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

[Product name] is a combination of two analgesics, tramadol and paracetamol, which act together to relieve your pain.

[Product name] is intended for use in the treatment of moderate to severe pain when your doctor recommends that a combination of tramadol and paracetamol is needed.

[Product name] should only be taken by adults and adolescents over 12 years.

Do not take [Product name]

• if you have had an allergic reaction (for instance skin rash, swelling of the face, wheezing or difficulty breathing) after taking tramadol or paracetamol or any of the other ingredients in [Product name];
• 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 or Parkinson’s disease) or have taken them in the last 14 days before treatment with [Product name];
• if you suffer from a severe liver disease;
• if you have epilepsy that is not adequately controlled on your current medicine.

Warnings and precautions

Talk to your doctor or pharmacist

• if you take other medicines containing paracetamol or tramadol;
• if you 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;
• if you have kidney problems;
• if you have severe difficulties in breathing for example asthma 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 headaches associated with vomiting;
• if you are dependent on any medicines including those used to relieve pain, for example morphine;
• if you take other medicines to treat pain that contain buprenorphine, nalbuphine or pentazocine;
• if you are going to have an anaesthetic. Tell your doctor or dentist that you are taking [Product name].

If any of the above-mentioned points applied to you in the past or applies to you while you are taking [Product name], please make sure your doctor knows. He/she can then decide whether you should continue to use this medicine.

Other medicines and [Product name]

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.

You must not take [Product name] together with monoamine oxidase inhibitors (“MAOIs”) (see section “Do not take [Product name] ”).

[Product name] 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 are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk having a fit may increase if you take [Product name] at the same time. Your doctor will tell you whether [Product name] is suitable for you.
• if you are taking certain antidepressants. [Product name] 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.

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

• 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.
• anaesthetics, neuroleptics (medicines that affect the state of mind) or bupropion (to help stop smoking). The risk of having a fit may increase. Your doctor will tell you whether [Product name] is suitable for you.
• warfarin or phenprocoumon (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 [Product name] 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).

Your doctor will tell you which medicines are safe to take with [Product name].

[Product name] with food, drink and alcohol

[Product name] may make you feel drowsy. Alcohol may make you feel more drowsy, so it is best not to drink alcohol while you are taking [Product name].

Pregnancy, breast-feeding and fertility

As this medicine contains tramadol, you should not take this medicine during pregnancy. If you become pregnant during treatment with [Product name], please consult your doctor before taking any further tablets.

Small amounts of tramadol may pass into the breast-milk. Therefore you should not take this medicine during 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 any medicine.

Driving and using machines

[Product name] may make you feel drowsy and this may affect your ability to drive, or use tools and machines, safely.

Always take [Product name] exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

You should take [Product name] for as short a time as possible.

Unless otherwise prescribed by your doctor, the usual starting dose for adults and adolescents over 12 years 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.

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.

Do not take more than 8 [Product name] film-coated tablets per day.

Do not take [Product name] more often than your doctor has told you.

Use in children

The use in children below the age of 12 years is not recommended.

Elderly patients

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

Severe liver or kidney disease (insufficiency)/dialysis patients

Patients with severe liver and/or kidney insufficiency should not take [Product name]. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

Method of administration: The tablets are for oral use.

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

If you think that the effect of [Product name] is too strong (i.e. you feel very drowsy or have difficulty breathing) or too weak (i.e. you have inadequate pain relief), contact your doctor.

If you take more [Product name] than you should

In such cases please contact your doctor or pharmacist immediately even if you feel well. There is a risk of liver damage which may only show later.

If you forget to take [Product name]

If you forget to take the tablets, pain is likely to return. Do not take a double dose to make up for forgotten individual doses, simply continue taking the tablets as before.

If you stop taking [Product name]

Generally there will be no after-effects when treatment with [Product name] is stopped. However, on rare occasions, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly (see section 4. “Possible Side Effects”). If you have been taking [Product name] for some time, you should talk to your doctor if you want to stop because your body may have become used to it.

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

Like all medicines, [Product name] can cause side effects, although not everybody gets them.

The following side effects have been reported at the approximate frequencies shown: very common: affects more than 1 user in 10

common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000

very rare: affects less than 1 user in 10,000

not known: frequency cannot be estimated from the available data

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 not really there), memory lapses,
• difficulty swallowing, blood in the stools,
• shivering, hot flushes, pain in the chest,
• difficulty breathing,
• increase in liver enzimes (hepatic transaminases).

Rare:

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

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 [Product name], you should tell your doctor:

• 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 [Product name], 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 [Product name] 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 sight and reach of children.

Do not use [Product name] after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.

Discard the bottle 50 days after first opening

This medicinal product does not require any special storage conditions.

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 to protect the environment.

What [Product name] contains

• The active substances are tramadol hydrochloride and paracetamol. Each film-coated tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol.
• The other ingredients are: tablet core: kollicoat IR coating [Macrogol poly(vinyl alcohol) grafted copolymer], pregelatinised maize starch, cellulose microcrystalline, sodium starch glycolate (type A), Hyprolose, magnesium stearate; film-coating: opadry II beige 85F97409:

polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).

What [Product name] looks like and contents of the pack

[Product name] film-coated tablets are peach coulored, capsule shaped, engraved with T37.5 on one side and A325 on the other side.

[Product name] comes in cartons with blister packs of 2, 10, 15, 20, 30, 40, 60 and 90 tablets and bottles with 10 tablets and 100 tablets.

Not all pack sizes may be marketed.

In het register ingeschreven onder nummer

RVG 111920

Marketing Authorisation Holder and Manufacturer

Vergunninghouder

Ratiopharm Nederland B.V.

Swensweg 5

2031 GA Haarlem

Nederland

Fabrikanten

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hongarije

Teva UK Ltd

Brampton Road, Hampden Park, Eastbourne, East

Sussex, B N22 9AG

Verenigd Koninkrijk

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Nederland

Teva Santé SA

Rue Bellocier, 89107 Sens

Frankrijk

Teva Czech Industries s.r.o.

Ostravska 29/305, 747 70 Opava-Komarov

Tsjechië

Teva Pharma, S.L.U.

C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza

Spanje

PLIVA Ljubljana d.o.o.

Pot k sejmišču 35, 1231 Ljubljana

Slovenië

Teva Operations Poland Sp.z.o.o.

Mogilska 80, 31-546 Krakow

Polen

Teva Operations Poland Sp.z.o.o.

Ul. Sienkeiwicza 25, 99-300 Kutno

Polen

This medicinal product is authorised in the Member States of the EEA under the following names: France: TRAMADOL/PARACETAMOL Ratiopharm TRAMADOL/PARACETAMOL PHR Lab TRAMADOL/PARACETAMOL TEVA Santé

Hungary: PANCONTRA 37,5 mg/325 mg filmtabletta

Iceland: Tramadol/Paracetamol Teva Pharma Tramadol/Paracetamol Teva Pharma B.V. Tramadol/Paracetamol Teva Pharmaceuticals

Netherlands: Tramadol HCl/Paracetamol 37,5/325 mg ratiopharm

This leaflet was last revised in april 2013

[To be completed nationally]