the pack

Light yellow, oblong, biconvex, film-coated tablet.

Cartons containing 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Centrafarm B.V.

Nieuwe Donk 3

4879 AC Etten-Leur

Nederland

In het register ingeschreven onder

Tramadol HCl/Paracetamol CF 37,5 mg/325 mg, filmomhulde tabletten RVG 112492

This medicinal product is authorised in the Member States of the EEA under the following names:

[To be completed nationally]

This leaflet was last approved in februari 2013.