Document: leaflet MAH GENERIC_PL 30464-0170 change

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Tramadol Hydrochloride/Paracetamol 37.5mg/325mg Film-Coated Tablets

Tramadol Hydrochloride/Paracetamol

Read all of this leaflet carefully before you start taking this medicine

o Keep this leaflet. You may need to read it again. o If you have any further questions, ask your doctor or pharmacist. o 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. o 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.

Tramadol Hydrochloride/Paracetamol tablets are used to treat moderate to severe pain when you doctor recommends that a combination of paracetamol and tramadol hydrochloride is needed.

Do not take Tramadol Hydrochloride/Paracetamol film coated tablets:

•    if you are hypersensitive or have had an allergic reaction (for instance skin rash, swelling of the face, wheezing or difficulty breathing) to tramadol, paracetamol or any of the other ingredients (see section 6) in Tramadol Hydrochloride/Paracetamol tablets.

•    in cases 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 have taken MAOIs in the last 14 days before treatment with Tramadol Hydrochloride/Paracetamol tablets. MAOIs are used in the treatment of depression or Parkinson’s disease.

•    if you have a severe liver disorder

•    if you have epilepsy that is not adequately controlled by your current medicine.

Before you take Tramadol hydrochloride/Paracetamol tablets, check with your doctor or pharmacist if you:

•    take other medicines containing paracetamol or tramadol

•    have liver problems or disease as your eyes and skin may turn yellow, which may suggest jaundice

•    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 (being sick)

•    are dependent on any medicine (for example morphine)

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

•    are going to have an anaesthetic (tell your doctor or dentist that you are taking Tramadol Hydrochloride/Paracetamol tablets).

Other medicines and Tramadol hydrochloride/Paracetamol

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor will tell you which medicines are safe to take with Tramadol Hydrochloride/Paracetamol tablets.

Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines. Do not take Tramadol Hydrochloride/Paracetamol tablets with MAOIs (see section ‘Do not take Tramadol Hydrochloride/Paracetamol tablets’).

Tramadol Hydrochloride/Paracetamol tablets are not recommended with the following medicines, as it may affect how well they work:

•    carbamazepine (a medicine used to treat epilepsy or some types of pain)

•    buprenorphine, nalbuphine or pentazocine (opioid-type pain relievers).

Tramadol Hydrochloride/Paracetamol tablets may increase the risk of side effects if you also take the following medicines:

•    triptans (used for migraine) or selective serotonin re-uptake inhibitors (SSRIs, used for depression). Check with your doctor if you experience confusion, restlessness, fever, sweating, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles or diarrhoea.

•    tranquilizers, 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. Check with your doctor if you feel drowsy or feel faint.

•    antidepressants, anaesthetics, medicines that affect the state of mind, or bupropion (used to help stop smoking). The risk of having a fit may increase. Your doctor will tell you whether Tramadol Hydrochloride/Paracetamol tablets are suitable for you.

•    warfarin or phenprocoumon (for blood thinning). The effectiveness of such medicines may be altered and bleeding may occur (see section 4).

The effectiveness of Tramadol Hydrochloride/Paracetamol tablets may be altered if you also take the following medicines:

•    metoclopramide, domperidone or ondansetron (medicines used to treat nausea and vomiting/being sick)

•    cholestyramine (medicine used to reduce cholesterol in the blood)

•    ketoconazole or erythromycin (medicines used against infections).

Taking Tramadol hydrochloride/Paracetamol tablets with food and drink

Do not drink alcohol while you are taking Tramadol Hydrochloride/Paracetamol tablets, as you may feel drowsy.

Pregnancy and breast-feeding

Do not take Tramadol Hydrochloride/Paracetamol tablets while you are pregnant.

Check with your doctor if you become pregnant during treatment with Tramadol Hydrochloride/Paracetamol tablets and before taking any further tablets. Do not take Tramadol Hydrochloride/Paracetamol tablets while you are breast-feeding, as small amounts of tramadol may pass into the breast- milk.

Driving and using machines

If you feel drowsy while taking Tramadol Hydrochloride/Paracetamol tablets, do not drive, use tools or use machinery. The medicine can affect your ability to drive as it may make you sleepy or dizzy.

o Do not drive while taking this medicine until you know how it affects you. o It is an offence to drive if this medicine affects your ability to drive. o However, you would not be committing an offence if:

■    The medicine has been prescribed to treat a medical or dental problem and

■    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

■    It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Take Tramadol Hydrochloride/Paracetamol tablets as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Swallow the tablets whole with sufficient liquid. Do not break or chew the tablets.

Take Tramadol Hydrochloride/Paracetamol tablets for as short a time as possible and no longer than your doctor has told you.

Adults and adolescents over 12 years:

The recommended dosage is to start with 2 tablets, unless otherwise prescribed by your doctor. If required, further doses may be taken, as instructed by your doctor.

The shortest time between doses must be at least 6 hours. Do not take more than 8 tablets per day.

Your doctor may increase the time between doses if:

•    you are older than 75 years

•    you have kidney problems

•    you have liver problems

Children under 12 years of age:

•    not recommended

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

If you take more Tramadol hydrochloride/Paracetamol tablets than you should

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.

If you forget to take Tramadol hydrochloride/Paracetamol tablets

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 Tramadol hydrochloride/Paracetamol tablets

Generally, there will be no after-effects when treatment with Tramadol Hydrochloride/Paracetamol tablets is stopped.

Rarely, people who have been using a medicine containing tramadol may become dependent on it, making it hard to stop taking it. If you have been taking Tramadol Hydrochloride/Paracetamol tablets for some time and want to stop, contact your doctor because your body may have become used to Tramadol Hydrochloride/Paracetamol tablets.

People may:

•    feel agitated, anxious, nervous or shaky

•    be over active

•    have difficulty sleeping

•    have stomach or bowel disorders. Very few people may also get:

•    panic attacks

•    hallucinations, unusual perceptions such as itching, tingling and numbness

•    ringing in the ears.

If you experience any of these complaints after stopping Tramadol Hydrochloride/Paracetamol tablets, please contact your doctor. Other side effect information is listed in section 4.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Tramadol Hydrochloride/Paracetamol tablets can cause side effects, however not everybody gets them.

Some side effects could be serious. Contact your doctor immediately if any of the following occur:

•    rarely cases of 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. Do not take the medicine again.

•    prolonged or unexpected bleeding, from the use of Tramadol Hydrochloride/Paracetamol tablets with medicines used to thin the blood(e.g. warfarin, phenprocoumon).

Additionally, if any of the following side effects get serious, contact your doctor or pharmacist:

Very common side effects (affecting more than 1 in 10 people treated)

•    nausea

•    dizziness, drowsiness.

Common side effects (affecting less than 1 in 10, but more than 1 in 100 people treated)

•    vomiting (being sick), digestion problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth

•    itching, sweating

•    headache, shaking

•    confusion, sleep disorders, mood changes (anxiety, nervousness, feeling of high spirits).

Uncommon side effects (affecting less than 1 in 100, but more than 1 in 1,000 people treated)

•    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 ears, 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.

Rare side effects (affecting less than 1 in 1,000, but more than 1 in 10,000 people treated)

•    fits, uncoordinated movements

•    addiction

•    blurred vision

•    transient loss of consciousness (syncope).

Unknown frequency:

•    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

•    nose bleeds or bleeding gums, which may result from a low blood platelet count. 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 yellow card scheme at www. mhra. gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

Do not use Tramadol Hydrochloride/Paracetamol tablets after the expiry date which is printed on the carton and blister. 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 waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Tramadol hydrochloride/Paracetamol tablets contain

The active substances are tramadol hydrochloride and paracetamol.

One (1) tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol. The other ingredients are:

Pregelatinised starch

Sodium starch glycolate (Type A)

Cellulose Microcrystalline Magnesium Stearate Hypromellose Titanium dioxide Macrogol 400 Yellow Iron oxide Polysorbate 80

What Tramadol hydrochloride/Paracetamol tablets looks like and contents of the pack

Tramadol Hydrochloride/Paracetamol tablets are pale yellow, film-coated tablets, marked with “325” on one side and ’37.5’ on the other side.

Tramadol Hydrochloride/Paracetamol tablets are packed in blister strips. Tramadol Hydrochloride/Paracetamol tablets comes in cartons of 60 Tablets

Marketing Authorisation Holder

Athlone Pharmaceuticals Limited,

Ballymurray,

Co. Roscommon,

Ireland

Manufacturer:

Kent Pharmaceuticals Limited, Unit 200, Westminster 42, Westminster Industrial Estate, Repton Road, Measham, Swadlincote, DE 12 7DT, U.K.

&

Kent Pharmaceuticals Limited

Joshna House, Crowbridge Road, Orbital Park, Ashford, Kent, TN24 0GR, U.K.

This Leaflet was last revised in: April 2016 PL 30464/0170

UK: Tramadol Hydrochloride/Paracetamol 37.5mg/325mg Film-Coated Tablets Ireland: Tramadol Hydrochloride/Paracetamol 37.5mg/325mg Film-Coated Tablets