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Package leaflet: information for the user

Tramadol/Paracetamol Xantis 75 mg/650 mg tablets hydrochloride/paracetamol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet 1. What Tramadol/Paracetamol Xantis 75 mg/650 mg is and what it is used for 2. What you need to know before you take Tramadol/Paracetamol Xantis 75 mg/650 mg 3. How to take Tramadol/Paracetamol Xantis 75 mg/650 mg 4. Possible side effects 5. How to store Tramadol/Paracetamol Xantis 75 mg/650 mg 6. Contents of the pack and other information

1. What Tramadol/Paracetamol Xantis 75 mg/650 mg is and what it is used for

Tramadol/Paracetamol Xantis 75 mg/650 mg is composed of two relieving active substances, tramadol and paracetamol. Tramadol/Paracetamol Xantis 75 mg/650 mg is used to treat moderate to severe pain when your doctor recommends that a combination of tramadol and paracetamol is needed.

Tramadol/Paracetamol Xantis 75 mg/650 mg is indicated for adults, adolescents and children over 12 years of age.

2. What you need to know before you take Tramadol/Paracetamol Xantis 75 mg/650 mg

Do not take Tramadol/Paracetamol Xantis 75 mg/650 mg • if you are allergic to tramadol, paracetamol or any of the other ingredients of this medicine (listed in section 6) • in cases of acute poisoning with , sleeping pills, pain relievers or psychotropic (that affect mood, emotions and state of mind) • if you are taking medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the last 14 days before treatment with Tramadol/Paracetamol Xantis 75 mg/650 mg (MAOIs are used to treat depression or Parkinson’s disease) • if you have a severe disorder • if you have epilepsy that is not adequately controlled by your current medicine

Warnings and precautions Talk to your doctor before taking Tramadol/Paracetamol Xantis 75 mg/650 mg - if you take other medicines containing also active substances paracetamol or tramadol - if you have liver disease, or your eyes and skin turn yellow, which may suggest - if you have problems - if you have severe difficulties with breathing, for example or severe lung problems - if you have epilepsy or have already experienced fits or seizures - if you have recently suffered from a head injury, shock or severe associated with (being sick) - if you think you are addicted to other , for example 1

- if you take other medicines to treat pain that contain , or - if you are going to have an anaesthetic administered (tell your doctor or dentist that you are taking Tramadol/Paracetamol Xantis 75 mg/650 mg)

Should any of these problems occur during the treatment with Tramadol/Paracetamol Xantis 75 mg/650 mg or has it occurred in the past, inform your doctor.

Please, pay attention to the fact that the active substance tramadol may induce physical or psychic dependence. The effect of tramadol may diminish with long-term use (the development of tolerance) and an increase in dosage may be needed. A treatment by Tramadol/Paracetamol Xantis 75 mg/650 mg of patients with -abusing tendencies or drug-dependent patients should be only for a short term under strict medical supervision.

Children Tramadol/Paracetamol Xantis 75 mg/650 mg is not recommended for children under 12 years.

Other medicines and Tramadol/Paracetamol Xantis 75 mg/650 mg Tell your doctor if you are taking, have recently taken or might take any other medicines.

Tramadol/Paracetamol Xantis 75 mg/650 mg contains paracetamol and tramadol. Tell your doctor if you take any other medicine containing also paracetamol or tramadol. Do not exceed the total maximum daily doses of paracetamol or tramadol from this or other medicines (see section 3).

Do not take Tramadol/Paracetamol Xantis 75 mg/650 mg with MAOIs (see section Do not take Tramadol/Paracetamol Xantis 75 mg/650 mg).

Tramadol/Paracetamol Xantis 75 mg/650 mg is not recommended with the following medicines - (a medicine used to treat epilepsy or some types of pain) - buprenorphine, nalbuphine or pentazocine ( type pain relievers), their pain relieving effect may be decreased

Tramadol/Paracetamol Xantis 75 mg/650 mg may increase the risk of side effects if you also take the following medicines - certain antidepressants (such as selective serotonin re-uptake inhibitors, SSRIs) and (used for ). Tramadol/Paracetamol Xantis 75 mg/650 mg 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. - tranquilizers, sleeping pills, other pain relievers such as morphine and (also as cough medicine), baclofen (a ), medicines used to lower or medicines to treat allergies. Check with your doctor if you feel drowsy or faint. - medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics (medicine affecting your state of mind) or bupropion (medicine used to stop smoking). The risk of having a fit may increase if you take Tramadol/Paracetamol Xantis 75 mg/650 mg at the same time. Your doctor will tell you whether Tramadol/Paracetamol Xantis 75 mg/650 mg is suitable for you. - or phenprocoumon (for blood thinning). The effectiveness of such medicines may be altered and bleeding may occur (see section 4). Inform your doctor about any prolonged or unexpected bleeding.

The effectiveness of Tramadol/Paracetamol Xantis 75 mg/650 mg may be also altered if you take concomitantly the following medicines - , domperidone or ondansetron (medicines used to treat and vomiting/being sick) - cholestyramine (medicine used to reduce cholesterol in the blood) - ketoconazole or erythromycin (medicines used against infections).

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Tramadol/Paracetamol Xantis 75 mg/650 mg with food, drink and alcohol Do not drink alcohol while you are taking Tramadol/Paracetamol Xantis 75 mg/650 mg because you can feel sleepy.

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. Tramadol/Paracetamol Xantis 75 mg/650 mg should not be taken during or breast-feeding.

Driving and using machines Tramadol/Paracetamool Xantis 75 mg/650 mg may make you feel sleepy. If you feel drowsy while taking Tramadol/Paracetamol Xantis 75 mg/650 mg, do not drive, use tools or use machinery.

3. How to take Tramadol/Paracetamol Xantis 75 mg/650 mg

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take Tramadol/Paracetamol Xantis 75 mg/650 mg for as short time period as possible and no longer than your doctor has told you. The dosage should be adjusted to the intensity of your pain and your individual pain sensitivity. In general the lowest pain-relieving dose should be taken.

Adults, adolescents and children over 12 years of age - The recommended dose is 1 tablet, unless otherwise prescribed by your doctor. If required, further doses may be taken, as instructed by your doctor. - Tablet can be divided into equal doses. - Swallow the tablets with sufficient liquid. - The shortest time between doses must be at least 6 hours. - Do not take more than 4 tablets per day.

If you think that the effect of Tramadol/Paracetamol Xantis 75 mg/650 mg is too strong (you feel very drowsy or have difficulty breathing) or too weak (you do not have enough pain relief), contact your doctor.

Use in children Tramadol/Paracetamol Xantis 75 mg/650 mg is not recommended in children under 12 years of age.

Elderly In elderly (above 75 years) the of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosage interval.

Severe liver or (insufficiency)/dialysis patients Patients with severe liver and/or kidney insufficiency should not take Tramadol/Paracetamol Xantis 75 mg/650 mg. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

If you take more Tramadol/Paracetamol Xantis 75 mg/650 mg than you should In case of overdose or accidental taking this medicine by children see immediately your doctor or the nearest hospital and tell them precisely what amount of this medicine was taken. Take all the remaining tablets and this package leaflet to your doctor. Overdose with paracetamol may cause serious impairment progressing to failure of liver function that may lead to death.

If you forget to take Tramadol/Paracetamol Xantis 75 mg/650 mg If you forget to take the tablets, pain is likely to return. Do not take a double dose to make up for a forgotten dose, simply continue taking the tablets as before.

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If you stop taking Tramadol/Paracetamol Xantis 75 mg/650 mg If you discontinue or abruptly interrupt the treatment with Tramadol/Paracetamol Xantis 75 mg/650 mg, the pain is likely to reappear. If you wish to discontinue the treatment due to the unpleasant side effects of the product, consult your doctor.

The discontinuation of treatment with Tramadol/Paracetamol Xantis 75 mg/650 mg is not usually followed by withdrawal symptoms. After a discontinuation of long-term treatment, however, symptoms such as restlessness, anxiety, nervousness, panic attacks, hallucinations, unusual sensory sensations (itching, tingling and loss of sensation), tinnitus, insomnia, tremors or gastrointestinal symptoms may occur in some patients. Please contact your doctor, if any of these symptoms occur following the discontinuation of Tramadol/Paracetamol Xantis 75 mg/650 mg.

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

4. Possible side effects

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

Some side effect could be serious. Stop taking Tramadol/Paracetamol Xantis 75 mg/650 mg and see a doctor immediately if any of the following symptoms occur: - swelling of your face, lips or throat, swallowing or breathing difficulties or drop in blood pressure and fainting. Rash or pruritus can also appear. This can indicate that you have a serious allergic reaction - prolonged or unexpected bleeding in case you use concomitantly Tramadol/Paracetamol Xantis 75 mg/650 mg and medicines for blood thinning (warfarin or phenprocoumon) - severe skin reactions, including redness, blisters and skin peeling

Additionally, following side effects can occur during the treatment with Tramadol/Paracetamol Xantis 75 mg/650 mg:

Very common side effects (may affect more than 1 in 10 people) - nausea (being sick) - dizziness, drowsiness

Common side effects (may affect up to 1 in 10 people) - vomiting - digestion problems (constipation, flatulence, diarrhea) - stomach pain - dry mouth - itching - sweating - - shaking - confusion - disorders - mood changes (anxiety, nervousness, feeling of high spirits)

Uncommon side effects (may affect up to 1 in 100 people) - increase in pulse or blood pressure - heart rate or heart rhythm disorders - difficulty or pain during urinating - skin reactions (for example rashes, hives) - tingling, numbness or feeling of pins and needles in the limbs - ringing in the ears - involuntary muscle twitching - depression 4

- nightmares - hallucinations (hearing, seeing or sensing things that are not really there) - memory lapses - difficulty swallowing - blood in the stools - shivering - hot flushes - pain in the chest - difficulty breathing - increased liver - albumin (protein) in urine

Rare side effects (may affect up to 1 in 1,000 people) - fits - uncoordinated movements - addiction, delirium - blurred vision - miosis (constriction of the pupil) - mydriasis (dilatation of the pupil) - speech disorder - short-term loss of consciousness (syncope)

Very rare (may affect up to 1 in 10,000 people) - drug abuse

Not known (frequency cannot be estimated from the available data) - decrease in blood sugar level

In addition, the following side effects have been reported by people using medicines that contain only tramadol or only paracetamol: - 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 - very rare cases of serious skin reactions - nose bleeds or bleeding gums, which may result from a low blood platelet count - withdrawal symptoms – set of symptoms occurring after abrupt discontinuation of treatment or decrease of the dose, such as restlessness, anxiety, nervousness, sleep problems, hyperactivity, tremors or gastrointestinal symptoms. Very rare have been reported panic attacks, serious restlessness, hallucinations (auditory, visual and tactile sensations that are not real), lack of skin, tinnitus or unusual signs or central nervous system.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tramadol/Paracetamol Xantis 75 mg/650 mg

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to 5 the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Tramadol/Paracetamol Xantis 75 mg/650 mg contains The active substances are tramadol hydrochloride and paracetamol. Each tablet contains 75 mg tramadol hydrochloride and 650 mg paracetamol.

The other ingredients are pregelatinised starch, povidone 25, croscarmellose sodium, microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate.

What Tramadol/Paracetamol Xantis 75 mg/650 mg looks like and contents of the pack Tramadol/Paracetamol Xantis 75 mg/650 mg are almost white oblong tablets with a break line on one side of tablet, length 18 mm. Tablet can be divided into equal doses.

Tramadol/Paracetamol Xantis 75 mg/650 mg is supplied in blisters package of 10, 20, 30, 40, 50, 60, 90 or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder XANTIS PHARMA LIMITED Lemesou 5, EUROSURE TOWER, 1st floor, Flat/Office 101 2112, Nicosia, Cyprus

Manufacturer Saneca Pharmaceuticals a.s., Nitrianska 100, 920 27 Hlohovec, Slovak Republic

This leaflet was last revised in

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