Package leaflet: Information for the user

Paracetamol/Tramadol Hydrochloride 325 mg/37.5 mg film-coated tablets

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 Paracetamol/Tramadol is and what it is used for

2.    What you need to know before you take Paracetamol/Tramadol

3.    How to take Paracetamol/Tramadol

4.    Possible side effects

5.    How to store Paracetamol/Tramadol

6.    Contents of the pack and other information

1.    What Paracetamol/Tramadol is and what it is used for

Paracetamol/Tramadol contains a combination of the active substances paracetamol and tramadol hydrochloride, which belongs to a group of medicines used to treat pain.

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

2.    What you need to know before you take Paracetamol/ Tramadol

Do not take Paracetamol/Tramadol

•    if you are allergic 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 of this medicine (listed in section 6)

•    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 Paracetamol/Tramadol. 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Paracetamol/Tramadol. Your doctor needs to know before you take Paracetamol/Tramadol if you have or have had any of the following conditions:

•    taking 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 Paracetamol/Tramadol).

Adolescents and adults 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 and adolescents

This medicine is not recommended in children and adolescents under 12 years of age.

Other medicines and Paracetamol/Tramadol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor will tell you which medicines are safe to take with Paracetamol/Tramadol.

Do not exceed the maximum daily doses of paracetamol or tramadol from this or other medicines.

Do not take Paracetamol/Tramadol with MAOIs (see section 'Do not take Paracetamol/Tramadol').

Paracetamol/Tramadol is 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). Paracetamol/Tramadol 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 Paracetamol/ Tramadol is 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 Paracetamol/Tramadol 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). Paracetamol/Tramadol with food, drink and alcohol

Do not drink alcohol or alcoholic drinks or medicinal products containing alcohol while you are taking Paracetamol/Tramadol, as you may feel drowsy. Paracetamol/Tramadol can be taken with food.

Pregnancy, breast-feeding and fertility 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.

Do not take Paracetamol/Tramadol while you are pregnant. Check with your doctor if you become pregnant during treatment with Paracetamol/Tramadol and before taking any further tablets.

Do not take Paracetamol/Tramadol 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 Paracetamol/Tramadol, do not drive, use tools or use machinery.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you.

•    It is an offence to drive if this medicine affects your ability to drive.

•    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.

Client:	Somex Pharma,
Leaflet:	PIL Paracetamol Tramadol Hydrochloride 325mg 37.5mg film-coated tablets 180x330 (v2).indd
Color:	Black	Dimemsions: 180 x 330 mm
Font:	Helvetica Neue LT 9 pt	Title: 22 pt Subtitle: 9 pt
Leading:	3,81 mm	(10.8 pt) Page: 1

3.    How to take Paracetamol/Tramadol

Always take this medicine exactly as your doctor or pharmacist 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 Paracetamol/Tramadol for as short a time as possible and no longer than your doctor has told you.

Use in adolescents and adults 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.

If you think that the effect of Paracetamol/Tramadol 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 Paracetamol/Tramadol than you should

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

If you forget to take Paracetamol/Tramadol

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 Paracetamol/Tramadol

Generally, there will be no after-effects when treatment with Paracetamol/Tramadol 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 Paracetamol/Tramadol for some time and want to stop, contact your doctor because your body may have become used to Paracetamol/Tramadol.

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 Paracetamol/ Tramadol, please contact your doctor. Other side effect information is listed in section 4.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although 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 Paracetamol/ Tramadol 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 (may affect more than 1 in 10 people)

•    nausea

•    dizziness, drowsiness.

Common (may affect up to 1 in 10 people)

•    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 (may affect up to 1 in 100 people)

•    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 (may affect up to 1 in 1,000people)

•    fits, uncoordinated movements

•    addiction

•    blurred vision

•    transient loss of consciousness (syncope).

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

•    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. Website: www. mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Paracetamol/Tramadol

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

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

This medicinal product does not require any special storage conditions. Store in the original package.

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 Paracetamol/Tramadol contains

The active substances are paracetamol and tramadol hydrochloride. Each film-coated tablet contains 325mg paracetamol and 37.5mg tramadol hydrochloride.

The other ingredients are: Tablet core: microcrystalline cellulose, pregelatinised starch maize starch, sodium starch glycolate, magnesium stearate. Film-coating: hypromellose, titanium dioxide (E171), macrogol, yellow iron oxide (E172), polysorbate 80.

What Paracetamol/Tramadol looks like and contents of the pack

Pale yellow colour capsule shaped biconvex film-coated tablets with engraved "SP” on one side and plain on other side.

They come in PVC/PVDC blister packs with Glassine paper (35 GSM) soft/ temper printed aluminium foil of 10 tablets.

Marketing Authorisation Holder

Somex Pharma

Ilford, Essex

IG3 8BS.UK

Manufacturer

Somex Pharma

Ilford, Essex

IG3 8RA.UK

This leaflet was last revised in

09/2016

Client:	Somex Pharma,
Leaflet:	PIL Paracetamol Tramadol Hydrochloride 325mg 37.5mg film-coated tablets 180x330 (v2).indd
Color:	Black	Dimemsions: 180 x 330 mm
Font:	Helvetica Neue LT 9 pt	Title: 22 pt Subtitle: 9 pt
Leading:	3,81 mm	(10.8 pt) Page: 2